reports
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Livio Luyten
- Lynn Hautekeete
- Mathijs Geerts Danau
- Michiel Declercq
- Guy Sips
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Livio Luyten
- Lynn Hautekeete
- Wim Hoste
- Wim Lewi
- Guy Sips
Biotalys EPA's review on Evoca in 4Q rather than by end September
In an update on the regulatory approval procedure in the US of Evoca, its first protein-based biocontrol product, Biotalys has received further guidance from EPA, the U.S. Environmental Protection Agency on the regulatory review of Evoca. The EPA has confirmed that the scientific review of the dossier is progressing, and that all the requests for additional information have been addressed. While the agency continues to work diligently on the review, Biotalys now expects the final steps of the re...
- Jacob Mekhael
- Livio Luyten
- Michiel Declercq
- Thomas Couvreur
- Thomas Vranken
- Wim Hoste
- Thomas Vranken
Biotalys The planned Evoca-tion of a first US approval
Biotalys is a Belgian AgTech company developing protein-based biocontrols through its proprietary Agrobody Foundry platform. The company aims to replace traditional chemical pesticides with safer, sustainable alternatives. The company recently guided for market approval in the US for its lead product Evoca by the end of September 2025, which would reflect an important value inflection point for the company. We have updated our model, and taking into account the expected near-term trigger, raise ...
- Thomas Vranken
Biotalys Regulatory update points to end of 3Q25 for Evoca's US approv...
Biotalys announced regulatory progress for its lead biofungicide candidate, Evoca, in both the US and Europe. In the US, the EPA confirmed that Biotalys has met its data requirements and expects to complete its review by September 30, 2025. In Europe, Dutch authorities have positively evaluated Evoca's active ingredient as low risk, paving the way for EU-level peer review with Biotalys expecting a potential decision in 2H26. The update provides greater clarity on regulatory timelines, supporting...
- Jacob Mekhael
- Lynn Hautekeete
- Thomas Vranken
- David Seynnaeve
- PhD
(Sponsored) Biotalys NV - Fungal foes, natural fixes
Today, we initiate coverage on Biotalys, a Belgian regulatory-stage agricultural biotech (AgBiotech) company, with a BUY rating & TP of EUR 7.2.In this report, we deep-dive into the company's differentiated AGROBODY FoundryTM platform and the unique value-add of its protein-based biocontrols (AGROBODIESTM) meant to treat fungal diseases affecting fruits & vegetables. We consider Biotalys a compelling investment opportunity, based on:1/ Growing awareness on the impact of chemical crop protec...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Thomas Vranken
- Wim Hoste
- Wim Lewi
- Guy Sips
- Jacob Mekhael
- Kristof Samoy
- Thomas Couvreur
- Thomas Vranken
- Wim Hoste
- Thomas Vranken
Biotalys FIRST LOOK: Unlocking post-harvest setting with AgroFresh par...
Biotalys has entered a collaboration with US-based AgroFresh Solutions to develop and commercialize its biocontrols for post-harvest use, targeting a $ ~300m global market. AgroFresh is a global leader in the post-harvest niche and featured $ 162m revenues at the time of its takeover by private equity Paine Schwartz in 2023, having grown significantly from ~300 to ~700 employees since then. We see the collaboration as highly complementary to Biotalys' pre-harvest efforts as it unlocks access to ...
- Guy Sips
- Jacob Mekhael
- Sharad Kumar S.P
- Guy Sips
- Thomas Vranken
Biotalys FIRST LOOK: Good financial management; but focus could be on ...
In FY24, Biotalys optimized its capital resources, achieving a significant reduction in operating expenses while strengthening its balance sheet through a successful private placement. Looking ahead, they plan to further advance their product portfolio and develop novel modes of action, as well as expand options to scale and produce their biobased solutions. So we saw in FY24 good financial management - runway reaching into May-26 - but focus could be on some operational hiccups.
- Guy Sips
- Michiel Declercq
- Thomas Vranken
- Wim Hoste
- Thomas Vranken
Biotalys Positive first field trial results with 2nd biocontrol BioFun...
Biotalys announced strong results from field trials of its second biofungicide BioFun-6, which targets Botrytis and powdery mildew in fruits and vegetables. The trials showed BioFun-6 effectively controlled fungi compared to synthetic and biological solutions at lower dosage rates than Evoca. While further field trials still need to be conducted before a regulatory filing, we estimate BioFun-6 could reach the market by the end of the decade and reach a significant share of the today € 1.2bn mark...
- Guy Sips
- Jacob Mekhael
- Michiel Declercq
- Sharad Kumar S.P
- Thomas Vranken
- Thomas Vranken
Biotalys FIRST LOOK: The regulatory process marches on
Biotalys provided an update on its regulatory review procedure for Evoca in Europe, where the Dutch authority Ctgb has now issued a positive draft assessment report, recommending the approval of Evoca's active ingredient throughout the EU. The draft report follows the earlier decision to allow large-scale demonstration trials with human consumption, and marks an important milestone in the regulatory review. The procedure will now be further followed up by EFSA with Biotalys anticipating full app...
- Guy Sips
- Hilde Van Boxstael
- Sharad Kumar S.P
- Thomas Vranken
- Wim Lewi
- Thomas Vranken
Biotalys FIRST LOOK: Fresh cash through € 15m private placement
Biotalys raises € 15m through a private placement with a strong syndicate of existing investors AvH and AIF, as well as new investor ASR. The new shares are issued at € 2.83, representing a discount of 10% on the 30-day VWAP. Proceeds will be used to support Evoca's regulatory filing, advance the pipeline and strengthen the Agrobody platform. We expect the additional funds to extend the cash runway by approx. 4 quarters into mid-2026 (KBCSe), and in the meantime continue to look out for EPA appr...
Unfortunately, this report is not available for the investor type or country you selected.
Report is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.