HOUSTON, TX / ACCESS Newswire / September 24, 2026 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos" or the "Company") today announced that it has entered into a VELDONA® License Agreement with BioPhoenix Co., Ltd. ("BioPhoenix"), establishing a collaboration framework with a potential aggregate value of $10 million. The framework comprises an initial license fee, conditional consideration for licenses covering 15 additional indications, and a one-time fee upon the first sublicense.
The agreement marks a significant milestone for VELDONA by establishing a partner-funded development model. BioPhoenix will assume primary funding and execution responsibilities for the clinical and regulatory development activities allocated to it under the agreement for the two initial licensed indications, while Ainos retains core platform ownership and long-term commercial interests. Development expenditures funded by BioPhoenix, potential product supply revenue and downstream revenue sharing are separate from, and are not included in, the $10 million collaboration framework.
Two Initial Licenses and Additional Indication Opportunities
Under the agreement, BioPhoenix receives an exclusive worldwide license to VELDONA for two initial indications-Sjögren's disease and thrombocytopenia-to conduct research, development, manufacturing, marketing authorization activities and commercialization within the agreed scope.
The collaboration framework includes:
- An initial license fee for the two initial indications, payable in accordance with the agreement.
- Potential license consideration for 15 additional indications under the BioPhoenix agreement, assuming all 15 licenses are completed on the contemplated terms, subject to the execution of separate license agreements and payment of the applicable consideration.
- A one-time fee upon the first sublicense, payable by BioPhoenix within 30 days after the effective date of its first sublicense to a third party under the agreement. This fee is payable only once under the entire agreement, regardless of which indication is covered by the first sublicense. Subsequent sublicenses, whether involving the same or different indications or additional third parties, do not trigger another first-sublicense fee.
Each additional indication requires a separate license agreement and payment. Neither party is obligated to complete all 15 licenses, and there can be no assurance that all will be completed. Accordingly, the $10 million collaboration framework is conditional and does not represent guaranteed revenue or a valuation of the VELDONA platform.
The consideration contemplated for additional indication licenses applies to the arrangements between Ainos and BioPhoenix and does not establish a ceiling on the consideration Ainos may negotiate when directly licensing available indications to other third parties, subject to BioPhoenix's applicable contractual priority rights. Such direct licenses may generate higher consideration based on development progress, market opportunities and negotiated terms. These transactions are distinct from sublicenses granted by BioPhoenix and would be governed by separate agreements between Ainos and the third-party licensees.
Potential additional indications include Behçet's disease, chronic fatigue syndrome, fibromyalgia, hepatitis B, hepatitis C, idiopathic pulmonary fibrosis, influenza and other indications.
Partner-Funded Development Addresses Substantial Capital Requirements
Late-stage clinical development requires sustained capital and specialized expertise. A 2025 study published in Pharmaceutical Medicine analyzed 631 development projects across 22 Japanese pharmaceutical companies. Using the reference exchange rate reported in the study, the sum of the median costs for Phase II and Phase III was approximately $54 million. For projects targeting approval in the United States or Europe, the median cost of Phase III alone was approximately $74 million.[1]
These figures are provided solely as industry context. They do not represent a VELDONA development budget, a fixed funding commitment by BioPhoenix or an estimate of anticipated cost savings for Ainos. Actual development costs will depend on trial design, patient enrollment, geographic scope, regulatory requirements and other factors.
Under the agreement, BioPhoenix will fund and execute the clinical and regulatory activities assigned to it, including clinical studies, contract research organization (CRO) services, clinical trial sites and investigators, investigational drug procurement, testing and monitoring, data management and statistical analysis, safety reporting, regulatory consultants, regulatory submissions, supplemental studies, and responses to questions and requirements from regulatory authorities. Development-related chemistry, manufacturing and controls (CMC) work, applicable intellectual property maintenance and other execution costs will be handled in accordance with the allocation of responsibilities under the agreement.
The parties intend to advance the licensed programs toward applicable marketing authorizations, including activities required to seek approval from the U.S. Food and Drug Administration (FDA), as well as Taiwan Food and Drug Administration (TFDA) activities specified in the agreed development plan.
This structure is designed to reduce Ainos' need to independently fund subsequent clinical and regulatory development and expand its internal development organization. Ainos will provide existing licensed assets, technology transfer and technical support as specified in the agreement, together with product supply under separately agreed arrangements. Each party remains responsible for its respective contractual, regulatory and statutory obligations.
Ainos Retains Platform Ownership and Multiple Sources of Commercial Value
Ainos retains ownership of its existing VELDONA platform and background intellectual property, including relevant patents, CMC assets and manufacturing technology, subject to the licenses and other rights granted under the agreement. The initial license includes manufacturing rights for the agreed indications but does not transfer ownership of the existing platform.
Ainos also retains opportunities to supply products under separately negotiated arrangements. Volumes, pricing, delivery schedules and payment terms will be established through individual agreements and accepted purchase orders.
In addition to applicable license fees, potential product supply revenue and the first-sublicense fee, Ainos is contractually entitled to a 25% share of applicable net sublicensing revenue. Sublicensing consideration may include upfront payments, option fees, milestone payments, royalties and other consideration included under the agreement, subject to its definitions, permitted deductions and provisions preventing double counting.
Initial and additional indication license fees, the first-sublicense fee and separately agreed product supply revenue are independent sources of consideration payable to Ainos; they are not payments of which Ainos receives only a 25% share. The first-sublicense fee also does not reduce or offset Ainos' contractual share of sublicensing revenue.
The 25% revenue share applies to the revenue-sharing base defined in the BioPhoenix agreement. The economics of any licenses Ainos grants directly to other third parties will be governed by their respective agreements.
Advancing VELDONA Through Partner-Funded Development
Eddy Tsai, Chairman, President and Chief Executive Officer of Ainos, commented:
"This agreement marks an important milestone for VELDONA. Its strategic value extends beyond the contemplated license consideration by combining partner-funded development with Ainos' continued ownership of the platform and participation in its future commercial value."
Tsai continued:
"Clinical trials, CRO oversight, regulatory engagement and marketing authorization applications require sustained funding and specialized expertise. Through this collaboration, we aim to reduce the capital and organizational resources Ainos would otherwise need to commit directly, while retaining future licensing, product supply and downstream commercialization opportunities. Our goal is to advance VELDONA through a partner-funded development model that enables shareholders to participate in its long-term value."
BioPhoenix's Development Capabilities
The BioPhoenix team has experience in drug research and development, preclinical studies, multinational clinical trials, CRO management, regulatory submissions and biopharmaceutical operations. Its capabilities span early-stage research, activities supporting investigational new drug (IND) applications, and Phase I-IV clinical development.
The parties intend to combine BioPhoenix's development capabilities with Ainos' existing VELDONA assets and work with clinical trial sites, investigators, CROs and other external specialists to advance the licensed programs.
VELDONA Clinical Development Background
VELDONA is a low-dose oral interferon alpha platform being developed as a lozenge for administration through the oral mucosa. The platform is supported by approximately 40 years of research and clinical development experience.
Ainos' previously disclosed development experience encompasses 68 studies, including three Phase I, 63 Phase II and two Phase III studies, spanning 16 disease indications and studies in healthy volunteers, with nearly 6,000 participants in total. Approximately 4,600 participants received oral interferon alpha, with treatment durations extending up to five years in certain studies.
This historical clinical, safety and tolerability experience, together with existing regulatory records, patents, formulations and manufacturing know-how, provides a foundation for further development. Historical data do not replace the clinical, CMC or regulatory work required under current applicable standards.
The parties will advance the two initial indications based on clinical results, regulatory requirements and commercial progress, while evaluating additional development and licensing opportunities. Neither party guarantees clinical trial outcomes, regulatory approval, commercialization timelines or ultimate commercial results.
[1] Okada, N. and Takahashi, Y. "Cost and Duration of Clinical Trials in Drug Development by Japanese Pharmaceutical Companies." Pharmaceutical Medicine 39, 199-207 (2025). Dollar amounts above are calculated using the study's reference exchange rate of JPY 109 per U.S. dollar. The approximately $54 million figure is the sum of separate phase-specific medians, not an observed median total development cost. Study
Forward-Looking Statements
Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company's business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, the uncertainty of the contemplated collaboration framework and the expected receipt of license fees, manufacturing license fees and other consideration thereunder; our expectation that we will incur net losses for the foreseeable future; our ability to become profitable; our ability to raise additional capital to continue our product development; our ability to accurately predict our future operating results; our ability to advance our current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates we develop; the ability to obtain and maintain regulatory approval of our licensed indications and product candidates; delays in completing the development and commercialization of our current and future product candidates; developing and commercializing additional products, including diagnostic testing devices; our ability to compete in the marketplace; compliance with applicable laws, regulations and tariffs, and factors described in the Risk Factors section of our public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.
Contact Information
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SOURCE: Ainos, Inc.
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