Evogene Ltd.

Q4 2020 Earnings Conference Call

3/3/2021

spk14: Ladies and gentlemen, thank you for standing by. Welcome to EvoGen's fourth quarter and full year 2020 results conference call. All participants aren't present in listen-only mode. Following management's formal presentation, instructions will be given for the question and answer session. For operator assistance during the conference, please press star zero. As a reminder, this conference is being recorded March 3, 2021. Before we begin, I would like to caution that certain statements made during this earnings conference call by Evogen's management will constitute forward-looking statements that relate to future events, risks and uncertainties regarding business strategy, operations and future performance, and results of Evogen. I encourage you to review Evogen's filings with the U.S. Securities and Exchange Commission and read the note regarding forward-looking statements in their earnings releases, which states, that statements made in those earnings releases and in similar way on this earnings conference call that are not historical facts may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All forward-looking statements made herein speak only as of the date of the announcement of results. Many of the factors that impact whether forward-looking statements will come true are beyond the control of Evogen and may cause actual results to differ materially from anticipated results.
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spk14: EvoGen is under no obligation to update publicly or alter our forward-looking statements, whether as a result of new information, future events, or otherwise. Except as otherwise required by law, we expressly disclaim any obligation to do so. More detailed information about the risk factors potentially adversely impacting our performance can be found in our reports filed with the U.S. Securities and Exchange Commission. That said, I would now like to turn over the call to Ofer Chaviv, Evogen's CEO. Ofer, please go ahead.
spk18: Thank you, and good day, everyone. We appreciate you joining us today for our full year and first quarter 2020 conference call. Joining me today is Mr. Rick Kleiner, our CFO, and Dr. Arnon Hyman, CEO of our subsidiary, Canonic, which is focusing on medical cannabis. Following my initial remarks, Arnon will then provide an update for Canonic, and following Arnon, the which will summarize Evergen financial results for the full year and the fourth quarter of 2020. We will then open the call for your questions. In view of the sharply increased trading volume for our shares on Nasdaq during the last few months, it is reasonable to assume that we now have many new shareholders and hopefully some of these new shareholders are participating in our call today. Therefore, in my prepared remarks today, in addition to summarizing some highlights of our recent progress, I will briefly refer to the reasons why we are confident that Avogen has and will continue to have unique competitive advantages in its existing and future market area of focus. Currently, Most life science based industries are becoming aware of the enormous potential that exists in computational biology to substantially decrease the time and cost of discovery and development of new products, and more importantly, to greatly increase the probability of success. Evogen has, for almost two decades, and with an investment of many tens of millions of dollars, undertaken often in collaboration with some of the leading companies in the world, a focused multidisciplinary research and development effort to establish a world leading broadly applicable computational predictive biology platform, which we refer to as the CPB platform. The CPB platform combines advanced computational capabilities of which artificial intelligence is a key component with deep understanding of biology for the integration and analysis of multilayered relevant big data. The goal of this integration and analysis has been to create a platform that provides key predictive insights for the discovery and development of life science-based products. The CPB platform is designed to lead to higher probability of success while significantly reducing both time and cost. In recent years, Avogen took these assets to the next level by creating specific engines that utilize the CPP capabilities to address the development of life science products based on specific core biological and chemical components. To date, three such engines have been created.
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spk18: First engine, MicroBoost AI, is the engine that supports the discovery and development of products based on microbes. The second engine is Campus AI, to support the discovery and development of small molecules-based products. And the third engine, generator AI, for products based on genetic elements. It's important for me to emphasize that Evogen continuously invests significant resources in developing its CPB platform and the three engines to strengthen its capabilities and address new challenges. How do we choose where to utilize our technology and capabilities. Avogen considers, among other, the following main factors in deciding which fields of activity to enter. Market size, need for novel products, the existence of complex challenges in product discovery and development, can solutions to challenge be addressed via computational biology, Existing solutions in the market are inadequate, and of course, the product core components are one of the following, microbes, small molecules, or genetic elements. So how do we capture the value of our unique offerings? Avogen has two different business models. The first, which is more common and was our main business model until 2014, is product development through collaborations. In this business model, Avogen engaged with a partner for joint product development of a defined product requested by the partner. In this frame, Avogen typically conducts the initial R&D activity, discovery and early stage development, while later stage development and commercialization is conducted by the partner. Under this model, Avogen's potential revenues include R&D funding for activities that Avogen conducts in the collaboration, milestone payments for when the candidates advance in our partners' pipeline, and revenue sharing from the end product. Until 2014, Avogen engaged in several collaborations of this type with Bayer, Monsanto, DuPont, and Syngenta focused on improving seed traits using the GMO approach. Moving to the second business model. Starting in 2015, Avogen made a strategic decision that in addition to product development with the partner, based on the partner's request, it will begin developing its own product pipeline, each focusing on a specific industry segment benefiting from our unique technology. When such product pipeline reaches a certain level of maturity and due to the quality of our technology, it reaches this stage rather fast, we spin this activity into a dedicated subsidiary. Each subsidiary is focusing on continued development of its pipeline and adding new products to its specific market segment while using Evogen's technology as its core competitive advantage. I would like to emphasize that each subsidiary has its own board of directors, separate management, scientific advisory board, and its own R&D team, which focuses on developing its own pipeline while they all benefit from using Evogenous technology. According to the end market, the subsidiaries can decide to commercialize their products independently or in collaboration with a partner. Today, Avogen has four main subsidiaries, two focused on human health and two on agriculture. I would now like to provide key information on our subsidiaries, their main achievements in 2020, and lead on to their future plans. Let's start with Biomica. Biomica's mission is to discover and develop novel therapies for microbiome-related human disorder using computational biology. Currently, Biomeka is engaged in a few different drug product programs utilizing Avogen's MicroBoost AI and Campus AI engines. One program in the area of immune oncology two programs in the area of GI-related disorders, the first focusing on IBD and the second on IBS, and two additional programs in the area of antimicrobial resistance, CDI and MRSA. In 2020, the company successfully achieved two main targets in its immune oncology program. positive results in a preclinical study, and initial scale-up and initiation of the first GMP production of drug candidates.
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spk18: We consider this excellent achievement as a major milestone for Biomica, and in our last analyst call, Dr. Elran Hever, Biomica's CEO, elaborated in more detail on them. Biomica has set aggressive targets for the next two years. For 2021, the company is planning to initiate proof of concept, first in-man study in its immune oncology program, and extend its preclinical work in the IBD program. For 2022, Biomica expects to obtain the clinical data from its first in-man immunology study and to initiate first GMP production of drug candidates for IBD as preparation for future clinical trials in this program. Our second subsidiary in the area of human health is Canonic. Canonic's mission is to develop and commercialize precise and stable medical cannabis products for better therapeutics effects using computational biology. Currently, the company is engaged in the development of two product families utilizing the generator AI engine. The MetaYield family focused on stable enhancement of total plant compounds for high yield, and the Precise family focused on stable enhancement of specific active compounds for therapeutic traits such as pain and inflammation. In 2020, Canonic achieved the following main targets. Firstly, the identification of leading meta-yeet lines to be further developed into commercial varieties towards expected commercial launch in 2022. Secondly, signing an agreement with a commercial partner for cultivation and production of its proprietary cannabis varieties as part of its strategic goal to build an end-to-end value chain from seed to product sale. Canonic has set clear targets for the next two years. In 2021, the meta-yield product pipeline is expected to reach first commercial varieties, and in the precise product pipeline, Canonic aims to identify specific lines that exhibit distinct effect in model systems for reducing pain or inflammation. With respect to 2022, Canonic is expecting to launch its first meta-yield commercial product in Israel and reach first precise commercial variety for reducing pain or inflammation as preparation for commercial launch in 2023. Arnon will provide more details on Canonics activity later in the call. Moving on to our Adi Thatcher subsidiaries, starting with Axe-Planus. Axe-Planus' mission is to design next-generation, effective, sustainable, and safer crop protection products by leveraging computational biology and chemistry. Axe-Planus focuses on developing two product lines utilizing the campus AI engine. Novel mode of action herbicide and insecticide with new site of action. iPlanus achieved important targets in 2020 in its herbicide program. Entering into a strategic collaboration with Corteva to develop a novel herbicide based on trail lead candidates. And the second, reaching a lead phase for its lead candidate as announced in December 2020. I would like to elaborate on the second achievement. The achievement of this milestone follows the completion of field tests that demonstrated that product candidate APH1 at the commercial dose rate effectively controlled a broad panel of weeds, including weeds that are known to have resistance to existing herbicides. These results were confirmed in independent field tests conducted by Syntec Research, an agriculture R&D contract research organization located in California. I strongly believe that this remarkable achievement put Agplanus in an excellent position to engage with world-leading ag-chemical companies for future development and commercialization of APH1. For the coming two years, I expect that AgPlanus will continue focusing mainly on its herbicide product development activity. During 2021, the two main targets of AgPlanus will be to reach a herbicide tolerance rate, proof of concept for APH1, and engage in a licensing agreement for an additional candidate. In 2022, the two main targets of AgPlanus will be to reach an optimized lead phase for APH1 and sign a strategic agreement for continued development and commercialization for APH1. Moving to our AgBiologicals subsidiary, Labibio. Labibio aims to improve food quality, sustainability, and agriculture productivity through the introduction of microbiome-based ag-biological products. La Vie Bio is developing the following live microbial products utilizing Evogen's MicroBoost AI engine, biostimulants for improving crop yield, and biopesticides that protect the plant from pests such as disease, fungi, and insects. Two important achievements were reported in 2020. In October 2020, La Vie Bio shared results demonstrating the power of biopesticide candidate Lab 312 to protect grapes from botrytis, based on results obtained in a trial that took place in an Italian winery. We expect this product will reach the market in 2024. In December, La Vie Bio announced that its biostimulant candidate, LAV211, was successfully combined with harvesting spring wheat in North Dakota. Based on results gained during the last three years, product launch is expected in 2022. Currently, La Vie Bio has a robust product pipeline spanning from corn and wheat biostimulant to biofungicide for grapes. For 2021, LAVI-Bio has set the following main targets. To conduct pre-commercial trials for biostimulant LAV211 in spring wheat and to complete biofungicides LAV311 and LAV312 development toward regulation. In 2022, LAVI-Bio is expected to initiate product sales of biostimulant LAV211 for spring wheat, and five for regulatory approval for its leading biofungicide product candidate, LAB 311 and LAB 312. You can find all the future expected milestones for our subsidiaries in our updated presentation that we upload in parallel to our annual financial reports. I conclude the review of our subsidiaries and I hope you are as excited as I am about their expected future achievements. But these are not all the highlights I wish to update you with today. I am very pleased to share with you that we are now evaluating the entry into various new fields of activity, including using MicroBoost AI for developing products based on microbes, to address various market needs in the aquaculture industry, using campus AI for drug optimization in human health, using generator AI with focus on genome editing to developing high-quality plant-based food. Before turning the mic over to Arnon for an overview of our cannabis-focused subsidiary, I can summarize today's prepared remarks by stating that our excitement at Avogen today is based on two substantial value-creating centers that have resulted from our long-term commitment to computational predictive biology for the development of life science-based products. The first being our growing group of highly focused subsidiaries in multiple key markets, each with very attractive products under development and a unique capability to rapidly develop them. And the second, being a powerful technology hub at the parent company level in the form of our CPB and specific engines for the establishment of product pipelines in new fields of activity. With this, I hand over to our known Canonic CEO, Thank you. Arnon?
spk16: Thank you, Ofer. I would like to begin by introducing myself. My name is Arnon Heyman and I serve as Canonic CEO. I have been with Avogyn for the last six years, previously serving as the Vice President and General Manager of the Ag Seeds Division. My background is in biotechnology and I hold a PhD from the Hebrew University in Jerusalem. Canonix's mission statement is to develop and commercialize precise and stable medical cannabis products for better therapeutic effects using computational biology. We are here because genetics can make cannabis much more effective. Our genomic approach is powered by our exclusive access to Evogen's CPB platform and its generator AI engine. We believe that these assets and the capabilities that we bring uniquely position us to bring substantial added value to this market and address the market's three main challenges, stability, increased yield and specificity, as I will describe momentarily. As you are probably aware, the cannabis market is growing at a fast pace worldwide, and according to industry publication, is expected to reach more than $40 billion in the next four years. Canonic is focusing on the Israeli market to begin with, expecting to be followed by the European market and North America. I would like to highlight some facts about the Israeli market and why we believe it to be an exciting business opportunity to start with. By the end of 2020, we had more than 80,000 licensed patients in Israel, which corresponds to approximately $260 million per year. There is a steady increase of 30 to 50% per year in patients. Analysts forecast the Israeli market to reach 250,000 licensed patients in four years, which corresponds to an approximately $830 million per year. In addition, we see the increasing demand for premium products with patients willing to pay higher prices. Based on this growth forecast, Canonic is targeting this attractive premium product market in Israel, expecting our first product launch to the Israeli market in 2022. Once again, I would like to emphasize that the Israeli market is only our starting point. to be followed by the European and later the North American markets. The first key challenge we see in the cannabis global market is variety stability. Current cannabis lines demonstrate high variability in active compound concentration and other desired traits. Patients continuously seek more reliable consistent products. This variability starts with the cannabis line demonstrating unstable genetics and it leads to frustration with inconsistent and unreliable products. The second challenge is the current active compound yield. Yield in cannabis refers to the active compounds or metabolites found in the plant. Currently, low yield leads to higher production costs and subsequently higher costs for the patients. But maybe the most challenging gap in the industry today is the specificity. Cannabis is known to contain hundreds of active compounds and a critical need is to connect specific active compounds to the relevant medical indication and to develop cannabis varieties and products that include these specific active compounds in a stable and consistent manner. We believe that the use of artificial intelligence together with deep understanding of genomics and analysis of big data can decode cannabis genomics to address these three challenges. This is what makes Canonic unique. Canonic is engaged in the development of two product families. The meta-yield family, focused on stable enhancement of total plant compounds for high yield and consumer-related traits. and the precise focus on stable enhancement of specific active compounds for therapeutic traits such as pain and inflammation. As mentioned by offer, it is a canonic strategy goal to build an end-to-end value chain from seed to product sale. As we've described in previous announcements, we are building our strengths from both ends of the value chain. starting with the genetic development of unique strains in our breeding and propagation facility, then outsourcing the intermediate stages of cultivation, packaging, and distribution, and ending with product marketing by Canonic. Canonic is the youngest subsidiary in Evogen Group, established in 2019 and has already achieved significant milestones. most of which were previously reported, and I am proud to share some of them today with you again. I'll start with two important technological infrastructure achievements. The first is the completion of one of the biggest dedicated R&D facilities for cannabis in Israel. We also imported more than 100 different cannabis lines and initiated cultivation after receiving all required regulatory approvals. The second is the establishment of our proprietary genetic and phenotypic database to support our breeding program and the initial identification of relevant genomic markers for our diverse product programs. With respect to the MetaYield product family and our strategic goal to launch first product in 2022, we are currently testing our most advanced MetaYield lines at local growers' sites as a pre-commercial preparation. This involves the cultivation of the most advanced lines, yield evaluation, additional testing including consumer ranking for selected varieties, and marketing activities to prepare for product launch. We recently signed a cultivation service agreement with Telcan, an Israeli cannabis cultivator. The agreement with Telcan supports our go-to-market strategy to use subcontractors for cultivation, production, and distribution of Canonix medical cannabis products. This is a major milestone for building the value chain, supporting our intention to launch first product in 2022. With respect to the precise product family, we've entered collaborations with research centers to use preclinical high throughput systems to screen dozens of genetic lines for two main indications, pain and inflammation. The generated data is integrated into our proprietary database and is directing our product development efforts for optimized therapeutic products. Last but not least, we have announced last week the signing of the collaboration agreement with Canbit, a subsidiary of Tikkun Olam Canbit, a leading cannabis company in Israel for the development of novel, precise medical cannabis products. The companies expect that the combination of cannabis vast clinical data on the impact of medical cannabis strains collected over many years together with Canonix recognized leading computational biology platform and cannabis breeding capabilities will lead the companies to successful joint development of precise products. The development of new products will be performed at Canonix R&D facility and will be based on cannabis trends that both companies will contribute to the collaboration. To summarize, the opportunity we found in the cannabis market for the computational genomic technology we have in-house and our advanced breeding capabilities is unique. The team and I believe we are on track to meet the company goals and are excited to be so close to our first product launch. After Dorit's review of the financial results, I will be happy to answer any questions you may have. And with that, I would like to turn the call over to Dorit. Dorit?
spk12: Thank you, Arnon. I will begin by reviewing our cash balance. As of December 31st, 2020, our consolidated cash, cash-related accounts, and bank deposits includes approximately $48.2 million. Approximately $13 million of average and consolidated cash is appropriate to its subsidiary, La Vie Bayeux. The $48.2 million does not include $28 million received after the year end from the companies at the market offering initiated January 2021 and concluded during February 2021. The weighted average selling price under the ATM offering was $7.36 per share. With that, we exhausted the remaining amount under the shelf prospectus we filed in July 2020. During the fourth quarter of 2020, our consolidated cash usage was approximately $6.1 million or $5.1 million if excluding La Vie Bio. During the full year of 2020, our consolidated NAS cash usage was approximately $19.3 million or $14.7 million, if excluding LaVie Bio, which is in the range we estimated for the full year of 2020. This year, 2021, we expect to see an increase in the cash usage as our subsidiaries enter advanced stages of product development and commercialization. Biomica is expecting to conduct its first in-man clinical trial. ActLenus is expecting to conduct a broad-field trial in its herbicide program towards the advanced lead. And both Canonic and LaVie Bio are preparing for first product launch June 2022. For the full year of 2021, we estimate that our net cash usage will be within the range of $26 to $28 million. Excluding cash usage by LaviBio, our subsidiary, we estimate that our net cash usage will be within the range of $20 to $22 million. The company does not have bank debt. Before we turn to the statement of operations, I would like to explain a new line item on our balance sheet this quarter relating to pre-funded warrants that were issued in conjunction with a $12 million investment in November 2020. In accordance with IFRS accounting practices, the warrant was recorded as liability as of December 31st, 2020. The warrants were exercised for shares at the beginning of January 2021 and therefore will not appear on our balance sheet next quarter. Let's now turn to the statement of operations. R&D expenses, which are reported net of grants received, were approximately $4.8 million for the fourth quarter of 2020 in comparison to $5.2 million in the fourth quarter of 2019. This decrease in R&D expenses during the fourth quarter was mainly due to grants received from the Israeli Innovation Authority. For the full year of 2020, R&D expenses were approximately $17.3 million compared to $15.8 million in 2019. The increase in R&D expenses for 2020 were mainly attributable to payments made to third parties in connection with the preclinical studies conducted for Biomeka, field trials conducted in target locations for LaVieBio, and an increase in non-cash expenses of $1.4 million for amortization of share-based compensation. General and administrative expenses for the fourth quarter of 2020 were $1.7 million in comparison to $1.1 million in the fourth quarter of 2019. For the full year of 2020, G&A expenses were approximately $5.3 million compared with $3.8 million in 2019. The increase during the fourth quarter was partially attributed to the impact of an interest-wide increase of the cost of directors' and officers' insurance. For the full year of 2020, the increase was also attributed to the impact of the cost of directors' and officers' insurance, and in addition to an increase in non-cash expenses, of amortization of share-based compensation. Operating loss for the fourth quarter of 2020 was $7.2 million in comparison to $6.9 million for the fourth quarter of 2019. For the full year of 2020, the operating loss was $24.8 million compared with $21.2 million in 2019. The increase in loss during the fourth quarter and for the full year of 2020 is attributed to the increase in the aforementioned operating expenses. The loss for the fourth quarter of 2020 was $8.8 million in comparison to loss of $6.7 million during the fourth quarter of 2019. For the full year of 2020, the loss was $26.2 million compared with $19.1 million in 2019. The increase in the loss during the fourth quarter and for the full year of 2020 is attributed to an increase in operating expenses and an increase in financing expenses, mainly attributed to $1.9 million non-cash expenses related to the revaluation of pre-funded warrants mentioned earlier. With that said, we would now like to open up the call for any questions you may have. Operator?
spk14: Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. If you have a question, please press star 1. If you wish to cancel your request, please press star 2. If you are using speaker equipment, kindly lift the handset before pressing the numbers. Your questions will be pulled in the order they are received. Please stand by while we poll for your questions. The first question is from Kristin Kluska of Cantor Fitzgerald. Please go ahead.
spk11: Hi, everyone. Thanks for taking the questions and for providing the in-depth overview this morning. So Ofer, I wanted to first ask you about some of the new announcements you had today related to where you might look to use the CPP platform in other fields such as aquaculture, human health, and plant-based food. Could you maybe walk us through how you view those markets right now and some of the key limitations from other approaches in this field? And then on that note, what are the learnings that you've found from, you know, both the internal work and through your subsidiaries that you think could help address some of these markets?
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spk18: Hi, Christian, and nice talking with you. So first, as I emphasized in my script today, we are in the initial stage of validating this new field of activity where we believe we can use our technology. For us to decide to move into a specific area of activity is after we are addressing set of criteria, and one of the criteria, as an example, is market size. Then there is a question if there is a need for novel product. Another question is, is there a challenge to develop this product, and what type of challenges need to be addressed in order to develop this product? And if we come to the conclusion that the answer to all these questions is yes, there is a big market. There is a real need for new product. There is a significant challenge in developing this product. The challenges are in the discovery stage, in development stage, and the core components of this product is based on microbes, small molecules, or genetic elements. Only then we are looking into this field of activity with more detail. The area that I mentioned today, I think that they are all addressing this type of question positively. and we are now learning more into the details on what does it mean for Evogen to engage and be more committed to develop activity in this area. So as an example, and it's somehow connected to your second part of your question, the area of improving small molecules toward the drug So we already have two project in this area that is managed by Biomica, the MRSA and the CDIF. And we also even had a small project that we didn't disclose because of the size of it with an external company where we use our technology in order to improve the efficacy of the molecules. And we feel that the technologies we develop in this field originally, originally, for ag planus, for developing herbicides and insecticides. So the technology that we developed there in many directions can address some of the challenges existing in this field. And we are now starting to look in more, and we even recruit some people to learn more about Evogen technology and how we would like to navigate it to play a significant role in the future in this area. Another example that I mentioned is improving a quality trait using genome editing. So in genome editing, you know, there is a few questions you need to address. The first one is what gene you want to edit, and this is definitely an existing technology in Evogen. The next question is, what is the specific edit you want to do? And we have this technology already. And one of the important questions is, do you have the technology actually to execute the edit you are interested in? And this is part from our work today in the Israeli consortium CRISPR-IL, which is trying to address some limitations that exist in this area. And yes, I mean, Evogen was heavily engaged in the field of improved crop traits. in the area, but in the old days we were focusing mainly on GMO approach. So now we want to leverage all the technology existing in Evogen, all the databases, all the know-how, expertise, but toward genome editing, and we want to focus on quality trade, and not just trade that are relevant for the farmers, more trade that are relevant for the consumer. And we are now seriously evaluating this opportunity. And the third is the aquaculture. Here we believe that there is a growing market that I personally also have a very strong feeling about this because I really hate to see that we continue to take all the fishes in the oceans and eat them and I would prefer to see that we are growing them in a more on pools or in different cultured ways but going into this direction where I believe the world is more and more going into this through this channel creates a new problem and new disease coming that you need to address and you would like maybe also to improve the growth rate of the fish in order to reach to the right size etc. and we believe that you can address some of these challenges with microbes. And when you look at the microboost technology that we have, that we're using it for La Vie Bio, we are using it for Biomica, two completely different kingdoms. I think that it's really natural development to move also and to use this technology for the aquaculture industry. Of course, there is questions such as the relevant data exists. There is the question of the maturity of the industry to use this type of product. There is many other commercial questions and technical questions that still need to be addressed. But I felt that it's the time that I will share with our shareholders that Evogen start to explore additional opportunity to the existing subsidiary and activity we are already managed, which we are very excited about. And I believe that we will hear more about those areas in the future. I just want to make sure that, as I said at the beginning, we are in the beginning of the evaluation of this new area. It's hard for me to believe that we will push all of them at the same time. We need to make sure what we are choosing and where we are going to focus on. And, well, we will have more clear decision. Of course, I will share it in future analyst call.
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spk11: Great, thanks. Look forward to those updates down the line. And then Arnon, thanks for your comments as well. I wanted to ask you, once the product is potentially commercialized in 2022, could you please walk through the work that either you and or a partner will have to do to make sure the Israeli market is aware of the key advantages here to MetaYield versus what's currently available in the market, both from a pharmacy and web platform, as well as a consumer or patient standpoint? And then on that note, how are you thinking about the initial uptake trends in light of the stability and yield issues we've seen from marketed products? And I know in your prepared remarks, you did discuss a lot of the current frustrations.
spk16: Okay, thank you, Kristin. So, in terms of our market entry next year, 2022, here in Israel, So we need to do a lot of work through web platforms. Actually, as I mentioned in my talk, there's roughly 80,000 licensed patients now in Israel, and we expect this community to grow next year. So we're talking about a very specific community of patients, of consumers, that we will need to address, we will need to approach them in order to demonstrate what kind of product attributes, what kind of traits we are presenting with our varieties. We are targeting our first product to be at the premium product category, at least here in Israel, where we're talking about high THC, which is currently the most popular product. And of course there is a lot of marketing work branding and so on To be done in order to to enter this market in terms of challenges, so yes, I talked about stability and specificity and of course yield I can say that at least till now those challenges are are met roughly, well, I would say not in an optimal way in terms of the product stability. So most companies devote their efforts for the cultivation protocols in order to get stability, but not as much as needed on the genetic side. We see clinical trials conducted all around the world, but still the major question of specificity and to connect between active compounds in the plant and the therapeutic effect is still a big question. This is one of the reasons why we've signed a collaboration with Tikkun Olam here in Israel. We've published its last week, I believe so. And we truly believe that both companies together can address this challenge, which is one of the biggest challenges today in the industry. I hope I answered your questions, Kristen.
spk11: Yes, thank you so much. Appreciate it.
spk02: Thank you, Kristen.
spk14: If there are any additional questions, please press star 1. If you wish to cancel your request, please press star 2. Please stand by while we poll for more questions. The next question is from Ross Haberman of RLH Investments. Please go ahead.
spk10: Good morning, Ofer. Thank you for the call today. Could you just talk about the cash burn you burned? I think you said about $7 million. This quarter, what's your expectation for the next couple quarters?
spk18: Thank you. I think that we, in the risk part, we were talking about the burn rate is expected for next year, for the total year. For the company, excluding LaVie, it's around $20 million, 2022. And with LaVie Bio, it's around 26 to 28. The reason for the growth of the burning rate is next year Biomica is planned to conduct a first-in-man clinical trial and just this A trial is estimated around $5 million. Not all of this will be paid this year, but a significant portion will be paid this year. La Vie Bio is going to conduct a very broad field experiment for its advanced product in North Dakota, in USA, and other territory in the US. as preparation for a first product launch in 2022. Canonics is expanding its activity significantly. And we are really excited with the results we start to see lately from the MetaYield family product. And we are very positive with our expectation for first product launch in 2022. And we are now in the preparation including the marketing activity, including building this patient club that are going to be our investors in the cannabis community here in Israel. And also ActPlanus is now moving toward lead optimization with its lead candidates, and there is other candidates that we hope to reach to a lead phase during this year. So lots of activity, lots of excitement, lots of progress. cost more money than previous year, but it's all good news that I believe that we'll see the fruit coming from all of this activity starting from 2022 and on.
spk10: So you're saying a total of $48 million? Is that correct in total?
spk12: As of December, yes.
spk18: For next year, the burn rate for next year is projected to be $20 to $28 million for the whole year. Okay, 2028, got it.
spk10: Okay, thank you very much, guys. The best of luck.
spk14: Okay. The next question is from Kenny Green of Edison Group. Please go ahead.
spk02: Hi, everyone. So I'm the investor relations, external investor relations of Evergene, and we have received a number of questions via email from investors. I will go through them now. First question is, what is the purpose for your new shelf filing?
spk18: The self-registration statement and the ATM files recently is effective for three years. And the filing was to have something in place in the event the company wants to raise capital in the future. Also, as I'm sure you're aware, this is routine practice for many companies. With respect to the cash needs of the Epogen group, we see no short-term needs for additional funds to meet our current plan and the budget. However, as publicly disclosed, we are very pleased with the rapid progress, as I described in the previous question, being made by our subsidiaries, and therefore we continue to consider various alternatives for possible acceleration of their progress. Of course, if we were to choose to do so, it would be done only in a manner that consists with the best interest of the average shareholders.
spk02: Okay, thank you for that. Do you have plans to establish new subsidiaries in the coming year? And if so, what would the process be?
spk18: So, in a way, it's somehow, I think, when I answered the question of Christian, I think that I was giving quite a broad overview to this question, but in high level, there is certain criteria that we need to make sure that we address positively before we will decide to enter into this activity. Based on the past experience, usually we prefer to have a small group inside of Evogen that start to use our technology or modify our technology to address specific challenges in the field of interest. And only when we start to see the initial pipeline of product that was developed dedicated to this field of interest, only then we are moving to the stage of establishing a subsidiary focusing on this specific segment. So if something like this is expected to happen this year, It's hard to guess, maybe close to the end of the year, but probably make more sense at the beginning of next year. And probably it will be one, if it will have to take place, it will be one of the three fields of activity I described earlier that we already start to investigate and learn, as I mentioned earlier.
spk02: Okay, next question will be for Dorit. Dorit, what is the current share count post the ATM.
spk12: Okay, so the currently outstanding share after the ATM is 40,386,448 shares.
spk02: Okay, thank you. Total is 40 million. 40 million. 40 million shares. 40.3, yes, you're right. Next question is for Arnon. With regard to Canonix, So with the Tikkun Olam agreement, what are your targets? When do you expect to see a first product in the market? And a follow-up question to that would be, are you looking to do other similar joint ventures with other non-Israeli companies?
spk16: Okay, so thank you for the question. I want to explain that we see the essence of this collaboration in combining our computational capabilities, computational genomics, and of course, reading capabilities, with the vast clinical data and market know-how of Tikkun Olam. As we have explained in previous talks and also in our website, our precise product family is focused on closing the gap of the specificity challenge in the market, meaning we are trying to connect therapeutic effects with genetic elements in the plant. Combining forces with the company that has so many, so much clinical trials conducted here in Israel, treated thousands of patients for more than 10 years since the reform here in Israel initiated, would truly help us in moving forward with this specific product program. This is part of the precise program, and we are truly excited to start this collaboration. In terms of timelines, so this is something that we have not disclosed so far, and when we will make this public, of course, I can relate to specific timelines and product launch and so on. Talking about future collaborations outside of Israel, so I can say that we see The cannabis market in North America, very, I would say, enthusiastic towards collaboration and new technologies, especially now with the new administration in the U.S. and big hopes for legalization of cannabis on the federal level. We have been in contact with several companies in North America, and I'm sure that our way outside of Israel would be in collaboration with those global companies. As I mentioned before, Israel is our first base for commercialization, but then Europe and North America would follow, and there we would also look for local collaborations, of course.
spk02: Okay, thank you, Arnon. And two more questions for Ofer. First one is, please provide more details and an update on Evergene's participation within the CRISPR consortium.
spk18: Okay, so the CRISPR consortium is a group of companies from all from life science and and together with local academic institutions that is found by the israeli innovation center authority uh and the idea is of this consortium is to try to solve certain problems in using CRISPR-Cas9 that the industry is facing, which is mainly that the edit you can conduct using CRISPR-9 is not precise, and sometimes it's happening in more than one place in the genome. And the consortium is focused on trying to design, derive what is called guided RNA, that will increase the probability or will ensure that Cas9 will make the edit precise and only in the place you want it to be. Evogen, as part of this consortium, is using its AI capabilities in order to design the guided RNA and the technology that we are going to develop in this mean will stay under Evogen responsibility. So we will have the right to use all the technologies and the know-how that we will develop and other members on the consortium will develop through this process to use inside of Evogen. And we are planning that it will be far from the generator AI technology platform. And all our programs that are focusing on genome editing can benefit from it. And this is why I believe that one of the areas we should start to explore in more detail is improving crop quality traits using genome editing.
spk02: Okay, thank you. And the last question is, what is your vision for Evogen in five years' time?
spk18: Wow, okay. So first and most important is the technology. I think that Evogen should continue to stay the technology hub that is focusing on computational biology, strength our CPB platform, and definitely strength our three engine microboost AI, generator AI, and campus AI for the three core components that we are focusing on. Because there is all the time challenges we need to address and there is all the time new data and new algorithms that you can integrate into our system in order to make it much more efficient and much more robust. And with respect to how to capture the value of this technology, so we already have the four of our main subsidiaries, Canonic, Acplanus, Labibio, and Biomica. And I can envision those four companies are advancing and towards a completely independent company. I believe that each one of them should stand by itself. There could be public companies with the right valuation that represent the assets and the product that they will develop. Maybe they will be acquired. I really believe that each one of them has a huge, huge potential by themselves. In addition, as I start to disclose in this analysis call, Evogen will start to develop the new set of subsidiaries, new set of activities. Not necessarily subsidiaries, it could be also just activities that we can leverage through strategic collaboration. Evogen can do strategic collaboration, not necessarily through subsidiaries. But definitely there will be new area that we are going to use as our technology to generate and create more value to our loyal shareholders. And in five years from now, I really hope to see Evogen as a lighthouse of technology in the area of computational biology. The four subsidiaries that today we have, they are already a successful company. Each one of them is a world-leading company in its sector. And we also have some new subsidiaries in different phase moving to their success as well. So I have a lot of expectation from Evogen for the next five years.
spk02: Okay, thank you, Ofer. And I'll hand it back to the operator.
spk14: Thank you. The next question is from Jeff Gilbert of Inuksuk Investments. Please go ahead.
spk17: Thank you for taking my call and appreciate the comprehensive review, especially the insights into the new potential markets like you were talking about over. One question for Arnon specifically since he's on the call today. While it's a couple years off, how do you see with your go-to-market strategy the actual sales development? Are you thinking direct-to-consumer? partnering like you have done. Maybe you can comment on industry inquiries and might you have different strategies for each of your product lines, i.e. if there's a medical cannabis partner with somebody more in the medical field versus recreational meta yield. Thanks for taking my question.
spk16: Hi, thank you for the question. Our current go-to-market strategy relies on two sides of the value chain, actually. On one side, we are heavily structured to develop new genetics, to reproduce those genetics and work with cultivators on cultivating them. On the other side, we are building the canonic brand, all the way reaching to patients and learning about market needs and trying to implement it into our genetics. So here in Israel, the structure that we are building is developing our genetics, producing the reproductive material, and working with subcontractors in order to get those products all the way to the pharmacy, cultivators, producers, distributors, and so on. And we expect to see our first product in the pharmacy here in Israel under the Canonic brand. Going out of Israel, we understand that we will need to work or we would prefer to work with local brands. We would like to cultivate our developed genetics abroad, either in Europe or in North America. and work with local brands in order to get those products all the way to the market. But at the end of the day, the canonic product would be a final product approaching the consumer. If it's a patient here in Israel or in other territories, any other consumer that would prefer our products. Did that answer your question?
spk17: It did. So we can expect to see multiple strategies in getting the Canonic brand to consumers.
spk16: Right. Depends on the territory. We depend to develop the strategy, sure.
spk17: Excellent. Exciting times. Thanks again.
spk16: Thank you.
spk14: If there are any additional questions, please press star 1. If you wish to cancel your request, please press star 2. Please stand by while we poll for more questions. There are no further questions at this time. Before I ask Mr. Ofer Khabib to go ahead with his concluding statement, I would like to remind participants that a replay of this call is scheduled to begin two hours after the conference. In the US, please call 1-888-326-9310. In Israel, please call 03-925-5901. Internationally, please call 972-3-9255-901. Mr. Chaviv, would you like to make your concluding statement?
spk18: Yes, thank you. Thank you all for joining the call today. I look forward to updating you with our progress over the next few months. Thank you and good day, everyone.
spk14: Thank you. This concludes Evogen's fourth quarter and full year 2020 results conference call. Thank you for your participation.
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