- Strong cash position of CHF 138.1 million provides resources
to advance pipeline of seven therapeutic and three diagnostic
candidates
- Second pivotal Phase 3 clinical trial of crenezumab - CREAD
2 - started by partner Genentech
- Encouraging first clinical data of Tau-PET Imaging tracer in
Alzheimer's
- Milestone from Piramal Imaging for start of Phase 1 trial in
PSP , an orphan tauopathy disease
Lausanne,
Switzerland, May 11, 2017 - AC Immune SA (NASDAQ: ACIU), a
Swiss-based, clinical stage biopharmaceutical company with a broad
pipeline focused on neurodegenerative diseases, today announced
financial results for the first quarter ended March 31, 2017.
Prof. Andrea Pfeifer, CEO of AC Immune,
commented: "We have started 2017 with the very significant
decision of our partner Genentech to undertake a second Phase 3
clinical trial of crenezumab in patients with prodromal to mild
Alzheimer's disease. Our collaboration with Piramal for developing
companion diagnostics is bearing fruit. These Q1 results reflect
our strategic investments beyond Alzheimer's disease, into other
neurodegenerative indications, leveraging our core knowledge of
misfolding proteins and our two discovery platforms."
Key Financial Data - (IFRS in CHF million, except for share
and per share data)1
|
For the Three Months Ended March 31, |
|
2017 |
2016 |
Total revenues |
2.0 |
0.5 |
R&D expenses |
7.5 |
5.4 |
G&A expenses |
2.4 |
0.9 |
Loss for the period |
(9.5) |
(6.2) |
Basic and diluted, loss per share (EPS) |
(0.17) |
(0.13) |
Weighted-average no of shares basic and diluted |
56,855,987 |
46,402,500 |
|
As of |
|
March 31, 2017 |
Dec 31, 2016 |
Cash and cash equivalents |
138.1 |
152.2 |
Total current assets |
142.4 |
154.9 |
Total shareholder's equity |
133.1 |
142.4 |
1This summary table should be read in
conjunction with our unaudited condensed financial statements as of
and for the period ended March 31, 2017, including the accompanying
notes which form an integral part of the interim financial
statements. These financial statements are available on our
website under the tab labelled "Investors - Financial
Information".
RevenuesOur revenues experience
significant fluctuations as a result of securing new collaboration
agreements, the timing of milestone achievements and the size of
each milestone payment.
AC Immune generated revenues of CHF 2.0 million
in the three months ended March 31, 2017 compared with CHF 0.5
million in the three months ended March 31, 2016. The increase in
revenues was mainly driven by the EUR 1 million (CHF 1.1 million)
milestones from Piramal Imaging for the initiation of the Phase 1
clinical trial in an orphan indication, Progressive Supranuclear
Palsy (PSP).
Research & Development (R&D)
ExpensesFor the three months ended March 31, 2017, the Company
incurred R&D expenses of CHF 7.5 million compared with CHF 5.4
million in the same period in 2016.
This is primarily attributable to increased
investment in the two anti-Abeta ACI-24 vaccine programs in
Alzheimer's disease and Down syndrome, in programs focused on
Parkinson's disease such as alpha-synuclein PET imaging, and in
discovery programs for neurodegenerative orphan indications. The
R&D investment also reflects the addition of new talents to
accelerate the development of proprietary and partnered pipeline
candidates.
General and Administrative (G&A)
ExpensesG&A expenses amounted to CHF 2.4 million in the
three months ended March 31, 2017 compared with CHF 0.9 million in
the same period in 2016. The increase in G&A expenses is
largely related to advisory, regulatory and legal costs associated
with the Company being publicly listed since September 2016,
intellectual property costs as well as remuneration expenses.
Loss for the period For the three months
ended March 31, 2017, the Company had a net loss after taxes of CHF
9.5 million compared with a CHF 6.2 million loss for the same
period in 2016. The decline in profitability is attributable to the
increased R&D and G&A expenses as outlined above.
Balance SheetAs of March 31, 2017 AC Immune
had total cash of CHF 138.1 million compared to CHF 152.2 million
as of December 31, 2017. The decrease is due to the higher
investments in our major discovery and development programs and the
strengthening of the Company's infrastructures, systems and
organization.
For a more detailed review of our financial
performance, please refer to the "Management's Discussion and
Analysis of Financial Condition and Results of Operations" attached
as an exhibit to our Current Report on Form 6-K filed today with
the U.S. Securities and Exchange Commission and on our website
under the tab labelled "Investors - Financial Information".
First Quarter 2017 R&D Highlights
Crenezumab - anti-Abeta antibody for Alzheimer's disease
(AD) partnered with Genentech in Phase 3AC Immune's
partner Genentech/Roche has started a second pivotal Phase 3
clinical trial, CREAD 2, in 750 prodromal or mild Alzheimer's
disease. Similar to the CREAD 1 Phase 3 clinical trial, which is
ongoing since Q1 2016, this study will evaluate the effect of
crenezumab on the composite endpoint Clinical Dementia Rating-Sum
of Boxes (CDR-SB) Score.
Tau-PET imaging agent - AD diagnostic
partnered with PiramalNew insights into the Tau-PET imaging
tracer, being developed in collaboration with Piramal Imaging, were
provided at the International Conference on Alzheimer's and
Parkinson's Diseases (AD/PD). The results included its excellent
preclinical properties, human dosimetry and first encouraging
clinical data which show a distinct, specific pattern of binding in
patients with Alzheimer's disease and Progressive Supranuclear
Palsy.
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.
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.
For further information please
contact:
Prof. Andrea PfeiferChief Executive OfficerPhone: +41-21-345 91
21E-mail:andrea.pfeifer@acimmune.com |
Eva SchierCorporate Communications ManagerPhone: +41-21-345 91
34Mobile: +41 79 926 66 03E-mail: eva.schier@acimmune.com |
Nick Miles/ Toomas Kull Cabinet Privé de Conseils Phone : +41
22 321 45 40E-mail : miles@cpc-pr.com kull@cpc-pr.com
|
In the USTed AgneThe Communications Strategy Group
Inc.Phone: +1 781 631 3117E-mail: edagne@comstratgroup.com
|
Attachments:
http://www.globenewswire.com/NewsRoom/AttachmentNg/81d22144-f8f9-4fbc-a1c0-c352bc76c99e
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