Core Insights - Cibus, Inc. announced that two of its disease resistance trait products for canola have been designated as not regulated by the USDA-APHIS, allowing for unrestricted product development in the U.S. [1][2] Regulatory Developments - The USDA-APHIS confirmed that the products developed using Cibus' Rapid Trait Development System™ (RTDS®) do not meet the definition of a "regulated article," enabling Cibus to advance product development without regulatory restrictions [2][3] - The designation aligns with evolving regulatory frameworks globally, including the EU's recent endorsement of regulations for plants developed by New Genomic Techniques (NGTs), which will treat certain gene-edited products similarly to conventional varieties [3][4] Product Features and Benefits - Cibus' Sclerotinia resistance trait in canola provides multiple modes of action, helping farmers improve yields and reduce reliance on fungicides, which are necessary for controlling Sclerotinia sclerotiorum, a significant pathogen that can reduce canola yields by 7-15% [4][5] - The company anticipates that the application of its traits will extend to other crops like soybean, broadening the benefits of these traits across different agricultural sectors [5] Company Overview - Cibus is a technology company focused on gene editing to develop and license traits to seed companies, addressing productivity and sustainability challenges in agriculture, with an estimated global economic impact of $300 billion annually due to diseases and pests [5] - The company has a pipeline of five productivity traits, including those for weed management in rice and disease resistance, with a long-term focus on major global row crops such as canola, rice, and soybean [5]

Financial Data and Key Metrics Changes - Cash and cash equivalents were $14.4 million as of December 31, 2024, with $21.6 million net proceeds received in 2025 from a registered direct offering [37] - R&D expense decreased to $12.4 million for Q4 2024 from $14.2 million in the previous year, primarily due to lower non-cash stock compensation and cost-saving initiatives [38] - Net loss improved to $25.8 million for Q4 2024 compared to a net loss of $277.2 million in the prior year, which included a non-cash goodwill impairment charge of $249 million [38] Business Line Data and Key Metrics Changes - The rice platform is gaining momentum with collaborations affirming herbicide resistance traits, and agreements with four major rice seed companies covering approximately 40% of accessible rice acres [15][16] - In canola, Cibus has developed productivity traits for Pod Shatter Reduction and continues to progress on advanced traits for disease resistance and herbicide tolerance [18][19] - The soybean platform achieved a significant milestone with successful editing of soybean cells for HT2 traits, allowing access to an estimated 125 million accessible soybean acres [26][27] Market Data and Key Metrics Changes - The global regulatory environment is evolving favorably, with the EU's pending legislation expected to regulate gene-edited plants similarly to conventional breeding, opening new markets for Cibus [29][30] - The California Rice Commission approved planned field trials for advanced rice traits, marking a significant milestone in a key American market [30] Company Strategy and Development Direction - Cibus is transitioning from an agricultural trait development company to a commercial trait company, focusing on gene-edited productivity traits that address sustainability challenges for farmers [8][9] - The company emphasizes its proprietary Rapid Trait Development System (RTDS) as a key differentiator, enabling rapid and predictable trait development [14] - Cibus is also advancing its Sustainable Ingredients program, targeting low carbon ingredients and biofragrances for the consumer packaged goods industry [32][33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum in key markets and the potential for significant value capture as regulatory frameworks evolve [41][42] - The company is positioned to capitalize on the global adoption of gene-edited solutions, with traits moving into customer germplasm and showing promising results in field trials [42] Other Important Information - Cibus expects existing cash and cash equivalents to fund planned operating expenses into late Q3 2025, supported by recent financing [37][64] - The company is focused on achieving several important milestones in 2025, including the completion of EU legislation and continued development of its soybean platform [34][35] Q&A Session Summary Question: What does the EU decision mean for commercial products in Europe? - Management highlighted the importance of the EU's regulatory process and its implications for accelerating customer programs and trade [46][49] Question: Can you discuss the patentability of genetic modifications under the current EU law? - Management noted that the EU Council advocates for transparency in patenting, which is seen as beneficial for the seed industry [52][54] Question: Are commercialization dates for products on track? - Management confirmed that all timelines are on track, with significant progress expected in the current year [58][60] Question: Will there be meaningful revenues from the sustainable ingredient business in 2026? - Management expressed confidence in generating revenues from biofragrance products in 2026, indicating strong market interest [68][70] Question: Are you in touch with potential customers in Europe? - Management confirmed ongoing collaboration with European customers on various traits, including Sclerotinia tolerance [72][74] Question: What are the expectations for operating costs moving forward? - Management indicated that while current cost reductions are significant, further optimizations are expected as processes are refined [76][78] Question: What priority traits and crops will receive the most resources? - Management emphasized focus on rice, canola, and soybean platforms, particularly in disease resistance and productivity traits [84][86]

Financial Performance and Challenges - Cibus has incurred significant losses and anticipates continuing to incur significant losses for several years, relying on obtaining additional financing in the near term[26] - Cibus relies on distributions from Cibus Global to cover corporate expenses, making it vulnerable to changes in its financial structure[26] - The agricultural industry is highly seasonal, which may cause Cibus' sales and operating results to fluctuate significantly[28] - Cibus faces significant competition, with many competitors having greater financial and technical resources[26] - The company’s financial statements include goodwill from Merger Transactions, which could become impaired and significantly impact results[26] - Cibus expects to save approximately $10 million annually from its restructuring initiative, with a 20% reduction in monthly cash use by the end of Q1 2025 compared to fiscal year 2024[46] Technology and Innovation - The company’s core technology, the Rapid Trait Development System™ (RTDS), is covered by over 500 patents or patents pending, representing a breakthrough in standardized, high-throughput gene editing[36] - The Trait Machine process allows for a time-bound, reproducible, and predictable breeding process, significantly improving the productivity of the breeding process compared to conventional methods[39] - Cibus' RTDS technology enables rapid incorporation of new traits into elite germplasm, significantly accelerating the breeding process[92] - The RTDS process allows for scalable trait development, facilitating the production of customizable crops with multiple stacked traits[93] - Cibus' proprietary technologies are designed to prevent excessive mutations, ensuring precision in gene editing[104] - Cibus' GRON technology enhances gene editing efficiency by utilizing a chemically synthesized oligonucleotide that acts as a targeted mutagen[98] - The company’s gene editing process is non-transgenic, ensuring that the final traits are indistinguishable from those developed through conventional breeding[109] Product Development and Market Potential - Cibus has a pipeline of five productivity traits, with three classified as "developed" and two as "advanced," targeting crops like Canola and Rice[43] - The PSR productivity trait in Canola has been successfully edited into elite lines and transferred back to customers, with an estimated potential market royalty of over $435 million across 57 million accessible acres[56] - Cibus has established material transfer agreements with four leading rice seed companies, representing approximately 40% of the addressable acres for its herbicide tolerance traits HT1 and HT3 in Rice[49] - The total market for Rice is estimated at approximately 218 million acres, with potential royalties of $350 million from the developed HT1 and HT3 traits[61] - Cibus has successfully edited a Soybean cell with genetic changes associated with its HT2 productivity trait, achieving high editing rates for commercial development[64] - The total market for Soybean is approximately 245 million acres across North America, Latin America, and Europe, with an estimated potential market royalties exceeding $875 million[65][66] - Cibus' advanced productivity traits for Soybean include Sclerotinia resistance (50 million accessible acres, estimated trait fee of $10-15 per acre) and HT2 (75 million accessible acres, estimated trait fee of $5-12 per acre)[65] - The company is expanding its operational platforms to include Wheat and Corn, focusing on productivity traits such as disease resistance and nitrogen use efficiency[67][68] Regulatory Environment - Regulatory changes are evolving to treat gene-edited traits similarly to those developed through conventional breeding, facilitating broader acceptance of gene editing technologies[38] - Major markets are increasingly treating gene editing traits as conventional, with Canada and the EU moving towards more favorable regulations for gene editing technologies[53] - Cibus has confirmed that its RTDS-developed trait products are recognized as non-transgenic and are not subject to heightened GMO regulation in key markets such as the United States, Canada, and Argentina[144] - The company has received regulatory opinions confirming that certain early products of its RTDS technology will be regulated in alignment with conventional breeding standards in North and South America[128] - The regulatory landscape for gene editing is evolving positively, with many countries modernizing regulations to distinguish between gene editing and GMO technology[133] Research and Development - Cibus has made substantial investments in R&D, with a focus on developing innovative productivity traits and products with high commercial value[139] - Cibus' R&D expenses were $50.4 million and $42.4 million for the years ended December 31, 2024, and 2023, respectively, indicating a year-over-year increase of approximately 4.7%[151] - Cibus has received additional patents across 10 plant gene editing and trait families, strengthening its intellectual property portfolio[46] - Cibus anticipates applying for additional patents as it continues to develop new products and technologies[123] Business Model and Market Strategy - Cibus' commercial model involves receiving royalty or license fees from seed companies for traits developed, similar to established practices in the agricultural sector[77] - The agricultural trait business generates approximately $8.0 billion in trait fees annually, with significant contributions from GMO-based traits[79] - Cibus estimates that the average trait fee for Sclerotinia resistance will be based on yield lost due to the disease, similar to the economic model of the Bt trait[82] - Cibus aims to partner and license its productivity traits to leading seed companies, leveraging their expertise for commercialization while focusing on R&D[143] - Cibus aims to develop sustainable low carbon ingredients through gene editing, collaborating with companies like Procter & Gamble to meet sustainability objectives[71] Management and Operations - Cibus' management team has over 300 years of cumulative industry experience, enhancing its competitive position in the market[145] - The company has a total of 159 employees, with 119 engaged in R&D, including trait development and production[146] - The Trait Machine Process allows Cibus to accelerate the development and commercialization of new productivity traits, providing a significant competitive advantage[142]

Financial Performance - Cibus reported a net loss of $25.8 million for Q4 2024, a significant decrease from a net loss of $277.2 million in the same period last year, primarily due to a prior goodwill impairment[12] - Cibus reported total revenue of $1,212,000 for the three months ended December 31, 2024, compared to $1,103,000 for the same period in 2023, representing an increase of 9.9%[29] - For the year ended December 31, 2024, total revenue was $4,262,000, a significant increase of 134.8% from $1,817,000 in 2023[29] - The net loss attributable to Cibus, Inc. for the year ended December 31, 2024, was $251,388,000, compared to a net loss of $267,627,000 in 2023, reflecting an improvement of 6.0%[29] - The company incurred total operating expenses of $19,236,000 for the three months ended December 31, 2024, significantly lower than $270,415,000 in the same period of 2023, primarily due to a reduction in impairment charges[29] Research and Development - Research and development (R&D) expenses were $12.4 million for Q4 2024, down from $14.2 million year-over-year, attributed to lower non-cash stock compensation and a reduction in personnel costs[12] - Research and development expenses for the three months ended December 31, 2024, were $12,433,000, down from $14,208,000 in 2023, indicating a decrease of 12.5%[29] Cash and Liquidity - Cash and cash equivalents as of December 31, 2024, were $14.4 million, with expectations to fund operations into late Q3 2025[12] - Cash and cash equivalents decreased to $14,433,000 as of December 31, 2024, from $32,699,000 in 2023, a decline of 55.8%[31] - The company anticipates the need for additional near-term funding to finance its activities, highlighting ongoing liquidity challenges[21] Strategic Initiatives - Cibus expects to achieve $10 million in annualized cost savings through strategic initiatives, which will reduce monthly cash use by approximately 20%[9] Partnerships and Collaborations - The company has established a partnership with Biographica to enhance disease resistance in canola and oilseed rape using AI technology[6] Product Development and Market Expansion - The company is advancing its herbicide tolerance traits in rice, generating commercial interest across multiple markets, including the U.S. and Latin America[2] - Cibus has made significant progress in its soybean platform, achieving successful edits for the HT2 trait and targeting a 75 million accessible acre market[6] - Cibus received positive greenhouse data for canola plants containing multiple modes of action, enhancing disease resistance[8] Intellectual Property - The company expanded its intellectual property coverage with additional patents across 10 plant gene editing and trait families in 2024[9] Assets and Liabilities - Total assets decreased to $350,069,000 as of December 31, 2024, down from $544,411,000 in 2023, a reduction of 35.7%[27] - Total liabilities increased to $252,238,000 as of December 31, 2024, compared to $206,117,000 in 2023, an increase of 22.4%[27] Capital Structure - Cibus' additional paid-in capital increased to $825,298,000 as of December 31, 2024, from $775,017,000 in 2023, an increase of 6.5%[27]

Core Insights - Cibus, Inc. is advancing its gene editing technologies and has made significant progress in commercializing herbicide tolerance traits in rice, with interest from markets in Uruguay, Colombia, Brazil, Asia, and the United States [2][3] - The company has established partnerships for disease resistance in canola and oilseed rape, and is making strides in developing multiple modes of action for disease resistance traits [3][7] - Cibus has reported a net loss of $25.8 million for the quarter ended December 31, 2024, a significant decrease from a net loss of $277.2 million in the same period the previous year, primarily due to a prior goodwill impairment [10][12] Regulatory and Market Developments - The California Rice Commission approved Cibus' field research proposal, marking the first authorization for gene-edited rice planting in California [1][8] - The EU is progressing towards finalizing legislation on New Genomic Techniques (NGTs), which could facilitate international trade and improve crop varieties for EU growers [1][8] Financial Performance - Cibus reported revenue of $1.2 million for the quarter ended December 31, 2024, compared to $1.1 million in the same quarter of 2023 [10][26] - Research and development expenses decreased to $12.4 million from $14.2 million year-over-year, reflecting cost-saving measures [12][26] - The company had cash and cash equivalents of $14.4 million as of December 31, 2024, down from $32.7 million in the previous year [12][29] Strategic Initiatives - Cibus is focused on expanding its partnerships with rice seed companies across North and South America, with plans for initial trait validation trials in Latin America [9] - The company aims to achieve $10 million in annual cost savings through strategic realignment and facility consolidation [9] - Cibus is developing a fully operational soybean platform, with expectations for HT2 trait edits in soybean plants in 2025 [9][12]

Core Viewpoint - The proposed legislation in the EU aims to adapt regulations to support New Genomic Techniques (NGTs) like gene editing, promoting sustainable agriculture and food security while aligning EU policies with global trading partners [1][4]. Group 1: Legislation and Regulatory Changes - The EU member states have endorsed the Council's negotiating mandate on NGT regulations, allowing for trilogue discussions with the EU Parliament and European Commission to finalize the legislation [2]. - The legislation introduces a 'conventional-like' category for NGT-1 products, which will be regulated similarly to conventional varieties, exempting them from EU GMO legislation and labeling requirements [3][4]. Group 2: Industry Impact and Opportunities - The regulation is expected to benefit EU growers by providing access to improved plant varieties and facilitating international trade by aligning EU policies with those of North and South America, the UK, India, Australia, and Japan [4]. - Cibus, a leader in agricultural technology, supports the regulation as it will enhance opportunities for innovators, particularly in academia and SMEs, to develop NGT products that contribute to a sustainable agri-food system [5]. - Cibus' RTDS technologies produce 'conventional-like' crop varieties, focusing on traits such as reduced seed loss and increased disease resistance, which will be developed under the new EU regulatory framework [6]. Group 3: Company Overview - Cibus specializes in gene editing to address productivity and sustainability challenges in agriculture, with a focus on major global row crops like canola, rice, and soybean [7]. - The company operates as a technology provider, licensing traits to seed companies and generating royalties from seed sales, aiming to commercialize plant traits more efficiently than conventional breeding methods [7].

Core Points - The proposed legislation in the EU aims to adapt laws to reflect advancements in scientific and technological progress, particularly focusing on New Genomic Techniques (NGTs) like gene editing to enhance sustainable agriculture, climate resilience, and food security [1][3] - The legislation introduces a 'conventional-like' category for NGT-1 products, which will be regulated similarly to conventional varieties, aligning EU regulations more closely with those of global trading partners [1][4] - The Council's agreement on the negotiating mandate allows for trilogue discussions with the European Parliament and the European Commission to finalize the legislation [2][5] Industry Impact - The legislation is part of a broader initiative to ensure sustainable resource use and strengthen the resilience of EU food systems, allowing for the development of plants that can be classified as 'conventional-like' and exempt from GMO regulations [3][4] - This regulatory framework is expected to facilitate international trade by aligning EU policies with those of major trading partners, including North and South America, the UK, India, Australia, and Japan [4][5] - The advancements in NGT regulation are anticipated to provide a boost to innovators, particularly in academia and small to mid-sized enterprises, who are developing NGT products for a sustainable agri-food system [5][6] Company Overview - Cibus, Inc. is a leading agricultural technology company that develops and licenses plant traits to seed companies, focusing on gene editing to address productivity and sustainability challenges in agriculture [7] - The company utilizes RTDS® technologies to produce improved crop varieties that fall under the 'conventional-like' category, targeting reduced seed loss, increased disease resistance, and enhanced nutrient use efficiency [6][7] - Cibus is not a seed company but a technology firm that licenses traits to seed companies, with a long-term focus on major global row crops such as canola, rice, and soybean [7]

Core Insights - Cibus, Inc. will report its fourth quarter 2024 financial results on March 20, 2025, with a conference call scheduled for 4:30 p.m. ET to discuss these results and other updates [1][2] Company Overview - Cibus is a leading agricultural biotechnology company specializing in proprietary gene editing technologies to develop specific genetic traits in seeds [1][3] - The company focuses on addressing critical productivity and sustainability challenges for farmers, particularly diseases and pests, which cost the global economy approximately $300 billion annually according to the United Nations [3] - Cibus operates as a technology company rather than a seed company, licensing traits to seed companies in exchange for royalties on seed sales [3] - The long-term focus of Cibus is on productivity traits for major global row crops such as canola, corn, rice, soybean, and wheat [3] - Cibus has developed a pipeline of five productivity traits, including weed management in rice, pod shatter reduction, and sclerotinia resistance, which are its near-term focus areas [3]

Core Insights - Cibus has demonstrated promising results in its third mode of action for Sclerotinia resistance in canola, which is expected to help preserve crop yields and reduce fungicide usage for farmers [1][4] - The company's Rapid Trait Development System™ (RTDS) allows for efficient gene editing and development of plant traits that are indistinguishable from conventional breeding [2][7] - Cibus has completed edits in four modes of action for Sclerotinia resistance and anticipates completing field tests by the end of 2025 [3] Company Overview - Cibus is a technology company focused on gene editing to develop and license traits to seed companies, addressing productivity and sustainability challenges in agriculture [6][7] - The company is not a seed company but rather licenses its traits for royalties on seed sales, with a focus on major global row crops like canola, rice, and soybean [7] - Cibus aims to develop traits at a fraction of the time and cost compared to conventional breeding, with a current pipeline that includes productivity traits for weed management and disease resistance [7] Industry Context - Sclerotinia sclerotiorum is a significant fungal pathogen affecting canola and other crops, causing yield losses of 7-15% and potentially up to 90% in severe cases [5] - The economic impact of diseases and pests in agriculture is estimated to cost the global economy approximately $300 billion annually, highlighting the importance of Cibus' innovations [6][7] - The development of durable resistance traits is crucial as climate change continues to affect crop diseases and their geographic distribution [4][5]

Core Insights - Cibus has announced promising results from its third mode of action for Sclerotinia resistance in canola, which is expected to enhance crop yields and reduce fungicide usage for farmers [1][4] - The company's Rapid Trait Development System™ (RTDS) allows for efficient gene editing and development of plant traits that are indistinguishable from conventional breeding [2][7] - Cibus has completed edits in four modes of action for Sclerotinia resistance and anticipates completing field tests by the end of 2025 [3] Company Overview - Cibus is a technology company focused on gene editing to develop and license traits to seed companies, addressing productivity and sustainability challenges in agriculture [6][7] - The company is not a seed company but aims to improve productivity traits for major global crops such as canola, rice, and soybean [7] - Cibus has a pipeline of five productivity traits, including Sclerotinia resistance, which is a near-term focus [7] Industry Context - Sclerotinia sclerotiorum is a significant fungal pathogen affecting canola and other crops, causing yield losses of 7-15% and potentially up to 90% in severe cases [5] - The economic impact of diseases and pests in agriculture is estimated to cost the global economy approximately $300 billion annually [6][7] - The development of durable resistance traits is crucial as climate change affects the prevalence and distribution of crop diseases [4][5]