BRUSSELS--(BUSINESS WIRE)--Regulatory News:
ASIT biotech (Paris:ASIT) (BSE:ASIT) (ASIT - BE0974289218), a Belgian clinical-stage biopharmaceutical company focused on the research, development and future commercialization of breakthrough immunotherapy products for the treatment of allergies, today announces its annual results1 for the year 2017, prepared in accordance with the IFRS standards adopted by the European Union, as well as its recent clinical developments and 2018 outlook.
Thierry Legon, CEO of ASIT biotech, says: “2017 was a pivotal year in terms of both clinical and corporate developments. The first Phase III clinical study with gp-ASIT+™ in grass pollen rhinitis has confirmed, for the first time ever, the clinical efficacy in real life of our proprietary allergenic peptides. This clinical study has also allowed a more complete understanding of the mechanism of action of our peptides. This understanding paves the way for the development of other ASIT+™ therapeutic product candidates for house dust mite and food allergies, indications with even higher unmet medical need. The publications of the clinical data of gp-ASIT+™ in renowned scientific peer-reviewed journals such as Allergy and JACI (Journal of Allergy and Clinical Immunology) confirmed the high quality and the real originality of the results that we have obtained with our first product candidate. ASIT biotech is now focusing all its efforts on maximizing the chances of success of the next Phase III clinical trial with gp-ASIT+™. Site selection would start in late 2018 in order to treat all patients prior to the 2019 grass pollen season. In parallel, we continue the optimization of our second product candidate for house dust mite rhinitis, hdm-ASIT+™ with the objective to start human trials at the beginning of 2019. ASIT biotech also received a €6 million non-diluting financing from the Walloon Region for a very promising food allergy drug development program with the objective to select, by the end of this year, at least one product candidate with an optimal immunogenicity. Finally, the approval received in December from our shareholders to proceed with a refinancing round was a strong mark of confidence that allowed us to successfully complete a €9.4 million private placement at the very beginning of this year, with a potential further funding of €23 million. This strengthened financial structure will enable us to continue the development of all our drug candidates aiming to treat millions of people suffering from allergies.”
Financial results1 at 31 December 2017
|In thousands of euros - IFRS||31.12.2017||31.12.2016|
|Other operating income||590||1,667|
|Research & Development expenses||-10,903||-12,123|
|General & Administrative expenses||-1,663||-1,822|
|Operating profit / loss||-11,976||-12,278|
|Financial income / expense||-9||-60|
|Net profit / loss||-11,986||-12,339|
Operating income, which totaled €590 thousand, consisted mainly of a recoverable advance of €458 thousand from the Walloon government for the food-ASIT+™ program and research tax credit of €112 thousand.
Operating expenses totaled €12.6 million over the year 2017 (versus €13.9 million at 31 December 2016) given the stabilization of the Company’s clinical development. R&D spending, which accounted for 87% of the total operating expenses, was entirely devoted to the development of ASIT biotech’s R&D programs and was allocated as follows:
- 70% for the most advanced drug candidate, gp-ASIT+™, for the treatment of grass pollen rhinitis;
- 15% for the second drug candidate, hdm-ASIT+™, for the treatment of house dust mite rhinitis;
- 15% for preclinical activities and the discovery of product candidates for other types of allergies (mainly peanut, cow milk and egg white).
The operating loss over the year ending 31 December 2017 was thus €11.9 million, versus a loss of €12.3 million at 31 December 2016.
ASIT biotech had a net cash position of €2.1 million at 31 December 2017, compared with €13.4 million at 31 December 2016. The €11.2 million cash decrease over the last 12 months was in line with budget and notably the result of:
- Operating cash burn up to €12.3 million
- €400 thousand in working capital increase
- €200 thousand in investments
- €1.7 million received from the Walloon government as recoverable advances
The cash position at 31 December 2017 does not include the proceeds of €9.4 million from the first phase of the private placement, as announced on 25 January 2018. A second subscription phase is currently taking place, allowing the Company to raise additional €2 million.
Furthermore, each newly issued share within the framework of this private placement being coupled with two warrants enabling the holder to subscribe two new shares at the price of €3.83 per share, ASIT biotech has the possibility of raising up to a further €23 million over the upcoming two years.
As of the date of this press release, the audit by the Statutory Auditors of the consolidated financial statements as of 31 December 2017 is in progress. The Statutory Auditors have already indicated that their report would include a supplementary statement recalling the conditions and assumptions set by the Board of Directors, which are subject to the assumption of the business continuity in accordance with Article 144 §7 of the Belgian Company Code.
The annual financial report (regulated information) will be available in the Investors / Documentation section of the Company’s website from 18 April 2018.
2018 outlook and upcoming milestones
gp-ASIT+™ in grass pollen allergy
- Preparation of a 2nd Phase III in Europe in adults with site selection in Q4 2018 and first-patient first-visit in Q1 2019
- Pre-IND Meeting with FDA in H2 2018 to agree on the clinical development strategy in the US
hdm-ASIT+™ in house dust mite allergy
Screening of several product candidates to select one with the best
immunogenicity profile for further clinical development in house dust
- ex vivo immunogenicity screening on house dust mite allergic patient blood samples
- preclinical in vivo immunogenicity testing
- Regulatory required preclinical development and IMP2 GMP3 manufacturing
food-ASIT+™ in food allergy
Design, development and screening of several product candidates to
select the ones with the best immunogenicity profile for further
clinical development in food allergies:
- ex vivo immunogenicity screening on food allergic patient blood samples
- preclinical in vivo immunogenicity testing
- Regulatory required preclinical development and IMP GMP manufacturing for one food allergen
About ASIT biotech
ASIT biotech is a Belgian clinical stage biopharmaceutical company focused on the development and future commercialization of a range of breakthrough immunotherapy products for the treatment of allergies. Thanks to its innovative ASIT+™ technology, ASIT biotech is currently the only developer of AIT product candidates consisting of carefully size selected and qualified natural peptides extracted from highly purified original allergen. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotech’s product pipeline entails two novel ASIT+™ product candidates targeting respiratory allergy with the highest prevalence (i.e. grass pollen: gp-ASIT+™ and house dust mite: hdm-ASIT+™), that could significantly expand the current immunotherapy market. The Company believes that its innovative ASIT+™ platform is flexible and would be applicable across a range of allergies.
ASIT biotech has a headcount of 22 staff members, at its headquarters in Brussels and a laboratory in Liège, Belgium.
Further information can be found at www.asitbiotech.com.
All statements in this announcement that do not relate to historical facts and events are “forward-looking statements”. In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the words “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” “plans,” “continue,” “ongoing,” “potential,” “predict,” “project,” “target,” “seek” or “should” or, in each case, their negative or other variations or comparable terminology or by discussions of strategies, plans, objectives, targets, goals, future events or intentions. Forward-looking statements include statements regarding the Company’s intentions, beliefs or current expectations. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements are not guarantees of future performance. Given these risks and uncertainties, you should not rely on forward-looking statements as a prediction of actual results. Any forward-looking statements are made only as of the date of this announcement and, without prejudice to the Company’s obligations under applicable law in relation to disclosure and ongoing information, the Company does not intend, and does not assume any obligation, to update the forward-looking statements set forth in this announcement.
This announcement does not constitute, or form part of, an offer or invitation to sell or issue, or any solicitation of an offer to purchase or subscribe for shares of ASIT biotech SA (the “Company” and the “Shares”). Any purchase of, subscription for or application for, Shares to be issued in connection with the intended offering should only be made on the basis of information contained in the prospectus and any supplements thereto, as the case may be. This announcement does not constitute a prospectus and the information contained herein is for information purposes only and does not purport to be full or complete. Investors should not subscribe for any Shares except on the basis of the information contained in the prospectus that the Company expects to publish after its approval by the Belgian Financial Services and Markets Authority, and which can then be obtained at the Company’s registered office and on www.asitbiotech.com.
This announcement is not for distribution, directly or indirectly, in or into the United States or to any U.S. person within the meaning of the U.S. Securities Act of 1933, as amended (the “Securities Act”). The Shares have not been and will not be registered under the Securities Act and may not be offered or sold in the United States, except pursuant to an exemption from the registration requirements of the Securities Act. The Company has not registered, and does not intend to register, any portion of the intended offering of Shares in the United States, and does not intend to conduct a public offering of Shares in the United States.
This announcement and the information contained herein are not for publication, distribution or release in or into the United States, Australia, Canada, Japan or any jurisdiction where to do so would constitute a violation of the relevant laws of such jurisdiction.
The Company is responsible for the information contained in this press release.
1 Audit in progress
2 IMP: Investigational Medicinal Products
3 GMP: Good Manufacturing Practice