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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d)
of
the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): September 24, 2026
| AINOS,
INC. |
| (Exact
name of registrant as specified in its charter) |
| Texas |
|
001-41461 |
|
75-1974352 |
(State
or other Jurisdiction
of
Incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
3050
Post Oak Blvd, Suite 510-T80, Houston, TX 77056
(281)
898-6586
(Address
and telephone number, including area code, of registrant’s principal executive offices)
(Former
name or former address if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ☐ |
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Common Stock, par value
$0.01 per share |
|
AIMD |
|
The Nasdaq Stock Market
LLC |
| Warrants to purchase Common
Stock |
|
AIMDW |
|
The Nasdaq Stock Market
LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
1.01 Entry into a Material Definitive Agreement
On
September 24, 2026 (the “Effective Date”), Ainos, Inc. (the “Company”) entered into a Global Exclusive License
Agreement (the “License Agreement”) with BioPhoenix Co., Ltd., a company organized under the laws of the Republic of China
(Taiwan) (“BioPhoenix”). The License Agreement covers the Company’s VELDONA® low-dose oral interferon alpha technology
platform.
Under
the License Agreement, the Company granted BioPhoenix an exclusive, worldwide, irrevocable, transferable and sublicensable license under
certain of the Company’s intellectual property and related assets. The license allows BioPhoenix to research, develop, manufacture,
have manufactured, use, import, export, offer for sale, sell, commercialize and otherwise exploit VELDONA® for Sjögren’s
Disease and Thrombocytopenia (the “Licensed Indications”). The licensed territory covers all countries and territories worldwide.
During the term and for 10 years after it ends, the Company may not compete with the Licensed Indications anywhere in the world. The
Company also granted BioPhoenix a right of first refusal and a call option to license certain additional VELDONA® indications that
have progressed to Phase 2 clinical trials. BioPhoenix further has an option to license other non-licensed VELDONA® indications under
separate written agreements.
In
consideration for the license, BioPhoenix will pay the Company an upfront license fee of $600,000. The upfront fee is due after BioPhoenix
receives the complete data package and written confirmation that technology transfer is complete. BioPhoenix will also pay the Company
a one-time fee when it grants its first sublicense to a third party. If BioPhoenix licenses all of the additional VELDONA® indications
available under the License Agreement, the total license fees payable to the Company, including the upfront license fee and the first
sublicense fee, would be approximately $10.0 million. In addition, the Company will receive twenty-five percent (25%) of BioPhoenix’s
net sublicensing revenue for the Licensed Indications.
The
License Agreement continues on an indication-by-indication and country-by-country basis until the later of (a) the expiration of the
last-to-expire patent covering the applicable Licensed Indication or (b) 20 years after the Effective Date, unless terminated earlier.
Either party may terminate the License Agreement for the other party’s uncured material breach or insolvency. The License Agreement
contains customary representations, warranties, covenants, indemnification obligations and confidentiality provisions.
The
foregoing description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the full
text of the License Agreement, a copy of which is filed with this current report on Form 8-K as Exhibit 10.1 and is hereby incorporated
herein by reference.
Item
7.01 Regulation FD Disclosure
On
September 28, 2026, the Company announced the execution of the License Agreement with BioPhoenix. A copy of the press release issued
by the Company in this connection is furnished herewith as Exhibit 99.1.
The
information furnished with this Item 7.01 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities
of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended,
or the Exchange Act.
Item
9.01 Financial Statement and Exhibits
(d)
Exhibits.
| Exhibit No. |
|
Description |
| 10.1#+ |
|
Global Exclusive License Agreement, dated September 24, 2026, by and between Ainos, Inc. and BioPhoenix Co., Ltd. |
| 99.1 |
|
Press Release dated September 28, 2026, issued by the Ainos, Inc. |
| 104 |
|
Cover Page Interactive
Data File (embedded within the Inline XBRL document). |
#
Annexes, schedules and/or exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby undertakes to
furnish on a supplemental basis a copy of any omitted schedules and similar attachments to the Securities and Exchange Commission upon
request.
+
Certain portions of this Exhibit were redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K. The Company hereby agrees to furnish
a copy of any omitted portion to the Securities and Exchange Commission upon request.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| |
Ainos, Inc. |
| |
|
| Date: September 28, 2026 |
By: |
/s/ Chun-Hsien
Tsai |
| |
Name: |
Chun-Hsien Tsai |
| |
Title: |
Chief Executive Officer |
Exhibit 99.1
Ainos
Details Partner-Funded VELDONA Development and Revenue Opportunities, Reinforcing Focus on Chemical Intelligence
Initial
license payment tied to near-term contractual delivery; additional payment opportunities may arise during development, before drug approval
Partner
assumes assigned clinical and regulatory funding and execution, reducing Ainos’ independent capital and staffing requirements
Ainos
retains existing platform ownership and 25% of applicable net sublicensing revenue; potential economic participation extends beyond the
$10 million licensing framework
HOUSTON,
TX / September 28, 2026 / Ainos, Inc. (NASDAQ: AIMD, AIMDW) (“Ainos” or the “Company”) today detailed the financial
and strategic benefits of the VELDONA® License Agreement announced on September 24, 2026 (the “Agreement”). Ainos expects
to complete the agreed contractual delivery shortly, with an initial license fee of $600,000 payable within 15 business days after
the applicable payment conditions are satisfied. This payment does not depend on completion of future clinical trials or receipt of marketing
approval.
The
pharmaceutical development partner identified in the September 24 announcement (the “licensee”) will fund and execute the
clinical and regulatory activities assigned to it for the two initial globally licensed indications, Sjögren’s disease and
thrombocytopenia. This structure reduces Ainos’ need to independently finance subsequent development, expand specialist teams and
devote additional management resources to pharmaceutical execution, supporting the Company’s priority investment in Chemical Intelligence.
Ainos
is also entitled to 25% of applicable net sublicensing revenue. Qualifying transactions may generate upfront payments, option
fees and development or regulatory milestones during clinical development, creating opportunities for payments to Ainos before a product
reaches the market.
Multiple
Payment Opportunities Beyond the Initial License
The
Agreement provides distinct sources of potential consideration:
| ● | Initial
license fee: $600,000 payable under the contractual delivery and payment provisions. |
| ● | Sublicensing
participation: 25% of applicable net sublicensing revenue, which may include upfront
payments, option fees, milestones, royalties and other consideration covered by the Agreement. |
| ● | First-sublicense
fee: A separate, one-time fee payable within 30 days after the first third-party sublicense
takes effect, without reducing or offsetting Ainos’ applicable revenue share. |
| ● | Additional
indication licenses: A pathway for 15 additional VELDONA indications, subject to applicable
contractual rights, separate definitive agreements and payment. |
| ● | Product
supply: Opportunities under separately negotiated agreements and accepted purchase orders. |
The
potential $10 million framework comprises the initial license fee, conditional additional-indication consideration and the first-sublicense
fee. Partner-funded development expenditures, applicable sublicensing revenue participation and potential product supply revenue are
additional to that framework. Where additional indication licenses carry forward the 25% net sublicensing participation, that share would
be additional to the corresponding license fees.
Accordingly,
$10 million is not a ceiling on Ainos’ total economic participation. Further value will depend on completed licenses, qualifying
sublicensing transactions and supply arrangements. Neither party is obligated to complete all 15 additional licenses, and the framework
represents neither guaranteed revenue nor a platform valuation.
The
25% share applies to the defined net sublicensing revenue base, subject to permitted deductions and other applicable terms. Payments
depend on qualifying transactions, receipt of consideration and contractual payment provisions; clinical activity alone does not trigger
a payment. License fees, the first-sublicense fee and separate supply payments are independent of that percentage calculation.
Ainos
may also negotiate direct licenses for available indications with other third parties, subject to the licensee’s applicable contractual
priority rights. Consideration contemplated under this Agreement does not set a ceiling on those separately negotiated transactions.
Established
Clinical and Intellectual Property Foundations
VELDONA
is a low-dose oral interferon alpha platform administered as a lozenge through the oral mucosa. Its clinical records, relevant patents,
regulatory history and manufacturing knowledge provide an established base for further development.
Sjögren’s
disease: Historical Phase II and Phase III programs include approximately 497 patients across two Phase III studies, providing human
exposure and clinical information to inform future trial design and regulatory discussions. This is historical development experience;
it does not indicate that a new registration trial is underway or that approval is assured.
Thrombocytopenia:
Assets addressing this blood disorder—characterized by low platelet counts and increased bleeding risk—include relevant patent
protection and human research examining platelet recovery. Historical evidence includes findings in patients with thrombocytopenia from
a randomized, double-blind, placebo-controlled study involving 169 participants. These records support further investigation and patient-population
selection, rather than establishing approval or clinical benefit for every cause of low platelet counts.
Across
the broader platform, Ainos’ previously disclosed history spans approximately four decades and 68 studies—three Phase I,
63 Phase II and two Phase III—covering 16 disease indications and healthy volunteers. Nearly 6,000 participants were enrolled,
approximately 4,600 received oral interferon alpha, and treatment extended up to five years in certain studies. This history provides
safety, tolerability and exposure information, while further clinical, manufacturing and regulatory evidence remains necessary under
current standards.
Complementary
Expertise, Defined Responsibilities and Lower Independent Resource Requirements
Ainos
contributes its existing VELDONA assets and agreed technical support. The licensee funds and executes its assigned development activities,
including clinical studies, CRO services, trial sites and investigators, investigational drug procurement, testing, data management,
statistical analysis and safety reporting. Regulatory responsibilities include specialist consultants, applications, supplemental studies
and responses to agency questions.
The
parties intend to advance the programs toward applicable marketing authorizations, including activities required to seek U.S. FDA approval
and TFDA activities specified in the agreed development plan. Ainos retains its contractual responsibilities; chemistry, manufacturing
and controls work, intellectual property maintenance and other costs remain subject to the agreed allocation.
This
division of work reduces the need for Ainos to independently build and finance a larger pharmaceutical development organization. Existing
records can also inform planning and reduce duplication of certain preparatory work. Actual time and cost benefits will depend on development
requirements and execution. Near-term priorities are contractual delivery, satisfaction of the initial payment conditions and development
planning.
Industry
research illustrates the scale of late-stage development. A 2025 study covering 631 projects across 22 Japanese pharmaceutical companies
reported separate Phase II and Phase III median costs that together equated to approximately $54 million; for projects targeting U.S.
or European approval, the Phase III median alone was approximately $74 million.[1] These figures are industry context, not
a VELDONA budget, a fixed partner funding commitment or an estimate of Ainos’ savings.
Preserving
VELDONA Ownership and Prioritizing Chemical Intelligence
Ainos
retains ownership of its existing VELDONA platform and background intellectual property, subject to the rights granted under the Agreement.
The initial license includes manufacturing rights for the agreed indications and does not transfer ownership of the existing platform.
Eddy
Tsai, Chairman, President and Chief Executive Officer of Ainos, commented:
“As
we continue to make progress in AI Nose and Chemical Intelligence, the importance of focused execution is increasing. Chemical Intelligence
is our first strategic priority, and we want our capital, talent and management attention concentrated on advancing customer adoption
and the chemical sensing, real-world data and AI capabilities behind it. Bringing in a pharmaceutical development partner for VELDONA
supports that focus while providing a path forward for the clinical knowledge, intellectual property and manufacturing expertise we have
already built. We contribute our existing assets and technical knowledge; the partner funds and executes its assigned clinical and regulatory
work.
“We
retain ownership of our existing platform, subject to the licensed rights, and participate through contractual payments, applicable sublicensing
proceeds and potential supply opportunities. This creates opportunities to receive value before drug approval while reducing our need
to independently finance development or expand a pharmaceutical organization. For shareholders, the objective is to advance VELDONA through
complementary expertise and keep Ainos focused on Chemical Intelligence. We will measure progress through delivery, payments received,
development milestones and execution in our core AI business.”
About
Ainos
Ainos,
Inc. (NASDAQ: AIMD, AIMDW) develops AI Nose and Chemical Intelligence technologies that convert real-world chemical and scent signals
into actionable information. The Company also holds the VELDONA low-dose oral interferon alpha platform, which it seeks to advance through
pharmaceutical licensing and development collaborations.
Forward-Looking
Statements
This
release contains forward-looking statements within the meaning of applicable U.S. securities laws, including statements concerning delivery
and payment timing; partner funding and execution; sublicensing, additional licenses and product supply; clinical and regulatory plans;
resource efficiencies; and future commercial value. These statements reflect current expectations and are subject to risks and uncertainties,
including satisfaction of contractual conditions, counterparty performance and financial resources, completion of qualifying transactions,
clinical results, regulatory requirements, manufacturing readiness and execution of the Company’s strategy. Actual results may
differ materially.
Historical
clinical experience does not guarantee future safety, efficacy, approval or commercial success. No guaranteed commercialization timetable
or quantified savings have been established. Potential receipts are not equivalent to recognized revenue; recognition depends on applicable
accounting requirements and satisfaction of relevant performance obligations. Additional risks are described in Ainos’ SEC filings.
The Company undertakes no obligation to update forward-looking statements except as required by law.
Reference
[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 equivalents use the study’s reference exchange rate of JPY 109
per U.S. dollar. The approximately $54 million figure adds separate phase-specific medians; it is not an observed median total development
cost. Source.
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.
Investor
Relations
ir@ainos.com
