UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of November, 2023

Commission file number: 001-37891

AC IMMUNE SA

(Exact Name of Registrant as Specified in Its Charter)

EPFL Innovation Park

Building B

1015 Lausanne, Switzerland

(Address of Principal Executive Offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F      Form 40-F


This Report on Form 6-K (other than Exhibit 99.3 hereto) shall be deemed to be incorporated by reference into the registration statements on Form F-3 (File No. 333- 255576, File No. 333-227016 and File No. 333-249655) and Form S-8 (File No. 333-233019) of AC Immune SA and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

AC IMMUNE SA

By:

/s/ Andrea Pfeifer

Name:  Andrea Pfeifer

Title:    Chief Executive Officer

By:

/s/ Christopher Roberts

Name:  Christopher Roberts

Title:    Vice President, Finance and Interim Chief Financial Officer

Date:     November 3, 2023


EXHIBIT INDEX

Exhibit
Number

    

Description

99.1

Interim Condensed Consolidated Financial Statements (Unaudited) (IFRS) as of and for the three and nine months ended September 30, 2023

99.2

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

99.3

Press Release dated November 3, 2023


Exhibit 99.1

Condensed Consolidated Balance Sheets (Unaudited)

(In CHF thousands)

As of

September 30, 

December 31, 

    

Note

    

2023

    

2022

Assets

 

  

 

  

 

  

Non-current assets

 

  

 

  

 

  

Property, plant and equipment

 

5

 

3,627

 

4,259

Right-of-use assets

 

6

 

2,403

 

2,808

Intangible asset

 

9

 

50,416

 

50,416

Long-term financial assets

 

6

 

361

 

361

Total non-current assets

 

56,807

 

57,844

Current assets

 

 

Prepaid expenses

 

10

 

5,534

 

4,708

Accrued income

 

3

 

312

 

408

Other current receivables

 

 

406

 

392

Short-term financial assets

 

11

 

48,000

 

91,000

Cash and cash equivalents

 

11

 

31,927

 

31,586

Total current assets

 

86,179

 

128,094

Total assets

 

142,986

 

185,938

Shareholders' equity and liabilities

 

 

Shareholders’ equity

 

 

Share capital

 

 

1,802

 

1,797

Share premium

 

 

434,451

 

431,323

Treasury shares

 

12

 

(106)

 

(124)

Currency translation differences

5

10

Accumulated losses

 

(310,488)

 

(264,015)

Total shareholders’ equity

 

125,664

 

168,991

Non-current liabilities

 

 

Long-term lease liabilities

 

6

 

1,838

 

2,253

Net employee defined benefit liabilities

 

7

 

3,774

 

3,213

Total non-current liabilities

 

5,612

 

5,466

Current liabilities

 

 

Trade and other payables

 

 

1,479

 

929

Accrued expenses

 

8

 

9,338

 

9,417

Deferred income

 

3

 

338

 

587

Short-term lease liabilities

 

6

 

555

 

548

Total current liabilities

 

11,710

 

11,481

Total liabilities

 

17,322

 

16,947

Total shareholders’ equity and liabilities

 

142,986

 

185,938

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

For the Nine Months

Ended September 30, 

Ended September 30, 

Note

2023

2022

2023

2022

Revenue

    

  

    

  

    

  

    

  

    

  

Contract revenue

 

3

 

 

3,934

 

 

3,934

Total revenue

 

 

3,934

 

 

3,934

 

 

 

 

Operating expenses

 

 

 

 

Research & development expenses

 

 

(12,407)

 

(14,385)

 

(39,962)

 

(45,200)

General & administrative expenses

 

 

(3,465)

 

(3,274)

 

(11,252)

 

(11,828)

Other operating income/(expense), net

 

3

 

406

 

262

 

1,131

 

944

Total operating expenses

 

(15,466)

 

(17,397)

 

(50,083)

 

(56,084)

Operating loss

 

(15,466)

 

(13,463)

 

(50,083)

 

(52,150)

Financial income

 

 

285

 

11

 

753

 

11

Financial expense

 

 

(26)

 

(77)

 

(150)

 

(356)

Exchange differences

 

 

67

 

17

 

 

502

Finance result, net

 

326

 

(49)

 

603

 

157

Loss before tax

 

(15,140)

 

(13,512)

 

(49,480)

 

(51,993)

Income tax expense

 

 

(3)

 

(4)

 

(9)

 

(11)

Loss for the period

 

(15,143)

 

(13,516)

 

(49,489)

 

(52,004)

Loss per share:

4

 

 

 

 

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

 

 

(0.18)

 

(0.16)

 

(0.59)

 

(0.62)

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

(In CHF thousands)

For the Three Months

For the Nine Months

Ended September 30, 

Ended September 30, 

    

Note

    

2023

    

2022

    

2023

    

2022

Loss for the period

 

(15,143)

 

(13,516)

 

(49,489)

 

(52,004)

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

 

 

 

 

Currency translation differences

 

11

 

23

 

(5)

 

72

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

 

 

 

 

Remeasurement gains on defined-benefit plans

 

 

 

178

 

 

7,559

Total comprehensive loss (net of tax)

 

(15,132)

 

(13,315)

 

(49,494)

 

(44,373)

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, 2022

1,794

431,251

(124)

(200,942)

231,979

Net loss for the period

(52,004)

(52,004)

Other comprehensive income

 

 

 

 

 

7,559

 

72

 

7,631

Total comprehensive income/(loss)

 

 

 

 

 

(44,445)

 

72

 

(44,373)

 

 

 

Share-based payments

 

 

 

 

2,441

 

 

2,441

Issuance of shares, net of transaction costs:

 

 

  

 

  

 

  

 

  

 

  

 

  

restricted share awards

 

 

 

48

 

 

(48)

 

 

exercise of options

 

 

3

 

4

 

 

 

 

7

Balance as of September 30, 2022

 

 

1,797

 

431,303

 

(124)

 

(242,994)

 

72

 

190,054

    

    

    

    

    

    

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

 

 

 

 

(49,489)

 

 

(49,489)

Other comprehensive loss

 

 

 

 

 

 

(5)

 

(5)

Total comprehensive loss

 

 

 

 

(49,489)

 

(5)

 

(49,494)

 

 

Share-based payments

 

 

 

 

3,568

 

 

3,568

Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs

12

2,522

18

2,540

Issuance of shares, net of transaction costs:

 

 

 

  

 

 

 

restricted share awards

 

4

 

548

 

 

(552)

 

 

exercise of options

 

1

 

58

 

 

 

 

59

Balance as of September 30, 2023

 

1,802

 

434,451

 

(106)

 

(310,488)

 

5

 

125,664

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 Nine Months

Ended September 30, 

Note

2023

2022

Operating activities

    

  

    

  

    

  

    

Loss for the period

 

(49,489)

 

(52,004)

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

 

 

Depreciation of property, plant and equipment

 

5

 

1,255

 

1,331

 

Depreciation of right-of-use assets

 

6

 

405

 

423

 

Finance (income), net

 

 

(369)

 

(743)

 

Share-based compensation expense

 

 

3,568

 

2,441

 

Change in net employee defined benefit liability

 

7

 

561

 

461

 

Interest expense

 

 

151

 

349

 

Changes in working capital:

 

  

 

  

(Increase) in prepaid expenses

 

10

 

(841)

 

(165)

 

Decrease in accrued income

 

3

 

96

 

940

 

(Increase) in other current receivables

 

 

(14)

 

(3,802)

 

(Decrease) in accrued expenses

 

8

 

(98)

 

(4,440)

 

(Decrease) in deferred income

 

3

 

(249)

 

(207)

 

Increase / (decrease) in trade and other payables

 

 

567

 

(372)

 

Cash used in operating activities

 

(44,457)

 

(55,788)

Interest received

 

 

391

 

11

 

Interest paid

 

 

(142)

 

(376)

 

Finance expenses paid

 

 

(9)

 

(8)

 

Net cash flows used in operating activities

 

(44,217)

 

(56,161)

 

  

 

  

Investing activities

 

  

 

  

Short-term financial assets, net

 

11

 

43,000

 

20,000

 

Purchases of property, plant and equipment

 

5

 

(635)

 

(1,198)

 

Rental deposits

 

6

 

 

2

 

Net cash flows provided by investing activities

 

42,365

 

18,804

 

  

 

  

Financing activities

 

  

 

  

Principal payments of lease obligations

 

6

 

(409)

 

(426)

 

Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs

12

2,571

Transaction costs associated with issuance of shares in relation to asset acquisition previously recorded in Accrued expenses

(776)

Proceeds from issuance of common shares, net of transaction costs

60

7

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

 

2,222

 

(1,195)

 

  

 

  

Net increase/(decrease) in cash and cash equivalents

 

370

 

(38,552)

Cash and cash equivalents at January 1

 

31,586

 

82,216

Exchange (loss)/gain on cash and cash equivalents

 

(29)

 

839

Cash and cash equivalents at September 30

 

31,927

 

44,503

Net increase/(decrease) in cash and cash equivalents

 

370

 

(38,552)

Supplemental non-cash activity

 

  

 

  

Capital expenditures in Trade and other payables or Accrued expenses

 

5

 

 

7

 

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

 

12

 

31

 

 

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 and nine months ended September 30, 2023 were authorized for issuance by the Company’s Audit and Finance Committee on November 2, 2023.

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

Statement of compliance

These Interim Condensed Consolidated Financial Statements as of September 30, 2023 and for the three and nine months ended September 30, 2023 and 2022, 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, 2022.

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 US 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 September 30, 

Nine Months Ended September 30, 

Year Ended December 31,

2023

    

2022

2023

    

2022

2022

CHF/USD

 

  

 

  

 

  

 

  

 

  

Closing rate, USD 1

 

0.924

 

0.985

 

0.924

 

0.985

 

0.933

Weighted average exchange rate, USD 1

 

0.892

 

0.976

 

0.911

 

0.962

 

0.965

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) clinical development accruals, (ii) net employee defined benefit liability, (iii) share-based compensation, (iv) right-of-use assets, short-term lease liabilities and long-term lease liabilities and (v) our IPR&D 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 and long-term financial assets, cash and cash equivalents, trade and other payables, accrued expenses, short-term lease liabilities and long-term 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, 2022.

There are no new IFRS standards, amendments or interpretations that are mandatory as of January 1, 2023 that are relevant to the Company. Additionally, the Company has not adopted any standard, interpretation or amendment that has been issued but is not yet effective. Such standards are not currently expected to have a material impact on the entity in the current or future reporting periods and on foreseeable future transactions.

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 31.9 million and short-term financial assets of CHF 48.0 million as of September 30, 2023. 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 Licensing and Collaboration Agreements (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 revenues and other operating income

For the three and nine months ended September 30, 2023, AC Immune generated no contract revenues in comparison to CHF 3.9 million in contract revenues in the prior comparable period.

For the Three Months

Ended September 30,

in CHF thousands

    

2023

    

2022

Life Molecular Imaging

 

3,934

Total contract revenue

 

 

3,934

For the Nine Months

Ended September 30,

in CHF thousands

    

2023

    

2022

Life Molecular Imaging

 

 

3,934

Total contract revenue

 

 

3,934

3.1Licensing and collaboration agreements

For a discussion of our licensing and collaboration agreements for the fiscal year ended December 31, 2022, please refer to Note 13.1 “Licensing and Collaboration agreements” of our Annual Report on Form 20-F for the year ended December 31, 2022 filed on March 16, 2023.

During the three and nine months ended September 30, 2023 and 2022, the Company recognized the following contract revenues as a result of performance obligations satisfied in previous periods:

For the Three Months

Ended September 30,

in CHF thousands

    

2023

    

2022

Revenue recognized in the period from:

 

    

 

  

Amounts included in the contract liability at the beginning of the period

 

 

Performance obligations satisfied in previous periods

 

 

3,934

For the Nine Months

Ended September 30,

in CHF thousands

    

2023

    

2022

Revenue recognized in the period from:

 

  

 

  

Amounts included in the contract liability at the beginning of the period

 

 

Performance obligations satisfied in previous periods

 

 

3,934

As it relates to revenue recognition, there have been no significant events or transactions associated with our license and collaboration agreements that have occurred for the three and nine months ended September 30, 2023. In September 2022, the Company earned a milestone linked to the progression of the Tau PET Tracer PI-2620 partnered with Life Molecular Imaging (LMI) into late-stage development in Alzheimer’s disease. The Company recorded EUR 4 (CHF 3.9) million in contract revenue for the three and nine months ended September 30, 2022 as a result of achieving this milestone.

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, 2022, please refer to Note 13.2 “Grant Income” of our Annual Report on Form 20-F for the year ended December 31, 2022 filed on March 16, 2023.

7


In August 2022, the Company received follow-on grant funding as part of its joint arrangement with Skåne University Hospital (Skåne) in Sweden totaling USD 0.5 (CHF 0.5) million for the continued development of its alpha-synuclein PET imaging diagnostic agent. As part of this grant, AC Immune received USD 0.4 (CHF 0.4) million directly from the MJFF. Skåne will receive USD 0.1 (CHF 0.1) million of the total grant directly from the MJFF duration of the grant period.

In February 2023, the Company was awarded a new grant from the MJFF totaling USD 0.5 (CHF 0.5) million to support the development of its TDP-43 PET tracer program.

For the three months ended September 30, 2023 and 2022, the Company has recognized CHF 0.3 million and CHF 0.2 million in grant income under other operating income/(expense), net, respectively. For the nine months ended September 30, 2023 and 2022, the Company has recognized CHF 1.0 million and CHF 0.8 million in grant income, respectively. As of September 30, 2023, the Company has recorded CHF 0.3 million in deferred income.

4.Loss per share

    

For the Three Months

Ended September 30, 

In CHF thousands except for share and per share data

    

2023

    

2022

Loss per share (EPS)

 

  

 

  

Numerator

 

  

 

  

Net loss attributable to equity holders of the Company

 

(15,143)

 

(13,516)

Denominator

 

  

 

  

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

 

84,715,515

 

83,590,948

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

 

(0.18)

 

(0.16)

For the Nine Months

Ended September 30, 

In CHF thousands except for share and per share data

    

2023

2022

Loss per share (EPS)

  

    

  

Numerator

  

 

  

Net loss attributable to equity holders of the Company

(49,489)

 

(52,004)

Denominator

 

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

84,012,166

 

83,537,655

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

(0.59)

 

(0.62)

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 September 30, 

    

2023

    

2022

Share options issued and outstanding

 

1,350,738

 

97,875

Restricted share awards subject to future vesting

 

1,166,173

 

240,923

For the Nine Months

Ended September 30, 

2023

2022

Share options issued and outstanding

    

97,875

    

148,617

Restricted share awards subject to future vesting

 

1,205,291

 

85,829

8


5.Property, plant and equipment

The following table shows the movement in the net book values of property, plant and equipment for the nine months ended September 30, 2023:

    

As of September 30, 2023

    

IT

    

Lab

    

Leasehold

    

Assets under

    

In CHF thousands

Furniture

equipment

equipment

improvements

construction

Total

Acquisition cost:

 

  

 

  

 

  

 

  

 

  

 

  

Balance at December 31, 2022

 

285

 

1,909

 

9,765

 

1,640

 

3

 

13,602

Additions

 

6

 

232

 

392

 

 

5

 

635

Disposals

(19)

(12)

(31)

Transfers

 

 

 

 

3

 

(3)

 

Balance at September 30, 2023

 

291

 

2,122

 

10,157

 

1,631

 

5

 

14,206

Accumulated depreciation:

 

 

 

 

 

 

Balance at December 31, 2022

 

(159)

 

(1,599)

 

(7,017)

 

(568)

 

 

(9,343)

Depreciation expense

 

(41)

 

(205)

 

(812)

 

(197)

 

 

(1,255)

Disposals

 

19

19

Balance at September 30, 2023

 

(200)

 

(1,785)

 

(7,829)

 

(765)

 

 

(10,579)

Carrying amount:

 

 

  

 

  

 

  

 

  

 

  

December 31, 2022

 

126

 

310

 

2,748

 

1,072

 

3

 

4,259

September 30, 2023

 

91

 

337

 

2,328

 

866

 

5

 

3,627

AC Immune continues to enhance its laboratory equipment to support its R&D functions and continues to invest in its IT infrastructure. This effort has continued since the year ended December 31, 2022, with CHF 0.6 million invested in lab equipment, including the expansion of our leased lab space, and IT equipment, representing an increase of 5.3% from the beginning of the year in these categories.

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

AC Immune recognized no additions for its right-of-use leased assets for the nine months ended September 30, 2023.

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 nine months ended September 30, 2023:

    

    

Office

    

IT

    

In CHF thousands

Buildings

equipment

equipment

Total

Balance as of December 31, 2022

 

2,708

 

74

 

26

 

2,808

Depreciation

 

(376)

 

(18)

 

(11)

 

(405)

Balance as of September 30, 2023

 

2,332

 

56

 

15

 

2,403

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.

9


For the three and nine months ended September 30, 2023, and 2022, 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 September 30, 

In CHF thousands

    

2023

    

2022

Statements of income/(loss)

 

  

 

  

Depreciation of right-of-use assets

 

136

 

142

Interest expense on lease liabilities

 

22

 

17

Expense for short-term leases and leases of low value

 

109

 

212

Total

 

267

 

371

Statements of cash flows

 

 

  

Total cash outflow for leases

 

268

 

371

For the Nine Months

Ended September 30, 

In CHF thousands

    

2023

    

2022

Statements of income/(loss)

 

  

 

  

Depreciation of right-of-use assets

 

405

 

423

Interest expense on lease liabilities

 

69

 

53

Expense for short-term leases and leases of low value

 

596

 

559

Total

 

1,070

 

1,035

Statements of cash flows

 

 

  

Total cash outflow for leases

 

1,075

 

1,037

The following table presents the contractual undiscounted cash flows for lease obligations as of September 30, 2023:

As of

In CHF thousands

    

September 30, 2023

Less than one year

 

630

1-3 years

 

1,207

3-5 years

 

739

Total

 

2,576

The Company also has deposits in escrow accounts totaling CHF 0.4 million for leases of the Company’s premises as of both September 30, 2023 and December 31, 2022, respectively. These deposits are presented in Long-term financial assets on the Company’s condensed consolidated balance sheets.

7.Net employee defined benefit liabilities

For the nine months ended September 30, 2023, the Company recorded CHF 0.6 million in service cost in the condensed consolidated statements of income/(loss), which includes current service costs and service costs related to the impact of a plan amendment effected in 2023.

8.Accrued expenses

Accrued expenses consist of accrued R&D costs, accrued payroll expenses and other accrued expenses totaling CHF 9.3 million and CHF 9.4 million as of September 30, 2023 and December 31, 2022, respectively.

10


9.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 September 30, 2023

As of December 31, 2022

    

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 December 31, 2022. As of September 30, 2023, the Company did not identify any triggering events that could result in an impairment of the IPR&D asset.

10.Prepaid expenses

Prepaid expenses include prepaid R&D and administrative costs totaling CHF 5.5 million and CHF 4.7 million as of September 30, 2023 and December 31, 2022, respectively.

11.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 September 30, 2023 and December 31, 2022:

    

As of

In CHF thousands

September 30, 2023

    

December 31, 2022

Cash and cash equivalents

 

31,927

 

31,586

Total cash and cash equivalents

 

31,927

 

31,586

    

As of

In CHF thousands

September 30, 2023

    

December 31, 2022

Short-term financial assets due in one year or less

 

48,000

 

91,000

Total short-term financial assets

 

48,000

 

91,000

For the nine months ended September 30, 2023, the net proceeds associated with the maturity of investments in short-term financial assets amounted to CHF 43.0 million, compared to CHF 20.0 million in the prior comparable period.

11


12.Treasury shares

For a discussion of our at the market offering program with Jefferies LLC for the fiscal year ended December 31, 2022, please refer to Note 11 “Share capital” of our Annual Report on Form 20-F for the year ended December 31, 2022 filed on March 16, 2023.

In Q2 2023, the Company sold 712,993 common shares previously held as treasury shares pursuant to the Sales Agreement, raising USD 2.3 (CHF 2.1) million, net of underwriting fees.

In Q3 2023, the Company sold 205,015 common shares previously held as treasury shares pursuant to the Sales Agreement, raising USD 0.6 (CHF 0.6) million, net of underwriting fees.

As of September 30, 2023 and December 31, 2022, the Company had 5,296,013 and 6,214,021 treasury shares remaining, respectively.

13.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. The Company has determined that there were no other such events that warrant disclosure or recognition in these Interim Condensed Consolidated Financial Statements.

12


Exhibit 99.2

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited interim condensed consolidated financial information as of and for the three and nine months ended September 30, 2023, included as Exhibit 99.1 to this Report on Form 6-K. We also recommend that you read our management’s discussion and analysis and our audited consolidated financial statements and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2022 on file with the U.S. Securities and Exchange Commission (the “SEC”).

Unless otherwise indicated or the context otherwise requires, the terms “Company,” “AC Immune,” “ACIU,” “we,” “our,” “ours,” or “us” refer to AC Immune SA together with its fully-owned subsidiary, AC Immune USA, Inc.

We prepare and report our consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). None of our consolidated financial statements were prepared in accordance with generally accepted accounting principles in the United States. We maintain our books and records in Swiss Francs (CHF). We have made rounding adjustments to some of the figures included in this management’s discussion and analysis. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that precede them. Unless otherwise indicated, all references to currency amounts in this discussion and analysis are in Swiss Francs.

This discussion and analysis is dated as of November 3, 2023.

Business Overview

Our goal is to continue leveraging our proprietary discovery platforms, SupraAntigen and Morphomer, to shift the treatment paradigm for neurodegenerative diseases towards Precision Medicine and disease prevention. We are executing a clear business strategy built on three pillars: (i) accelerate development of novel therapeutics in Alzheimer’s disease (AD) with our partners; (ii) expand our strategic interests to address Parkinson’s disease (PD) and non-AD neurodegenerative diseases, including NeuroOrphan indications, such as amyotrophic lateral sclerosis (ALS) and limbic-predominant age-related TDP-43 encephalopathy (LATE); and (iii) a continued focus on diagnostics enabling Precision Medicine to be an ultimate differentiator for the Company.

Our three-pillar execution strategy reflects our unique Precision Medicine approach, which ultimately creates differentiation due to our ability to address the high levels of co-pathologies present in AD and other neurodegenerative diseases. Much like cancer, neurodegenerative diseases are heterogeneous and may require multiple therapeutic interventions tailored to patients’ specific disease drivers, potentially to be used in combination in order to slow or stop the disease course. Ultimately, it is our belief that Precision Medicine will increase the chance of treatment success by enabling clinical trial participants to be better defined by their various proteinopathies, allowing for treatment with the right therapies at the right time.

Leveraging our dual proprietary technology platforms, SupraAntigen and Morphomer, we have built a comprehensive pipeline of first-in-class or best-in-class candidates spanning multiple treatment modalities and targeting both established and emerging neurodegenerative pathologies. We are currently advancing 16 therapeutic and diagnostic programs, including one Phase 3 program and five Phase 2 programs, targeting different types of misfolded pathological proteins related to AD, PD and other neurodegenerative disorders. Our pipeline assets are further validated by the multiple partnerships we have established with leading global pharmaceutical companies. We believe our clinically validated technology platforms and multi-target, multimodal approaches position AC Immune to revolutionize the treatment paradigm for neurodegenerative diseases by shifting it towards Precision Medicine and disease prevention based on an active immunotherapy approach.


Our clinical-stage product candidates include:

ACI-35.030. AC Immune and Janssen Pharmaceuticals, Inc. (Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson, have evaluated the anti-phosphorylated-Tau (anti-pTau) active immunotherapy ACI-35.030 in a Phase 1b/2a study in subjects with early AD (NCT04445831). Interim results showed that ACI-35.030 immunization generated a strong antigen-specific antibody response against pTau in 100% of participants, achieving anti-pTau antibody levels of about two orders of magnitude higher than pre-treatment levels, whereas anti-ePHF (enriched paired helical filaments) antibody titers increased by one order of magnitude from baseline as early as two weeks after the second injection at week 8 of the mid-dose of ACI-35.030. Based on these results, the second highest dose cohort was expanded in Q2 2021 to facilitate plans for further development. The good safety and the tolerability in the study enabled the trial to be concluded without modification following reviews by the Data Safety Monitoring Board. Two serious adverse events (SAEs) (injection site rash and dizziness in the same participant) were considered probably/possibly related to the study active immunotherapy while none of the other 7 SAEs that occurred in the study were considered to be possibly or probably related to the study active immunotherapy. ACI-35.030 specifically targets pathological pTau species and is eventually intended as a disease-modifying treatment for AD and other Tauopathies.

In Q4 2022, it was announced that, based on the Phase 1b/2a interim data, ACI-35.030 had been selected for further development. Clinical data from the Phase 1b/2a trial showed that ACI-35.030 treatment rapidly leads to the strong and durable induction of antibodies specific for pathological forms of Tau such as pTau and its aggregated form, ePHF. The ACI-35.030-induced antibody response was sustained and could be periodically boosted over a period of 72 weeks. The decision to select ACI-35.030 follows the comparison demonstrating its strengths relative to an alternative anti-pTau protein conjugate active immunotherapy, JACI-35.054.

ACI-24.060 for AD and for AD in DS. Based on safety, tolerability, pharmacodynamics, and immunogenicity results with an earlier formulation of ACI-24, the optimized formulation, ACI-24.060, which incorporates Abeta unrelated T-helper cell epitopes to increase the magnitude and the boost-ability of the antibody response, was advanced into the ABATE Phase 1b/2 trial.

ABATE is a multicenter, adaptive, double-blind, randomized, placebo-controlled study designed to assess the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACl-24.060 in subjects with prodromal AD and subsequently in adults with DS (NCT05462106). The clinical trial application (CTA) has been approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and by the Spanish Agency for Medicines and Health Products (AEMPS) with the first AD patient dosed in Q2 2022. In Q2 2023, AC Immune received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ACI-24.060, for the treatment of AD. This followed FDA clearance of the Investigational New Drug (IND) application enabling expansion of the ABATE study to include clinical trial sites and participants in the USA.

ACI-7104.056. ACI-7104.056, the optimized formulation of the clinically-validated PD active immunotherapy PD01A, has advanced into an adaptive, biomarker-based Phase 2 study (VacSYn). This trial is evaluating an initial dose-response of ACI-7104.056 focusing on safety and immunogenicity against a-syn and pathological a-syn species. Additionally, the identification or verification of disease-specific biomarkers and progression of motor and non-motor symptoms of PD will be monitored, together with digital, imaging and fluid biomarkers, in the second part of the study. The trial was recently initiated.
Semorinemab. Our collaboration partner, Genentech, a member of the Roche Group, is developing semorinemab for the treatment of AD. A Phase 2 study (Lauriet) conducted in patients with mild-to-moderate AD was completed in Q3 2021 and data showed a statistically significant reduction on one of two co-primary endpoints, ADAS-Cog11. The second co-primary endpoint, ADCS-ADL, and secondary endpoints were not met. Safety data showed that semorinemab is well tolerated with no unanticipated safety signals. CSF and plasma biomarker data presented at CTAD 2022 confirmed peripheral target engagement and reduction in CSF total Tau, pTau181 and pTau217, observed after semorinemab treatment but not with placebo. Genentech reported that the open label portion of the study will continue as planned and that further analyses are ongoing. At CTAD 2023, Genentech presented further biomarker data from the Lauriet study focusing on Tau, synaptic function and gliosis. Semorinemab is designed to slow the spreading of Tau pathology, which coincides with both clinical symptoms and disease progression in AD.

2


Crenezumab. In Q3 2022, the Company provided an update on the Alzheimer’s Prevention Initiative study evaluating crenezumab in autosomal dominant AD, a specific genetic mutation which causes early-onset AD. While numerical differences favoring crenezumab over placebo were observed across the co-primary, multiple secondary and exploratory endpoints, none of these effects were statistically significant. Initial data was presented at the Alzheimer's Association International Conference (AAIC) on August 2, 2022. Further plasma biomarker analyses presented at the CTAD 2022 conference further favored crenezumab over placebo. All participants in the study were offered up to one year of continued treatment (crenezumab for all carriers and placebo for all non-carriers) following the end of the double-blind period while primary results and additional analyses were pending. Final efficacy visits are ongoing.
Morphomer Tau aggregation inhibitors. In collaboration with our partner, Lilly, we are researching and developing small molecule Tau aggregation inhibitors with plans to evaluate candidates in AD and NeuroOrphan tauopathies. We completed a Phase 1 clinical study in healthy volunteers with ACI-3024, in Q2 2020, which showed a dose-dependent exposure and brain penetration, achieving the desired levels of ACI-3024 in the CSF. Continued candidate characterization across the research program has also identified new and highly differentiated candidates with excellent cerebrospinal fluid exposure and selectivity for pathological aggregated Tau.
PI-2620. PI-2620 is the Tau-PET imaging agent discovered during the collaboration of AC Immune and LMI. We are working with our partner, LMI, to advance PI-2620 as a highly differentiated, best-in-class Tau diagnostic for AD as well as non-AD Tauopathies such as progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD). Results have demonstrated PI-2620’s differentiated characteristics as a diagnostic tool for studying Tau-related diseases. Results on the use of PI-2620 in AD patients from an investigator sponsored Phase 2 trial at the Asan Medical Center (NCT03903211) were presented at the 2022 AAIC. Following these results, LMI moved PI-2620 into late-stage clinical development in AD and made a milestone payment. The first Alzheimer’s patient in ADvance, the pivotal Phase 3 histopathology study in AD (NCT05641688), was imaged in January 2023.
ACI-12589. Our next-generation a-syn-PET imaging tracer, ACI-12589, derived from our Morphomer platform, has shown significant potential to reliably detect and map deposits of pathological alpha-synuclein protein in the brain. Supported by the Michael J. Fox Foundation for Parkinson’s Research (MJFF), ACI-12589 completed a first-in-human study and an investigator-initiated study in 2022. The readouts of these trials in patients with PD, multiple system atrophy (MSA) and other synucleinopathies were reported at the AD/PD and AAIC 2022 conferences. These images provided the first clinical proof-of-concept for an a-syn-PET tracer, as ACI-12589 clearly distinguished patients with MSA from those with other alpha-synucleinopathies and healthy controls. Moreover, our Morphomer platform is delivering additional candidates with improved binding properties and the potential to image a-syn pathology in patients with PD. This work was published on October 27, 2023 in Nature Communications (https://doi.org/10.1038/s41467-023-42305-3).

Interim 2023 Company Highlights

A peer-reviewed paper featuring the first-in-human trial of AC Immune’s wholly owned experimental alpha-synuclein (a-syn) positron emission tomography (PET) tracer ACI-12589 comparing healthy control subjects to patients with a-synucleinopathies and other neurological diagnoses was published in Nature Communications.
KOL webinar on PET imaging in AD featuring Victor Villemagne, M.D. (University of Pittsburg) will be held on November 9, 2023 at 10:00 AM ET.
The first patient with PD was dosed in the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, AC Immune’s wholly-owned anti-a-syn active immunotherapy.
Several programs were showcased at the annual Alzheimer’s Association International Conference (AAIC 2023), including presentations on ABATE’s trial design, TDP-43 proteinopathy in neurodegenerative diseases, and ACI-12589, a novel PET tracer targeting a-syn.
Announced the appointment of new Chief Medical Officer, Dr Nuno Mendonça.

3


Initiated a research collaboration with Prof. Michael Heneka, director of the Luxembourg Centre for Systems Biomedicine, University of Luxembourg, to evaluate the therapeutic potential of AC Immune’s SupraAntigen®- and Morphomer®-derived inhibitors of the NLRP3-ASC inflammasome pathway in preclinical disease models.

Results of Operations

Comparison of the three and nine months ended September 30, 2023 and 2022

Contract revenues

The Company generated no contract revenues for the three months and nine months ended September 30, 2023, compared to CHF 3.9 million in the comparable prior period. This represents a decrease of CHF 3.9 million, which is predominantly related to CHF 3.9 million that was recognized in the prior period for a milestone associated with our agreement with Life Molecular Imaging (LMI).

Research and development expenses

Research and development (R&D) activities are essential to our business and represent the majority of our costs incurred. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using information from the clinical sites and our vendors. Our collaboration agreements have different arrangements to share costs for the development of our product candidates.

We have completed our R&D spending in both of our Genentech collaborations. Additionally, we have completed our co-development costs with Janssen for the Phase 1b/2a studies for our active immunotherapy, ACI-35.030 and JACI-35.054. AC Immune and Janssen will jointly share research and development costs for the first Phase 2b (however, AC Immune’s contribution to the first Phase 2b trial is capped (and remaining costs for AC Immune are non-material)). From Phase 2b and onwards, Janssen will assume responsibility for the clinical development, manufacturing and commercialization.

We intend to increase our R&D costs associated with the advancement of our active immunotherapies, ACI-24.060 targeting Abeta in AD and AD in DS and ACI-7104.056 targeting a-syn in PD, through mid- and late-stage clinical development, as well as, investments in our diagnostic programs.

Finally, we intend to further advance the characterization of our other clinical and preclinical candidates, such as our Morphomer Tau program. In addition to the collaborative arrangements and proprietarily held assets, we expect that our total future R&D costs will increase over current levels, in line with our three-pillar strategy that focuses on (i) AD, (ii) focused non-AD NDD including PD, ALS and NeuroOrphan indications and (iii) diagnostics.

The table below provides a breakdown of our R&D costs, including direct R&D costs, manufacturing costs related to R&D and other R&D costs not allocated directly to programs for the periods covered by these Interim Condensed Consolidated Financial Statements. The R&D costs not allocated to specific programs include employment costs, regulatory, quality assurance and intellectual property costs. We do not assign our internal costs, such as salary and benefits, share-based compensation expenses, laboratory supplies, and other direct expenses and infrastructure costs to individual R&D projects, because the employees within our R&D groups are typically deployed across multiple R&D programs.

4


For the three months ended September 30, 2023, R&D expenses totaled CHF 12.4 million compared with CHF 14.4 million for the comparable period in 2022, respectively. This represents a decrease of CHF 2.0 million. The following table presents the R&D expenses during the three months ended September 30, 2023 and 2022:

    

For the Three Months

    

  

Ended September 30, 

In CHF thousands, unaudited

    

2023

    

2022

    

Change

Discovery and preclinical expenses

 

2,704

 

3,812

 

(1,108)

Clinical expenses

 

1,904

 

3,578

 

(1,674)

Group function expenses

 

406

 

343

 

63

Total direct R&D expenses

 

5,014

 

7,733

 

(2,719)

Payroll expenses

 

4,591

 

4,013

 

578

Share-based compensation

 

298

 

470

 

(172)

Other non-allocated

 

2,504

 

2,169

 

335

Total R&D expenses

 

12,407

 

14,385

 

(1,978)

    

For the Three Months

    

  

Ended September 30, 

In CHF thousands, unaudited

2023

2022

Change

Operating expenses1

 

7,518

 

9,902

 

(2,384)

Salaries and related costs2

 

4,889

 

4,483

 

406

Total R&D expenses

 

12,407

 

14,385

 

(1,978)


1

Includes depreciation expense

2

Includes share-based compensation expense

For the three months ended September 30, 2023:

Discovery and preclinical expenses decreased by CHF 1.1 million, primarily due to:

a decrease for our anti-TDP-43 antibody of CHF 0.5 million due to the completion of certain manufacturing activities in the prior period, and CHF 0.5 million in ACI-7104.056 due to toxicology studies and validation activities conducted in the prior period.

Clinical expenses decreased by CHF 1.7 million, primarily due to:

a decrease of CHF 0.8 million for the clinical development of ACI-35.030 driven by timing of activities across various cohorts started in prior years in the ongoing Phase 1b/2a study and expenses associated with the R&D cost sharing, a transient quarterly decrease of CHF 0.4 million compared to the prior year period, despite a year-to-date increase, for the clinical development of our ACI-7104.056 in the Phase 2 VacSyn Study and a timing-related decrease of CHF 0.5 million in other clinical programs.

The variances in Group function expenses relate to regulatory and quality assurance, and intellectual property costs.

The variances in Other non-allocated expenses relate to infrastructure and functional expenses not allocated to direct R&D expenses.

Total salaries and related costs increased by CHF 0.4 million, primarily due to the annualization of 2022 hires.

5


For the nine months ended September 30, 2023, R&D expenses totaled CHF 40.0 million compared with CHF 45.2 million for the comparable period in 2022. This represents a decrease of CHF 5.2 million. The following table presents the R&D expenses during the nine months ended September 30, 2023 and 2022:

    

For the Nine Months

    

Ended September 30, 

In CHF thousands, unaudited

2023

2022

Change

Discovery and preclinical expenses

 

7,460

 

12,518

 

(5,058)

Clinical expenses

 

7,802

 

9,975

 

(2,173)

Group function expenses

 

1,191

 

1,080

 

111

Total direct R&D expenses

 

16,453

 

23,573

 

(7,120)

Payroll expenses

 

14,564

 

13,098

 

1,466

Share-based compensation

 

1,515

 

1,225

 

290

Other non-allocated

 

7,430

 

7,304

 

126

Total R&D expenses

 

39,962

 

45,200

 

(5,238)

For the Nine Months

Ended September 30, 

In CHF thousands, unaudited

2023

2022

Change

Operating expenses1

    

23,883

    

30,877

    

(6,994)

Salaries and related costs2

 

16,079

 

14,323

 

1,756

Total R&D expenses

 

39,962

 

45,200

 

(5,238)


1

Includes depreciation expense

2

Includes share-based compensation expense

For the nine months ended September 30, 2023:

Discovery and preclinical expenses decreased by CHF 5.1 million, primarily due to:

a decrease of CHF 1.2 million for our anti-TDP-43 antibody due to the completion of certain manufacturing activities in the prior period, CHF 1.1 million due to the completion of preclinical studies for our Morphomer Tau program, CHF 1.0 million in ACI-24.060 due to the program advancing into the Phase 1b/2 ABATE study and CHF 1.8 million in other discovery and preclinical programs.

Clinical expenses decreased by CHF 2.2 million, primarily due to:

a decrease of CHF 3.6 million for the clinical development of ACI-35.030 driven by timing of activities across various cohorts started in prior years in the ongoing Phase 1b/2a study and expenses associated with the R&D cost sharing.

This was partially offset by:

an increase of CHF 1.6 million for the initiation of our Phase 1b/2 ABATE study for our ACI-24.060, and CHF 0.2 million for the clinical development of our ACI-7104.056 in the Phase 2 VacSYn study.

The variances in Group function expenses relate to regulatory and quality assurance, and intellectual property costs.

The variances in Other non-allocated expenses relate to infrastructure and functional expenses not allocated to direct R&D expenses.

Total salaries and related costs increased by CHF 1.8 million, primarily due to the annualization of 2022 hires, which resulted in an increase in salary- and benefit-related costs of CHF 1.5 million, as well as an incremental CHF 0.3 million in share-based compensation expense.

6


General and administrative expenses

General and administrative expenses consist of salaries and related costs, including share-based compensation, professional fees such as legal and accounting related services, infrastructure expenses, and other operating expenses.

For the three months ended September 30, 2023, general and administrative expenses totaled CHF 3.5 million compared with CHF 3.3 million for the comparable period in 2022. This represents an increase of CHF 0.2 million. The following table presents the general and administrative expenses during the three months ended September 30, 2023 and 2022:

    

For the Three Months

    

    

Ended September 30, 

In CHF thousands, unaudited

2023

    

2022

    

Change

Operating expenses1

 

1,096

 

1,534

 

(438)

Salaries and related costs2

 

2,369

 

1,740

 

629

Total general and administrative expenses

 

3,465

 

3,274

 

191


1

Includes depreciation expense

2

Includes share-based compensation expense

For the three months ended September 30, 2023, this increase is primarily due to:

a CHF 0.6 million increase in salaries and related costs, mostly related to an increase in share-based compensation expense associated with the forfeiture of awards to a former member of management in the prior period, which did not occur in the current period.

This was partially offset by:

a decrease of CHF 0.4 million in our directors’ and officers’ insurance for the period.

For the nine months ended September 30, 2023, general and administrative expenses totaled CHF 11.3 million compared with CHF 11.8 million for the comparable period in 2022. This represents a decrease of CHF 0.5 million. The following table presents the general and administrative expenses during the nine months ended September 30, 2023 and 2022:

    

For the Nine Months

    

    

Ended September 30, 

In CHF thousands, unaudited

2023

2022

Change

Operating expenses1

 

3,367

 

4,405

 

(1,038)

Salaries and related costs2

 

7,885

 

7,423

 

462

Total general and administrative expenses

 

11,252

 

11,828

 

(576)


1

Includes depreciation expense

2

Includes share-based compensation expense

For the nine months ended September 30, 2023, this decrease is primarily due to:

a decrease of CHF 1.0 million in operating expenses predominantly related to a reduction of CHF 0.6 million in our directors’ and officers’ insurance for the period.

This was partially offset by:

a CHF 0.5 million increase in salaries and related costs, mostly related to an increase in share-based compensation expense, which is explained by the equity awards granted in 2023 to the members of management and employees.

7


Other operating income/(expense), net

Other operating income/(expense) consists primarily of income associated with foundation grants such as those from the MJFF or Target ALS.

For the three months ended September 30, 2023, other operating income/(expense) totaled CHF 0.4 million compared with CHF 0.3 million for the comparable period in 2022. This represents an increase of CHF 0.1 million, which is immaterial. The following table presents the other operating income/(expense) during the three months ended September 30, 2023 and 2022:

    

For the Three Months

    

  

Ended September 30, 

In CHF thousands, unaudited

2023

    

2022

    

Change

Other operating income/(expense), net

 

406

 

262

 

144

Total other operating income/(expense), net

 

406

 

262

 

144

For the nine months ended September 30, 2023, other operating income/(expense) totaled CHF 1.1 million compared with CHF 0.9 million for the comparable period in 2022. This represents an increase of CHF 0.2 million, which is immaterial. The following table presents the other operating income/(expense) during the nine months ended September 30, 2023 and 2022:

For the Nine Months

Ended September 30, 

In CHF thousands, unaudited

    

2023

    

2022

    

Change

Other operating income/(expense), net

 

1,131

 

944

 

187

Total other operating income/(expense), net

 

1,131

 

944

 

187

Finance result, net

For the three months ended September 30, 2023, finance result was a CHF 0.3 million gain compared with a loss of less than CHF 0.1 million for the comparable period in 2022. This represents an increase of CHF 0.4 million. The following table presents the finance result during the three months ended September 30, 2023 and 2022:

    

For the Three Months

    

  

Ended September 30, 

In CHF thousands, unaudited

2023

    

2022

    

Change

Financial income

 

285

 

11

 

274

Financial expense

 

(26)

 

(77)

 

51

Exchange differences

 

67

 

17

 

50

Finance result, net

 

326

 

(49)

 

375

For the three months ended September 30, 2023, a change in net finance result of CHF 0.4 million primarily related to:

a CHF 0.3 million increase in financial income related to interest income on short-term deposits, driven by changes in the interest rate environment.

For the nine months ended September 30, 2023, net finance result was a CHF 0.6 million gain compared with a CHF 0.2 million gain for the comparable period in 2022. This represents an increase of CHF 0.4 million. The following table presents the finance result during the nine months ended September 30, 2023 and 2022:

For the Nine Months

Ended September 30, 

In CHF thousands, unaudited

2023

2022

Change

Financial income

    

753

 

11

 

742

Financial expense

 

(150)

 

(356)

 

206

Exchange differences

 

 

502

 

(502)

Finance result, net

 

603

 

157

 

446

8


For the nine months ended September 30, 2023, the increase of CHF 0.4 million in net finance result primarily related to:

a CHF 0.7 million increase in financial income, mostly related to interest income on short-term deposits, driven by changes in the interest rate environment.

This was partially offset by:

a CHF 0.5 million decrease in foreign currency exchange differences, mostly driven by an exchange gain on cash and cash equivalents recognized in the prior period, which did not repeat in the current period.

Liquidity and Capital Resources

To date, the Company has financed its cash requirements primarily from its public offerings, share issuances, contract revenues from license and collaboration agreements (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. As of September 30, 2023, we had cash and cash equivalents of CHF 31.9 million and short-term financial assets of CHF 48.0 million for a total liquidity balance of CHF 79.9 million.

Our primary uses of capital are, and we expect will continue to be, R&D investments, compensation and related expenses and other operating expenses including rent. Cash and cash equivalents used to fund operating expenses are impacted by the timing of when we pay expenses, as reflected in the change in our outstanding trade and other payables and accrued expenses. We expect to incur substantial expenses in connection with our product candidates in various stages of clinical development. We and Janssen have completed the co-development of the second-generation lead therapeutic active immunotherapies, ACI-35.030 and JACI-35.054, through Phase 1b/2a. In Q4 2022, it was announced that ACI-35.030 was selected to advance into further development based on interim data from the ongoing Phase 1b/2a trial. AC Immune and Janssen will jointly share research and development costs until the completion of the first Phase 2b however, AC Immune’s contribution to the first Phase 2b trial is capped (and remaining costs for AC Immune are non-material). From Phase 2b and onwards, Janssen will assume responsibility for the clinical development, manufacturing and commercialization of ACI-35.030. We intend to increase our R&D costs associated with the advancement through mid-and late-stage clinical development of our active immunotherapies ACI-24.060 in AD and ACI-7104.056 in PD, as well as, investments in our diagnostic programs. Finally, we intend to further advance the candidate characterization of our other clinical and preclinical candidates, such as our Morphomer Tau program, Morphomer a-synuclein and neuroinflammation programs.

We plan to continue to fund our operating and capital funding needs through proceeds received from licensing and collaboration agreements (LCAs) and through equity or other forms of financing. For example, in Q3 2020 we entered into the Open Market Sale Agreement (Sale Agreement) with Jefferies LLC (Jefferies), which provides that, upon the terms and subject to the conditions and limitations set forth in the Sale Agreement, we may elect to issue and sell, from time to time, shares of our common shares having an aggregate offering price of up to USD 80.0 (CHF 73.9) million through Jefferies acting as our sales agent. We replaced this Sale Agreement in Q2 2021 to continue the ATM program. Under the new Sale Agreement, Jefferies may sell the shares of common shares by any method permitted by law deemed to be an “at the market offering” as defined under the Securities Act of 1933, as amended, in privately negotiated transactions with our consent or in block transactions. Jefferies will use commercially reasonable efforts to sell the shares of common shares subject to the new Sales Agreement from time to time, consistent with its normal sales and trading practices, on mutually agreed terms. We will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any common shares sold through Jefferies under the new Sales Agreement. We are not obligated to make any sales of common shares under the new Sales Agreement. Through September 30, 2023, the Company has sold 1,332,170 treasury shares pursuant to the new Sales Agreement, raising USD 7.7 (CHF 7.0) million net of underwriting fees.

9


We may also consider entering into additional LCAs and selectively partnering for clinical development and commercialization.

Cash Flows

The following table summarizes AC Immune’s cash flows for the periods indicated:

    

For the Nine Months

    

    

Ended September 30, 

In CHF thousands, unaudited

2023

2022

Change

Net cash provided by/(used in):

 

  

 

  

 

  

Operating activities

 

(44,217)

 

(56,161)

 

11,944

Investing activities

 

42,365

 

18,804

 

23,561

Financing activities

 

2,222

 

(1,195)

 

3,417

Net increase/(decrease) in cash and cash equivalents

 

370

 

(38,552)

 

38,922

Operating activities

Net cash used in operating activities was CHF 44.2 million for the nine months ended September 30, 2023, compared with net cash used in operating activities of CHF 56.2 million for the nine months ended September 30, 2022. The change in cash used in operating activities for the nine months ended September 30, 2023 was due to (i) the Company’s reporting a net loss of CHF 49.5 million for the period, compared with a net loss of CHF 52.0 million for the same period in 2022, (ii) an increase of CHF 1.3 million in non-cash adjustments, predominantly driven by an increase of CHF 1.1 million in share-based compensation expenses, (iii) a decrease of CHF 0.1 million in accrued expenses for the period, compared with a decrease of CHF 4.4 million in the prior period, representing cash outflows associated with the timing of certain payments during the period, and (iv) an increase of less than CHF 0.1 million in other current receivables, compared with an increase of CHF 3.8 million in the prior period, which related to the milestone recognized in the prior period.

Investing activities

Net cash provided by investing activities was CHF 42.4 million for the nine months ended September 30, 2023, compared with net cash provided by investing activities of CHF 18.8 million for the nine months ended September 30, 2022. The Company settled short-term financial assets totaling CHF 43.0 million in the current period compared to CHF 20.0 million in the prior period. The Company additionally acquired CHF 0.6 million in fixed assets in the current period compared to CHF 1.2 million in the prior period.

Financing activities

Net cash provided by financing activities was CHF 2.2 million for the nine months ended September 30, 2023, compared with net cash used in financing activities of CHF 1.2 million for the nine months ended September 30, 2022. The increase of CHF 3.4 million is related to CHF 2.6 million received from proceeds from the sale of treasury shares in public offerings, net of underwriting fees and transaction costs in the current period which were not received in the prior comparable period and CHF 0.8 million in transaction costs associated with the issuance of shares in the comparable prior period.

Operating Capital Requirements and Plan of Operations

We do not expect to generate revenues from royalties based on product sales unless and until our collaboration partners or we obtain regulatory approval of, and successfully commercialize, our current or any future product candidates. As of September 30, 2023, we had cash and cash equivalents of CHF 31.9 million and short-term financial assets of CHF 48.0 million, resulting in CHF 79.9 million of liquidity. The decrease relative to December 31, 2022 was predominantly related to R&D spending on our major discovery and R&D programs, the strengthening of the Company’s infrastructure, systems and organization and other operating expenditures. There can be no certainty as to the exact timing of future milestone payments, or in fact, whether any of these will ever be made, given that they are contingent on clear milestones being reached. Accordingly, we believe that our existing capital resources will be

10


sufficient to meet our projected operating requirements into Q4 2024, based on our most recent board approval liquidity forecast, excluding the receipt of any potential milestone payments.

We expect to generate losses for the foreseeable future, and these losses could increase as we continue product development until we successfully achieve regulatory approvals for our product candidates and begin to commercialize any approved products. We are subject to all the risks pertinent to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. We anticipate that we will need substantial additional funding in connection with our continuing operations. If we need to raise additional capital to fund our operations and complete our ongoing and planned clinical studies, funding may not be available to us on acceptable terms, or at all.

Our future funding requirements will depend on many factors, including but not limited to the following:

The scope, rate of progress, results and cost of our preclinical and clinical studies and other related activities, according to our long-term strategic plan;
The cost of manufacturing clinical supplies and establishing commercial supplies of our product candidates and any other products we may develop;
The cost, timing and outcomes of regulatory approvals;
The costs and timing of establishing sales, marketing and distribution capabilities;
The terms and timing of any collaborative, licensing and other arrangements that we may establish, including any required milestone and royalty payments thereunder;
The emergence of competing technologies or other adverse market developments; and
The potential cost and timing of managing, protecting, defending, and enforcing our portfolio of intellectual property.

Quantitative and Qualitative Disclosures about Market Risk

During the three and nine months ended September 30, 2023, there were no significant changes to our quantitative and qualitative disclosures about market risk described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Quantitative and Qualitative Disclosures About Market Risk” in the Annual Report on Form 20-F.

Critical Judgments and Accounting Estimates

There have been no material changes to the significant accounting policies and estimates described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Judgments and Accounting Estimates” in the Annual Report on Form 20-F.

11


Cautionary Statement Regarding Forward Looking Statements

This discussion and analysis contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this discussion and analysis, including statements regarding our future results of operations and financial position, business strategy, product candidates, product pipeline, ongoing and planned clinical studies, including those of our collaboration partners, regulatory approvals, R&D costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Many of the forward-looking statements contained in this prospectus can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “will” and “potential,” among others. Forward-looking statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under the section entitled “Risk Factors” in our Annual Report on Form 20-F. These forward-looking statements speak only as of the date of this discussion and analysis, and are subject to a number of risks, uncertainties and assumptions as described under the sections in our Annual Report on Form 20-F entitled “Risk Factors” and in this discussion and analysis. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

12


Exhibit 99.3

Graphic

PRESS RELEASE

AC Immune Reports Third Quarter 2023 Financial Results and
Provides a Corporate Update

Results from amyloid plaque reduction analysis (Abeta-PET) after 6 months of treatment with ACI-24.060 in ABATE Phase 1b/2 study on track for H1 2024
ACI-24.060 ABATE interim safety and immunogenicity data in Alzheimers disease (AD) expected by year-end
ACI-7104.056 alpha-synuclein active immunotherapy in Phase 2 VacSYn Parkinsons disease (PD) trial to complete Cohort 1 enrollment and report initial safety findings by year-end
Cash position of CHF 79.9 million finances the Company into Q4 2024, excluding the benefit of anticipated milestone payments

Lausanne, Switzerland, November 3, 2023 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today reported results for the third quarter ended September 30, 2023, and provided a corporate update.

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “As we look to year-end and into 2024, AC Immune is poised to achieve multiple milestones across our clinical programs. We remain on track to report safety and immunogenicity data from the AD cohort of our ABATE trial of ACI-24.060 this year. Then, in the first half of 2024 results are anticipated from the important Abeta-PET imaging analyses on amyloid plaque reduction following 6 months of treatment. With amyloid clearance as measured by PET imaging now established as a reliable surrogate for efficacy, these results could significantly de-risk the program and enable advancement into a registrational study. We look forward to further discussing the clinical utility of PET imaging in AD at our KOL webinar on November 9, 2023.”

“We continue to progress our pipeline, and are looking forward to the initiation of the next AD trial of anti-pTau (phosphorylated Tau) active immunotherapy ACI-35.030 later this year, which will be followed by a milestone payment. Taken together with ACI-24.060 and our a-syn active immunotherapy, ACI-7104.056, we will have three active immunotherapies in mid- to late-stage clinical testing for neurodegeneration. With further clinical readouts from our precision medicine pipeline ahead, we continue to work diligently towards earlier diagnosis and treatment to prevent progression of neurodegenerative diseases.”

Q3 2023 and Subsequent Highlights

A peer-reviewed paper featuring the first-in-human trial of AC Immune’s wholly owned experimental alpha-synuclein (a-syn) positron emission tomography (PET) tracer ACI-12589 comparing healthy control subjects to patients with a-synucleinopathies and other neurological diagnoses was published in Nature Communications.
KOL webinar on PET imaging in AD featuring Victor Villemagne, M.D. (University of Pittsburg) will be held on November 9, 2023 at 10:00 AM ET.
The first patient with PD was dosed in the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, AC Immune’s wholly-owned anti-a-syn active immunotherapy.
Several programs were showcased at the annual Alzheimer’s Association International Conference (AAIC 2023), including presentations on ABATE’s trial design, TDP-43 proteinopathy in neurodegenerative diseases, and ACI-12589, a novel PET tracer targeting a-syn.
Announced the appointment of new Chief Medical Officer, Dr Nuno Mendonça.


Initiated a research collaboration with Prof. Michael Heneka, director of the Luxembourg Centre for Systems Biomedicine, University of Luxembourg, to evaluate the therapeutic potential of AC Immune’s SupraAntigen®- and Morphomer®-derived inhibitors of the NLRP3-ASC inflammasome pathway in preclinical disease models.

Anticipated Milestones

ACI-24.060
anti-Abeta active immunotherapy

Additional interim safety and immunogenicity data from AD cohorts of ABATE study expected in Q4 2023
First Abeta-PET data on amyloid plaque reduction in AD following 6 months of treatment expected in H1 2024

ACI-7104.056

anti-a-syn active immunotherapy

Completion of cohort 1 enrollment and initial safety findings in the Phase 2 VacSYn study in PD expected by year-end

ACI-35.030

anti-pTau active immunotherapy

Initiation of next trial in AD expected in Q4 2023 (to be followed by a milestone payment)

Anti-TDP-43 antibody

Advancement of candidate into preclinical development (tox) expected in Q4 2023

a-syn-PET tracer

Declaration of next clinical candidate for development in PD expected in Q4 2023

Analysis of Financial Statements for the Quarter Ended September 30, 2023

Cash Position: The Company ended Q3 with a total cash balance of CHF 79.9 million (CHF 122.6 million as of December 31, 2022), composed of CHF 31.9 million in cash and cash equivalents and CHF 48.0 million in short-term financial assets. The Company’s cash balance provides sufficient capital resources to progress into Q4 2024 without considering receipt of potential future milestone payments.
R&D Expenditures: R&D expenses for the three months ended September 30, 2023, were CHF 12.4 million compared to CHF 14.4 million in the comparable period in 2022, due to lower expenses in our preclinical portfolio and reduced clinical expenses.
G&A Expenditures: For the three months ended September 30, 2023, G&A increased by CHF 0.2 million, which is materially consistent with the comparable period.
Other Operating Income: The Company recognized CHF 0.3 million in grant income from Michael J. Fox Foundation and Target ALS grants.
IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 15.1 million for the three months ended September 30, 2023, compared with a net loss of CHF 13.5 million for the comparable period in 2022.

About AC Immune SA

AC Immune SA is a clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features sixteen therapeutic and diagnostic programs, five of which are currently in Phase 2 clinical trials and one of which is in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company, and others, resulting in substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments.

SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, KR, NO and RU.

The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release.

For further information, please contact:

Head of Investor Relations & Corporate Communications 

Gary Waanders, Ph.D., MBA 

AC Immune 

Phone: +41 21 345 91 91 

Email: gary.waanders@acimmune.com 

 

U.S. Investors 

Corey Davis, Ph.D. 

LifeSci Advisors 

Phone: +1 212 915 2577  

Email: cdavis@lifesciadvisors.com 

 

International Media 

Chris Maggos 

Cohesion Bureau 

Phone: +41 79 367 6254 

Email: chris.maggos@cohesionbureau.com  

 

 

Forward looking statements

This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.


Condensed Consolidated Balance Sheets (Unaudited)

(In CHF thousands)

    

As of

September 30, 

December 31, 

2023

2022

Assets

 

  

 

  

Non-current assets

 

  

 

  

Property, plant and equipment

 

3,627

 

4,259

Right-of-use assets

 

2,403

 

2,808

Intangible asset

 

50,416

 

50,416

Long-term financial assets

 

361

 

361

Total non-current assets

 

56,807

 

57,844

Current assets

 

 

Prepaid expenses

 

5,534

 

4,708

Accrued income

 

312

 

408

Other current receivables

 

406

 

392

Short-term financial assets

 

48,000

 

91,000

Cash and cash equivalents

 

31,927

 

31,586

Total current assets

 

86,179

 

128,094

Total assets

 

142,986

 

185,938

Shareholders' equity and liabilities