Caution Regarding Forward-Looking Information
This report includes "forward-looking statements" that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements including continued compliance with government regulations, changing legislation or regulatory environments; any statements of expectation or belief and any statements of assumptions underlying any of the foregoing. These risks, uncertainties and other factors, and the general risks associated with the businesses of the Company described in the reports and other documents filed with theSEC , could cause actual results to differ materially from those referred to in the forward-looking statements. The Company cautions readers not to rely on these forward-looking statements. All forward-looking statements are based on information currently available to the Company and are qualified in their entirety by this cautionary statement. The Company anticipates that subsequent events and developments may cause its views to change. The information contained in this report speaks as of the date hereof and the Company has or undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise unless required by law. Company OverviewEvolutionary Genomics, Inc. (the "registrant" or "Company") was incorporated under the laws of the state ofMinnesota inNovember 1990 under the nameFonahome Corporation . OnMarch 24, 2009 , the Company reincorporated in the state ofNevada and merged with its wholly-owned subsidiary,Fona, Inc. , adopting the surviving company's name,Fona, Inc. and simultaneously adopted the capital structure ofFona Inc. , which includes total authorized capital stock of 800,000,000 shares, of which 780,000,000 are common stock and 20,000,000 are blank check preferred stock. The preferred stock may be issued from time to time in one or more series with such designations, preferences and relative participating, optional or other special rights and qualifications, limitations or restrictions thereof, as shall be stated in the resolutions adopted by the Corporation's Board providing for the issuance of such preferred stock or series thereof.
OnJune 6, 2014 ,Evolutionary Genomics, Inc. , aDelaware corporation merged withFona, Inc. treated as a reverse acquisition withEvolutionary Genomics, Inc. as the acquirer and Fona as the acquired party. Subsequent to the Merger,Fona, Inc. was renamedEvolutionary Genomics, Inc. and our subsidiary was renamed fromEvolutionary Genomics, Inc. toEG Crop Science, Inc. OnMay 9, 2016 , we formedICAM Therapeutics, Inc. (aDelaware corporation) as a wholly owned subsidiary ofEvolutionary Genomics, Inc. We have not incurred any transactions in this company nor have we established any business plan for the future. The Company maintains headquarters at the office of its Chief Executive Officer. The Company maintains a website at www.evolgen.com. The Company is not required to deliver an annual report to security holders and at this time does not anticipate the distribution of such a report. The Company will file reports
with theSEC . OnAugust 14, 2000 , the Company was issued patent number 6274319, titled "Methods to identify evolutionarily significant changes in polynucleotide and polypeptide sequences in domestic plants and animals". OnJune 1, 2004 , the Company was issued patent number 6743580, titled "Methods for producing transgenic plants containing evolutionarily significant polynucleotides". These patents are for the core Adapted Traits Platform that we use for the discovery of genes in humans, animals and commercial crops. The Company has applied the Adapted Traits Platform in research projects including identifying genes believed to be responsible for increases in yield in corn, increases in yield in rice, salt tolerance and sugar content in tomatoes and pest/disease resistance in soybeans, bananas and multiple other crops. In the past century, agriculture has been characterized by enhanced productivity, the use of synthetic fertilizers and pesticides, selective breeding, mechanization, water contamination, and farm subsidies. Proponents of organic farming such as SirAlbert Howard argued in the early 20th century that the overuse of pesticides and synthetic fertilizers damages the long-term fertility of the soil. While this feeling lay dormant for decades, as environmental awareness has increased in the 21st century there has been a movement towards sustainable agriculture by some farmers, consumers, and policymakers. Advances in genetic research and modification of crop species have led to increased yield, drought tolerance and disease/pest resistance. These advances have also led to an increased concentration within the providers of seed and seedling plants to crop producers. The top seed and plantlet providers control much of the implementation of new crop varieties through patents and licensing agreements. Genetic traits providers, likeEvolutionary Genomics , identify and develop genes that impact traits of interest to the industry and market those genes to these companies. 14 The single most valuable step in the process of crop improvement is the identification of the key genes that have the desired impact. EG set out to find genes in soybeans that impact pest and disease resistance. We identified two that showed promise and, in hairy root assays on one of these genes, EG261, at theUniversity of Wisconsin - Madison , proved that EG261 impacted resistance. When we discussed these results with the larger seed companies, they indicated interest but wanted to see two generation, whole plant testing results before entering licensing negotiations. We have engaged theUniversity of Missouri and theUniversity of Wisconsin's Wisconsin Crop Innovation Center ("UW") to independently perform these validation studies for us. As a small company restricted by our limited resources, we cannot afford to generate vast numbers of transformation plant lines, known as events. Moderate success is important enough to indicate that further optimization can lead to significantly improved results. We must prove that there is enough evidence to warrant additional trials by companies with vastly more resources to build on our success but the single most valuable step in this process is the identification of the gene that has the desired impact and we have identified two of these genes, EG261 and EG19. OnApril 29, 2014 , the United States Patent and Trademark Office issued patent 8,710,300 titled EXPRESSION OF DIRIGENT GENE EG261 AND ITS ORTHOLOGS AND PARALOGS ENHANCES PATHOGEN RESISTANCE IN PLANTS. OnDecember 5, 2017 andMarch 3, 2020 , the United States Patent and Trademark Office issued additional patents which extended the previous patent to include additional variations of the gene. During 2017, the Company was issued similar patents inCanada ,Brazil andChina and has additional patents pending inArgentina andIndia . OnJanuary 15, 2021 , the Company filed a patent application on its second soybean pest/disease resistance gene, EG19, and has included that gene in its ongoing two generation, whole plant validation research. The Company has also discovered additional candidate genes that may impact pathogen resistance. There can be no assurance that any of these genes will be proven effective in validation testing or lead to licensing agreements or revenue. We entered into a Service Agreement withUW under which they transformed soybeans using our genes and helped to establish the right combinations to achieve a range of expression.UW grew events from seven constructs of EG261 and EG19 in their greenhouses. These plants were harvested inMay 2020 for generation T2 seeds. The seeds were transferred to theUniversity of Missouri and testing began inNovember 2020 . We have completed three cycles of planting, growing and testing and expect to complete another two to three cycles by late summer 2021. The results of the second cycle were discarded because of process issues but the results of the other two cycles were very promising with significant improvement in disease resistance observed in plants transformed with our genes. If results from the next two or three cycles confirm these findings, the Company intends to enter negotiations for a long-term research collaboration and licensing agreement with seed companies. If these negotiations are successful, this type of agreement will likely have an upfront payment, milestone payments during their testing and a licensing royalty stream once the genes are incorporated into commercial seed lines. The testing phase includes field trials which may proceed for several years prior to generating licensing revenue. There are many risks in this process including some that are outside ofEvolutionary Genomics' control and there can be no guarantee that we will ever generate any revenue from these potential agreements. The Company has identified pest/disease resistance genes in other commercially valuable crops. The Company is in various stages of projects identifying genes in tomatoes and corn that may lead to increased pest/disease resistance. If successful, we intend to market them to the seed industry. This strategy will requireEvolutionary Genomics to incur significant research costs prior to any confirmation of commercial viability and there can be no guarantee that the desired results can be achieved or that commercialization can be reached. During the 1950s the global banana industry was devastated by a disease (caused by Fusarium fungus) that effectively wiped out the predominate variety of commercial bananas know as Gros Michel leading to the development of the Cavendish banana, which makes up well over 90% of the commercial banana market today. Cavendish was resistant to the strain of Fusarium that wiped out the Gros Michel variety but, in recent years, is being challenged by a new race of Fusarium that threatens to, once again, devastate the global banana industry. This crisis is imminent and has no solution. The recent emergence ofPanama Disease TR4 in the Western Hemisphere makes a swift solution to the crisis even more urgent. A substantial part of the banana market consists of exports from Central andSouth America tothe United States . 15 In 2018, the Company began a project to identify genes in wild banana relatives that are resistant to Fusarium. We used our platform to isolate a banana gene that controls Fusarium Wilt (FW), aka Panama Disease, Tropical Race 4. The gene, which we have named FusR1 (Fusarium Resistance 1), is a native gene in Musa species, including cultivated bananas. We have found that, for all FW-resistant banana cultivars/species that we have tested, one version of our gene exists while, in all FW-sensitive banana cultivars/species that we have tested, there is a different version of FusR1. And notably, a third version exists in semi-resistant varieties that has allowed us to identify the particular nucleotide changes that are crucial for resistance to Fusarium Wilt. We believe that this native banana gene can be introduced into cultivated bananas, particularly the Fusarium-sensitive Cavendish cultivar in order to make these cultivars resistant to Fusarium Wilt. Cavendish cultivars are sterile and seedless, but it should be possible to use MAB (marker assisted breeding), though perhaps difficult and time-consuming, to move FusR1 into Cavendish and other cultivated bananas. We believe that a gene transformation approach would be faster and easier. Given the threat of possible extinction for Cavendish, rapid approaches are not only warranted but essential and minimally genetically edited bananas will be accepted depending upon how the gene transfer is accomplished. Transfer of this native banana gene to cultivated bananas can also be accomplished with CRISPR technology, which allows a targeted, clean, and efficient transfer and which, as compared to more traditional genetic editing techniques, minimizes potential side effects. We believe that Cavendish bananas can be rendered Fusarium Wilt resistant by changing only a few base pairs. These sorts of minimal changes have been allowed by theUSDA and FDA in several crops. Even inEurope , use of CRISPR technology has gained substantial traction. OnJune 26, 2019 , we filed aUnited States patent application titled IDENTIFICATION AND RESISTANCE GENES FROM WILD RELATIVES OF BANANA AND THEIR USES IN CONTROLLINGPANAMA DISEASE. We are awaiting review of these patents by the United States Patent Office. OnAugust 19, 2020 , the Company entered into the DCA with Dole for the development of plant varieties within the Musa genus of the Musaceae family (including the Cavendish variety of banana) that exhibit resistance to Fusarium Wilt Tropical Race 4 (popularly known as Panama Disease). Subject to compliance with various provisions of the agreement, the agreement includes working capital funding from Dole to the Company over the next four years. In addition to working capital funding, Dole will reimburse the Company for the development of banana plants and incur additional costs for the commercialization of plants upon successful completion of the development portion of this project. In the year endedDecember 31, 2020 , the Company received$800,000 of working capital funding and$1,295,831 of reimbursement of development costs pursuant to this agreement. Per the Agreement, 50% of future royalties may be offset with the research funding provided by Dole. In the event that Dole terminates the agreement for material breach by the Company or the Company's bankruptcy, the Company must repay all funding provided by Dole within six months of termination. The parties have agreed to negotiate the terms of the long-term license agreement upon successful completion of the development portion of
this project. If we are able to successfully transform and validate our banana genes, which will likely take 24-36 months from the start of the project inSeptember 2020 , under the terms of the agreement with Dole, we expect to negotiate a long-term royalty contract for the commercialization of banana plants using our genes. This licensing arrangement will likely be exclusively with Dole and contain royalty payments based on the number of plants and/or hectares of plants. Even if EG's genes are proven to be effective, it is difficult to predict the future revenue stream that any licensing arrangement can generate and will be heavily dependent upon the speed with which Panama Disease spreads throughout the world necessitating a solution and any changes in the price of bananas based on supply and demand. Many articles are available in the public realm detailing the significance of the disease and the spread throughout the world. Since bananas are seedless, they are propagated by clones which allows for very rapid production of plants. An initial batch of 100 successful plants can generate a secondary propagation of over 15,000 plants in one year (enough for 10 hectares) and 15 million in the next generation. There are over 400,000 hectares of banana production inLatin America fromMexico toPeru . Adoption of the new variety will be dependent upon its effectiveness and the infection
rate ofPanama disease.
There are many risks associated with achieving these desired results including but not limited to:
- We may not be able to adequately establish patent protection for our intellectual property or others may have competing claims. - Others may develop competitive approaches to compete with our genes. - Our transformation academic labs may fail to develop enough events for testing. - Our genes may cause unforeseen and undesirable changes beyond the pest
resistance such as yield degradation or changes in the appearance or taste of
the fruit. 16
- Our genes may fail to deliver the desired results of resistance to Fusarium.
- Globally regulations and/or consumer preference may prevent the successful
commercial launch of bananas with genetics changed using our methods.
- We will be dependent on others for the successful production and marketing of
bananas with our genes and many factors will be outside of our control.
- Our cash flow is highly dependent upon our only expected source of funding
provided under our Development and Commercialization Agreement with Dole Food
Company.
- Our expected future royalty revenue will be highly dependent upon the
successful execution of the banana development project in the DCA with Dole
and the negotiation of a long-term royalty licensing agreement expected in the
third year of that agreement.
These and other risk factors are discussed in more detail in our 10-K filing
dated
Evolutionary Genomics has no registered trademarks. The Company had two full time employees and one part-time employee as ofMarch 31, 2021 and leases its operating facility on a month-to-month basis afterJune 30, 2017 .Evolutionary Genomics is not currently involved in or aware of any threatened or actual
legal proceedings.
Unaudited Results of Operations
Three Months Ended March 31, 2021 2020 Percent of Percent of Amount Revenue Amount Revenue Grant revenue $ - N/A$ 12,500 100.0 % Research and development 96,815 N/A 93,222 745.8 % Salaries and benefits 92,430 N/A 92,430 739.4 % General and administrative 324,605 N/A 56,665 453.3 % Total operating expenses 513,850 N/A 242,317 1938.5 % Operating (loss) (513,850 ) N/A (229,817 ) (1838.5 )% Other income and (expenses) 108 N/A (11,999 ) (96.0 )% Income Taxes - N/A - 0.0 % Net loss$ (513,742 ) N/A$ (241,816 ) (1934.5 )% Preferred stock dividend (71,392 ) N/A (71,391 ) (571.1 )% Net loss attributable to common stockholders$ (585,134 ) N/A$ (313,207 ) (2505.7 )% Grant Revenue
Grant revenue decreased
Operating Expenses
Operating expenses increased
Research and Development Research and development increased$3,593 , or 3.9%, to$96,815 for the three months endedMarch 31, 2021 from$93,222 for the three months endedMarch 31, 2020 . The increase was primarily due to increased costs for our banana disease resistance project. 17 Salaries and Benefits
Salaries and benefits was unchanged at
General and Administrative General and administrative expenses increased$267,940 , or 472.8%, to$324,605 for the three months endedMarch 31, 2021 from$56,665 for the three months endedMarch 31, 2020 . The increase was primarily due to the amortization of our research in progress which was placed into serviceAugust 19, 2020 . Other Income Total other income increased$12,107 , or 100.9%, to$108 for the three months endedMarch 31, 2021 from ($11,999 ) for the three months endedMarch 31, 2020 . The loss in the three months endedMarch 31, 2020 was due to an unrealized loss in our investments which were sold inDecember 2020 . Net Loss Net loss increased$271,926 , or 112.5%, to$513,742 for the three months endedMarch 31, 2021 from$241,816 for the three months endedMarch 31, 2020 . The increase was primarily due to the amortization of our research in progress
and decrease in grant revenue. Financial Condition The Company's working capital decreased$122,714 to$151,715 as ofMarch 31, 2021 from$274,429 as ofDecember 31, 2020 primarily due to the operating loss partially offset by proceeds of notes payable. Liquidity The Company has historically financed operations through debt and equity transactions. Net cash used in operating activities was$194,673 for the three months endedMarch 31, 2021 compared to$34,788 for the three months endedMarch 31, 2020 . The$159,885 , or 459.6%, increase was primarily due to the increased net operating loss and a decrease in accounts payable outstanding. Net cash provided from financing activities was$76,395 from notes payable from the PPP loan in the three months endedMarch 31, 2021 . As ofMarch 31, 2021 , the Company had$97,558 in bank accounts. The Company's current projections for cash required in operations over the twelve months endingMarch 31, 2022 is$1,323,669 . This raises substantial doubt as to the Company's ability to continue as a going concern. To address these factors, management believes that it will secure additional funding to meet prospective cash requirements. Management believes the Company's existing cash balances along with funding from our agreement with Dole, prospective funding from marketing additional genes and additional contributions from our largest shareholder will provide the necessary liquidity to meet our obligations as they come due over the next year. We expect that the funding from these sources will be more than enough to cover our obligations for the next twelve months. However, if the funding does not arrive, the Company may not be able to meet its obligations as they become due.
Off-Balance Sheet Arrangements
The Company has no off-balance sheet arrangements that have a material current effect, or that are reasonably likely to have a material future effect, on its financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures, or capital resources. Contractual Obligations The Company leases its operating facility and pays its rent in monthly installments. The lease was renewed inJune 2016 for a period of twelve months and monthly rentals for the period ofJuly 1, 2016 throughMarch 31, 2021 are$2,378 per month which continues on a month-to-month basis. There is no minimum lease commitment as ofMarch 31, 2021 . Renewals afterJune 30, 2017 are by mutual agreement. The Company's rent expense for the three months endedMarch 31, 2021 and 2020 was$7,134 . 18 The Company is obligated to pay royalties to the United Soybean Board of 10% of the sale of products derived from the soybean genes that were the subject of the research performed by the Contractor or from royalties received by the Company from the sale of products by a third party not to exceed 150% of the total amount paid to the Contractor under this Agreement. The Company has recognized to date grant revenue from the contract of$262,400 as ofMarch 31, 2021 , thus limiting any future royalties as ofMarch 31, 2021 to a total of$393,600 . The Company has not accrued or paid any royalties under the terms of the Agreement as of and during the three months endedMarch 31, 2021 because it has not received any revenue from the sale of products to date. OnSeptember 18, 2020 , the Company entered into a Standard Research Agreement withUW for the development of our banana genes. The agreement includes payments from the Company in the amount of$2,159,719 over the two-year expected term of the project. These costs will be reimbursed, in the form of notes payable by Dole in accordance with our DCA.
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