OTC: INIS

Theranostics Products

This segment includes the production and distribution of various isotopically pure radiopharmaceuticals, APIs, and radiochemicals for medical, industrial, and research applications. These products are produced by us from radioisotopes supplied by our vendors. We produce and distribute various products in customized volumes, concentrations, chemical formulations, packages, and specifications tailored to meet our FDA specifications or customer and market demands. To our knowledge, our FDA approved generic sodium iodide I-131 drug product is the only generic product of this type manufactured in the U.S. and offers customers an attractive domestic alternative to the single existing foreign commercial drug manufacturer. Additionally, this segment distributes APIs, and radiochemicals from third party suppliers for pre-clinical, industrial, and research applications. According to BCC Research, the theranostics market was valued at $4.3 billion in 2024 and is expected to grow to $12.7 billion by 2029, reflecting a 24% compound annual growth rate.

Cobalt Products

Our Cobalt Products segment includes the production of various cobalt-60 products and services, including the fabrication of cobalt-60 sealed sources for radiation therapy, various industrial and medical applications, and recycling of expended cobalt-60 sources.

We have explored, and intend to continue to explore, opportunities to further develop cobalt-60 and other high-energy and high-activity products and sales on an ongoing basis. The production, use, transport, and import/export of these products are all heavily regulated by the NRC and DOT, state and local agencies as well as similar regulatory authorities in territories outside of the United States (i.e., EU, China, Australia, Brazil and Argentina), but we have developed a highly experienced staff of technicians, shipping specialists, and supervisors in order to comply with the regulations and to deliver these products in a cost-effective, timely manner.

We believe that our domestically manufactured products and service offerings provide us with a competitive edge over other cobalt-60 manufacturers.

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Calibration & Reference Products (Previously Called Nuclear Medicine Standards)

The Calibration & Reference Products segment consists of various sealed source calibration and reference products, including our own manufactured products, jointly manufactured products, and third-party products. These products are sold through our RadQual subsidiary for use with SPECT and PET imaging equipment, patient positioning, radiopharmacy and radiopharmaceutical Contract Development and Manufacturing Organization (“CDMO”) lab equipment, pre-clinical imaging equipment, clinical trial or custom geometry applications, and calibration or operational testing of measuring and/or testing equipment. Our Calibration & Reference Products include flood sources, dose calibrator sources, cylinder phantoms, annulus phantoms, rod sources, line sources, flexible and rigid rulers, spot markers, pen point markers, and a host of specialty design items. Our pre-clinical products include distribution of fillable sources from Phantech and pre-clinical sealed sources via our PhanQual joint venture with Phantech. Our Calibration and Reference sources include RadQual products for lab equipment; we also distribute non-medical sealed source calibration and reference standards manufactured by ORANO LEA, with whom we have a bilateral relationship. Our Calibration & Reference Products segment also commercializes bulk isotope sales and shielding and accessories related to our sealed source products. In 2025 we completed construction of a dedicated facility for our Calibration & Reference Products at our 1359 Commerce Way leased facility. We plan to continue to invest in that facility in 2026 to complete the fit-out and receive an NRC operational license. We expect the dedicated facility to greatly expand our manufacturing capacity, allow us to expand our product portfolio, as well as improve product quality.

According to the International Atomic Energy Agency’s Medical imAGIng and Nuclear mEdicine global resources database (IMAGINE), as of September 2025, at least 131 countries have SPECT and/or PET imaging cameras, with more than 29,000 installed units in total. These installed cameras use calibration and reference sources on a regular repeat basis, with many of them requiring calibration as part of on-going certification. Most Calibration and Reference Product sales are to U.S. customers. However, in recent years, because of stronger marketing efforts, we have seen an increase in foreign sales. All these products contain radioactive isotopes that decay at a predictable rate. Therefore, customers are required to periodically replace most of these products when they reach the end of their useful lives. The useful life of these products varies depending on the isotope used in manufacture, but in most cases averages eighteen months to two years. The various isotopes used in manufacturing these Calibration & Reference Products are from several sources world-wide, and we are continually working to develop multiple sources of each isotope. In addition to the products themselves, we have developed a line of specialty packaging for the safe transportation and handling of these products.

Medical Devices

We started the Medical Devices segment in 2024 and many of our products in this segment remain under development. In 2022 we entered a joint venture to develop the EasyFill Automated Capsule System, a robotic lab device to be paired with our Theranostics Products. The EasyFill Automated Capsule System (or “EasyFill”) is still in the developmental stage. We are targeting a Q3 2026 roll out and Q2 2027 commercial ramp up, including additional sales of I-131.

In 2023, we entered into an asset purchase agreement with AMICI, Inc. to purchase manufacturing molds, device registrations, trademarks, and all production rights to several AMICI, Inc. medical device and accessory products for lung ventilation; this included the Swirler Radioaerosol System and Tru-Fit mouthpiece products. In January 2025, as part of an amendment to the AMICI, Inc. asset purchase agreement, we received the manufacturing molds, device registrations, trademarks, and all production rights to the AMICI, Inc. line of Xenon System products. These acquired assets from AMICI, Inc. are currently under development and are expected to be released in 2026 to be sold through our RadVent subsidiary. In 2024, our Medical Device segment entered into a distribution and servicing agreement with Scintomics ATT for their complete line of radiosynthesis modules; to date, all of our revenue in the Medical Devices segment comes from the sale of third party products.

Fluorine Products and the Planned Uranium De-Conversion Facility

We established the fluorine products business segment in 2004 to support production and sale of various fluoride gases produced using our Fluorine Extraction Process ("FEP"). FEP was intended to be completed in conjunction with the operation of a proposed depleted uranium ("DUF6") de-conversion facility in Lea County, New Mexico. DUF6 is the waste by-product of uranium enrichment, and any uranium enrichment facility will create very large quantities of DUF6. In October 2012, we received a construction and operating license from the U.S. Nuclear Regulatory Commission ("NRC") for the planned facility. Changes in the nuclear industry near the end of 2013, however, significantly reduced commercial demand for this type of facility. Therefore, we suspended all further development work on the project, but we have maintained all licenses and permits for the project.

On March 11, 2026, we executed a mutual termination of an asset purchase agreement ("DUF6 APA") dated February 8, 2024 to sell all our assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility to American Fuel Resources ("AFR"), which was expected to close in the first quarter of 2026. AFR contacted the Company requesting a 1-year extension due to AFR being unable to make payment of the balance of the purchase price by March 31, 2026 (the “Outside Date”) in order to meet the Condition to Seller’s Obligations as defined in the DUF6 APA. The parties were in the final stages of the NRC consent process and were on the cusp of receiving NRC consent to transfer; however, the parties mutually agreed to withdraw the application and terminate the APA.

AFR already made a non-refundable $50,000 prepayment and twelve non-refundable NRC extension fee payments totaling $120,000 and was to pay an additional $12,450,000 at closing. We decided it was in the best interest of the shareholders to regain control of the assets as we believe they have appreciated in value since we entered the DUF6 APA and we had low confidence that AFR would be able to secure funding to close the deal by the requested extension date. We will evaluate all possible options for the DUF6 Plant and related assets.

Given the recent boom in nuclear energy and fuel cycle industry and related global investments, the Company will evaluate all possible options for the DUF6 Plant and related assets, including keeping the assets and developing them into an operating entity focused on uranium deconversion. The company will also explore the potential to amend the current NRC approved license to include additional up-stream and down-stream uranium related activities.

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Industry Overview, Target Markets, and Competition

The radioisotope market encompasses the production, distribution, and application of radioactive isotopes for medical, industrial, and research purposes. Such radioisotopes include iodine-131, technetium-99m, cobalt-60, and lutetium-177, which are used in nuclear medicine diagnostics, targeted therapies, cancer treatment, and imaging procedures such as PET and SPECT scans. In addition to medical uses, radioisotopes serve industrial applications including sterilization, material testing, and scientific research.

Demand in the radioisotope market is driven by growth in nuclear medicine, expansion of radiopharmaceutical therapies, increasing clinical and research applications, and the continued need for industrial isotopes. Overall, the radioisotope market represents a specialized segment of healthcare, research, and industrial supply chains, providing essential materials that enable both emerging therapies and established diagnostic procedures.

Theranostics and radiopharmaceuticals are downstream applications of the radioisotope market. Radiopharmaceuticals are medicinal formulations that contain radioisotopes and are used for both diagnostic imaging and targeted therapy. Theranostics, an approach that combines therapeutics and diagnostics, applies these agents to enable personalized medicine by pairing a diagnostic radiopharmaceutical that identifies the presence of a molecular target with a therapeutic radiopharmaceutical that delivers a cytotoxic dose of radiation to diseased tissue. Global demand for radiopharmaceuticals is influenced by the rising prevalence of cancer and cardiovascular disease, ongoing advances in molecular imaging, and the adoption of precision oncology approaches, and is expected to grow. According to BCC Research, the global theranostics market was valued at $4.3 billion in 2024 and is forecast to grow at a compound annual growth rate of 24%, to reach an estimated $12.7 billion by 2029.

Within this industry context, our operations span multiple market segments that leverage radioactive materials across healthcare, research, and industrial applications. Our business provides radiopharmaceuticals, medical devices, high-energy isotopes, and calibration and reference standards, addressing the specialized demands of end-users such as radiopharmacies, clinical research organizations, and industrial operators. These segments are shaped by high barriers to entry, technical expertise requirements, and supply chain considerations, positioning our operations within the broader framework of established and emerging markets for radioactive materials.

Our competitors include companies such (i) as Jubilant DraxImage, where we compete on I-131 radiopharmaceutical products, (ii) Eckert & Ziegler, where we compete on our entire portfolio of Calibration & Reference Products, and (iii) in some limited markets, we compete with Epsilon Radioactive Sources’s limited portfolio of products. Our cobalt-60 Products competes with Nordion. Our Medical Device segment will compete with Jubilant and Eckert & Ziegler. Various government entities also manufacture competing products. Such entities include NTP (South Africa), which manufactures finished I-131 for the African markets; BRIT (India), which manufactures I-131 for local use; CIRC (China), which manufactures I-131 for the mainland Chinese markets; and Rosatom (Russia), which makes I-131 for Russian hospitals and clinics and a limited number of calibration and reference source products for the local market.

Theranostics Products

In February 2020, our abbreviated new drug application (“ANDA”) for a generic radiopharmaceutical sodium iodide I-131 drug product was approved by the FDA. This product is approved for use in treatment of hyperthyroidism and carcinoma of the thyroid and is the only generic sodium iodide I-131 product approved by the FDA that is manufactured in the U.S. We believe we currently are the only U.S. supplier of an FDA approved sodium iodide product that otherwise is only available from a foreign manufacturer.

We sell our generic sodium iodide I-131 to radiopharmacy customers, who manufacture patient-specific capsules and make direct sales in the U.S. to clinicians. We directly ship our generic sodium iodide I-131 to all 50 states and we also periodically supply a GMP equivalent to some overseas locations.

Since the launch of this drug product in 2020, the corresponding sales have had a significant positive impact on our revenues. This growth in sales has continued in 2025 and we expect growth to continue as we grow our market share in the U.S., expand into new territories, and develop strategic joint-ventures in countries where it is not economical to serve from our existing manufacturing site.

We also supply Theranostics Products in API and radiochemical form. The markets for most radiochemicals are highly competitive. The target markets for these products are customers who (1) incorporate them into finished industrial or medical devices; (2) use radioisotope products in clinical trials for various medical applications with the aim to further process and include the radioisotope products into pharmaceutical products approved by the U.S. FDA for labeled use in therapy or imaging, or (3) include our radioisotope products into their pharmaceutical products approved outside the U.S. for encapsulated and/or labeled use in therapy or imaging. We can ship to all 50 states and internationally. We are deploying a unique product strategy which we believe will make us the go-to API supplier for third party radiopharmaceutical products.

We believe that we are well positioned to hold a competitive advantage in the growing theranostics space because of our unique combination of high energy and high activity NRC licensing status that permits handling of high energy and high activity radioisotopes, our compliance with GMP, our FDA licensed operating facility, and experienced and skilled personnel.

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Cobalt Products

Cobalt-60 products are used in various applications where high-energy isotopes are required, such as radiation therapy, gamma sterilization, security devices, radiography examination and industrial applications.

Stringent regulatory, facility safety, and operator qualification requirements associated with the manufacturer and distribution of sealed cobalt-60 sources present significant entry barriers for new market participants. To our knowledge, there are no other domestic suppliers of cobalt-60 products in the US and there is one major foreign supplier in the North American market. We are actively working to add robustness to our supply chain, exploring the availability of cobalt-60 material from foreign suppliers.

Calibration & Reference Products

We manufacture and distribute sealed sources and devices for various applications, including medical, laboratory, pre-clinical, industrial, and research. Many of our products are registered with the NRC and FDA where required, as well as their equivalent regulatory authorities in international jurisdictions. We ship these products directly to all 50 states and many overseas locations. We are certified under ISO-9001:2015 and ISO-13485-2016 quality programs which allow us to sell our products into several foreign countries where these quality certifications are required for manufacturers.

We have varying target markets and distribution tactics and channels, depending on the type of products we are selling. We predominately sell our medical products through distributors who make direct sales in the U.S. and internationally to end-users. Medical calibration and reference standards are used for daily or periodic operational checks and calibration of nuclear medicine devices, such as SPECT and PET cameras and lab equipment, which are routinely used in nuclear medicine clinics and radiopharmacies around the world. As part of licensing and certification requirements in the U.S. and other high-regulatory jurisdictions, calibration and quality assurance testing for equipment accuracy is required to be part of routine operations of this equipment. Over 140 countries have availability of SPECT and/or PET cameras, with more than 33,000 installed units in total. We believe that there are more than 400 radiopharmacy and CDMO sites which use lab equipment that relies on calibration and reference standards. We also commercialize our PhanQual pre-clinical products in partnership with PhanTech; these products are targeted directly to end-users. Our non-medical industrial products are sold direct to end-users or to OEMs who bundle the sealed sources with their equipment. In the U.S., the core target market for industrial sources and calibration standards are utilities, mining operations, the U.S. Department of Energy, and environmental laboratories.

To our knowledge there are a few small regional suppliers internationally and only one major producer of a similar catalog of products in the world that competes directly with us for this broad portfolio of products. Most of the products manufactured by our major competitor are similar in design to our products as these products must meet Original Equipment Manufacturer (“OEM”) dimensional and performance standards. We attempt to differentiate our products through strategic alignment with OEMs, high levels of service, competitive pricing, patent protections, and exclusive arrangements with OEMs.

We continue working to expand the number and types of products that are manufactured in this segment and expand our qualified suppliers for the raw material used for our products. We plan to eventually manufacture some of our medical products in China through our joint-venture, Radnostix China. In 2025 we completed construction of a dedicated facility for our Calibration & Reference Products at our 1359 Commerce Way leased facility. We plan to continue to invest in that facility in 2026 to complete the fit-out and receive an NRC operational license. We expect the dedicated facility to greatly expand our manufacturing capacity, allow us to expand our product portfolio, as well as improve product quality.

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Medical Devices

Our Medical Device segment will consist of our own medical devices and the distribution and servicing of third-party products. We intend to leverage our existing network of distributors for Theranostics Products and Calibration & Reference Products to purchase, use, and distribute our catalog of Medical Device products. We are actively working to launch three products in this segment: EasyFill, RadVent, and third-party products.

We intend to complete development of our EasyFill Automated Capsule System and then subsequently market it to radiopharmacy partners both in the US and around the world. There are over 400 radiopharmacy locations globally, of which approximately 20% of them prepare sodium iodide I-131 capsules in house. Currently, most of these radiopharmacies lease a shielded encapsulation device from a single foreign supplier that is also the only other supplier of sodium iodide I-131 into the U.S. We believe a launch of EasyFill will allow us to improve our market share of sodium iodide I-131. We expect to complete development of the EasyFill Automated Capsule system in the first half of 2026. We are targeting a roll out in the third quarter of 2026 and a commercial ramp up in the second quarter of 2027 of both the EasyFill Automated Capsule System and our generic sodium iodide I-131.

Our RadVent products were purchased from AMICI, Inc and are used with various lung imaging studies in conjunction with other approved radiopharmaceuticals, such as technetium-99m-DTPA and xenon-133. We generally sell RadVent products to the same end-users through the same distributors we use for our Theranostics Products and Calibration & Reference Products. The AMICI, Inc. products are well-established in the market however, AMICI, Inc. faltered during the COVID pandemic when lung imaging was curtailed. After amending our agreement with AMICI, Inc. in January 2025, we are establishing new manufacturing channels and expect to relaunch the first products from the RadVent portfolio before the end of the second quarter of 2026.

Our Medical Devices segment also plans to commercialize various nuclear medicine focused devices which target the same core user base as our own devices and could leverage our existing personnel skills, facilities, logistics, and service engineering capabilities. In 2024 we entered an exclusive agreement for U.S. and Canada to distribute, service, and supply consumables for Scintomics ATT’s entire lineup of radiosynthesis equipment.

Fluorine Products and the Planned Depleted Uranium De-Conversion Facility

Our Fluorine Products segment was developed in conjunction with uranium de-conversion to take advantage of the anticipated need for depleted uranium de-conversion services. During 2013, we curtailed all further work on the de-conversion facility because of a lack of demand for uranium de-conversion services at that time. We have continued to maintain the assets and licenses related to our previously planned de-conversion facility. On March 11, 2026, we executed a mutual termination of our DUF6 APA dated February 8, 2024 to sell all our assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility to AFR. We will evaluate all possible options for the DUF6 Plant and related assets.

Given the recent boom in nuclear energy and fuel cycle industry and related global investments, the Company will evaluate all possible options for the DUF6 Plant and related assets, including keeping the assets and developing them into an operating entity focused on uranium deconversion. The company will also explore the potential to amend the current NRC approved license to include additional up-stream and down-stream uranium related activities.

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Government Regulation

Nuclear Regulatory Commission Oversight

We currently operate under two NRC licenses, one for broad scope operations and another for exempt distribution. Our broad scope license covers calibration and reference standard manufacturing and distribution, radioisotope processing and distribution, large scale cobalt-60 processing and recycle operations, radioactive gemstone processing, environmental sample analysis, certain field service activities, and research and development. The exempt distribution license permits the release and distribution of irradiated gemstones to unlicensed entities in the U.S. All of our existing licenses and permits are adequate to allow current business operations. We do not handle “special nuclear materials” (i.e. nuclear fuels and weapons grade uranium, thorium or plutonium); therefore, our facility is not designated as a “nuclear” facility that would require additional licensing.

As a condition of our NRC licenses in Idaho, we are required to provide financial assurance for decommissioning activities. We fulfill this license requirement with a surety bond which names the NRC as beneficiary and is supported by a restricted cash account held in trust by a third party.

In October 2012, we were granted a 40-year construction and operating license by the NRC for our planned depleted uranium de-conversion and fluorine extraction processing facility (the “de-conversion facility”). The de-conversion facility was planned to be located in Lea County, New Mexico. Further engineering work on the proposed deconversion facility was placed on hold in 2013 due to changes in market conditions. There is no specific timeline required by the NRC for the start of construction on this project. Most of the pre-construction design, licensing and state permitting has already been completed for the project. These licenses for the de-conversion facility are expected to be included in any proposed sale of the DUF6 assets.

Regulation of Radioisotope Production Waste

Our manufacturing processes generate some radioactive waste. We handle this waste pursuant to the Low-Level Radioactive Waste (“LLRW”) Policy Act (“LLRW Act”), which requires the safe disposal of mildly radioactive materials. The estimated costs for storage and disposal of these materials have been included in the manufacturing and sales price of our products. Actual disposal costs are subject to change at the discretion of the disposal sites. We have obtained all necessary permits and approvals for the disposal of our waste materials, and we do not anticipate any negative changes in capacity or regulatory conditions that would limit or restrict our waste disposal capabilities.

Other Regulations

We are registered as a medical device manufacturer through the FDA for several of our Calibration & Reference Products segment’s and Medical Devices segment’s products. We are registered with the U.S. Department of Transportation (DOT) for the shipment of radioactive materials. We also have an NRC license for the import and export of radioactive materials. Because of increasing security controls and regulations, it is likely that we may encounter additional regulations affecting transportation, storage, sale, and import/export of radioactive materials.

We are also subject to inspection by the FDA to manufacture our sodium iodide I-131 product in compliance with our ANDA for sodium iodide I-131 and all applicable cGMP requirements for this and other contract manufactured products. We are registered with the FDA as a drug manufacturing facility, and we are subject to periodic and random inspections by the FDA for the continued manufacture of drug products.

We are subject to government regulation and intervention both in the U.S. and in all foreign jurisdictions in which we conduct business. Compliance with applicable laws and regulations results in higher capital expenditures and operating costs and changes to current regulations with which we must comply can necessitate further capital expenditures and increases in operating costs to enable continued compliance.

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Environmental Compliance

We are subject to various federal, state, local and foreign government requirements regulating the discharge of materials into the environment or otherwise relating to the protection of the environment. These laws and regulations include, but are not limited to CERCLA, RCRA and state statutes such as the Idaho Hazardous Waste Management Act, the LLRW Act, NRC regulations concerning various irradiated, radioactive, and depleted uranium materials, and DOT regulations concerning shipment of radioactive materials. Certain of these laws and regulations can impose substantial fines and criminal sanctions for violations and require installation of costly equipment or operational changes to limit emissions and/or decrease the likelihood of accidental hazardous substance releases. We have incurred, and expect to continue to incur, capital and operating costs to comply with these laws and regulations. In addition, changes in laws, regulations and enforcement of policies, or the imposition of new clean-up requirements or remedial techniques, could require us to incur costs in the future that would have a negative effect on our financial condition or results of operations.

Distribution Methods for Products

We sell our products directly to our customers who, in some cases, are both end users and distributors. We use common commercial carriers for delivery of our products, and in some cases our customers arrange for deliveries from our manufacturing facilities.

Dependence on Customers

Combined sales, on which we are dependent, to our three largest customers, accounted for 31% of our total gross revenues in 2025 and accounted for 32% of our total gross revenues in 2024.

Patents, Trademarks, Licenses and Royalty Agreements

In 2001 we received a USPTO trademark for Radshield. The trademark is assigned to our RadQual subsidiary.

In 2004, we obtained certain patents related to the FEP. In 2010, we were granted an additional process patent on the FEP process. During 2012, we were granted additional process patents for the FEP process in the United States. These patents are included in the DUF6 Asset Sale as noted above.

In 2009, the University of Washington entered an exclusive utility patent license and royalty agreement with RadQual whereby RadQual has the exclusive right to exploit a patent for a calibration method and system for PET scanners.

In 2009, the USPTO granted a utility patent for Simulated dose calibrator source standard for positron emission tomography radionuclides. The patent is assigned to our RadQual subsidiary.

In 2013, the USPTO granted a patent for Universal mounting system for calibration source for use in PET scanners. The patent is assigned to our RadQual subsidiary.

In 2015, we received a USPTO trademark for Radlite. The trademark is assigned to our RadQual subsidiary.

In 2022, we filed a patent application for a Barium-based standard which simulates the energy outputs of I-131. This patent is still pending approval.

In 2023, we filed utility patents in the U.S. and other international jurisdictions for our EasyFill product. These patents are currently pending approval by the USPTO and international authorities.

In 2023, as part of an asset purchase agreement with AMICI, Inc., we acquired the trademarks for the Swirler Radioaerosol System.

In 2024, we received trademarks in China for our RadQual and Radnostix branding.

In 2024, our application to trademark our RadVent branding and logo in the U.S. was accepted. These marks are awaiting final registration by the USPTO.

In 2024, Phantech LLC entered an exclusive Joint Venture to develop Phanqual products with RadQual whereby the Phanqual joint venture has the exclusive rights to exploit Phantech’s patent for Systems and methods for a linearly filled nuclear imaging phantom as a sealed source product.

Seasonality

Our management believes that our operations are generally not subject to seasonal influences.

Employees

As of December 31, 2025, we had 45 total employees, including 44 full-time employees.

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Available Information

Our internet website address is www.radnostix.com. We are subject to the reporting requirements under the Securities Exchange Act of 1934, as amended (the Exchange Act). Consequently, we are required to file reports and information with the SEC, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act. These reports and other information concerning us are available free of charge through (i) our website as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC, and (ii) the SEC’s website at www.sec.gov. Information contained on, or accessible through, our website is not incorporated by reference into this Annual Report or other reports filed with the SEC.