- Operation aimed at replacing TheraVet's veterinary
activities with a high potential biotech program linked to the
repositioning of an innovative molecule in idiopathic pulmonary
fibrosis;
- Operation based on a strategic agreement between TheraVet
and H4Orphan, under which H4Orphan's flagship clinical program in
idiopathic pulmonary fibrosis is contributed to TheraVet in
exchange for the issue of new shares;
- Operation aimed at accelerating the development of an
innovative treatment for pulmonary fibrosis, in particular through
the launch of a Phase II study, and leveraging on the complementary
expertise and resources of the two companies;
- Operation associated with an initial refinancing of EUR
300,0001, offering a financial visibility up to the end of
the first quarter of 2025;
- The Operation will be submitted to shareholders for approval
at an Extraordinary General Meeting on October 17, 2024.
Regulatory News:
TheraVet (ISIN: BE0974387194 - ticker: ALVET) today announces
a strategic transformation project with H4Orphan aimed at
creating a leader in idiopathic pulmonary fibrosis and accelerating
the development of its multi-target drug candidate.
Operational highlights
The proposed Operation is part of the strategic transformation
project between TheraVet and H4Orphan aimed at developing the
H4Orphan's flagship clinical program in idiopathic pulmonary
fibrosis and capitalizing on TheraVet teams to accelerate its
development by leveraging its regulatory advances in Belgium.
Idiopathic pulmonary fibrosis is a rare disease that appears
after the age of 50, with a prevalence of ~2.7/10,000 inhabitants
(i.e., slightly more than 220,000 patients in Europe and the United
States), and for which there is currently no curative treatment.
With a median survival of 2.5 years from diagnosis, there are
almost 50,000 deaths per year in Europe and the United States.
More precisely, the objective of this strategic agreement is to
substitute TheraVet’s existing activities by high potential human
biotech development activities along the following axes:
- Launch, over 9 to 12 next months, of a Phase II clinical study
(of an estimated duration of 18 to 24 months) for patients
suffering of idiopathic pulmonary fibrosis through the opening of
clinical centers, primarily in Belgium;
- Elaboration of a research and development strategy based on
H4Orphan’s platforms and expertise, particularly in the
repositioning of existing molecules;
- Capitalize on TheraVet's presence in Belgium and the United
States to facilitate access to investors and clinical and
regulatory players in Belgium and North America in preparation of
clinical developments;
- Divestment of veterinary activities (incl. BIOCERA-VET® product
line and VISCO-VET® clinical program).
TheraVet will maintain its teams at its office in Gosselies,
Belgium. Beyond the first quarter of 2025, the continuation of
these activities will be conditional on refinancing (e.g.,
convertible bond line, subsidies, etc.).
“This operation stems from an in-depth review of TheraVet's
expertise in Belgium and the opportunity for the Company to acquire
a human clinical program in a major indication whose regulatory
advances have been welcomed in Belgium. Given TheraVet's track
record, we looked to apply our company's structure and capabilities
to a Phase II clinical asset in a major indication with significant
unmet needs. Moreover, the asset concerned is based on the
repositioning of an existing molecule which had already been
approved and demonstrated to be effective in patients with
pulmonary fibrosis in other respiratory indications, such as cystic
fibrosis. The H4Orphan team has carried out major preclinical and
regulatory developments on this molecule in this indication. We at
TheraVet believe that our capabilities and expertise could
contribute to tangible value creation, and what is more, on Belgian
soil. Together with our Board of Directors, we believe that the
strategic agreement with H4Orphan would enable Theravet to become a
leader in pulmonary fibrosis, where the need for treatment is more
than urgent,” stated Enrico BASTIANELLI, Founder and Chief
Executive Director of TheraVet.
“Our Board of Directors is convinced that the strategic
agreement with TheraVet will boost our development program in
Belgium, and fully supports this Operation. The TheraVet team will
be able to lead and accelerate the clinical development plan in
pulmonary fibrosis with a Phase II study aimed at validating the
clinical evidence of our treatment, enabling a breakthrough
innovation in a field with no truly effective treatment. With our
management team, we look forward to working with TheraVet,” stated
Gaétan TERRASSE, Chairman and CEO of H4Orphan.
About the proposed Operation
Main terms of the Operation
According to the Memorandum of Understanding between TheraVet
and H4Orphan, the Operation is structured as a contribution of
assets, valued at EUR 14 million2, under which H4Orphan’s
shareholders will receive newly issued TheraVet ordinary shares in
counterpart of contributed assets.
The number of new shares issued to H4Orphan will be calculated
by dividing the total value of the assets contributed by the issue
price per share, which will be equal to the average closing price
of the Company's shares on the Euronext Growth market over a period
running from the date of convening to the day before the
Extraordinary General Meeting, i.e., from September 30 to October
16, 2024.
Following the completion of the Operation, H4Orphan shareholders
will hold a very significant proportion (>95%) of TheraVet's
share capital and voting rights.
The Operation is fully supported by the main shareholders of
TheraVet and H4Orphan, namely Mr. Enrico BASTIANELLI on TheraVet's
side, and a pool of shareholders represented by Mr. Gaétan TERRASSE
and DOMUNDI represented by Mr. Emmanuel HUYNH on H4Orphan's
side.
Detailed information on the Operation, in particular a
description of the assets contributed and its dilutive impact, is
available in the Special Report of the Board of Directors, which
can be consulted on TheraVet's investor website
www.theravet-finances.com.
Indicative timetable and next deadlines
The Memorandum of Understanding, unanimously approved by the
Boards of Directors of TheraVet and H4Orphan, sets out the usual
provisions of a strategic agreement until approval of the agreement
by the Extraordinary General Meeting (“EGM”) on October 17,
2024.
The TheraVet EGM will be called to vote on the proposed
Operation, which is available at www.theravet-finances.com.
The resolution to approve the proposed Operation will require a
quorum of 50% of the shares (if not, a second meeting will be
convened on October 28 with the same agenda during which no minimum
quorum must be met) and obtain, at the TheraVet General Meeting,
the positive vote of three quarters of the shareholders present or
represented. The TheraVet EGM will also be required to approve:
- Business continuity;
- The authorized capital increase of the Company by EUR
2,500,000;
- Appointment of new directors;
- The change of name of the Company to EGEIRO Pharma, to mark the
start of a new stage of development for the new biotech
activity.
TheraVet has received undertakings from Mr Enrico BASTIANELLI,
who represents approximately 17% of TheraVet's share capital and
17% of its voting rights, to vote in favor of the resolutions
relating to the operation at TheraVet's EGM.
It is also planned that the IRIS Capital Investissement fund
represented by Mr Fabrice EVANGELISTA will grant, on the date of
TheraVet's EGM, a cash advance totaling EUR 300,000 in connection
with the existing convertible bond issue.
Governance of the new entity
Following the completion of the proposed Operation, all
directors, with the exception of Enrico BASTIANELLI SRL, will
resign their positions, and Mr Gaétan TERRASSE, Chairman of
H4Orphan, will become Chairman of the Board of Directors of
TheraVet. It is intended that TheraVet's Board of Directors will be
made up of directors proposed by H4Orphan's current shareholders,
alongside Mr Enrico BASTIANELLI.
TheraVet and H4Orphan have agreed to set up a strategic steering
committee to oversee the execution of the Memorandum of
Understanding, in particular the implementation of the proposed
operation and operational integration within TheraVet.
Finally, in addition to its participation as a director,
H4Orphan's management has requested the services of Enrico
Bastianelli SRL for 1.5 to 2 days a week.
About the EUR 300,000 financing
The initial financing of EUR 300,000, contributed in a single
tranche immediately after the approval of the Operation by the
Extraordinary General Assembly, comes from the equity-linked
financing facility set up by the Company in November 2023. This
line, for a maximum amount of €3,000,000, takes the form of
convertible bonds issued under the authorized capital and
subscribed by the French company IRIS. Afterwards, the new tranches
will be subscribed in tranches of €200,000, and then converted into
TheraVet shares over a period of up to 24 months: they are
subscribed one after the other when all the shares for the amount
of the tranche are sold. The bonds will have a par value of €2,500
and will be converted into shares at a discount of 5% to the
weighted average share price over the previous 15 days. Apart from
this conversion option, no other benefits are granted to IRIS: no
fees, commissions or expenses, and no subscription rights
(warrants).
About the attempts to refinance the veterinary
activities
Over the past 12 months, in addition to setting up the
equity-linked financing facility in November 2023, the Company has
explored numerous ways, without success, to raise additional funds
to continue its operations:
- the sale of its osteosarcoma franchise: no serious interest
shown by the companies contacted;
- a private placement: over 200 potential investors contacted; a
few introductory meetings but no clear appetite;
- the sale of the Company's US assets through a renowned
intermediary: the timeframe and budget did not allow to guarantee
feasibility;
- a merger with other veterinary companies to increase the
Company's visibility: preliminary discussions never led to a
Memorandum of Understanding.
About the contributed assets
Tritoqualin is a molecule known for its safety and multi-target
pharmacological activity (multifunctional ligand). It has
demonstrated very encouraging preclinical results in animal models
of idiopathic pulmonary fibrosis (IPF). In December 2023,
tritoqualine obtained a full “Scientific and Technical Advice”
(Full STA) from the AFMPS (Belgian Drug Agency) with approval to go
directly to Phase II for the IPF. It enjoys strong intellectual
protection worldwide, and in particular in the US, China and
Europe. Detailed information regarding the contributed assets is
available in Appendices 1 and 3 of the Special Report of the Board
of Directors, which can be consulted on TheraVet’s investors
website www.theravet-finances.com.
About the idiopathic pulmonary fibrosis
Idiopathic pulmonary fibrosis (IPF) is a rare and progressive
disease of the respiratory system, marked by thickening and
rigidification of lung tissue, associated with the formation of
scar tissue leading to a progressive decline in lung function.
Symptoms are generally marked by the progressive onset of
breathlessness and dry cough, and fatigue feeling. Once
established, IPF can lead to complications including pulmonary
hypertension, heart failure, pneumonia or pulmonary embolism. IPF
is fibrosis, i.e. the transformation of healthy tissue into
fibrotic tissue following an excessive accumulation of collagen and
fibronectin in the extracellular matrix. When excessively produced,
collagen progressively invades the matrix between the pulmonary
alveoli, with progressive extension from patch to patch. Fibrosis
is a tissue dysregulation resulting from many types of injuries,
including smoking, acid reflux, certain viral infections,
associated with genetic predisposition. IPF is a rare disease,
appearing after the age of 50, with a low prevalence: 2.7/10,000
inhabitants with over 250,000 patients worldwide (United States and
Europe). There is currently no curative treatment. There are almost
50,000 deaths per year in Europe and North America (median
survival: 2.5 years).
About TheraVet SA
TheraVet is a veterinary biotechnology company specialising in
osteoarticular treatments for companion animals. The Company
develops targeted, safe and effective treatments to improve the
quality of life of pets suffering from joint and bone diseases. For
pet owners, the health of their pets is a major concern and
TheraVet’s mission is to address the need for innovative and
curative treatments. TheraVet works closely with international
opinion leaders in order to provide a more effective response to
ever-growing needs in the field of veterinary medicine. TheraVet is
listed on Euronext Growth® Paris and Brussels, has its head office
in Belgium (Gosselies) with a US subsidiary.
For more information, visit the TheraVet website or follow us on
LinkedIn / Facebook / Twitter
Forward-looking statements
This release may contain forward-looking statements.
Forward-looking statements may include statements regarding the
Company's plans, objectives, goals, strategies, future events, the
safety and clinical activity of TheraVet’s pipelines and financial
condition, results of operation and business outlook. By their
nature, forward-looking statements involve inherent risks and
uncertainties, both general and specific, and there are risks that
predictions, forecasts, projections, and other forward-looking
statements will not be achieved. These risks, uncertainties and
other factors include, among others, those listed and fully
described in the “Risk Factors” section in the Annual Report.
TheraVet expressly disclaims any obligation to update any such
forward-looking statements in this document to reflect any change
in its expectations with regard thereto or any change in events,
conditions, or circumstances on which any such statement is based,
unless required by law or regulation.
1 Refinancing, from convertible bonds from the equity-linked
financing facility set up in November 2023, contributed in one
tranche immediately after approval by the Extraordinary General
Meeting.
2 This is a conventional negotiated value; the value of the
assets contributed estimated by an independent expert is EUR 42
million (see Appendix 2 of the Special Report (Contribution in
Kind).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240929854806/en/
TheraVet Chief Executive Officer Enrico Bastianelli
investors@thera.vet Tel: +32 (0) 71 96 00 43
NewCap Investor Relations and Financial Communications
theravet@newcap.eu Tel: +33 (0)1 44 71 94 94
Press Relations theravet@newcap.eu Tel: +33 (0)1 44 71 00 15
NewCap Belgique Press Relations Laure-Eve Monfort
lemonfort@newcap.fr Tel: + 32 (0) 489 57 76 52
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