AC Immune Reports Second Quarter 2023 Financial Results and Provides a Corporate Update
04 Aug 2023
Phase 2Financial StatementFast TrackImmunotherapyExecutive Change
AC Immune Reports Second Quarter 2023 Financial Results and Provides a Corporate Update
AC Immune Reports Second Quarter 2023 Financial Results and Provides a Corporate Update
Received FDA Fast Track Designation for ACI-24.060 anti-amyloid-beta (Abeta) active immunotherapy to treat Alzheimer’s disease (AD)
Enrollment in ongoing Phase 1b/2 ABATE study of ACI-24.060 in AD and Down syndrome (DS) is on track and expanding to sites in USA following IND clearance, dosed first individual with DS
Next interim safety and immunogenicity data from AD and DS cohorts in ABATE expected in H2 2023
Results of amyloid plaque reduction analysis (Abeta-PET) after treatment with ACI-24.060 in ABATE study expected in H1 2024; these results could potentially provide an opportunity to accelerate into a registrational program
Cash position of CHF 93.0 million finances the Company into Q3 2024, excluding the benefit of anticipated milestone payments
Lausanne, Switzerland, August 4, 2023 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today reported results for the second quarter ended June 30, 2023, and provided a corporate update.
Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “We entered the second half of 2023 with strong momentum. ACI-24.060’s Fast Track designation acknowledges its potential as a next-generation anti-Abeta active immunotherapy positioned to offer best-in-class efficacy, an improved safety profile, and fewer administration and distribution constraints compared to monoclonal antibodies. With our ABATE trial enrolling AD patients in Europe and expanding the DS cohort via US sites, ACI-24.060 is moving expeditiously towards additional interim safety and immunogenicity data, and Abeta-PET imaging analyses on amyloid plaque reduction in AD in the first half of 2024. Demonstration of Abeta plaque clearance, a validated surrogate marker for clinical efficacy, would provide a major opportunity to rapidly transition to a registrational program.”
“We also look forward to the initiation of the next AD trial of ACI-35.030, the anti-pTau (phosphorylated Tau) active immunotherapy later this year, to be followed by a milestone payment. The progress of our programs affirms our commitment to developing precision medicine approaches to improve outcomes for patients, and ultimately, to prevent progression of neurodegenerative diseases through earlier diagnosis and early intervention.”
Q2 2023 and Subsequent Highlights
Received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ACI-24.060, AC Immune’s wholly-owned SupraAntigen®-based anti-Abeta active immunotherapy candidate, for the treatment of AD.
Ongoing Phase 1b/2 ABATE study of ACI-24.060 in patients with AD and individuals with DS is on track and expanding to sites in the USA following FDA Investigational New Drug (IND) clearance.
The first participant with DS was dosed in the Phase 1b/2 ABATE trial.
The first patient with Parkinson’s disease was dosed in the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, AC Immune’s wholly-owned anti-alpha-synuclein (a-syn) active immunotherapy.
Several programs were showcased at the annual Alzheimer’s Association International Conference (AAIC 2023), which included a poster detailing ABATE’s trial design, a “Perspectives Session” focused on TDP-43 proteinopathy in neurodegenerative diseases organized by AC Immune scientists, and an oral presentation showing detailed data on ACI-12589, a novel positron emission tomography (PET) tracer targeting a-syn.
The TDP-43-PET tracer program has progressed as planned and a clinical candidate has been selected. Over the coming months further preclinical work will be completed to permit the initiation of a first in human study in 2024.
A peer-reviewed paper describing our therapeutic antibody candidate targeting TDP-43 was publishedpublished in the journal ‘mAbs’.
Initiated a research collaboration with Prof. Michael Heneka, director of the Luxembourg Centre for Systems Biomedicine, University of Luxembourg, to further evaluate the therapeutic potential of AC Immune’s SupraAntigen®- and Morphomer®-derived inhibitors of the NLRP3-ASC inflammasome pathway in preclinical disease models.
Hosted a webinar on early diagnosis and prevention of AD featuring presentations by key opinion leaders Kaj Blennow, MD, PhD, of University of Gothenburg and Sahlgrenska University Hospital, and Giovanni Frisoni, MD, of University of Geneva and the Memory Clinic at Geneva University Hospital. To view a replay of the webinar, click here.
Announced the appointment of new Chief Medical Officer, Nuno Mendonça, MD.
Anticipated Milestones
ACI-24.060
anti-Abeta active immunotherapy Additional interim safety and immunogenicity data from AD cohorts of ABATE study expected in H2 2023
Interim safety and immunogenicity data from DS cohort of ABATE study expected in H2 2023
Initial Abeta-PET data on amyloid plaque reduction in AD expected in H1 2024
ACI-7104.056
anti-a-syn active immunotherapy Completion of recruitment of first cohort in the Phase 2 VacSYn study in Parkinson’s disease expected in H2 2023
ACI-35.030
anti-pTau active immunotherapy Initiation of next trial in AD expected in H2 2023 (to be followed by a milestone payment)
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
Analysis of Financial Statements for the Quarter Ended June 30, 2023
Cash Position: The Company ended Q2 with a total cash balance of CHF 93.0 million (CHF 122.6 million as of December 31, 2022), composed of CHF 40.0 million in cash and cash equivalents and CHF 53.0 million in short-term financial assets. The Company’s cash balance provides sufficient capital resources to progress into at least Q3 2024 without considering receipt of potential future milestone payments.
R&D Expenditures: R&D expenses for the three months ended June 30, 2023, were CHF 13.7 million compared to CHF 15.7 million in the comparable period in 2022. The decrease was due mainly to lower discovery and preclinical expenses.
Other Operating Income: The Company recognized CHF 0.3 million in grant income from Michael J. Fox Foundation and Target ALS grants.
IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 16.8 million for the three months ended June 30, 2023, compared with a net loss of CHF 19.6 million for the comparable period in 2022.
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 sixteen therapeutic and diagnostic programs, 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
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. 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 June 30, December 31, 2023 2022Assets Non-current assets Property, plant and equipment 3,760 4,259Right-of-use assets 2,539 2,808Intangible asset 50,416 50,416Long-term financial assets 361 361Total non-current assets 57,076 57,844Current assets Prepaid expenses 5,167 4,708Accrued income 675 408Other current receivables 303 392Short-term financial assets 53,000 91,000Cash and cash equivalents 40,007 31,586Total current assets 99,152 128,094Total assets 156,228 185,938 Shareholders' equity and liabilities Shareholders’ equity Share capital 1,800 1,797Share premium 433,699 431,323Treasury shares (110) (124)Currency translation differences (6) 10Accumulated losses (296,055) (264,015)Total shareholders’ equity 139,328 168,991 Non-current liabilities Long-term lease liabilities 1,976 2,253Net employee defined-benefit liabilities 3,771 3,213Total non-current liabilities 5,747 5,466 Current liabilities Trade and other payables 1,352 929Accrued expenses 8,818 9,417Deferred income 430 587Short-term lease liabilities 553 548Total current liabilities 11,153 11,481Total liabilities 16,900 16,947Total shareholders’ equity and liabilities 156,228 185,938 Condensed Consolidated Statements of Income/(Loss) (Unaudited)
(In CHF thousands, except for per-share data)
For the Three Months For the Six Months Ended June 30, Ended June 30, 2023 2022 2023 2022Revenue Contract revenue — — — —Total revenue — — — — Operating expenses Research & development expenses (13,682) (15,692) (27,555) (30,815)General & administrative expenses (3,681) (4,374) (7,787) (8,550)Other operating income/(expense), net 317 207 725 677Total operating expenses (17,046) (19,859) (34,617) (38,688)Operating loss (17,046) (19,859) (34,617) (38,688) Financial income 259 — 468 —Financial expense (27) (126) (124) (279)Exchange differences (16) 345 (67) 485Finance result, net 216 219 277 206 Loss before tax (16,830) (19,640) (34,340) (38,482)Income tax expense (3) (3) (6) (7)Loss for the period (16,833) (19,643) (34,346) (38,489)Loss per share: (0.20) (0.23) (0.41) (0.46) Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)
(In CHF thousands)
For the Three Months For the Six Months Ended June 30, Ended June 30, 2023 2022 2023 2022Loss for the period (16,833) (19,643) (34,346) (38,489)Items that will be reclassified to income or loss in subsequent periods (net of tax): Currency translation differences (8) 39 (16) 49Items that will not to be reclassified to income or loss in subsequent periods (net of tax): Remeasurement gains on defined-benefit plans — 7,381 — 7,381Total comprehensive loss (net of tax) (16,841) (12,223) (34,362) (31,059)
Attachment
20230804_ACIU_Q2_Earnings_Final
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