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

ACIU 11.05.2024

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Drug:ACI-7104.056 ACI-7104.056
Drug:JNJ-2056 ACI-35.030
Diseases:Alzheimer's disease
Diseases:Parkinson's disease
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AC Immune Reports Third Quarter 2024 Financial Results and Provides a Corporate Update

  • ACI-7104.056 VacSYn Phase 2 trial in Parkinson's disease (PD) on track to report interim safety and immunogenicity data

  • Prescreening rate for Phase 2b Retain trial of JNJ-2056 (ACI-35.030) in Alzheimer's disease (AD) triggeredCHF 24.6 millionmilestone under agreement
  • JNJ-2056 received Fast Track designation from theU.S.FDA

  • Cash ofCHF 157.9 millionat the end of September, plus theCHF 24.6 millionmilestone payment received in October, provides runway into 2027

Lausanne,Switzerland,November 5, 2024–AC Immune SA(NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today reported results for the quarter endedSeptember 30, 2024, and provided a corporate update.

Dr.Andrea Pfeifer, CEO ofAC Immune SA, commented,"AC Immune has continued to make great strides in our pipeline programs and partnerships throughout the third quarter and recent months. We are particularly excited about the recognition received for ACI-35.030 from both our partner Janssen, in the form of aCHF 24.6 millionmilestone payment, and theU.S. Food and Drug Administration(FDA), in the form of Fast Track designation for JNJ-2056, and that the first patient has been dosed in the Retain trial. These milestones and the high level of patient and investigator enthusiasm fueling the rapid rate of prescreening for Retain, further highlight ACI-35.030's unique potential to prevent or slow progression in pre-symptomatic Alzheimer's disease. We are eagerly anticipating reporting in the coming weeks the interim safety and immunogenicity data from the Phase 2 VacSYn study of ACI-7104.056 for the treatment of early PD, as we move towards establishing clinical proof of concept with this active immunotherapy. Overall, this quarter has seen important incremental progress towards our overarching goal of shifting the treatment paradigm of neurodegenerative diseases towards precision medicine and disease prevention. We are now looking forward to a number of potentially transformational value inflection points in the future."

Anticipated 2024 Milestones

ACI-24.060anti-Abeta active immunotherapyABATE Phase 2 trial in AD remains on track withenrollment expectations
ACI-7104.056anti-a-syn active immunotherapyOn track to report interim safety and immunogenicity fromVacSYn Phase 2 trial by year end 2024
TDP-43-PET tracerPhase 1 initiation expected by year end 2024
ACI-15916a-syn-PET tracerIND-enabling studies in PD expected to be completed byyear end 2024

Q3 2024 and Subsequent Highlights

  • The Phase 2 VacSYn clinical trial of ACI-7104.056 in PD is progressing well with over 30 patients randomized in Part 1 of the study. We are on track to report the first interim safety and immunogenicity data from the trial.

  • AC Immuneachieved the second Retain-related milestone payment (CHF 24.6 million) under its agreement withJanssen Pharmaceuticals, Inc.(Janssen), a Johnson & Johnson company. The payment was triggered by the rapid rate of prescreening in the potentially registrational Phase 2b Retain trial investigating active-immunotherapy candidate ACI-35.030 (JNJ-2056) to treat preclinical (pre-symptomatic) AD. ACI-35.030 has been shown in Phase 1b/2a clinical testing to induce an antibody response targeting pathologic phosphorylated Tau, while sparing normal physiologic forms of Tau.

    • Retain-related milestone payments now totalCHF 40 million, including the first milestone payment earned inDecember 2023.

    • JNJ-2056 received Fast Track designation from the FDA for AD inJuly 2024.

  • AC Immune's partner Life Molecular Imaging (LMI) received Fast Track Designation for the partners' Tau positron emission tomography (PET) diagnostic, [18F]PI-2620, from the FDA in AD, progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD).

    • PI-2620 has demonstrated robust brain uptake and fast wash-out in non-target regions, a broad imaging window between 30- and 90-minutes post-injection for AD, and excellent reproducibility between test and retest scans.

  • AC Immune's preclinical results were featured in multiple presentations at the Alzheimer'sAssociation International Conference(AAIC) 2024:

    • A new class of neurodegenerative disease-fighting drugs: morADC (Morphomer®-antibody drug conjugates), presented by M. Derouazi, PhD (CSO of ACIU), featured data from the proprietary morADC platform. Results demonstrated the ability of morADCs to penetrate the blood brain barrierin vivoand produce potent catalytic activityin vitrocompared to the parental monoclonal antibody or small molecule alone.

    • Active immunotherapy, ACI-24.060, induces anti-Abeta antibodies with binding profiles mirroring clinically validated monoclonal antibodies,presented byE. Fiorini, PhD (ACIU), featured results from non-human primates showing that ACI-24.060 induced antibody responses with preferential oligomeric Abeta binding as compared to monomeric Abeta.

    • Discovery and preclinical development of [18F]ACI-19626, a first-in-class TDP-43 PET tracer,presented by T. Seredenina, PhD (ACIU), described the selection of [18F]ACI-19626 as a potential PET tracer for detection and monitoring progression of TDP-43 aggregates.

Analysis of Financial Statements for the Quarter EndedSeptember 30, 2024

  • Cash Position:The Company had a total cash balance ofCHF 157.9 million(CHF 103.1 millionas ofDecember 31, 2023), composed ofCHF 32.4 millionin cash and cash equivalents andCHF 125.5 millionin short-term financial assets. The Company's cash balance plus the second Retain-related milestone payment ofCHF 24.6 million, received inOctober 2024, provides sufficient capital resources into 2027, assuming no other milestones.

  • Contract Revenues:The Company recordedCHF 25.5 millionin contract revenues for the three months endedSeptember 30, 2024, compared to nil in the comparable prior period. For the three months endedSeptember 30, 2024, our contract revenues ofCHF 25.5 millionwere related to:

    • the recognition of the second Retain-related milestone payment ofCHF 24.6 millionunder the agreement with Janssen. This milestone payment was triggered by the rapid rate of prescreening in the potentially registrational Phase 2b Retain trial investigating active-immunotherapy candidate ACI-35.030 to treat preclinical AD; and

    • the efforts made under the agreement with Takeda.

  • R&D Expenditures:R&D expenses for the three months endedSeptember 30, 2024, wereCHF 14.5 millioncompared toCHF 12.4 millionin the comparable period in 2023. The increase was due mainly to higher clinical expenses, driven by the expansion of the ABATE study in our ACI-24.060 active immunotherapy.

  • G&A Expenditures:For the three months endedSeptember 30, 2024, G&A increased byCHF 0.3 milliontoCHF 3.8 million, mostly due to an increase in salaries and related costs, primarily due to new hires and higher expenses from equity awards granted in 2024, which have a higher fair value.

  • Other Operating Income:The Company recognized less thanCHF 0.1 millionin grant income from Target ALS grants.

  • IFRS Income/Loss for the Period:The Company reported a net income after taxes ofCHF 5.5 millionfor the three months endedSeptember 30, 2024, compared with a net loss ofCHF 15.1 millionfor the comparable period in 2023.

AboutAC Immune SAAC Immune SAis 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 Immunehas 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 billionin potential milestone payments plus royalties.

SupraAntigen® is a registered trademark ofAC Immune SAin the following territories: AU, EU, CH, GB, JP, RU, SG andUSA. Morphomer® is a registered trademark ofAC Immune SAin 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:

AC ImmuneGary Waanders, Ph.D., MBASenior Vice PresidentInvestor Relations & Corporate CommunicationsPhone: +41 21 345 91 91Email:gary.waanders@acimmune.comU.S. InvestorsChristina TartagliaPrecision AQPhone: +1 332 322 7430Email:christina.tartaglia@precisionaq.com
International MediaChris MaggosCohesion BureauPhone: +41 79 367 6254Email:chris.maggos@cohesionbureau.com

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

Condensed Consolidated Balance Sheets (Unaudited)

(In CHF thousands)

As of
September 30,December 31,
20242023
Assets
Non-current assets
Property, plant and equipment2,7363,376
Right-of-use assets3,0913,508
Intangible asset50,41650,416
Long-term financial assets415361
Total non-current assets56,65857,661
Current assets
Prepaid expenses3,4466,437
Accrued income780246
Other current receivables869622
Accounts receivable24,60014,800
Short-term financial assets125,47824,554
Cash and cash equivalents32,41778,494
Total current assets187,590125,153
Total assets244,248182,814
Shareholders' equity and liabilities
Shareholders' equity
Share capital2,2182,089
Share premium477,126474,907
Treasury

shares

(218)(105)
Currency translation differences(24)(51)
Accumulated losses(348,937)(316,197)
Total shareholders' equity130,165160,643
Non-current liabilities
Long-term deferred contract revenue4,790—
Long-term lease liabilities2,3892,825
Net employee defined benefit liabilities5,9175,770
Total non-current liabilities13,0968,595
Current liabilities
Trade and other payables1,4161,679
Accrued expenses12,89911,087
Short-term deferred income16138
Short-term deferred contract revenue85,962—
Short-term lease liabilities694672
Total current liabilities100,98713,576
Total liabilities114,08322,171
Total shareholders' equity and liabilities244,248182,814

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

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

For the Three MonthsFor the Nine Months
EndedSeptember 30,EndedSeptember 30,
2024202320242023
Revenue
Contract revenues25,485—26,172—
Total revenue25,485—26,172—
Operating expenses
Research & development expenses(14,482)(12,407)(46,785)(39,962)
General & administrative expenses(3,753)(3,465)(13,275)(11,252)
Other operating income/(expense), net194061281,131
Total operating expenses(18,216)(15,466)(59,932)(50,083)
Operating income/(loss)7,269(15,466)(33,760)(50,083)
Financial income9392852,307753
Financial expense(33)(26)(103)(150)
Exchange differences(2,672)67(3,563)—
Finance result, net(1,766)326(1,359)603
Income/(loss) before tax5,503(15,140)(35,119)(49,480)
Income tax expense—(3)—(9)
Income/(loss) for the period5,503(15,143)(35,119)(49,489)
Earnings/(loss) per share:
Basic income/(loss) for the period attributable to equity holders0.06(0.18)(0.35)(0.59)
Diluted income/(loss) for the period attributable to equity holders0.05(0.18)(0.35)(0.59)

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

For the Three MonthsFor the Nine Months
EndedSeptember 30,EndedSeptember 30,
2024202320242023
Income/(loss) for the period5,503(15,143)(35,119)(49,489)
Items that will be reclassified to income or loss in subsequent periods (net of tax):
Currency translation differences111127(5)
Items that will not to be reclassified to income or loss in subsequent periods (net of tax):
Remeasurement gains on defined-benefit plans————
Other comprehensive income/(loss)111127(5)
Total comprehensive income/(loss) (net of tax)5,514(15,132)(35,092)(49,494)

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  • 20241105__ACIU 3Q24 Earnings FINAL

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Source: AC Immune SA

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