EX-99.3 4 aciu-20241105xex99d3.htm EX-99.3

Exhibit 99.3

Graphic

PRESS RELEASE

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

ACI-7104.056 VacSYn Phase 2 trial in Parkinsons 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 Alzheimers disease (AD) triggered CHF 24.6 million milestone under agreement
JNJ-2056 received Fast Track designation from the U.S. FDA
Cash of CHF 157.9 million at the end of September, plus the CHF 24.6 million milestone 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 ended September 30, 2024, and provided a corporate update.

Dr. Andrea Pfeifer, CEO of AC 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 a CHF 24.6 million milestone payment, and the U.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-24.060

anti-Abeta active immunotherapy

ABATE Phase 2 trial in AD remains on track with enrollment expectations

ACI-7104.056

anti-a-syn active immunotherapy

On track to report interim safety and immunogenicity from VacSYn Phase 2 trial by year end 2024

TDP-43-PET tracer

Phase 1 initiation expected by year end 2024

ACI-15916

a-syn-PET tracer

IND-enabling studies in PD expected to be completed by year 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 Immune achieved the second ReTain-related milestone payment (CHF 24.6 million) under its agreement with Janssen 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.
oReTain-related milestone payments now total CHF 40 million, including the first milestone payment earned in December 2023.
oJNJ-2056 received Fast Track designation from the FDA for AD in July 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).
oPI-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’s Association International Conference (AAIC) 2024:
oA 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 barrier in vivo and produce potent catalytic activity in vitro compared to the parental monoclonal antibody or small molecule alone.
oActive immunotherapy, ACI-24.060, induces anti-Abeta antibodies with binding profiles mirroring clinically validated monoclonal antibodies, presented by E. 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.
oDiscovery 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 Ended September 30, 2024

Cash Position: The Company had a total cash balance of CHF 157.9 million (CHF 103.1 million as of December 31, 2023), composed of CHF 32.4 million in cash and cash equivalents and CHF 125.5 million in short-term financial assets. The Company’s cash balance plus the second ReTain-related milestone payment of CHF 24.6 million, received in October 2024, provides sufficient capital resources into 2027, assuming no other milestones.
Contract Revenues: The Company recorded CHF 25.5 million in contract revenues for the three months ended September 30, 2024, compared to nil in the comparable prior period. For the three months ended September 30, 2024, our contract revenues of CHF 25.5 million were related to:
othe recognition of the second ReTain-related milestone payment of CHF 24.6 million under 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


othe efforts made under the agreement with Takeda.
R&D Expenditures: R&D expenses for the three months ended September 30, 2024, were CHF 14.5 million compared to CHF 12.4 million in 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 ended September 30, 2024, G&A increased by CHF 0.3 million to CHF 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 than CHF 0.1 million in grant income from Target ALS grants.
IFRS Income/Loss for the Period: The Company reported a net income after taxes of CHF 5.5 million for the three months ended September 30, 2024, compared with a net loss of CHF 15.1 million for the comparable period in 2023.

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:

AC Immune

Gary Waanders, Ph.D., MBA 

Senior Vice President

Investor Relations & Corporate Communications

Phone: +41 21 345 91 91 

Email: gary.waanders@acimmune.com 

U.S. Investors 

Christina Tartaglia

Precision AQ 

Phone: +1 332 322 7430  

Email: christina.tartaglia@precisionaq.com 

 

 

International Media 

Chris Maggos 

Cohesion Bureau 

Phone: +41 79 367 6254 

Email: chris.maggos@cohesionbureau.com  


Forward looking statements

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


Condensed Consolidated Balance Sheets (Unaudited)

(In CHF thousands)

    

As of

September 30, 

December 31, 

2024

2023

Assets

 

  

 

  

Non-current assets

 

  

 

  

Property, plant and equipment

 

2,736

 

3,376

Right-of-use assets

 

3,091

 

3,508

Intangible asset

 

50,416

 

50,416

Long-term financial assets

 

415

 

361

Total non-current assets

 

56,658

 

57,661

Current assets

 

 

Prepaid expenses

 

3,446

 

6,437

Accrued income

 

780

 

246

Other current receivables

 

869

 

622

Accounts receivable

24,600

14,800

Short-term financial assets

 

125,478

 

24,554

Cash and cash equivalents

 

32,417

 

78,494

Total current assets

 

187,590

 

125,153

Total assets

 

244,248

 

182,814

Shareholders' equity and liabilities

 

 

Shareholders’ equity

 

 

Share capital

 

2,218

 

2,089

Share premium

 

477,126

 

474,907

Treasury shares

 

(218)

 

(105)

Currency translation differences

 

(24)

 

(51)

Accumulated losses

 

(348,937)

 

(316,197)

Total shareholders’ equity

 

130,165

 

160,643

Non-current liabilities

 

 

Long-term deferred contract revenue

4,790

Long-term lease liabilities

 

2,389

 

2,825

Net employee defined benefit liabilities

 

5,917

 

5,770

Total non-current liabilities

 

13,096

 

8,595

Current liabilities

 

 

Trade and other payables

 

1,416

 

1,679

Accrued expenses

 

12,899

 

11,087

Short-term deferred income

16

138

Short-term deferred contract revenue

 

85,962

 

Short-term lease liabilities

 

694

 

672

Total current liabilities

 

100,987

 

13,576

Total liabilities

 

114,083

 

22,171

Total shareholders’ equity and liabilities

 

244,248

 

182,814


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

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

For the Three Months

For the Nine Months

Ended September 30, 

Ended September 30, 

    

2024

    

2023

    

2024

    

2023

Revenue

 

  

 

  

 

  

 

  

Contract revenues

 

25,485

 

 

26,172

 

Total revenue

 

25,485

 

 

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), net

 

19

 

406

 

128

 

1,131

Total operating expenses

 

(18,216)

 

(15,466)

 

(59,932)

 

(50,083)

Operating income/(loss)

 

7,269

 

(15,466)

 

(33,760)

 

(50,083)

Financial income

 

939

 

285

 

2,307

 

753

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 tax

 

5,503

 

(15,140)

 

(35,119)

 

(49,480)

Income tax expense

 

 

(3)

 

 

(9)

Income/(loss) for the period

 

5,503

 

(15,143)

 

(35,119)

 

(49,489)

Earnings/(loss) per share:

 

Basic income/(loss) for the period attributable to equity holders

0.06

 

(0.18)

 

(0.35)

 

(0.59)

Diluted income/(loss) for the period attributable to equity holders

 

0.05

 

(0.18)

 

(0.35)

 

(0.59)

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

(In CHF thousands)

For the Three Months

For the Nine Months

Ended September 30, 

Ended September 30, 

    

2024

    

2023

    

2024

    

2023

Income/(loss) for the period

 

5,503

 

(15,143)

 

(35,119)

 

(49,489)

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

Currency translation differences

11

 

11

 

27

 

(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)

 

11

 

11

 

27

 

(5)

Total comprehensive income/(loss) (net of tax)

 

5,514

 

(15,132)

 

(35,092)

 

(49,494)