AC Immune Reports First Quarter 2022 Financial Results and Provides Corporate Update
Two clinical readouts delivered in Q1; five more expected by year-end
Interim data from the Phase 1b/2a trial of ACI-35.030 confirm the favorable safety and potent immunogenicity of this first-in-class anti-pTau vaccine
First images of alpha-synuclein in patients’ brains presented at AD/PDTM Conference provide clinical proof-of-concept for ACI-12589 as a PET tracer for alpha-synucleinopathies (e.g. MSA)
Strong financial position of
Q1 2022 and Subsequent Highlights
- Reported the first live images of alpha-synuclein in the human brain with ACI-12589, AC Immune’s wholly-owned alpha-synuclein (a-syn) positron emission tomography (PET) tracer, at the AD/PDTM 2022 Conference. Clinical PET image analyses 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. Together with preclinical data also presented at AD/PDTM 2022, these analyses demonstrate ACI-12589’s potential to be the first non-invasive diagnostic for alpha-synucleinopathies (e.g. MSA).
- Hosted a key opinion leader webinar on a-syn as a target in neurodegenerative diseases featuring
Oskar Hansson, MD, PhD, of Skåne University Hospital and Lund University. To view the presentation and a replay of the webinar, click here.
- Announced interim Phase 1b/2a trial data confirming the consistent safety and potent immunogenicity of ACI-35.030, a first-in-class phosphorylated-Tau (pTau) vaccine candidate. Data from the high-dose cohort showed the strong induction of antibodies selective for pTau and its aggregated form, enriched paired helical filaments (ePHF). The data also support ACI-35.030’s favorable safety profile and plans for its continued late-stage development.
- Published new data on the optimized formulation of ACI-24 in the peer-reviewed journal
Brain Communications, showing that the anti-Abeta vaccine was well tolerated in preclinical models and generated a broad polyclonal anti-Abeta response with high titers of antibodies against neurotoxic pyroglutamate Abeta (pyroGlu-Abeta), a major component of Abeta plaques. Optimized ACI-24 was also shown to have enhanced and sustained immunogenicity against another key pathological Abeta species, oligomeric Abeta, in preclinical studies presented at AD/PDTM 2022.
- Expanded leadership with the appointment of
Howard Donovanas Chief HR Officer and member to the Executive Committee. Mr. Donovanis an internationally experienced, commercially focused leader. He joins from the World Economic Forum, where he led People Services since 2015.
Joerg Hornstein, Chief Financial Officer, will leave in the second half of 2022 to pursue a new opportunity. AC Immuneis well positioned with two members of the company’s proven Finance Leadership Team who will transition to new roles. Christopher Roberts is appointed Vice President, Finance and interim CFO. Julian Snowis appointed Vice President, U.S.Finance & Corporate Development.
Achieved and Anticipated 2022 Clinical Milestones
|Reported results from first-in-human study at AD/PD™ 2022 conference|
|Reported Phase 1b/2a interim analysis from highest dose group in Q1; Expect to disclose future late-stage development plans in H2 2022|
|ACI-24 (optimized vaccine formulation) Phase 1b/2a first-patient-in (AD) in H1 2022
Phase 1b in AD readout and decision to move into DS expected in H2 2022
|Top line Phase 2 results from AD prevention trial in patients with autosomal dominant AD expected in H1 2022|
|Additional fluid biomarker data from the Phase 2 Lauriet study in mild-to-moderate AD expected in H2 2022|
|Phase 2 and Phase 1 results in AD and progressive supranuclear palsy (PSP) respectively, expected in H2 2022|
|Initiation of Phase 2 trial in early PD expected in H2 2022|
Analysis of Financial Statements for the Quarter Ended
- Cash Position: The Company had a total cash balance of
CHF 173.8 million, composed of CHF 57.8 millionin cash and cash equivalents and CHF 116.0 millionin short-term financial assets. This compares to a total cash balance of CHF 198.2 millionas of December 31, 2021. The Company’s cash balance provides enough capital resources to progress through at least Q1 2024 without consideration of potential incoming milestone payments.
- R&D Expenditures: R&D expenses increased by
CHF 1.8 millionfor the three months ended March 31, 2022, to CHF 15.1 million.
- Discovery and preclinical expenses (-
CHF 0.6million): The Company decreased expenditures across a variety of its discovery and preclinical programs, led by ACI-24 for DS as this program advances into clinical development.
- Clinical expenses (+
CHF 0.9million): The Company increased expenditures across multiple clinical programs, predominantly for ACI-24 for DS and ACI-7104 as the program prepares to enter Phase 2 testing in early PD patients in H2 2022.
- Other non-allocated (+
CHF 1.5million): The Company’s other non-allocated R&D expenditure increased by CHF 0.9 millionrelated to the reallocation of certain IT and facilities costs and IT related investments as well as CHF 0.6 millionacross various other cost centers.
- Discovery and preclinical expenses (-
- G&A Expenditures: For the three months ended
March 31, 2022, G&A decreased by CHF 0.2 millionto CHF 4.2 million. This decrease is predominantly related to a CHF 0.7 millionreallocation of certain IT and facilities expenditures made in Q1 2022 that were not reclassified in the prior period.
- Other Operating Income: The Company recognized
CHF 0.5 millionin grant income for R&D activities performed under our Michael J. Fox Foundationfor Parkinson’s Research (MJFF) and Target ALS grants, an increase of less than CHF 0.1 millioncompared to the prior period.
- IFRS Loss for the Period: The Company reported a net loss after taxes of
CHF 18.8 millionfor the three months ended March 31, 2022, compared with a net loss of CHF 16.7 millionfor the comparable period in 2021.
2022 Financial Guidance
- For the full year 2022, the Company expects its total cash burn to be in the range,
CHF 75 millionto CHF 80 million. 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).
SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU,
For further information, please contact:
Phone: +41 21 345 91 34
Phone: +41 21 345 91 91
Phone: +1 609 516 5761
Phone: +1 212 915 2577
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
Consolidated Balance Sheets
(In CHF thousands)
|Property, plant and equipment||4,908||5,116|
|Long-term financial assets||363||363|
|Total non-current assets||58,461||58,809|
|Other current receivables||266||428|
|Short-term financial assets||116,000||116,000|
|Cash and cash equivalents||57,835||82,216|
|Total current assets||177,058||202,634|
|SHAREHOLDERS’ EQUITY AND LIABILITIES|
|Total shareholders’ equity||214,131||231,979|
|Long-term lease liabilities||2,196||2,340|
|Net employee defined-benefit liabilities||7,281||7,098|
|Total non-current liabilities||9,477||9,438|
|Trade and other payables||501||2,003|
|Short-term lease liabilities||573||570|
|Total current liabilities||11,911||20,026|
|Total shareholders’ equity and liabilities||235,519||261,443|
Consolidated Statements of Income/(Loss)
(In CHF thousands, except for per-share data)
|For the Three Months
|Research & development expenses||(15,123)||(13,329)|
|General & administrative expenses||(4,166)||(4,338)|
|Other operating income/(expense)||459||416|
|Total operating expenses||(18,830)||(17,251)|
|Finance result, net||(14)||517|
|Loss before tax||(18,844)||(16,734)|
|Income tax expense||(4)||—|
|Loss for the period||(16,848)||(16,734)|
|Loss per share:|
|Basic and diluted loss for the period attributable to equity holders||(0.23)||(0.23)|
Consolidated Statements of Comprehensive Income/(Loss)
(In CHF thousands)
|For the Three Months
|Loss for the period||(18,848)||(16,734)|
|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):|
|Re-measurement losses on defined-benefit plans||—||—|
|Other comprehensive income/(loss)||10||—|
|Total comprehensive loss, net of tax||(18,838)||(16,734)|
Reconciliation of income/(loss) to adjusted income/(loss) and
earnings/(loss) per share to adjusted earnings/(loss) per share
|For the Three Months
|In CHF thousands, except for share and per share data||2022||2021|
|Non-cash share-based payments1||989||857|
|Foreign currency (gains)/losses2||(218)||(621)|
|Loss per share – basic and diluted||(0.23)||(0.23)|
|Adjustment to loss per share – basic and diluted||0.01||0.00|
|Adjusted loss per share – basic and diluted||(0.22)||(0.23)|
|Weighted-average number of shares outstanding Adjusted loss –basic and diluted||83,486,354||72,305,949|
1 Reflects 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.
2 Reflects foreign currency re-measurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and Euro with the Swiss Franc.
Adjustments for the three months ended
Source: AC Immune SA