ASIT biotech announces the achievement of new clinical and corporate development milestones

  • The treatment phase of the confirmatory phase III clinical study with gp-ASIT+™ in grass pollen rhinitis is now completed for all patients, in time before the grass pollen season, with no major safety concerns. DSMB recommends continuing the study without modification.
  • The Company appointed an experienced Chief Financial Officer, Frank Hazevoets, to support its further development.

BRUSSELS--()--Regulatory News:

ASIT biotech (BSE:ASIT) (Paris: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 announced the achievement of new clinical and corporate development milestones.

The confirmatory phase III clinical study with gp-ASIT+™ is on track with the last treatment visit of the last patient reached before the start of the pollen season

A total of 651 patients with moderate to severe allergic rhinitis have been treated, above the initial target of 624 patients. This high number of patients has been reached earlier than planned, that reflects the strong interest for the short-course immunotherapy developed by ASIT biotech and provides a solid sample for statistical analysis.

Safety data were followed up by an independent Data Safety Monitoring Board (DSMB) on a weekly basis during this treatment period. The DSMB always recommended to continue the study without modification.

Patients monitoring and data collection in 70 participating European centers is ensured using performant electronic diaries. The whole process during the entire pollen season will be under the tight control of the ASIT biotech clinical team and the dedicated CRO, ICON Plc., with the aim of obtaining primary efficacy results by end-2019 as expected.

Frank Hazevoets appointed as Chief Financial Officer

Previously CFO at Promethera Biosciences, a private biopharmaceutical company targeting liver diseases, Frank Hazevoets has over 25 years’ experience in defining and executing financial strategies for both listed and private companies, raising capital and creating value for shareholders. He held leading financial positions in Investment Banking (Director of Investment Banking at BBL/ING from 1999 to 2001), and the consumer-goods sector (Director Strategy and External Growth at AB InBev from 2001 to 2006). He then entered the life sciences industry as CFO and Company secretary at TiGenix (2006-2012), a Belgian biopharmaceutical company recently acquired by Takeda, where he actively participated in the IPO, supported its funding and growth strategy as well as contributed to the first European marketing authorization obtained for its cell-based drug candidate in cartilage repair.

Frank Hazevoets holds a Master degree in Business Economics and a Master degree in Engineering in Artificial Intelligence & Cognitive Science from the Katholieke Universiteit Leuven (K.U. Leuven).

“I am delighted to join ASIT biotech at a time when the company is executing its confirmatory Phase III study of its lead compound, gp-ASIT+TM. I look forward to working closely with the team in order to continue the excellent work accomplished so far in such a short timeframe on both the financing and scientific fronts. We will capitalize on this sound base and implement a detailed financial roadmap to support the growth of the Company. With the strong involvement of Yves Désiront, we also expect to successfully complete, by the end of the second quarter of 2019, the private placement of convertible notes announced previously,” said Frank Hazevoets, CFO of ASIT biotech.

Michel Baijot, CEO of ASIT biotech, concluded: “Administrating the last gp-ASIT+™ treatment before the start of the pollen season, with no major safety concerns, is a great achievement that considerably de-risks our plan to publish the primary efficacy results by the end of this year. We believe that, given the solid design of this pivotal study, targeting the most allergic patients in regions that are the most exposed to grass pollen, and by using an accurate electronic reporting system, we can collect strong and statistically significant data that will determine the capacity of our innovative immunotherapy to treat such a widespread allergy. Furthermore, we are pleased to welcome Frank Hazevoets to the management team of ASIT biotech at this key stage of our development. His strategic vision combined to his financial expertise will be extremely valuable for our growth. We would also like to thank Yves Désiront for his outstanding commitment to the Company as interim CFO during the important transitional period we have been through, and are glad to count on his support as a board member.”

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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 platform, ASIT biotech is currently the only developer of allergy immunotherapy (AIT) product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotech’s product pipeline contains three novel ASIT+™ product candidates targeting respiratory allergies with the highest prevalence (i.e. grass pollen: gp-ASIT+™ - in ongoing phase III - and house dust mite: hdm-ASIT+™), and food allergies (peanut allergy: pnt-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 26 staff members, at its headquarters in Brussels and its facilities in Liège, Belgium.

Further information can be found at www.asitbiotech.com.

Forward-looking statements

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.

Legal notice

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.

Contacts

Company
Michel Baijot, CEO
ASIT biotech
Tel.: +32 2 264 03 90
investors@asitbiotech.com

Media and Investor Relations - France
NewCap
Dusan Oresansky / Pierre Laurent
Tel.: +33 1 44 71 94 92
asitbiotech@newcap.eu

Media Relations - Belgium
Laure-Eve Monfort
Tel.: +32 2 290 90 93
monfort@comfi.be

Contacts

Company
Michel Baijot, CEO
ASIT biotech
Tel.: +32 2 264 03 90
investors@asitbiotech.com

Media and Investor Relations - France
NewCap
Dusan Oresansky / Pierre Laurent
Tel.: +33 1 44 71 94 92
asitbiotech@newcap.eu

Media Relations - Belgium
Laure-Eve Monfort
Tel.: +32 2 290 90 93
monfort@comfi.be