ASP Isotopes Inc
For the period ended Sep 30, 2024. Filed Nov 19, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 19, 2024
ASPI$2.08+20.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-19.
0001477932-24-005128
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-19.
0000950170-24-128551
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 122 previous paragraphs and 155 current paragraphs.
71 unchanged; 43 reworded; 39 added; 8 removed; 0 previous and 2 current paragraphs rearranged.
Tables are not compared: 11 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (39)
Current report
Our Subsidiaries
Current report
We operate principally through our subsidiaries. ASP Isotopes Guernsey Limited (the holding company for subsidiaries in the Cayman Islands, South Africa, Iceland and the United Kingdom) is 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). ASP Isotopes UK Ltd is the owner of our technology.
Current report
In September 2023, we formed Quantum Leap Energy LLC, or “QLE,” which also has subsidiaries in the United Kingdom (Quantum Leap Energy Limited) and South Africa (Quantum Leap Energy (Pty) Limited), to focus on the development and commercialization of advanced nuclear fuels such as HALEU and Lithium-6.
Current report
In addition, in the fourth quarter of 2023, we entered into a strategic relationship with Pet Labs Pharmaceuticals (Pty) Limited (PET Labs) by acquiring a 51% ownership stake in PET Labs. We anticipate this transaction will allow us to enter the downstream medical isotope production and distribution market. Beginning in 2024, primarily as a result of the increased business activities of QLE, we have two operating segments: (i) nuclear fuels, and (ii) specialist isotopes and related services.
Current report
Although no assurance can be given, we plan to spin-out QLE as a separate public company and list the shares of QLE on a U.S. national exchange and distribute a portion of QLE’s common equity to ASPI’s stockholders as of a to-be-determined future record date, in each case subject to obtaining applicable approvals and consents and complying with applicable rules and regulations and public market trading and listing requirements. The regulatory landscape and supply chain for nuclear fuel production differs significantly from that of medical isotopes, hence we and QLE have different business models and we believe that both companies would benefit if QLE is independently managed and financed.
Current report
In connection with the anticipated spin-out, in February 2024, we entered into a number of agreements with QLE, including a License Agreement, pursuant to which QLE has licensed from us 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 perpetual royalty in the amount of 10% of all future QLE revenues, and an EPC Services Framework Agreement, pursuant to which we will 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 commissioning, start-up and test services for each such facility, subject to the receipt of all applicable regulatory approvals, permits, licenses, authorizations, registrations, certificates, consents, orders, variances and similar rights. In addition, in February 2024, we assigned to QLE certain existing memoranda of understanding with U.S.-based small modular reactor companies for the use of Quantum Enrichment for the production of High-Assay Low Enriched Uranium (HALEU). The MOUs provide for substantial financial support for the development of HALEU production facilities that should be capable of supplying metric ton quantities of HALEU by 2027.
Current report
High-Assay Low-Enriched Uranium (HALEU) Production
Current report
In October 2024, we entered into a term sheet with TerraPower, LLC related to the construction of a uranium enrichment facility capable of producing HALEU and the future supply of HALEU to TerraPower. The term sheet contemplates the parties entering into a definitive agreement, pursuant to which TerraPower would provide funding for the construction of a HALEU production facility. In addition, the parties anticipate entering into a long-term supply agreement for HALEU expected to be produced at this facility, pursuant to which the customer would purchase all HALEU produced at the facility over a 10-year period after the expected completion of the facility in 2027. It is anticipated that the definitive agreements will be assigned to QLE. Except for binding periods of exclusivity, during which we will not negotiate with third parties for the supply of HALEU or work on another ASP technology-based uranium enrichment facility, the term sheet is non-binding and there is no assurance that the parties will enter into definitive agreements.
Current report
In November 2024, we entered into a memorandum of understanding (“MOU”) with The South African Nuclear Energy Corporation (Necsa) to collaborate on the research, development and ultimately the commercial production of advanced nuclear fuels. Necsa is a state-owned company established by the Republic of South Africa Nuclear Energy Act in 1999 with a mandate to undertake and promote research and development in the field of nuclear energy and radiation sciences. Necsa is also responsible for processing source material, and co-operating with other institutions on nuclear and related matters. The proposed structure under discussion for the delivery of the objectives of the MOU contemplates the formation of a new entity in South Africa with a board of directors consisting of at least two representatives from the Company and Necsa. Discussions between the parties during the last three years have focused on advancing new nuclear fuel to cater especially for small modular reactors as a start and eventually the construction of a nuclear fuel facility for the production of HALEU. It is anticipated that the research, development and ultimate construction of a HALEU production facility will take place at Pelindaba in Pretoria, South Africa. Pelindaba is South Africa’s main nuclear research center and is the home of the 20MW research nuclear reactor, SAFARI-1, which over the last several years has become one of the world’s largest suppliers of Molybdenum-99 and other radioisotopes.
Current report
Financings
Current report
In October 2024, a warrant to purchase 151,741 shares of common stock was exercised and the Company received gross proceeds of $299,688.
Current report
In November 2024, the Company issued an additional 2,754,250 shares of common stock in a public offering at a public offering price of $6.75 per share for aggregate gross proceeds totaling approximately $18,600,000. The estimated issuance costs, including commissions and expenses, are expected to be approximately $1,455,000.
Current report
costs related to designing the development processes of isotope production.
Current report
facilities and other various expenses.
Current report
the scope, rate of progress, expense and results of our development activities;
Current report
the phase of development of our future isotopes;
Current report
the timing, receipt, and terms of any approvals from applicable regulatory authorities including the FDA and foreign regulatory authorities;
Current report
significant and changing government regulation and regulatory guidance;
Current report
the cost and timing of designing the development processes of isotope production;
Current report
the extent to which we establish additional strategic collaborations or other arrangements; and
Current report
the impact of any business interruptions to our operations or to those of the third parties with whom we work.
Current report
Research and development expenses were $1,034,446 for the three months ended September 30, 2024. These expenses include $368,515 of personnel-related costs, including $82,619 in stock-based compensation expense, $316,157 in consulting and professional costs and $349,774 in facility and other expenses.
Current report
Selling, general and administrative expenses were $4,693,158 for the three months ended September 30, 2024. These expenses include $2,985,744 of personnel-related costs, including $1,985,471 in stock-based compensation expense, $1,063,595 of professional services and legal related fees and $643,819 in facility and other corporate expenses.
Current report
Selling, general and administrative expenses were $3,707,311 for the three months ended September 30, 2023. These expenses include $2,484,637 of personnel-related costs, including $1,978,904 in stock-based compensation expense, $669,118 of professional services and legal related fees and $553,556 in facility and other corporate expenses.
Current report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Current report
Research and development expenses were $1,722,882 for the nine months ended September 30, 2024. These expenses include $673,140 of personnel-related costs, including $247,403 in stock-based compensation expense, $490,647 in consulting and professional, and $559,095 in facility and other expenses.
Current report
Research and development expenses were $699,413 for the nine months ended September 30, 2023. These expenses include $369,136 of personnel-related costs, including $278,686 in stock-based compensation expense, $150,000 in consulting expenses and $180,277 in facility and other expenses.
Current report
Selling, general and administrative expenses were $17,976,882 for the nine months ended September 30, 2024. These expenses include $9,048,993 of personnel-related costs, including $6,052,357 in stock-based compensation expense, $4,720,772 of professional services and legal related fees and $4,207,117 in facility and other corporate expenses.
Current report
Selling, general and administrative expenses were $11,319,465 for the nine months ended September 30, 2023. These expenses include $7,720,997 of personnel-related costs, including $6,311,890 in stock-based compensation expense, $2,165,926 of professional services and legal related fees and $1,432,542 in facility and other corporate expenses.
Current report
the type, number, scope, progress, expansions, results, costs and timing of, our development activities for our future isotopes;
Current report
the outcome, timing and costs of regulatory review of our future isotopes;
Current report
the costs and timing of manufacturing for our future isotopes;
Current report
our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal controls over financial reporting;
Current report
the costs associated with hiring additional personnel and consultants as our preclinical and clinical activities increase;
Current report
the costs and timing of establishing or securing sales and marketing and distribution capabilities, whether alone or with third parties, to commercialize future isotopes for which we may obtain regulatory approval, if any;
Current report
our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products;
Current report
the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements;
Current report
the costs of obtaining, expanding, maintaining and enforcing our patent and other intellectual property rights; and
Current report
costs associated with any products or technologies that we may in-license or acquire.
Removed paragraphs (8)
Previous report
Research and development expenses were $473,302 for the three months ended June 30, 2024. These expenses include $149,020 of personnel-related costs, including $81,721 in stock-based compensation, $174,490 in consulting and professional costs, $88,344 in facility expenses and $61,448 in other expenses.
Previous report
Selling, general and administrative expenses were $7,405,178 for the three months ended June 30, 2024. These expenses include $1,176,113 of personnel-related costs, $2,436,295 in stock-based compensation, $1,484,255 of professional services and legal related fees and $2,308,515 in facility and other corporate expenses.
Previous report
Selling, general and administrative expenses were $4,094,664 for the three months ended June 30, 2023. These expenses include $2,895,595 of personnel-related costs, $2,281,277 in stock-based compensation, $743,389 of professional services and legal related fees and $455,680 in facility and other corporate expenses.
Previous report
Comparison of the Six Months Ended June 30, 2024 and 2023
Previous report
Research and development expenses were $688,436 for the six months ended June 30, 2024. These expenses include $304,625 of personnel-related costs, including $164,784 in stock-based compensation, $174,490 in consulting and professional, and $209,321 in facility and other expenses.
Previous report
Research and development expenses were $460,214 for the six months ended June 30, 2023. These expenses include $255,800 of personnel-related costs, including $185,800 in stock-based compensation, and $204,414 in consulting, facility and other expenses.
Previous report
Selling, general and administrative expenses were $13,283,724 for the six months ended June 30, 2024. These expenses include $1,996,363 of personnel-related costs, $4,066,886 in stock-based compensation, $3,657,175 of professional services and legal related fees and $3,563,300 in facility and other corporate expenses.
Previous report
Selling, general and administrative expenses were $7,612,154 for the six months ended June 30, 2023. These expenses include $903,374 of personnel-related costs, $4,332,985 in stock-based compensation, $1,496,808 of professional services and legal related fees and $878,987 in facility and other corporate expenses.
Reworded paragraphs (43)
Previous wording
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. 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”). 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, and we expect to start commercial supply of C-14 during the second half of 2024. We anticipate completion and commissioning of a multi-isotope enrichment plant in Pretoria, South Africa during the second half 2024, and we expect to start initial commercial supply of Si-28 during the second half 2024. In addition, we have started planning additional isotope enrichment plants. We believe the C-14 we may produce using the ASP technology could be used in the development of new pharmaceuticals and agrochemicals. 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. We believe the Si-28 we may produce using the ASP technology may be used to create advanced semiconductors and in quantum computing. 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.
Current wording
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. 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”). We have completed an isotope enrichment plant for the enrichment of C-14 located in Pretoria, South Africa and we expect to start commercial supply of C-14 in the first quarter of 2025 assuming timely delivery of the feedstock from the Company’s customer. We anticipate completion and commissioning of a multi-isotope enrichment plant in Pretoria, South Africa in the fourth quarter of 2024, and we expect to start initial commercial supply of Si-28 in early 2025. In addition, we have started planning additional isotope enrichment plants. We believe the C-14 we may produce using the ASP technology could be used in the development of new pharmaceuticals and agrochemicals. 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. We believe the Si-28 we may produce using the ASP technology may be used to create advanced semiconductors and in quantum computing. 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.
Previous wording
We are also developing Quantum Enrichment technology to produce enriched Ytterbium-176, Nickel-64, Lithium 6, Lithium7 and Uranium-235 (“U-235”). Quantum enrichment is an advanced isotope enrichment technique that is currently in development that uses lasers. 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 HALEU- fueled small modular reactors that are now under development for commercial and government uses. Our first quantum enrichment facility is expected to complete construction and commissioning during the fourth quarter 2024 with first commercial production of Yb-176 also expected during the fourth quarter 2024.
Current wording
We are also developing Quantum Enrichment technology to produce enriched Ytterbium-176 (“Yb-176”), Nickel-64, Lithium 6, Lithium7 and Uranium-235 (“U-235”). Quantum enrichment is an advanced isotope enrichment technique that is currently in development that uses lasers. 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 HALEU- fueled small modular reactors that are now under development for commercial and government uses. The construction of our first quantum enrichment facility was completed in August 2024, and we produced the first semi-finished material of enriched Yb-176 during the commissioning phase of the plant in October 2024. We expect to be able to achieve a 99.75% enrichment for Yb-176 and offer highly enriched Yb-176 for commercial sale during 2025. We also expect to proceed with the plans to construct Nickel-64 and Lithium- 6/7 quantum enrichment plants with targeted production during 2025.
Previous wording
In October 2023, the Company entered into Securities Purchase Agreements with certain institutional and other accredited investors and certain directors of the Company to issue and sell an aggregate of 9,952,510 shares of the Company’s common stock, for aggregate cash consideration of $9,129,461, as follows: (i) 8,459,093 shares to investors at a purchase price per share of $0.9105, (ii) 1,190,239 shares to investors at a purchase price per share of $0.9548, and (iii) 303,178 shares to directors at a purchase price per share of $0.96. The Company incurred issuance costs equivalent to 5% of the gross proceeds from new investors which was settled in stock through the issuance of 472,582 shares to the placement agent and additional cash issuance costs totaling $57,083.
Current wording
In October 2023, we entered into Securities Purchase Agreements with certain institutional and other accredited investors and certain directors of ours to issue and sell an aggregate of 9,952,510 shares of our common stock, for aggregate cash consideration of $9,129,495, as follows: (i) 8,459,093 shares to investors at a purchase price per share of $0.9105, (ii) 1,190,239 shares to investors at a purchase price per share of $0.9548, and (iii) 303,178 shares to directors at a purchase price per share of $0.96. We incurred issuance costs equivalent to 5% of the gross proceeds from new investors which was settled in stock through the issuance of 472,582 shares to the placement agent and additional cash issuance costs totaling $57,083.
Previous wording
In March 2024, the Company’s wholly owned subsidiary Quantum Leap Energy received gross proceeds of $20,550,000 through the issuance of Convertible Promissory Notes with a stated interest rate of 6% for the first year and 8% thereafter. The maturity date of the Convertible Promissory Notes is March 7, 2029. The Convertible Promissory Notes automatically convert into common shares upon Quantum Leap Energy’s closing of an IPO or other qualifying public transaction at 80% of the share price taking into consideration a valuation cap.
Current wording
In March 2024, our wholly owned subsidiary Quantum Leap Energy received gross proceeds of $20,550,000 through the issuance of Convertible Promissory Notes with a stated interest rate of 6% for the first year and 8% thereafter. The maturity date of the Convertible Promissory Notes is March 7, 2029. The Convertible Promissory Notes automatically convert into common shares upon Quantum Leap Energy’s closing of an IPO or other qualifying public transaction at 80% of the share price taking into consideration a valuation cap.
Previous wording
In April 2024, the Company received approximately $5.5 million from the issuance of 3,164,557 shares of common stock upon the exercise of warrants.
Current wording
In April 2024, we received approximately $5.5 million from the issuance of 3,164,557 shares of common stock upon the exercise of warrants.
Previous wording
In July 2024, the Company issued 13,800,000 in a public offering at a public offering price of $2.50 per share resulting in net proceeds of approximately $32.3 million after deducting underwriting discounts, commissions and offering expenses.
Current wording
In July 2024, we issued 13,800,000 in a public offering at a public offering price of $2.50 per share resulting in net proceeds of approximately $32.3 million after deducting underwriting discounts, commissions and offering expenses.
Previous wording
Acquisition of 51% of PET Labs Pharmaceuticals
Current wording
Acquisition of 51% of PET Labs
Previous wording
In October 2023, the Company entered into a Share Purchase Agreement with Nucleonics Imaging Proprietary Limited, a company incorporated in South Africa, to purchase 51% of the ordinary shares in Nucleonics’ wholly-owned subsidiary, Pet Labs Pharmaceuticals Proprietary Limited, a company incorporated in South Africa and dedicated to nuclear medicine and the science of radiopharmaceutical production.
Current wording
In October 2023, we entered into a Share Purchase Agreement with Nucleonics Imaging Proprietary Limited, a company incorporated in South Africa, to purchase 51% of the ordinary shares in Nucleonics’ wholly-owned subsidiary, Pet Labs Pharmaceuticals Proprietary Limited ("Pet Labs"), a company incorporated in South Africa and dedicated to nuclear medicine and the science of radiopharmaceutical production.
Previous wording
Per the Share Purchase Agreement, the Company has agreed to pay a total of $2,000,000 for the shares in two installments. The first installment of $500,000 was paid in November 2023. In January 2024, the Company paid $264,750 towards the balance due. The remaining balance of $1,235,250 is due upon demand any time after October 31, 2024 and is expected to be paid in November 2024.
Current wording
Per the Share Purchase Agreement, we have agreed to pay a total of $2,000,000 for the shares in two installments. The first installment of $500,000 was paid in November 2023. In January 2024, we paid $264,750 towards the balance due. The remaining balance of $1,235,250 is due upon demand any time after October 31, 2024 and is expected to be paid in November 2024.
Previous wording
***Omnibus Klydon License.***On July 26, 2022, ASP Isotopes UK Ltd, as licensee, entered into a license agreement with Klydon, as licensor, pursuant to which ASP Isotopes UK Ltd acquired from Klydon an exclusive license to use, develop, modify, improve, subcontract and sublicense certain intellectual property rights relating to the ASP technology for the production, distribution, marketing and sale of all isotopes produced using the ASP technology (the “Klydon license agreement”). The intellectual property rights granted to us through the Klydon license agreement included all existing and/or future proprietary rights of Klydon relating to the ASP technology, whether or not such rights have been registered, including the copyright, designs, know-how, patents and trademarks (although Klydon currently has no such patents, patent applications or copyrights). The Klydon license agreement was royalty-free, had a term of 999 years and was worldwide for the development of the ASP technology and the distribution, marketing and sale of isotopes. Future production of isotopes is limited to member countries of the Nuclear Suppliers Group. In connection with the Klydon license agreement, we agreed to make an upfront payment of $100,000 (to be included within the payments we made under the Turnkey Contract (described below) and deferred payments of $300,000 over 24 months. Effective April 4, 2023, pursuant to the Acknowledgement of Debt Agreement described below, we acquired the ASP technology, among other things, from Klydon, and the Klydon license agreement is no longer in effect.
Current wording
Omnibus Klydon License. On July 26, 2022, ASP Isotopes UK Ltd ("ASP UK"), as licensee, entered into a license agreement with Klydon, as licensor, pursuant to which ASP UK acquired from Klydon an exclusive license to use, develop, modify, improve, subcontract and sublicense certain intellectual property rights relating to the ASP technology for the production, distribution, marketing and sale of all isotopes produced using the ASP technology (the “Klydon license agreement”). The intellectual property rights granted to us through the Klydon license agreement included all existing and/or future proprietary rights of Klydon relating to the ASP technology, whether or not such rights have been registered, including the copyright, designs, know-how, patents and trademarks (although Klydon currently has no such patents, patent applications or copyrights). The Klydon license agreement was royalty-free, had a term of 999 years and was worldwide for the development of the ASP technology and the distribution, marketing and sale of isotopes. Future production of isotopes is limited to member countries of the Nuclear Suppliers Group. In connection with the Klydon license agreement, we agreed to make an upfront payment of $100,000 (to be included within the payments we made under the Turnkey Contract (described below) and deferred payments of $300,000 over 24 months. Effective April 4, 2023, pursuant to the Acknowledgement of Debt Agreement described below, we acquired the ASP technology, among other things, from Klydon, and the Klydon license agreement is no longer in effect.
Previous wording
On April 4, 2023, the Company perfected its interests in the assets under the Acknowledgement of Debt Agreement, pursuant to which the Company acquired the Pledged Assets, including certain intellectual property, from Klydon and settled all amounts due to Klydon, including the ZAR 6,000,000 for the acquisition of the Silicon-28 plant assets.
Current wording
On April 4, 2023, we perfected our interests in the assets under the Acknowledgement of Debt Agreement, pursuant to which we acquired the Pledged Assets, including certain intellectual property, from Klydon and settled all amounts due to Klydon, including the ZAR 6,000,000 for the acquisition of the Silicon-28 plant assets.
Previous wording
Lease for additional production space. On April 1, 2023, ASP South Africa entered into an agreement of lease with the landlord of facility located in Pretoria where we plan to perform production activities. The initial term of the lease was set to end on March 31, 2024. The Company entered into a new agreement of lease with the landlord. The terms of the new lease ends on February 28, 2026.
Current wording
Lease for additional production space. On April 1, 2023, ASP South Africa entered into an agreement of lease with the landlord of facility located in Pretoria where we plan to perform production activities. The initial term of the lease was set to end on March 31, 2024. We entered into a new agreement of lease with the landlord. The terms of the new lease ends on February 28, 2026.
Previous wording
Lease for PET Labs Pharmaceutical operations. Commencing with our acquisition of PET Labs Pharmaceuticals in October 2023, this facility has an initial term set to expire in March 2026 with automatic monthly extensions thereafter. This space is used for office and production activities.
Current wording
Lease for PET Labs operations. Commencing with our acquisition of PET Labs in October 2023, this facility has an initial term set to expire in March 2026 with automatic monthly extensions thereafter. This space is used for office and production activities.
Previous wording
Lease for additional PET Labs Pharmaceutical operations. Commencing with our acquisition of PET Labs Pharmaceuticals in October 2023, this facility had an initial term which expired in December 2023 and is currently under automatic monthly extensions. This space is used for production activities.
Current wording
Lease for additional PET Labs operations. Commencing with our acquisition of PET Labs in October 2023, this facility had an initial term which expired in December 2023 and is currently under automatic monthly extensions. This space is used for production activities.
Previous wording
Effective with the acquisition of 51% of PET Labs Pharmaceuticals, the Company recognizes revenue from the sale of nuclear medical doses for PET scanning.
Current wording
Effective with the acquisition of 51% of PET Labs, the Company recognizes revenue from the sale of nuclear medical doses for PET scanning.
Previous wording
Selling, general and administrative expenses consist primarily of personnel-related costs, which include salaries, payroll taxes, employee benefits, and other employee-related costs, including stock-based compensation, for personnel in executive, sales, finance and other administrative functions. Other significant costs include legal fees relating to corporate matters, professional fees for accounting and consulting services and facility-related costs.
Current wording
Selling, general and administrative expenses consist primarily of personnel-related costs, which include salaries, payroll taxes, employee benefits, and other employee-related costs, including stock-based compensation expense, for personnel in executive, sales, finance and other administrative functions. Other significant costs include legal fees relating to corporate matters, professional fees for accounting and consulting services and facility-related costs.
Previous wording
The specialist isotopes and related services 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 Pharmaceuticals.
Current wording
The specialist isotopes and related services 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.
Previous wording
The financial information is regularly reviewed by the chief operating decision maker (“CODM”) in deciding how to allocate resources. The Company’s CODM is its chief executive officer.
Current wording
The financial information is regularly reviewed by the chief operating decision maker (“CODM”) in deciding how to allocate resources. Our CODM is our chief executive officer.
Previous wording
The Company manages assets on a total company basis, not by operating segment, as the assets are shared or commingled. Therefore, the chief operating decision maker does not regularly review any asset information by operating segment and, accordingly, asset information is not reported on a segment basis.
Current wording
We manage assets on a total company basis, not by operating segment, as the assets are shared or commingled. Therefore, the chief operating decision maker does not regularly review any asset information by operating segment and, accordingly, asset information is not reported on a segment basis.
Previous wording
Select income statement information as of the three months ended June 30, 2024 and 2023 is as follows:
Current wording
Select information from the consolidated statements of operations and comprehensive loss as of the three months ended September 30, 2024 and 2023 is as follows:
Previous wording
Select income statement information as of the six months ended June 30, 2024 and 2023 is as follows:
Current wording
Select information from the consolidated statements of operations and comprehensive loss as of the nine months ended September 30, 2024 and 2023 is as follows:
Previous wording
Effective with the acquisition of 51% of PET Labs Pharmaceuticals, the Company has recognized revenue from the sale of nuclear medical doses for PET scanning for the two month period since the acquisition was effective on October 31, 2023 and December 31, 2023 and the three and six months ended June 30, 2024. In addition, the Company has recognized the related cost of goods sold, operating expenses and other income and expenses of PET Labs Pharmaceuticals for the same periods. No revenue or cost of goods sold was recognized for the three months ended June 30, 2023.
Current wording
Effective with the acquisition of 51% of PET Labs, we have recognized revenue from the sale of nuclear medical doses for PET scanning for the two month period since the acquisition was effective on October 31, 2023 and December 31, 2023 and the three and nine months ended September 30, 2024. In addition, we have recognized the related cost of goods sold, operating expenses and other income and expenses of PET Labs for the same periods. No revenue or cost of goods sold was recognized for the three months ended September 30, 2023.
Previous wording
Research and development expenses were $252,880 for the three months ended June 30, 2023. These expenses include $133,409 of personnel-related costs, including $93,409 in stock-based compensation, and $50,000 in consulting and professional costs, and $69,471 in facility expenses.
Current wording
Research and development expenses were $239,199 for the three months ended September 30, 2023. These expenses include $113,336 of personnel-related costs, including $92,886 in stock-based compensation expense, and $50,000 in consulting and professional costs, and $75,863 in facility and other expenses.
Previous wording
The increase in personnel-related costs is due to an increase in headcount and salaries. The increase in stock-based compensation is due to the timing of the vesting of awards. The increase in professional services and legal related fees is primarily attributable to the timing of corporate activity. The increase in facility and other corporate expenses is primarily attributable to the expansion of our operations in 2024 and commission and fee expenses related to the issuance of convertible notes payable.
Current wording
The increase in personnel-related costs is due to an increase in headcount and salaries. The increase in professional services and legal related fees is primarily attributable to the timing of corporate activity. The increase in facility and other corporate expenses is primarily attributable to the expansion of our operations in 2024.
Previous wording
Other expense for the three months ended June 30, 2024 was $1,410,217, which includes a $164,000 change in the fair value of the share liability related to the shares issuable to a consultant and a $1,574,816 change in fair value of the convertible notes payable issued in March and June 2024.
Current wording
Other expense for the three months ended September 30, 2024 was $1,930,136, which includes a loss of $2,692,073 due to change in fair value of the convertible notes payable issued in March and June 2024, partially offset by interest income of $602,181.and a gain of $381,969 due to change in fair value of share liability.
Previous wording
Other income for the three months ended June 30, 2023 was $61,198, which includes a $60,100 change in the fair value of the share liability related to the shares issuable to a placement agent and other consultants.
Current wording
Other expense for the three months ended September 30, 2023 was $275,973, which includes a $279,425 change in the fair value of the share liability related to the shares issuable to a placement agent and other consultants.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023:
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023:
Previous wording
Effective with the acquisition of 51% of PET Labs Pharmaceuticals, the Company has recognized revenue from the sale of nuclear medical doses for PET scanning for the two month period since the acquisition was effective on October 31, 2023 and December 31, 2023 and the three and six months ended June 30, 2024. In addition, the Company has recognized the related cost of goods sold, operating expenses and other income and expenses of PET Labs Pharmaceuticals for the same periods. No revenue or cost of goods sold was recognized for the six months ended June 30, 2023.
Current wording
Effective with the acquisition of 51% of PET Labs, we have recognized revenue from the sale of nuclear medical doses for PET scanning for the two month period since the acquisition was effective on October 31, 2023 and December 31, 2023 and the three and nine months ended September 30, 2024. In addition, we have recognized the related cost of goods sold, operating expenses and other income and expenses of PET Labs for the same periods. No revenue or cost of goods sold was recognized for the nine months ended September 30, 2023.
Previous wording
The following table summarizes our research and development expenses for the six months ended June 30, 2024 and 2023:
Current wording
The following table summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023:
Previous wording
The increase in personnel-related costs is due to an increase in headcount and salaries. The increase in stock-based compensation is due to the timing of the vesting of awards. The increase in professional services and legal related fees is mainly due to the timing of corporate activity. The increase in facility and other corporate expenses is mainly due to the expansion of our operations in 2024 and commission and fee expenses related to the issuance of convertible notes payable.
Current wording
The increase in personnel-related costs is due to an increase in headcount and salaries. The increase in professional services and legal related fees is mainly due to the timing of corporate activity. The increase in facility and other corporate expenses is mainly due to the expansion of our operations in 2024 and commission and fee expenses related to the issuance of convertible notes payable.
Previous wording
Other expense for the six months ended June 30, 2024 was $2,607,870, which includes a $54,000 change in the fair value of the share liability related to the shares issuable to a consultant and a $2,528,526 change in fair value of the convertible notes payable issued in March and June 2024.
Current wording
Other expense for the nine months ended September 30, 2024 was $4,538,006, which includes a loss of $5,220,599 due to change in fair value of the convertible notes payable issued in March and June 2024, partially offset by $657,899 of interest income and a gain of $327,969 due to change in fair value of share liability.
Previous wording
Other income for the six months ended June 30, 2023 was $170,944, which includes a $170,385 change in the fair value of the share liability related to the shares issuable to a placement agent and other consultants.
Current wording
Other expense for the nine months ended September 30, 2023 was $105,029, which includes a $109,040 change in the fair value of the share liability related to the shares issuable to a placement agent and other consultants.
Previous wording
We have incurred net losses and negative cash flows from operations since our inception, and we expect to continue to incur significant and increasing net losses for the foreseeable future. We have principally financed our operations to date through the issuance of our common stock, including our IPO, subsequent common stock offerings and the issuance of convertible notes payable. In July 2024, the Company issued 13,800,000 in a public offering at a public offering price of $2.50 per share resulting in net proceeds of approximately $32.3 million after deducting underwriting discounts, commissions and offering expenses.
Current wording
We have incurred net losses and negative cash flows from operations since our inception, and we expect to continue to incur significant and increasing net losses for the foreseeable future. We have principally financed our operations to date through the issuance of our common stock, including our IPO, subsequent common stock offerings and the issuance of convertible notes payable. In July 2024, we issued 13,800,000 in a public offering at a public offering price of $2.50 per share resulting in net proceeds of approximately $32.3 million after deducting underwriting discounts, commissions and offering expenses. In November 2024, we issued an additional 2,754,250 shares of common stock in a public offering at a public offering price of $6.75 per share resulting in net proceeds of approximately $17.1 million after deducting underwriting discounts, commissions and offering expenses.
Previous wording
As of June 30, 2024, we had cash and cash equivalents of $28.3 million. We have not generated any revenue from the sale of our enriched isotopes, and our ability to generate product revenue from the sale of enriched isotopes sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our current or future enriched isotopes.
Current wording
As of September 30, 2024, we had cash and cash equivalents of $51,571,540. We have not generated any revenue from the sale of our enriched isotopes, and our ability to generate product revenue from the sale of enriched isotopes sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our current or future enriched isotopes.
Previous wording
Based on our current operating plan, we estimate that our existing cash and cash equivalents, along with gross proceeds of $34.5 million received in July 2024 from the issuance of common stock, will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months from the date the financial statements are issued. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of developing isotopes is costly, and the timing of progress and expenses in these development activities is uncertain.
Current wording
Based on our current operating plan, we estimate that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months from the date the financial statements are issued. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of developing isotopes is costly, and the timing of progress and expenses in these development activities is uncertain.
Previous wording
Developing isotopes is a time-consuming, expensive and uncertain process that takes years to complete, and we may never achieve the necessary results required or obtain applicable regulatory approval for any isotopes or generate revenue from the sale of any future isotopes (assuming applicable regulatory approval is received). In addition, our future isotopes (assuming applicable regulatory approval is received) may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of isotopes that we do not expect to be commercially available in substantial quantities until at least the second half of 2024. If we receive permits and licenses to enrich U-235 (which in itself is highly uncertain), we do not expect U-235 to be commercially available for at least several years, if ever. As a result, we may need substantial additional financing to support our continuing operations and further the development of and commercialization of our future isotopes.
Current wording
Developing isotopes is a time-consuming, expensive and uncertain process that takes years to complete, and we may never achieve the necessary results required or obtain applicable regulatory approval for any isotopes or generate revenue from the sale of any future isotopes (assuming applicable regulatory approval is received). In addition, our future isotopes (assuming applicable regulatory approval is received) may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of isotopes that we expect to be commercially available in substantial quantities in the last quarter of 2024. If we receive permits and licenses to enrich U-235 (which in itself is highly uncertain), we do not expect U-235 to be commercially available for at least several years, if ever. As a result, we may need substantial additional financing to support our continuing operations and further the development of and commercialization of our future isotopes.
Previous wording
Net cash used in operating activities was $8,095,256 for the six months ended June 30, 2024 and was primarily due to our net loss of $15,846,286, adjusted for stock-based compensation expense of $4,231,670, non-cash issuance costs for the convertible notes payable of $621,915, amortization of right-of-use asset of $217,997, issuance of common stock to a consultant with a fair value of $619,200, change in fair values of $2,582,526, change in deferred tax liabilities of $39,068 and a $734,590 change in our operating assets and liabilities.
Current wording
Net cash used in operating activities was $12,935,554 for the nine months ended September 30, 2024 and was primarily due to our net loss of $23,201,675, adjusted for stock-based compensation expense of $6,299,760, non-cash issuance costs for the convertible notes payable of $621,915, amortization of right-of-use asset of $343,473, depreciation expense of $425,630, issuance of common stock to a consultant with a fair value of $783,200, change in fair values for the convertible notes payable of $5,220,599 and a $3,071,004 change in our operating assets and liabilities.
Previous wording
Net cash used in operating activities was $2,701,890 for the six months ended June 30, 2023, and was primarily due to our net loss of $7,901,424, adjusted for stock-based compensation expense of $4,518,785, expense related to the issuance of common stock to consultants of $496,300 and amortization of right-of-use asset of $32,553, partially offset by a change in fair value of share liability of $170,385 and partially offset by a $294,165 change in our operating assets and liabilities.
Current wording
Net cash used in operating activities was $3,355,171 for the nine months ended September 30, 2023, and was primarily due to our net loss of $12,123,907, adjusted for stock-based compensation expense of $6,590,576, expense related to the issuance of common stock to consultants of $669,700, a change in fair value of share liability of $109,040 and amortization of right-of-use asset of $49,173, partially offset by a $1,349,278 change in our operating assets and liabilities.
Previous wording
Net cash used in investing activities was $3,867,903 for the six months ended June 30, 2024 and was comprised of the purchase of machinery and equipment, vehicles and construction in progress.
Current wording
Net cash used in investing activities was $8,352,422 for the nine months ended September 30, 2024 and was comprised of the purchases of machinery and equipment, vehicles and construction in progress.
Previous wording
Net cash used in investing activities was $508,607 for the six months ended June 30, 2023 and was comprised of additional construction in progress.
Current wording
Net cash used in investing activities was $1,190,157 for the nine months ended September 30, 2023 and was comprised of additional construction in progress.
Showing the first 40 of 43 pairs. Open the source sections for the rest.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
external research and development expenses; and
Current report — wording carried from elsewhere
personnel-related costs, which include salaries, payroll taxes, employee benefits, and other employee-related costs, including stock-based compensation expense, for personnel engaged in research and development functions; and