0000950103-22-013084.txt : 20220728 0000950103-22-013084.hdr.sgml : 20220728 20220728073644 ACCESSION NUMBER: 0000950103-22-013084 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20220728 FILED AS OF DATE: 20220728 DATE AS OF CHANGE: 20220728 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AC Immune SA CENTRAL INDEX KEY: 0001651625 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: V8 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37891 FILM NUMBER: 221112830 BUSINESS ADDRESS: STREET 1: EPFL INNOVATION PARK, BUILDING B CITY: 1015 LAUSANNE STATE: V8 ZIP: 00000 BUSINESS PHONE: 41 21 345 91 21 MAIL ADDRESS: STREET 1: EPFL INNOVATION PARK, BUILDING B CITY: 1015 LAUSANNE STATE: V8 ZIP: 00000 6-K 1 dp177641_6k.htm FORM 6-K

 

 

 

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 July, 2022

 

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

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

 

Yes   No

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

 

Yes   No

 

 

 

 

This Report on Form 6-K (excluding Exhibit 99.3 herewith) is incorporated by reference into the Registrant's registration statement on Form F-3 (File Nos. 333-227016, 333-249655 and 333-255576) and Form S-8 (File No. 333-233019).

 

 

 

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/ Joerg Hornstein
    Name: Joerg Hornstein
    Title: Chief Financial Officer

 

Date:        July 28, 2022

 

 

 

EXHIBIT INDEX

 

Exhibit Number

Description

99.1 Interim Condensed Consolidated Financial Statements (Unaudited) (IFRS) as of and for the three and six months ended June 30, 2022
99.2 Management’s Discussion and Analysis of Financial Condition and Results of Operations
99.3 Press Release dated July 28, 2022

 

EX-99.1 2 dp177641_ex9901.htm EXHIBIT 99.1

 

Exhibit 99.1

 

Condensed Consolidated Balance Sheets (Unaudited)

(in CHF thousands)

 

Balance Sheets  Notes 

As of June 30,

2022

 

As of December 31,

2021

ASSETS             
Non-current assets             
Property, plant and equipment   5   4,997    5,116 
Right-of-use assets   6   2,632    2,914 
Intangible asset  9   50,416    50,416 
Long-term financial assets  6   361    363 
Total non-current assets       58,406    58,809 
              
Current assets             
Prepaid expenses   10   3,465    3,015 
Accrued income   3   433    975 
Other current receivables       335    428 
Short-term financial assets   11   91,000    116,000 
Cash and cash equivalents   11   63,147    82,216 
Total current assets       158,380    202,634 
Total assets      216,786    261,443 
              
SHAREHOLDERS’ EQUITY AND LIABILITIES             
              
Shareholders’ equity             
Share capital       1,796    1,794 
Share premium       431,260    431,251 
Treasury shares  12   (124)   (124)
Currency translation differences      49     
Accumulated losses       (230,169)   (200,942)
Total shareholders’ equity      202,812    231,979 
              
Non-current liabilities             
Long-term lease liabilities  6   2,050    2,340 
Net employee defined benefit liabilities  7       7,098 
Total non-current liabilities       2,050    9,438 
              
Current liabilities             
Trade and other payables       337    2,003 
Accrued expenses   8   10,585    16,736 
Deferred income   3   425    717 
Short-term lease liabilities  6   577    570 
Total current liabilities      11,924    20,026 
Total liabilities       13,974    29,464 
Total shareholders’ equity and liabilities       216,786    261,443 

 

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 June 30,
  For the Six Months
Ended June 30,
   Notes  2022  2021  2022  2021
Revenue               
Contract revenue   3                
Total revenue                    
                        
Operating expenses                       
Research & development expenses       (15,692)   (13,710)   (30,815)   (27,040)
General & administrative expenses       (4,374)   (5,235)   (8,550)   (9,573)
Other operating income/(expense)   3   207    256    677    673 
Total operating expenses       (19,859)   (18,689)   (38,688)   (35,940)
Operating loss      (19,859)   (18,689)   (38,688)   (35,940)
                        
Financial income                   
Financial expense      (126)   (202)   (279)   (228)
Exchange differences      345    (178)   485    365 
Finance result, net   13   219    (380)   206    137 
                        
Loss before tax       (19,640)   (19,069)   (38,482)   (35,803)
Income tax expense      (3)       (7)    
Loss for the period       (19,643)   (19,069)   (38,489)   (35,803)
                        
Loss per share:  4                    
Basic and diluted loss for the period attributable to equity holders       (0.23)   (0.26)   (0.46)   (0.50)

 

Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)     For the Three Months
ended June 30,
  For the Six Months
ended June 30,
(in CHF thousands)  Notes  2022  2021  2022  2021
                
Loss for the period       (19,643)   (19,069)   (38,489)   (35,803)
Items that will be reclassified to income or loss in subsequent periods (net of tax):                       
Currency translation differences      39        49     
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)   7
   7,381        7,381     
Total comprehensive loss, net of tax       (12,223)   (19,069)   (31,059)   (35,803)

 

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)

 

   Notes  Share
capital
  Share
premium
  Treasury shares  Accumulated losses 

Currency Translation

Differences

  Total
Balance as of January 1, 2021       1,538    346,890    (100)   (132,850)       215,478 
Net loss for the period                   (35,803)       (35,803)
Other comprehensive income/(loss)                           
Total comprehensive loss                   (35,803)       (35,803)
                                
Share-based payments                   1,694        1,694 
Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs          7,825    15            7,840 
Issuance of shares, net of transaction costs:                                 
 restricted share awards       1    104        (112)       (7)
 exercise of options           80                80 
Balance as of June 30, 2021      1,539    354,899    (85)   (167,071)       189,282 

 

   Notes  Share
capital
  Share
premium
  Treasury shares  Accumulated losses 

Currency Translation

Differences

  Total
Balance as of January 1, 2022       1,794    431,251    (124)   (200,942)       231,979 
Net loss for the period                   (38,489)       (38,489)
Other comprehensive income/(loss)  7               7,381    49    7,430 
Total comprehensive loss                   (31,108)   49    (31,059)
                                
Share-based payments                   1,886        1,886 
Transaction offering costs                           
Issuance of shares, net of transaction costs:                                 
 restricted share awards           5        (5)        
 exercise of options       2    4                6 
Balance as of June 30, 2022       1,796    431,260    (124)   (230,169)   49    202,812 

 

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 Six Months
Ended June 30,
   Notes  2022  2021
Operating activities         
Loss for the period       (38,489)   (35,803)
Adjustments to reconcile net loss for the period to net cash flows:             
Depreciation of property, plant and equipment   5   893    916 
Depreciation of right-of-use assets   6   282    225 
Finance (income)/expense, net   13   (598)   (395)
Share-based compensation expense       1,886    1,694 
Change in net employee defined benefit liability       283    310 
Interest expense   13   274    224 
Changes in working capital:             
(Increase)/decrease in prepaid expenses   10   (601)   1,131 
Decrease in accrued income   3   552    870 
Decrease in other current receivables       93    48 
(Decrease) in accrued expenses   8   (4,982)   (677)
(Decrease)/increase in deferred income   3   (306)   113 
Decrease in trade and other payables      (1,584)   (1,824)
Cash used in operating activities      (42,297)   (33,168)
Interest income           
Interest paid       (322)   (190)
Finance costs      (5)   (4)
Net cash flows used in operating activities       (42,624)   (33,362)
              
Investing activities             
Short-term financial assets, net   11   25,000    (30,000)
Purchases of property, plant and equipment   5   (1,077)   (1,418)
Rental deposits   6   2    (29)
Net cash flows provided by/(used in) investing activities       23,925    (31,447)
              
Financing activities             
Principal payments of lease obligations   6   (283)   (225)
Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs  12       7,840 
Transaction costs associated with issuance of shares in relation to asset acquisition previously recorded in Accrued expenses      (776)    
Proceeds from issuance of common shares       6    73 
Net cash flows (used in)/provided by financing activities       (1,053)   7,688 
              
Net decrease in cash and cash equivalents       (19,752)   (57,121)
              
Cash and cash equivalents at January 1       82,216    160,893 
Exchange gain on cash and cash equivalents       683    363 
Cash and cash equivalents at June 30       63,147    104,135 
Net decrease in cash and cash equivalents       (19,752)   (57,121)
              
  Supplemental non-cash activity             
Capital expenditures in Trade and other payables or Accrued expenses  5   1    247 

 

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 registered and is organized under the laws of Delaware, USA in June 2021. The Company and its Subsidiary form the Group (See “Note 2. Basis of preparation and changes to the Company’s accounting policies”).

 

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 six months ended June 30, 2022 were authorized for issuance by the Company’s Audit and Finance Committee on July 27, 2022. 

 

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

 

Statement of compliance

 

These Interim Condensed Consolidated Financial Statements as of June 30, 2022 and for the three and six months ended June 30, 2022 and 2021, 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, 2021.

 

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 June 30,
  For the Six Months
Ended June 30,
   2022  2021 

2022

  2021
CHF/USD            
Closing rate, USD 1    0.9650        0.9650     
Weighted average exchange rate, USD 1   0.9871        0.9913     

 

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

 

5 

 

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, (ii) clinical development accruals, (iii) net employee defined benefit liability, (iv) income taxes, (v) share-based compensation, (vi) right-of-use assets and lease liabilities and (vii) 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 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, 2021.

 

The Company has not adopted any other 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 June 30, 2022, after considering the Company’s cash position of CHF 63.1 million and short-term financial assets of CHF 91.0 million as of June 30, 2022. Hence, the 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 license and collaboration agreements 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. 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.

 

In addition to the foregoing, based on the Company’s current assessment, the Company does not expect any material impact on its long-term development timeline, its liquidity or ability to remain a going concern due to the worldwide spread of the Covid-19 virus. The Company continues to assess the effect on its operations by carefully monitoring the spread of Covid-19 and taking appropriate steps intended to offset any negative impacts from the Covid-19 virus.

 

3.Contract revenues and other operating income

 

For the three and six months ended June 30, 2022 and 2021, AC Immune generated no contract revenues.

 

The following table presents changes in the Company’s contract assets and liabilities during the six months ended June 30, 2022 and 2021:

 

6 

 

in CHF thousands  Balance at the beginning of the reporting period  Additions  Deductions  Balance at the end of the reporting period
Six months ended June 30, 2022:            
Accrued income    975    602    (1,144)   433 
Deferred income    717    359    (651)   425 
                     
Six months ended June 30, 2021:                    
Accrued income    1,591    781    (1,652)   720 
Deferred income    306    781    (678)   409 

 

During the three and six months ended June 30, 2022 and 2021, the Company did not recognize contract revenues as a result of changes in the contract asset and the contract liability balances in the respective periods nor from performance obligations satisfied in previous periods.

 

3.1Licensing and collaboration agreements

 

For a discussion of our licensing and collaboration agreements for the fiscal year ended December 31, 2021, please refer to Note 13.1 “Licensing and Collaboration agreements” of our Annual Report on Form 20-F for the year ended December 31, 2021 filed on March 22, 2022.

 

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 six months ended June 30, 2022.

 

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, 2021, please refer to Note 13.2 “Grant Income” of our Annual Report on Form 20-F for the year ended December 31, 2021 filed on March 22, 2022.

 

For the three and six months ended June 30, 2022 and 2021, the Company has recognized CHF 0.2 million and CHF 0.6 million in grant income, respectively. As of June 30, 2022, the Company has recorded CHF 0.4 million in both accrued income and deferred income, respectively.

 

Grant from the Target ALS Foundation

 

For a discussion of our Grants from the Target ALS Foundation (Target ALS) for the fiscal year ended December 31, 2021, please refer to Note 13.2 “Grant Income” of our Annual Report on Form 20-F for the year ended December 31, 2021 filed on March 22, 2022.

 

For the three and six months ended June 30, 2022 and 2021, the Company recognized less than CHF 0.1 million and CHF 0.1 million, respectively. As of June 30, 2022, the Company has recorded CHF 0.1 million in in deferred income.

 

7 

 

4.Loss per share

 

   For the Three Months
Ended June 30,
in CHF thousands except for share and per share data  2022  2021
Loss per share (EPS)      
Numerator      
Net loss attributable to equity holders of the Company    (19,643)   (19,069)
Denominator          
Weighted-average number of shares outstanding used to compute EPS basic and diluted attributable to equity holders   84,462,675    72,715,783 
Basic and diluted loss per share for the period attributable to equity holders   (0.23)   (0.26)

 

   For the Six Months
Ended June 30,
in CHF thousands except for share and per share data  2022  2021
Loss per share (EPS)      
Numerator      
Net loss attributable to equity holders of the Company    (38,489)   (35,803)
Denominator          
Weighted-average number of shares outstanding used to compute EPS basic and diluted attributable to equity holders   83,510,567    72,113,581 
Basic and diluted loss per share for the period attributable to equity holders   (0.46)   (0.50)

 

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 June 30,
   2022  2021
Share options issued and outstanding    149,457    1,174,014 
Restricted share awards subject to future vesting    16,039    8,511 

 

   For the Six Months
Ended June 30,
   2022  2021
Share options issued and outstanding    174,408    1,179,992 
Restricted share awards subject to future vesting    8,328    11,594 

8 

 

5.Property, plant and equipment

 

The following table shows the movement in the net book values of property, plant and equipment for the six months ended June 30, 2022:

 

   As of June 30, 2022
in CHF thousands  Furniture  IT Equipment  Lab Equipment  Leasehold Improvements  Assets Under Construction  Total
Acquisition Cost                              
Balance at December 31, 2021   263    1,756    9,142    810    695    12,666 
Additions   17    81    528    38    110    774 
Transfers        4    18    7    (29)    
Balance at June 30, 2022   280    1,841    9,688    855    776    13,440 
                               
Accumulated depreciation                              
Balance at December 31, 2021   (106)   (1,316)   (5,739)   (389)       (7,550)
Depreciation expense   (25)   (143)   (657)   (68)       (893)
Balance at June 30, 2022   (131)   (1,459)   (6,396)   (457)       (8,443)
                               
Carrying Amount                              
December 31, 2021    157    440    3,403    421    695    5,116 
June 30, 2022    149    382    3,292    398    776    4,997 

 

AC Immune continues to enhance its laboratory equipment to support its R&D functions and IT equipment. This effort has continued since the year ended December 31, 2021, with CHF 0.6 million invested in lab equipment, including the expansion of our leased lab space, and IT equipment, representing an increase of 5.8% from the beginning of the year in these categories.

 

6.Right-of-use assets and lease liabilities

 

AC Immune recognized no additions for its right-of-use of leased assets for the six months ended June 30, 2022.

 

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 2.5% 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 six months ended June 30, 2022:

 

in CHF thousands  Buildings  Office Equipment  IT
Equipment
  Total
Balance as of December 31, 2021   2,776    98    40    2,914 
Depreciation   (262)   (12)   (8)   (282)
Balance as of June 30, 2022   2,514    86    32    2,632 

 

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.

 

For the three and six months ended June 30, 2022, and 2021, the impact on the Company’s condensed consolidated statements of income/(loss) and consolidated statements of cash flows is as follows:

 

9 

 

For the Three Months

Ended June 30,

in CHF thousands 2022   2021
Statements of income/(loss)      
Depreciation of right-of-use assets 141   119
Interest expense on lease liabilities 18   15
Expense for short-term leases and leases of low value 173   169
Total 332   303
       
Statements of cash flows
 
 
 
Total cash outflow for leases

333

 

303

 

  

For the Six Months

Ended June 30,

in CHF thousands  2022  2021
Statements of income/(loss)      
Depreciation of right-of-use assets   282    225 
Interest expense on lease liabilities   36    30 
Expense for short-term leases and leases of low value   347    356 
Total   665    611 
           
Statements of cash flows          
Total cash outflow for leases   666    611 

 

The following table presents the contractual undiscounted cash flows for lease obligations as of June 30, 2022:

 

in CHF thousands 

As of

June 30, 2022

Less than one year    638 
1-3 years    1,245 
3-5 years    900 
Total    2,783 

 

The Company also has deposits in escrow accounts totaling CHF 0.4 million for leases of the Company’s premises as of both June 30, 2022 and December 31, 2021, respectively. These deposits are presented in Long-term financial assets on the Company’s condensed consolidated balance sheets.

 

7.Net employee defined benefit liabilities

 

The Company used its independent actuaries to update the calculation of the defined benefit obligation and plan assets as of June 30, 2022. As of the June 30, 2022, the Company recognized a remeasurement gain of CHF 7.4 million on the Company’s condensed consolidated statements of comprehensive income/(loss) related to its net employee defined benefit liability. The primary component of the remeasurement gain as of and for the three and six months period ended June 30, 2022 relates to the increase in the discount rate by 195 basis points to 2.25% from 0.3% as of December 31, 2021.

 

The resulting impact as a result of the asset ceiling test is to record nil for the net employee defined benefit liability on the Company’s condensed consolidated balance sheets as of June 30, 2022 compared to CHF 7.1 million as of December 31, 2021.

 

10 

 

8.Accrued expenses

 

  

As of

in CHF thousands  June 30, 2022  December 31, 2021
Accrued Expenses   10,585    16,736 
Total   10,585    16,736 

 

The Company paid CHF 3.7 million in the period for a previous accrual associated with our cost sharing arrangement with Janssen and CHF 2.3 million related to performance-related remuneration for the six months ended June 30, 2022.

 

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 June 30, 2022  As of December 31, 2021
In CHF thousands  Gross Carrying Amount  Accumulated Amortization  Net Book Value  Gross Carrying Amount  Accumulated Amortization  Net Book 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 not determined the IPR&D asset to be impaired as of June 30, 2022.

 

10. Prepaid expenses

 

Prepaid expenses include prepaid R&D costs, administrative costs and net employee defined benefit liability expenses totaled CHF 3.5 million and CHF 3.0 million as of June 30, 2022 and December 31, 2021, respectively.

 

  11. Cash and cash equivalents and financial assets

 

The following table summarizes AC Immune’s cash and cash equivalents and short-term financial assets as of June 30, 2022 and December 31, 2021:

 

   As of
in CHF thousands  June 30, 2022  December 31, 2021
Cash and cash equivalents   63,147    82,216 
Total    63,147    82,216 

 

   As of
in CHF thousands  June 30, 2022  December 31, 2021
Short-term financial assets due in one year or less    91,000    116,000 
Total    91,000    116,000 

For the six months ended June 30, 2022, the Company purchased a net CHF 25.0 million in short-term financial assets.

 

11 

 

12.Treasury shares

 

For a discussion of our at the market offering program with Jefferies LLC for the fiscal year ended December 31, 2021, please refer to Note 11 “Share capital” of our Annual Report on Form 20-F for the year ended December 31, 2021 filed on March 22, 2022.

 

As of June 30, 2022, the Company has 6,221,617 treasury shares remaining.

 

13.Finance result, net

 

For the three months ended June 30, 2022 and 2021, AC Immune recorded CHF 0.2 million in net financial gains compared to CHF 0.4 million in net financial losses for the prior period. The Company recorded CHF 0.3 million in foreign currency gains compared to CHF 0.2 million foreign currency losses in the prior period.

 

For the six months ended June 30, 2022 and 2021, the Company recorded CHF 0.2 million and CHF 0.1 million in net financial gains, respectively. The Company recorded CHF 0.5 million and CHF 0.4 million in foreign currency gains, respectively.

 

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

 

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EX-99.2 3 dp177641_ex9902.htm EXHIBIT 99.2

 

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 six months ended June 30, 2022, 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, 2021 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 (the “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 July 28, 2022.

 

Business Overview

 

Our goal is to continue leveraging our proprietary discovery platforms, SupraAntigen and Morphomer, to become a global leader in precision medicine for the diagnosis and treatment of neurodegenerative diseases. We are executing a clear business strategy built on three pillars: (i) accelerate development of novel therapeutics in AD with our partners; (ii) expand our strategic focus in Parkinson’ disease (PD) and non-AD neurodegenerative diseases, including NeuroOrphan indications 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, to be used in concert 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, affording treatment with the right therapies at the right time.

 

Leveraging our dual proprietary technology platforms, 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 eleven therapeutic and three diagnostic programs, with seven currently in clinical trials, targeting five 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 validated technology platforms and personalized medicine approach position AC Immune to revolutionize the treatment of neurodegenerative disease in the way precision diagnostics and targeted therapies are revolutionizing the treatment of cancer.

 

Our clinical-stage product candidates include:

 

·ACI-35.030. Janssen and AC Immune are evaluating the anti-phosphorylated-Tau (anti-pTau) vaccine candidate ACI-35.030 in a Phase 1b/2a study in subjects with early AD. Interim results show that ACI-

 

 

 

35.030 vaccination 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-vaccination 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. No clinically relevant safety concerns related to the vaccine candidate were observed. Based on these results, the second highest dose cohort was expanded in Q2 2021 to facilitate plans for further late-stage development. ACI-35.030 specifically targets pathological pTau species and is eventually intended as a disease-modifying treatment for AD and other Tauopathies.

 

·ACI-24 for AD. A first Phase 1/2 study was completed and finalized in 2019. The subsequent Phase 2 study in AD assessed the safety, tolerability, immunogenicity and target engagement of ACI-24 using intramuscular immunizations and analyzed the effects of ACI-24 on brain amyloid as assessed by PET imaging. This trial was completed and finalized in November 2021. ACI-24 was safe and well tolerated and triggered a clear IgM response with lower Abeta-specific IgG titers. While no apparent effect in amyloid-PET was observed in this limited study population, there was evidence of a pharmacodynamic effect observed by an increase of CSF Aβ1-40 and Aβ1-42 levels compared to the placebo, thus suggesting target engagement. These results support the clinical development of the optimized formulation of ACI-24 (i.e. ACI-24.060) with Abeta unrelated T-helper cell epitopes to increase the magnitude and the boost-ability of the antibody response. A phase 1b/2, multicenter, adaptive, double-blind, randomized, placebo-controlled study to assess the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACl-24.060 is being evaluated in subjects with prodromal Alzheimer's disease and subsequently in adults with Down syndrome. The Clinical Trial Application (CTA) for a study evaluating the optimized formulation of ACI-24 in AD and Down syndrome populations has been approved and the first patient dosed in Q2 2022.

 

·ACI-24 for DS. Our Phase 1b clinical study of ACI-24 for individuals with DS, intended to assess safety, tolerability and immunogenicity at two doses, was completed and results reported in Q1 2021. The results support a favorable safety and tolerability profile of ACI-24 and show a pharmacodynamic response in this vulnerable patient population and the advancement of this program with the optimized formulation of ACI-24 (i.e. ACI-24.060).

 

·ACI-7104. ACI-7104, the optimized formulation of the clinically-validated PD vaccine candidate PD01, will advance into an adaptive, biomarker-based Phase 2 study. This trial will evaluate an initial dose-response of the optimized formulation focusing on 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 Parkinson’s disease will be monitored, together with digital, imaging and fluid biomarkers, in the second part of the study. The trial initiation is planned in H2 2022.

 

·Semorinemab. Our collaboration partner, Genentech, a member of the Roche Group, completed a first Phase 2 study (Tauriel) conducted in patients with prodromal-to-mild AD in Q3 2020. This trial did not meet its primary efficacy endpoint of reducing decline on Clinical Dementia Rating-Sum of Boxes (CDR-SB) compared to placebo; the primary safety endpoint was met. A second Phase 2 study (Lauriet) conducted in patients with mild-to-moderate AD was completed in Q3 2021 and top-line 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. Genentech reported that the open label portion of the study will continue as planned and that further analyses are ongoing. Semorinemab is designed to slow the prion-like propagation of Tau pathology, which coincides with both clinical symptoms and disease progression in AD.

 

·Crenezumab. In Q2 2022, the Company provided an update on its Alzheimer’s Prevention Initiative study evaluating crenezumab in autosomal dominant Alzheimer’s disease. Crenezumab did not statistically significantly slow or prevent cognitive decline in people with a specific genetic mutation which causes early-onset Alzheimer’s disease. However, numerical differences favoring crenezumab over placebo were observed across the co-primary, multiple secondary and exploratory endpoints. Initial data will be presented at the Alzheimer's Association International Conference (AAIC) on August 2, 2022.

 

2 

 

·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 indications. 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. In addition to AD, the program was expanded to NeuroOrphan indications and ACI-3024 will be further evaluated for efficacy in models of rare Tauopathies. 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. These will be broadly developed in Tau-dependent neurodegenerative diseases.

 

·Tau-PET tracer. PI-2620 is our Tau-PET imaging agent. 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. PI-2620 completed a Phase 2 clinical trial in AD in Q4 2021.

 

A study published in Movement Disorders indicated a value of PI-2620 for evaluating corticobasal syndrome, providing quantitatively and regionally distinct signals in beta-amyloid-positive as well as beta-amyloid-negative corticobasal syndrome. Further, results demonstrated PI-2620’s excellent characteristics as a diagnostic tool for studying Tau-related diseases following a recent publication (J Cereb Blood Flow Metab) that PI-2620 binding characteristics in cortical regions differentiated between 3/4R- and 4R-tauopathies and might serve as a supportive readout in the diagnostic workup of neurodegenerative disorders. Two test-retest studies in PSP (Phase 1) are open and recruiting with results anticipated in H2 2022.

 

·A-syn-PET tracer. Our next-generation PET imaging tracer, 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), a first-in-human study and an investigator-initiated study of our latest diagnostic agent targeting a-syn, ACI-12589 were initiated in Q1 and Q3 2021, respectively. The readouts of these trials in patients with PD, multiple system atrophy (MSA) and other synucleinopathies were reported at the AD/PDTM 2022 Conference. 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.

 

Interim 2022 Company Highlights

 

·Dosed the first patient in the placebo-controlled, Phase 1b/2 ABATE study evaluating the anti-Abeta vaccine ACI-24.060 in patients with prodromal Alzheimer’s disease (AD) and individuals with Down syndrome (DS). An interim data readout from the Phase 1b portion of the trial in AD is expected in H2 2022.

 

·Announced a peer-reviewed publication in JAMA Neurology featuring data showing that ACI-24, the predecessor of ACI-24.060, was safe and elicited an immune response in a Phase 1b clinical trial in adults with DS. This was the first-ever anti-Abeta vaccine study conducted in people living with DS and the paper also highlighted data providing evidence of target engagement in the trial.

 

·Announced topline results from the Phase 2 Alzheimer’s Prevention Initiative (API) study evaluating the anti-Abeta monoclonal antibody crenezumab in autosomal dominant Alzheimer’s disease (ADAD). Results showed that both co-primary endpoints of the study were not statistically significant but numerical differences favoring crenezumab were observed across the majority of primary, secondary and exploratory endpoints. More detailed results will be presented at the Alzheimer's Association International Conference (AAIC) on August 2, 2022 by AC Immune’s partner Genentech, a member of the Roche group and the Banner Alzheimer’s Institute.

 

·Announced that AC Immune Co-Founder and CEO Dr. Andrea Pfeifer received the prestigious Aenne Burda Award for Creative Leadership in recognition of her work.

 

3 

 

·Expanded leadership by appointing Howard Donovan as Chief Human Resources Officer and member of the Executive Committee. Mr. Donovan is an internationally experienced, commercially focused leader. He joins from the World Economic Forum, where he led People Services since 2015.

 

·Joerg Hornstein, Chief Financial Officer (CFO), will leave AC Immune in the second half of 2022 to pursue a new opportunity. AC Immune is well positioned with two members of the Company’s proven Finance Leadership Team who will transition to new roles. Christopher Roberts has been appointed Vice President, Finance and interim CFO. Julian Snow has been appointed Vice President, U.S. Finance & Corporate Development.

 

Results of Operations

 

The Covid-19 global pandemic has impacted various countries in which AC Immune currently operates clinical trials and business operations. The extent to which Covid-19 may impact us will depend on future developments, which are currently uncertain and cannot be predicted with confidence, such as the duration of the outbreak, the severity of Covid-19, or the effectiveness of actions to contain and treat Covid-19.

 

The Company continues to effect its business continuity plan and adapt as the situation evolves. Currently, we have resumed normal operations at full capacity, with minimal disruption to our business. We are continuously assessing and adapting our working practices and business operations to ensure compliance with official guidance and orders related to the pandemic and are working proactively with our partners and other stakeholders to take steps intended to mitigate and minimize any negative impact to our research, clinical programs and other business operations.

 

The Company does not currently have or project material impacts to the ongoing key trials. Additionally, the Company has drug supplies that are expected to be sufficient to complete ongoing trials as well as additional drug substance supplies expected to be sufficient to support ongoing cohorts of clinical trials for a period of at least three to six months. The Company will refrain from starting new clinical trials if a minimum of a six-month supply on hand cannot be secured. Finally, the Company currently does not expect delays to its clinical trials due to manufacturing or supply-chain issues.

 

Comparison of the three and six months ended June 30, 2022 and 2021

 

Contract revenues

 

The Company generated no contract revenues for the three and six months ended June 30, 2022 and 2021, respectively.

 

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 arrangements 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. We and Janssen are co-developing second-generation therapeutic vaccines, ACI-35.030 and JACI-35.054, through Phase 1b/2a completion. AC Immune and Janssen will jointly share R&D costs until the completion of the first Phase 2b (AC Immune’s contribution to the first Phase 2b trial is capped). From Phase 2b and onwards, Janssen will assume responsibility for the clinical development, manufacturing and commercialization of the vaccines. We also expect to incur additional R&D expenditures associated with the expansion of our Morphomer Tau program into AD and NeuroOrphan indications.

 

We also intend to increase our R&D costs associated with the advancement of ACI-7104 in Parkinson’s disease and our ACI-24 vaccine program (i.e. ACI-24 AD and ACI-24 DS) through mid- and late-stage clinical development.

 

Finally, we intend to further characterize our other clinical and preclinical candidates. In addition to these arrangements and proprietarily held assets, we expect that our total future R&D costs will increase over

 

4 

 

current levels, in line with our three-pillar strategy that focuses on (i) AD, (ii) focused non-AD NDD including Parkinson’s disease, 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, QA 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.

 

For the three months ended June 30, 2022, R&D expenses totaled CHF 15.7 million compared with CHF 13.7 million for the comparable period in 2021, respectively. This represents an increase of CHF 2.0 million. The following table presents the R&D expenses during the three months ended June 30, 2022 and 2021:

 

   For the Three Months
Ended June 30,
   
in CHF thousands, unaudited  2022  2021  Change
Discovery and preclinical expenses   4,405    4,932    (527)
Clinical expenses   3,326    2,958    368 
Group function expenses   338    141    197 
Total Direct R&D   8,069    8,031    38 
Payroll expenses   4,743    4,021    722 
Share-based compensation   362    328    34 
Other non-allocated   2,518    1,330    1,188 
Total R&D   15,692    13,710    1,982 

 

   For the Three Months
Ended June 30,
   
in CHF thousands, unaudited  2022  2021  Change
Operating expenses1   10,587    9,361    1,226 
Salaries and related costs2    5,105    4,349    756 
Total R&D expenses    15,692    13,710    1,982 

1Includes depreciation expense
2Includes share-based compensation expense

 

For the three months ended June 30, 2022:

 

Discovery and preclinical expenses decreased by CHF 0.5 million, primarily due to:

 

·a decrease of CHF 0.5 million in ACI-24 for DS for the development costs associated with the vaccine formulation and CHF 0.3 million for other discovery programs,

 

This was partially offset by:

 

·an increase of CHF 0.3 million associated with investments in our ACI-7104 vaccine, our alpha-synuclein vaccine for Parkinson’s disease acquired in Q4 2021.

 

Clinical expenses increased by CHF 0.4 million, primarily due to:

 

·an increase of CHF 0.8 million for the clinical development of ACI-7104, which were not incurred in the prior period and CHF 0.5 million for the clinical development of ACI-24 for DS,

 

This was partially offset by:

 

·a decrease of CHF 0.4 million for the clinical development of ACI-35.030 driven by timing of activities across various cohorts started in prior years and expenses associated with the R&D cost sharing, CHF 0.1 million for our alpha-synuclein imaging agent and CHF 0.4 million for other clinical programs.

 

5 

 

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

 

The variances in Other non-allocated expenses relate to administrative R&D and certain non-allocated functional expenses, primarily due to:

 

·an increase of CHF 0.7 million associated with the reallocation of certain IT and facilities expenditures made in Q2 2022 that were not reclassified in the prior period, CHF 0.2 million in certain IT related investments and CHF 0.3 million across various cost centers particularly in clinical and technical operations.

 

Total salaries and related costs increased by CHF 0.8 million, primarily due to:

 

·an increase in salary- and benefit-related costs of CHF 0.7 million primarily related to new hires during the quarter and annualization of 2021 hires.

 

For the six months ended June 30, 2022, R&D expenses totaled CHF 30.8 million compared with CHF 27.0 million for the comparable period in 2021. This represents an increase of CHF 3.8 million. The following table presents the R&D expenses during the six months ended June 30, 2022 and 2021:

 

   For the Six Months
Ended June 30,
   
in CHF thousands, unaudited  2022  2021  Change
Discovery and preclinical expenses   8,706    9,812    (1,106)
Clinical expenses   6,396    5,162    1,234 
Group function expenses   737    426    311 
Total Direct R&D   15,839    15,400    439 
Payroll expenses   9,085    8,521    564 
Share-based compensation   755    644    111 
Other non-allocated   5,136    2,475    2,661 
Total R&D   30,815    27,040    3,775 

 

   For the Six Months
Ended June 30,
   
in CHF thousands, unaudited  2022  2021  Change
Operating expenses1   20,975    17,875    3,100 
Salaries and related costs2    9,840    9,165    675 
Total R&D expenses    30,815    27,040    3,775 
1Includes depreciation expense
2Includes share-based compensation expense

 

For the six months ended June 30, 2022:

 

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

 

·a decrease of CHF 1.0 million in ACI-24 for DS for the development costs associated with the vaccine formulation and CHF 0.3 million for other discovery programs,

 

This was partially offset by:

 

·an increase of CHF 0.3 million associated with investments in our ACI-7104 vaccine, our alpha-synuclein vaccine for Parkinson’s disease acquired in Q4 2021.

 

Clinical expenses increased by CHF 1.2 million, primarily due to:

 

·an increase of CHF 1.3 million for the clinical development of ACI-24 for DS and CHF 1.0 million for the clinical development of ACI-7104, which were not incurred in the prior period,

 

6 

 

This was partially offset by:

 

·a decrease of CHF 0.3 million for the clinical development of ACI-35.030 driven by timing of activities across various cohorts started in prior years and expenses associated with the R&D cost sharing, CHF 0.2 million for our alpha-synuclein imaging agent and CHF 0.4 million for other clinical programs.

 

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

 

The variances in Other non-allocated expenses relate to administrative R&D and certain non-allocated functional expenses, primarily due to:

 

·an increase of CHF 1.4 million associated with the reallocation of certain IT and facilities expenditures for the six months ended June 30, 2022 that were not reclassified in the prior period, CHF 0.4 million in certain IT related investments and CHF 0.9 million across various cost centers particularly in research.

 

Total salaries and related costs increased by CHF 0.7 million, primarily due to:

 

·an increase in salary- and benefit-related costs of CHF 0.7 million primarily related to new hires during the period and annualization of 2021 hires.

 

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 June 30, 2022, general and administrative expenses totaled CHF 4.4 million compared with CHF 5.2 million for the comparable period in 2021. This represents a decrease of CHF 0.8 million. The following table presents the general and administrative expenses during the three months ended June 30, 2022 and 2021:

 

   For the Three Months
Ended June 30,
   
in CHF thousands, unaudited  2022  2021  Change
Operating expenses1    1,428    2,393    (965)
Salaries and related costs2    2,946    2,842    104 
Total general and administrative expenses    4,374    5,235    (861)
1Includes depreciation expense
2Includes share-based compensation expense

 

For the three months ended June 30, 2022, this decrease is primarily due to:

 

·a decrease of CHF 0.7 million associated with the reallocation of certain IT and facilities expenditures made in Q2 2022 that were not reclassified in the prior period; and

 

·a decrease CHF 0.4 million for transaction costs associated with our asset acquisition for a portfolio of therapeutics targeting alpha-synuclein and cash in 2021, which were not incurred in the current comparable period,

 

This was partially offset by;

 

·an increase in personnel expenses, including share-based compensation expense, of CHF 0.1 million and CHF 0.1 million increase in certain professional costs.

 

7 

 

For the six months ended June 30, 2022, general and administrative expenses totaled CHF 8.6 million compared with CHF 9.6 million for the comparable period in 2021. This represents a decrease of CHF 1.0 million. The following table presents the general and administrative expenses during the six months ended June 30, 2022 and 2021:

 

   For the Six Months
Ended June 30,
   
in CHF thousands, unaudited  2022  2021  Change
Operating expenses1    2,869    4,337    (1,468)
Salaries and related costs2    5,681    5,236    445 
Total general and administrative expenses    8,550    9,573    (1,023)
1Includes depreciation expense
2Includes share-based compensation expense

 

For the six months ended June 30, 2022, this decrease is primarily due to:

 

·a decrease of CHF 1.4 million associated with the reallocation of certain IT and facilities expenditures for the six months ended June 30, 2022 that were not reclassified in the prior period; and

 

·a decrease of CHF 0.4 million for transaction costs associated with our asset acquisition for a portfolio of therapeutics targeting alpha-synuclein and cash in 2021, which were not incurred in the current comparable period,

 

This was partially offset by;

 

·an increase in personnel expenses, including share-based compensation expense, of CHF 0.4 million, CHF 0.2 million increase in certain professional costs and CHF 0.2 million in other administrative expenses.

 

Other operating income/(expense)

 

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

 

For the three months ended June 30, 2022, other operating income/(expense) totaled CHF 0.2 million compared with CHF 0.3 million for the comparable period in 2021. This represents a decrease of CHF 0.1 million. The following table presents the other operating income/(expense) during the three months ended June 30, 2022 and 2021:

 

   For the Three Months
Ended June 30,
   
in CHF thousands, unaudited  2022  2021  Change
Other operating income/(expense)   207    256    (49)
Total other operating income/(expense)   207    256    (49)
                

For the three months ended June 30, 2022, this decrease is primarily due to:

 

·a decrease of less than CHF 0.1 million in grant income related to activities for the Company’s MJFF awards.

 

For the six months ended June 30, 2022, other operating income/(expense) totaled CHF 0.7 million compared with CHF 0.7 million for the comparable period in 2021. This represents an increase of less than CHF 0.1 million. The following table presents the other operating income/(expense) during the six months ended June 30, 2022 and 2021:

 

   For the Six Months
Ended June 30,
   
in CHF thousands, unaudited  2022  2021  Change
Other operating income/(expense)   677    673    4 
Total other operating income/(expense)   677    673    4 

 

For the six months ended June 30, 2022, this increase is primarily due to:

 

8 

 

·an increase of less than CHF 0.1 million in grant income related to activities for two MJFF awards awarded in Q4 2021.

 

Finance result, net

 

For the three months ended June 30, 2022, finance result was a CHF 0.2 million gain compared with a CHF 0.4 million loss for the comparable period in 2021. This represents an increase of CHF 0.6 million. The following table presents the finance result during the three months ended June 30, 2022 and 2021:

 

   For the Three Months
Ended June 30,
   
in CHF thousands, unaudited  2022  2021  Change
Financial income            
Financial expense    (126)   (202)   76 
Exchange differences   345    (178)   523 
Finance result, net    219    (380)   599 

 

For the three months ended June 30, 2022, net finance result was a gain, primarily related to:

 

·a CHF 0.5 million increase in exchange differences, primarily related to favorable movement in the USD-CHF exchange rate during the period as well as interest expense paid on short-term deposits.

 

For the six months ended June 30, 2022, finance result was a CHF 0.2 million gain compared with a CHF 0.1 million gain for the comparable period in 2021. This represents an increase of CHF 0.1 million. The following table presents the finance result during the six months ended June 30, 2022 and 2021:

 

   For the Six Months
Ended June 30,
   
in CHF thousands, unaudited  2022  2021  Change
Financial income            
Financial expense    (279)   (228)   (51)
Exchange differences   485    365    120 
Finance result, net    206    137    69 

 

For the six months ended June 30, 2022, net finance result was a gain, primarily related to:

 

·a CHF 0.1 million increase in exchange differences, primarily related to overall favorable movement in the USD-CHF exchange rate during the period,

 

This was partially offset by;

 

·CHF 0.1 million paid in finance costs and interest expense on short-term deposits.

 

Liquidity and Capital Resources

 

To date, AC Immune has financed its cash requirements primarily from its public offerings, share issuances, contract revenues from license and collaboration agreements 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. 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 June 30, 2022, we had cash and cash equivalents of CHF 63.1 million and short-term financial assets of CHF 91.0 million for a total liquidity balance of CHF 154.1 million.

 

Our primary uses of capital are, and we expect will continue to be, R&D expenses, 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

 

9 

 

accounts payable and accrued expenses. We expect to incur substantial expenses in connection with a number of our product candidates in various stages of clinical development. We and Janssen are co-developing second-generation therapeutic vaccines, ACI-35.030 and JACI-35.054, through Phase 1b/2a completion. AC Immune and Janssen will jointly share R&D costs until the completion of the first Phase 2b (AC Immune’s contribution to the first Phase 2b trial is capped). From Phase 2b and onwards, Janssen will assume responsibility for the clinical development, manufacturing and commercialization of the vaccines. We expect to incur additional R&D expenditures associated with the expansion of our Morphomer Tau program into AD and NeuroOrphan indications. We intend to increase our R&D costs associated with the advancement of ACI-7104 in Parkinson’s disease and our ACI-24 vaccine program (i.e. ACI-24 AD and ACI-24 DS) through mid-stage clinical development. We also intend to further characterize our preclinical candidates.

 

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 77.2) 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, and we have not yet sold any common shares pursuant to the new Sales Agreement.

 

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 Six Months
Ended June 30,
   
in CHF thousands, unaudited  2022  2021  Change
Net cash provided by/(used in):         
Operating activities    (42,624)   (33,362)   (9,262)
Investing activities    23,925    (31,447)   55,372 
Financing activities    (1,053)   7,688    (8,741)
Net decrease in cash and cash equivalents   (19,752)   (57,121)   37,369 

 

Operating activities

 

Net cash used in operating activities was CHF 42.6 million for the six months ended June 30, 2022, compared with net cash used in operating activities of CHF 33.4 million for the six months ended June 30, 2021. The change in cash used in operating activities for the six months ended June 30, 2022 was due to (i) the Company’s reporting a net loss of CHF 38.5 million for period, compared with a net loss of CHF 35.8 million for the same period in 2021, driven by a CHF 3.8 million increase in R&D expenditures for the six months ended June 30, 2022 and (ii) and a decrease of CHF 4.3 million in accrued expenses, representing cash outflows associated with the timing of certain accrual payments during the period.

 

Investing activities

 

Net cash provided by investing activities was CHF 23.9 million for the six months ended June 30, 2022, compared with net cash used in investing activities of CHF 31.4 million for the six months ended June 30, 2021. The Company settled short-term financial assets totaling CHF 25.0 million for the current period compared to

 

10 

 

the investment of a net CHF 30.0 million in the prior period. The Company additionally acquired CHF 1.1 million in fixed assets in the current period compared to CHF 1.4 million in the prior period.

 

 Financing activities

 

Net cash used in financing activities was CHF 1.1 million for the six months ended June 30, 2022, compared with net cash provided by financing activities of CHF 7.7 million for the six months ended June 30, 2021. The decrease of CHF 8.7 million is predominantly related to CHF 7.8 million received from proceeds from the sale of treasury shares in public offerings, net of underwriting fees and transaction costs in the prior period which were not received in the current comparable period. Additionally, the Company paid CHF 0.8 million in stamp duty associated with issuance of shares in relation to the asset acquisition that were previously accrued.

 

Operating Capital Requirements and Plan of Operations

 

We do not expect to generate revenues from royalties based on product sales unless and until our partners obtain regulatory approval of, and successfully commercialize, our current or any future product candidates. As of June 30, 2022, we had cash and cash equivalents of CHF 63.1 million and short-term financial assets of CHF 91.0 million, resulting in CHF 154.1 million of liquidity. The decrease relative to December 31, 2021 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, assuming that we do not receive potential milestone payments and based upon our currently contemplated R&D strategy, we believe that our existing capital resources will be sufficient to meet our projected operating requirements through at least Q1 2024.

 

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 expect to incur additional costs associated with operating a public company and 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 cost, timing and outcomes of managing, protecting and defending our intellectual property portfolio.

 

Quantitative and Qualitative Disclosures about Market Risk

 

During the three and six months ended June 30, 2022, there were no significant changes to our quantitative and qualitative disclosures about market risk described under the heading “Management’s Discussion and

 

11 

 

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, except as it relates to the Company’s derivative financial instruments.  

 

Non-IFRS Financial Measures

 

In addition to AC Immune’s operating results, as calculated in accordance with International Financial Reporting Standards (IFRS), as issued by the International Accounting Standards Board, we use adjusted loss and adjusted loss per share when monitoring and evaluating our operational performance. Adjusted loss is defined as loss for the relevant period, as adjusted for certain items that we believe are not indicative of our ongoing operating performance. Adjusted loss per share is defined as adjusted loss for the relevant period divided by the weighted-average number of shares for such period.

 

We believe that these measures assist our shareholders because they enhance the comparability of our results each period and provide more useful insight into operational results for the period. The Company’s executive management uses these non-IFRS measures to evaluate our operational performance. These non-IFRS financial measures are not meant to be considered alone or as substitutes for our IFRS financial measures and should be read in conjunction with the Company’s consolidated financial statements prepared in accordance with IFRS. The most directly comparable IFRS measure to these non-IFRS measures is net loss. The following table reconciles net loss to adjusted loss and adjusted loss per share for the periods presented:

 

Reconciliation of Loss to Adjusted Loss and
Loss Per Share to Adjusted Loss Per Share
 

 

   For the Three Months
Ended June 30,
  For the Six Months
Ended June 30,
in CHF thousands except for share and per share data, unaudited  2022  2021  2022  2021
Loss   (19,643)   (19,069)   (38,489)   (35,803)
Adjustments:                    
Non-cash share-based payments1   898    836    1,886    1,694 
Foreign currency (gains)/losses2   (430)   258    (683)   (363)
Transaction costs3       410        410 
Adjusted Loss   (19,175)   (17,565)   (37,286)   (34,062)
                     
Loss per share – basic and diluted   (0.23)   (0.26)   (0.46)   (0.50)
Adjustment to loss per share – basic and diluted       0.02    0.01    0.03 
Adjusted loss per share – basic and diluted   (0.23)   (0.24)   (0.45)   (0.47)
Weighted-average number of shares outstanding Adjusted loss – basic and diluted   84,462,675    72,715,783    83,510,567    72,113,581 

 

1Reflects non-cash expenses associated with share-based compensation for equity awards issued to Directors, Management and employees of the Company. This expense reflects the awards’ fair value recognized for the portion of the equity award which is vesting over the period.
2Reflects foreign currency re-measurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and Euro with the Swiss Franc.
3Reflects transaction costs associated with our asset acquisition for a portfolio of therapeutics targeting alpha-synuclein and cash.

 

Adjustments for the three and six months ended June 30, 2022, decreased net loss by CHF 0.5 million and CHF 1.2 million, respectively compared with a decrease to net loss of CHF 1.5 million and CHF 1.7 million, respectively, for the comparable periods in 2021. The Company recorded CHF 0.9 million and CHF 1.9 million for share-based compensation expenses, respectively, in each of these periods, and there were foreign currency re-measurement gains of CHF 0.4 million and CHF 0.7 million, respectively, primarily related to movement in the USD-CHF exchange rate during the respective periods. Finally, the Company incurred CHF 0.4 million in

 

12 

 

transaction costs associated with its acquisition of a portfolio of therapeutics targeting alpha-synuclein in the three and six months ended June 30, 2021, which were not incurred in the current comparable periods.

 

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, including the impact of Covid-19 on our business, suppliers, patients and employees, and any other impact of Covid-19. 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 such as the global pandemic originating with Covid-19, 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.

 

13 

EX-99.3 4 dp177641_ex9903.htm EXHIBIT 99.3

 

Exhibit 99.3

 

 

Press Release

 

 

AC Immune Reports Second Quarter 2022 Financial Results and Provides Corporate Update

 

·Three clinical readouts delivered year to date; four more expected by year-end

 

·First patient dosed with anti-Abeta vaccine ACI-24.060 in Phase 1b/2 ABATE study in patients with prodromal Alzheimer’s disease and individuals with Down syndrome

 

·Crenezumab API ADAD study results to be presented in detail at AAIC on August 2 after top-line data showed numerical differences favoring crenezumab over placebo across the majority of endpoints, though not statistically significant

 

·10 presentations on data from AC Immune pipeline to be presented at AAIC

 

·Strong financial position of CHF 154.1 million ensures the Company is fully financed until Q1 2024 not considering any incoming milestone payments

 

Lausanne, Switzerland, July 28, 2022 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today reported results for the quarter ended June 30, 2022, and provided a corporate update.

 

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “With world-class collaborators, including three major pharma companies, and cash for operations until Q1 2024, we believe we are well positioned to execute on multiple value-creating milestones. Our experienced team is working to deliver in H2 2022 four further clinical readouts from our precision medicine pipeline, adding to the three already reported.

 

“We continue to make real progress towards our goal of earlier diagnosis and prevention,” Dr. Pfeifer continued, “We recently treated the first prodromal Alzheimer’s disease patient in our innovative adaptive design Phase 1b/2 trial of ACI-24.060, a highly differentiated best-in-class vaccine-candidate that has demonstrated strong immunogenicity against the two most toxic forms of Abeta, pyroGlu-Abeta and oligomeric Abeta. We expect interim data later this year from the Phase 1b, enabling us to advance into Phase 2 in individuals with Down syndrome, virtually all of whom develop Alzheimer’s.”

 

Q2 2022 and Subsequent Highlights

 

Dosed the first patient in the placebo-controlled, Phase 1b/2 ABATE study evaluating the anti-Abeta vaccine ACI-24.060 in patients with prodromal Alzheimer’s disease (AD) and individuals with Down syndrome (DS). An interim data readout from the Phase 1b portion of the trial in AD is expected in H2 2022.

 

Announced a peer-reviewed publication in JAMA Neurology1 featuring data showing that ACI-24, the predecessor of ACI-24.060, was safe and elicited an immune response in a Phase 1b clinical trial in adults with DS. This was the first-ever anti-Abeta vaccine study

 

 

 

conducted in people living with DS and the paper also highlighted data providing evidence of target engagement in the trial.

 

Announced topline results from the Phase 2 Alzheimer’s Prevention Initiative (API) study evaluating the anti-Abeta monoclonal antibody crenezumab in autosomal dominant Alzheimer’s disease (ADAD). Results showed that both co-primary endpoints of the study were not statistically significant but numerical differences favoring crenezumab were observed across the majority of primary, secondary and exploratory endpoints. More detailed results will be presented at the Alzheimer's Association International Conference (AAIC) on August 2, 2022 by AC Immune’s partner Genentech, a member of the Roche group and the Banner Alzheimer’s Institute.

 

Announced that AC Immune Co-Founder and CEO Dr. Andrea Pfeifer received the prestigious Aenne Burda Award for Creative Leadership in recognition of her work.

 

Expanded leadership by appointing Howard Donovan as Chief Human Resources Officer and member of the Executive Committee. Mr. Donovan is an internationally experienced, commercially focused leader. He joins from the World Economic Forum, where he led People Services since 2015.

 

Joerg Hornstein, Chief Financial Officer (CFO), will leave AC Immune in the second half of 2022 to pursue a new opportunity. AC Immune is well positioned with two members of the Company’s proven Finance Leadership Team who will transition to new roles. Christopher Roberts has been appointed Vice President, Finance and interim CFO. Julian Snow has been appointed Vice President, U.S. Finance & Corporate Development.

 

Achieved and Anticipated 2022 Clinical Milestones

 

ACI-12589
a-syn-PET tracer
Reported breakthrough results from first-in-human study at AD/PD™ 2022 conference
ACI-35.030
anti-pTau vaccine
Reported Phase 1b/2a interim analysis from highest dose group; Expect to disclose late-stage development plans in H2 2022
ACI-24.060
anti-Abeta vaccine

Dosed first patient in Phase 1b/2 trial of ACI-24.060 in patients with AD and individuals with DS

 

Phase 1b in AD readout and decision to move into DS expected in H2 2022

Crenezumab
anti-Abeta antibody
Reported top line Phase 2 results from API study  in autosomal dominant AD .
Semorinemab
anti-Tau antibody
Additional biomarker data from the Phase 2 Lauriet study in mild-to-moderate AD expected in H2 2022
PI-2620
Tau-PET tracer

Phase 2 results in AD to be unveiled at AAIC in San Diego, California (United States) and online, July 31 – August 4, 2022.

 

Clinical PET study readout in orphan indication expected in H2 2022

ACI-7104
anti-a-syn vaccine
Initiation of Phase 2 trial in early PD expected in H2 2022

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Analysis of Financial Statements for the Quarter Ended June 30, 2022

 

Cash Position: The Company had a total cash balance of CHF 154.1 million, composed of CHF 63.1 million in cash and cash equivalents and CHF 91.0 million in short-term financial assets. This compares to a total cash balance of CHF 198.2 million as of December 31, 2021. The Company’s cash balance provides enough capital resources to progress through at least Q1 2024 without consideration of potential incoming milestone payments.

 

R&D Expenditures: R&D expenses increased by CHF 2.0 million for the three months ended June 30, 2022, to CHF 15.7 million.

 

oDiscovery and preclinical expenses (- CHF 0.5 million): The Company decreased expenditures across a variety of its discovery and preclinical programs, led by ACI-24 for DS as this program advances into clinical development.

 

oClinical expenses (+ CHF 0.4 million): The Company increased expenditures across multiple clinical programs, predominantly for ACI-24 for DS and ACI-7104.

 

oOther non-allocated (+ CHF 1.2 million): The Company’s other non-allocated R&D expenditure increased by CHF 0.9 million mostly related to the reallocation of certain IT and facilities costs, IT investments, as well as CHF 0.3 million across various other cost centers.

 

G&A Expenditures: For the three months ended June 30, 2022, G&A decreased by CHF 0.9 million to CHF 4.4 million. This decrease is mostly related to the reallocation of certain IT and facilities expenditures made in Q2 2022 that were not reclassified in the prior period.

 

Other Operating Income: The Company recognized CHF 0.2 million in grant income for R&D activities performed under our Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Target ALS grants, a decrease of less than CHF 0.1 million compared to the prior period.

 

IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 19.6 million for the three months ended June 30, 2022, compared with a net loss of CHF 19.1 million for the comparable period in 2021.

 

References

 

1.Rafii MS et al, Safety, Tolerability, and Immunogenicity of the ACI-24 Vaccine in Adults With Down Syndrome, A Phase 1b Randomized Clinical Trial, JAMA Neurology, 2022 May 9:79(5).

 

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 eleven therapeutic and three diagnostic candidates, six of which are currently in Phase 2 clinical trials. 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 Janssen

 

 3 / 7 

 

Pharmaceuticals, Inc., 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 and SG. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, NO and RU.

 

For further information, please contact:

 

Media Relations

Saoyuth Nidh 

AC Immune

Phone: +41 21 345 91 34 

Email: saoyuth.nidh@acimmune.com

Investor Relations

Gary Waanders, Ph.D., MBA 

AC Immune

Phone: +41 21 345 91 91 

Email: gary.waanders@acimmune.com

   

U.S. Media

Shani Lewis 

LaVoieHealthScience

Phone: +1 609 516 5761 

Email: slewis@lavoiehealthscience.com

U.S. Investors 

Corey Davis, Ph.D.

LifeSci Advisors 

Phone: +1 212 915 2577

Email: cdavis@lifesciadvisors.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. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. 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.

 

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Consolidated Balance Sheets

(In CHF thousands)

 

  

As of June 30,

2022

 

As of December 31,

2021

ASSETS      
Non-current assets      
Property, plant and equipment   4,997    5,116 
Right-of-use assets   2,632    2,914 
Intangible asset   50,416    50,416 
Long-term financial assets   361    363 
Total non-current assets   58,406    58,809 
Current assets          
Prepaid expenses   3,465    3,015 
Accrued income   433    975 
Other current receivables   335    428 
Short-term financial assets   91,000    116,000 
Cash and cash equivalents   63,147    82,216 
Total current assets   158,380    202,634 
Total assets   216,786    261,443 
           
SHAREHOLDERS’ EQUITY AND LIABILITIES          
Shareholders’ equity          
Share capital   1,796    1,794 
Share premium   431,260    431,251 
Treasury shares   (124)   (124)
Currency translation differences   49     
Accumulated losses   (230,169)   (200,942)
Total shareholders’ equity   202,812    231,979 
           
Non-current liabilities          
Long-term lease liabilities   2,050    2,340 
Net employee defined-benefit liabilities       7,098 
Total non-current liabilities   2,050    9,438 
           
Current liabilities          
Trade and other payables   337    2,003 
Accrued expenses   10,585    16,736 
Deferred income   425    717 
Short-term lease liabilities   577    570 
Total current liabilities   11,924    20,026 
Total liabilities   13,974    29,464 
Total shareholders’ equity and liabilities   216,786    261,443 

 5 / 7 

 

Statements of Income/(Loss)

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

 

   For the Three Months
Ended June 30,
  For the Six Months
Ended June 30,
   2022  2021  2022  2021
Revenue            
Contract revenue                
Total revenue                
                     
Operating expenses                    
Research & development expenses   (15,692)   (13,710)   (30,815)   (27,040)
General & administrative expenses   (4,374)   (5,235)   (8,550)   (9,573)
Other operating income/(expense)   207    256    677    673 
Total operating expenses   (19,859)   (18,689)   (38,688)   (35,940)
Operating loss   (19,859)   (18,689)   (38,688)   (35,940)
                     
Financial income                
Financial expense   (126)   (202)   (279)   (228)
Exchange differences   345    (178)   485    365 
Finance result, net   219    (380)   206    137 
Loss before tax   (19,640)   (19,069)   (38,482)   (35,803)
Income tax expense   (3)       (7)    
Loss for the period   (19,643)   (19,069)   (38,489)   (35,803)
Loss per share:   (0.23)   (0.26)   (0.46)   (0.50)

 

Statements of Comprehensive Income/(Loss)

(In CHF thousands)

 

   For the Three Months
Ended June 30,
  For the Six Months
Ended June 30,
   2022  2021  2022  2021
Loss for the period    (19,643)   (19,069)   (38,489)   (35,803)
Items that will be reclassified to income or loss in subsequent periods (net of tax):                    
Currency translation differences:   39        49     
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)    7,381        7,381     
Total comprehensive loss, net of tax   (12,223)   (19,069)   (31,059)   (35,803)

 6 / 7 

 

Reconciliation of loss to adjusted loss and
loss per share to adjusted loss per share

 

   For the Three Months
Ended June 30,
  For the Six Months
Ended June 30,
In CHF thousands, except for share and per share data  2022  2021  2022  2021
Loss   (19,643)   (19,069)   (38,489)   (35,803)
Adjustments                    
Non-cash share-based payments1   898    836    1,886    1,694 
Foreign currency (gains)/losses2   (430)   258    (683)   (363)
Transaction costs3       410        410 
Adjusted Loss   (19,175)   (17,565)   (37,286)   (34,062)
                     
Loss per share – basic and diluted   (0.23)   (0.26)   (0.46)   (0.50)
Adjustment to loss per share – basic and diluted       0.02    0.01    0.03 
Adjusted loss per share – basic and diluted   (0.23)   (0.24)   (0.45)   (0.47)
Weighted-average number of shares outstanding Adjusted loss –basic and diluted   84,462,675    72,715,783    83,510,567    72,113,581 

 

1Reflects non-cash expenses associated with share-based compensation for equity awards issued to Directors, Management and employees of the Company. This expense reflects the awards’ fair value recognized for the portion of the equity award which is vesting over the period.

2Reflects foreign currency re-measurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and Euro with the Swiss Franc.

3Reflects transaction costs for the asset acquisition for a portfolio of therapeutics targeting alpha-synuclein and cash.

 

Adjustments for the three and six months ended June 30, 2022, decreased net loss by CHF 0.5 million and CHF 1.2 million, respectively compared with a decrease to net loss of CHF 1.5 million and CHF 1.7 million, respectively, for the comparable periods in 2021. The Company recorded CHF 0.9 million and CHF 1.9 million for share-based compensation expenses, respectively, in each of these periods, and there were foreign currency re-measurement gains of CHF 0.4 million and CHF 0.7 million, respectively, primarily related to movement in the USD-CHF exchange rate during the respective periods. Finally, the Company incurred CHF 0.4 million in transaction costs associated with its acquisition of a portfolio of therapeutics targeting alpha-synuclein in the three and six months ended June 30, 2021, which were not incurred in the current comparable periods.

 

 7 / 7 

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