−Removed: are an early-clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer.
−Removed: Our business now consists
−Removed: of one early-clinical-stage therapeutic program (QN-302) and one preclinical therapeutic program (Pan-RAS).
−Removed: addition, on April 11, 2024, we entered into a Co-Development Agreement (the “Co-Development Agreement”) with Marizyme, Inc.
−Removed: (“Marizyme”).
−Removed: The Co-Development Agreement contemplated that we would invest an aggregate of $800,000 in Marizyme in April
−Removed: 2024 (the “Funding Payment”) and pay Marizyme a $200,000 Exclusivity Fee (Provided, that if the parties so agree the total
−Removed: Funding Payment can be increased from time to time to up to a total of $1,500,000.) To date our Funding Payment investment has been $500,000,
−Removed: and in July 2024 we have advanced an additional $1,250,000 pursuant to an 18% demand promissory note, and in August 2024 we amended the
−Removed: Co-Development Agreement to increase the total Funding Payment to up to a total of $1,750,000.
−Removed: The Funding Payment is designed to provide
−Removed: financial support for commercialization of Marizyme’s DuraGraft™ vascular conduit solution, which is indicated for adult
−Removed: patients undergoing coronary artery bypass grafting surgeries and is intended for the flushing and storage of the saphenous vein grafts
−Removed: used in coronary artery bypass grafting surgery.
−Removed: In return for the Funding Payment we will receive quarterly a 33% payment in the nature
−Removed: of royalties on any Net Sales (as defined with a meaning tantamount to gross profit on net sales) of DuraGraft, capped at double the
−Removed: amount of the Funding Payment cash provided.
−Removed: No such payments-in-the-nature-of-royalties would accrue until after DuraGraft has been
−Removed: launched in the United States and a cumulative total of $500,000 of DuraGraft Net Sales have been made in the United States.
−Removed: Exclusivity Fee entitled us to an exclusivity period until May 31, 2024 (the “Exclusivity Period”) for purposes of proposing
−Removed: and outlining a broader strategic relationship with Marizyme with regard to Marizyme’s DuraGraft business.
−Removed: The Exclusivity Period
−Removed: has ended, and we do not intend to expand the Exclusivity Period.
−Removed: lead program, QN-302, is an investigational small molecule G-quadruplexes (G4)-selective transcription inhibitor with strong binding
−Removed: affinity to G4s prevalent in cancer cells (such as pancreatic cancer).
−Removed: Such binding could, by stabilizing the G4s against DNA “unwinding,”
−Removed: help inhibit cancer cell proliferation.
−Removed: QN-302 is currently undergoing a Phase 1a clinical trial at START Midwest in Grand Rapids, Michigan,
−Removed: and HonorHealth in Scottsdale, Arizona.
−Removed: Pan-RAS program, which is currently at the preclinical stage, consists of a family of RAS oncogene protein-protein interaction inhibitor
−Removed: small molecules believed to inhibit or block mutated RAS genes’ proteins from binding to their effector proteins thereby leaving
−Removed: the proteins from the mutated RAS unable to cause further harm.
−Removed: In theory, such mechanism of action may be effective in the treatment
−Removed: of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers.
−Removed: The investigational compounds
−Removed: within our Pan-RAS portfolio are designed to suppress the interaction of endogenous RAS with c-RAF, upstream of the KRAS, HRAS and NRAS
−Removed: effector pathways.
−Removed: May 22, 2020, we completed a “reverse recapitalization” transaction with Qualigen, Inc.
−Removed: (not to be confused with the Company);
−Removed: pursuant to which our merger subsidiary merged with and into Qualigen, Inc.
−Removed: with Qualigen, Inc.
−Removed: surviving as a wholly owned subsidiary
−Removed: of the Company.
−Removed: The Company, which had previously been known as Ritter Pharmaceuticals, Inc., was renamed Qualigen Therapeutics, Inc.,
−Removed: and the former stockholders of Qualigen, Inc.
−Removed: acquired, via the recapitalization, a substantial majority of the shares of the Company.
−Removed: Ritter/Qualigen Therapeutics common stock, which was previously traded on the Nasdaq Capital Market under the ticker symbol “RTTR,”
−Removed: commenced trading on Nasdaq, on a post-reverse-stock-split adjusted basis, under the ticker symbol “QLGN” on May 26, 2020.
−Removed: We are no longer pursuing the gastrointestinal disease treatment business on which Ritter Pharmaceuticals, Inc.
−Removed: had focused before the
−Removed: reverse recapitalization transaction.
−Removed: July 20, 2023, we sold our Qualigen, Inc.
−Removed: subsidiary, which contained our former FastPack ® diagnostics business to Chembio
−Removed: Diagnostics, Inc.
−Removed: (“Chembio”), an American subsidiary of French diagnostics provider Biosynex, S.A.
−Removed: The aggregate net purchase
−Removed: price for Qualigen, Inc.
−Removed: was $5.4 million in cash, of which $450,000 was being held in escrow to satisfy certain of our indemnification
−Removed: obligations until January 20, 2025.
−Removed: On June 4, 2024, the $450,000 escrow account was settled early and liquidated by mutual agreement
−Removed: between us and Chembio.
−Removed: In exchange for the early settlement, $350,000 was paid to the Company, and $100,000 was paid to Chembio.
−Removed: settlement resulted in a $100,000 loss from discontinued operations in the second quarter of 2024.
−Removed: Interest in NanoSynex
−Removed: own a minority interest in NanoSynex, Ltd.
−Removed: (“NanoSynex”), a privately-held microbiologics diagnostic company domiciled in
−Removed: NanoSynex’s technology is for Antimicrobial Susceptibility Testing that aims to enable better targeting of antibiotics
−Removed: for their most suitable uses to ultimately result in faster and more efficacious treatment, hence reducing hospitals’ mortality
−Removed: and morbidity rates.
−Removed: On May 26, 2022, we acquired a 52.8% interest in NanoSynex from our related party Alpha Capital Anstalt (“Alpha”)
−Removed: and NanoSynex, and entered into a Master Agreement for the Operational and Technological Funding of NanoSynex with NanoSynex (the “NanoSynex
−Removed: Funding Agreement”).
−Removed: On July 20, 2023, we entered into an Amendment and Settlement Agreement with NanoSynex (the “NanoSynex
−Removed: Amendment”), pursuant to which we agreed to, in exchange for eliminating all future NanoSynex Funding Agreement obligations for
−Removed: us to invest further cash in NanoSynex (except for obligations to lend NanoSynex $560,000 on or before November 30, 2023, and $670,000
−Removed: on or before March 31, 2024), surrender 281,000 Series B Preferred Shares of NanoSynex held by us, resulting in our ownership in NanoSynex
−Removed: being reduced from approximately 52.8% to approximately 49.97% of the voting equity of NanoSynex;
−Removed: in addition, we agreed to surrender
−Removed: approximately $3.0 million of promissory notes which NanoSynex had issued to us under the Funding Agreement.
−Removed: On November 22, 2023 we
−Removed: further agreed to eliminate our obligations to lend NanoSynex $560,000 on or before November 30, 2023, and $670,000 on or before March
−Removed: 31, 2024, by instead surrendering shares of Series A-1 Preferred Stock of NanoSynex in an amount that reduced our ownership in NanoSynex
−Removed: voting equity from approximately 49.97% to 39.90%.
−Removed: to Certificate of Designation of Series A-2 Preferred Stock
−Removed: December 23, 2024, we filed an Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of the Series A-2
−Removed: Preferred Stock (the “Amended and Restated Certificate of Designation”) with the Secretary of State of Delaware, following
−Removed: approval by the Board of Directors of the Company (“Board”) and by the holders of at least 67% of the outstanding shares
−Removed: of Series A-2 Preferred Stock, par value $0.001 per share (the “Series A-2 Preferred Stock”).
−Removed: The Amended and Restated Certificate
−Removed: of Designation amends certain provisions of the Series A-2 Preferred Stock, specifically to prohibit any adjustment to the conversion
−Removed: price unless approved by a majority of the shareholders entitled to vote in accordance with Nasdaq Rule 5635(d).
−Removed: 2024 Preferred Stock Offering
−Removed: entered into a Securities Purchase Agreement (the “November Securities Purchase Agreement”) on November 18, 2024 with certain
−Removed: institutional and accredited investors (the “Investors”).
−Removed: Pursuant to the Securities Purchase Agreement, the Company agreed
−Removed: to sell and issue shares of Qualigen’s newly designated Series A-2 Preferred Stock, par value $0.001 per share (the “Qualigen
−Removed: Series A-2 Preferred Stock”), in a private placement transaction (the “November Private Placement”).
−Removed: The closing of
−Removed: the November Private Placement was on November 20, 2024.
−Removed: We sold and issued to the Investors 5,100 shares of Qualigen Series A-2 Preferred
−Removed: Stock at a purchase price of $1,000 per share, for an aggregate purchase price of $5.1 million.
−Removed: share of Qualigen Series A-2 Preferred Stock was, at any time at the option of the holder, convertible into a number of shares of the
−Removed: Company’s common stock equal to $1,000 shares divided by a conversion price initially equal to $3.64, subject to adjustment for
−Removed: any stock splits, stock dividends and similar events and also subject to “ratchet” antidilution adjustment (subject to certain
−Removed: customary exceptions), provided that any conversion of Qualigen Series A-2 Preferred Stock by a holder into shares of the Company’s
−Removed: common stock would be prohibited if, as a result of such conversion, the holder, together with its affiliates and any other person or
−Removed: entity whose beneficial ownership of the common stock would be aggregated with such holder’s for purposes of Section 13(d) of the
−Removed: Securities Exchange Act of 1934, as amended, would beneficially own more than 4.99% of the total number of shares of the Company’s
−Removed: common stock issued and outstanding after giving effect to such conversion.
−Removed: Upon written notice to the Company, the holder could from
−Removed: time to time increase or decrease such limitation to any other percentage not in excess of 9.99% specified in such notice.
−Removed: of Qualigen Series A-2 Preferred Stock was entitled to a preference of $1,000 per share upon liquidation of the Company.
−Removed: Without consent
−Removed: of the holders of at least 67% of the Qualigen Series A-2 Preferred Stock, The Company could not amend its charter documents to materially
−Removed: and adversely affect the rights of the Qualigen Series A-2 Preferred Stock, repurchase certain junior securities of the Company, pay
−Removed: cash dividends on junior securities of us or (unless it is at arm’s-length and is approved by a majority of our disinterested directors)
−Removed: enter into a material transaction with an affiliate of us.
−Removed: Agreement with Chen
−Removed: November 18, 2024, we entered into an Exchange Agreement (the “Exchange Agreement”) with Yi Hua Chen (“Chen”)
−Removed: pursuant to which we issued 1,154 shares of our newly-designated Series A-2 Convertible Preferred Stock, par value $0.001 per share.
−Removed: The shares of Series A-2 Preferred Stock was issued in exchange for the conversion of the $1,100,000 convertible notes issued on April
−Removed: November 5, 2024, we implemented a 1-for-50 reverse stock split of the issued shares of its common stock (the “Reverse Stock Split”),
−Removed: effective at 12:01 a.m.
−Removed: Eastern time on November 5, 2024.
−Removed: Our common stock began trading on a split-adjusted basis when the market opened
−Removed: on Tuesday, November 5, 2024, and will continue to trade on The Nasdaq Capital Market under the symbol “QLGN.” The new CUSIP
−Removed: number for the common stock is 74754R301.
−Removed: Reverse Stock Split is intended to increase the bid price of the common stock to enable the Company to regain compliance with the minimum
−Removed: bid price requirement for continued listing on The Nasdaq Capital Market.
−Removed: The Company’s stockholders authorized the Reverse Stock
−Removed: Split at the Company’s annual meeting of stockholders held on October 25, 2024, with the final ratio subsequently determined by
−Removed: a result of the Reverse Stock Split, every 50 shares of the Company’s pre-split common stock issued and outstanding were automatically
−Removed: reclassified into one new share of the Company’s common stock.
−Removed: This reduced the number of shares outstanding from 36,837,020 shares
−Removed: to 736,431 shares as of November 5, 2024.
−Removed: The number of authorized shares of the Company’s common stock will remain unchanged.
−Removed: Stockholders who would otherwise be entitled to receive a fractional share will receive cash (without interest or deduction) in lieu
−Removed: of such fractional shares, after aggregating all the fractional interests of such holder resulting from the Reverse Stock Split.
−Removed: Proportionate
−Removed: adjustments will be made to the exercise prices and the number of shares underlying the Company’s equity plans and grants thereunder,
−Removed: as applicable.
−Removed: The Reverse Stock Split will not affect the par value of the common stock.
−Removed: All share numbers and exercise prices in this document have been adjusted
−Removed: for the Reverse Stock Split.
+Added: Holdings, Inc.
+Added: AIXC) (“AIxC,” “we,” “us,” or the “Company”) is a technology
+Added: infrastructure company focused on the convergence of artificial intelligence and blockchain-based programmable systems.
+Added: The Company develops
+Added: software platforms and programmable infrastructure designed to facilitate the tokenization of real-world assets (“RWA”) and
+Added: the deployment of Embodied Artificial Intelligence (“EAI”) in commercial environments.
+Added: Our mission is to serve as the regulated,
+Added: programmable infrastructure layer connecting traditional capital markets with on-chain systems and AI-enabled commercial systems.
+Added: believe that two structural shifts are reshaping global capital markets and physical infrastructure simultaneously:
+Added: the migration of
+Added: asset ownership and transaction finalization to distributed ledger technology, and the proliferation of AI-enabled physical systems such
+Added: as autonomous vehicles, robotics, and connected systems that generate, consume, and require programmable infrastructure.
+Added: AIxC is purpose-built
+Added: to sit at the intersection of these trends.
+Added: In September 2025, the Company
+Added: closed a $41 million PIPE financing and subsequently , in November 2025, rebranded from Qualigen Therapeutics to AIxCrypto Holdings, Inc.
+Added: Following the transaction, the Company operated across three business lines under its “Three Driving Forces”
+Added: the BesTrade DeAI Agent platform, the C10 digital asset treasury and portfolio management tools, and the RWA Embodied AI (EAI)
+Added: In February 2026, the Company’s board determined
+Added: to concentrate on the RWA + Embodied AI (EAI) ecosystem.
+Added: In connection with that decision, the Company has determined to discontinue development
+Added: of the BesTrade platform and the C10 portfolio management tools.
+Added: These products were developed as early-stage proofs of concept and did
+Added: not meet the scale, regulatory profile, or margin characteristics consistent with the Company’s revised focus on enterprise and institutional
+Added: infrastructure.
+Added: The Company does not anticipate material impairment charges in connection with this discontinuation beyond what has been
+Added: previously disclosed.
+Added: Separately, the Company continues
+Added: to evaluate strategic options for its therapeutics programs, previously conducted under the Qualigen brand.
+Added: These options may include
+Added: proceeding with the existing QN-302 trial, licensing the asset, or an outright sale.
+Added: The effect of these actions is a Company that operates with a
+Added: focused capital structure, reduced operational complexity, and a business model that institutional investors can evaluate against a defined
+Added: set of infrastructure and programmable technology benchmarks.
+Added: The Dual-Pillar Strategy
+Added: operations are organized around two integrated business pillars, which we refer to collectively as our Dual Flywheel strategy.
+Added: pillars are designed to be mutually reinforcing:
+Added: revenue and data generated through RWA tokenization activities support the development
+Added: and refinement of EAI infrastructure, and EAI deployment generates on-chain transaction volume and ecosystem participation that drives
+Added: RWA structuring demand.
+Added: Asset Tokenization
+Added: develops and operates software infrastructure for the digitization of traditional assets onto distributed ledger networks.
+Added: Our tokenization
+Added: framework is designed to preserve regulatory compliance at each stage of the asset lifecycle by encoding compliance logic, transfer restrictions,
+Added: and ownership records directly into smart contracts.
+Added: This approach is intended to give institutional counterparties the auditability
+Added: and mathematical certainty that trust-based legacy systems cannot provide at scale.
+Added: initial commercial application involves a $10 million strategic equity investment in common stock of Faraday Future Intelligent Electric
+Added: FFAI), which is currently anticipated to close before March 31, 2026.
+Added: Pursuant to an Entrusted Investment Agreement, the shares are currently held by an independent third party.
+Added: The Company intends to develop
+Added: a tokenization framework for these holdings as a reference implementation for investors seeking access to on-chain liquidity for traditional
+Added: equity positions.
+Added: The tokenization of this investment has not yet been completed and is subject to the development of applicable technical
+Added: and regulatory infrastructure.
+Added: The Company intends to generate revenue from this pillar through structuring fees, platform licensing
+Added: to enterprises utilizing our tokenization infrastructure, and management fees associated with on-chain asset administration.
+Added: AI Infrastructure
+Added: Company’s EAI pillar is focused on building the execution and monetization layer for AI-enabled physical systems.
+Added: As autonomous
+Added: mobility, robotics, and connected equipment generate increasing volumes of operational data, we believe there is a significant unaddressed
+Added: need for programmable infrastructure that can govern the economic relationships between AI agents, human principals, and the capital
+Added: that funds their deployment.
+Added: is developing the AIxC Hub, a decentralized application ecosystem designed to facilitate the registration, validation, and deployment
+Added: of AI models, with transaction finalization and incentive structures encoded on-chain.
+Added: The Company’s early-stage commercial collaboration
+Added: with FFAI Robotics Inc., a subsidiary of Faraday Future Intelligent Electric Inc.
+Added: FFAI), is expected to provide an initial deployment
+Added: environment for this infrastructure, with FFAI Robotics’ EAI-enabled vehicle and robotics programs serving as a primary source
+Added: of real-world operational data.
+Added: No definitive commercial agreements governing this collaboration have been executed, and there can be
+Added: no assurance that any such agreements will be reached.
+Added: Company expects to generate revenue through three primary channels as its platforms achieve commercial scale.
+Added: Platform licensing fees
+Added: will be charged to enterprise customers utilizing AIxC’s EAI infrastructure and tokenization stack.
+Added: Structuring and transaction
+Added: fees will be earned in connection with the management and administration of tokenized assets.
+Added: Ecosystem participation revenue will be
+Added: derived from the growth and utilization of the AIxC Hub, including validator economics, model deployment fees, and protocol-level participation
+Added: Company’s EAI and RWA platforms are in the early stages of commercialization and have not generated material revenue to date.
+Added: should review the risk factors and forward-looking statement disclosures in this filing carefully before making an investment decision.
+Added: Position and Regulatory Framework
+Added: competes with a range of participants across the tokenization and AI infrastructure competitive environment, including both established
+Added: technology companies and early-stage blockchain-native platforms.
+Added: We believe our differentiation lies in our focus on institutional compliance
+Added: infrastructure, our existing regulatory posture as a Nasdaq-listed public company, and our early commercial relationship with an EAI-focused
+Added: hardware partner that provides real-world data and deployment context for our AI infrastructure.
+Added: Company’s operations are subject to evolving regulatory frameworks governing digital assets, blockchain-based securities, and AI
+Added: systems in the United States and other jurisdictions.
+Added: We maintain an active regulatory compliance program and are engaged with applicable
+Added: regulatory bodies as the legal landscape for these technologies continues to develop.
+Added: Market Opportunity
+Added: The macro backdrop supports
+Added: our strategy.
+Added: Blockchain adoption is accelerating across industries from roughly $41 billion in 2025 to approximately $1.9 trillion by
+Added: 2034, representing more than a 50% compound annual growth rate.
+Added: Institutional interest continues to grow, with surveys showing over 70%
+Added: of organizations adopting or planning to adopt blockchain for supply chain, payments, and data systems.
+Added: The on-chain RWA market has grown
+Added: to more than $20 billion in 2025, a more than 300% increase over three years, with some forecasts projecting tokenized assets reaching
+Added: many trillions within a decade.
+Added: The global AI Agent market is approximately $7 billion today and is projected to exceed $47 billion by
+Added: 2030, representing a compound annual growth rate of nearly 45%.
+Added: These two markets are each growing at exceptional rates, and the intersection
+Added: between them has virtually no competition.
+Added: Human Capital Management
+Added: As of December 31, 2025, we had
+Added: 10 employees.
+Added: in addition, we engaged certain consultants and advisors, including a Chief Advisor role and
+Added: executive advisors, who provide strategic guidance to the company.
+Added: The company also benefits from a Transition Service Agreement (TSA)
+Added: between Faraday Future (“FF”) and AIXC, under which FF provides certain operational support, expertise, and resources to assist
+Added: the company in advancing its strategic and business objectives.
+Added: February 12, 2026, we announced a strategic partnership with BitMart to launch a co-branded virtual prepaid card.
+Added: will enhance real-world payment flexibility for digital asset users.
+Added: February 2, 2026, AIxC Hub surpassed 1 million registered wallets and launched Tenk, a new AI-;powered interactive game further enhancing
+Added: user retention.
+Added: AIxC official X account ranked seven among top regional discussion leaderboards.
+Added: January 15, 2026, AIxC announced that AIxC Hub exceeded 500,000 registered wallets and 200,000 daily active participants in the first
+Added: week following the launch.
+Added: The AIxC Hub is data engine that captures human decision-making patterns to train embodied AI models.
+Added: It is based on zero capital participation model, minimizing financial barriers with forecasting capabilities for the C10 Index, and provides
+Added: Points systems for community participants.
+Added: November 20, 2025, the company was renamed from Qualigen and rebranded as AixCrypto Holdings, Inc.
+Added: The Company will take
+Added: blockchain as foundational technology and artificial intelligence as a major driver of creating a global ecosystem connecting Web2 and
+Added: September 2025 PIPE Financing
+Added: In September 2025, the Company
+Added: consummated a subscription agreement (the “Subscription Agreement”) with certain investors, including Faraday Future Intelligent
+Added: Electric Inc.
+Added: FFAI) (the “Lead Investor”), pursuant to which the investors purchased $40.7 million (the “Offering”)
+Added: of the Company’s common stock and shares of a newly created Series B Convertible Preferred Stock, par value $0.001 per share (the “Series
+Added: B Preferred Stock”).
+Added: Up to $6.8 million of the net proceeds from the Offering were used to pay existing debt and fund existing business
+Added: The remainder of the proceeds, including contributed cryptocurrency, was allocated to the establishment of the Company’s digital
+Added: asset treasury operations and related Web3 and AI infrastructure initiatives.
+Added: Further, in connection with the closing of the Subscription
+Added: Agreement, 1,087,266 warrants were issued to the placement agent, (the “Placement Agent Warrants”).
+Added: The Placement Agent Warrants
+Added: were immediately exercisable and have an initial exercise price of $2.47 per share.
+Added: At December 31, 2025, 1,087,266 Placement Agent Warrants
+Added: remain outstanding.
+Added: In connection with the closing
+Added: of the Offering, the Company rebranded from Qualigen Therapeutics, Inc.
+Added: to AIxCrypto Holdings, Inc.
+Added: and began trading on Nasdaq under
+Added: the ticker symbol AIXC in November 2025.
+Added: Following the rebrand, the Company operated across three business lines:
+Added: the BesTrade DeAI Agent
+Added: trading platform, the C10 digital asset treasury and portfolio management tools, and its Real World Asset and Embodied AI (EAI) ecosystem.
+Added: Subsequent to the closing
+Added: of the Offering, the Company undertook a further strategic realignment, as described above under “Strategic Realignment.”
+Added: July 2025 Financing
+Added: In July 2025, the Company closed a private placement transaction to raise
+Added: additional funding through the sale of 4,500 shares of Series A-3 Preferred Stock at a purchase price of $1,000 per share, for a net total
+Added: of $4.2 million.
Agency LLC Consulting Agreement
10 unchanged sentences
dated October 9, 2024, between the Company and IR Agency, LLC (“IR Agency”), a provider of investor relations services, became
−Removed: Pursuant to the terms of the agreement, $800,000 of the proceeds has been paid to IR Agency for services to be rendered up until the third quarter of 2025.
−Removed: 2024 Public Offering
−Removed: September 5, 2024, we entered into a placement agency agreement (the “September Placement Agent Agreement”) with
−Removed: Univest Securities, LLC (“Univest”), to sell the September Shares (as defined below) to certain institutional investors that
−Removed: were included in a public offering (the “September Offering”) of 294,481 shares of common stock (each a “September Share,” and collectively, the “September Shares”) at public offering price
−Removed: of $6.50 per September Share and pre-funded warrants to purchase up to 239,455 shares at a price of $6.45 per share with an exercise
−Removed: price of $0.05 per share (the “September Pre-Funded Warrants”).
−Removed: The September Pre-Funded Warrants are exercisable upon issuance
−Removed: and will remain exercisable until all the September Pre-Funded Warrants are exercised in full.
−Removed: closing of the September Offering occurred on September 6, 2024, and the Company received aggregate gross proceeds of $3.47 million,
−Removed: before payment of placement agent fees and expenses and other transaction costs.
−Removed: At the closing of the September Offering, the Company
−Removed: also issued to Univest, the exclusive placement agent in the September Offering, a warrant to purchase 16,018 Shares (the “September
−Removed: Placement Agent Warrant”), pursuant to the September Placement Agent Agreement.
−Removed: The September Placement Agent Warrant has a term
−Removed: of five years commencing from the date of sales in the September Offering, is exercisable after 180 days after issuance, and has an exercise
−Removed: price of $7.80 per share of common stock.
−Removed: We paid Univest a cash fee equal to 3% of the gross proceeds received in the September
−Removed: Offering and certain other amounts for reimbursement of expenses incurred by Univest in connection with the September Offering.
−Removed: 2024 Private Placement
−Removed: February 26, 2024, we entered into a Securities Purchase Agreement (the “February Purchase Agreement”) with Alpha.
−Removed: transactions contemplated by the February Purchase Agreement closed on February 27, 2024, at which time we delivered to Alpha a new
−Removed: debenture and warrant, as described in this paragraph, and Alpha paid us a cash purchase price of $500,000 (less expenses).
−Removed: to the February Purchase Agreement, we issued to Alpha an 8% Convertible Debenture (the “2024 Debenture”) in the
−Removed: principal amount of $550,000.
−Removed: The 2024 Debenture has a maturity date of December 31, 2024 and was convertible from time to time, at
−Removed: Alpha’s option, into shares of common stock, at $6.50 per share, subject to adjustment as described in the 2024 Debenture.
−Removed: 2024 Debenture accrues interest on its outstanding principal balance at the rate of 8% per annum, payable at maturity.
−Removed: the terms of the February Purchase Agreement, we also issued to Alpha a 5-year common stock purchase warrant to purchase 18,001
−Removed: shares of common stock at $13.00 per share.
−Removed: We also granted to Alpha an option (the “Option”) that was exercisable until
−Removed: July 1, 2024, to purchase from us additional 8% Convertible Debentures, of like tenor, with face amounts of up to an aggregate of
−Removed: $1,100,000 (and with a proportional number of accompanying common stock warrants of like tenor, up to a total of 36,001 additional
−Removed: warrants), which would (if and when Alpha exercises such option) provide us up to an additional $1.0 million in cash proceeds (less
−Removed: expense reimbursement, and not including any possible cash proceeds from any future exercise of the additional warrants).
−Removed: Alpha assigned the Option to Chen in April 2024.
−Removed: exclusively in-licensed the global rights to the G-Quadruplex (“G4”) selective transcription inhibitor platform from University
−Removed: College London (“UCL”) in January 2022.
−Removed: The licensed technology comprises lead compound QN-302 (formerly known as SOP1812)
−Removed: and back-up compounds that target regulatory regions of cancer genes that down-regulate gene expression in multiple cancer pathways.
−Removed: Developed by Dr.
−Removed: Stephen Neidle and his group at UCL, the G4 binding concept is derived from nucleic acid research conducted over more
−Removed: than over 30 years, including research on G4s, which are higher order DNA and RNA structures formed by sequences containing guanine-rich
−Removed: G4s are overrepresented in telomeres (a region of repetitive DNA sequences at the end of a chromosome) as well as promoter sequences
−Removed: and untranslated regions of many oncogenes.
−Removed: Their prevalence is therefore significantly greater in cancer cells compared to normal human
−Removed: small molecules such as QN-302 and backup compounds target the regulatory regions of cancer genes, which have a high prevalence of enriched
−Removed: Stable G4-QN-302 complexes can be impediments to replication, transcription or translation of those cancer genes containing G4s,
−Removed: and the drugs’ binding to G4s are believed to stabilize the G4s against possible “unwinding.” G4 binders like QN-302
−Removed: could be efficacious in a variety of cancer types with a high prevalence of G4s.
−Removed: believe that QN-302 has the potential to demonstrate superior efficacy and activity against pancreatic ductal adenocarcinoma (“PDAC”),
−Removed: which represents 98% of pancreatic cancers.
−Removed: Pancreatic cancer is the tenth most common cancer in men and the seventh most common in women,
−Removed: but it is the fourth leading cause of cancer deaths in men and the third leading cause in women;
−Removed: it accounts for about 3% of all cancers
−Removed: in the United States but is responsible for about 8% of all cancer-related deaths.
−Removed: It has one of the lowest rates of survival of all
−Removed: cancer types.
−Removed: and in-vivo studies have shown that G4 stabilization by QN-302 resulted in inhibition of target gene expression and cessation
−Removed: of cell growth in various cancers, including PDAC.
−Removed: In in-vitro studies, QN-302 was potent in inhibiting the growth of several
−Removed: PDAC cell lines at low nanomolar concentrations.
−Removed: Similarly, in in-vivo studies, QN-302 showed a longer survival duration in a
−Removed: KPC genetic mouse model for pancreatic cancer than gemcitabine (the current standard of care for PDAC) has historically shown.
−Removed: preclinical in-vivo studies suggest activity in gemcitabine-resistant PDAC.
−Removed: Data further demonstrated that QN-302 had significant
−Removed: anti-tumor activity in three patient-derived PDAC xenograft models.
−Removed: Early safety indicators in pancreatic cancer mouse in-vivo
−Removed: models suggest no significant adverse toxic effects at proposed therapeutic doses.
−Removed: January 9, 2023, the U.S.
−Removed: Food and Drug Administration (“FDA”) granted Orphan Drug Designation (“ODD”) to QN-302
−Removed: for the indication of pancreatic cancer.
−Removed: ODD provides advantages to pharmaceutical companies that are developing investigational drugs
−Removed: or biological products that show promise in treating rare diseases or conditions that affect fewer than 200,000 people in the United
−Removed: States, including seven-year marketing exclusivity and eligibility to receive regulatory support and guidance from the FDA in the design
−Removed: of an overall drug development plan.
−Removed: are also economic advantages to receiving ODD, including a 25% federal tax credit for expenses incurred in conducting clinical research
−Removed: on the orphan designated product within the United States.
−Removed: Tax credits may be applied to the prior year or applied to up to 20 years
−Removed: of future taxes.
−Removed: ODD recipients may also have their Prescription Drug User Fee Act (PDUFA) application fees waived, a potential savings
−Removed: of around $3.2 million (as of fiscal year 2023) for applications requiring covered clinical data, and may qualify to compete for research
−Removed: grants from the Office of Orphan Products Development that support clinical studies.
−Removed: August 1, 2023 we announced that the FDA had cleared our investigational new drug (“IND”) application for QN-302, and on
−Removed: November 1, 2023 the first patient in our Phase 1a clinical trial for QN-302 was dosed at START Midwest in Grand Rapids, Michigan.
−Removed: will require additional cash resources to be able to continue and complete this Phase 1a clinical trial.
−Removed: (formerly referred to as RAS or RAS-F)
−Removed: July 2020 we entered into an exclusive worldwide in-license agreement with the University of Louisville Research Foundation, Inc.
−Removed: for the intellectual property covering the “RAS” family of pan-RAS inhibitor small molecule drug candidates, which are believed
−Removed: to work by blocking RAS mutations directly, thereby inhibiting tumor formation (especially in pancreatic, colorectal and lung cancers).
−Removed: Pursuant to the license agreement, we will seek to identify and develop a lead drug candidate from the compound family and, upon commercialization,
−Removed: will pay UofL royalties in the low-to-mid-single-digit percentages on net sales of Pan-RAS inhibitor licensed products.
−Removed: The license agreement
−Removed: with UofL for Pan-RAS was amended in March 2021 and June 2023.
−Removed: is the most common oncogene in human cancer.
−Removed: Activating mutations in one of the three human RAS gene isoforms (KRAS, HRAS or NRAS) are
−Removed: present in about one-fourth to one-third of all cancers.
−Removed: For example, mutant KRAS is found in 98% of pancreatic ductal adenocarcinomas,
−Removed: 52% of colon cancers, and 32% of lung adenocarcinomas.
−Removed: For these three cancer types, cancers with mutant KRAS are diagnosed in more than
−Removed: 170,000 people each year in the United States and cause more than 120,000 deaths.
−Removed: Drugs that target signaling downstream of RAS are available;
−Removed: however, such drugs have shown disappointing clinical durability because RAS is a “hub” that activates multiple effectors,
−Removed: so drugs that block a single pathway downstream may not account for the many other activated pathways.
−Removed: also had a sponsored research agreement with UofL for Pan-RAS research;
−Removed: that agreement expired in December 2023.
−Removed: February 15, 2024, we entered into a License and Sublicense Agreement with Pan-RAS Holdings, Inc., a New York corporation (“Pan-RAS
−Removed: Holdings”), which contemplated an exclusive out-license of our Pan-RAS drug development program, including our rights under the
−Removed: UofL license agreement, Pan-RAS Holdings.
−Removed: Although the License and Sublicense Agreement called for a closing by March 16, 2024, the License
−Removed: and Sublicense Agreement was in essence structured as a 30-day option in favor of Pan-RAS Holdings.
−Removed: At the contemplated closing, Pan-RAS
−Removed: Holdings would have paid us an upfront fee of $1,000,000 in cash.
−Removed: In addition, Pan-RAS Holdings would have become responsible to pay
−Removed: on our behalf our in-license royalty obligations to UofL, as and when required.
−Removed: Finally, if the contemplated closing had occurred, Pan-RAS
−Removed: Holdings would have been required to pay to us for our own account, on a semiannual basis, royalties equal to 1.0% of net sales of any
−Removed: RAS products.
−Removed: We would have owed certain amounts to UofL under our in-license agreement from them, if, as and when we received any Non-Royalty
−Removed: Sublicensing Income from Pan-RAS Holdings.
−Removed: Holdings did not effectuate the closing by March 16, 2024, and we and they voluntarily terminated the License and Sublicense Agreement
−Removed: effective as of March 16, 2024.
−Removed: have discontinued all of our efforts as to the following programs, and we do not plan to resume them:
−Removed: QN-247 (formerly referred
−Removed: to as ALAN or AS1411-GNP) – an oligonucleotide aptamer-based, nucleolin-inhibiting anticancer drug candidate, consisting
−Removed: of QN-165 conjugated with gold nanoparticles.
−Removed: QN-165 (formerly referred to as AS1411)
−Removed: – an oligonucleotide aptamer-based drug candidate for the potential broad-spectrum treatment of infectious diseases such as
−Removed: Selective Target Antigen Removal System (STARS)
−Removed: – a therapeutic blood-filtering device product concept, which would be designed to remove circulating tumor cells,
−Removed: viruses, inflammation factors and immune checkpoints.
−Removed: and Development
−Removed: research and development of our drug candidates, we have historically leveraged the scientific and technical resources and laboratory
−Removed: facilities of UofL and UCL, through technology licensing, sponsored research, and other consulting agreements.
−Removed: We have engaged contract
−Removed: research organizations (“CROs”) and clinical sites for the Phase 1a clinical trial of QN-302.
−Removed: We intend to focus our internal
−Removed: research and development on oversight of these CROs.
+Added: Pursuant to the terms of the agreement, $800,000 of the proceeds has been paid to IR Agency.
+Added: Research and Development
+Added: For research and development
+Added: of our drug candidates, we have historically leveraged the scientific and technical resources and laboratory facilities of UofL and UCL,
+Added: through technology licensing, sponsored research, and other consulting agreements.
+Added: We have engaged contract research organizations (“CROs”)
+Added: and clinical sites for the Phase 1a clinical trial of QN-302.
+Added: We intend to focus our internal research and development on oversight of
We currently have no internal research and development facilities.
−Removed: have obtained FDA clearance/approval for our QN-302 Phase 1a clinical trial.
−Removed: We have not obtained FDA or other regulatory approval for
−Removed: any other drug candidate.
−Removed: States—FDA Drug Approval Process
−Removed: research, development, testing, and manufacture of product candidates are extensively regulated by governmental authorities in the United
−Removed: States and other countries.
−Removed: In the United States, the FDA regulates drugs under the Food, Drug and Cosmetics Act and its implementing
−Removed: steps required to be completed before a drug may be marketed in the United States include, among others:
−Removed: preclinical laboratory tests, animal
−Removed: studies, and formulation studies, all performed in accordance with the FDA’s Good Laboratory Practice (“GLP”) regulations;
−Removed: submission to the FDA of an IND application for human
−Removed: clinical testing, which must become effective before human clinical trials may begin and for which progress reports must be submitted
−Removed: annually to the FDA;
−Removed: an independent institutional review board (“IRB”) or Ethics Committee (“EC”) at each clinical trial site
−Removed: before each trial may be initiated;
−Removed: adequate and well-controlled
−Removed: human clinical trials, conducted in accordance with applicable IND regulations, Good Clinical Practices (“GCP”), and
−Removed: other clinical trial related regulations, to establish the safety and efficacy of the drug for each proposed indication to the FDA’s
−Removed: satisfaction;
−Removed: submission to the FDA of
−Removed: a New Drug Application (“NDA”) and payment of user fees for FDA review of the NDA (unless a fee waiver applies);
−Removed: satisfactory completion
−Removed: of an FDA pre-approval inspection of one or more clinical trial site(s) at which the drug was studied in a clinical trial(s) and/or
−Removed: of us as a clinical trial sponsor to assess compliance with GCP regulations;
−Removed: satisfactory completion
−Removed: of an FDA pre-approval inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance
−Removed: with current GMPs regulations;
−Removed: agreement with the FDA
−Removed: on the final labeling for the product and the design and implementation of any required Risk Evaluation and Mitigation Strategy;
−Removed: FDA review and approval
−Removed: of the NDA, including satisfactory completion of an FDA advisory committee review, if applicable, based on a determination that the
−Removed: drug is safe and effective for the proposed indication(s).
−Removed: tests include laboratory evaluation of product chemistry, toxicity, and formulation, as well as animal studies.
−Removed: The conduct of the preclinical
−Removed: tests and formulation of the compounds for testing must comply with federal regulations and requirements, including GLP regulations.
−Removed: The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of
−Removed: an IND application, which must become effective before human clinical trials may begin.
−Removed: We cannot be certain that submission of an IND
−Removed: application will result in the FDA allowing clinical trials to begin.
−Removed: trials necessary for product approval are typically conducted in three sequential phases, but the phases may overlap or be combined.
−Removed: The study protocol and informed consent information for study subjects in clinical trials must also be approved by an IRB for each institution
−Removed: where the trials will be conducted, and each IRB must monitor the study until completion.
−Removed: Study subjects must provide informed consent
−Removed: and sign an informed consent form before participating in a clinical trial.
−Removed: Clinical testing also must satisfy the extensive GCP regulations
−Removed: for, among other things, informed consent and privacy of individually identifiable information.
−Removed: Phase 1—Phase
−Removed: 1 clinical trials involve initial introduction of the study drug in a limited population of healthy human volunteers or patients
−Removed: with the target disease or condition.
−Removed: These studies are typically designed to test the safety, dosage tolerance, absorption, metabolism
−Removed: and distribution of the study drug in humans, evaluate the side effects associated with increasing doses, and, if possible, to gain
−Removed: early evidence of effectiveness.
−Removed: Phase 2—Phase 2 clinical
−Removed: trials typically involve administration of the study drug to a limited patient population with a specified disease or condition to
−Removed: evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks.
−Removed: Multiple Phase 2 clinical trials may be conducted to obtain information before beginning larger and more expensive Phase 3 clinical
−Removed: Phase 3—Phase 3 clinical
−Removed: trials typically involve administration of the study drug to an expanded patient population to further evaluate dosage, to provide
−Removed: substantial evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical
−Removed: These clinical trials are intended to establish the overall risk/benefit ratio of the study drug and to provide an adequate
−Removed: basis for product approval.
−Removed: Generally, adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval
−Removed: FDA has various programs, including fast track designation, breakthrough therapy designation, priority review and accelerated approval,
−Removed: which are intended to expedite or simplify the process for the development, and the FDA’s review of drugs ( e.g., approving
−Removed: an NDA on the basis of surrogate endpoints subject to post-approval trials).
−Removed: Generally, drugs that may be eligible for one or more of
−Removed: these programs are those intended to treat serious or life-threatening diseases or conditions, those with the potential to address unmet
−Removed: medical needs for those disease or conditions, and/or those that provide a meaningful benefit over existing treatments.
−Removed: a sponsor may be granted FDA designation of a drug candidate as a “breakthrough therapy” if the drug candidate is intended,
−Removed: alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical
−Removed: evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant
−Removed: endpoints, such as substantial treatment effects observed early in clinical development.
−Removed: If a drug is designated as breakthrough therapy,
−Removed: the FDA will take actions to help expedite the development and review of such drug.
−Removed: Moreover, if a sponsor submits an NDA for a product
−Removed: intended to treat certain rare pediatric or tropical diseases or for use as a medical countermeasure for a material threat, and that
−Removed: meets other eligibility criteria, upon approval such sponsor may be granted a priority review voucher that can be used for a subsequent
−Removed: From time to time, we anticipate applying for such programs where we believe we meet the applicable FDA criteria.
−Removed: A company cannot
−Removed: be sure that any of its drugs will qualify for any of these programs, or even if a drug does qualify, that the review time will be reduced.
−Removed: results of the preclinical studies and of the clinical studies, together with other detailed information, including information on the
−Removed: manufacture and composition of the drug, are submitted to the FDA in the form of an NDA requesting approval to market the product for
−Removed: one or more proposed indications.
−Removed: The testing and approval process requires substantial time, effort and financial resources.
−Removed: the applicant qualifies for an exemption, the filing of an NDA typically must be accompanied by a substantial “user fee”
−Removed: payment to the FDA.
−Removed: To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety
−Removed: and efficacy of the product in the proposed patient population to the satisfaction of the FDA.
−Removed: After an NDA is accepted for filing, the
−Removed: FDA substantively reviews the application and may deem it to be inadequate, and companies cannot be sure that any approval will be granted
−Removed: on a timely basis, if at all.
−Removed: The FDA may also refer the application to an appropriate advisory committee, typically a panel of clinicians,
−Removed: for review, evaluation and a recommendation as to whether the application should be approved, but is not bound by the recommendations
−Removed: of the advisory committee.
−Removed: approving an NDA, the FDA usually will inspect the facility or the facilities at which the drug is manufactured and determine whether
−Removed: the manufacturing and production and testing facilities are in compliance with cGMP regulations.
−Removed: Once issued, the FDA may withdraw product
−Removed: approval if, among other things, ongoing regulatory requirements are not met, certain defects exist in the NDA, or safety or efficacy
−Removed: problems occur after the product reaches the market.
−Removed: regarding our (in-licensed) issued patents and pending patent applications, as of December 31, 2024, is as follows (excluding patents
−Removed: and pending patent applications which pertain to programs which we have discontinued).
−Removed: As of that date we did not have any directly-owned
−Removed: issued patents and pending patent applications.
−Removed: University College London (UCL)
−Removed: U.S., Europe, Australia, Canada, China, Hong Kong,
−Removed: India, Japan, Korea, Russia
−Removed: University of Louisville
−Removed: U.S., Europe, Australia, Canada, China, Hong Kong,
−Removed: India, Israel, Japan, Korea, Mexico, Russia, South Africa
−Removed: * Anticipated
−Removed: Capital Management
−Removed: of June 24, 2025, we had no employees.
+Added: We significantly reduced the amount of research and development
+Added: performed in the year ended December 31, 2025 due to a lack of funding.
+Added: Regulatory Matters
+Added: While in prior years we
+Added: have considered the regulatory requirements of the FDA regarding drug trials, there were no trials performed in the year ended December
+Added: 31, 2025, and therefore no approvals from regulatory agencies were required.
+Added: Intellectual Property
+Added: Qualigen manages and licensed the patents titled
+Added: “Substitued Naphthalene Dimides and Their Use” .
+Added: The patent is for the drug QN-302 and covers the product and their methods
+Added: of manufacturing.
+Added: In total 20 countries in Europe have patent coverage, as well as India, China, and Russia.
+Added: The expiration of these patents
+Added: extends into 2040.
+Added: The company will maintain these patents in these geographies as well as look to expand global coverage.
Concern Qualification
−Removed: working capital deficiency, stockholders’ equity deficit, and recurring losses from operations raise substantial doubt about our
−Removed: ability to continue as a going concern.
−Removed: As a result, our independent registered public accounting firm included an explanatory paragraph
−Removed: in its report on our financial statements for the year ended December 31, 2024 with respect to this uncertainty.
−Removed: Our ability to continue
−Removed: as a going concern will require us to obtain additional funding.
−Removed: Pharmaceuticals, Inc.
−Removed: (our predecessor) was formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural
−Removed: Sciences, LLC.
−Removed: In September 2008, this company converted into a Delaware corporation under the name Ritter Pharmaceuticals, Inc.
−Removed: 22, 2020, upon completing the “reverse recapitalization” transaction with Qualigen, Inc., Ritter Pharmaceuticals, Inc.
−Removed: renamed Qualigen Therapeutics, Inc.
−Removed: and Qualigen, Inc.
−Removed: became a wholly-owned subsidiary of the Company.
−Removed: On July 20, 2023 we sold Qualigen,
−Removed: to Chembio Diagnostics, Inc., an American subsidiary of French diagnostics provider Biosynex S.A.
−Removed: principal executive offices are located at 5857 Owens Avenue, Suite 300, Carlsbad, CA 92008.
−Removed: Our telephone number is (760) 452-8111.
−Removed: Our corporate website address is www.qlgntx.com .
+Added: working capital deficiency, stockholders’ equity, and recurring losses from operations raise substantial doubt about our ability
+Added: to continue as a going concern.
+Added: As a result, our independent registered public accounting firm included an explanatory paragraph in its
+Added: report on our financial statements for the year ended December 31, 2025 with respect to this uncertainty.
+Added: Our ability to continue as
+Added: a going concern will require us to obtain additional funding.
+Added: principal executive offices are located at 5857 Owens Avenue Suite 300, Carlsbad CA 92008 Our telephone number is (760) 452-8111.
+Added: Our corporate website address is www.aixcrypto.ai .
Our website and the information contained on, or that can be accessed through,
7 unchanged sentences
The SEC maintains a website at www.sec.gov that contains reports, proxy statements
−Removed: and other information regarding SEC registrants, including Qualigen.
+Added: and other information regarding SEC registrants, including AIxCrypto Holdings, Inc.
are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K.
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.