−Removed: We are a commercial-stage
−Removed: company dedicated to developing and delivering precision diagnostic consumer products.
−Removed: We are currently marketing the Keto Air breathalyzer
−Removed: device and plan to develop additional diagnostic uses of the breathalyzer technology.
−Removed: We also provided laboratory services in 2024 and
−Removed: 2023, offering a broad portfolio of diagnostic tests, including drug testing, toxicology, and a broad array of test services, from general
−Removed: bloodwork to anatomic pathology, and urine toxicology.
−Removed: We completed an acquisition of a 40% membership interest in Laboratory Services
−Removed: MSO, LLC (“Lab Services MSO”), which closed in February 2023.
−Removed: During 2025, to preserve cash, the Company entered into discussions
−Removed: with Lab Services MSO for the potential redemption of our investment and on February 26, 2025, we and Lab Services MSO entered into a
−Removed: Redemption and Abandonment Agreement, whereby Lab Services MSO redeemed the 40% equity interest in Lab Services MSO held by us.
−Removed: beginning in February 2025, we no longer offer laboratory services.
−Removed: initiated sales of our first diagnostic consumer product, Keto Air, a device that tests ketosis levels.
−Removed: We had the following areas of focus in 2024 and 2023:
−Removed: Laboratory Acquisitions
−Removed: We had embarked on a laboratory rollup strategy focused on forming joint ventures and acquiring laboratories that were accretive to our
−Removed: commercial strategy.
−Removed: As a first step, in February 2023, we acquired a 40% membership interest in Lab Services MSO.
−Removed: Among other things,
−Removed: Lab Services MSO provides toxicology and wellness testing services, a broad portfolio of diagnostic tests, and a broad array of test services.
−Removed: During 2025, to preserve cash, the Company entered into discussions with Lab Services MSO for the potential redemption of our investment
−Removed: and on February 26, 2025, we and Lab Services MSO entered into a Redemption and Abandonment Agreement, whereby Lab Services MSO redeemed
−Removed: the 40% equity interest in Lab Services MSO held by us.
−Removed: Accordingly, beginning in February 2025, we no longer offer laboratory services.
−Removed: Research and Development
−Removed: We are focused on bringing forward intellectual property through joint
−Removed: patent filings with the Massachusetts Institute of Technology (“MIT”).
−Removed: We completed a sponsored research and co-development
−Removed: project with MIT led by Professor Shuguang Zhang as Principal Investigator.
−Removed: Using the unique QTY code protein design platform, six water-soluble
−Removed: variant cytokine receptors have been successfully designed and tested to show binding affinity to the respective cytokines.
−Removed: are focused on bringing forward the intellectual property associated with this program through joint patent submissions, new research
−Removed: and development has been suspended.
−Removed: Product Commercialization
−Removed: We have begun the commercialization
−Removed: and development of a versatile breathalyzer system.
−Removed: We were granted
−Removed: exclusive distributorship rights for the KetoAir from Qi Diagnostics for the following territories:
−Removed: North America, South America,
−Removed: the EU and the UK.
−Removed: For our commercialization strategy, we intend to target the diabetes and obesity markets.
−Removed: product through the KetoAir website and social media.
−Removed: We believe the KetoAir device has some competitive advantages to other methods
−Removed: for measuring ketosis.
−Removed: The KetoAir device is
−Removed: a handheld device that allows the user to detect acetone levels in exhaled breath.
−Removed: The acetone level is in concentration units (ppm, part-per-million)
−Removed: such that the user will know his/her real-time ketosis status:
−Removed: inadequate ketosis (0-3.99 ppm), mild ketosis (4-9.99 ppm), optimal ketosis
−Removed: (10-40 ppm), or alarming level (> 40 ppm).
−Removed: The KetoAir is registered with the United States Food and Drug Administration as a Class
−Removed: I medical device.
−Removed: The device is also paired with an “AI Nutritionist” software program (via Bluetooth connection) which is
−Removed: downloadable from Google Play (for Android mobile phones, approved) and iPhone It helps users monitor and manage their ketogenic diet
−Removed: and related programs.
−Removed: We believe the KetoAir can be an essential tool to help diabetic patients adhere to their therapeutic programs and
−Removed: optimize their ketogenic dietary management.
−Removed: In order to preserve
−Removed: cash and focus on our core laboratory rollup strategy and product commercialization, we have currently suspended all research and development
−Removed: efforts related to cellular therapy in order to redirect our funding efforts to our core business strategies outlined above.
−Removed: China Operations
−Removed: Due to the winding down of the medical related consulting services
−Removed: segment, in November 2022, we decided to cease all operations in the People’s Republic of China (the “PRC”) with the
−Removed: exception of a small administrative office, in Beijing.
−Removed: We do not expect nor do we plan
−Removed: that we will further operate in the PRC or generate revenue from PRC operations for the foreseeable future.
−Removed: The accompanying consolidated financial statements
−Removed: reflect the activities of the Company and each of the following entities:
−Removed: Name of Subsidiary
−Removed: Place and Date of
−Removed: Incorporation
−Removed: Percentage of
−Removed: Principal Activities
−Removed: Avalon Healthcare System, Inc.
−Removed: 100% held by Company
−Removed: Holding company for payroll and other expenses
−Removed: Avalon RT 9 Properties, LLC (“Avalon RT 9”)
−Removed: New Jersey February 7, 2017
−Removed: 100% held by Company
−Removed: Owns and operates an income-producing real property and holds and manages the corporate headquarters
−Removed: Avalon (Shanghai) Healthcare Technology Co., Ltd.
−Removed: (“Avalon Shanghai”)
−Removed: PRC April 29, 2016
−Removed: 100% held by AHS
−Removed: Is not considered an operating entity
−Removed: Genexosome Technologies Inc.
−Removed: (“Genexosome”)
−Removed: Nevada July 31, 2017
−Removed: 60% held by Company
−Removed: No current activities to report, dormant
−Removed: Avactis Biosciences Inc.
−Removed: July 18, 2018
−Removed: 60% held by Company
−Removed: is in process of being dissolved
−Removed: Avactis Nanjing Biosciences Ltd.
−Removed: (“Avactis Nanjing”)
−Removed: 100% held by Avactis
−Removed: is in process of being dissolved
−Removed: Avalon Laboratory Services, Inc.
−Removed: (“Avalon Lab”)
−Removed: October 14, 2022
−Removed: 100% held by Company
−Removed: Laboratory holding company with a 40% membership interest in Lab Services MSO as of December 31, 2024 (1)
−Removed: Q&A Distribution LLC
−Removed: (“Q&A Distribution”)
−Removed: 100% held by Company
−Removed: Distributes KetoAir device
−Removed: (1) On February 26, 2025, we and Lab Services MSO entered into a Redemption and Abandonment Agreement, whereby
−Removed: Lab Services MSO redeemed the 40% equity interest in Lab Services MSO held by us.
−Removed: Sales and Marketing
−Removed: We launched sales of the KetoAir in the U.S.
−Removed: We have retained a marketing expert to assist us to bring this product to market through social media, influencer promotion and
−Removed: We launched this product at the 2024 “KetoCon” convention which took place May 31, 2024 in Austin Texas.
−Removed: Laboratory Services
−Removed: During 2024 and 2023 and until February 2025,
−Removed: through our membership interest in Lab Services MSO, we were focused on delivering high quality services related to toxicology and wellness
−Removed: The panels that we tested for were thyroid panel, comprehensive metabolic panel, kidney profile, liver function tests, and other
−Removed: individual tests.
−Removed: We offered our laboratory services in California,
−Removed: Texas and Arizona.
−Removed: During 2025, to preserve cash, the Company entered into discussions with Lab Services MSO for the potential redemption
−Removed: of our investment and on February 26, 2025, we and Lab Services MSO entered into a Redemption and Abandonment Agreement, whereby Lab Services
−Removed: MSO redeemed the 40% equity interest in Lab Services MSO held by us.
−Removed: Accordingly, beginning in February 2025, we no longer offer laboratory
−Removed: Breathalyzer System (KetoAir)
−Removed: Our current area of focus for the launch of the
−Removed: KetoAir is within the U.S.
−Removed: We are focused on the population within the U.S.
−Removed: that is using the Keto Diet approach to weight loss and diabetic
−Removed: Avalon RT 9 Properties, LLC
−Removed: We own commercial property located in Freehold,
−Removed: This property serves as our corporate headquarters and contains several commercial tenants that generate revenue through rental
−Removed: Strategic Development
−Removed: In late 2024, we launched an initiative seeking
−Removed: transformational merger candidates.
−Removed: The Company determined that it had limited access to cash and it was in the best interest of shareholders
−Removed: to seek a strategic merger.
+Added: We are a technology-innovation company with a
+Added: strategic focus on developing innovative products and services that serve growing consumer health and technology markets.
+Added: Throughout our
+Added: operating history, we have maintained our corporate identity, management team and original mission while strategically evolving our business
+Added: in response to market conditions and commercial opportunities, with each such evolution being the product of deliberate decisions.
+Added: are actively seeking complementary bolt-on AI acquisitions that could generate near-term revenue to supplement our current operations
+Added: as both segments continue to develop.
+Added: We believe our diverse and evolving portfolio of commercial activities reflects our ongoing commitment
+Added: to identifying and building value-oriented technology businesses for the benefit of its stockholders.
+Added: Current Business Operations
+Added: We currently operates through two business segments:
+Added: (i) a consumer health technology segment, through which we distributes the Keto Air breathalyzer device — a non-invasive consumer
+Added: breathalyzer that measures ketosis levels and is sold in North America, bearing an FDA registration number;
+Added: and (ii) an artificial intelligence
+Added: content technology segment, through which we develop and commercialize an AI-driven, short-form video generation platform operated by
+Added: Avalon Quantum AI, LLC, our wholly owned subsidiary formed in connection with our acquisition of RPM Interactive, Inc.
+Added: in December 2025.
+Added: Each segment is described in full below.
+Added: Consumer Health Technology Segment - Keto-Air
+Added: Our consumer health technology segment is centered
+Added: on the Keto Air breathalyzer device, a non-invasive consumer health product that allows users to determine whether they are in a state
+Added: of nutritional ketosis, and at what level, by exhaling into a compact, pen-like breathalyzer.
+Added: Ketosis is a metabolic state in which the
+Added: body burns fat for fuel rather than carbohydrates, and is widely associated with low-carbohydrate and ketogenic dietary regimens.
+Added: Keto Air device represents a meaningful improvement over prior methods of measuring ketosis, such as urine test strips or earlier-generation
+Added: breathalyzers that required cartridge replacements, offering users a convenient, reusable, and non-invasive testing experience.
+Added: We entered into an exclusive North American distribution
+Added: agreement for the Keto-Air technology and device in 2024.
+Added: Pursuant to this agreement, we have exclusive distribution rights in the United
+Added: States, Canada and Mexico through July of 2025 and since that time, we continue to be the only distributor in North America.
+Added: this provides us with a meaningful competitive advantage in the North American ketosis monitoring market for the duration of the agreement.
+Added: We previously had a THC breathalyzer device under development.
+Added: 2026, we discontinued development of that product due to a lack of available funding.
+Added: The discontinuation of the THC breathalyzer does
+Added: not affect our Keto Air operations or sales of the Keto Air device..
+Added: Market Opportunity
+Added: Our commercial sales strategy for Keto Air utilizes
+Added: two primary channels:
+Added: social media influencer relationships and a commercial relationship with the Law Enforcement Association of America,
+Added: which was developed through one of our consultants.
+Added: We believe the Law Enforcement Association of America relationship is particularly
+Added: well-suited to the Keto Air product given the relevance of metabolic health monitoring to the wellness programs of law enforcement personnel
+Added: and their families.
+Added: We are currently in an early-stage commercial
+Added: testing phase, during which we are assessing broader market demand, refining our distribution and marketing approach, and evaluating the
+Added: most effective channels for scaling sales.
+Added: We are continuing to assess the future strategic direction of our Keto Air product line in
+Added: light of its commercial performance and our overall business portfolio.
+Added: Regulatory Status
+Added: The Keto Air device bears an FDA registration
+Added: number, which is required for the commercial sale of such devices in the United States.
+Added: The device is classified as a consumer product
+Added: and is not a regulated medical device requiring FDA pre-market approval, and accordingly may be sold directly to any consumer without
+Added: a prescription or other regulatory authorization.
+Added: We believe this regulatory profile provides us with a straightforward commercial pathway
+Added: to market in the United States and across North America.
+Added: Artificial Intelligence Content Technology
+Added: Segment — Avalon Quantum AI, LLC / RPM Interactive
+Added: Our artificial intelligence content technology segment is operated
+Added: through Avalon Quantum AI, LLC, a wholly owned subsidiary of our company organized in the State of Nevada and formed in connection with
+Added: our acquisition of RPM Interactive, Inc.
+Added: ("RPM") in December 2025.
+Added: RPM merged with and into Avalon Quantum AI, LLC pursuant
+Added: to the merger, and Avalon Quantum AI, LLC continues to operate as our wholly owned subsidiary.
+Added: The RPM Platform — Phase 1
+Added: The RPM platform is an AI-driven, short-form video
+Added: generation software.
+Added: In its current Phase 1 form, the platform enables content creators — with an initial focus on the podcasting
+Added: market — to input a topic of their choosing, after which the platform automatically scrapes the internet for relevant videos, identifies
+Added: the most-viewed or most-discussed content on that topic, and generates a structured, three-minute video featuring an AI-generated avatar
+Added: of the creator that replicates their voice and likeness.
+Added: Each generated video consists of three segments:
+Added: an introduction delivered by
+Added: the creator's AI avatar, the featured video clip sourced by the platform, and a concluding statement also delivered by the AI avatar.
+Added: The core appeal of the RPM platform to content
+Added: creators is efficiency:
+Added: the software automates the time-consuming process of identifying and sourcing video content, writing scripts,
+Added: and producing recordings, enabling creators to generate daily content at scale and drive increased views, clicks, and subscriber engagement
+Added: across their platforms.
+Added: We believe the demand for automated, high-quality content generation tools among the creator economy is substantial
+Added: and growing, and that the RPM platform is well-positioned to address this demand.
+Added: The platform is currently in beta testing with
+Added: a limited number of content creators.
+Added: We are using this beta period to refine the platform's AI avatar generation capabilities, test the
+Added: content sourcing and curation algorithms, and gather user feedback in advance of a broader commercial launch.
+Added: Phase 2 Development
+Added: Phase 2 of the RPM platform is currently in development and is expected
+Added: to launch in Q3 of 2026.
+Added: Phase 2 is expected to expand the platform's user base beyond podcasters to a substantially broader range of content creators
+Added: and marketers, including social media influencers and individuals or businesses engaged in product marketing and e-commerce.
+Added: also feature a more refined AI avatar generation system, with enhanced voice and likeness replication capabilities designed to produce
+Added: higher-quality, more personalized content at scale.
+Added: We believe the expansion of the platform's addressable
+Added: market from podcasters to the broader creator and marketer economy in Phase 2 represents a significant step toward the commercial scaling
+Added: of the RPM platform, and we intend to pursue a phased commercial launch strategy following the completion of Phase 2 development.
+Added: While we continue to develop and complete Phase 2, we continue to evaluate
+Added: possible AI acquisitions that we believe could generate near-term revenue to supplement our current operations while the RPM platform
+Added: continues through its development and commercial launch phases.
+Added: We have not entered into any definitive agreement with respect to any
+Added: such acquisition as of the date of this Annual Report, and there can be no assurance that we will identify, complete, or successfully
+Added: integrate any such acquisition.
+Added: History of Operations
+Added: Wind-Down of China Operations (2022–2023)
+Added: Our initial commercial strategy was focused on
+Added: the cellular therapy sector, where we sought to advance innovative cellular therapy technologies in both the United States and China.
+Added: Beginning in 2022 and continuing through 2023, our Board of Directors determined to wind down our operations in the People's Republic
+Added: of China and to divest all assets, subsidiaries, and relationships associated with our China-based activities.
+Added: This decision reflected
+Added: both the changed commercial and regulatory landscape applicable to our cellular therapy program and our inability to secure the capital
+Added: necessary to advance the program at the scale required to achieve commercial viability.
+Added: By November 2022, we had ceased all active operations
+Added: in the PRC, and the wind-down was completed during 2023.
+Added: Laboratory Services Strategy (2023–2025)
+Added: In February 2023, through our subsidiary Avalon Lab, LLC, we acquired
+Added: a 40% equity interest in Laboratory Services MSO, LLC, a California-based clinical laboratory company, for total consideration of approximately
+Added: $20.7 million, comprised of approximately $9.0 million in cash, 11,000 shares of our Series B Convertible Preferred Stock, and an additional
+Added: $666,667 cash payment made in February 2024.
+Added: On February 26, 2025, we exited the investment entirely pursuant to a Redemption and Abandonment
+Added: Agreement, receiving cash proceeds of $1,745,000 and surrendering our Series B Preferred Stock.
+Added: Search for Strategic Acquisitions and YOOV
+Added: Merger Agreement (2024–2025)
+Added: In early 2024, our Board made a strategic determination to focus our
+Added: acquisition efforts on YOOV Group Holding Limited ("YOOV"), a Hong Kong-based company.
+Added: We conducted extensive due diligence,
+Added: engaging on-site due diligence meetings with the YOOV management team.
+Added: On March 7, 2025, we entered into an Agreement and Plan of Merger
+Added: with YOOV and Nexus MergerSub Limited, pursuant to which YOOV would have become a direct, wholly owned subsidiary of our company.
+Added: our continued review of YOOV's financial statements for the fiscal year ended December 31, 2024, our Board of Directors determined that
+Added: it was not in the best interests of our stockholders to proceed with the transaction.
+Added: We terminated the merger agreement with YOOV effective
+Added: January 21, 2026.
+Added: Acquisition of RPM Interactive, Inc.
+Added: Formation of Avalon Quantum AI, LLC (December 2025)
+Added: On December 15, 2025, we completed the acquisition of RPM Interactive,
+Added: ("RPM"), a generative artificial intelligence software company, through a subsidiary merger whereby RPM merged with and
+Added: into Avalon Quantum AI, LLC, a newly formed, wholly owned subsidiary of our company organized in the State of Nevada.
+Added: Avalon Quantum AI,
+Added: LLC is the surviving entity and continues as our wholly owned subsidiary.
+Added: We, as the surviving listed parent entity, continue to operate
+Added: under our existing Nasdaq listing, and neither our corporate identity, our Nasdaq listing, nor our principal executive offices were altered
+Added: as a result of the acquisition.
+Added: The acquisition was effected as an all-stock transaction pursuant to which we issued 19,500 shares of
+Added: our Series E Non-Voting Convertible Preferred Stock to RPM's former stockholders at a stated value of $1,000 per share, for a total stated
+Added: purchase price of $19.5 million.
+Added: Each share of Series E Preferred Stock is convertible into shares of our common stock at a conversion
+Added: price of $1.50 per share, subject to:
+Added: (i) a beneficial ownership cap of 4.99% per holder;
+Added: (ii) an exchange cap preventing issuance in
+Added: excess of applicable Nasdaq thresholds (the "Exchange Cap");
+Added: and (iii) stockholder approval required under Nasdaq Listing Rule
+Added: 5635, which we intend to seek at our 2026 annual meeting of stockholders.
+Added: The Series E Preferred Stock is non-voting prior to conversion.
+Added: In connection with the acquisition, we appointed Michael Mathews to our Board of Directors.
+Added: A full description of our RPM platform and
+Added: Phase 2 development plans is set forth in Item 1.B above.
Intellectual Property
−Removed: Our goal is to obtain, maintain and enforce
−Removed: patent rights for our products, formulations, processes, methods of use and other proprietary technologies, preserve our trade
−Removed: secrets, and operate without infringing on the proprietary rights of other parties, both in the United States and abroad.
−Removed: is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for our current product
−Removed: candidates and any future product candidates, proprietary information and proprietary technology through a combination of
−Removed: contractual arrangements and patents, both in the United States and abroad.
−Removed: Even patent protection, however, may not always afford
−Removed: us with complete protection against competitors who seek to circumvent our patents.
−Removed: If we fail to adequately protect or enforce our
−Removed: intellectual property rights or secure rights to patents of others, the value of our intellectual property rights would diminish.
−Removed: this end, we require all of our employees, consultants, advisors and other contractors to enter into confidentiality agreements that
−Removed: prohibit the disclosure and use of confidential information and, where applicable, require disclosure and assignment to us of the
−Removed: ideas, developments, discoveries and inventions relevant to our technologies and important to our business.
−Removed: Many of our existing and potential future competitors
−Removed: have significantly greater financial resources and expertise in operations, research and development, manufacturing, obtaining marketing
−Removed: approvals and marketing approved products than we do.
−Removed: Mergers and acquisitions may result in even more resources being concentrated among
−Removed: a smaller number of our competitors.
−Removed: Smaller, or early stage, companies may also prove to be significant competitors, particularly through
−Removed: collaborative arrangements with large and established companies.
−Removed: These competitors also compete with us in recruiting and retaining qualified
−Removed: scientific and management personnel, as well as in acquiring technologies complementary to, or necessary for, our programs.
−Removed: We expect that our ability to compete effectively
−Removed: will depend upon our ability to:
−Removed: ● maintain a proprietary position
−Removed: for our manufacturing processes and other technology;
−Removed: ● produce our products in accordance
−Removed: with FDA and international regulatory guidelines;
−Removed: ● attract and retain key personnel;
−Removed: ● build or access an adequate
−Removed: sales and marketing infrastructure for any approved products.
−Removed: Failure to do one or more of these activities
−Removed: could have an adverse effect on our business, financial condition or results of operations.
−Removed: Avalon RT 9 Properties, LLC
−Removed: We own commercial property located in Freehold,
−Removed: This property serves as our corporate headquarters and contains several commercial tenants that generate revenue through rental
−Removed: The property is located on a major highway and is one of the largest buildings in the surrounding areas.
−Removed: It is centrally located
−Removed: and maintains high occupancy.
−Removed: There are other commercial properties in the vicinity that offer similar amenities.
−Removed: However, premier executive
−Removed: offices are limited and as such, we expect to continue to maintain high occupancy in the near term.
−Removed: As of March 31, 2025, we employed five employees,
−Removed: four of which are full time employees.
+Added: Cellular Therapy Patent Portfolio
+Added: We hold a portfolio of patents developed during
+Added: our cellular therapy operating period.
+Added: This portfolio includes patents that are co-owned with the Massachusetts Institute of Technology
+Added: ("MIT"), arising from a prior joint research agreement between our company and MIT, as well as patents co-owned with Arbelli,
+Added: a Hong Kong-based company that collaborated with us during our cellular therapy research activities.
+Added: We regard the MIT co-ownership as
+Added: a material component of our patent portfolio, and we disclose it accordingly.
+Added: Although we have ceased all active research and
+Added: development activities related to cellular therapy, we have made a deliberate decision to continue actively maintaining, or "prosecuting,"
+Added: these patents rather than allowing them to lapse or be abandoned.
+Added: We believe the patents may have potential future value — whether
+Added: through licensing, sale, or the resumption of activity in the cellular therapy space — and we intend to continue maintaining them
+Added: for so long as we consider it commercially reasonable to do so.
+Added: Any decisions regarding the licensing or enforcement of co-owned patents
+Added: are subject to the terms of our co-ownership arrangements with MIT and Arbelli, which may limit our ability to license or enforce such
+Added: patents unilaterally without the consent of our co-owners.
+Added: Artificial Intelligence Platform —
+Added: Provisional Patent Applications
+Added: In connection with our acquisition of RPM Interactive,
+Added: and the development of our generative AI content platform operated through Avalon Quantum AI, LLC, we have filed three provisional
+Added: patent applications relating to aspects of the RPM platform's technology.
+Added: Provisional applications establish an early filing date and
+Added: provide a twelve-month period during which we may file corresponding non-provisional patent applications.
+Added: We intend to evaluate the commercial
+Added: and strategic value of converting these provisional applications into non-provisional applications during the applicable filing window.
+Added: There can be no assurance that any patents will issue from these applications, or that any issued patents will provide meaningful competitive
+Added: General Intellectual Property Policy
+Added: Our general policy is to seek, where appropriate,
+Added: broad intellectual property protection for our current and future products, technologies, and proprietary information through a combination
+Added: of patents, trade secrets, contractual arrangements, and other available means, both in the United States and internationally.
+Added: all employees, consultants, advisors, and contractors to enter into confidentiality agreements that prohibit the disclosure and unauthorized
+Added: use of our confidential information and, where applicable, require the disclosure and assignment to us of ideas, developments, discoveries,
+Added: and inventions relevant to our technologies and important to our business.
+Added: We also rely on trade secret protection for certain aspects
+Added: of our proprietary technology and business processes, including aspects of the RPM platform's content sourcing and curation algorithms
+Added: that we have determined are better protected as trade secrets than through patent disclosure.
+Added: We operate in two distinct and competitive markets,
+Added: each with its own competitive dynamics.
+Added: We face competition in both our consumer health technology segment and our artificial intelligence
+Added: content technology segment, as described below.
+Added: Consumer Health Technology — Keto
+Added: Air Breathalyzer
+Added: The market for consumer ketosis monitoring products
+Added: is competitive and includes a range of products at varying price points and technology levels.
+Added: Our primary competitors in this space include
+Added: manufacturers and distributors of urine-based ketone test strips, which represent the most widely used and lowest-cost method of ketosis
+Added: measurement and are available through a broad range of retail and online channels.
+Added: We also compete with other breath-based ketone monitoring
+Added: devices, including earlier-generation breathalyzers that required consumable cartridge replacements and more recent reusable breath ketone
+Added: monitors that have been introduced to the market by consumer health technology companies.
+Added: We believe the Keto Air device competes favorably
+Added: on the basis of its reusable design, ease of use, and the convenience of non-invasive breath-based testing relative to urine strip alternatives.
+Added: As we are currently the only one selling the device in North America, we believe this provides us with a meaningful structural advantage
+Added: relative to other distributors of similar products in our territory..
+Added: However, many of our actual and potential competitors in this space
+Added: have significantly greater financial resources, brand recognition, established retail distribution networks, and marketing infrastructure
+Added: than we do, and we may not be able to compete effectively with them over the long term.
+Added: Artificial Intelligence Content Technology
+Added: — Avalon Quantum AI, LLC / RPM Platform
+Added: The market for AI-driven content creation tools
+Added: is rapidly evolving, highly competitive, and characterized by continuous technological development and the frequent entry of new participants.
+Added: We compete with a broad range of companies offering AI-powered video generation, content automation, and creator economy tools, including
+Added: both established technology companies with significant resources and early-stage companies developing competing generative AI platforms.
+Added: Key competitive factors in this market include
+Added: the quality and realism of AI-generated content, the breadth of the platform's addressable user base, the speed and automation of content
+Added: generation workflows, the sophistication of voice and likeness replication technology, integration with major social media and content
+Added: distribution platforms, and the ability to scale rapidly to meet growing creator demand.
+Added: We believe our RPM platform competes on the basis
+Added: of its end-to-end automation of the video content creation process — from topic input through content sourcing, curation, avatar
+Added: generation, and final video production — which we believe meaningfully reduces the time and technical burden on content creators
+Added: relative to less automated alternatives.
+Added: However, many of our actual and potential competitors
+Added: in the generative AI space have substantially greater financial resources, research and development capabilities, engineering talent,
+Added: data assets, and market presence than we do.
+Added: Several large technology companies are actively investing in AI-generated content tools and
+Added: avatar technology, and we expect competition in this market to intensify significantly as the technology matures and the creator economy
+Added: continues to grow.
+Added: Smaller and early-stage companies may also prove to be significant competitors, particularly those that secure strategic
+Added: partnerships with established platform operators or content networks.
+Added: As of March 25, 2026, we employed two full time
+Added: employees and several independent contractors.
None of our employees is represented by a collective bargaining arrangement.
−Removed: Government Regulation
−Removed: The healthcare industry in the U.S.
−Removed: regulated and subject to changing political, legislative, regulatory, and other influences.
−Removed: Further, the healthcare industry is currently
−Removed: undergoing rapid change.
−Removed: We are uncertain how, when or in what context these new changes will be adopted or implemented.
−Removed: These new regulations
−Removed: could create unexpected liabilities for us, could cause us or our members to incur additional costs and could restrict our or our clients’
−Removed: Many of the laws are complex and their application to us, our clients, or the specific services and relationships we have
−Removed: with our members are not always clear.
−Removed: Our failure to anticipate accurately the application of these laws and regulations, or our other
−Removed: failure to comply, could create liability for us, result in adverse publicity, and otherwise negatively affect our business.
−Removed: Holding Foreign Companies Accountable Act
−Removed: The Holding Foreign Companies Accountable Act,
−Removed: or the HFCA Act, was enacted on December 18, 2020.
−Removed: According to the HFCA Act, if the SEC determines that Avalon has filed audit reports
−Removed: issued by a registered public accounting firm that has not been subject to inspection by the PCAOB for three consecutive years beginning
−Removed: in 2021, the SEC will prohibit Avalon’s securities from being traded on a national securities exchange or in the over-the-counter
−Removed: trading market in the United States.
−Removed: On December 16, 2021, the PCAOB issued a Determination
−Removed: Report which reported that the PCAOB is unable to inspect or investigate completely registered public accounting firms headquartered in:
−Removed: (1) mainland China of the People’s Republic of China, because of a position taken by one or more authorities in mainland China;
−Removed: and (2) Hong Kong, a Special Administrative Region of the PRC, because of a position taken by one or more authorities in Hong Kong.
−Removed: Avalon’s auditor is M&K CPAS PLLC (M&K”), based
−Removed: M&K is registered with the PCAOB and is subject to laws in the United States pursuant to which the PCAOB conducts regular
−Removed: inspections to assess their compliance with the applicable professional standards.
−Removed: Since M&K is located in the United States, the
−Removed: PCAOB has been able to conduct inspections of M&K.
−Removed: In addition, M&K is not among the PCAOB registered public accounting firms
−Removed: registered in mainland China or Hong Kong that are subject to PCAOB’s determination on December 16, 2021.
−Removed: Other Healthcare Fraud and Abuse Laws
−Removed: In the U.S., our activities are potentially subject
−Removed: to regulation by various federal, state and local authorities in addition to the FDA, including but not limited to, the Centers for Medicare
−Removed: and Medicaid Services, or CMS, other divisions of the U.S.
−Removed: Department of Health and Human Services (such as the Office of Inspector General
−Removed: and the Health Resources and Service Administration), the U.S.
−Removed: Department of Justice, or the DOJ, and individual U.S.
−Removed: Attorney offices
−Removed: within the DOJ, and state and local governments.
−Removed: For example, sales, marketing and scientific/educational grant programs may have to comply
−Removed: with the anti-fraud and abuse provisions of the Social Security Act, the false claims laws, the privacy and security provisions of the
−Removed: Health Insurance Portability and Accountability Act, or HIPAA, and similar state laws, each as amended, as applicable.
−Removed: The federal Anti-Kickback Statute prohibits, among
−Removed: other things, any person or entity from knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or
−Removed: indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for the purchase,
−Removed: lease or order of any item or service reimbursable, in whole or in part, under Medicare, Medicaid or other federal healthcare programs.
−Removed: The term remuneration has been interpreted broadly to include anything of value.
−Removed: The Anti-Kickback Statute has been interpreted to apply
−Removed: to arrangements between therapeutic product manufacturers on one hand and prescribers, purchasers, and formulary managers on the other.
−Removed: There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution.
−Removed: The exceptions
−Removed: and safe harbors are drawn narrowly and practices that involve remuneration that may be alleged to be intended to induce prescribing,
−Removed: purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor.
−Removed: Failure to meet all of the
−Removed: requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the
−Removed: Anti-Kickback Statute.
−Removed: Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review
−Removed: of all of its facts and circumstances.
−Removed: Additionally, the intent standard under the Anti-Kickback Statute was amended by the ACA to a stricter
−Removed: standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order
−Removed: to have committed a violation.
−Removed: In addition, the ACA codified case law that a claim including items or services resulting from a violation
−Removed: of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act, or FCA.
−Removed: The federal false claims and civil monetary penalty
−Removed: laws, including the FCA, which imposes significant penalties and can be enforced by private citizens through civil qui tam actions, prohibit
−Removed: any person or entity from, among other things, knowingly presenting, or causing to be presented, a false or fraudulent claim for payment
−Removed: to, or approval by, the federal healthcare programs, including Medicare and Medicaid, or knowingly making, using, or causing to be made
−Removed: or used a false record or statement material to a false or fraudulent claim to the federal government.
−Removed: A claim includes “any request
−Removed: or demand” for money or property presented to the U.S.
−Removed: For instance, historically, pharmaceutical and other healthcare
−Removed: companies have been prosecuted under these laws for allegedly providing free product to customers with the expectation that the customers
−Removed: would bill federal programs for the product.
−Removed: Other companies have been prosecuted for causing false claims to be submitted because of
−Removed: the companies’ marketing of the product for unapproved, off-label, and thus generally non-reimbursable, uses.
−Removed: HIPAA created additional federal criminal statutes
−Removed: that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means
−Removed: of false or fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any
−Removed: healthcare benefit program, including private third-party payors, willfully obstructing a criminal investigation of a healthcare offense,
−Removed: and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially
−Removed: false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
−Removed: the Anti-Kickback Statute, the ACA amended the intent standard for certain healthcare fraud statutes under HIPAA such that a person or
−Removed: entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
−Removed: Many states have similar, and typically more prohibitive,
−Removed: fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and other state programs, or, in several
−Removed: states, apply regardless of the payor.
−Removed: Additionally, to the extent that our product candidates may in the future be sold in a foreign
−Removed: country, we may be subject to similar foreign laws.
−Removed: We may be subject to data privacy and security
−Removed: regulations by both the federal government and the states in which we conduct our business.
−Removed: HIPAA, as amended by the Health Information
−Removed: Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, imposes requirements relating to the privacy,
−Removed: security and transmission of individually identifiable health information.
−Removed: Among other things, HITECH makes HIPAA’s privacy and
−Removed: security standards directly applicable to business associates, independent contractors, or agents of covered entities that receive or
−Removed: obtain protected health information in connection with providing a service on behalf of a covered entity.
−Removed: HITECH also created four new
−Removed: tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and
−Removed: gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek
−Removed: attorneys’ fees and costs associated with pursuing federal civil actions.
−Removed: In addition, many state laws govern the privacy and security
−Removed: of health information in specified circumstances, many of which differ from each other in significant ways, are often not pre-empted by
−Removed: HIPAA, and may have a more prohibitive effect than HIPAA, thus complicating compliance efforts.
−Removed: We expect our product, after approval, may be
−Removed: eligible for coverage under Medicare, the federal health care program that provides health care benefits to the aged and disabled, and
−Removed: covers outpatient services and supplies, including certain pharmaceutical products, that are medically necessary to treat a beneficiary’s
−Removed: health condition.
−Removed: In addition, the product may be covered and reimbursed under other government programs, such as Medicaid and the 340B
−Removed: Drug Pricing Program.
−Removed: The Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into and have in effect a national
−Removed: rebate agreement with the Secretary of the Department of Health and Human Services as a condition for states to receive federal matching
−Removed: funds for the manufacturer’s outpatient drugs furnished to Medicaid patients.
−Removed: Under the 340B Drug Pricing Program, the manufacturer
−Removed: must extend discounts to entities that participate in the program.
−Removed: As part of the requirements to participate in certain government programs,
−Removed: many pharmaceutical manufacturers must calculate and report certain price reporting metrics to the government, such as average manufacturer
−Removed: price, or AMP, and best price.
−Removed: Penalties may apply in some cases when such metrics are not submitted accurately and timely.
−Removed: Additionally, the federal Physician Payments Sunshine
−Removed: Act, or the Sunshine Act, within the ACA, and its implementing regulations, require that certain manufacturers of drugs, devices, biological
−Removed: and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain
−Removed: exceptions) report annually to CMS information related to certain payments or other transfers of value made or distributed to physicians
−Removed: and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals
−Removed: and to report annually certain ownership and investment interests held by physicians and their immediate family members.
−Removed: Failure to report
−Removed: accurately could result in penalties.
−Removed: In addition, many states also govern the reporting of payments or other transfers of value, many
−Removed: of which differ from each other in significant ways, are often not pre-empted, and may have a more prohibitive effect than the Sunshine
−Removed: Act, thus further complicating compliance efforts.
−Removed: New Legislation and Regulations
−Removed: From time to time, legislation is drafted, introduced
−Removed: and passed in Congress that could significantly change the statutory provisions governing the testing, approval, manufacturing and marketing
−Removed: of products regulated by the FDA.
−Removed: In addition to new legislation, FDA regulations and policies are often revised or interpreted by the
−Removed: agency in ways that may significantly affect our business and our products.
−Removed: It is impossible to predict whether further legislative changes
−Removed: will be enacted or whether FDA regulations, guidance, policies or interpretations will be changed or what the effect of such changes,
−Removed: if any, may be.
−Removed: Recent Developments
−Removed: Mortgage and Security
−Removed: On March 27, 2024, the Company entered into a Mortgage and Security
−Removed: Agreement (the “Mast Hill Mortgage”) with Mast Hill Fund L.P.
−Removed: (“Mast Hill”) to secure the payment performance
−Removed: and obligation under certain follow-up financing agreements described below.
−Removed: In March 2024, the Company entered into follow-up financing agreements
−Removed: with Mast Hill, which included the issuance of 13% senior secured promissory notes totaling $700,000 convertible into common stock, as
−Removed: well as the issuance of up to 7,000 shares of common stock as a commitment fee, and warrants for the purchase of up to 8,750 shares of
−Removed: common stock at an initial price per share of $30.00, and common share purchase warrants for the purchase of up to 8,077 shares of common
−Removed: stock at an initial price per share of $19.50, with a total purchase price of $665,000 (the “2024 Financing Agreements”).
−Removed: These agreements were made under the same terms and conditions of the prior rounds of convertible note financing in October 2023 and May
−Removed: 2023 (the “2023 Financing Agreements”).
−Removed: On March 27, 2024, the Company also entered into a Mortgage and Security
−Removed: Agreement (the “Firstfire Mortgage”) with Firstfire Global Opportunities Fund, LLC (“Firstfire”) to secure the
−Removed: payment performance and obligation under the 2023 Financing Agreements.
−Removed: Convertible Note
−Removed: Financing and Mortgage and Security Agreement
−Removed: On June 5, 2024, the Company entered into securities purchase agreements
−Removed: (the “ Securities Purchase Agreements ”) with Mast Hill for the issuance of 13% senior secured promissory notes in the
−Removed: aggregate principal amount of $2,845,000 (collectively, the “Notes”) convertible into shares of the Company’s common
−Removed: stock, as well as the issuance of up to 26,800 shares of common stock as a commitment fee and warrants for the purchase of up to 146,667
−Removed: shares of common stock (the “Convertible Note Financing”).
−Removed: The Company and its subsidiaries entered into those certain security
−Removed: agreements (the “Security Agreements”), creating a security interest in certain property of the Company and its subsidiaries
−Removed: to secure the prompt payment, performance and discharge in full of all of the Company’s obligations under the Notes.
−Removed: The transaction
−Removed: closed on June 5, 2024.
−Removed: Mast Hill acquired the Notes with principal amount of $2,845,000
−Removed: and paid the purchase price of $2,702,750 after an original issue discount of $142,250, with a conversion price of $11.25, subject to
−Removed: adjustment as provided in Notes.
−Removed: Also on June 5, 2024, the Company issued (i) a warrant to purchase 66,667 shares of common stock with
−Removed: an exercise price of $9.75 exercisable until June 5, 2029 (the “First Warrant”), (ii) a warrant to purchase 80,000 shares
−Removed: of common stock with an exercise price of $7.50 exercisable until June 5, 2029, which warrant shall be cancelled and extinguished against
−Removed: payment of the Notes (the “Second Warrant” and collectively with the First Warrant, the “Warrants”), and (iii)
−Removed: 26,800 shares of common stock to Mast Hill as additional consideration for the purchase of the Note ( the “Commitment Shares”),
−Removed: which were earned in full as of June 5, 2024.
−Removed: On the closing date, the Company delivered such duly executed Notes, warrants and common
−Removed: stock to Mast Hill against delivery of such purchase price.
−Removed: The Company used the
−Removed: proceeds from the Convertible Note Financing to pay off all previously issued convertible notes to Mast Hill and Firstfire.
−Removed: On June 5, 2024, the Company also entered into a Mortgage and Security
−Removed: Agreement (the “Mortgage”) with Mast Hill to secure the payment, performance, and obligations under the above-mentioned Convertible
−Removed: Note Financing.
−Removed: As of June 5, 2024, the Company was indebted to Mast Hill in the combined principal sum of $2,845,000.
−Removed: 15, 2024, the Company and Mast Hill entered into that certain consent, acknowledgement, and waiver agreement, pursuant to which Mast Hill
−Removed: waived all amortization payments required to be made under the Note, the Company paid a waiver fee of $150,000 to Mast Hill, and the Company
−Removed: issued to Mast Hill a common stock purchase warrant for the purchase of up to 150,000 shares of the Company’s common stock.
−Removed: At-the-Market
−Removed: In June 2023, the Company entered
−Removed: into a sales agreement (the “Sales Agreement”) with Roth Capital Partners, LLC (“Roth”) under which the Company
−Removed: could offer and sell from time to time shares of its common stock having an aggregate offering price of up to $3.5 million.
−Removed: July 1, 2023 to August 16, 2024, we sold an aggregate of 312,285 shares of our common stock at an average price of $11.19 per share to
−Removed: investors pursuant to the Sales Agreement, and received net cash proceeds of $3,388,251, net of cash paid for Roth’s commissions
−Removed: and other fees of $104,992.
−Removed: Reverse Stock Split & Decrease in Authorized
−Removed: On October 23, 2024,
−Removed: the Company filed a certificate of amendment (the “Amendment”) to its Certificate of Incorporation with the Secretary of State
−Removed: of the State of Delaware to effectuate a reverse stock split of the Company’s common stock at a ratio of 1-for-15 (the “Reverse
−Removed: Stock Split”), as well as the decrease in the number of shares of common stock authorized for issuance from 490,000,000 to 100,000,000.
−Removed: The Amendment became effective at 5:00 p.m.
−Removed: ET on October 25, 2024.
−Removed: Series C Convertible Preferred Stock
−Removed: On December 13, 2024,
−Removed: the Company filed a certificate of designations of preferences, rights, and limitations of Series C Convertible Preferred Stock (the “Series
−Removed: C Certificate of Designations”) with the State of Delaware which provides for the designation of 10,000 shares of Series C preferred
−Removed: stock of the Company, par value $0.0001 per share, upon the terms and conditions as set forth in the Series C Certificate of Designations.
−Removed: Each share of Series C Preferred Stock has a stated value of $1,000 (the “Stated Value”).
−Removed: The Series C Preferred
−Removed: Stock shall rank (i) senior to the Company’s common stock (the “Common Stock”) and any other class or series of capital
−Removed: stock of the Company created hereafter, the terms of which specifically provide that such class or series shall rank junior to the Series
−Removed: C Preferred Stock, (ii) pari passu with any class or series of capital stock of the Company created hereafter specifically ranking, by
−Removed: its terms, on par with the Series C Preferred Stock, (iii) pari passu with Series B Convertible Preferred Stock of the Company (the “Series
−Removed: B Preferred Stock”) with respect to its rights, preferences and restrictions, and (iv) subordinate to the Series A Convertible Preferred
−Removed: Stock of the Company (the “Series A Preferred Stock”).
−Removed: Holders of the Series
−Removed: C Preferred Stock shall be entitled to receive, and the Company shall pay, dividends on shares of Series C Preferred Stock equal (on an
−Removed: as-if-converted-to-common-stock basis, disregarding for such purpose any conversion limitations hereunder) to and in the same form as
−Removed: dividends actually paid on shares of the common stock when, as and if such dividends are paid on shares of the common stock.
−Removed: Holders of the Series
−Removed: C Preferred Stock have no voting power except as otherwise required by the Delaware General Corporation Law.
−Removed: Upon any liquidation,
−Removed: dissolution or winding-up of the Company, whether voluntary or involuntary (a “Liquidation”), the holders of the Series C
−Removed: Preferred Stock shall be entitled to receive out of the assets available for distribution to stockholders, (i) after and subject to the
−Removed: payment in full of all amounts required to be distributed to the holders of another class or series of stock of the Company ranking on
−Removed: liquidation prior and in preference to the Series C Preferred Stock, including the Series A Preferred Stock, (ii) ratably with any class
−Removed: or series of stock ranking on liquidation on parity with the Series C Preferred Stock and (iii) in preference and priority to the holders
−Removed: of the shares of common stock, an amount equal to 100% of the Stated Value of the Series C Preferred Stock, in proportion to the full
−Removed: and preferential amount that all shares of the Series C Preferred Stock are entitled to receive.
−Removed: Each share of Series
−Removed: C Preferred Stock shall be convertible into common stock (the “Conversion Shares”) at a conversion per share equal to $2.41,
−Removed: at the option of the holder, at any time after the later of (i) the date of the shareholder approval of the issuance of the Conversion
−Removed: Shares pursuant to the rules of the Nasdaq Stock Market and (ii) the one year anniversary of the date of the first issuance of any shares
−Removed: of the Series C Preferred Stock.
−Removed: In addition, the holder shall not have the right to convert any portion of the Series C Preferred Stock
−Removed: if, after giving effect to the conversion, such holder (together with its affiliates) would beneficially own in excess of 19.99% of the
−Removed: number of shares of the common stock outstanding immediately after giving effect to the issuance of the respective Conversion Shares.
−Removed: York Sun Securities
−Removed: Purchase Agreement
−Removed: On December 19, 2024,
−Removed: the Company entered into that certain securities purchase agreement (the “Securities Purchase Agreement”), with an accredited
−Removed: investor, York Sun Investment Holding Limited (the “Investor”), pursuant to which the Company agreed to issue and sell to
−Removed: the Investor, upon the terms and conditions set forth in the Securities Purchase Agreement, up to 7,000 shares of Series C Convertible
−Removed: Preferred Stock for up to an aggregate of $7,000,000 (the “Purchase Price”), which is equal to $1,000 per share.
−Removed: closing occurred on December 24, 2024, with respect to the Investor’s purchase of 3,500 shares of Series C Convertible Preferred
−Removed: Stock in exchange for $3,500,000.
−Removed: The Investor shall also
−Removed: have a right of first refusal during the period beginning on the date of the Securities Purchase Agreement and continuing until such shareholder
−Removed: approval is obtained, on all issuances of convertible preferred stock of the Company, excluding agreements that are in place prior to
−Removed: the date of the Securities Purchase Agreement and issuances of new classes of convertible preferred stock in exchange for existing classes
−Removed: of convertible preferred stock.
−Removed: Additionally, the Investor has the right, pursuant to the Securities Purchase Agreement to appoint one
−Removed: member to, or to replace one member of, the Company’s board of directors, subject to all applicable Nasdaq rules.
−Removed: The Investor’s
−Removed: purchase of the remaining 3,500 shares of Series C Convertible Preferred Stock under the Securities Purchase Agreement in exchange for
−Removed: an additional $3,500,000 is required to occur within 120 calendar days of the date of the Securities Purchase Agreement, subject to the
−Removed: satisfaction of customary closing conditions.
−Removed: Series D Convertible Preferred Stock
−Removed: On January 6, 2025, the
−Removed: Company filed a certificate of designations of preferences, rights, and limitations of Series D Convertible Preferred Stock (the “Series
−Removed: D Certificate of Designations”) with the Department of State, Division of Corporations, of the State of Delaware, which provides
−Removed: for the designation of 5,000 shares of Series D Preferred Stock of the Company, par value $0.0001 per share, upon the terms and conditions
−Removed: as set forth in the Series D Certificate of Designations.
−Removed: Each share of Series D Preferred Stock has a stated value of $1,000 (the “Stated
−Removed: The Series D Preferred
−Removed: Stock shall rank (i) senior to the Company’s common stock and any other class or series of capital stock of the Company created
−Removed: hereafter, the terms of which specifically provide that such class or series shall rank junior to the Series D Preferred Stock, (ii) pari
−Removed: passu with any class or series of capital stock of the Company created hereafter specifically ranking, by its terms, on par with the Series
−Removed: D Preferred Stock, (iii) pari passu with the Series B Convertible Preferred Stock of the Company (the “Series B Preferred Stock”)
−Removed: with respect to its rights, preferences and restrictions, and (iv) pari passu with the Series C Convertible Preferred Stock of the Company
−Removed: (the “Series C Preferred Stock”).
−Removed: Holders of the Series
−Removed: D Preferred Stock have no voting power except as otherwise required by the Delaware General Corporation Law.
−Removed: Upon any liquidation,
−Removed: dissolution or winding-up of the Company, whether voluntary or involuntary (a “Liquidation”), the holders of the Series D
−Removed: Preferred Stock shall be entitled to receive out of the assets available for distribution to stockholders, (i) after and subject to the
−Removed: payment in full of all amounts required to be distributed to the holders of another class or series of stock of the Company ranking on
−Removed: liquidation prior and in preference to the Series D Preferred Stock, including the Series A Preferred Stock, (ii) ratably with any class
−Removed: or series of stock ranking on liquidation on parity with the Series D Preferred Stock and (iii) in preference and priority to the holders
−Removed: of the shares of Common Stock, an amount equal to 100% of the Stated Value of the Series D Preferred Stock, in proportion to the full
−Removed: and preferential amount that all shares of the Series D Preferred Stock are entitled to receive.
−Removed: Each share of Series
−Removed: D Preferred Stock shall be convertible into common stock (the “Conversion Shares”) at a conversion per share equal to $2.41,
−Removed: at the option of the holder, at any time after the Company has obtained shareholder approval for the issuance of the Conversion Shares
−Removed: pursuant to the rules of the Nasdaq Stock Market.
−Removed: In addition, the holder shall not have the right to convert any portion of the Series
−Removed: D Preferred Stock if, after giving effect to the conversion, such holder (together with its affiliates) would beneficially own in excess
−Removed: of 4.99% of the number of shares of the common stock outstanding immediately after giving effect to the issuance of the respective Conversion
−Removed: Wenzhao Lu Exchange Agreement
−Removed: 9, 2025, the Company entered into an exchange agreement with Wenzhao Lu, the Chairman of the Board of Directors of the Company, pursuant
−Removed: Lu exchanged 9,000 shares of Series A Preferred Stock of the Company for 5,000 shares of Series D Preferred Stock of the
−Removed: Company pursuant to an exemption from registration under Section 3(a)(9) of the Securities Act of 1933, as amended (the “Exchange”).
−Removed: Upon consummation of the Exchange, there were no shares of Series A Preferred Stock of the Company outstanding.
−Removed: Redemption Agreement
−Removed: During 2025, to preserve
−Removed: cash, the Company entered into discussions with Lab Services MSO for the potential redemption of our investment and on February 26, 2025,
−Removed: the Company, Avalon Lab, Laboratory Services MSO, and the other parties signatory thereto, entered into a Redemption and Abandonment Agreement
−Removed: (the “Redemption Agreement”), whereby Laboratory Services MSO redeemed the 40% equity interest in Laboratory Services MSO
−Removed: held by Avalon Lab for cash and the surrender of its Series B Convertible Preferred Stock having a carrying value of $11,000,000 (the
−Removed: “Redemption”).
−Removed: The aggregate cash amount to Avalon Lab for the Redemption was $1,745,000, to be paid as follows:
−Removed: of $95,000 at the closing of the Redemption and, beginning in March 2025, monthly payments of $75,000 until December 2026.
−Removed: pursuant to the terms of the Redemption Agreement, all shares of Avalon’s Series B Convertible Preferred Stock previously issued
−Removed: to SCBC Holdings LLC as partial consideration for the equity interests of Laboratory Services MSO, were permanently surrendered and relinquished
−Removed: to Avalon for no additional consideration.
−Removed: As a result of the Redemption, beginning in February 2025, we no longer offer laboratory services.
−Removed: Agreement and Plan
−Removed: On March 7, 2025, the
−Removed: Company, Nexus MergerSub Limited, a wholly owned subsidiary of the Company (“Merger Sub”), and YOOV Group Holding Limited
−Removed: (“YOOV”) entered into an Agreement and Plan of Merger (the “Merger Agreement”) pursuant to which Merger Sub will
−Removed: merge with and into YOOV, with YOOV surviving the merger and becoming a direct, wholly owned subsidiary of the Company (the “Merger”).
−Removed: The Merger is expected to be completed in the third quarter of 2025, subject to customary closing conditions.
−Removed: Subject to the terms
−Removed: and conditions of the Merger Agreement, immediately prior to the effective time of the Merger (the “Effective Time”), each
−Removed: then-outstanding share of YOOV preferred shares, par value $0.10 per share, will either automatically be converted into shares of YOOV
−Removed: ordinary shares, par value $0.10 per share (the “YOOV Ordinary Shares”) or canceled and cease to exist in accordance with
−Removed: At the Effective Time, each then-outstanding YOOV Ordinary Share (other than any shares held in treasury and Dissenting Shares
−Removed: (as defined in the Merger Agreement)) will be automatically converted into a number of shares of the Company’s common stock equal
−Removed: to the Exchange Ratio.
−Removed: The “Exchange Ratio” will be the ratio (rounded to four decimal places), determined as follows:
−Removed: the closing price of the Company’s common stock on Nasdaq on the second trading day immediately preceding the Effective Time is
−Removed: (x) less than or equal to $5.00, the Exchange Ratio shall be 60,000,000 divided by the Company Outstanding Shares (as defined in the Merger
−Removed: or (y) greater than $5.00, the Exchange Ratio shall be 54,000,000 divided by the Company Outstanding Shares.
−Removed: Pursuant to the terms
−Removed: of the Merger Agreement, (i) each then-outstanding share of the Company’s common stock will remain issued and outstanding after
−Removed: the Effective Time and (ii) each then-outstanding option to purchase Company common stock, whether or not vested, will remain issued and
−Removed: outstanding after the Effective Time.
−Removed: The then-outstanding shares of Series C Convertible Preferred Stock and Series D Convertible Preferred
−Removed: Stock will remain outstanding in accordance with their terms.
−Removed: Additionally, at the Effective Time, the Company’s name will be changed
−Removed: to “YOOV, Inc.”
−Removed: In connection with the
−Removed: Merger, the Company will seek approval of its stockholders to, among other things, (i) approve the issuance of the shares of the Company’s
−Removed: common stock to be issued to YOOV shareholders in connection with the Merger pursuant to the rules of Nasdaq and (ii) amend the Company’s
−Removed: certificate of incorporation to effect a reverse stock split of the Company’s common stock to the extent the Company and YOOV mutually
−Removed: agree implementing such reverse stock split is necessary to meet Nasdaq’s listing requirements (collectively, the “Avalon
−Removed: Stockholder Matters”).
−Removed: Each of the Company
−Removed: and YOOV have made customary representations, warranties and covenants in the Merger Agreement, including, among other things,
−Removed: covenants relating to (i) obtaining the requisite approval of its respective stockholders, (ii) non-solicitation or facilitation of
−Removed: any Takeover Proposal or Superior Proposal (as each is defined in the Merger Agreement), (iii) the conduct of its respective
−Removed: business during the period between the signing of the Merger Agreement and the closing of the Merger, and (iv) the Company filing
−Removed: with the SEC and causing to become effective a registration statement on Form S-4 (the “Registration Statement”) to
−Removed: register the shares of the Company’s common stock to be issued in connection with the Merger.
−Removed: Consummation of the Merger
−Removed: is subject to certain closing conditions, including, among other things, (i) approval of the Avalon Stockholder Matters by the requisite
−Removed: stockholders of the Company, (ii) adoption and approval of the Merger Agreement, and the transactions contemplated thereby, by the requisite
−Removed: YOOV shareholders, (iii) the effectiveness of the Registration Statement and (iv) the listing of the Company’s common stock issuable
−Removed: in connection with the Merger on Nasdaq.
−Removed: Each party’s obligation to consummate the Merger is also subject to other specified customary
−Removed: conditions, including regarding the accuracy of the representations and warranties of the other party, subject to the applicable materiality
−Removed: standard, and the performance in all material respects by the other party of its obligations under the Merger Agreement required to be
−Removed: performed on or prior to the Effective Time.
−Removed: The Merger Agreement
−Removed: contains certain termination rights for both the Company and YOOV, including the right to terminate the Merger Agreement at any time before
−Removed: the Effective Time, whether before or after the Avalon Stockholder Matters have been approved, by mutual written consent of the parties.
−Removed: In addition, the Merger Agreement may be terminated at any time by either party if the Merger is not consummated on or before March 7,
−Removed: 2026 (the “End Date”), provided that the End Date may be extended by either party for up to 60 days in the event that the
−Removed: SEC has not declared effective the Registration Statement by the date which is 60 days prior to the End Date.
−Removed: Upon termination of the
−Removed: Merger Agreement under specified circumstances, the Company may be required to pay YOOV a termination fee of $1.0 million;
−Removed: however, YOOV
−Removed: is not required to pay the Company a termination fee.
−Removed: At the Effective Time,
−Removed: the Company’s board of directors (the “Avalon Board”) is expected to consist of seven members, five of whom will be
−Removed: designated by YOOV and two of whom will be designated by the Company, as provided in the Merger Agreement.
−Removed: Voting and Support
−Removed: Concurrently with the
−Removed: execution of the Merger Agreement, (i) the officers, directors and certain shareholders of YOOV (solely in their respective capacities
−Removed: as YOOV shareholders) have entered into voting and support agreements with the Company and YOOV, pursuant to which such YOOV shareholders
−Removed: agree, among other things to, (a) not transfer their capital stock of YOOV, subject to certain limited exceptions and (b) vote all of
−Removed: their shares of capital stock of YOOV in favor of the adoption and approval of the Merger Agreement and the transactions contemplated
−Removed: thereby and against, among other things, any Takeover Proposals (the “YOOV Voting Agreement”) and (ii) the officers, directors
−Removed: and certain stockholders of the Company (solely in their respective capacities as the Company stockholders) have entered into voting and
−Removed: support agreements with the Company and YOOV, pursuant to which such Company stockholders agree, among other things to, (a) not transfer
−Removed: their capital stock of the Company, subject to certain limited exceptions and (b) vote all of their shares of Company capital stock in
−Removed: favor of, among other things, the Avalon Stockholder Matters and against, among other things, any Takeover Proposals (the “Avalon
−Removed: Voting Agreement”).
−Removed: Lock-Up Agreements
−Removed: Concurrently with the
−Removed: execution of the Merger Agreement, certain directors, officers and stockholders of each of the Company and YOOV have entered into lock-up
−Removed: agreements (the “Lock-Up Agreement”), pursuant to which, subject to specified exceptions, they have agreed not to transfer
−Removed: their shares of the Company’s common stock during the 180-day period following the Effective Time.
−Removed: Certificates of Elimination
−Removed: On March 7, 2025, the
−Removed: Company filed a Certificate of Elimination relating to each of the Series A Preferred Stock and the Series B Preferred Stock (the “Eliminations
−Removed: of Designation”) with the Secretary of State of the State of Delaware, thereby terminating the designations of the Series A Preferred
−Removed: Stock and the Series B Preferred Stock.
−Removed: The Eliminations of Designation were effective upon filing and eliminated from the Company’s
−Removed: Amended and Restated Certificate of Incorporation all matters set forth in the previously-filed Certificates of Designations with respect
−Removed: to the previously designated Series A Preferred Stock and Series B Preferred Stock.
−Removed: Bylaws Amendment
−Removed: On March 7, 2025, the
−Removed: Board approved and adopted an amendment (the “Amendment”) to the Company’s Amended and Restated Bylaws (the “Bylaws”).
−Removed: Amendment reduces the quorum at any meeting of stockholders, except as otherwise required by law or by the Company’s Amended and
−Removed: Restated Certificate of Incorporation or the Bylaws, to one-third of the voting power of the shares of capital stock outstanding and entitled
−Removed: to vote at the meeting, present in person, present by remote communication, if applicable, or represented by proxy.
+Added: Regulatory Environment
+Added: Our business is subject to a variety of laws and
+Added: regulations in the United States and, to the extent we expand internationally, abroad.
+Added: The principal regulatory frameworks applicable
+Added: to our two current operating segments are described below.
+Added: We anticipate that the regulatory environment applicable to our business —
+Added: particularly with respect to artificial intelligence and consumer data privacy — will continue to evolve rapidly, and we intend
+Added: to monitor legislative and regulatory developments and adapt our compliance programs accordingly.
+Added: Consumer Health Technology — FDA Regulatory
+Added: Framework Applicable to Keto Air
+Added: The Keto Air breathalyzer device is subject to
+Added: the regulatory authority of the U.S.
+Added: Food and Drug Administration ("FDA") under the Federal Food, Drug, and Cosmetic Act ("FD&C
+Added: The device is currently classified as a consumer product bearing an FDA registration number, which is required for the lawful
+Added: commercial sale of such devices in the United States.
+Added: The Keto Air device is not classified as a regulated medical device requiring FDA
+Added: pre-market approval or clearance under Section 510(k) of the FD&C Act, and accordingly may be sold directly to consumers without a
+Added: prescription or other regulatory authorization.
+Added: We are required to maintain the device's FDA registration
+Added: on an annual basis and to comply with applicable FDA general controls, including labeling requirements and prohibitions on the promotion
+Added: of the device for uses beyond its registered classification.
+Added: We do not make any medical claims with respect to the Keto Air device, and
+Added: our marketing materials are reviewed to ensure compliance with FDA labeling and advertising standards.
+Added: We are also subject to applicable
+Added: Consumer Product Safety Commission regulations governing the safety of consumer products sold in the United States.
+Added: We note that the regulatory classification of
+Added: consumer health and wellness devices is subject to ongoing FDA review and interpretation, and there can be no assurance that the FDA will
+Added: not, in the future, subject the Keto Air device or similar products to more stringent regulatory requirements, including pre-market approval
+Added: or clearance obligations.
+Added: Any such reclassification could materially affect our ability to sell the Keto Air device in the United States.
+Added: See Item 1A — Risk Factors for a further discussion of regulatory risks applicable to our consumer health technology segment.
+Added: Artificial Intelligence Content Technology
+Added: — AI-Specific Regulatory Landscape
+Added: The regulatory environment applicable to our artificial
+Added: intelligence content technology segment is rapidly evolving and subject to significant uncertainty.
+Added: The RPM platform generates AI-driven
+Added: short-form video content featuring AI-generated avatars that replicate the voice and likeness of content creators.
+Added: This functionality
+Added: implicates a range of existing and emerging regulatory frameworks, each of which is described below.
+Added: Right of Publicity and Name and Likeness Laws
+Added: The RPM platform's AI avatar feature — which
+Added: replicates the voice and likeness of a content creator based on input data provided by or about that creator — implicates state
+Added: right of publicity laws in the United States, which protect individuals against the unauthorized commercial use of their name, image,
+Added: voice, and likeness.
+Added: Right of publicity laws vary significantly across states, with particularly robust statutory frameworks in California,
+Added: New York, and Texas, among others.
+Added: Several states have recently enacted or are actively considering legislation specifically addressing
+Added: the use of artificial intelligence to generate synthetic media replicating an individual's voice or likeness.
+Added: We are actively monitoring
+Added: developments in this area and have structured our platform's onboarding process to require content creators to affirmatively authorize
+Added: the creation of their AI avatar as a condition of use.
+Added: There can be no assurance, however, that our current practices will be sufficient
+Added: to satisfy the requirements of all applicable state laws as they continue to evolve.
+Added: Federal Trade Commission Regulation
+Added: The Federal Trade Commission ("FTC")
+Added: has broad authority to regulate unfair or deceptive acts and practices under Section 5 of the FTC Act, and has increasingly focused its
+Added: enforcement activity on the use of artificial intelligence in commercial contexts.
+Added: The FTC has issued guidance requiring clear and conspicuous
+Added: disclosure of AI-generated content in advertising and commercial communications, and has signaled that the use of AI-generated endorsements,
+Added: testimonials, or representations of real individuals without adequate disclosure may constitute an unfair or deceptive trade practice.
+Added: We intend to comply with applicable FTC disclosure guidance in connection with the commercial deployment of the RPM platform and will
+Added: include appropriate disclosures in our platform's terms of service and content labeling practices.
+Added: Platform Content Policies
+Added: The RPM platform is designed to generate content
+Added: for distribution across major social media and content platforms, including YouTube, TikTok, Instagram, and others.
+Added: Each of these platforms
+Added: maintains its own content policies governing the disclosure and permissibility of AI-generated content, synthetic media, and avatar-based
+Added: representations of real individuals.
+Added: These policies are subject to frequent revision and vary across platforms.
+Added: Failure to comply with
+Added: applicable platform content policies could result in the removal of content generated through the RPM platform, the suspension or termination
+Added: of creator accounts on those platforms, or other restrictions that could adversely affect the utility and commercial appeal of our platform
+Added: to content creators.
+Added: Evolving Federal AI Regulation
+Added: Congress and various federal agencies
+Added: are actively considering comprehensive federal legislation and regulatory frameworks governing the development, deployment, and commercial
+Added: use of artificial intelligence technologies.
+Added: While no comprehensive federal AI law has been enacted as of the date of this Annual Report,
+Added: we anticipate that federal AI regulation will develop in the near to medium term and may impose disclosure, transparency, accountability,
+Added: or other obligations on companies operating AI-powered content generation platforms such as ours.
+Added: We are monitoring these legislative
+Added: and regulatory developments and intend to engage with applicable regulatory processes as they evolve.
+Added: International Regulatory Considerations
+Added: To the extent the RPM platform is accessed by
+Added: users located outside the United States, we may become subject to international AI regulatory frameworks, including the European Union
+Added: Artificial Intelligence Act (the "EU AI Act"), which entered into force in 2024 and establishes a tiered risk-based regulatory
+Added: framework for AI systems deployed in the European Union.
+Added: AI systems that generate synthetic audio or video content depicting real individuals
+Added: may be subject to specific transparency and disclosure obligations under the EU AI Act.
+Added: We are evaluating the extent to which our current
+Added: and planned platform activities may implicate obligations under the EU AI Act and other international AI regulatory frameworks.
+Added: Data Privacy and Security
+Added: Our business activities involve the collection,
+Added: storage, and processing of certain personal information, including consumer data collected through Keto Air device sales and email communications,
+Added: and content creator data — including voice and likeness data — collected through the RPM platform's beta program.
+Added: We are subject
+Added: to a range of federal, state, and international data privacy and security laws and regulations governing the collection, use, sharing,
+Added: protection, and retention of personal data.
+Added: At the federal level, the FTC continues to apply
+Added: its general consumer protection authority under Section 5 of the FTC Act to commercial data practices, including data security failures
+Added: and unfair or deceptive privacy practices.
+Added: At the state level, we are subject to the California Consumer Privacy Act, as amended by the
+Added: California Privacy Rights Act ("CPRA"), which establishes transparency obligations, restricts certain uses of personal information
+Added: of California residents, and provides California residents with rights to access, correct, and delete their personal information and to
+Added: opt out of the sale or sharing of their personal information.
+Added: Similar state privacy laws have been enacted in a growing number of states,
+Added: and we are monitoring and evaluating our compliance obligations under each applicable framework.
+Added: states have enacted data breach
+Added: notification laws requiring notification to affected individuals and state regulators in the event of certain unauthorized access to or
+Added: disclosure of personal information.
+Added: The collection and processing of voice and likeness
+Added: data through the RPM platform's avatar generation feature may implicate additional obligations under state biometric data privacy laws,
+Added: including the Illinois Biometric Information Privacy Act ("BIPA") and similar statutes in other states, which impose specific
+Added: consent, retention, and data security requirements on the collection and use of biometric identifiers, including voiceprints.
+Added: We are actively
+Added: evaluating our obligations under applicable biometric data privacy laws in connection with the commercial deployment of the RPM platform.
+Added: The scope and interpretation of applicable data
+Added: privacy laws continue to evolve rapidly, and we anticipate that our compliance obligations will increase as our platform scales and as
+Added: new laws are enacted.
+Added: See Item 1A — Risk Factors and Item 1C — Cybersecurity for a further discussion of data privacy and
+Added: cybersecurity risks.
Corporate and Available Information
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