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 Monica Shaw, M.D., and Prof. Monika Bütler, Dr. Oec., to the Board of Directors
Strong financial position of CHF 188.6 million1 ensures the Company is fully financed through at least Q1 2024
LAUSANNE, Switzerland, Nov. 08, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today reported its financial results for the quarter ended September 30, 2021 and provided a corporate update.
Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “AC Immune concluded an exceptional third quarter, highlighted by the acquisition of a clinical α-syn vaccine candidate in Parkinson’s disease and topline Phase 2 Lauriet data showing that semorinemab was the first Tau antibody candidate to significantly slow cognitive decline in mild-to-moderate Alzheimer’s disease patients. Our partner Genentech, a member of the Roche Group, will present the topline Lauriet data, later this week at the CTAD 2021 conference, where we will present new clinical data on our p-Tau and Abeta vaccine candidates, ACI-35 and ACI-24, respectively. These achievements show the commitment, progress and breadth of our leadership in discovering and developing impactful therapeutics for neurodegenerative diseases.”
1 Total cash position does not include total gross proceeds of USD 30 million received in October 2021 from (i) USD 5 million as part of the Affiris asset acquisition and (ii) USD 25 million as part of a private placement with select group of Affiris investors.
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$3 billion in potential milestone payments.
SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP and RU. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, and NO.
Forward looking statementsThis 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 September 30, 2021
As of December 31, 2020
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
Treasury shares
(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 September 30,
For the Nine Months Ended September 30,
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 September 30,
For the Nine Months Ended September 30,
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 andloss per share to adjusted loss per share
For the Three Months Ended September 30,
For the Nine Months Ended September 30,
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.
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.
3
Reflects the change in the fair value of the derivative financial instruments associated with the convertible notes due to Investors.
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 September 30, 2021, increased net loss by CHF 2.8 million and CHF 1.1 million, respectively compared with a decrease to net loss of CHF 1.4 million and CHF 3.8 million for the comparable periods in 2020, respectively. The Company recorded CHF 1.4 million and CHF 3.1 million for share-based compensation expenses, respectively, in each of these periods. There were foreign currency re-measurement gains of CHF 0.1 million and CHF 0.5 million, respectively, primarily related to movement in the USD-CHF exchange rate during the respective periods. The Company also recognized a CHF 4.4 million gain on the change in fair value of the derivative financial assets associated with the convertible notes. This gain did not arise in the comparable prior periods. Finally, the Company incurred CHF 0.3 and CHF 0.7 million in transaction costs associated with its acquisition of a portfolio of therapeutics targeting alpha-synuclein in the three and nine months ended September 30, 2021.
