AC Immune Reports Full-Year 2020 Financial Results and Provides 2021 R&D Outlook
- Anti-pTau Alzheimer’s vaccine delivers potent immunogenicity in ongoing Phase 1b/2a study, supporting further development into Phase 2/3
- Anti-Abeta Alzheimer’s vaccine advancing based on Phase 1b safety and immunogenicity results in Down syndrome; further interim results expected in Q2 for Phase 2 in Alzheimer’s disease
- Morphomer™ Tau aggregation inhibitor achieves target brain exposure in Phase 1; program advancing in NeuroOrphan indications and Alzheimer’s disease
- First-in-class alpha-synuclein PET diagnostic to report clinical results in Q3 2021
- Advancing multiple candidates targeting the NLRP3 inflammasome pathway for CNS and non-CNS indications
- Ongoing strong financial position of
CHF 225.9 millionin cash ensures the Company is fully financed through Q1 2024, excluding potential incoming milestones
2020 and Q1 2021 Research & Development Highlights
Clinical Pipeline advancement
- Reported promising interim Phase 1b/2a results for ACI-35.030, a novel anti-phospho-Tau (pTau) vaccine candidate showing strong safety and high titers of antigen-specific antibodies in 100% of older patients with early AD. The study is currently enrolling patients into the highest dose group, with further clinical readouts expected this year.
- Advanced next-generation alpha-synuclein positron emission tomography (PET) tracer candidate, ACI-12589, into a first-in-human clinical study, with an expected data readout in Q3 2021
- Reported topline Phase 2 results for semorinemab, the Company’s investigational monoclonal anti-Tau antibody candidate for the treatment of prodromal to mild AD, partnered with
Genentech, a member of the Roche Group. These represent the first-ever Phase 2 results for an anti-Tau antibody therapeutic in AD. Primary completion of the second Phase 2 study in moderate AD patients is expected in Q2 2021.
- Completed a Phase 1 clinical study in healthy volunteers for ACI-3024, an oral small molecule Morphomer™ Tau aggregation inhibitor, which achieved target brain exposure. The Companies have decided to pursue other promising Tau Morphomer candidates from AC Immune’s research platform for potential clinical development in AD. ACI-3024 will be further evaluated for efficacy in models of rare Tauopathies.
Partnership milestone payments and grants
- Received a
CHF 10 millionmilestone payment from Eli Lilly and Company related to ACI-3024
- Amended the collaboration agreement with Lilly for Tau Morphomers to include a new
CHF 60 millionPhase 2 milestone payment, which increased the total potential deal value by CHF 40 millionto CHF 1.86 billion
- Received multiple prestigious and highly competitive grants in 2020 focused on acceleration of the Company’s proprietary and potentially game-changing diagnostic programs
Ken Griffin Alpha-synuclein Imaging Competitionfrom The Michael J. Fox Foundationfor Parkinson’s Research (MJFF) and is able to receive together with its clinical partner USD 3.2 million( CHF 3.1 million) to support AC Immune’s alpha-synuclein-PET tracers
- Awarded a
EUR 1.45 milliongrant to support the partnership between AC Immuneand the EU Joint Programme – Neurodegenerative Disease Research (JPND) ImageTDP-43 Consortiumto advance its first-in-class TAR DNA-binding protein 43 (TDP-43) PET tracers
- Awarded a
USD 600,000grant from Target ALS to develop novel immuno-assays to detect pathological TDP-43 in cerebrospinal fluid (CSF) and blood based on AC Immune’s SupraAntigen™-derived anti-TDP-43 antibodies
Strengthening of Management and Board
- Appointed Prof.
Johannes R. Streffer, former UCB Biopharma Head of Translational Neuroscience, to the new role of Chief Medical Officer
- Welcomed Prof.
Carl H. June, world authority on immune tolerance and adoptive immunotherapy, to the Company’s Board of Directors
- Appointed renowned Neurologist with a specific focus in the emerging field of Down syndrome (DS)-related Alzheimer’s disease, Dr.
Juan Forteato AC Immune’s Clinical Advisory Board
Future Value Creation
- Reported key advancements for several therapeutic programs targeting the NLRP3 inflammasome, including small molecule inhibitors, which showed the first evidence of in vivo activity in a model of peripheral inflammation, as well as high-affinity monoclonal antibodies that bind extracellular components of the (NOD)-like receptor protein 3 (NLRP3) pathway and inhibit inflammasome-mediated immune response in vitro
- Identified and characterized the first biologically active small molecule Morphomer alpha-synuclein aggregation inhibitors, which significantly decreased alpha-synuclein aggregate formation in cellular assays by interfering with the fibrillation process
- Strengthened strategic partnership with WuXi Biologics to accelerate advancement of TDP-43 antibody into clinical development for NeuroOrphan indications
2021 execution strategy to maximize value creation
AC Immune’s execution strategy is focused on three key initiatives, which support the Company’s overarching goal of enabling precision medicine for neurodegenerative diseases:
- The Company plans to accelerate the development of its late-stage therapies in AD in collaboration with its strategic partners, including its novel pTau vaccine with
Janssen Pharmaceuticals Inc., which continues to show great promise. AC Immuneis sharpening its strategic focus on non-AD indications with high unmet need. Currently this includes its anti-Abeta vaccine in people with DS, as well as its therapeutic and diagnostic candidates targeting TDP-43 and alpha-synuclein, where the Company may focus in-house efforts on select NeuroOrphan indications while seeking potential partnerships for larger indications like LATE (limbic-predominant age-related TDP-43 encephalopathy) and Parkinson’s disease (PD). Furthermore, AC Immune’s NLRP3 inflammasome-targeted programs have broad applicability both within central nervous system (CNS) and non-CNS indications.
- The Company plans to accelerate advancement of its diagnostic candidates to late-stage development, as continued leadership in precision medicine is a key differentiator for
AC Immune. These candidates include its Tau, alpha-synuclein, and TDP-43 PET tracers, which potentially enable earlier disease diagnosis, improved clinical trial outcomes and additional revenue generation for the Company.
Anticipated 2021 milestones
- ACI-35.030 anti-pTau vaccine: reported Phase 1b/2a in AD interim results in Q1 (second highest dose); further Phase 1b/2a interim analysis in Q4 (highest dose)
- JACI-35.054 alternative anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2 (low dose)
- Alpha-synuclein imaging agent: advanced third-generation candidate to first-in-human clinical study in Q1; readout expected in Q3
- ACI-24 anti-Abeta vaccine in DS: reported Phase 1b top line results in Q1; to present further study results at the Alzheimer's
Association International Conference® 2021 in Q2
- ACI-24 in AD: reported Phase 2, 12-month interim analysis in Q1; 18-month interim analysis in Q2
- Semorinemab anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in moderate AD in Q2
- ACI-3024 small molecule Morphomer Tau aggregation inhibitor: select NeuroOrphan indication for further development in Q2
- ACI-24 in DS: submit investigational new drug (IND) application for optimized vaccine formulation in Q4
- Alpha-synuclein small molecule inhibitor: identified first biologically active small molecule in Q1; start in vivo proof-of-concept studies in Q3
- TDP-43 imaging agent: initiate investigational new drug (IND)-enabling studies in Q3
- Morphomer NLRP3-ASC: report in vivo proof-of-concept results in a non-CNS disease model and begin in vivo proof-of-concept studies with validated candidate in CNS in Q4
- Anti NLRP3-ASC antibody: begin in vivo proof-of-concept studies in Q4
- Anti-TDP-43 antibody: initiate IND-enabling toxicology studies in Q4
- TDP-43 biofluid diagnostic: establish validation-ready assay in Q4
Therapeutic and Diagnostic Pipeline Overview
Analysis of Financial Statements for the year ended
- Cash Position: The Company had a total cash balance of CHF 225.9 million, comprised of CHF 160.9 million in cash and cash equivalents and CHF 65 million in short-term financial assets. This compares to a total cash balance of CHF 288.6 million as of December 31, 2019. The decrease of CHF 62.7 million is principally due to continued investments in our R&D pipeline. The total shareholders’ equity position decreased to CHF 215.5 million from CHF 272.4 million as of the prior year. The Company’s cash balance provides enough capital resources to progress through at least Q1 2024 without potential incoming milestone payments.
- Contract Revenues: Contract revenues for the year ended
December 31, 2020totaled CHF 15.4 millioncompared to CHF 110.5 millionin 2019, representing a CHF 95 milliondecrease. The Company recognized a CHF 10 millionmilestone and CHF 4.3 millionfor research and development activities in 2020 from its Lilly agreement compared to CHF 103.1 millionfor an upfront payment and milestone and CHF 2.6 millionfor research and development activities in 2019.
- R&D Expenditures: R&D expenses increased by
CHF 9.1 millionfor the year ended December 31, 2020.
- Discovery and preclinical expenses: The Company increased expenditures across a variety of its discovery and preclinical programs. These include investments to advance the second generation of our ACI-24 for Down Syndrome project, the initiation of IND-enabling studies of our anti-TDP-43 antibody project and various other investments across our alpha-synuclein and neuroinflammation programs.
- Clinical expenses: The Company also increased expenditures across multiple Clinical programs. These include investments to prepare a follow-on trial for our Abeta vaccine for Down Syndrome project, additional enrollment costs for the Phase 1b/2a study for ACI-35.030 and a full year of clinical activities to complete the Phase 1 of our Morphomer Tau asset in partnership with Lilly.
- Salary- and benefit-related costs: The Company’s salary- and benefit-related costs increased by
CHF 2.7 million, primarily due to the addition of 13 FTEs, annualization of 2019 hires and increases in share-based compensation.
- G&A Expenditures: For the year ended
December 31, 2020, G&A increased by CHF 2.5 millionto 18.6 million. Of this increase, CHF 1.7 millionis due to salary- and benefit-related costs, primarily due to the addition of 3 FTEs, annualization of 2019 hires and increases in share-based compensation. Additionally, the Company incurred a CHF 0.8 millionincrease in other G&A expenses, predominantly associated with depreciation expense, insurance and professional fees
- IFRS Income/(Loss) for the Period: The Company reported a net loss after taxes of
CHF 61.9 millionfor the year ended December 31, 2020, compared with net income of CHF 45.4 millionfor 2019
2021 Financial Guidance
For the full year 2021, the Company expects its total cash burn to range between
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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
(In CHF thousands)
|Property, plant and equipment||4,416||3,917|
|Long-term financial assets||334||304|
|Total non-current assets||6,973||6,476|
|Other current receivables||329||304|
|Short-term financial assets||65,000||95,000|
|Cash and cash equivalents||160,893||193,587|
|Total current assets||231,767||292,774|
|SHAREHOLDERS’ EQUITY AND LIABILITIES|
|Total shareholders’ equity||215,478||272,442|
|Long-term lease liabilities||1,780||1,813|
|Net employee defined benefit liabilities||7,464||7,485|
|Total non-current liabilities||9,244||9,298|
|Trade and other payables||2,184||142|
|Short-term financing obligation||—||652|
|Short-term lease liabilities||443||442|
|Total current liabilities||14,018||17,510|
|Total shareholders’ equity and liabilities||238,740||299,250|
Statements of Income/(Loss)
(In CHF thousands, except for per-share data)
|For the Years Ended
|Research & development expenses||(59,487||)||(50,432||)||(44,277||)|
|General & administrative expenses||(18,557||)||(16,058||)||(12,467||)|
|Other operating income/(expense)||1,353||570||282|
|Total operating expenses||(76,691||)||(65,920||)||(56,462||)|
|Change in fair value of conversion feature||—||4,542||—|
|Finance result, net||(661||)||906||(1,401||)|
|Income/(loss) before tax||(61,921||)||45,442||(50,951||)|
|Income tax expense||—||—||—|
|Income/(loss) for the period||(61,921||)||45,442||(50,951||)|
|Earnings/(loss) per share:|
|Basic income/(loss) for the period attributable to equity holders||(0.86||)||0.64||(0.82||)|
|Diluted income/(loss) for the period attributable to equity holders||(0.86||)||0.64||(0.82||)|
Statements of Comprehensive Income/(Loss)
(In CHF thousands)
|For the Years Ended
|Income/(loss) for the period||(61,921||)||45,442||(50,951||)|
|Other comprehensive income/(loss) not to be reclassified to income or loss in subsequent periods (net of tax)|
|Remeasurement income/(losses) on defined benefit plans (net of tax)||726||(1,304||)||(302||)|
|Total comprehensive income/(loss), net of tax||(61,195||)||44,138||(51,253||)|
Reconciliation of income/(loss) to adjusted income/(loss) and
earnings/(loss) per share to adjusted earnings/(loss) per share
|For the Years Ended
|In CHF thousands, except for share and per
|Non-cash share-based payments1||4,088||2,834||2,518|
|Foreign currency (gains)/losses2||703||826||1,179|
|Effective interest expenses3||—||1,355||—|
|Change in fair value of conversion feature4||—||(4,542||)||—|
|Earnings/(loss) per share – basic||(0.86||)||0.64||(0.82||)|
|Earnings/(loss) per share – diluted||(0.86||)||0.64||(0.82||)|
|Adjustment to earnings/(loss) per share – basic||0.07||0.01||0.06|
|Adjustment to earnings/(loss) per share – diluted||0.07||0.00||0.06|
|Adjusted earnings/(loss) per share – basic||(0.79||)||0.65||(0.76||)|
|Adjusted earnings/(loss) per share – diluted||(0.79||)||0.64||(0.76||)|
|Weighted-average number of shares used to compute adjusted loss per share – basic||71,900,212||70,603,611||61,838,228|
|Weighted-average number of shares used to compute adjusted loss per share – diluted||71,900,212||71,103,341||61,838,228|
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 US Dollar and the Swiss Franc.
3Effective interest expense for the period relates to the accretion of the Company’s convertible loan in accordance with the effective interest method.
4Change in fair value of conversion feature that is bifurcated from the convertible loan host debt with Lilly.
Adjustments for the years ended
Source: AC Immune SA