BioAlliance Pharma: Key milestones and consolidated accounts
BioAlliance Pharma: Key milestones and consolidated accounts
First semester 2013
Grant of the Marketing Authorization for Sitavig®in the US
Strong achievements in clinical trials with Livatag®(phase III) and Validive®(phase II)
Significant reinforcement of cash reserves thanks to the capital increase of July 2013
PARIS--(BUSINESS WIRE)-- Regulatory News:
BioAlliance Pharma SA (Euronext Paris - BIO), an innovative Company dedicated to the development of orphan oncology products and to supportive care products, today publishes its consolidated half-year accounts as of June 30, 2013, and the major key milestones achieved during the first semester and the last months.
The first semester 2013 was marked by significant steps achieved by the two product portfolios developed by the Company:
Extension of the phase III clinical trial with Livatag® in the primary liver cancer: 20 sites opened in France and more than 70 patients recruited end of August. The European study's extension is ongoing with authorizations already obtained in 6 European countries (Spain, Italy, Russia, Hungary, Austria and Belgium). As planned, the study should be extended to the US first semester 2014, enabling the end of recruitment in 2015 and results in 2016.
Acceleration of patient recruitment in the phase II trial with Validive® evaluating its efficacy in the prevention of radio/chemotherapy-induced severe oral mucositis in patients with head and neck cancer. To date, more than 70% of planned patients have been included and recruitment should be completed as scheduled beginning of 2014 for results expected in the second part of that year. These international phase II trial results represent a major step towards the validation of Validive® and a strong key value driver for the Company and its positioning in oncology.
At the same time, a major success was obtained with the grant of the marketing authorization for Sitavig® in the US for the treatment of recurrent herpes labial. Sitavig® becomes a suitable candidate to a partnership. This is the second time that BioAlliance successfully goes through the FDA registration process.
Steps have also been achieved by our partners on Loramyc®: Sosei has started the phase III clinical trial necessary to validate the product's registration in Japan and in the United States; Vestiq Phamaceuticals has initiated the commercialization of Oravig® since the beginning of the year.
A last, a collaborative agreement has been signed with one of the worldwide leaders in vaccines for a vaccine application of its patented Lauriad® mucoadhesive technology, showing the potential interest of the innovative Lauriad® system for a needle-free vaccination.
Analysis of the H1 2013 accounts
Consolidated accounts (IFRS-compliant) In thousands Euros | 30/06/2013 (6 months) | 30/06/2012 (6 months) | ||
Revenues | 845 | 842 | ||
Operating expenses | (8 430) | (8 705) | ||
R&D expenses | (5 213) | (4 849) | ||
Operating profit/loss | (7 585) | (7 864) | ||
Net profit/loss | (7 488) | (7 834) | ||
The revenue for the first semester 2013 amounted to €0.8 million. It is mainly generated by the sales of Loramyc®/Oravig® to the commercial partners and from royalties on sales for BioAlliance.
BioAlliance Pharma increased its investments in R&D by 8% as compared to the first semester 2012, with investments dedicated to Livatag® and Validive® doubled with the overall extension of clinical trials, from €1.8 million to €3.6 million. Nevertheless, the total operating expenses decreased by 3% thanks to a permanent control of general and administrative expenses.
Consequently, the net loss amounted to €7.5 million, improving when compared to €7.8 million in 2012.
Consolidated cash as of June 30, 2013 stood at €11.9 million compared to €14.5 million as of December 31, 2012.
The successful capital increase with maintenance of preferential subscription rights, launched on July 2, 2013, has enabled to raise a net amount of €8.4 million, after implementation of the extension clause, and strengthens significantly the Company's cash.
"During the first 2013 semester, we have made great progress on our product portfolio, in particular our key programs with Livatag®and Validive®while controlling our cash burn and our operating conditions," declares Judith Greciet, CEO of BioAlliance Pharma. "Once more,we have demonstrated with the American registration of Sitavig®our R&D teams' unique expertise and know-how. With this in mind, we are going to actively pursue our ongoing trials to achieve our objectives. Our cash situation, reinforced by our recent capital increase, enables us to progress in this way generating value for our shareholders."
BioAlliance Pharma will hold a meeting at 8:45 am Paris time on Friday September 20, 2013, at its Corporate Headquarter (49 boulevard Martial Valin, Paris 15°, France). An audio and web-conference in English will be organized at 11:00 am Paris time (GMT + 1):
Audio connection from France or abroad: Call in numbers: +331 70 77 09 34. For replay please dial : +331 72 00 15 00. Replay reference: 283145#
Weconference connection: https://bioalliancepharma-en.webex.com/bioalliancepharma-en/j.php?ED=271222417&UID=1649289147&PW=NOTM3ZjI3NTc2&RT=MiMyMw%3D%3D
Meeting Number: 700 838 602
Meeting Password: paris
About BioAlliance Pharma
Dedicated to cancer and supportive care treatment with a focus on resistance targeting and orphan products, BioAlliance conceives and develops innovative products, for specialty markets especially in the hospital setting and for orphan or rare diseases.
Created in 1997 and introduced to the Euronext Paris market in 2005, BioAlliance Pharma's ambition is to become a leading player in these fields by coupling innovation to patient needs. The company's teams have the key competencies required to identify, develop and register drugs in Europe and the USA.
BioAlliance Pharma has developed an advanced product portfolio:
Specialty products
Loramyc®/Oravig® (oropharyngeal candidiasis in immunocompromised patients): Registered in 26 countries (EU, US, Korea), commercialized in Europe and in the US.
Sitavig® (Acyclovir Lauriad®) (labialis herpes): Registered in the US and in 8 European countries, registration status in the other European countries.
Fentanyl Lauriad® (chronic cancer pain): Positive preliminary Phase I results
Orphan Oncology products
Livatag® (Doxorubicin Transdrug™) (primary liver cancer): Phase III on going
Validive® (Clonidine Lauriad®) (mucositis): Phase II on going
AMEP® (invasive melanoma): Phase I on going
For more information, visit the BioAlliance Pharma web site at www.bioalliancepharma.com
Disclaimer
This communication expressly or implicitly contains certain forward-looking statements concerning BioAlliance Pharma SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioAlliance Pharma SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioAlliance Pharma SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of BioAlliance Pharma SA to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the 2012 Reference Document filed with the AMF on April 18, 2013, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA's website (http://www.bioalliancepharma.com).
BioAlliance Pharma SA
Judith Greciet, CEO
judith.greciet@bioalliancepharma.com
or
Nicolas Fellmann, CFO
nicolas.fellmann@bioalliancepharma.com
Tel.: +33 1 45 58 76 00
or
ALIZE RP
Caroline Carmagnol, +33 6 64 18 99 59
caroline@alizerp.com
or
Christian Berg, +33 6 31 13 76 20
christian@alizerp.com
KEYWORDS: United States Europe North America France Massachusetts
INDUSTRY KEYWORDS:
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