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

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
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”.