−Removed: We are a pre-commercial stage advanced materials company dedicated to the development of technology and processes that, if successful, will allow for the enrichment of natural isotopes into higher concentration products, which could be used in several industries.
−Removed: We have an exclusive license to use proprietary technology, the Aerodynamic Separation Process (“ASP technology”), originally developed and licensed to us by Klydon Proprietary Ltd (“Klydon”), for the production, distribution, marketing and sale of all isotopes.
+Added: We are a development stage advanced materials company dedicated to the development of technology and processes that, if successful, will allow for the enrichment of natural isotopes into higher concentration products, which could be used in several industries.
+Added: Our proprietary technology, the Aerodynamic Separation Process (“ASP technology”), originally developed by Klydon Proprietary Ltd (“Klydon”), is designed to enable the production of isotopes used in several industries.
Our initial focus is on the production and commercialization of enriched Carbon-14 (“C-14”), Molybdenum-100 (“Mo-100”) and Silicon-28 (“Si-28”).
−Removed: Klydon has agreed to provide us a first commercial-scale isotope enrichment plant located in South Africa.
−Removed: We believe the C-14 we may develop using the ASP technology may be used in the development of new pharmaceuticals and agrochemicals.
−Removed: We believe that the Mo-100 we may develop using the ASP technology has significant potential advantages for use in the preparation of nuclear imaging agents by radiopharmacies and others in the medical industry.
−Removed: We believe the Si-28 we may develop using the ASP technology may be used to develop advanced semiconductors and in quantum computing.
−Removed: We also intend to develop the ASP technology to produce enriched Uranium-235 (“U-235”).
−Removed: We believe that the U-235 we may develop using the ASP technology may be commercialized as a nuclear fuel component for use in the new generation of HALEU-fuelled small modular reactors that are now under development for commercial and government uses.
−Removed: In addition, we are considering future development of the ASP technology for the separation of Zinc-68, Ytterbium-176, Zinc-67, Nickel-64 and Xenon-136 for potential use in the healthcare target end market, and Chlorine -37 and Lithium-6 for potential use in the nuclear energy target end market.
+Added: We have commissioned an isotope enrichment plant for the enrichment of C-14 located in Pretoria, South Africa, which will be ready for production upon the final installation of essential components.
+Added: We anticipate completion and commissioning of a multi-isotope enrichment plant in Pretoria, South Africa in mid-2024.
+Added: In addition, we have started planning additional isotope enrichment plants.
+Added: We believe the C-14 we may produce using the ASP technology could be used in the development of new pharmaceuticals and agrochemicals.
+Added: We believe the Mo-100 we may produce using the ASP technology could have significant potential advantages for use in the preparation of nuclear imaging agents by radiopharmacies and others in the medical industry.
+Added: We believe the Si-28 we may produce using the ASP technology may be used to create advanced semiconductors and in quantum computing.
+Added: In addition, we are considering the future development of the ASP technology for the separation of Zinc-68, Xenon-129/136 for potential use in the healthcare end market, Germanium 70/72/74 for possible use in the semiconductor end market, and Chlorine -37 for potential use in the nuclear energy end market.
+Added: We are also developing Quantum Enrichment technology to produce enriched Ytterbium-176, Nickel-64, Lithium 6, Lithium7 and Uranium-235 (“U-235”).
+Added: Quantum enrichment is an advanced isotope enrichment technique that is currently in development that uses lasers.
+Added: We believe that the U-235 we may produce using quantum enrichment technology may be commercialized as a nuclear fuel component for use in the new generation of high-assay low-enriched uranium (HALEU)-fueled small modular reactors that are now under development for commercial and government uses.
The aerodynamic separation technique has its origins in the South African uranium enrichment program in the 1980s, and the ASP technology has been developed during the last 18 years by the scientists at Klydon.
−Removed: In Klydon’s testing, the ASP technology has demonstrated efficacy and commercial scalability in the enrichment of oxygen-18 and silicon-28.
+Added: In Klydon’s testing, the ASP technology has demonstrated efficacy and commercial scalability in enriching oxygen-18 and silicon-28.
ASP Isotopes Inc.
was incorporated in Delaware in September 2021 to acquire assets and license intellectual property rights related to the production of Mo-100 using the ASP technology.
−Removed: In January 2022 we also licensed intellectual property rights related to the production of U-235 using the ASP technology.
+Added: In January 2022, we also licensed intellectual property rights associated with the production of U-235 using the ASP technology.
In July 2022, we licensed intellectual property rights related to the production of all isotopes using the ASP technology.
+Added: In April 2023, we acquired certain intellectual property assets of Klydon.
We operate principally through subsidiaries:
ASP Isotopes Guernsey Limited (the holding company of ASP Isotopes South Africa (Proprietary) Limited and Enlightened Isotopes (Pty) Ltd), which will be focused on the development and commercialization of high-value, low-volume isotopes for highly specialized end markets (such as C-14, Mo-100, and Si-28).
−Removed: Enriched Energy LLC, which will be focused on the development and commercialization of uranium for the nuclear energy market;
−Removed: and ASP Isotopes UK Ltd, which is the licensee of the ASP technology under the exclusive license agreement with Klydon.
+Added: In September 2023, we formed a new subsidiary, Quantum Leap Energy LLC, which also has a subsidiary in the United Kingdom (Quantum Leap Energy Ltd), to focus on the development and commercialization of advanced nuclear fuels such as HALEU and Lithium-6.
+Added: ASP Isotopes UK Ltd is the owner of our technology.
+Added: In addition, in the fourth quarter of 2023, we entered into a strategic relationship with Pet Labs Pharmaceuticals Proprietary Limited (PET Labs) by acquiring a 51% ownership stake in PET Labs.
+Added: We anticipate this transaction will allow us to enter the downstream medical isotope production and distribution market.
Our corporate structure and ownership of our subsidiaries is set forth in the chart below:
−Removed: Recent Events
−Removed: Completion of First Company Owned Plant
−Removed: Our wholly owned subsidiary, ASP Isotopes South Africa (Pty) Ltd successfully completed the construction of our first Company owned plant, for light isotopes, during the first quarter of 2023.
−Removed: This facility located in Pretoria, South Africa, will, when fully commissioned, satisfy the production to fulfill our obligations to our prospective C-14 customer.
−Removed: We employ 27 persons at this facility.
−Removed: We expect to conclude the construction of a second larger plant later in 2023.
−Removed: Klydon Agreements
−Removed: On November 1, 2021, ASP Isotopes South Africa (Proprietary) Ltd (“ASP South Africa”) and Klydon (Proprietary) Limited (“Kyldon”), as the contractor, entered into a contract under which Klydon was to supply ASP South Africa with a complete turnkey isotope enrichment plant (the “Turnkey Contract”).
−Removed: Among other things, the activities required to be undertaken or performed by Klydon include taking control of the assets acquired in the Molybdos Business Rescue Auction and the design of an isotope enrichment facility;
−Removed: the supply of components, equipment and labor required for the construction;
−Removed: the installation, testing and commissioning of the isotope enrichment plant;
−Removed: securing all required approvals, regulatory authorizations and other required consents for the operation of the plant;
−Removed: providing training to local ASP South Africa personnel to enable them to operate the plant going forward;
−Removed: and providing warranties in relation to the performance targets of the plant which are required to be met.
−Removed: Klydon performed a portion of the services required under the Turnkey Contract;
−Removed: however, services were incomplete and many of the services were not completed within the time frame required.
−Removed: As a result, Klydon and ASP South Africa entered into an Acknowledgement of Debt Agreement dated November 30, 2022, whereby Klydon (i) agreed to pledge its assets (the “Pledged Assets”) to ASP South Africa to secure its performance of the Turnkey Contract by December 31, 2022, and (ii) acknowledged that ASP South Africa would suffer damages in the amount of $6,050,000 (“Damage Amount”) should it fail to perform.
−Removed: Under the Acknowledgement of Debt Agreement, the Pledged Assets would serve as collateral for Klydon’s obligation to pay the Damage Amount should Klydon fail to perform.
−Removed: In connection therewith, also on November 30, 2022, ASP South Africa and Klydon entered into a Deed of Security Agreement whereby, if Klydon failed to complete its obligations under the Turnkey Contract by December 31, 2022, all of Klydon’s rights of any nature to and interests of any nature in the Pledged Assets would be transferred to ASP South Africa.
−Removed: Klydon failed to complete its obligations under the Turnkey Contract by December 31, 2022, and the Company plans to perfect its interests in the assets as soon as practicable.
−Removed: Private Placement
−Removed: On March 14, 2023, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a single institutional investor (the “Purchaser”), pursuant to which we issued, in a private placement (the “Offering”), an aggregate of (i) 3,164,557 shares (the “Shares”) of our common stock, par value $0.01 per share (the “Common Stock”);
−Removed: and (ii) warrants (the “Common Warrants”) to purchase up to an aggregate of 3,164,557 shares of Common Stock (the “Common Warrant Shares”), at a purchase price of $1.58 per one (1) share of Common Stock and accompanying Common Warrant, for a total gross proceeds of approximately $5.0 million, before deducting placement agent fees and other offering expenses.
−Removed: The Common Warrants have an exercise price of $1.75 per share, are exercisable on or after September 17, 2023 and will expire on September 18, 2028.
−Removed: The Offering closed on March 17, 2023 (the “Closing”).
−Removed: The Offering was conducted pursuant to the exemption from the registration requirements of the Securities Act, available under Section 4(a)(2) and/or Rule 506(b) of Regulation D.
−Removed: We engaged H.C.
−Removed: Wainwright & Co., LLC (the “Placement Agent”) to act as its exclusive placement agent in connection with the Offering, pursuant to the engagement letter (the “Engagement Letter”), dated as of February 15, 2023, between the Company and the Placement Agent.
−Removed: Pursuant to the Engagement Letter, we paid the Placement Agent (i) a total cash fee equal to 7.0% of the aggregate gross proceeds of the Offering;
−Removed: (ii) a management fee of 1.0% of the aggregate gross proceeds of the Offering;
−Removed: and (iii) reimbursement of certain expenses.
−Removed: In addition, we issued to the Placement Agent, or its designees warrants (the “PA Warrants”) to purchase up to 221,519 shares of Common Stock (the “PA Warrant Shares”) at an exercise price of $1.975 per share.
−Removed: The PA Warrants are exercisable on or after September 17, 2023 and will expire on September 18, 2028.
−Removed: We received net proceeds of approximately $4.5 million from the Offering, after deducting the Placement Agent fees and other Offering expenses.
−Removed: We plan to use the net proceeds from the Offering for working capital and general corporate purposes.
−Removed: In connection with the Offering, on March 14, 2023, we entered into a Registration Rights Agreement with the investor (the “Registration Rights Agreement”) pursuant to which we are required to file a registration statement with the Securities and Exchange Commission (the “SEC”) to register for resale the Shares and the Common Warrant Shares.
−Removed: We are required to use our best efforts to cause the registration statement to be declared effective by the SEC by April 28, 2023 or in the event of a “full review” by the SEC, by May 29, 2023.
−Removed: The Registration Rights Agreement imposed a penalty of 2% monthly of the total financing amount if the registration statement was not filed by March 29, 2023, which we failed to do.
−Removed: As such, we are obligated to pay a penalty of $100,000 to the Purchaser.
−Removed: Complete development and commissioning of our first enrichment facilities located in Pretoria, South Africa.
−Removed: We intend to complete the development and construction of two enrichment facilities located in Pretoria, South Africa.
−Removed: We currently have two enrichment facilities in Pretoria, South Africa under either construction or commissioning.
−Removed: The first facility is designed to enrich light isotopes such as Carbon-14.
−Removed: The second facility, which is substantially larger than the first, should have the potential to enrich kilogram quantities of isotopes such as Molybdenum-100 and/or Silicon-28.
−Removed: In October 2021, we acquired physical assets, including equipment, of Molybdos (Pty) Limited (Molybdos) located at the plant after having been declared the winner of a competitive auction process under Section 45 of the South Africa Consumer Protection Act, 2008 (the Molybdos Business Rescue Auction) and we licensed the ASP technology for the production of Mo-100 from Klydon Proprietary Ltd (Klydon).
−Removed: We subsequently entered into a turnkey contract with Klydon pursuant to which Klydon agreed to provide us a first commercial-scale isotope enrichment plant.
−Removed: The activities to be undertaken or performed by Klydon include:
−Removed: taking control of the assets acquired by us in the Molybdos Business Rescue Auction;
+Added: Recent Events and Key Milestones
+Added: Offering of Convertible Notes of Quantum Leap Energy LLC
+Added: On February 29, 2024, our wholly owned subsidiary, Quantum Leap Energy LLC (“QLE”), entered into a Convertible Note Purchase Agreement (the “Purchase Agreement”) with certain institutional and individual investors (collectively, the “Purchasers”), to issue and sell to the Purchasers convertible promissory notes of QLE (the “QLE Notes”) in an offering to non-U.S.
+Added: persons outside of the United States under Regulation S of the Securities Act of 1933, as amended (the “Securities Act”).
+Added: The closing of the offering of QLE Notes occurred on March 7, 2024 and resulted in gross proceeds to QLE of approximately $20.5 million.
+Added: We intend to use the net proceeds from the QLE Notes offering for planning, development and construction of QLE’s laser enrichment production facilities and for other general corporate purposes.
+Added: We engaged Ocean Wall Limited (the “Placement Agent”) to act as QLE’s sole placement agent in connection with the offering of QLE Notes, pursuant to a placement agency agreement (the “Placement Agent Agreement”), dated as of February 29, 2024, between the Company, QLE and the Placement Agent.
+Added: Pursuant to the Placement Agent Agreement, QLE agreed to pay the Placement Agent a fee equal to 5.0% of the gross proceeds received by QLE from the sale of QLE Notes, which was paid 50% in cash and 50% in the form of a convertible promissory note in substantially the same form and with substantially the same terms as the QLE Notes.
+Added: In connection with the offering of QLE Notes, on February 29, 2024, QLE and the Purchasers entered into a registration rights agreement (the “Registration Rights Agreement”).
+Added: Under the Registration Rights Agreement, all units or shares of QLE common equity issuable upon conversion of the QLE Notes will be deemed “Registrable Securities.” Under the Registration Rights Agreement holders of the QLE Notes have been granted certain long-form and short-form demand registration rights with respect to the Registrable Securities, including the right to demand an initial public offering (IPO) if QLE has not gone public within five years of the date of the agreement.
+Added: In addition, holders of the QLE Notes have been granted piggyback registration rights with respect to the Registrable Securities.
+Added: Certain cash penalties will apply to QLE in the event of registration failures, as described in the Registration Rights Agreement.
+Added: Intercompany Agreements between ASP Isotopes Inc.
+Added: and Quantum Leap Energy LLC
+Added: In anticipation of the closing of the offering of QLE Notes, the Company:
+Added: (1) caused ASP Isotopes UK Limited to enter into a License Agreement, dated as of February 16, 2024, among ASP Isotopes UK Limited, as licensor, and QLE and Quantum Leap Energy Limited (QLE’s UK subsidiary), as licensee, pursuant to which, among other things, the licensee has licensed from the Company the rights to technologies and methods used to separate Uranium-235 and Lithium-6 (including but not limited to the quantum enrichment and ASP technologies) in exchange for a royalty payment in the amount of 10% of QLE revenues (the “License Agreement”);
+Added: (2) entered into an EPC Services Framework Agreement, dated as of February 16, 2024, with QLE, pursuant to which, among other things, the Company has agreed to provide services for the engineering, procurement and construction of one or more turnkey Uranium-235 and Lithium-6 enrichment facilities in locations to be identified by QLE and owned or leased by QLE, and to commission, start-up and test each such facility, in each case subject to the receipt of all applicable regulatory approvals, permits, licenses, authorizations, registrations, certificates, consents, orders, variances and similar rights (the “EPC Services Agreement”);
+Added: and (3) effective as of February 16, 2024, assigned to QLE certain existing memoranda of understandings between the Company and certain small modular reactor companies.
+Added: Share Purchase Agreement relating to PET Labs
+Added: On October 31, 2023, we entered into a Share Purchase Agreement with Nucleonics Imaging Proprietary Limited, a company incorporated in the Republic of South Africa (the “Seller”), relating to the purchase and sale of ordinary shares in the issued share capital of Pet Labs Pharmaceuticals Proprietary Limited, a company incorporated in the Republic of South Africa (“PET Labs”).
+Added: PET Labs is a South African radiopharmaceutical operations company, dedicated to nuclear medicine and the science of radiopharmaceutical production.
+Added: Under the Purchase Agreement, we have agreed to purchase from the Seller 51 ordinary shares in the issued share capital of PET Labs (the “Initial Sale Shares”) (representing 51% of the issued share capital of PET Labs) and we have an option to purchase from the Seller the remaining 49 ordinary shares in the issued share capital of PET Labs (the “Option Shares”) (representing the remaining 49% of the issued share capital of PET Labs).
+Added: We agreed to pay to the Seller an aggregate of $2,000,000 for the Initial Sale Shares, of which aggregate amount $500,000 was paid on the completion of the sale of the Initial Sale Shares and $1,500,000 is payable on demand after one calendar year from the agreement date.
+Added: If we exercise our option to purchase the Option Shares (which option is exercisable from the agreement date until January 31, 2027, provided that the Initial Sale Shares have been paid for in full), we have agreed to pay an additional $2,200,000 for the Option Shares.
+Added: Company-Owned ASP Plants
+Added: In October 2021 and July 2022, we acquired two incomplete ASP plants in Pretoria, South Africa.
+Added: In September 2021, we obtained the required licenses from the nuclear regulators, including the Non-proliferation Council of South Africa, to complete construction of the plants.
+Added: We have commissioned the isotope enrichment plant for the enrichment of C-14, which will be ready for production upon the final installation of essential components.
+Added: We anticipate completion and commissioning of a multi-isotope enrichment plant in Pretoria, South Africa in mid-2024.
+Added: As of December 31, 2023, we employed 47 persons at this facility.
+Added: Supply Contracts
+Added: In July 2023, we entered into a supply agreement with a U.S.
+Added: customer to supply a highly enriched metal.
+Added: This contract has an annual sales value of $9 million, which we expect to realize during 2024.
+Added: In September 2023, we received a prepayment of approximately $900,000 for this contract.
+Added: In July 2023, we entered into a Memorandum of Understanding (MOU) with a U.S.
+Added: Small Modular Reactor company to supply HALEU.
+Added: The MOU focused on formalizing a collaboration to develop a HALEU production facility with financial support from the customer.
+Added: In June 2023, we entered into a multi-year supply agreement with a Canadian Customer for the supply of Carbon-14, which will be produced from our facility that was completed in March 2023.
+Added: The customer will supply carbon-14 in the form of carbon-dioxide gas.
+Added: We will then convert the carbon dioxide gas into methane under a chemical converting contract entered in June 2023.
+Added: We will then enrich the methane to greater than 85% C-14 under a tolling agreement, also entered in June 2023.
+Added: Finally, we will convert the enriched methane back into enriched carbon dioxide under a chemical converting contract.
+Added: The tolling agreement has a minimum “take or pay” amount of approximately $2.5 million per year, supported by a bank letter of guarantee.
+Added: In September 2023, we entered into a Memorandum of Understanding (MOU) with the same customer to separate Deuterium and Tritium currently stored at nuclear sites within Canada.
+Added: The timing and commercial implications of this MOU are subject to future agreement between the parties.
+Added: In November 2022, our wholly owned subsidiary, ASP Isotopes Guernsey Limited (“ASP Guernsey”), entered into an Amended Agreement with Klydon (Proprietary) Ltd (“Klydon”) related to a 25-year supply agreement for up to $27 million per annum of highly enriched Molybdenum-100 entered into by and between Klydon and Beijing BRICEM Science and Technology Co.
+Added: (“Bricem”) in August 2021 (the “August 2021 Purchase Agreement”).
+Added: Under the Amended Agreement, Klydon assigned all of its rights under the August 2021 Purchase Agreement to ASP Guernsey.
+Added: As of December 31, 2023, we managed our operations as a single segment, specialist isotopes and related services.
+Added: Beginning in 2024, primarily as a result of the increased business activities of our subsidiary, Quantum Leap Energy LLC, we will have two operating segments:
+Added: (i) nuclear fuels, and (ii) specialist isotopes and related services:
+Added: Nuclear Fuels.
+Added: This segment is focused on research and development of technologies and methods used to produce high-assay low-enriched uranium (HALEU) and Lithium-6 for the advanced nuclear fuels target end market.
+Added: Specialist Isotopes and Related Services.
+Added: This segment is focused on research and development of technologies and methods used to separate high-value, low-volume isotopes (such as C-14, Mo-100 and Si-28) for highly specialized target end markets other than advanced nuclear fuels, including pharmaceuticals and agrochemicals, nuclear medical imaging and semiconductors, as well as services related to these isotopes, and this segment includes PET Labs.
+Added: Complete development and commissioning of our enrichment facilities in Pretoria, South Africa.
+Added: We intend to complete the development and construction of our second enrichment facility located in Pretoria, South Africa, in mid-2024.
+Added: Our first facility, which will be ready for production upon the final installation of essential components, is designed to enrich light isotopes such as Carbon-14.
+Added: The second facility, which is substantially larger than the first, should have the potential to enrich kilogram quantities of relatively heavier isotopes, including but not limited to Molybdenum-100 and Silicon-28.
+Added: In October 2021, we acquired physical assets, including equipment, of Molybdos (Pty) Limited (Molybdos) located at the plant after having been declared the winner of a competitive auction process under Section 45 of the South Africa Consumer Protection Act, 2008 (the Molybdos Business Rescue Auction).
+Added: We licensed the ASP technology for the production of Mo-100 from Klydon.
+Added: We subsequently entered into a turnkey contract with Klydon, pursuant to which Klydon agreed to provide us with a first commercial-scale isotope enrichment plant.
+Added: The activities to be undertaken or performed by Klydon included taking control of the assets acquired by us in the Molybdos Business Rescue Auction;
the design of an enrichment facility;
4 unchanged sentences
and providing warranties in relation to the performance targets of the plant which are required to be met.
−Removed: Klydon will also be responsible for liaising with the relevant South African authorities including the South African Non-Proliferation Council, the Nuclear Suppliers Group and International Atomic Energy Agency to ensure that the enrichment plant is compliant with international laws and guidelines.
−Removed: In July 2022, we acquired a pilot plant, previously used by Klydon Proprietary Ltd (Klydon) to enrich Silicon-28 up to an abundance of 96.6%.
+Added: Klydon was also responsible for liaising with the relevant South African authorities, including the South African Non-Proliferation Council, the Nuclear Suppliers Group, and International Atomic Energy Agency, to ensure that the enrichment plant complied with international laws and guidelines.
+Added: In July 2022, we acquired a pilot plant previously used by Klydon to enrich Silicon-28 up to an abundance of 96.6%.
This enriched Silicon-28 was then used for experimental work in the solar and electronics industries.
−Removed: We have spent the subsequent six months refurbishing and upgrading the facility so that it can produce commercial quantities of Carbon-14.
−Removed: In September 2022, we entered into a Memorandum of Understanding (MOU) with a North American customer for the entire capacity of this facility, under which we will supply the customer with C-14 enriched to 85%.
−Removed: The timing, quantity and supply date are subject to future agreement between the parties.
−Removed: The MOU states that the customer will supply the feedstock and we will enrich it under a tolling agreement.
+Added: Since then we have been refurbishing and upgrading the facility to produce commercial quantities of Carbon-14.
+Added: In June 2023, we entered into a tolling agreement with a North American customer for the entire capacity of this facility, under which we will supply the customer with C-14 enriched to 85%.
Demonstrate the capability to produce C-14, Mo-100, and Si-28 using the ASP technology and capitalize on the opportunity to solve many supply chain challenges that currently exist.
3 unchanged sentences
Subject to the supply of feedstock from our customer, we intend to start the enrichment of C-14 during 2024.
−Removed: Mo-100 as alternative and potentially more convenient production route for Tc-99m used in nuclear medical diagnostic procedures.
−Removed: Mo-99’s decay product, technetium-99m (Tc-99m), is used in medical procedures to diagnose heart disease and cancer, to study organ structure and function, and to perform other important medical applications.
−Removed: We intend to offer our Mo-100 to customers that may convert Mo-100 into Mo-99 or directly into Tc-99m, and we believe that the use of Mo-100 in this way will be an attractive alternative route to production of Tc-99m for a number of reasons.
−Removed: Only a small number of major reactors located around the world (e.g., Australia, Belgium, the Netherlands and South Africa) produce large-scale amounts of Mo-99, and these reactors are taken off-line periodically for refueling and maintenance and go off-line on an unscheduled basis due to the need for extended repairs, which results in a global Mo-99 supply chain that is lengthy, complex and prone to interruption and has experienced supply shortages.
−Removed: Customers that could use and stockpile Mo-100 would not have to manage the periodic shortages and supply chain challenges related to Mo-99.
+Added: Mo-100 as an alternative and potentially more convenient production route for Tc-99m used in nuclear medical diagnostic procedures.
+Added: Mo-99’s decay product, technetium-99m (Tc-99m), is used in 80-85% of the world’s single-photon emission computed tomography (SPECT) procedures, which is used to diagnose heart disease and cancer, to study organ structure and function, and to perform other critical medical applications.
+Added: We intend to offer our Mo-100 to customers who may convert Mo-100 into Mo-99 or directly into Tc-99m, and we believe that the use of Mo-100 in this way will be an attractive alternative route to the production of Tc-99m for several reasons.
+Added: Only a small number of major reactors located around the world (e.g., Australia, Belgium, the Netherlands, and South Africa) produce large-scale amounts of Mo-99.
+Added: These reactors are taken off-line periodically for refueling and maintenance and go off-line on an unscheduled basis due to the need for extended repairs, which results in a global Mo-99 supply chain that is lengthy, complex, and prone to interruption and has experienced supply shortages.
+Added: Customers that could use and stockpile Mo-100 due to its stable profile when compared to Mo-99 would not have to manage the periodic shortages and supply chain challenges related to Mo-99.
Mo-99 (a radioisotope with a 66-hour half-life) decays and loses activity in transit, so it must be moved through the supply chain quickly to minimize decay losses, and it cannot be stockpiled.
−Removed: Mo-100 (a stable isotope of molybdenum that does not decay) will not decay in transit, so the supply chain would not be dependent on elapsed time from production of Mo-100 to the delivery of a Tc-99m dose to a hospital or clinic.
−Removed: Mo-99 (with decay product Tc-99m) must be shipped in shielded transport containers that comply with the regulatory requirements for safe transport of radioactive material.
+Added: Mo-100 (a stable isotope of molybdenum) will not decay in transit, so the supply chain would not depend on elapsed time from the production of Mo-100 to the delivery of a Tc-99m dose to a hospital or clinic.
+Added: Mo-99 (with decay product Tc-99m) must be shipped in shielded transport containers that comply with the regulatory requirements for the safe transport of radioactive material.
Mo-100 is stable (non-radioactive) and, therefore, does not have the same handling and shipping requirements.
−Removed: Isotopically enriched silicon is regarded as a promising material for semiconductor quantum information due to very long coherence times and its compatibility with the readily available industrial platform.
−Removed: We believe that the ASP technology is ideally suited to the production of this isotope because ASP technology has the ability to enrich molecules of low molecular mass.
+Added: Isotopically enriched silicon is regarded as a promising material for semiconductor quantum information due to its very long coherence times and its compatibility with the readily available industrial platform.
+Added: We believe that the ASP technology is ideally suited to the production of this isotope because it has the ability to enrich molecules of low molecular mass.
Other electronic gasses that can likely be enriched using ASP Technology include disilane and germane.
3 unchanged sentences
The contract has a value of up to $27.0 million per annum.
−Removed: We have had or are currently in active dialogue with many other potential customers that could use the entire anticipated annual capacity of an initial plant.
−Removed: In September 2022, we entered into an MOU for a tolling agreement with a potential Canadian Customer for the entire capacity of our C-14 production facility.
−Removed: We are currently in discussions with potential customers that have interest in entering into long term supply agreements for kilogram quantities of Si-28 and larger quantities of Zn-68 and Cl-37.
−Removed: Demonstrate the capability to produce high-assay low-enriched uranium (HALEU) using the ASP technology and meet anticipated demand for the new generation of HALEU-fueled small modular reactors and advanced reactor designs that are now under development for commercial and government uses.
−Removed: We plan to begin research and development for the enrichment of uranium to demonstrate our capability to produce HALEU using the ASP technology.
+Added: In July 2023, we entered into a supply agreement for a highly enriched metal with a U.S.
+Added: This contract has an annual sales value of $9 million.
+Added: We have had or are currently in active dialogue with many other potential customers who could use the entire anticipated annual capacity of an initial plant.
+Added: In June 2023, we entered into a tolling agreement with a Canadian customer for the entire capacity of our C-14 production facility.
+Added: We are currently in discussions with potential customers that have an interest in entering into long-term supply agreements for kilogram quantities of Si-28 and larger quantities of Xe-129, Ge 72, Ge-74, Zn-68, and Cl-37.
+Added: Demonstrate the capability to produce high-assay low-enriched uranium (HALEU) using Quantum Enrichment and meet anticipated demand for the new generation of HALEU-fueled small modular reactors and advanced reactor designs that are now under development for commercial and government uses.
+Added: We plan to begin research and development for the enrichment of uranium to demonstrate our capability to produce HALEU using Quantum Enrichment technology.
We anticipate a future demand for HALEU for the new generation of HALEU-fueled small modular reactors (SMRs) and advanced reactor designs that are now under development for commercial and government uses.
1 unchanged sentence
Department of Energy, as well as from the governments of other countries.
−Removed: There is currently no commercial production of HALEU in the United States and there has been a reliance on delivery from other countries, particularly Russia.
−Removed: We are currently conducting a feasibility study with respect to constructing an enrichment facility in either the United States or an international location.
−Removed: We would need to obtain approval of the U.S.
−Removed: Nuclear Regulatory Commission to produce HALEU in a U.S.-based facility.
+Added: There is currently no commercial production of HALEU in the United States.
+Added: We are currently conducting a feasibility study with respect to constructing an enrichment facility in either South Africa or the United Kingdom.
+Added: We are currently in discussions with both the UK Atomic Energy Authority, UK Office of Nuclear Regulation (ONR), Nuclear Energy Corporation of South Africa (NECSA) as well as the South African Department of Mineral Resources and Energy (DMRE) pursuing an approval to conduct nuclear research in either of these countries.
+Added: We would need to obtain approval from one of these regulatory bodies in order to proceed with our nuclear research.
+Added: Alongside our talks with regulators, we are currently discussing with multiple counterparties involved in the SMR space to produce HALEU to further their research efforts and, later, their commercial endeavors.
+Added: Initiate the R&D efforts of the Quantum Enrichment Process via the Company’s subsidiary, Enlightened Isotopes, for the enrichment of Ytterbium 176
+Added: We anticipate furthering our commercial development of the Quantum Enrichment process through the development of enriching Ytterbium-176 for the medical oncology market.
+Added: Enriched Ytterbium-176 can be irradiated to produce Lutetium-177, which has been identified for use in oncology, particularly in targeted radionuclide therapy (TRT).
+Added: TRT is used in the treatment of various types of cancers, including neuroendocrine tumors, prostate cancer, and bone metastases, among others.
+Added: There are 11 ongoing clinical trials studying Lutetium-177 PSMA-617 in patients with metastatic castration-resistant prostate cancer.
+Added: We have obtained all necessary licenses within South Africa to proceed with the commercial development of this product.
+Added: We anticipate that this continued R&D and later clinical applicability will help to refine the Quantum Enrichment process for broader commercial applicability in the future.
+Added: Demonstrate the effectiveness and value in the use of Mo-100 and other stable isotopes in the downstream radiopharmacy market, after acquiring 51% ownership interest in PET Labs, the leading radiopharmacy in South Africa.
+Added: This investment will address the radioisotope needs of South Africa as well as certain neighboring countries.
+Added: Under the terms of a Share Purchase Agreement, dated October 30, 2023, we acquired 51% of the issued share capital of Pet Labs Pharmaceuticals Proprietary Limited, a company incorporated in the Republic of South Africa (“PET Labs”).
+Added: PET Labs is a South African radiopharmaceutical operations company, dedicated to nuclear medicine and the science of radiopharmaceutical production.
+Added: As a result of this transaction, we entered into the downstream radiopharmacy market that we intend to service in the future.
+Added: This transaction will help provide the market with adequate proof of concept of the value of utilizing Mo-100 in downstream SPECT imaging procedures while providing supply chain stability to the region of South Africa and neighboring countries.
+Added: We intend to expand PET Labs’ existing operations by adding two new cyclotrons to its service footprint, enabling the company to properly expand its other revenue generation mediums, which is anticipated to drive free cash flow to the company.
Our Strengths
−Removed: ASP technology developed by Klydon.
+Added: ASP technology initially developed by Klydon and further developed by ASPI (S.Africa).
The aerodynamic separation technique has its origins in the South African uranium enrichment program in the 1980s, and the ASP technology has been developed during the last 18 years by the scientists at Klydon.
To date, the scientists at Klydon have constructed two ASP plants for the enrichment of oxygen-18 and silicon-28 in Pretoria, South Africa, which were commissioned in October 2015 and July 2018, respectively.
−Removed: While the technology has not yet been used to enrich either Molybdenum or Uranium or heavier isotopes, we believe the success of the enrichment process for oxygen-18 and silicon-28 has demonstrated the efficacy and commercial scalability of the ASP technology from laboratory to commercial.
−Removed: We have exclusive worldwide licenses from Klydon for the production of all isotopes and, if our research and development is successful (and subject to obtaining applicable regulatory approvals and appropriate licenses), we plan to commercialize many different isotopes produced using the ASP technology.
+Added: While the technology has not yet been used to enrich either Molybdenum or Uranium or heavier isotopes, we believe the success of the enrichment process for oxygen-18 and silicon-28 has demonstrated the efficacy and commercial scalability of the ASP technology.
+Added: If our research and development is successful (and subject to obtaining applicable regulatory approvals and appropriate licenses), we plan to commercialize many different isotopes produced using the ASP technology.
To date, we have completed the construction of one isotope enrichment facility, but we have not yet produced any commercial quantities of isotopes and we have not yet demonstrated the ability to produce any isotope in commercial quantities using ASP technology.
−Removed: High barriers to entry.
−Removed: We have exclusive worldwide licenses to the ASP technology for the production of all isotopes.
+Added: Extensive R&D Experience in Aerodynamic Separation Technology and Processes.
+Added: Subject to successful research and development, our ASP technology has the potential to produce many different types of isotopes.
Klydon has spent the last 18 years and tens of millions of dollars developing the aerodynamic separation technique used in the ASP technology, generating critical trade secrets.
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ASP technology is a flexible platform with the potential to produce many different isotopes that could serve a large addressable markets.
−Removed: ASP technology is a flexible platform, compact in size and weight, and easily scaled to industrial level with number of separation devices added in parallel.
+Added: ASP technology is a flexible platform, compact in size and weight, and could be easily scaled to an industrial level with number of separation devices added in parallel.
The ASP technology also has few moving parts, with low capital and operating costs in comparison to alternatives.
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We believe that, assuming receipt of required regulatory approvals and governmental permits, the ASP technology can be deployed quickly and with a relatively minimal capital cost, to enrich many different isotopes that we believe consumers require both today and in the future in end markets such as healthcare, technology and energy.
−Removed: We also believe that the ASP technology is well-positioned to address a substantial global HALEU market that is contemplating a transition from petroleum-based energy to energy produced in a new generation of HALEU-fuelled SMRs and advanced reactors.
ASP technology is designed to be low cost, low energy, and environmentally friendly.
−Removed: We recently completed the construction of our first isotope enrichment facility using SP technology located in Pretoria, South Africa.
+Added: We recently completed the construction of our first isotope enrichment facility using ASP technology located in Pretoria, South Africa.
The ASP technology is designed to be scalable, low cost, low energy, and environmentally friendly, with no radioactive waste or hazardous materials produced in the process and planned arrangements to reuse chemical by-products.
Experienced team
−Removed: Our board of directors and advisers have specialized expertise in isotopes enrichment, R&D, technology, plant development and manufacturing.
−Removed: Dr Einar Ronander, who serves as Chief Scientific Adviser to our board of directors, and Dr Hendrik Strydom, one of our directors, previously co-founded Klydon.
−Removed: The scientific team at Klydon combined has decades of experience in research and development of isotopes enrichment and amassed deep knowledge in the field.
−Removed: Our board of directors and our management team also has broad experience and successful track records in biopharmaceutical research, chemicals, manufacturing and commercialization, as well as in business, operations, and finance.
−Removed: Our board of directors’ and management team’s experience was gained at leading companies and financial institutions that include, Barclays Capital, Bear Stearns, Deutsche Bank, Highbridge Capital, Investec Bank, Lehman Brothers, LyondellBasell, Morgan Stanley and Soros Fund Management.
+Added: Our board of directors and advisers have specialized expertise in isotope enrichment, R&D, technology, plant development, and manufacturing.
+Added: Einar Ronander, who serves as Chief Scientific Adviser to our board of directors, and Dr Hendrik Strydom, one of our directors, previously co-founded Klydon.
+Added: The scientific team at Klydon combined has decades of experience in research and development of isotope enrichment and amassed deep knowledge in the field.
+Added: Our board of directors and our management team also have broad experience and successful track records in fusion technology and fusion materials, biopharmaceutical research, chemicals, manufacturing and commercialization, as well as in business, operations, and finance.
+Added: Our board of directors’ and management team’s experience was gained at leading companies and financial institutions that include, Bear Stearns, Deutsche Bank, Highbridge Capital, Investec Bank, Morgan Stanley and Soros Fund Management.
Technical Background
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Isotopic Mass
−Removed: Natural abundance
Isotopic Mass
−Removed: Natural abundance
Methods of Separation and Enrichment of Isotopes
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ASP Technology In Use
−Removed: To date, the scientists at Klydon have constructed two ASP plants for the enrichment of oxygen-18 and silicon-28 in Pretoria, South Africa, which were commissioned in October 2015 and July 2018, respectively, and remain fully operational.
+Added: To date, the scientists at Klydon have constructed two ASP plants for the enrichment of oxygen-18 and silicon-28 in Pretoria, South Africa, which were commissioned in October 2015 and July 2018, respectively,.
We believe the success of the enrichment of oxygen-18 and silicon-28 has demonstrated the efficacy and commercial scalability of the ASP technology.
−Removed: We are currently constructing two enrichment plants, which, if successful, will be able to produce C-14, Mo-100 and/or Si-28.
+Added: We are currently constructing two enrichment plants, which, if successful, will be able to produce a range of isotopes, including but not limited to C-14, Mo-100 and Si-28.
Nuclear Medicine
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Mo-100 as an Alternative Intermediate to Produce Mo-99 and Tc-99m
−Removed: Mo-100 is a stable isotope of molybdenum that does not decay.
+Added: Mo-100 is a stable isotope of molybdenum.
Naturally occurring molybdenum contains approximately 9.74% molybdenum-100.
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We believe it is likely that healthcare regulators in other countries will also require clinical data to support the use of Tc-99m that is produced directly from Mo-100.
+Added: ASP Technology for Carbon-14 Enrichment
+Added: C-14 is a radioactive isotope of carbon with a half-life of 5,700 years that has a natural abundance of 1 part per trillion.
+Added: The different isotopes of carbon do not differ appreciably in their chemical properties.
+Added: This resemblance is used in chemical and biological research, in a technique called carbon labelling:
+Added: carbon-14 atoms can be used to replace nonradioactive carbon, in order to trace chemical and biochemical reactions involving carbon atoms from any given organic compound.
+Added: Carbon-14 could be obtained from waste by-products in certain nuclear reactors.
+Added: In June 2023, we entered into a multi-year supply agreement with a Canadian Customer for the supply of Carbon-14, which will be produced from our facility that was completed in March 2023.
+Added: The customer will supply carbon-14 in the form of carbon-dioxide gas.
+Added: We will then convert the carbon dioxide gas into methane under a chemical converting contract entered in June 2023.
+Added: We will then enrich the methane to greater than 85% C-14 under a tolling agreement, also entered in June 2023.
+Added: Finally, we will convert the enriched methane back into enriched carbon dioxide under a chemical converting contract.
+Added: The tolling agreement has a minimum “take or pay” amount of approximately $2.5 million per year, supported by a bank letter of guarantee.
+Added: In September 2023, we entered into a Memorandum of Understanding (MOU) with the same customer to separate Deuterium and Tritium currently stored at nuclear sites within Canada.
+Added: The timing and commercial implications of this MOU are subject to future agreement between the parties.
ASP Technology for Silicon-28 Enrichment
−Removed: Si-28 is a stable isotope of silicon that does not decay.
+Added: Si-28 is a stable isotope of silicon.
Isotopically enriched Si-28 is regarded as an ideal host material for semiconducting quantum computing due to the lack of Si-29 nuclear spins.
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Quantum computers are expected to be thousands or millions of times more powerful than the most advanced of today’s conventional computers, opening new frontiers and opportunities in many industries, including medicine, artificial intelligence, cybersecurity, global logistics and global financial systems.
−Removed: Many countries around the world are investing heavily in the development of quantum computing technology, with governments and key corporates (such as Intel, IBM, Google, Microsoft and others) vying for leadership in this emerging strategic industry.
−Removed: ASP Technology for Carbon-14 Enrichment
−Removed: C-14 is a radioactive isotope of carbon with a half life of 5,700 years that has a natural abundance of 1 part per trillion.
−Removed: The different isotopes of carbon do not differ appreciably in their chemical properties.
−Removed: This resemblance is used in chemical and biological research, in a technique called carbon labelling:
−Removed: carbon-14 atoms can be used to replace nonradioactive carbon, in order to trace chemical and biochemical reactions involving carbon atoms from any given organic compound.
−Removed: Carbon-14 is produced as a waste product in certain nuclear reactors.
−Removed: In September 2022, we entered into an MOU with a potential Canadian Customer that provides consulting services to many nuclear reactors in North America.
−Removed: Under the terms of the MOU, it is anticipated that the customer will supply C-14 already enriched to at least 0.5%, which it sources from the waste products of nuclear reactors.
−Removed: We will enrich the C-14 to an abundance of over 85% under a “take or pay” agreement.
−Removed: The customer will be responsible for all non-enrichment activities and all marketing and sales of all finished product.
−Removed: ASP Technology for Uranium Enrichment
−Removed: We believe our ASP technology is also capable of enriching Uranium, which we may be able to commercialize as a nuclear fuel component for use in the new generation of HALEU-fuelled small modular reactors that are now under development for commercial and government uses.
+Added: Quantum Enrichment Technology for Uranium Enrichment
+Added: We believe our Quantum Enrichment technology is capable of enriching Uranium, which we may be able to commercialize as a nuclear fuel component for use in the new generation of HALEU-fueled small modular reactors that are now under development for commercial and government uses.
Uranium is a naturally occurring element and is mined from deposits located in Kazakhstan, Canada, Australia, and several other countries including the United States.
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Uranium enrichment is the process by which the concentration of U-235 is increased (see discussion on HALEU demand below).
−Removed: Separative work units (“SWU”) are a standard unit of measurement that represents the effort required to transform a given amount of natural uranium into two components:
+Added: Separative work units(“SWU”) is a standard unit of measurement that represents the effort required to transform a given amount of natural uranium into two components:
enriched uranium having a higher percentage of U-235 and depleted uranium having a lower percentage of U-235.
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Currently, it is fairly common practice to purchase both the SWU and uranium components of LEU from the enrichment company.
−Removed: Therefore, LEU prices typically consist of two prices or components:
−Removed: SWU and uranium.
+Added: Therefore, LEU prices typically consist of three components:
+Added: SWU, Conversion and uranium ore concentrate.
The following outlines the steps for converting natural uranium into LEU fuel, commonly known as the nuclear fuel cycle:
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In a letter to the DOE captioned “Updated Need for High-Assay Low Enriched Uranium” dated December 20, 2021, the NEI provided an estimate of what U.S.
−Removed: HALEU demand may be during the next 15 years:
+Added: HALEU demand may be during the next 15 years by companies denoted A to J:
Estimated Annual Requirements for High Assay Low Enriched Uranium to 2035 (MTU/yr)
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The data above does not include utilities that are considering enrichment between 5% and 10%.
−Removed: ASP Technology is ideally suited to the production of HALEU
+Added: Quantum Enrichment Technology is ideally suited to the production of HALEU
We believe that we are in a very different position to many of the entrenched domestic and international enrichers.
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cheaper in Capex, faster in construction, more flexible in design and location.
−Removed: We estimate that the capital cost of constructing an ASP plant for uranium enrichment is approximately 75% cheaper than that of a traditional gas centrifuge enrichment facility.
+Added: We estimate that the capital cost of constructing Quantum Enrichment plant for uranium enrichment is approximately 75% cheaper than that of a traditional gas centrifuge enrichment facility.
Our manufacturing plants are modular, so our construction time is likely faster and more flexible than competing technologies.
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Our operating costs of enriching uranium to 15.5% - 19.75% U-235 should be comparable to or cheaper than costs for other methods of uranium enrichment.
−Removed: The table below compares the ASP process with a traditional gas centrifuge when applied to a 20 mT plant.
+Added: The table below represents management’s estimated comparison of the Quantum Enrichment process with a traditional gas centrifuge.
+Added: Quantum Enrichment Plant
Gas Centrifuge
Separation mechanism
−Removed: Stationary Wall Centrifuge
+Added: Enhanced resonant multiphoton ionization
Differential diffusion
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for enrichment from 0.71% U235 to 5% U235
−Removed: We are currently conducting a feasibility study with respect to constructing an enrichment facility in either the United States or an international location.
−Removed: Construction of a new ASP enrichment facility in US would be done in three phases.
−Removed: The first phase would involve the construction and validation of an ASP test bench, the engineering design of the first segment and obtaining required permits and licenses from regulators.
−Removed: Excluding the licensing process, we expect this phase would take approximately 9-12 months.
−Removed: The second phase would involve the construction of the first segment and control systems for the plant and the engineering design of the additional stages.
−Removed: We expect this stage would take approximately 9-12 months, resulting in the plant capable of operating in a close-loop setup which would demonstrate enrichment and start to produce small quantities of enriched Uranium.
−Removed: The third phase would involve the construction of the remaining segments that will complete the plant and the commissioning phase.
−Removed: We expect this phase would take approximately 20-30 months and the production volume would gradually ramp up to the final capacity of 20 metric tons per year.
−Removed: Importantly, subject to licensure, we can produce commercial quantities of HALEU by 2026 that would satisfy the anticipated demand from all the advanced reactor currently in development.
−Removed: We can supply HALEU at a price lower than the HALEU currently imported from international enrichers and considerably lower than any potential domestic supply that may evolve.
−Removed: Much of the control systems, compressors and hardware used in a uranium enrichment plant would be similar to parts used to construct our Molybdenum plant in Pretoria.
−Removed: Our molybdenum plant uses molybdenum hexafluoride (MoF6) and a Uranium pant would use uranium hexafluoride (UF6).
+Added: We are currently constructing a Ytterbium-176 enrichment facility using the Quantum Enrichment technology in Pretoria, South Africa.
+Added: We received a manufacturing permit for this facility from the South African Department of Mineral Resources and Energy (DMRE) during 3Q 2023.
+Added: The construction of this plant will provide us with valuable experience in the construction of Quantum Enrichment facilities in the future.
+Added: Many of the control systems, compressors, lasers and hardware used in a uranium enrichment facility would be similar to parts used in this ytterbium-176 enrichment facility.
+Added: We expect the construction of a Uranium Enrichment facility would take approximately 30 months and the production volume would gradually ramp up to the final capacity of 20 metric tons per year.
+Added: Importantly, subject to licensure, we believe we can produce commercial quantities of HALEU by 2027 that would satisfy the anticipated demand from all the advanced reactor currently in development.
+Added: We believe that we can supply HALEU at a price lower than the HALEU currently imported from international enrichers and considerably lower than any potential domestic supply that may evolve.
Intellectual Property
−Removed: Our business will depend on the proprietary ASP technology that we licensed from Klydon.
−Removed: To date, we and Klydon have relied exclusively on trade secrets and other intellectual property laws, non-disclosure agreements with our respective employees, consultants, vendors, potential customers and other relevant persons and other measures to protect our intellectual property, and intend to continue to rely on these and other means.
+Added: Our business will depend on the proprietary ASP technology that was developed by and originally licensed to us from Klydon.
+Added: To date, we have relied exclusively on trade secrets and other intellectual property laws, non-disclosure agreements with our respective employees, consultants, vendors, potential customers and other relevant persons and other measures to protect our intellectual property, and intend to continue to rely on these and other means.
As we intend to transition into the commercialization of isotopes, we envision our intellectual property and its security becoming more vital to our future.
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Such assessments are made in consultation with regulatory bodies and with due consideration to the prospects of successfully obtaining patent protection in light of any disclosure constraints that are imposed by such bodies.
−Removed: On October 25, 2022, our outside counsel received a letter (the “NMS Letter”) from a law firm acting on behalf of Norsk Medisinsk Syklotronsenter AS (“NMS”), asserting, among other things, that the grant of a license to the ASP technology for the separation of isotopes of Molybdenum that have medical applications to ASP Isotopes Inc.
−Removed: by Klydon violates a pre-existing exclusive sub-license to the ASP technology granted to Radfarma, as more fully described below.
−Removed: NMS and ASP Isotopes had previously been briefly in discussions regarding a potential future collaboration on technology and product development.
−Removed: However, these preliminary discussions have not been active for several months, after death of a lead NMS scientist and ASPI decision to explore other options.
−Removed: The NMS Letter makes reference to:
−Removed: (1) a license agreement entered into on October 25, 2013 by Klydon and API Labs Pharmaceuticals (Proprietary) Limited (“API Labs”) to license the ASP technology for enriching certain isotopes of the element Molybdenum (“2013 API Labs License”);
−Removed: and (2) an exclusive sub-license to the ASP technology granted on October 1, 2019 to Radfarma, as licensee, by API Labs and SaPhotonica Limited (“SaPhotonica”), as licensors (the “2019 Radfarma Sub-License”).
−Removed: The NMS Letter states that Radfarma is a joint venture that is 45% owned by NMS and 45% owned by SaPhotonica.
−Removed: The NMS Letter asserts, among other things, that the grant of a license to the ASP technology to ASP Isotopes Inc.
−Removed: by Klydon violates a covenant in the 2019 Radfarma Sub-License that the licensors shall not be entitled, directly or indirectly, to use, grant or otherwise give the rights, or any similar rights, which were granted to Radfarma under the 2019 Radfarma Sub-License to any other person for use in the territory.
−Removed: The sub-license granted to Radfarma in the 2019 Radfarma Sub-License related to the use of intellectual property rights related to the ASP technology for the separation of isotopes of Molybdenum that have medical applications.
−Removed: “Territory” is defined in the 2019 Radfarma Sub-License as “the Kingdom of Norway for the construction of the 20-kilogram capacity plants;
−Removed: and means the international market where distribution agreements can be produced .” The NMS Letter asserts that while Klydon purported to give to ASP Isotopes Inc.
−Removed: a license to market the ASP technology globally, these rights were already granted to Radfarma.
−Removed: The NMS Letter includes a request for ASP Isotopes Inc.
−Removed: to enter into discussions for an agreement with NMS based on terms proposed in previous correspondence from NMS.
−Removed: The previous correspondence from NMS included the following key prerequisites to a possible cooperation between NMS and ASP Isotopes Inc.:(1) NMS will be granted the right to set up an enrichment facility for a Mo-100 in Norway;
−Removed: (2) NMS will be granted the exclusive rights to sales, marketing, and distribution in Europe, while ASPI gets similar rights for the rest of the world;
−Removed: and (3) NMS will support the development of the Mo-100 target production and Mo-99 generator production and if required the sales operations of ASPI.
−Removed: The NMS Letter does not include a threat of litigation against ASP Isotopes Inc.
−Removed: or any parties to the 2013 API Labs License or 2019 Radfarma Sub-License.
−Removed: However, if the licensed rights granted to us are found to be invalid or unenforceable (in whole or in part), or if our exclusive license agreement with Klydon is terminated or Klydon, as licensor, fails to abide by the terms of our exclusive license agreement, our ability to commercialize our future isotopes would suffer and our business, results of operations and financial condition may be adversely affected.
−Removed: If the prior sub-license granted to Radfarma is found to be valid, we would be required to cease using the ASP technology for the separation of isotopes of Molybdenum that have medical applications (unless we were able to obtain a license from Radfarma), and we would focus our business operations on the enrichment of isotopes other than Molybdenum.For example, instead of continuing to pursue the production of Molybdenum-100, we could focus on the production and commercialization of zinc, silicon and/or chlorine using the ASP technology.
−Removed: We expect that our Mo-100 plant in South Africa would need to be redesigned and retrofitted in order to produce other isotopes, which would take approximately six months and cost approximately $1.0 million.
−Removed: See “Risk Factors — Risks Related to Our Intellectual Property” — “We have received a letter asserting that the license for the ASP technology granted to us from Klydon, which is critical to our business, may be invalid because these rights were already granted to a third party, Radfarma” and “Our license for the ASP technology with Klydon may be found to infringe third party intellectual property rights.”
−Removed: Based on information currently available, and after consultation with legal counsel in South Africa, management believes that our exclusive license for the enrichment of Molybdenum-100 and all other isotopes from Klydon are valid and the company will vigorously defend its rights.
Regulatory Environment
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Many of our computer systems are not connected to the external internet and confidential information is secured at a controlled location.
−Removed: Currently, the production, distribution or sale of Mo-100 is not regulated by a healthcare regulator such as the Food and Drug Administration (FDA) in the USA, Health Canada in Canada, the European Medicines Agency in Europe and similar regulators in other countries.
−Removed: However, products that are produced from Mo-100 (such as Mo-99 and Tc-99m in a linear accelerator or cyclotron) are regulated by healthcare regulators and our customers are required to operate under the licensure of these healthcare regulators.
+Added: Currently, the production, distribution or sale of Mo-100 or Zn-68 is not regulated by a healthcare regulator such as the Food and Drug Administration (FDA) in the USA, Health Canada in Canada, the European Medicines Agency in Europe and similar regulators in other countries.
+Added: However, products that are produced from Mo-100 or Zn-68 (such as Mo-99 and Tc-99m in a linear accelerator or cyclotron and Ga-67 in a cyclotron) are regulated by healthcare regulators and our customers are required to operate under the licensure of these healthcare regulators.
Currently, the production and use of Tc-99m from Mo-100 in a cyclotron is only approved in one country (Canada).
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In the United States, each of the regulatory agencies administering these laws and regulations has a voluntary disclosure program that offers the possibility of significantly reduced penalties, if any are applicable, and we intend to use these programs as part of our overall compliance program, as necessary.
−Removed: As of December 31, 2022, we employed four full-time employees.
−Removed: As of March 23, 2023, we employ approximately 31 people on a full-time basis, 27 of whom work at our newly completed plant in South Africa.
−Removed: Of the total employees, 7 are in Research and Development, 15 are in construction and manufacturing and 5 are in general management.
+Added: As of December 31, 2023, we employed 76 people on a full-time basis.
+Added: Of the total employees, 6 employees are in research and development, 33 employees are in engineering, construction and manufacturing, 20 employees are in plant operations and 17 employees are in general management.
None of our employees are subject to collective bargaining agreements.
We consider our relationship with our employees to be good.
−Removed: We lease our research and development facility in Pretoria, South Africa under a lease with a term expiring on December 31, 2030.
+Added: We lease five facilities in Pretoria, South Africa for production, research and development and offices.
+Added: One lease is under automatic monthly extensions, another lease which expired on March 31, 2024 is now under automatic monthly extensions and the other three leases have terms that expire between March 30, 2026 and December 31, 2030.
We believe that our existing facilities are adequate to meet our current needs.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.