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...
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 ...
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.
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...
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...
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...
Biotalys announced the addition of a new biofungicide program to the pipeline. Biofun-8 leverages Biotalys' Agrobody platform and will target Alternaria, an important leaf spot fungus in fruits, vegetables and potato crops. Biotalys estimates a market opportunity around $ 1.1bn. We reiterate our € 6 TP and Buy rating.
Biotalys continues its work with the EPA and Ctgb for regulatory approval of Evoca in the US and EU. Impressively, Evoca can start a large-scale demo trial in the Netherlands with allowed harvest sale for human consumption, which we see as a major vote of confidence by the regulator. Overall, Biotalys is advancing on its key programs despite a significqnt opex cut, leaving runway into 2Q25. We maintain our conviction in Biotalys' tech while we await a regulatory decision, and reiterate a € 6.0 T...
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