CALYXT(CLXT) - 2025 Q1 - Quarterly Results

Executive Summary Cibus reported Q1 2025 financial and business highlights, emphasizing gene-edited rice and canola traits and RTDS technology validation Q1 2025 Business and Financial Highlights Cibus reported its Q1 2025 financial results and provided a year-to-date business update, highlighting significant progress in its gene-edited rice and canola traits, including regulatory approvals and commercial momentum. The company is on track for a 2027 commercial launch of its HT1 and HT3 rice traits - Cibus' first stacked gene-edited herbicide tolerance traits in Rice are believed to be an industry first, with customer germplasm integration underway across multiple markets, targeting a 2027 commercial launch for HT1 and HT3 traits[1] - Positive regulatory decision for Cibus' Rice traits HT1 and HT3 in Ecuador, with the Ministry of Agriculture and Livestock determining them equivalent to conventionally bred traits[1] - USDA-APHIS designated Canola disease resistance traits as not regulated, validating US regulatory treatment of Cibus' RTDS technologies and strengthening the commercial pathway[1] Management Commentary and Strategic Vision Management emphasized the validation of their Rapid Trait Development System (RTDS®) technology platform through significant commercial interest and regulatory advancements in the U.S. and EU. The company is demonstrating the unique power of its RTDS process, enabling a predictable path to commercialization and positioning Cibus for significant shareholder value - The Rapid Trait Development System (RTDS®) technology platform is generating significant commercial interest, validating Cibus' strategy and advancing its trait development pipeline[2] - Regulatory acceptance in the U.S. includes USDA-APHIS designation of next-generation Canola disease resistance traits as not regulated and the California Rice Commission's first-ever approval for planting gene-edited rice in California[2] - Cibus' ability to deliver edited traits in under 12 months creates a predictable path to commercialization, positioning the company to capture significant shareholder value[2] Commercial and Operational Progress Cibus achieved significant commercial and operational milestones across crop platforms and corporate initiatives, including regulatory advancements and RTDS process standardization Progress within Crop Platforms Cibus made substantial progress across its key crop platforms, including expanding stacked gene-edited herbicide tolerance traits in Rice, advancing Sclerotinia resistance in Canola with positive greenhouse data, continuing development of sustainable bio-based ingredients, and successfully editing Soybean cells for its HT2 trait Weed Management (HT1 and HT3) in Rice - In March 2025, Cibus expanded its stacked gene-edited herbicide tolerance traits in Rice to include additional trait stacking for broader weed management, with further field testing planned for 2025[7] - In 2024, Cibus secured four major Rice customer agreements, received germplasm, completed successful U.S. field trials, and affirmed a strategic collaboration with RTDC Corporation Limited and Albaugh LLC for Clethodim as part of its weed management solution[7] Sclerotinia Resistance - In March 2025, positive greenhouse data was announced for Canola plants containing the third mode of action for Sclerotinia resistance[7] - 2024 progress included field trial results for the second mode of action in Canola showing enhanced disease resistance, successful edits for the fourth mode of action, and a collaboration with Biographica to identify novel genetic targets[7] Sustainable Ingredients - In Q1 2025, the company continued successful advancement of its bio-based fermentation biofragrance product and is developing commercialization plans[7] - In 2024, Cibus progressed a partner-funded project with a large multi-national CPG company focused on developing sustainable low carbon ingredients[7] Soybean Platform - In January 2025, Cibus successfully edited a Soybean cell for its HT2 trait, achieving high editing rates that enabled expanded development of its Soybean platform[8] Corporate and Industry Progress Cibus achieved significant corporate and industry milestones, including standardizing its RTDS gene editing process for industrialized breeding and making substantial global regulatory advancements for gene editing technologies in key markets like California, the EU, USDA-APHIS, and Ecuador Standardized RTDS Gene Editing Process - In January 2025, Cibus established production standards for its proprietary RTDS gene editing process for developed traits in Rice and Canola, and advanced traits in Canola, aiming to edit and return customer germplasm within 12 months[10] Global Regulatory Progress - The California Rice Commission approved Cibus' field research proposal in February 2025, marking the first authorization for planting gene-edited Rice in California[10] - In March 2025, EU member states endorsed the EU Council's negotiating mandate on NGTs, enabling trilogue discussions for final legislation adoption[10] - In April 2025, USDA-APHIS designated two of Cibus' canola traits as not regulated, reinforcing the regulatory status of RTDS precision gene editing technologies in the U.S. Additionally, Ecuador determined Cibus' HT1 and HT3 Rice traits are equivalent to conventionally bred seeds[10] Expected Milestones for 2025 Cibus outlines key 2025 milestones for trait development, commercialization, and financial strategy, including cash runway and strategic alternatives evaluation Trait Development and Commercialization Milestones Cibus anticipates several key milestones in 2025 across its trait development pipeline, including expanding commercial relationships and initiating trait validation trials for Rice in Latin America, achieving HT2 edits in Soybean plants, conducting field trials for Sclerotinia resistance in Canola, and obtaining initial field trial data for HT2 in Canola - For Rice, Cibus expects to expand existing and develop new commercial relationships across North and South America, conduct first trait validation trials in Latin America, and prepare delivery of initial traits to California and Latin American customers by mid-2025 and end of 2025, respectively[10][13] - For the Soybean Platform, HT2 edits in Soybean plants are expected in 2025, building on successful cell edits earlier in the year[13] - For Sclerotinia, field trials for the third and fourth modes of action in Canola are planned for 2025, with early results from controlled environment testing for the fourth mode of action expected in Q2 2025[13] - Initial field trial data for HT2 in Canola is expected in 2025[13] Financial and Strategic Milestones Cibus expects to continue progress on its partner-funded sustainable low carbon ingredients project and receive nominal revenues from biofragrance products in 2025. The company's cash position of $23.6 million as of March 31, 2025, is expected to fund operations into Q3 2025, while the Board evaluates strategic alternatives - Cibus expects to continue progress on its partner-funded project to develop sustainable low carbon ingredients for the CPG industry and receive nominal revenues associated with the commercialization of its sustainable ingredient biofragrance products in 2025[13] Cash Position as of March 31, 2025 | Metric | Amount (Millions) | | :--------------------- | :---------------- | | Cash and cash equivalents | $23.6 | - Existing cash and cash equivalents are expected to fund planned operating expenses and capital expenditure requirements into the third quarter of 2025, with the Board evaluating a full range of strategic alternatives[13] First Quarter 2025 Financial Results Cibus' Q1 2025 financial results show a