- A maximum of 3 million new shares
will be issued
- The issue will be structured as a
private placement, with no discount to the average share price over
the last 30 days before the issue
- Each subscriber will receive two free
warrants enabling the subscription to two new shares at the issue
price – the first by June 30, 2018, and the second by December 31,
2019, provided that the first warrant has been exercised
- Assuming all 3 million shares are
subscribed to and that all the warrants are exercised, the Company
would raise approximately 3 x €10 million
Regulatory News:
ASIT biotech (Paris:ASIT) (BSE:ASIT) (Euronext: 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, announces the submission of a proposal to
the General Meeting on December 7, 2017, to issue 3 million
new shares, in the framework of a private placement subject to
approval by shareholders. The new shares will be issued without a
discount on the average share price of the last 30 days preceding
the issue of the new shares.
It shall be proposed to the General Shareholders’ Meeting that
each subscriber will receive two warrants free of charge. The first
warrant would expire on June 30, 2018, and the second on December
31, 2019. The second warrant may be exercised solely if the first
warrant has already been exercised. If exercised, these warrants
will increase the share capital and provide funds to cover the cost
of ASIT biotech’s research and clinical development activities. The
first warrant’s expiration date has been timed to coincide with the
expenditures associated with the launch of the Phase III trial with
gp-ASIT+™.
The Board of Directors believes that this financing structure is
best suited, at this stage of the Company’s development, to meet
the expectations of the different participants, including
shareholders, the Company and investors participating to the
offering.
The funds raised will be assigned in priority to the preparation
of the Phase III trial with gp-ASIT+™ and to the development of
products against allergies to dust mites, peanuts, cow’s milk and
egg white.
The Company’s shareholders will be invited to decide on the
issue of shares and warrants during the meeting on December 7,
2017. Arrangements for the subscription will be made after the
General Meeting’s approval has been secured.
18 months after the IPO, this fundraising provides the
opportunity to review ASIT biotech’s key strengths, clinical
developments and strategy.
1. Meeting an unmet medical need and commercial
opportunities
The number of patients suffering from allergies increases every
year: 15% of the world’s population suffers from allergic
rhino-conjunctivitis, and 2% of the world’s population has a food
allergy. Current commercialized drugs for allergic
rhino-conjunctivitis (intranasal antihistamines and
corticosteroids) reduce symptoms by no more than 20%1. Furthermore,
these treatments do not provide any relief to 20%-25% of patients2.
Sales of symptomatic treatments nonetheless add up to
$10 billion every year. Today, there are no drugs available to
treat food allergies.
The only viable alternative to drugs currently commercialized
for allergic rhino-conjunctivitis is immunotherapy. Its efficacy is
greater than that of symptomatic drugs, but requires a 3-year
treatment with a daily drug intake (sublingual route) or a total of
40-60 visits to the doctor (subcutaneous injections). These
constraints that are difficult to reconcile with the demands of
everyday life, make immunotherapy less attractive. The limited
number of patients under immunotherapy (estimated at 3 million
in the United States and approximately 1.4 million in
Europe) and the corresponding annual sales of less than
€1 billion support this reality.
2. Clinical development of gp-ASIT+™: releasing the
potential
Our gp-ASIT+™ product for the treatment of grass pollen
induced rhino-conjunctivitis has reached Phase III in Europe.
It is estimated that one out of every two drugs tested in Phase III
is approved (TCSDD, 2014). The results of the first Phase III trial
with gp-ASIT+™ obtained in June 2017 increase, in our view, the
chances of success:
- the 15% to 21% symptoms reduction
depending on the analyzed period (pollen peaks or throughout the
entire season) is statistically significant, i.e. there is little
chance that the results are merely fortuitous
- the immunology results obtained by
Prof. M. Shamji on a sub-group of patients enrolled at
the Ghent University Hospital revealed a highly positive and very
rapid mechanism of action, these results are supported by a more
important symptom reduction in these patients compared to the mean
of the study (link to the presentation)
- following the approval of a Scientific
Committee, the results of this first Phase III trial were presented
by Prof. R. M�sges of the University of Cologne (link to the
poster) and Prof. M. Shamji of Imperial College London at the
European Academy of Allergy and Clinical Immunology (EAAACI 2017)
conference in June 2017
- the results of this study were also
presented to the German health authority (Paul Ehrlich Institute),
which recognized the very high quality, consistency and statistical
significance, while stating that a second Phase III study was
needed before the submission of an NDA
- the publication of preliminary clinical
results obtained with gp-ASIT+™ in a prestigious peer-reviewed
journal (Journal of Allergy and Clinical Immunology - JACI) is a
recognition of the quality of the drug development by the world’s
leading immunology experts and allergists.
To further increase the chances of success of the next Phase III
trial in Europe, ASIT biotech has decided to implement the
following measures:
- the study will be managed by a single
CRO with an international network
- the inclusion criteria for patients
will be more selective to enroll a more allergic and more
homogenous group
- all patients will be given an
electronic journal to record daily symptoms and drug intake
- the number of clinical centers will be
increased to obtain a consistent enrollment of a limited number of
patients per center leading to an increased results
consistency
1 Canonica GW et al Allergy 2007; 62:317–324; Pfaar O et al
Allergo J Int 2014;23:282–3192 Marple BF Otolaryngol Head Neck
Surg. 2007; 136(6 Suppl):S107-24; Didier A et al Rev. Fr Allergol.
1999; 39:171-185
The Company recently hired Dr. Marie-Etienne Pinelli, an expert
in the clinical developments of anti-allergic drugs (Zyrtec and
Xyzal) to optimize the management of clinical developments and
oversee the upcoming Phase III trial of gp-ASIT+™.
3. Continue the clinical development of
hdm-ASIT+™
The hdm-ASIT+™ drug candidate for dust mite-induced rhinitis is
in an early clinical development stage. The Phase I results
confirmed that the drug was well tolerated and that it could be
tested in a Phase II trial.
The good tolerance of this second product supports the great
safety of other active compounds issued from the ASIT+™ technology
platform. Using this platform, ASIT biotech is also able to assess
the clinical potential of a new drug at the end of a Phase I trial
by comparing its properties with those of gp-ASIT+™. This
early-stage assessment of clinical properties helps to lower the
risk of upcoming clinical developments and increase cost-efficiency
given that the cost of a Phase II trial is between three and five
times higher than that of a Phase I.
Since the results obtained with hdm-ASIT+™ in the first trial
were different than those obtained at the same stage with
gp-ASIT+™, the Company made the strategic decision to postpone by
several months the next clinical developments of the drug in order
to:
- assess a possible increase of the
initial effect after an 8-month exposure to natural dustmite
allergens
- select a new product candidate better
suited to the targeted profile
Since the follow-up study has not shown a complementary effect,
the Company has decided to focus its resources on the selection of
a new product and hopes to resume clinical developments in this
indication in early 2019.
4. Develop ASIT+™ products to fight food
allergies
ASIT biotech received a €6 million research grant from the
Walloon Region to develop immunotherapy products for food allergies
to peanut, egg white and cow’s milk. This grant, in the form of
refundable advances, covers 55% of the investments – from product
conception through to the end of the first trial in allergic
patients (Phase I). The award of this research grant is the
positive result of an independent evaluation process of our
projects by the scientific experts from the Walloon Region. This
project is a collaboration between Imperial College London, the
Guy’s Hospital (King’s College London) and ASIT biotech. This
partnership with highly prestigious research institutions is a
recognition of the scientific caliber of our development work. The
first ex vivo tests (on blood cells of food allergies patients) to
select a product candidate per indication will be carried out to
the end of the second quarter of 2018. The first clinical trials
with an ASIT+™ product for peanut allergy are expected to take
place in the second half of 2018 to the end of 2019.
Thierry Legon, CEO of ASIT biotech CEO, commented: “The last 18
months have brought ASIT biotech strong clinical insights and
advances. Despite the delay, we are happy with the scientific
results obtained since our IPO in May 2016. The results of the
Phase III trial with gp-ASIT+™ have enabled the identification of
its unique mechanism of action, confirming the relevance of
short-term subcutaneous immunotherapy with linear peptides.
Although the safety of hdm-ASIT+™ in humans has been proven, three
new products for dust mite-induced rhinitis have been sent to the
Prof. M. Shamji laboratory to compare their immunological profile
with the one of gp-ASIT+™ and select the best one. Preclinical
development of a new series of products has started for the highly
attractive indications of allergy to peanuts, cow’s milk and egg
white. The first drug candidates for these food allergies are due
to be identified in the summer 2018. Given our expertise and the
scientific information acquired during the development of
gp-ASIT+™, we would be able to accelerate the development of our
product portfolio and consolidate our leadership in the development
of short and effective immunotherapy treatments to meet the strong
market demand.”
About ASIT biotech
ASIT biotech is a Belgian clinical stage biopharmaceutical
company focused on the development and future commercialisation 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 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 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.
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.
Important 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171106006509/en/
CompanyASIT biotechThierry Legon, CEO, +32 2 264 03
90investors@asitbiotech.comorMedia and Investor Relations -
FranceNewCapDusan Oresansky / Pierre Laurent, +33 1 44 71 94
92asitbiotech@newcap.euorMedia Relations - BelgiumLaure-Eve
Monfort, +32 2 290 90 93monfort@comfi.be
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