Biotalys Provides Company Update
Press release – Regulated information – Inside information (*)
- Progress to
next-generation AGROBODY™ technology platform
- Update on
product pipeline and regulatory review for EVOCA™(**)
- CSO Dr. Carlo
Boutton to drive all research and early development while Dr. Eva
Van Hende to head regulatory and field development; COO Luc
Maertens and CBO Patrick McDonnell leaving the company
- Management to
host a conference call and live webcast today at 15:00 CET / 14:00
GMT / 09:00 AM EST, details below
Biotalys (Euronext – BTLS), today provided a
company update following a strategic review of the company by CEO
Kevin Helash and the board of directors. The review leads to a
shift to the second-generation AGROBODY™ technology to develop
protein-based biocontrols for crop and food protection. This move
to AGROBODY 2.0 entails organizational changes to concentrate
resources on core R&D capabilities while focusing on obtaining
registration for Biotalys’ first product candidate EVOCA.
Kevin Helash, Chief Executive Officer of
Biotalys, commented: “Since my
appointment as CEO of Biotalys in early October, I have conducted a
thorough review and am even more convinced of the power and
potential of our AGROBODY Foundry™ platform and the company’s
strategy. As an organization focused on creating sustainable crop
protection products, we need to deliver on two fronts: one, to roll
out the next-generation AGROBODY technology, which we believe will
increase potency and efficacy of our bioactive agents with multiple
modes of action while lowering cost of goods per hectare, allowing
for a broader market penetration of our biocontrol products. And
two, to ensure that the organization is set up to operate with a
laser-like focus on execution while prudently managing costs.”
The AGROBODY 2.0 technology
platform
Biotalys’ AGROBODY platform is based on
VHH-technology already successfully applied in the pharmaceutical
industry and Biotalys is pioneering this technology for
agriculture. By applying a discovery method based on defined
molecular targets, Biotalys is now pursuing novel opportunities to
identify potent bioactive ingredients for use in crop protection.
This AGROBODY 2.0 approach will therefore become the main focus of
the R&D organization. It has the potential to clearly
differentiate the company’s protein-based biocontrols from other
biological solutions thanks to a larger range of modes of action to
fight agricultural pests and diseases.
With this new approach, Biotalys builds on
EVOCA, the company’s first protein-based product candidate, which
again showed convincing results in extension trials by academic
institutes in the U.S. and trials by its business partners.
Updated pipeline of protein-based
biocontrols
In view of the new approach, Biotalys has
evaluated its pipeline and decided to focus on biofungicides and
bioinsecticides. The company will proceed with the following
programs:
- EVOCA, a biofungicide candidate
aimed at targeting botrytis bunch rot and powdery mildew in fruits
and vegetables; see below for a regulatory update;
- EVOCA NG (next generation), a
biofungicide program currently in development, with the same
molecule as EVOCA but an optimized production process and
formulation;
- BioFun-4, a biofungicide program
aimed at targeting Oomycetes in fruits and vegetables;
- BioFun-6, a biofungicide program
aimed at targeting botrytis, powdery mildew and anthracnose in
fruits and vegetables;
- BioFun-7, a biofungicide program in
collaboration with the Bill & Melinda Gates Foundation, aimed
at targeting leafspot disease in cowpeas and other legumes;
- BioIns-2, a bioinsecticide program
in collaboration with Syngenta Crop Protection, aimed at targeting
key pests.
A leadership and organization fit for
purpose
Under the leadership of CEO Kevin Helash, the
new executive committee comprises CSO Dr. Carlo Boutton, who takes
responsibility for all early R&D activities, and CFO Douglas
Minder. COO Luc Maertens and CBO Patrick McDonnell will leave the
company and their roles will be consolidated into the new
leadership. The senior management team is completed by Dr. Eva Van
Hende, who will lead regulatory and field development; Sophie
Snijders, Head of HR; and Toon Musschoot, Head of IR &
Communications.
The organizational changes will result in a
reduction in headcount of 8 positions and annualized cost savings,
leading to an approximate 10% reduction in operating expenses going
forward. Together with savings realized during the current year and
planned reductions in future spend, the company has revised its
expected cash burn for FY 2023 from approximately €22 million to
less than €20 million.
Simon Moroney, Chairman of Biotalys,
said: “I would like to thank Luc Maertens for his pivotal
role in demonstrating that our AGROBODY biocontrols have
outstanding promise as novel crop protection agents. I also thank
Patrick McDonnell and our other departing colleagues for their
contribution to Biotalys over the past years and wish them well in
their future careers. Our new leadership is committed to driving
implementation of the second-generation AGROBODY platform with the
goal of maximising value for the company’s stakeholders and,
ultimately, for growers.”
Update on EVOCA’s regulatory review
The regulatory review of EVOCA is ongoing in
both the United States and the European Union.
In the U.S., the Environmental Protection Agency
(EPA) is evaluating the regulatory dossier, and we are working with
industry experts to support our submission. As part of the ongoing
dialogue and exchange of information with the authority, from time
to time the EPA requests additional information, which is not
uncommon considering the novelty of the product candidate. The
company remains committed to responding to all requests for
information in a timely and appropriate manner.
In the E.U., Biotalys received confirmation from
the competent authority – the Dutch Board for the Authorisation of
Plant Protection Products and Biocides (Ctgb) – that it had
concluded the first review of all sections of the full data
package. As a result, the Ctgb has requested additional
information, which the company plans to provide in due course. If
accepted, the authority will be able to finalise this first phase
of the E.U. review and pass its assessment report to both EFSA and
the European Member States for the next phase of the review at E.U.
level.
(*) This press release contains inside
information to the extent that it relates to the changes at the
level of the Executive Committee.
(**) EVOCA™: Pending Registration. This product
is not currently registered for sale or use in the United States,
the European Union, or elsewhere and is not being offered for
sale.
Live webcast and conference call
Company management will host a live webcast
today, 29 November 2023 at 15:00 CET / 14:00 GMT / 09:00 AM
EST.Webcast link: https://edge.media-server.com/mmc/p/avz2wgbp
Dial-in details: To ask questions live to the management, please
also register for the conference call via
https://register.vevent.com/register/BI1f6fce3935ef4e1e8243c13beccecc9a
About Biotalys
Biotalys is an Agricultural Technology (AgTech)
company developing protein-based biocontrol solutions for the
protection of crops and food and aiming to provide alternatives to
conventional chemical pesticides for a more sustainable and safer
food supply. Based on its novel AGROBODY™ technology platform,
Biotalys is developing a strong and diverse pipeline of effective
product candidates with a favorable safety profile that aim to
address key crop pests and diseases across the whole value chain,
from soil to plate. Biotalys was founded in 2013 as a spin-off from
the VIB (Flanders Institute for Biotechnology) and has been listed
on Euronext Brussels since July 2021. The company is based in the
biotech cluster in Ghent, Belgium. More information can be found on
www.biotalys.com.
For further information, please
contact
Toon Musschoot, Head of IR &
CommunicationsT: +32 (0)9 274 54 00E:
Toon.Musschoot@biotalys.com
Important Notice
Biotalys, its business, prospects and financial
position remain exposed and subject to risks and
uncertainties. A description of and reference to these risks
and uncertainties can be found in the 2022 annual report on the
consolidated annual accounts and the half-year report for 2023.
This announcement contains statements which are
"forward-looking statements" or could be considered as such. These
forward-looking statements can be identified by the use of
forward-looking terminology, including the words ‘aim’, 'believe',
'estimate', 'anticipate', 'expect', 'intend', 'may', 'will',
'plan', 'continue', 'ongoing', 'possible', 'predict', 'plans',
'target', 'seek', 'would' or 'should', and contain statements made
by the company regarding the intended results of its strategy. By
their nature, forward-looking statements involve risks and
uncertainties and readers are warned that none of these
forward-looking statements offers any guarantee of future
performance. Biotalys’ actual results may differ materially from
those predicted by the forward-looking statements. Biotalys makes
no undertaking whatsoever to publish updates or adjustments to
these forward-looking statements, unless required to do so by
law.
- Biotalys press release_Platform 2.0 v29November2023
- Persbericht_Biotalys geeft bedrijfsupdate_29 november 2023
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