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 March, 2023
Commission file number: 001-37891
AC IMMUNE SA
(Exact Name of Registrant as Specified in Its Charter)
|
EPFL Innovation Park
Building B
1015 Lausanne, Switzerland |
|
(Address of Principal Executive Offices) |
Indicate by check mark whether the registrant files
or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F
x 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 x
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 x
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
AC IMMUNE SA |
|
|
|
|
|
By: |
/s/
Andrea Pfeifer |
|
|
Name: |
Andrea Pfeifer |
|
|
Title: |
Chief Executive Officer |
|
By: |
/s/
Christopher Roberts |
|
|
Name: |
Christopher Roberts |
|
|
Title: |
Vice President Finance and interim Chief Financial Officer |
EXHIBIT INDEX
Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1651625/000110465923033059/tm239349d1_ex99-1img001.jpg) |
|
Press Release |
AC Immune Reports Full Year 2022 Financial
Results and Provides Corporate Update
· | Clinical-stage
vaccine programs targeting amyloid-beta (Abeta), phosphorylated-Tau (pTau), and alpha-synuclein
(a-syn) are all on track to reach important milestones in 2023 |
· | ACI-24.060
anti-amyloid-beta vaccine for Alzheimer’s disease (AD) showed positive initial safety
and immunogenicity in Phase 1b/2 ABATE trial; further interim data expected in H2 2023; first
amyloid plaque PET imaging results anticipated in 2024 |
· | ACI-35.030
anti-pTau vaccine for AD selected for further development by partner; anticipated H2 2023
initiation of next trial in AD to be followed by milestone payment |
· | 2022
cash burn of CHF 70.9 million was better than guidance (2022: CHF 75-80 million) resulting
in strong end of year financial position of CHF 122.6 million providing runway into Q3 2024,
excluding potential milestone payments |
Lausanne, Switzerland,
March 16, 2023 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine
for neurodegenerative diseases, today reported results for the year ended December 31, 2022, and provided a corporate update.
Dr. Andrea
Pfeifer, CEO of AC Immune SA, commented: “Thanks to the strong progress by our experienced team over
the past year, we now have highly innovative vaccines targeting neurotoxic species of Abeta, Tau or a-syn in mid- to late-stage development
for Alzheimer’s and Parkinson’s disease, respectively. This progress was highlighted by ABATE’s successful interim
readout in AD, which is enabling the quick and informed transition to this adaptive trial’s next cohorts. Importantly, ABATE remains
on track for additional readouts on ACI-24.060’s safety and immunogenicity this year, and for interim Abeta PET analyses in 2024
that will provide an opportunity for early de-risking and potentially a rapid transition to a pivotal program.”
“Together, our vaccines and the highly
specific diagnostics we are developing against targets such as Tau and a-syn form the cornerstone of our strategy to enable precision
medicine for neurodegenerative diseases. With this strategy, our long-term goal is to identify and treat the multifactorial pathologies
of each patient at their earliest stages, so that we can minimize irreversible neuronal damage and enable disease prevention.”
2022 and Subsequent Highlights
Pipeline Progress
Vaccine Programs
| · | Positive
initial interim safety and immunogenicity data from the first AD cohort of the Phase 1b/2
ABATE trial of ACI-24.060, AC Immune’s wholly-owned anti-amyloid beta (Abeta) SupraAntigen®
vaccine candidate. Based on these data, ABATE has been expanded, as planned, to begin screening
of individuals with Down syndrome (DS) for participation in part 2 of the trial and also
to evaluate higher doses in patients with AD. Interim safety and immunogenicity data from
AD and DS cohorts are expected in the second half of 2023. |
| · | ACI-35.030,
a potential first-in-class anti-pTau vaccine candidate, was selected for further development,
based on clinical data from a Phase 1b/2 trial in AD presented at CTAD 2022. These data showed
that vaccination with ACI-35.030 was well tolerated and elicited a strong, durable, and boost-able
antibody response against pathological forms of Tau such as pTau and its aggregated form,
enriched paired helical filaments. ACI-35.030, generated using AC Immune’s SupraAntigen®
technology platform, is being developed in collaboration with Janssen Pharmaceuticals, Inc.
(Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson. |
| · | ACI-24.060
preclinical data published in the peer-reviewed journal Brain Communications, showed
it was well tolerated and generated a broad polyclonal immune response with high titers of
antibodies against neurotoxic pyroglutamate Abeta (pyroGlu-Abeta), a major component of Abeta
plaques. Additional preclinical data demonstrated ACI-24.060’s strong immunogenicity
against another key neurotoxic Abeta species, oligomeric Abeta. |
| · | A peer-reviewed
publication in JAMA Neurology showed that the first generation formulation of
ACI-24.060 was safe and elicited an immune response in the first-ever clinical study of an
anti-Abeta vaccine in individuals with DS. Data from the Phase 1b study also provided evidence
of target engagement by the polyclonal response to the studied vaccine. |
Antibody Programs
| · | Detailed
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) were presented at the 2022 Alzheimer’s Association International Conference
(AAIC) by AC Immune’s partner Genentech, a member of the Roche group, and the Banner
Alzheimer’s Institute. Numerical differences favoring crenezumab were observed across
both co-primary endpoints, as well as multiple secondary and exploratory endpoints, though
none were statistically significant. All participants in the study were offered up to one
year of continued treatment (crenezumab for all carriers and placebo for all non-carrier)
following the end of the double-blind period while primary results and additional analyses
were pending. Final efficacy visits have begun. |
| · | Further
biofluid biomarker data from the Phase 2 Lauriet trial of the anti-Tau antibody semorinemab
in mild-to-moderate AD were presented in a poster at CTAD 2022. Results featured in the poster
showed statistically significant post-treatment reductions in pTau and total Tau in the cerebrospinal
fluid with semorinemab versus placebo, supporting target engagement and modulation in the
central nervous system. The Lauriet open label extension study is ongoing. |
Diagnostic Programs
| · | The
first live images of a-syn in human brains were shown using ACI-12589, an a-syn PET tracer
discovered using AC Immune’s Morphomer® platform. Analyses from a clinical study
of the tracer presented at AD/PD™ 2022 showed enhanced contrast and a-syn target specificity
in patients with multiple system atrophy (MSA), as well as increased tracer retention in
brain areas affected by MSA disease processes, highlighting ACI-12589’s potential as
the first non-invasive diagnostic for alpha-synucleinopathies (e.g. MSA). |
| · | AC
Immune’s partner, Life Molecular Imaging, imaged the first patient in the pivotal Phase
3 ADvance trial evaluating the Tau PET tracer, PI-2620, in AD. PI-2620 was discovered
and developed using the Morphomer® platform as part of a research collaboration between
AC Immune and LMI. |
Management Team
| · | Expanded
executive team with the appointment of Howard Donovan as Chief HR Officer. Prior to joining
AC Immune, Mr. Donovan led People Services at the World Economic Forum. |
| · | Promoted
Christopher Roberts to Interim Chief Financial Officer and Vice President, Finance. Mr. Roberts
previously held the title of Associate Vice President, Finance, and prior to joining AC Immune
worked as a Senior Manager for Ernst and Young. |
| · | Promoted
Julian Snow to Vice President, U.S. Finance & Corporate Development. Mr. Snow
previously held the title of Associate Vice President, Financial Reporting and prior to joining
AC Immune worked as a manager at BDO. |
Thought Leadership and Collaborations
| · | Received
a follow-on grant from The Michael J. Fox Foundation for Parkinson’s Research
(MJFF) to support enhanced clinical studies of ACI-12589. |
| · | Received
new grants from MJFF and the Target ALS Foundation that collectively provide more than
USD 500,000 in additional non-dilutive capital to support the advancement of diagnostic programs
targeting TDP-43 (TAR DNA-binding protein 43). |
| · | AC
Immune Co-Founder and CEO Dr. Andrea Pfeifer received the prestigious Aenne Burda Award
for Creative Leadership in recognition of her work in the field of neurodegenerative
diseases. |
Key Achieved and Anticipated 2023 Milestones
ACI-24.060
anti-Abeta vaccine |
· Reported
interim Phase 1b safety and immunogenicity data from first AD cohort of Phase 1b/2 ABATE study
· Initiation
of first DS cohort of ABATE study expected in H1 2023
· Submission
of an Investigational New Drug (IND) application to enable expansion of ABATE study to the U.S. expected in H1 2023
· Additional
interim safety and immunogenicity data from AD cohort of ABATE study expected in H2 2023
· Interim
safety and immunogenicity data from DS cohort of ABATE study expected in H2 2023 |
ACI-7104
anti-a-syn vaccine |
· Update
from Phase 2 VACSYN study expected in H2 2023 |
ACI-35.030
anti-pTau vaccine |
· Initiation
of next trial in AD expected in H2 2023 (to be followed by milestone payment) |
Semorinemab
anti-Tau antibody |
· Results
from the open-label extension of the Phase 2 Lauriet trial in mild-to-moderate AD expected in H2 2023 |
Anti-TDP-43
antibody |
· Advancement
of candidate into preclinical development (tox) expected in H2 2023 |
a-syn-PET
tracer |
· Declaration
of next clinical candidate for development in Parkinson’s disease expected in H2 2023 |
TDP-43-PET
tracer |
· Clinical
candidate declaration expected in H1 2023 |
Analysis of Financial
Statements for the Year Ended December 31, 2022
| · | Cash
Position: The Company had a total cash balance of CHF 122.6 million, composed of CHF
31.6 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 sufficient capital resources to progress into at
least Q3 2024 without consideration of potential income milestone payments. |
| · | Contract
Revenues: The Company recorded CHF 3.9 million in contract revenues for the year end
December 31, 2022 compared with no contract revenues in the prior year. The increase
relates to the progression of PI-2620 into Phase 3 development in AD. |
| · | R&D
Expenditures: R&D expenses decreased by CHF 1.9 million for the year ended December 31,
2022 to CHF 60.3 million, predominantly due to: |
| o | Discovery
and preclinical expenses (- CHF 3.1 million): The Company decreased expenditures across
a variety of its discovery and preclinical programs. This decrease was predominantly due
to the advancement of the Company’s ACI-24.060 vaccine into clinical studies. |
| o | Clinical
expenses (- CHF 1.8 million): The Company had a net decrease in clinical expenditures
largely due to the timing of activities across various cohorts and the completion of certain
R&D cost sharing activities for our ACI-35.030 vaccine. We increased expenditures in
other clinical programs, notably for the clinical development of ACI-7104.056 and the initiation
of our Phase 1b/2a ABATE study for ACI-24.060. |
| o | Salary-
and benefit-related costs (+ CHF 1.2 million): Personnel expenses increased due to the
net increase in FTEs in 2022 along with the annualization of 2021 hires. |
| · | G&A
Expenditures: G&A expenses decreased by CHF 2.1 million for the year ended December 31,
2022 to CHF 15.8 million. This decrease is related to prior year transaction costs incurred
to complete the asset acquisition of Affiris’ a-syn portfolio and the reduction in
personnel expenses. |
| · | Other
Operating Income: The Company recorded CHF 1.3 million in grant income for R&D activities
performed under our grants for the year ended December 31, 2022, an increase of CHF
0.1 million compared to the prior period. |
| · | IFRS
Loss for the Period: The Company reported a net loss after taxes of CHF 70.8 million
for the year ended December 31, 2022, compared with a net loss of CHF 73.0 million for
the prior period. |
2023 Financial Guidance
| · | AC
Immune anticipates that its total cash burn will be in the range of CHF 65 to CHF 75 million
for the full year 2023. The Company defines cash burn as operating expenditures adjusted
to include capital expenditures and offset by significant non-cash items (including share-based
compensation and depreciation expense). |
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 ten therapeutic and three diagnostic candidates, five of which are currently in Phase 2 clinical trials
and one of which is in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global
pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company, and others, resulting in
substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments.
SupraAntigen® is a registered trademark
of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark
of AC Immune SA in CN, CH, GB, JP, KR, NO and RU.
The information on our website and any other
websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release.
For further information, please contact:
Head of Investor Relations & Corporate Communications
Gary Waanders, Ph.D., MBA
AC Immune
Phone: +41 21 345 91 91
Email: gary.waanders@acimmune.com
|
U.S. Investors
Corey Davis, Ph.D.
LifeSci Advisors
Phone: +1 212 915 2577
Email: cdavis@lifesciadvisors.com
|
International Media
Chris Maggos
Cohesion Bureau
Phone: +41 79 367 6254
Email: chris.maggos@cohesionbureau.com |
|
Forward looking statements
This press release contains statements that constitute
“forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of
the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements
that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you
can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,”
“expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,”
“projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking
statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could
cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks
and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item
5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the
Securities and Exchange Commission. 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.
Consolidated Balance Sheets
(In CHF thousands)
| |
As of December 31,
2022 | | |
As of December 31,
2021 | |
ASSETS | |
| | | |
| | |
Non-current assets | |
| | | |
| | |
Property, plant and equipment | |
| 4,259 | | |
| 5,116 | |
Right-of-use assets | |
| 2,808 | | |
| 2,914 | |
Intangible asset | |
| 50,416 | | |
| 50,416 | |
Long-term financial assets | |
| 361 | | |
| 363 | |
Total non-current assets | |
| 57,844 | | |
| 58,809 | |
Current assets | |
| | | |
| | |
Prepaid expenses | |
| 4,708 | | |
| 3,015 | |
Accrued income | |
| 408 | | |
| 975 | |
Other current receivables | |
| 392 | | |
| 428 | |
Short-term financial assets | |
| 91,000 | | |
| 116,000 | |
Cash and cash equivalents | |
| 31,586 | | |
| 82,216 | |
Total current assets | |
| 128,094 | | |
| 202,634 | |
Total assets | |
| 185,938 | | |
| 261,443 | |
| |
| | | |
| | |
SHAREHOLDERS’ EQUITY AND LIABILITIES | |
| | | |
| | |
Shareholders’ equity | |
| | | |
| | |
Share capital | |
| 1,797 | | |
| 1,794 | |
Share premium | |
| 431,323 | | |
| 431,251 | |
Treasury shares | |
| (124 | ) | |
| (124 | ) |
Currency translation differences | |
| 10 | | |
| — | |
Accumulated losses | |
| (264,015 | ) | |
| (200,942 | ) |
Total shareholders’ equity | |
| 168,991 | | |
| 231,979 | |
| |
| | | |
| | |
Non-current liabilities | |
| | | |
| | |
Long-term lease liabilities | |
| 2,253 | | |
| 2,340 | |
Net employee defined-benefit liabilities | |
| 3,213 | | |
| 7,098 | |
Total non-current liabilities | |
| 5,466 | | |
| 9,438 | |
| |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Trade and other payables | |
| 929 | | |
| 2,003 | |
Accrued expenses | |
| 9,417 | | |
| 16,736 | |
Deferred income | |
| 587 | | |
| 717 | |
Short-term lease liabilities | |
| 548 | | |
| 570 | |
Total current liabilities | |
| 11,481 | | |
| 20,026 | |
Total liabilities | |
| 16,947 | | |
| 29,464 | |
Total shareholders’ equity and liabilities | |
| 185,938 | | |
| 261,443 | |
Consolidated Statements of Income/(Loss)
(In CHF thousands, except for per share data)
| |
For the Year Ended December 31, | |
| |
2022 | | |
2021 | | |
2020 | |
Revenue | |
| | | |
| | | |
| | |
Contract revenue | |
| 3,935 | | |
| — | | |
| 15,431 | |
Total revenue | |
| 3,935 | | |
| — | | |
| 15,431 | |
| |
| | | |
| | | |
| | |
Operating expenses | |
| | | |
| | | |
| | |
Research & development expenses | |
| (60,336 | ) | |
| (62,282 | ) | |
| (59,487 | ) |
General & administrative expenses | |
| (15,789 | ) | |
| (17,910 | ) | |
| (18,557 | ) |
Other operating income/(expense), net | |
| 1,343 | | |
| 1,182 | | |
| 1,353 | |
| |
| | | |
| | | |
| | |
Total operating expenses | |
| (74,782 | ) | |
| (79,010 | ) | |
| (76,691 | ) |
| |
| | | |
| | | |
| | |
Operating loss | |
| (70,847 | ) | |
| (79,010 | ) | |
| (61,260 | ) |
Financial income | |
| 69 | | |
| 6,485 | | |
| 78 | |
Financial expense | |
| (355 | ) | |
| (581 | ) | |
| (184 | ) |
Exchange differences | |
| 393 | | |
| 113 | | |
| (555 | ) |
Finance result, net | |
| 107 | | |
| 6,017 | | |
| (661 | ) |
Loss before tax | |
| (70,740 | ) | |
| (72,993 | ) | |
| (61,921 | ) |
Income tax expense | |
| (13 | ) | |
| (3 | ) | |
| — | |
Loss for the period | |
| (70,753 | ) | |
| (72,996 | ) | |
| (61,921 | ) |
Loss per share: | |
| | | |
| | | |
| | |
Basic and diluted loss for the period attributable to equity holders | |
| (0.85 | ) | |
| (0.97 | ) | |
| (0.86 | ) |
Consolidated Statements of Comprehensive Income/(Loss)
(In CHF thousands)
| |
For the Year Ended December 31, | |
| |
2022 | | |
2021 | | |
2020 | |
Loss for the period | |
| (70,753 | ) | |
| (72,996 | ) | |
| (61,921 | ) |
Items that may be reclassified to income or loss in subsequent periods (net of tax): | |
| | | |
| | | |
| | |
Currency translation differences | |
| 10 | | |
| — | | |
| — | |
Items that will not be reclassified to income or loss in subsequent periods (net of tax): | |
| | | |
| | | |
| | |
Remeasurement gains on defined-benefit plans (net of tax) | |
| 4,426 | | |
| 956 | | |
| 726 | |
Other comprehensive income | |
| 4,436 | | |
| 956 | | |
| 726 | |
Total comprehensive loss, net of tax | |
| (66,317 | ) | |
| (72,040 | ) | |
| (61,195 | ) |
Reconciliation of loss to adjusted loss and
loss per share to adjusted loss per share
| |
For the Year Ended December 31, | |
(In CHF thousands, except for share and per share data) | |
2022 | | |
2021 | | |
2020 | |
Loss | |
| (70,753 | ) | |
| (72,996 | ) | |
| (61,921 | ) |
Adjustments: | |
| | | |
| | | |
| | |
Non-cash share-based payments1 | |
| 3,330 | | |
| 4,126 | | |
| 4,088 | |
Foreign currency (gains)/losses2 | |
| (521 | ) | |
| 70 | | |
| 703 | |
Change in fair value of derivative financial assets3 | |
| — | | |
| (6,459 | ) | |
| — | |
Transaction costs4 | |
| — | | |
| 1,144 | | |
| — | |
Adjusted loss | |
| (67,944 | ) | |
| (74,115 | ) | |
| (57,130 | ) |
| |
| | | |
| | | |
| | |
Loss per share – basic and diluted | |
| (0.85 | ) | |
| (0.97 | ) | |
| (0.86 | ) |
Adjustment to loss per share – basic and diluted | |
| 0.04 | | |
| (0.02 | ) | |
| 0.07 | |
Adjusted loss per share – basic and diluted | |
| (0.81 | ) | |
| (0.99 | ) | |
| (0.79 | ) |
Weighted-average number of shares used to compute adjusted loss per share – basic and diluted | |
| 83,554,412 | | |
| 74,951,833 | | |
| 71,900,212 | |
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 U.S. Dollar and the Swiss Franc.
3Reflects the change in the fair value
of the derivative financial instruments associated with two convertible notes sold to certain Affiris affiliated entities.
4Reflects transaction costs associated
with our asset acquisition for a portfolio of therapeutics targeting alpha-synuclein.
This regulatory filing also includes additional resources:
tm239349d1_ex99-2.pdf
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