Item 1. Business
Item
1. Business
Company
Overview
Unless
otherwise provided in this Annual Report, references to the “Company,” “we,” “us”, and “our”
refer to Range Impact, Inc., a Nevada corporation formed on June 29, 2007 as Legend Mining Inc., and its consolidated subsidiaries. On
October 10, 2011, we completed a merger with our wholly-owned subsidiary, Stevia First Corp., whereby we changed our name from “Legend
Mining Inc.” to “Stevia First Corp.” On July 15, 2016, our Board of Directors and shareholders approved a name change
to “Vitality Biopharma, Inc.” On October 1, 2021, we completed a merger with our wholly-owned subsidiary, Malachite Innovations,
Inc., whereby we changed our name from “Vitality Biopharma, Inc.” to “Malachite Innovations, Inc.” On December
14, 2023, we completed a merger with our wholly-owned subsidiary, Range Impact, Inc., whereby we changed our name from “Malachite
Innovations, Inc.” to “Range Impact, Inc.”
Range Impact, Inc. (“Range”)
is a public company dedicated to improving the health and wellness of people and the planet through a novel and innovative approach to
impact investing. Range owns and operates several complementary operating businesses focused on developing long-term solutions to environmental,
social, and health challenges, with a particular focus on acquiring, reclaiming and repurposing mine sites and other undervalued land
in economically disadvantaged communities throughout Appalachia. Range takes an opportunistic approach to impact investing by leveraging
its competitive advantages and looking at solving old problems in new ways. Range seeks to thoughtfully allocate its capital into strategic
opportunities that are expected to make a positive impact on the people-planet ecosystem and generate strong investment returns for its
shareholders.
Our
corporate headquarters is located in Cleveland, Ohio, with additional office locations in Flatwoods, West Virginia, Fola, West Virginia
and Rocklin, California. As of March 28, 2024, we employed 56 full-time employees. In addition, we have, from time to time, engaged various consultants and professional service
firms to provide us with flexible and experienced resources to advance our corporate objectives in order to maintain a cost-effective overhead
structure. We strive to instill a corporate culture of honesty, integrity and respect while advancing our mission of doing well by doing
good.
Impact
Investing Strategy
Our
impact investing strategy aims to improve the health and wellness of people and the planet, while also generating long-term sustainable
financial returns for our shareholders. We believe that doing well and doing good are not mutually exclusive, and that an impact investing
strategy can balance the environmental, social and economic needs of people and the planet while also generating attractive risk-adjusted
financial returns for shareholders.
Our
impact investing strategy provides an opportunity for our dedicated team to address pressing environmental, social and economic
challenges, such as air and water pollution, educational inequality and economic disparity, and climate change, through the
development of technology-based solutions. By actively directing investment capital towards businesses that are working to create
positive environmental, social and economic outcomes, we believe that our impact investing strategy can contribute to
an improved people-planet ecosystem and a healthier and happier way of life.
We
have a particular interest in providing environmental and social solutions in economically-disadvantaged regions of the United States.
Initially, the Company is targeting the Appalachian region, which is home to communities with some of the most disadvantaged income,
education and employment demographics in the United States. Our ambitious strategy is to allocate investment capital and build operating
businesses that provide positive environmental and social impact in the disadvantaged coal communities of Appalachia to maximize the
good we can do for people and the planet.
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Operating
Business Segments
Our
five operating business segments are: (i) Range Reclaim, (ii) Range Water, (iii) Range Security, (iv) Range Land, and (v) Drug Development.
Information
about our business segments should be read together with “Part II. Item 7. Management’s Discussion and Analysis of Financial
Condition and Results of Operations.”
Range
Reclaim
In
May 2022, the Company acquired Range Environmental Resources, Inc., a West Virginia corporation (“Range Environmental”) and
Range Natural Resources, Inc., a West Virginia corporation (“Range Natural” and together with Range Environmental, the “Range
Reclamation Entities”). The Range Reclamation Entities provide land reclamation, water restoration and environmental consulting
services to mining and non-mining customers throughout the Appalachian region with the goal of returning land to pre-mining conditions
or repurposing the land for natural, commercial, agricultural, residential or recreational use. The Range Reclamation Entities’ water restoration
services seek to improve rivers, streams and discharges through novel and innovative treatment applications to help customers meet their
various regulatory standards and requirements. The Range Reclamation Entities also provide environmental consulting services to customers,
typically in connection with land reclamation and water restoration projects, and, as an additional value-add service, sell water treatment
chemicals manufactured by third parties to their customers. Range Natural also mines, directly and through subcontractors, natural resources, including coal, for customers
incidental to the reclamation and repurposing of mine sites.
According
to the U.S. Energy Information Administration (“EIA”), the United States had 551 coal mines in 2020, comprised of 370 active
mines, 141 idled or closed mines, and 40 new or activated mines. Approximately 82% of those coal mines were located in Appalachia (which
comprises the Appalachian Mountains and is commonly known as the cultural region in the Eastern United States stretching from the southern
part of New York to the northern parts of Alabama and Georgia). According to the EIA, there were approximately three times as many coal
mines in the United States in 2008 (compared to 2020) with approximately 89% located in Appalachia. The precipitous decline in the number
of operating coal mines since 2008 is due to various supply, demand and regulatory factors, including a reduction in demand for coal
as a source of electricity due to the increased use of natural gas and renewable energy, an increase in coal production costs due to
inflation and the dearth of cost-effective locations remaining for mining, and a more stringent and costly regulatory environment, all
of which have resulted in an increasingly difficult market for coal producers.
In
2000, coal was responsible for 1,966 billion kWh of electricity generation, representing 52% of the total electricity generation in
the United States. In 2022, coal was responsible for only 828 billion kWh of electricity generation, representing 20% of the total
electricity generation in the United States, a decline of approximately 58%. According to the EIA, 23% of the 200,568 megawatts of
coal-fired capacity currently operating in the United States is scheduled to retire by the end of 2029 due to the high cost of
operations, competition from natural gas and renewable energy resources, and sustainable initiatives of energy
producers.
However,
the reclamation of closed and inactive mine sites has not kept pace with the increase in the number of closed and idled mine sites,
thus creating a substantial backlog of reclamation work that needs to be completed on former mine sites. According to the U.S.
Office of Surfacing Mining Reclamation and Enforcement (“OSMRE”), there are approximately 50,000 high-priority abandoned
mine land locations in the United States resulting from legacy coal mining operations that failed to adequately reclaim the land and
waterways back to their natural state as required by federal regulations. Additionally, there are tens of thousands of active mine sites in the United States that
require contemporaneous reclamation of land and waterways during the active mining process, and an estimated equally large number of
idled mine locations that also require significant land reclamation and water restoration.
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Under
the Surface Mining Control and Reclamation Act of 1977 (“SMRCA”), OSMRE was established for two basic purposes: (i) to ensure
coal mines in the United States operate in a manner that protects citizens and the environment during mining operations and to restore
the land to beneficial use following mining, and (ii) to implement an Abandoned Mine Land (“AML”) reclamation program to
address the hazards and environmental degradation resulting from two centuries of coal mining activities that occurred before SMRCA was
passed in 1977. The AML reclamation program is funded through fees levied against coal producers based on tons of coal produced. As of
September 2020, the AML reclamation fund had collected a total of $11.7 billion in coal mining fees over the life of the program, with
$9.5 billion (81%) appropriated and distributed in accordance with SMCRA, and $2.2 billion (19%) unappropriated and available for future
disbursement. In November 2021, the Infrastructure Investment and Jobs Act was enacted, which, among other things, authorized $11.3 billion
in new funding to be appropriated for deposit into the AML reclamation fund. The AML reclamation fund is only available
to help fund the reclamation of mines abandoned before SMCRA was enacted in 1977, and therefore, all mines abandoned after the year 1977
cannot access funding from the AML reclamation fund and must obtain funding from other sources.
While much of
the funding for this reclamation work comes from the federal government, each state in Appalachia has a Department of Environmental
Protection (“DEP”) or an equivalent agency that oversees coal mining permitting, operations, and reclamation. Under DEP
rules and regulations, coal mining companies are required to develop a mining and reclamation plan that is approved by the
applicable state agency, obtain a mining permit from the state, and secure a reclamation surety bond from a qualified third-party
insurance company or provide a comparable financial guarantee. The reclamation surety bond provides the state with financial
assurances that land reclamation and waterway restoration will be performed in accordance with the reclamation plan once mining is
complete if the coal mining company, as primary obligor, fails to perform. Therefore, there are at least three groups who may need
land reclamation, water restoration and environmental consulting services: (i) mining companies when permits are active and
reclamation bonds are not in default, (ii) surety bond insurers when reclamation bonds are in default, and (iii) states through
their AML reclamation funds for mine lands abandoned before 1977 and for mine lands with defaulted coal mining companies and
forfeited surety bonds on or after 1977.
At
the time of its acquisition in May 2022, the Range Reclamation Entities had one reclamation customer, 15 pieces of owned and
financed equipment, eight pieces of rented equipment, and 12 employees, all located and operating in West Virginia. As of March 2024,
less than two years later, the businesses had five reclamation customers, more than 100 pieces of owned and financed equipment, and
35 employees in West Virginia. For the full year 2021, the Range Reclamation Entities had revenues of approximately $2.5 million.
For the full year 2023, the Range Reclamation Entities generated revenues of approximately $18.7 million, an increase of $16.2
million over a two-year period. The Range Reclamation Entities have also made a significant investment in recruiting, retaining and
rewarding employees, including providing new benefits such as health insurance, paid time off, vacation days, 401(k) retirement plan,
and job advancement training. The Range Reclamation Entities’ employees are their most valuable asset, and therefore we are
committed to building a best-in-class culture and financially rewarding our talented, hard-working employees so that we can maximize
the good we can do for our people and their families.
The
Range Reclamation Entities are planning for continued growth in their land reclamation, water restoration and consulting businesses by
expanding their market share with existing coal mining customers and reclamation bond insurers, adding new coal mining and non-coal mining
customers, and collaborating with the Company’s other operating businesses to generate incremental sales opportunities. We will
seek to add additional people, equipment and technologies to support our ambitious growth goals to ensure we successfully execute our
value creation plans for the Company and our shareholders.
In
August 2023, the Company acquired Collins Building & Contracting, Inc. (“Collins Building”), a West Virginia-based environmental
services business focused on performing reclamation services on abandoned mine lands throughout West Virginia. Collins Building, along
with the Range Reclamation Entities, are classified within the Range Reclaim operating business segment.
Range
Water
Terra
Preta, LLC, an Ohio limited liability company (“Terra Preta”), is a biochar product development and environmental solutions
business started by the Company in December 2022. Terra Preta is developing a novel and innovative combination of biochar, proprietary
materials and structural designs intended to create several first-of-its-kind agricultural and water filtration products and solutions.
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Biochar
is a solid, lightweight carbon-rich material produced by the thermal decomposition of organic material (such as cellulosic feedstock,
including wood and plants) using a chemical-conversion process known as pyrolysis. Carbonization pyrolysis is a chemical degradation
process that heats organic materials to produce carbon-rich biochar, liquid bio-oils, and syngas products. Since organic material is
thermally decomposed without oxygen during the pyrolysis process, combustion does not occur, so the process allows for the permanent
capture of carbon in the biochar end-product and eliminates the release of climate-damaging carbon dioxide into the atmosphere. The specific
yield of biochar during the carbonization pyrolysis process depends on several variables such as temperature, heating time and heating
rate. Lower temperatures, longer heating times and lower heating rates typically yield more biochar and less bio-oil and syngas.
Terra
Preta has been launched to build a full-cycle, carbon-negative business that reduces greenhouse gases from the atmosphere, passively
filters contaminated water without the use of harsh chemicals, and provides a fortified, nutrient-rich soil amendment to improve the
growth of agricultural products.
Greenhouse
gases, comprised of carbon dioxide, methane, nitrous oxide and fluorinated gases, are gases that trap heat in the atmosphere, and are
generally believed to result in warmer temperatures and climate change, including changing weather patterns, rising sea levels, and more
extreme weather events. Carbon dioxide enters the atmosphere through, among other things, the burning of fossil fuels, solid waste and
other biomass materials, and is removed from the atmosphere when absorbed by plants during the photosynthesis process. Terra Preta is
in discussions with a large affiliated landowner to enter into a long-term lease or purchase of at least 100 acres of former mine land
in West Virginia for the planting, growth and harvesting of crops to serve as the primary feedstock for our biochar production operations.
The newly planted crops would then act as a “carbon sink”, drawing substantial amounts of carbon dioxide from the atmosphere
into the plants through the photosynthesis process. When the plants are harvested, biochar is produced through the carbonization pyrolysis
process and the captured carbon dioxide is permanently preserved as carbon in the biochar product for use in water treatment and agricultural
end uses.
Pursuant
to rules adopted under the Clean Water Act of 1972 (“Clean Water Act”), the U.S. Environmental Protection Agency (“EPA”)
has implemented various pollution control programs such as wastewater standards for industry and recommendations for pollutants in surface
waters. The Clean Water Act prohibits any party from discharging pollutants into a water of the United States unless they have a permit
issued under the National Pollutant Discharge Elimination System (“NPDES”), which contains limits on what a party can discharge
and establishes monitoring and reporting requirements. On mining sites, coal operators are required to sample and test their water discharges
on a regular basis to ensure compliance with the Clean Water Act and applicable NPDES permits. Currently, most mining operators treat
non-compliant water with temporary holding ponds and expensive chemicals such as pH adjusters, coagulants and flocculants that require
constant reapplication to ensure compliance. Terra Preta will focus on developing a proprietary, biochar-based passive treatment system
that treats non-compliant mine site discharges to ensure compliance with the Clean Water Act and NPDES permits without the need for holding
ponds or expensive chemicals.
Sustainable
agriculture plays a critical role in the stability, growth, and diversification of our future food supply chain and the growth of plants
intended to serve as a carbon sink to reduce greenhouse gases. High-quality soil, a key condition for sustainable agriculture, requires
organic matter, microorganisms, nutrients, and optimal compaction. Subsoils with a sufficient number of air-filled pores have little
restriction to drainage and aeration, and typically are able to decompose and cycle organic matter and nutrients more efficiently. Alternatively,
soil with poor aeration leads to the build-up of carbon dioxide, reduces the ability of plants to absorb water and nutrients, and leads
to increased plant stress and root disease. To help address the ill effects of soil compaction, Terra Preta is developing a proprietary,
fortified biochar soil amendment that provides unique soil structuring characteristics that will allow plants to grow strong roots that
optimize the absorption of water and nutrients, thereby reducing root stress and disease.
In
December 2022, Terra Preta filed trademarks for biochar goods and services related to agricultural and water treatment applications, and in March 2023, filed provisional patents related to novel and innovative agricultural and water treatment solutions and designs.
Additionally, in March 2023, Terra Preta purchased two pyrolysis ovens that each produce one ton of biochar per day to advance our research
and development activities. We are currently evaluating the purchase of a large continuous-process pyrolysis oven to increase
the scale of our biochar production to commercial levels.
7
Range
Security
Range
Security Resources, LLC, an Ohio limited liability company (“Range Security”), is an environmental security services business
started by the Company in November 2022. Range Security is focused on providing eco-friendly, technology-driven security services to
active and former mine sites, with a particular focus on locations transitioning from coal mining to next generation industries. Range
Security is intended to serve as a complementary business to the Range Reclamation Entities.
Mine
sites in the Appalachian region frequently comprise thousands of acres of natural habitat with valuable infrastructure and operating
assets disbursed across large tracts of land. However, many of these mine sites lack adequate broadband access or cellular service, and
therefore traditional technology-based security solutions are not available. Also, due to the large land areas and often challenging
access roads and mountainous terrain, consistent visual confirmation of the safety and security of high value assets is problematic,
and unnecessary amounts of carbon dioxide are emitted from heavy-duty trucks used to perform frequent visual security checks. Furthermore,
due to the remoteness and lack of technological options, most security services in the market fail to provide an independent verification
of the security status of a mine site and confirmation of visual security checks, resulting in a customer’s uncertainty regarding
the actual security services being provided.
Valuable
assets commonly found on mine sites requiring high-levels of security services include office buildings, coal operation facilities
such as preparation plants and loadout facilities, power stations and electrical lines, vehicles and heavy equipment, supplies and
chemicals, and spare parts and components. These high-value assets are frequently the target of theft since all or parts of these
assets can be easily removed from the mine site and sold for cash. Unfortunately, the actual damage to the operation resulting from
this type of destructive theft is frequently many times the market value of the stolen item, primarily due to the losses resulting
from the down-time of operations, the cost of repairs and replacement components, and the long-term damage to critical
infrastructure that could be repurposed and used to attract next generation industries once mining is complete.
In
March 2023, Range Security was engaged by its first customer for environmental security services covering a 13,000-acre coal mine site
in West Virginia. Range Security currently employs 17 security professionals, and is focusing its recruitment efforts on military veterans,
police officers, and other professionals with security experience. Range Security has purchased two fuel-efficient utility task vehicles
for ground surveillance and a thermal-imaging drone for aerial surveillance, all of which use significantly less fuel and electricity
to operate than traditional security vehicles and provide a much broader coverage range with a substantially lower carbon footprint.
Range Security is also in the process of establishing satellite-based wireless service to support video surveillance and enable a mobile
technology solution used by our security professionals to provide real-time evidence of visual security checks. Range Security plans
to expand its security service business onto additional mine sites, with a particular focus on locations with valuable infrastructure
being repurposed into non-coal multi-use complexes with attractive job growth prospects and next generation industry opportunities.
Range
Land
Range
Land, LLC, an Ohio limited liability company (“Range Land”), is a land acquisition company started by the Company in
August 2023. Range Land is focused on acquiring former mine lands with the goal of reclaiming and repurposing the sites for
non-fossil fuel uses, including commercial, industrial, residential and recreational developments. Range Land is specifically
interested in acquiring land to be used for renewable energy facilities, innovative agricultural installations, and projects focused
on improving the quality and condition of our air, land and waterways.
According
to industry estimates, Appalachia contains approximately one million acres of abandoned, idled and non-performing mine sites that
are burdened with significant land reclamation and water restoration obligations. Many of these troubled mine sites are subject to
mining permits and associated reclamation bonds, which as a result, prevents the land from being repurposed for non-mining uses
until the land has been reclaimed and the permits and bonds have been released by the applicable state’s environmental
protection department. Water quality is a particularly challenging issue since a permit can only be released if the site has at
least 12-months of compliant water samples without active chemical treatment, which heightens the need for water restoration
solutions to help transition former mine land to economically viable non-mining uses.
The
Company, through its several operating businesses, has assembled the internal resources and capabilities to reclaim land, restore waterways,
install innovative water treatment solutions, and secure the mine site to protect the significant historical investment in infrastructure.
In addition to these in-house capabilities, the Company and its operating businesses also possess deep knowledge and expertise about
the permit and bond release process, which is a critical step necessary to unlock the underlying value of former mine land for non-fossil
fuel uses. Range Land is actively evaluating several mine sites in Appalachia to acquire, reclaim and repurpose in order to improve
the land and create non-fossil fuel economic development opportunities for disadvantaged local coal communities.
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In
September 2023, Range Land, through its wholly-owned subsidiary CLV Azurite Land, LLC, an Ohio limited liability company (“CLV
Azurite”), acquired over 1,900 acres of surface interest at an idled mine complex in West Virginia.
CLV Azurite is in active discussions with the holder of the permits and bonds associated with the acquired land to ensure that the acquired
surface acreage can be repurposed for alternative non-fossil fuel uses. Concurrently, CLV Azurite is in active discussions with two experienced
and well-capitalized solar developers to convert the former mine land into a large solar energy facility on a majority of the
acquired surface acreage, as well as additional acreage for commercial, industrial, recreational and residential development. Under the
solar arrangements, CLV Azurite would be the landlord and the solar developer-operator would be the tenant required to pay CLV Azurite
a negotiated lease payment on a per acre basis.
Drug
Development
Graphium
Biosciences, Inc., a Nevada corporation (“Graphium”), is a cannabinoid-based drug development company tracing its history
of technological innovation and drug advancement back to October 2011 through two predecessor entities, Stevia First Corp. and Vitality
Biopharma, Inc. In October 2021, the Company formed Graphium as a wholly-owned subsidiary and transferred all of its drug development
assets to this newly-formed entity.
Graphium
is advancing a broad portfolio of glycosylated cannabinoid prodrugs that have been developed to unlock the rebalancing effects of the
endocannabinoid system to address numerous chronic conditions with inadequate pharmaceutical options. Graphium’s leading drug candidate,
VBX-100, is a glycosylated tetrahydrocannabinol (“THC”) cannabinoid that targets inflammatory conditions of the gastrointestinal
tract but without unwanted psychoactive or intoxicating side effects.
Cannabinoids,
including THC and cannabidiol (“CBD”), have well-known therapeutic benefits through their interaction with the human endocannabinoid
system, which serves a regulating and rebalancing function in the body. For decades, patients have used cannabinoids to activate the
endocannabinoid system to provide relief for numerous chronic and debilitating ailments, including inflammation, pain, anxiety, depression,
and cancer. However, THC, a commonly-used cannabinoid with significant therapeutic benefit, is psychoactive and intoxicating, and therefore
its use has many practical, and in some cases legal, limitations. Nevertheless, many patients with chronic health conditions, including
gastrointestinal inflammation, continue to use cannabinoids because current pharmaceutical offerings do not provide adequate therapeutic
relief or result in unwanted side effects.
Our
novel scientific discovery was the development of a proprietary enzymatic bioprocessing technology that adds one or more glucose molecules
to a cannabinoid, resulting in our proprietary glycosylated cannabinoid compounds. Our glycosylated cannabinoids act as prodrugs that
achieve targeted delivery of the bioactive cannabinoids within the body once they are activated. Prodrugs are compounds that, after administration,
are metabolized into a pharmacologically active drug and are often designed to improve drug properties and reduce known or expected toxicities
and adverse side effects. The advantages of our glycosylated cannabinoid prodrugs may include: (i) administration in a convenient oral
formulation, (ii) targeted delivery with release in the colon or large intestine, (iii) improved stability with limited degradation or
drug metabolism, and (iv) delayed release enabling longer-lasting effects and fewer administrations by patients.
We
have learned through our animal studies that glucose bound to cannabinoid molecules are inactive and poorly absorbed from the intestines,
allowing the combined molecule to reach the large intestine where glycoside hydrolase enzymes cleave the glucose and the cannabinoid
is released in a targeted and restricted manner. Further, we have learned through our animal studies that a targeted release of THC,
which could be provided in very low doses to achieve physiologically beneficial results, serves as an anti-inflammatory agent in the
lower gastrointestinal tract and minimizes the amount of THC absorbed into the blood stream. Therefore, we anticipate our glycosylated
cannabinoid prodrug will provide the anti-inflammatory benefits of low-dose THC while avoiding the psychoactive and intoxicating properties
that hinder the broader pharmaceutical use of THC. Initially, we are targeting the $20 billion inflammatory bowel disease (“IBD”)
market in the United States, which is composed of patients suffering from ulcerative colitis and Crohn’s disease, both chronic
and debilitating conditions with no cure. We also believe our glycosylated cannabinoids could also be used to treat other indications,
including, among others, irritable bowel syndrome (“IBS”), anxiety, depression, autism and cancer.
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By
using our proprietary enzymatic bioprocessing technologies, our research team has developed a novel family of over 100 glycosylated cannabinoid
prodrugs. These glycosylated cannabinoids have unique commercial applications and patentable compositions of matter, which are separate
and distinct from ordinary cannabinoids. Currently, our intellectual property is comprised of the following patents: (i) Cannabinoid
Glycoside Prodrugs and Methods of Synthesis: Patent filed in 2016 and granted in 2021 for the invention of novel glycosylated cannabinoids
and methods of targeted delivery for the treatment of gastrointestinal disorders, including IBD and IBS, (ii) Antimicrobial Compositions
Comprising Cannabinoids and Methods of Using the Same: Patent filed in 2018 and granted in 2021 for the use of cannabinoids as antibiotics
for the treatment of Clostridioides difficile , (iii) Novel Cannabinoid Glycosides and Uses Thereof: Patent filed in 2020 and in
prosecution for additional novel cannabinoid glycosides and includes research data supporting the improved characteristics and commercial
production strategies for these new molecules, and (iv) Continuous Enzymatic Perfusion Reactor System: Patent filed in 2021 and in prosecution
for our improved reactor system for the efficient enzymatic glycosylation of hydrophobic small molecules, including cannabinoids. We
believe our intellectual property portfolio of glycosylated cannabinoids possess significant value and, as a result, we have allocated
substantial resources to ensure that our U.S. and international patents are properly filed and successfully prosecuted. As our research
efforts involving glycosylated cannabinoids continue to progress, we plan to file additional patents to further expand our growing family
of intellectual property assets and create long-term value for our shareholders.
Our
research team has performed 23 animal studies to test the safety, efficacy and dosing levels of our glycosylated cannabinoids, which
have provided us with favorable scientific data and the opportunity to further refine our drug development plan. We have performed two
industry standard colitis disease mouse models: (i) TNBS model in 2017 and 2018 that generated favorable colitis prevention data, and
(ii) DSS model in 2021 that generated favorable colitis treatment data. In 2021, we received a letter from the Food and Drug Administration’s
(“FDA”) Office of Orphan Products Development stating that we have been granted Orphan Drug Designation for our glycosylated
cannabinoid VBX-100 for the treatment of pediatric ulcerative colitis. An Orphan Drug Designation provides several benefits, including
fee waivers, tax credits, fast tracking of regulatory processes, and seven years of market exclusivity.
Due
to our development of pharmaceutical products, we are subject to extensive regulation by the FDA and other federal, state, and local
agencies. Also, since we are researching and developing cannabinoid-based products, we are subject to regulation by the U.S. Drug Enforcement
Administration (“DEA”). Our research and development activities focus on cannabinoids, particularly THC and CBD derived from
the cannabis plant, which the DEA has classified as Schedule I substances. Schedule I substances are defined as drugs with no currently
accepted medical use and a high potential for abuse. In May 2019, the DEA informed us that it had determined that they consider our VBX-100
prodrug a Schedule I substance. As a result, any developing, testing, manufacturing, or clinical studies involving our VBX-100 prodrug,
and by inference potentially all of our THC-glycoside molecules, are required to be properly licensed by the DEA and adhere to strict
diversion control standards.
We
are working closely with a third-party contract research organization to develop a detailed drug development plan to advance our leading
drug candidate, VBX-100, through Phase II clinical trials by the end of 2027, subject to receipt of sufficient funding, which is currently
estimated to be approximately $16.0 million. We have engaged an investment banker to assist with an initial capital raise of $4.0 million
and are targeting a closing of that initial capital raise in 2Q 2024, with the remaining $12.0 million to be raised in 2025 once key
drug development milestones are achieved.
Competition
Our
Company is focused on a large and growing marketplace for impact investing initiatives, and therefore, is anticipated to face competition
from a variety of operating businesses and investment funds who are developing similar business plans and operating strategies to satisfy
the increasing demands of these types of investments in the marketplace. In many cases, these competitors are larger and better capitalized
operating businesses and investment funds.
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Our
Company competes on the basis of a number of factors, including our geographic focus on Appalachia, access to mission-driven
energy-transition capital, access to impact investing opportunities, strategic relationships with reclamation bond insurance
companies, recruitment and retention of key personnel, market share with key customers, and supply relationships with critical
vendors. Our ability to continue to compete effectively in our businesses will depend upon our ability to attract new employees and
retain and motivate our existing employees.
Information
Systems
In
2023, the Company engaged Foundation Software, LLC (“Foundation Software”) as its new accounting software provider and converted all of the Company’s accounting
system operations from QuickBooks to Foundation Software during the second quarter of 2023.
Founded in
Cleveland, Ohio in 1985, Foundation Software is specifically designed for service companies, particularly those in the construction,
contracting and reclamation industries. Foundation Software offers the Company several enhanced features critical to the successful
execution of its shareholder value creation plan, including (i) general ledger accounting, including accounts payable, accounts
receivable, inventory and customer billing, (ii) equipment tracking on job sites, maintenance, utilization and depreciation, (iii)
employee tracking on job sites, time and materials, utilization, and billing, (iv) job costing and profitability reporting segmented
by customers, job types and location, and (v) numerous real-time management dashboard and key performance indicator reports that
will allow management to closely monitor financial and operational performance and quickly react to business opportunities and
issues. Furthermore, Foundation Software will allow the Company to quickly scale operations and efficiently and cost-effectively
support the anticipated growth of each business, thereby preventing our accounting and management systems from becoming a limiting
factor to our growth initiatives.
General
Information
We
maintain a corporate website at: www.rangeimpact.com. Information contained on our website is not incorporated by reference in this Annual
Report. We file reports with the Securities and Exchange Commission (“SEC”) and make available free-of-charge through our
website our annual reports, quarterly reports, current reports, proxy and information statements and amendments to those reports filed
or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
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