A/C Immune Reports Full Year 2022 Financial Results and Provides Corporate Update

A/C Immune Reports Full Year 2022 Financial Results and Provides Corporate Update

• Clinical-phase vaccine programs targeting amyloid-beta (Abeta), phosphorylated-Tau (pTau), and alpha-synuclein (a-syn) are all on track to reach crucial turning points in 2023

  

• ACI-24.060 anti-amyloid-beta vaccine for Alzheimer’s illness (ADVERTISEMENT) revealed favorable preliminary safety and immunogenicity in Phase 1b/2 ABATE trial; even more interim information anticipated in H2 2023; initially amyloid plaque animal imaging results expected in 2024

• ACI-35.030 anti-pTau vaccine for advertisement chosen for more advancement by partner; expected H2 2023 initiation of next trial in advertisement to be followed by turning point payment

• 2022 money burn of CHF 70.9 million was much better than assistance (2022: CHF 75-80 million) leading to strong end of year monetary position of CHF 122.6 million supplying runway into Q3 2024, omitting possible turning point payments

Lausanne, Switzerland, March 16, 2023 – A/C Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical business pioneering accuracy medication for neurodegenerative illness, today reported outcomes for the year ended December 31, 2022, and supplied a business update.

Dr. Andrea Pfeifer, CEO of A/C 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.”

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2022 and Subsequent Highlights

Pipeline Progress

Vaccine Programs

• Positive initial interim safety and immunogenicity data from the very first advertisement friend of the Phase 1b/2 ABATE trial of ACI-24.060, A/C Immune’s wholly-owned anti-amyloid beta (Abeta) SupraAntigen® vaccine prospect. Based on these information, ABATE has actually been broadened, as prepared, to begin screening of people with Down syndrome (DS) for involvement in part 2 of the trial and likewise to examine greater dosages in clients with advertisement. Interim safety and immunogenicity information from advertisement and DS friends are anticipated in the 2nd half of 2023.

• ACI-35.030, a prospective first-in-class anti-pTau vaccine prospect, was selected for further development, based upon medical information from a Phase 1b/2 trial in advertisement provided at CTAD 2022. These information revealed that vaccination with ACI-35.030 was well endured and generated a strong, long lasting, and boost-able antibody reaction versus pathological kinds of Tau such as pTau and its aggregated form, enriched paired helical filaments. ACI-35.030, produced utilizing a/c Immune’s SupraAntigen® innovation platform, is being established in partnership with Janssen Pharmaceuticals, Inc. (Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

• ACI-24.060 preclinical data released in the peer-reviewed journal Brain Communications, revealed it was well endured and produced a broad polyclonal immune reaction with high titers of antibodies versus neurotoxic pyroglutamate Abeta (pyroGlu-Abeta), a significant part of Abeta plaques. Additional preclinical information showed ACI-24.060’s strong immunogenicity versus another essential neurotoxic Abeta types, oligomeric Abeta.

• A peer-reviewed publication in JAMA Neurology revealed that the very first generation solution of ACI-24.060 was safe and generated an immune reaction in the first-ever medical research study of an anti-Abeta vaccine in people with DS. Data from the Phase 1b research study likewise supplied proof of target engagement by the polyclonal reaction to the studied vaccine.

Antibody Programs

• Detailed results from the Phase 2 Alzheimer’s Prevention Initiative (API) research study assessing the anti-Abeta monoclonal antibody crenezumab in autosomal dominant Alzheimer’s illness (ADAD) existed at the 2022 Alzheimer’s Association International Conference (AAIC) by A/C Immune’s partner Genentech, a member of the Roche group, and the Banner Alzheimer’s Institute. Numerical distinctions preferring crenezumab were observed throughout both co-primary endpoints, in addition to several secondary and exploratory endpoints, though none were statistically substantial. All individuals in the research study were provided to one year of ongoing treatment (crenezumab for all providers and placebo for all non-carrier) following completion of the double-blind duration while main outcomes and extra analyses were pending. Final effectiveness check outs have actually started.

• Further biofluid biomarker information from the Phase 2 Lauriet trial of the anti-Tau antibody semorinemab in mild-to-moderate advertisement existed in a poster at CTAD 2022. Results included in the poster revealed statistically substantial post-treatment decreases in pTau and overall Tau in the cerebrospinal fluid with semorinemab versus placebo, supporting target engagement and modulation in the main nerve system. The Lauriet open label extension research study is continuous.

Diagnostic Programs

• The first live images of a-syn in human brains were revealed utilizing ACI-12589, an a-syn animal tracer found utilizing a/c Immune’s Morphomer® platform. Analyses from a scientific research study of the tracer provided at AD/PD™ 2022 revealed boosted contrast and a-syn target uniqueness in clients with several system atrophy (MSA), in addition to increased tracer retention in brain locations impacted by MSA illness procedures, highlighting ACI-12589’s capacity as the very first non-invasive diagnostic for alpha-synucleinopathies (e.g. MSA).

• A/C Immune’s partner, Life Molecular Imaging, imaged the first patient in the critical Phase 3 ADvance trial assessing the Tau animal tracer, PI-2620, in advertisement. PI-2620 was found and established utilizing the Morphomer® platform as part of a research study partnership in between a/c Immune and LMI.

Management Team

Thought Leadership and Collaborations

• Received a follow-on grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to support boosted medical research studies of ACI-12589.

• Received new grants from MJFF and the Target ALS Foundation that jointly offer more than USD 500,000 in extra non-dilutive capital to support the development of diagnostic programs targeting TDP-43 (TAR DNA-binding protein 43).

• A/C Immune Co-Founder and CEO Dr. Andrea Pfeifer received the prestigious Aenne Burda Award for Creative Leadership in acknowledgment of her operate in the field of neurodegenerative illness.

Key Achieved and Anticipated 2023 Milestones

Analysis of Financial Statements for the Year Ended December 31, 2022

• Cash Position: The Company had an overall money balance of CHF 122.6 million, made up of CHF 31.6 million in money and money equivalents and CHF 91.0 million in short-term monetary possessions. This compares to an overall money balance of CHF 198.2 million since December 31, 2021. The Company’s money balance supplies enough capital resources to advance into a minimum of Q3 2024 without factor to consider of possible earnings turning point payments.

• Contract Revenues: The Company tape-recorded CHF 3.9 million in agreement incomes for the year end December 31, 2022 compared to no agreement incomes in the previous year. The boost connects to the development of PI-2620 into Phase 3 advancement in advertisement.

• R&D Expenditures: R&D costs reduced by CHF 1.9 million for the year ended December 31, 2022 to CHF 60.3 million, mainly due to:

  • Discovery and preclinical costs (- CHF 3.1 million): The Company reduced expenses throughout a range of its discovery and preclinical programs. This reduction was mainly due to the development of the Company’s ACI-24.060 vaccine into medical research studies.

  • Clinical costs (- CHF 1.8 million): The Company had a net reduction in medical expenses mainly due to the timing of activities throughout numerous friends and the conclusion of specific R&D cost sharing activities for our ACI-35.030 vaccine. We increased expenses in other medical programs, especially for the medical advancement of ACI-7104.056 and the initiation of our Phase 1b/2a ABATE research study for ACI-24.060.

  • Salary- and benefit-related expenses (+ CHF 1.2 million): Personnel costs increased due to the net boost in FTEs in 2022 together with the annualization of 2021 hires.

• G&A Expenditures: G&A expenses reduced by CHF 2.1 million for the year ended December 31, 2022 to CHF 15.8 million. This reduction is connected to previous year deal expenses sustained to finish the property acquisition of Affiris’ a-syn portfolio and the decrease in workers costs.

• Other Operating Income: The Company tape-recorded CHF 1.3 million in grant earnings for R&D activities carried out under our grants for the year ended December 31, 2022, a boost of CHF 0.1 million compared to the previous duration.

• IFRS Loss for the Period: The Company reported a bottom line after taxes of CHF 70.8 million for the year ended December 31, 2022, compared to a bottom line of CHF 73.0 million for the previous duration.

2023 Financial Guidance

• A/C Immune prepares for that its overall money burn will remain in the series of CHF 65 to CHF 75 million for the complete year 2023. The Company specifies money burn as running expenses gotten used to consist of capital investment and balanced out by substantial non-cash products (consisting of share-based settlement and devaluation expense).

About A/C Immune SA
A/C Immune SA is a clinical-stage biopharmaceutical business that intends to end up being an international leader in accuracy medication for neurodegenerative illness, consisting of Alzheimer’s illness, Parkinson’s illness, and NeuroOrphan indicators driven by misfolded proteins. The Company’s 2 scientifically confirmed innovation platforms, SupraAntigen^® and Morphomer^®, fuel its broad and varied pipeline of very first- and best-in-class possessions, which presently includes 10 restorative and 3 diagnostic prospects, 5 of which are presently in Phase 2 medical trials and among which remains in Phase 3. A/C Immune has a strong performance history of protecting tactical collaborations with leading international pharmaceutical business consisting of Genentech, a member of the Roche Group, Eli Lilly and Company, and others, leading to considerable non-dilutive financing to advance its exclusive programs and >$3 billion in possible turning point payments.

SupraAntigen® is a signed up hallmark of A/C Immune SA in the list below areas: AU, EU, CH, GB, JP, RU, SG and U.S.A.. Morphomer® is a signed up hallmark of A/C Immune SA in CN, CH, GB, JP, KR, NO and RU.

The details on our website and any other sites referenced herein is specifically not included by recommendation into, and does not make up a part of, this news release.

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Forward looking declarations
This news release consists of declarations that make up “forward-looking statements” within the significance of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking declarations are declarations aside from historic reality and might consist of declarations that deal with future operating, monetary or business efficiency or a/c Immune’s methods or expectations. In some cases, you can determine these declarations by positive words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other similar terms. Forward-looking declarations are based upon management’s existing expectations and beliefs and include substantial dangers and unpredictabilities that might trigger real outcomes, advancements and business choices to vary materially from those considered by these declarations. These dangers and unpredictabilities consist of those explained under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in A/C Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These consist of: the effect of Covid-19 on our business, providers, clients and workers and any other effect of Covid-19. Forward-looking declarations speak just since the date they are made, and a/c Immune does not carry out any responsibility to update them because of brand-new details, future advancements or otherwise, other than as might be needed under appropriate law. All positive declarations are certified in their whole by this cautionary declaration.

Consolidated Balance Sheets
(In CHF thousands)

Consolidated Statements of Income/(Loss)
(In CHF thousands, other than for per share information)

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

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

¹Reflects non-cash costs related to share-based settlement for equity awards provided to directors, management and workers of the Company. This expense shows the awards’ reasonable worth acknowledged for the part of the equity award which is vesting over the duration.
²Reflects foreign currency re-measurement gains and losses for the duration, mainly affected by the modification in the currency exchange rate in between the U.S. Dollar and the Swiss Franc.
³Reflects the modification in the reasonable worth of the acquired monetary instruments related to 2 convertible notes offered to specific Affiris associated entities.
⁴Reflects deal expenses related to our property acquisition for a portfolio of rehabs targeting alpha-synuclein.

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