EQNX::TICKER_START
(NasdaqGM:ACIU), EQNX::TICKER_END AC Immune SA (NASDAQ: ACIU), a
clinical-stage biopharmaceutical company pioneering precision medicine
for neurodegenerative diseases, today reported results for the quarter
ended June 30, 2022, and provided a corporate update.
Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "With
world-class collaborators, including three major pharma companies, and
cash for operations until Q1 2024, we believe we are well positioned to
execute on multiple value-creating milestones. Our experienced team is
working to deliver in H2 2022 four further clinical readouts from our
precision medicine pipeline, adding to the three already reported.
"We continue to make real progress towards our goal of earlier
diagnosis and prevention," Dr. Pfeifer continued, "We recently treated
the first prodromal Alzheimer's disease patient in our innovative
adaptive design Phase 1b/2 trial of ACI-24.060, a highly differentiated
best-in-class vaccine-candidate that has demonstrated strong
immunogenicity against the two most toxic forms of Abeta, pyroGlu-Abeta
and oligomeric Abeta. We expect interim data later this year from the
Phase 1b, enabling us to advance into Phase 2 in individuals with Down
syndrome, virtually all of whom develop Alzheimer's."
Q2 2022 and Subsequent Highlights
Achieved and Anticipated 2022 Clinical Milestones
ACI-12589 Reported breakthroughresults from first-in-human study at AD/PD(TM) 2022 conference
a-syn-PET tracer
ACI-35.030 Reported Phase 1b/2a interim analysis from highest dose group; Expect to disclose late-stage development plans in H2 2022
anti-pTau vaccine
ACI-24.060 Dosed first patient in Phase 1b/2 trial of ACI-24.060 in patients with AD and individuals with DS
anti-Abeta vaccine Phase 1b in AD readout and decision to move into DS expected in H2 2022
Crenezumab Reported top line Phase 2 results from API study in autosomal dominant AD .
anti-Abeta antibody
Semorinemab Additional biomarker data from the Phase 2 Lauriet study in mild-to-moderate AD expected in H2 2022
anti-Tau antibody
PI-2620 Phase 2 results in AD to be unveiled at AAIC in San Diego, California (United States) and online, July 31 - August 4, 2022.
Tau-PET tracer Clinical PET study readout in orphan indication expected in H2 2022
ACI-7104 Initiation of Phase 2 trial in early PD expected in H2 2022
anti-a-syn vaccine
Analysis of Financial Statements for the Quarter Ended June 30, 2022
-- Cash Position: The Company had a total cash balance of CHF
154.1 million, composed of CHF 63.1 million in cash and cash equivalents
and CHF 91.0 million in short-term financial assets. This compares to a
total cash balance of CHF 198.2 million as 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 2.0
million for the three months ended June 30, 2022, to CHF 15.7 million.
-- Discovery and preclinical expenses (- CHF 0.5 million):
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.
-- Discovery and preclinical expenses (- CHF 0.5 million): 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 0.4 million): The Company increased
expenditures across multiple clinical programs, predominantly for ACI-24
for DS and ACI-7104.
-- Other non-allocated (+ CHF 1.2 million): The Company's other
non-allocated R&D expenditure increased by CHF 0.9 million mostly
related to the reallocation of certain IT and facilities costs, IT
investments, as well as CHF 0.3 million across various other cost
centers.
-- G&A Expenditures: For the three months ended June 30,
2022, G&A decreased by CHF 0.9 million to CHF 4.4 million. This
decrease is mostly related to the reallocation of certain IT and
facilities expenditures made in Q2 2022 that were not reclassified in
the prior period.
-- Other Operating Income: The Company recognized CHF 0.2 million
in grant income for R&D activities performed under our Michael J.
Fox Foundation for Parkinson's Research (MJFF) and Target ALS grants, a
decrease of less than CHF 0.1 million compared to the prior period.
-- IFRS Loss for the Period: The Company reported a net loss
after taxes of CHF 19.6 million for the three months ended June 30,
2022, compared with a net loss of CHF 19.1 million for the comparable
period in 2021.
References
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 eleven therapeutic and
three diagnostic candidates, six of which are currently in Phase 2
clinical trials. 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 Janssen Pharmaceuticals, Inc., 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 and SG. Morphomer is a
registered trademark of AC Immune SA in CN, CH, GB, JP, NO and RU.
For further information, please contact:
Media Relations Investor Relations
Saoyuth Nidh Gary Waanders, Ph.D., MBA
AC Immune AC Immune
Phone: +41 21 345 91 34 Phone: +41 21 345 91 91
Email: saoyuth.nidh@acimmune.com Email: gary.waanders@acimmune.com
U.S. Media U.S. Investors
Shani Lewis Corey Davis, Ph.D.
LaVoieHealthScience LifeSci Advisors
Phone: +1 609 516 5761 Phone: +1 212 915 2577
Email: slewis@lavoiehealthscience.com 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.
Consolidated Balance Sheets
(In CHF thousands)
As of June 30, As of December 31,
2022 2021
ASSETS
Non-current assets
Property, plant and equipment 4,997 5,116
Right-of-use assets 2,632 2,914
Intangible asset 50,416 50,416
Long-term financial assets 361 363
Total non-current assets 58,406 58,809
Current assets
Prepaid expenses 3,465 3,015
Accrued income 433 975
Other current receivables 335 428
Short-term financial assets 91,000 116,000
Cash and cash equivalents 63,147 82,216
Total current assets 158,380 202,634
Total assets 216,786 261,443
SHAREHOLDERS' EQUITY AND LIABILITIES
Shareholders' equity
Share capital 1,796 1,794
Share premium 431,260 431,251
Treasury shares (124 ) (124 )
Currency translation differences 49 --
Accumulated losses (230,169 ) (200,942 )
Total shareholders' equity 202,812 231,979
Non-current liabilities
Long-term lease liabilities 2,050 2,340
Net employee defined-benefit liabilities -- 7,098
Total non-current liabilities 2,050 9,438
Current liabilities
Trade and other payables 337 2,003
Accrued expenses 10,585 16,736
Deferred income 425 717
Short-term lease liabilities 577 570
Total current liabilities 11,924 20,026
Total liabilities 13,974 29,464
Total shareholders' equity and liabilities 216,786 261,443
Statements of Income/(Loss)
(In CHF thousands, except for per-share data)
For the Three Months For the Six Months
Ended June 30, Ended June 30,
2022 2021 2022 2021
Revenue
Contract revenue -- -- -- --
Total revenue -- -- -- --
Operating expenses
Research & development expenses (15,692 ) (13,710 ) (30,815 ) (27,040 )
General & administrative expenses (4,374 ) (5,235 ) (8,550 ) (9,573 )
Other operating income/(expense) 207 256 677 673
Total operating expenses (19,859 ) (18,689 ) (38,688 ) (35,940 )
Operating loss (19,859 ) (18,689 ) (38,688 ) (35,940 )
Financial income -- -- -- --
Financial expense (126 ) (202 ) (279 ) (228 )
Exchange differences 345 (178 ) 485 365
Finance result, net 219 (380 ) 206 137
Loss before tax (19,640 ) (19,069 ) (38,482 ) (35,803 )
Income tax expense (3 ) -- (7 ) --
Loss for the period (19,643 ) (19,069 ) (38,489 ) (35,803 )
Loss per share: (0.23 ) (0.26 ) (0.46 ) (0.50 )
Statements of Comprehensive Income/(Loss)
(In CHF thousands)
For the Three Months For the Six Months
Ended June 30, Ended June 30,
2022 2021 2022 2021
Loss for the period (19,643 ) (19,069 ) (38,489 ) (35,803 )
Items that will be reclassified to income or loss in subsequent periods (net of tax):
Currency translation differences: 39 -- 49 --
Items that will not to be reclassified to income or loss in subsequent periods (net of tax):
Remeasurement gains on defined-benefit plans (net of tax) 7,381 -- 7,381 --
Total comprehensive loss, net of tax (12,223 ) (19,069 ) (31,059 ) (35,803 )
Reconciliation of loss to adjusted loss and
loss per share to adjusted loss per share
For the Three Months For the Six Months
Ended June 30, Ended June 30,
In CHF thousands, except for share and per share data 2022 2021 2022 2021
Loss (19,643 ) (19,069 ) (38,489 ) (35,803 )
Adjustments
Non-cash share-based payments 898 836 1,886 1,694
Foreign currency (gains)/losses (430 ) 258 (683 ) (363 )
Transaction costs -- 410 -- 410
Adjusted Loss (19,175 ) (17,565 ) (37,286 ) (34,062 )
Loss per share - basic and diluted (0.23 ) (0.26 ) (0.46 ) (0.50 )
Adjustment to loss per share - basic and diluted -- 0.02 0.01 0.03
Adjusted loss per share - basic and diluted (0.23 ) (0.24 ) (0.45 ) (0.47 )
Weighted-average number of shares outstanding Adjusted loss -basic and diluted 84,462,675 72,715,783 83,510,567 72,113,581
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.
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.
Reflects transaction costs for the asset acquisition for a portfolio of therapeutics targeting alpha-synuclein and cash.
Adjustments for the three and six months ended June 30, 2022,
decreased net loss by CHF 0.5 million and CHF 1.2 million, respectively
compared with a decrease to net loss of CHF 1.5 million and CHF 1.7
million, respectively, for the comparable periods in 2021. The Company
recorded CHF 0.9 million and CHF 1.9 million for share-based
compensation expenses, respectively, in each of these periods, and there
were foreign currency re-measurement gains of CHF 0.4 million and CHF
0.7 million, respectively, primarily related to movement in the USD-CHF
exchange rate during the respective periods. Finally, the Company
incurred CHF 0.4 million in transaction costs associated with its
acquisition of a portfolio of therapeutics targeting alpha-synuclein in
the three and six months ended June 30, 2021, which were not incurred in
the current comparable periods.
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