AC Immune Reports Third Quarter 2021 Financial Results and Provides Corporate Update
Announced the first positive cognitive results for a Tau-targeting monoclonal antibody in mild-to-moderate Alzheimer’s disease
Closed its strategic acquisition of an industry-leading Parkinson’s disease vaccine and an equity financing led by key investors
Appointed
Strong financial position of
Prof.
1 Total cash position does not include total gross proceeds of
Q3 2021 and Subsequent Highlights
- Announced the first positive cognitive results for a Tau-targeting monoclonal antibody in Alzheimer’s disease (AD). Topline data from the Lauriet Phase 2 trial of semorinemab in mild-to-moderate AD showed a statistically significant (p<0.0025) 43.6% reduction at week 49 in cognitive decline vs. placebo as measured by ADAS-Cog11, one of the trial’s co-primary endpoints. The second co-primary endpoint, ADCS-ADL, was not met. AC Immune’s partner
Genentech is continuing with the trial’s open label extension and is scheduled to present the topline data from the Lauriet study at the CTAD (Clinical Trials on Alzheimer's Disease) conference onNovember 10, 2021 , at10:50am EST . - Completed an all-stock acquisition of Affiris’ portfolio of therapeutics targeting alpha-synuclein, notably PD01/ACI-7104, a clinically validated active vaccine candidate that places
AC Immune at the forefront of Parkinson’s disease drug development. Through this acquisition and a concurrent financing,AC Immune has also strengthened its cash position and addedAthos Service GmbH (Strüngmann family office),First Capital Partner GmbH (Egger Family Office), and MIG Fonds to its shareholder base. - Presented the full results from the landmark Phase 1b clinical trial evaluating the wholly-owned anti-Abeta vaccine ACI-24 in subjects with Down syndrome (DS) at the Alzheimer’s
Association International Conference (AAIC) 2021. Data showed that ACI-24 generated immunogenicity along with a positive pharmacodynamic response and a favorable safety and tolerability profile. Based on these results, the Company plans to advance an optimized formulation of ACI-24 into mid-stage clinical testing to treat and prevent the progression of DS-related AD. - Extended the Company’s research partnership with leading scientists at the
Center for Neurodegenerative Disease Research at thePerelman School of Medicine at theUniversity of Pennsylvania (Penn). The goal of the collaboration is to further understand the role of distinct pathogenic TDP-43 species in the different TDP-43 proteinopathies. Through the development of novel experimental models,AC Immune and Penn hope to unravel the underlying mechanisms of cell-to-cell transmission of TDP-43 pathology that could provide new therapeutic strategies to target TDP-43-related proteinopathies. - Welcomed pharmaceutical industry expert
Monica Shaw , M.D., and leading Swiss economist Prof. Monika Bütler, Dr. Oec., to the Company’s Board of Directors. - Announced that the
Swiss Economic Forum (SEF) awarded AC Immune Co-Founder and CEO Prof.Andrea Pfeifer with the SEF.WomenAward for CEO of the Year. This award recognizes women with an excellent entrepreneurial track record, giving greater prominence to role models who can inspire the next generation of businesswomen.
Achieved and Anticipated 2021 milestones
Clinical Milestones
- ACI-35.030 anti-pTau vaccine: reported Phase 1b/2a interim results in AD patients in Q1 (second highest dose); further Phase 1b/2a interim analysis in Q4 (highest dose)
- JACI-35.054 alternative anti-pTau vaccine: reported a Phase 1b/2a interim analysis in AD patients in Q2 (low dose)
- Alpha-synuclein PET imaging agent: advanced third-generation candidate to first-in-human clinical study in Q1; data to be presented at upcoming scientific meeting
- ACI-24 anti-Abeta vaccine in DS: reported Phase 1b topline results in Q1
- ACI-24 in AD: reported Phase 2, 12-month interim analysis in Q1; reporting full data set at CTAD in
November 2021 - Semorinemab anti-Tau antibody partnered with
Genentech : topline results reported in Q3 - Small molecule Morphomer® Tau aggregation inhibitor program: select NeuroOrphan indication for further development in H2
- ACI-24 in DS: submit investigational new drug (IND) application for optimized vaccine formulation in Q4
Preclinical Milestones
- Alpha-synuclein small molecule inhibitor: identified first biologically active small molecule in Q1; start in vivo proof-of-concept studies in Q4
- Morphomer® NLRP3-ASC: report in vivo proof-of-concept results in a non-central nervous system (CNS) disease model and begin in vivo proof-of-concept studies with validated candidate in central nervous system 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
Analysis of Financial Statements for the quarter ended
- Cash Position: The Company had a total cash balance of
CHF 188.6 million , composed ofCHF 93.6 million in cash and cash equivalents and CHF 95.0 million in short-term financial assets. This compares to a total cash balance ofCHF 225.9 million as ofDecember 31, 2020 . The Company’s cash balance provides enough capital resources to progress through at least Q1 2024 without consideration of potential incoming milestone payments. - Contract Revenues: The Company did not record contract revenues for the three months ended
September 30, 2021 , a decrease ofCHF 1.1 million from the comparable period in 2020. The overall decrease is predominantly related toCHF 1.1 million of contract revenue associated with R&D activities in our agreement withLilly that were recognized in 2020 and did not repeat in the current period. - R&D Expenditures: R&D expenses decreased by
CHF 0.4 million for the three months endedSeptember 30, 2021 , toCHF 15.1 million .- Discovery and preclinical expenses (-1.7 million): The Company decreased expenditures across a variety of its discovery and preclinical programs. This was predominantly led by a decrease in investment for the research of alpha-synuclein antibodies and other discovery programs.
- Clinical expenses (+0.6 million): The Company increased expenditures across multiple clinical programs, predominantly for ACI-35-030 driven by R&D cost sharing and increased patient enrollments into the Phase 1b/2a study. This increase was offset as the Company incurred less expense for ACI-24 for AD as the prior six-month safety period completed.
- Salary- and benefit-related costs (+0.5 million): The Company’s salary- and benefit-related costs increased primarily due to the internal reallocation of certain employees’ salaries and the annualization of 2020 hires.
- G&A Expenditures: For the three months ended
September 30, 2021 , G&A increased byCHF 0.5 million toCHF 5.4 million . This increase is predominantly related to transaction costs incurred to complete the asset acquisition forAffiris' alpha-synuclein portfolio as well as other administrative items. - Other Operating Income: The Company recognized
CHF 0.3 million in grant income for R&D activities performed under ourMichael J. Fox Foundation for Parkinson’s Research (MJFF) and Target ALS grants, a decrease ofCHF 0.2 million compared to the prior period. - IFRS Loss for the Period: The Company reported a net loss after taxes of
CHF 15.9 million for the three months endedSeptember 30, 2021 , compared with a net loss ofCHF 19.0 million for the comparable period in 2020.
About
SupraAntigen® is a registered trademark of
For further information, please contact:
Media Relations Phone: +41 21 345 91 34 Email: saoyuth.nidh@acimmune.com |
Investor Relations Phone: +41 21 345 91 90 Email: yves.kremer@acimmune.com |
LaVoie Health Science Phone: +1 609 516 5761 Email: slewis@lavoiehealthscience.com |
U.S. Investors Phone: +1 212 915 2577 Email: cdavis@lifesciadvisors.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. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. 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.
Balance Sheets
(In CHF thousands)
As of |
As of |
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ASSETS | |||||
Non-current assets | |||||
Property, plant and equipment | 5,054 | 4,416 | |||
Right-of-use assets | 2,572 | 2,223 | |||
Long-term accrued income | 31 | — | |||
Long-term financial assets | 363 | 334 | |||
Total non-current assets | 8,020 | 6,973 | |||
Current assets | |||||
Prepaid expenses | 1,935 | 3,954 | |||
Short-term accrued income | 92 | 1,591 | |||
Other current receivables | 341 | 329 | |||
Derivative financial assets | 4,424 | — | |||
Short-term financial assets | 95,000 | 65,000 | |||
Cash and cash equivalents | 93,584 | 160,893 | |||
Total current assets | 195,376 | 231,767 | |||
Total assets | 203,396 | 238,740 | |||
SHAREHOLDERS’ EQUITY AND LIABILITIES | |||||
Shareholders’ equity | |||||
Share capital | 1,589 | 1,538 | |||
Share premium | 359,421 | 346,890 | |||
(124 | ) | (100 | ) | ||
Accumulated losses | (181,665 | ) | (132,850 | ) | |
Total shareholders’ equity | 179,221 | 215,478 | |||
Non-current liabilities | |||||
Long-term deferred income | 31 | — | |||
Long-term lease liabilities | 1,992 | 1,780 | |||
Net employee defined-benefit liabilities | 7,929 | 7,464 | |||
Total non-current liabilities | 9,952 | 9,244 | |||
Current liabilities | |||||
Trade and other payables | 215 | 2,184 | |||
Accrued expenses | 13,308 | 11,085 | |||
Short-term deferred income | 123 | 306 | |||
Short-term lease liabilities | 577 | 443 | |||
Total current liabilities | 14,223 | 14,018 | |||
Total liabilities | 24,175 | 23,262 | |||
Total shareholders’ equity and liabilities | 203,396 | 238,740 |
Statements of Income/(Loss)
(In CHF thousands, except for per-share data)
For the Three Months Ended |
For the Nine Months Ended |
||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||
Revenue | |||||||||||
Contract revenue | — | 1,123 | — | 14,487 | |||||||
Total revenue | — | 1,123 | — | 14,487 | |||||||
Operating expenses | |||||||||||
Research & development expenses | (15,118 | ) | (15,518 | ) | (42,158 | ) | (43,536 | ) | |||
General & administrative expenses | (5,420 | ) | (4,892 | ) | (14,993 | ) | (13,553 | ) | |||
Other operating income/(expense) | 255 | 482 | 928 | 807 | |||||||
Total operating expenses | (20,283 | ) | (19,928 | ) | (56,223 | ) | (56,282 | ) | |||
Operating loss | (20,283 | ) | (18,805 | ) | (56,223 | ) | (41,795 | ) | |||
Financial income | 4,424 | — | 4,424 | 78 | |||||||
Financial expense | (181 | ) | (46 | ) | (408 | ) | (159 | ) | |||
Exchange differences | 122 | (143 | ) | 487 | (545 | ) | |||||
Finance result, net | 4,365 | (189 | ) | 4,503 | (626 | ) | |||||
Loss before tax | (15,918 | ) | (18,994 | ) | (51,720 | ) | (42,421 | ) | |||
Income tax expense | — | — | — | — | |||||||
Loss for the period | (15,918 | ) | (18,994 | ) | (51,720 | ) | (42,421 | ) | |||
Loss per share: | (0.22 | ) | (0.26 | ) | (0.71 | ) | (0.59 | ) | |||
Basic and diluted loss for the period attributable to equity holders | 72,887,967 | 71,925,009 | 72,638,698 | 71,888,273 |
Statements of Comprehensive Income/(Loss)
(In CHF thousands)
For the Three Months Ended |
For the Nine Months Ended |
||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||
Loss for the period | (15,918 | ) | (18,994 | ) | (51,720 | ) | (42,421 | ) | |||
Other comprehensive loss that may be reclassified to income or loss in subsequent periods (net of tax): | |||||||||||
Currency translation differences | — | — | — | — | |||||||
Other comprehensive loss not to be reclassified to income or loss in subsequent periods (net of tax): | |||||||||||
Re-measurement losses on defined-benefit plans (net of tax) | — | — | — | — | |||||||
Total comprehensive loss, net of tax | (15,918 | ) | (18,994 | ) | (51,720 | ) | (42,421 | ) |
Reconciliation of loss to adjusted loss and
loss per share to adjusted loss per share
For the Three Months Ended |
For the Nine Months Ended |
||||||||||
In CHF thousands, except for share and per share data | 2021 | 2020 | 2021 | 2020 | |||||||
Loss | (15,918 | ) | (18,994 | ) | (51,720 | ) | (42,421 | ) | |||
Adjustments | |||||||||||
Non-cash share-based payments1 | 1,388 | 1,233 | 3,081 | 3,079 | |||||||
Foreign currency (gains)/losses2 | (117 | ) | 187 | (481 | ) | 686 | |||||
Change in fair value of derivative financial assets3 | (4,424 | ) | — | (4,424 | ) | — | |||||
Transaction costs4 | 335 | — | 745 | — | |||||||
Adjusted Loss | (18,736 | ) | (17,574 | ) | (52,799 | ) | (38,656 | ) | |||
Loss per share – basic and diluted | (0.22 | ) | (0.26 | ) | (0.71 | ) | (0.59 | ) | |||
Adjustment to loss per share – basic and diluted | (0.04 | ) | 0.02 | (0.02 | ) | 0.05 | |||||
Adjusted loss per share – basic and diluted | (0.26 | ) | (0.24 | ) | (0.73 | ) | (0.54 | ) | |||
Weighted-average number of shares outstanding Adjusted loss – basic and diluted | 72,887,967 | 71,925,009 | 72,638,698 | 71,888,273 |
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. |
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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. |
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3 | Reflects the change in the fair value of the derivative financial instruments associated with the convertible notes due to Investors. |
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4 | Reflects transaction costs associated with our asset acquisition for a portfolio of therapeutics targeting alpha-synuclein. Adjustments for the three and nine months ended |
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Source: AC Immune SA