AC Immune Reports Second Quarter 2022 Financial Results and

• Three medical readouts delivered 12 months thus far; 4 extra anticipated by year-end
• First affected person dosed with anti-Abeta vaccine ACI-24.060 in Part 1b/2 ABATE research in sufferers with prodromal Alzheimer’s illness and people with Down syndrome
• Crenezumab API ADAD research outcomes to be introduced intimately at AAIC on August 2 after top-line knowledge confirmed numerical variations favoring crenezumab over placebo throughout nearly all of endpoints, although not statistically important
• 10 displays on knowledge from AC Immune pipeline to be introduced at AAIC
• Robust monetary place of CHF 154.1 million ensures the Firm is totally financed till Q1 2024 not contemplating any incoming milestone funds

LAUSANNE, Switzerland, July 28, 2022 (GLOBE NEWSWIRE) — AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical firm pioneering precision medication for neurodegenerative ailments, at the moment reported outcomes for the quarter ended June 30, 2022, and supplied a company replace.

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “With world-class collaborators, together with three main pharma firms, and money for operations till Q1 2024, we imagine we’re nicely positioned to execute on a number of value-creating milestones. Our skilled workforce is working to ship in H2 2022 4 additional medical readouts from our precision medication pipeline, including to the three already reported.

“We proceed to make actual progress in direction of our aim of earlier analysis and prevention,” Dr. Pfeifer continued, “We not too long ago handled the primary prodromal Alzheimer’s illness affected person in our progressive adaptive design Part 1b/2 trial of ACI-24.060, a extremely differentiated best-in-class vaccine-candidate that has demonstrated robust immunogenicity towards the 2 most poisonous types of Abeta, pyroGlu-Abeta and oligomeric Abeta. We count on interim knowledge later this 12 months from the Part 1b, enabling us to advance into Part 2 in people with Down syndrome, just about all of whom develop Alzheimer’s.”

Q2 2022 and Subsequent Highlights

• Dosed the primary affected person within the placebo-controlled, Part 1b/2 ABATE research evaluating the anti-Abeta vaccine ACI-24.060 in sufferers with prodromal Alzheimer’s illness (AD) and people with Down syndrome (DS). An interim knowledge readout from the Part 1b portion of the trial in AD is predicted in H2 2022.
• Introduced a peer-reviewed publication in JAMA Neurology¹ that includes knowledge exhibiting that ACI-24, the predecessor of ACI-24.060, was protected and elicited an immune response in a Part 1b medical trial in adults with DS. This was the first-ever anti-Abeta vaccine research performed in individuals residing with DS and the paper additionally highlighted knowledge offering proof of goal engagement within the trial.
• Introduced topline outcomes from the Part 2 Alzheimer’s Prevention Initiative (API) research evaluating the anti-Abeta monoclonal antibody crenezumab in autosomal dominant Alzheimer’s illness (ADAD). Outcomes confirmed that each co-primary endpoints of the research weren’t statistically important however numerical variations favoring crenezumab had been noticed throughout nearly all of main, secondary and exploratory endpoints. Extra detailed outcomes can be introduced on the Alzheimer’s Affiliation Worldwide Convention (AAIC) on August 2, 2022 by AC Immune’s associate Genentech, a member of the Roche group and the Banner Alzheimer’s Institute.
• Introduced that AC Immune Co-Founder and CEO Dr. Andrea Pfeifer acquired the distinguished Aenne Burda Award for Artistic Management in recognition of her work.
• Expanded management by appointing Howard Donovan as Chief Human Sources Officer and member of the Govt Committee. Mr. Donovan is an internationally skilled, commercially centered chief. He joins from the World Financial Discussion board, the place he led Individuals Providers since 2015.
• Joerg Hornstein, Chief Monetary Officer (CFO), will go away AC Immune within the second half of 2022 to pursue a brand new alternative. AC Immune is nicely positioned with two members of the Firm’s confirmed Finance Management Staff who will transition to new roles. Christopher Roberts has been appointed Vice President, Finance and interim CFO. Julian Snow has been appointed Vice President, U.S. Finance & Company Improvement.

Achieved and Anticipated 2022 Scientific Milestones

Evaluation of Monetary Statements for the Quarter Ended June 30, 2022

• Money Place: The Firm had a complete money stability of CHF 154.1 million, composed of CHF 63.1 million in money and money equivalents and CHF 91.zero million in short-term monetary property. This compares to a complete money stability of CHF 198.2 million as of December 31, 2021. The Firm’s money stability supplies sufficient capital assets to progress by means of no less than Q1 2024 with out consideration of potential incoming milestone funds.
• R&D Expenditures: R&D bills elevated by CHF 2.zero million for the three months ended June 30, 2022, to CHF 15.7 million.
  • Discovery and preclinical bills (- CHF zero.5 million): The Firm decreased expenditures throughout quite a lot of its discovery and preclinical applications, led by ACI-24 for DS as this program advances into medical growth.
  • Scientific bills (+ CHF zero.four million): The Firm elevated expenditures throughout a number of medical applications, predominantly for ACI-24 for DS and ACI-7104.
  • Different non-allocated (+ CHF 1.2 million): The Firm’s different non-allocated R&D expenditure elevated by CHF zero.9 million largely associated to the reallocation of sure IT and amenities prices, IT investments, in addition to CHF zero.three million throughout numerous different price facilities.
• G&A Expenditures: For the three months ended June 30, 2022, G&A decreased by CHF zero.9 million to CHF four.four million. This lower is generally associated to the reallocation of sure IT and amenities expenditures made in Q2 2022 that weren’t reclassified within the prior interval.
• Different Working Earnings: The Firm acknowledged CHF zero.2 million in grant revenue for R&D actions carried out underneath our Michael J. Fox Basis for Parkinson’s Analysis (MJFF) and Goal ALS grants, a lower of lower than CHF zero.1 million in comparison with the prior interval.
• IFRS Loss for the Interval: The Firm reported a web loss after taxes of CHF 19.6 million for the three months ended June 30, 2022, in contrast with a web lack of CHF 19.1 million for the comparable interval in 2021.

References

1. Rafii MS et al, Security, Tolerability, and Immunogenicity of the ACI-24 Vaccine in Adults With Down Syndrome, A Part 1b Randomized Scientific Trial, JAMA Neurology, 2022 Might 9:79(5).

About AC Immune SA
AC Immune SA is a clinical-stage biopharmaceutical firm that goals to change into a world chief in precision medication for neurodegenerative ailments, together with Alzheimer’s illness, Parkinson’s illness, and NeuroOrphan indications pushed by misfolded proteins. The Firm’s two clinically validated know-how platforms, SupraAntigen^® and Morphomer^®, gas its broad and diversified pipeline of first- and best-in-class property, which at present options eleven therapeutic and three diagnostic candidates, six of that are at present in Part 2 medical trials. AC Immune has a robust monitor report of securing strategic partnerships with main world pharmaceutical firms together with Genentech, a member of the Roche Group, Eli Lilly and Firm, and Janssen Prescription drugs, Inc., leading to substantial non-dilutive funding to advance its proprietary applications and >$three billion in potential milestone funds.

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

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Ahead wanting statements
This press launch comprises statements that represent “forward-looking statements” inside the which means of Part 27A of the Securities Act of 1933 and Part 21E of the Securities Alternate Act of 1934. Ahead-looking statements are statements aside from historic reality and should embody statements that tackle future working, monetary or enterprise efficiency or AC Immune’s methods or expectations. In some circumstances, you may establish these statements by forward-looking phrases resembling “could,” “would possibly,” “will,” “ought to,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “initiatives,” “potential,” “outlook” or “proceed,” and different comparable terminology. Ahead-looking statements are based mostly on administration’s present expectations and beliefs and contain important dangers and uncertainties that might trigger precise outcomes, developments and enterprise selections to vary materially from these contemplated by these statements. These dangers and uncertainties embody these described underneath the captions “Merchandise three. Key Info – Danger Elements” and “Merchandise 5. Working and Monetary Evaluate and Prospects” in AC Immune’s Annual Report on Kind 20-F and different filings with the Securities and Alternate Fee. These embody: the affect of Covid-19 on our enterprise, suppliers, sufferers and staff and some other affect of Covid-19. Ahead-looking statements converse solely as of the date they’re made, and AC Immune doesn’t undertake any obligation to replace them in gentle of recent data, future developments or in any other case, besides as could also be required underneath relevant legislation. All forward-looking statements are certified of their entirety by this cautionary assertion.

Consolidated Stability Sheets
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Statements of Earnings/(Loss)
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Statements of Complete Earnings/(Loss)
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Reconciliation of loss to adjusted loss and
loss per share to adjusted loss per share

Changes for the three and 6 months ended June 30, 2022, decreased web loss by CHF zero.5 million and CHF 1.2 million, respectively in contrast with a lower to web lack of CHF 1.5 million and CHF 1.7 million, respectively, for the comparable intervals in 2021. The Firm recorded CHF zero.9 million and CHF 1.9 million for share-based compensation bills, respectively, in every of those intervals, and there have been overseas foreign money re-measurement beneficial properties of CHF zero.four million and CHF zero.7 million, respectively, primarily associated to motion within the USD-CHF alternate charge in the course of the respective intervals. Lastly, the Firm incurred CHF zero.four million in transaction prices related to its acquisition of a portfolio of therapeutics focusing on alpha-synuclein within the three and 6 months ended June 30, 2021, which weren’t incurred within the present comparable intervals.