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AC Immune Reports First Quarter 2024 Financial Results and Provides a Corporate Update

AC Immune Reports First Quarter 2024 Financial Results and Provides a Corporate Update

Lausanne, Switzerland, May 13, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering the development of precision medicine approaches for the diagnosis, treatment, and prevention of neurodegenerative diseases, today reported results for the quarter ended March 31, 2024, and provided a corporate update.

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “We are thrilled to have announced today our agreement with Takeda to advance ACI-24.060 anti-Abeta active immunotherapy in Alzheimer’s disease (AD). This landmark collaboration furthers our aim of pioneering Precision Prevention, establishing a powerful force in the neuroscience space that combines the neuroscience knowledge and expertise of AC Immune with the development and commercial experience of Takeda. We remain on track to report the first Phase 2 data this quarter on amyloid plaque reduction as assessed by PET scans after 6-months of treatment. This is a potentially de-risking event for ACI-24.060 that could enable advancement into a registrational study.”

“We continue to make strong progress elsewhere in our pipeline. Our partner Janssen continues to push ahead with the launch of the Phase 2b trial, ReTain, evaluating ACI-35.030 (JNJ-64042056), our anti-phospho-Tau active immunotherapy, in patients with pre-symptomatic AD. At the same time, our wholly-owned anti-alpha-synuclein active immunotherapy, ACI-7104.056, is advancing through Phase 2 testing to treat Parkinson’s disease, with safety and immunogenicity updates expected in the second half of 2024. Any of these three studies could be transformational for treatment of patients with neurodegenerative disease. With our significantly strengthened financial position, we are well-positioned to achieve our clinical development milestones across our pipeline through 2024 and beyond.”

Q1 2024 and Subsequent Highlights

Anticipated 2024 Milestones

ACI-24.060
anti-Abeta active immunotherapy
  • 6-month Abeta-PET data in AD expected in Q2 2024
  • Initial safety and immunogenicity data in Down syndrome cohort expected in H2 2024
  • 12-month Abeta-PET data in AD expected in H2 2024
ACI-7104.056
anti-a-syn active immunotherapy
  • Interim safety and immunogenicity update from the Phase 2 VacSYn study in Parkinson’s disease expected in H2 2024
ACI-35.030
anti-pTau active immunotherapy
  • First patient treated in ReTain Phase 2b clinical trial expected in the coming months
Anti-TDP-43 antibody
  • Completion of regulatory tox studies expected in H1 2024
TDP-43-PET tracer
  • Phase 1 initiation expected in H2 2024
ACI-15916
a-syn-PET tracer
  • IND-enabling studies in PD expected to be completed in H2 2024

Analysis of Financial Statements for the Quarter Ended March 31, 2024

About AC Immune SA

AC Immune SA is a clinical-stage biopharmaceutical company and a global leader in precision prevention for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features sixteen therapeutic and diagnostic programs, including five in Phase 2 development and one in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >$4.5 billion in potential milestone payments plus royalties.

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

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

For further information, please contact:

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

Condensed Consolidated Balance Sheets (Unaudited)
(In CHF thousands)

         
    As of
       March 31,       December 31, 
    2024   2023
Assets          
Non-current assets          
Property, plant and equipment   3,236   3,376
Right-of-use assets   3,341   3,508
Intangible asset   50,416   50,416
Long-term financial assets   415   361
Total non-current assets   57,408   57,661
         
Current assets        
Prepaid expenses   3,917   6,437
Accrued income   267   246
Other current receivables   868   622
Accounts receivable     14,800
Short-term financial assets   47,812   24,554
Cash and cash equivalents   57,009   78,494
Total current assets   109,873   125,153
Total assets   167,281   182,814
         
Shareholders’ equity and liabilities        
         
Shareholders’ equity        
Share capital   2,093   2,089
Share premium   475,286   474,907
Treasury shares   (105)   (105)
Currency translation differences   (35)   (51)
Accumulated losses   (332,558)   (316,197)
Total shareholders’ equity   144,681   160,643
         
Non-current liabilities        
Long-term lease liabilities   2,657   2,825
Net employee defined benefit liabilities   5,819   5,770
Total non-current liabilities   8,476   8,595
         
Current liabilities        
Trade and other payables   2,837   1,679
Accrued expenses   10,541   11,087
Deferred income   74   138
Short-term lease liabilities   672   672
Total current liabilities   14,124   13,576
Total liabilities   22,600   22,171
Total shareholders’ equity and liabilities   167,281   182,814

Condensed Consolidated Statements of Income/(Loss) (Unaudited)
(In CHF thousands, except for per-share data)

    For the Three Months
    Ended March 31, 
       2024      2023
Revenue          
Contract revenue    
Total revenue    
         
Operating expenses        
Research & development expenses   (15,165)   (13,873)
General & administrative expenses   (4,971)   (4,106)
Other operating income/(expense), net   68   408
Total operating expenses   (20,068)   (17,571)
Operating loss   (20,068)   (17,571)
         
Financial income   629   209
Financial expense   (36)   (97)
Exchange differences   1,613   (51)
Finance result, net   2,206   61
         
Loss before tax   (17,862)   (17,510)
Income tax expense     (3)
Loss for the period   (17,862)   (17,513)
Loss per share:   (0.18)   (0.21)

Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)
(In CHF thousands)

    For the Three Months
    Ended March 31, 
       2024      2023
Loss for the period   (17,862)   (17,513)
Items that will be reclassified to income or loss in subsequent periods (net of tax):         
Currency translation differences:   16   (8)
Items that will not to be reclassified to income or loss in subsequent periods (net of tax):         
Remeasurement gains on defined-benefit plans (net of tax)    
Total comprehensive loss, net of tax   (17,846)   (17,521)

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