Published:

2015-05-06 08:00:00 CEST

Registered:

2015-05-06 08:01:13 CEST

REGULATED INFORMATION

English

Biotie Therapies - Interim report (Q1 and Q3)

Biotie interim report 1 January - 31 March 2015

BIOTIE THERAPIES CORP. Interim Report 6 May, 2015 at
9.00 a.m.

Biotie interim report 1 January - 31 March 2015

This is a summary of the interim report 1 January - 31 March 2015 published
today. The complete report is attached to this release.

Company Highlights
January - March 2015

* Preparations to advance tozadenant into Phase 3 development in Parkinson's
disease as part of Biotie's proprietary portfolio continued during the
quarter. After the reporting period in April 2015, Biotie provided further
information on the design and conduct of the Phase 3 program. As announced
earlier, patient recruitment is expected to commence in the middle of 2015.
* After the reporting period in April 2015, Biotie also announced plans to
strengthen its capital structure by up to approximately €95 million through
a directed issue of convertible notes and warrants and a US Initial Public
Offering to finance a Phase 3 trial of tozadenant in Parkinson's disease.
The plans are subject to shareholder approval at Biotie's Annual General
Meeting to be held on 26 May 2015 and to US regulatory review.
* Biotie's partner H. Lundbeck A/S (Lundbeck) continued the rollout of
Selincro in Europe and the product has to date been introduced in 29
European markets.
* The Phase 2 study for SYN120 in Parkinson's disease dementia, funded by a
grant from the Michael J Fox Foundation (MJFF), continued to recruit
patients.
* Patient enrollment commenced in March 2015 into a Phase 2 clinical study
investigating Biotie's monoclonal anti-VAP-1 antibody BTT1023 in primary
sclerosing cholangitis (PSC). Also in March 2015, the European Commission
granted BTT1023 Orphan Drug Designation in the EU for the treatment of PSC.
* Biotie's revenue for three months ended March 31, 2015 (three months ended
March 31, 2014) was €0.9 million (€5.1 million) and the financial result was
a net loss of €5.9 million (net loss of €1.7 million).
* Biotie ended the first quarter on March 31, 2015 with cash, cash equivalents
and short term investments, which together are referred to as liquid assets,
of €27.8 million (€32.4 million, December 31, 2014). Operating cash flow for
the three months ended March 31, 2015 was €5.4 million outflow (€5.4 million
outflow for the three months ended March 31, 2014).
Key Financials
Figures in brackets, unless otherwise stated, refer to the same period in the
previous year (€ million)

for the period January - March 2015

* Revenues €0.9 million (€5.1 million).
* Research and development costs €4.8 million (€4.8 million)
* Financial result was a net loss of €5.9 million (net loss of €1.7 million)
* Cash flow from operating activities €5.4million outflow (€5.4 million
outflow)
* Loss per share €0.01 (€0.00)
* Liquid assets at the end of period €27.8million (€32.4 million, December
31, 2014).
The interim report is unaudited. Liquid assets are comprised of cash, cash
equivalents and investments held to maturity.

Timo Veromaa, Biotie's President and CEO commented, "Our focus in the last
quarter has been on preparing our lead product tozadenant to advance into Phase
3 development. As announced earlier this month, we are delighted to have
established a consortium, including certain U.S. based investors, to contribute
to the financing of the program. These funds, together with a proposed US IPO,
will allow us to commence a pivotal Phase 3 clinical trial that we believe could
form the basis for approval of tozadenant by the FDA as an adjunctive treatment
to levodopa in Parkinson's disease."

Outlook for 2015 and key upcoming milestones

Selincro(®) (nalmefene): Lundbeck will continue to increase its sales and
marketing efforts in respect of Selincro in European markets during 2015
following the positive pricing and reimbursement decisions received in the
second half of 2014. In addition to royalties, Biotie may also receive further
milestone payments if the product reaches certain pre-determined sales.

Tozadenant (SYN115): A Phase 3 clinical study, which is expected to be the
second pivotal study required for registration, is on track to commence patient
recruitment in the middle of 2015, as originally planned. Top-line data from the
double-blind part of the study is expected by the end of 2017. Additional
studies required to ensure a strong regulatory filing package will continue to
be performed at the same time as the clinical study.

SYN120: Patient enrollment into an 80-patient Phase 2 study with SYN120 in
Parkinson's disease dementia (the SYNAPSE study) started in December 2014. The
study, funded by MJFF, is being conducted by the Parkinson Study Group at
approximately 12 specialist sites in the United States. Top-line results of the
study are expected in the second half of 2016.

BTT1023: Patient enrollment into an investigator-sponsored Phase 2 study in
primary sclerosing cholangitis (the BUTEO study) started in March 2015. The 41-
patient study is being conducted in the UK and is supported by grant funding
from the UK's National Institute for Health Research. It is expected that the
requisite number of patients will have been treated by the end of 2016 to enable
a pre-planned futility analysis in this two-stage study to be completed.

Financial: During the remainder of 2015, the Company expects to continue
receiving Selincro royalties from Lundbeck and may receive a commercial sales
milestone. Research and development expenses on all development products are
expected to increase, predominantly due to the start of the tozadenant Phase 3
study, subject to the planned financing, including the US public offering,
concluding as planned. The planned financing will increase the level of liquid
resources in the Company.

Strategic: Pending shareholder approval in the Annual General Meeting of the
planned funding arrangements for the tozadenant Phase 3 program, the Company
will focus its efforts on efficiently commencing and executing the planned
clinical program. SYN120 and BTT1023, funded largely by non-dilutive financing,
are both expected to reach significant potential inflection points by the end of
2016.

Conference call

An analyst and media conference call will take place on 6 May 2015 at 8.00 a.m.
Central European Time. The conference call will be held in English.

Lines are to be reserved ten minutes before the start of conference call. The
event can also be viewed as a live webcast at www.biotie.com. An on demand
version of the conference will be published on Biotie's website later during the
day

Telephone conference numbers:

US callers: +1 646 254 3362
UK callers: +44(0)20 7136 2055
Finnish callers: +358(0)9 2310 1620

Access code: 7162757

In case you need additional information or assistance, please contact: Virve
Nurmi, IR Manager, Tel: +358 2 2748 911

Key events after the reporting period

On April 23, 2015, the Company announced further detail on its Phase 3 clinical
development plan for tozadenant.

On April 23, 2015, the Company announced plans to strengthen its capital
structure in aggregate by approximately €95 million, to finance a Phase 3
double-blinded clinical trial, including the open label extension, of its lead
product candidate tozadenant, through a direct issuance of up to €42.5 million
of convertible promissory notes and other equity-based instruments to certain US
investors and certain existing shareholders, as well as a potential US public
offering ("US IPO") and potential other offerings in connection with the US IPO.
The issue of the related shares is conditional on the granting of necessary
authorizations and election of new Board members by the Annual General Meeting.

On April 23, 2015, the Company and certain US based investors entered into a
subscription agreement for €27.5 million of convertible promissory notes
("Convertible Notes") and other equity-based instruments ("Warrants"). The
Convertible Notes can be converted into new shares in the Company by their
holders at any time prior to the repayment of the Convertible Notes, which is
scheduled to occur on or after May 1, 2035. Further, the Convertible Notes would
automatically convert into new shares in the Company upon completion of a
proposed US IPO. If the US IPO does not take place by May 1 2016, the Company
can force the conversion of the Convertible Notes at any time thereafter until
the repayment date. The Warrants will entitle to subscribe for shares in the
Company until November 1, 2020.

About Biotie

Biotie is a specialized drug development company focused on products for
neurodegenerative and psychiatric disorders. Biotie's development has delivered
Selincro (nalmefene) for alcohol dependence, which received European marketing
authorization in 2013 and is currently being rolled out across Europe by partner
Lundbeck. The current development products include tozadenant for Parkinson's
disease, which is transitioning into Phase 3 development, and two additional
compounds which are in Phase 2 development for cognitive disorders including
Parkinson's disease dementia, and primary sclerosing cholangitis (PSC), a rare
fibrotic disease of the liver.

Turku, 6 May 2015

Biotie Therapies Corp.

Board of Directors

For further information, please contact:
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900
e-mail: virve.nurmi@biotie.com