UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Item 1.01. Entry Into or Amendment of a Material Definitive Agreement.
On July 16, 2025, Klotho Neurosciences, Inc. (the “Company”) entered into a Terms of Agreement (“Agreement:”) with AAVnerGene Inc. (“AAVnerGene”) granting the Company the exclusive and global right to use AAVnerGene’s AAVone platform for development, manufacturing, and commercialization of gene therapy products based on the human Klotho gene isoforms for three clinical programs. The initial license fees to be paid by the Company scale up from a total of $250,000 for the Company’s first gene therapy product to $500,000 for the Company’s third gene therapy product. Additional fees will apply based upon the stage of clinical trials and the Company will pay a two percent (2%) royalty on revenue from all products created using the AAVone platform .
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the Agreement, a copy of which is filed herewith as Exhibit 4.1 and incorporated herein by reference.
Item 7.01 Regulation FD Disclosure.
On July 22, 2025, the Company issued a press release announcing the Terms of Agreement with AAVnerGene Inc. A copy of that press release is furnished as Exhibit 99.1 to this Current Report, and is incorporated herein by reference. A copy of the press release is attached hereto as Exhibit 99.1.
The information contained in this Item 7.01 and Exhibit 99.1, attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended and shall not be deemed incorporated by reference in any filing with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended or the Securities Act of 1933, as amended whether made before or after the date hereof and irrespective of any general incorporation language in any filings.
This Form 8-K contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Without limiting the generality of the foregoing, the forward-looking statements in this press release include descriptions of the Company’s future commercial operations. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, such as the Company’s inability to implement its business plans, identify and realize additional opportunities, or meet or exceed its financial projections and changes in the regulatory or competitive environment in which the Company operates. You should carefully consider the foregoing factors and the other risks and uncertainties described in the documents filed or to be filed by the Company with the U.S. Securities and Exchange Commission (the “SEC”) from time to time, which could cause actual events and results to differ materially from those contained in the forward-looking statements. Copies of these documents are available on the SEC’s website, www.sec.gov. All information provided herein is as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law.
Item 9.01 Financial Statements and Exhibits.
| Exhibits | Description | |
| 4.1 | Terms of Agreement | |
| 99.1 | Press Release | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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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.
| Dated: July 22, 2025 | KLOTHO NEUROSCIENCES, INC. | |
| By: | /s/ Joseph Sinkule | |
| Name: | Joseph Sinkule | |
| Title: | Chief Executive Officer | |
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Exhibit 4.1
AAVone License - Terms of Agreement
Between AAVnerGene Inc. and Klotho Neurosciences, Inc. (“KLTO”)
The License Terms of Agreement and collaboration (the “Agreement”) sets forth the terms of an exclusive license and the activities and deliverables associated with a license for KLTO to utilize the AAVone and potentially the AAVShD platform technologies developed by AAVnerGene. The primary activities are associated with a deliverable related to a product candidate called KLTO-202 which targets amyotrophic lateral sclerosis and other rare motor neuron diseases of mankind.
The core intellectual property of AAVnerGene being licensed to KLTO is critical to the success of KLTO’s product development programs. If the patent applications do not result in a patent being granted and issued, the monetary payments and terms of the yet-to-be-executed “Definitive License Agreement” may be amended by the two parties at some future date.
Part I and Part II of the agreement will ultimately result in Part III, the GMP production of KLTO’s gene therapy candidates designated KLTO-202 and potentially Part IV and Part V. KLTO-101 and a third candidate, KLTO-303, may also be developed once a successful outcome and a collaborative relationship has been shown with KLTO-202.
Part I. AAVone Production Platform License Terms and Scope
| 1. | License Scope |
(a). AAVnerGene Inc. hereby grants Klotho Neurosciences the exclusive and global right to use the AAVone platform for development, manufacturing, and commercialization of gene therapy products based on the human Klotho gene isoforms for three clinical programs targeting:
| ■ | CNS-targeted secreted Klotho (Alzheimer’s and ALS - KLTO-101); |
| ■ | Neuromuscular-targeted secreted Klotho (ALS - KLTO-202) |
| ■ | Full-length human soluble- Klotho (KLTO-303) |
This exclusivity applies solely to these three pipelines based on human Kloto gene and does not extend to other therapeutic areas and genes unless otherwise agreed in writing.
(b). The current gene constructs (promoter and s-KL gene sequences) will be provided by KLTO investigators and used to create the AAVone construct. A second-generation “optimization program” for KLTO-202 may be funded and operationalized at some point in the future.
(c). Scope – KLTO-202:
| ● | Subclone GOI and (Heidelberg) capsid to AAVone |
| ● | Procedure optimization for small scales |
| ● | One batch 5 L-scale production and QC release |
| ● | Stability program for 4 time points. |
Deliverables:
| ● | pAAVone plasmids carrying GOI and (Heidelberg) Capsid |
| ● | One batch 5 L Drug Product |
| ● | Batch record |
| ● | Certificate of Analysis (CoA) |
| ● | Stability report |
(d). Scope – KLTO-101
| ● | Subclone GOI and (CNS targeted) capsid to AAVone |
| ● | Procedure optimization for small scales |
| ● | One batch 5 L-scale production and QC release |
| ● | Stability program for 4 time points. |
Deliverables:
| ● | pAAVone plasmids carrying GOI and (CNS targeted) Capsid |
| ● | One batch 5 L Drug Product |
| ● | Batch record |
| ● | Certificate of Analysis (CoA) |
| ● | Stability report |
(e). Part I Fees – two constructs – KLTO-101 and KLTO-202
Fee：$50,000 per candidate/pipeline; $100,000 for 2 candidates and $150,000 for three candidates.
Duration: 3 months
Part II. Preclinical License Stage & Tech Transfer to CDMO
| License | Payment due | KLTO-202 | KLTO-101 | KLTO-303 | ||||||||||
| AAVone License | Upfront | $ | 150,000 | $ | 200,000 | $ | 300,000 | |||||||
| AAVone license | Maintenance | Free | Free | Free | ||||||||||
| Tech transfer | Upon Delivery | $ | 100,000 | $ | 100,000 | $ | 200,000 | |||||||
| Total | $ | 250,000 | $ | 300,000 | $ | 500,000 | ||||||||
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Part III. Tech Transfer and CDMO Manufacturing – (Outsourced- N/A)
| Stage | Price (USD) | |||
| Project Management and Technology Transfer | 100,000 | |||
| Establishment and Manufacture of Transfer Plasmid | $ | 250,000 | ||
| Process Development (2L, 10L, 50L) | $ | 700,000 | ||
| Analytical Development & Qualification | $ | 200,000 | ||
| GMP HEK293 Cell Banking & Characterization | $ | 250,000 | ||
| High-quality Grade Engineering Run (50L) | $ | 500,000 | ||
| GMP Manufacture (50L) | $ | 700,000 | ||
| Stability | $ | 200,000 | ||
| Total | $ | 2,900,000 | ||
Part IV. Clinical License (Milestone-Based)
| AAVone clinical License /indication | Payment due | KLTO-202 (USD) | KLTO-101 (USD) | KLTO-303 (USD) | ||||||||||
| Upon IND filling and Phase I/II trials | Once IND NTC# is being awarded | $ | 150,000 | $ | 200,000 | $ | 300,000 | |||||||
| Phase III | Upon completion of six (6) months of dosing in a Phase III clinical trial | $ | 150,000 | $ | 200,000 | $ | 300,000 | |||||||
| BLA | 1 month post approval | $ | 1,000,000 | $ | 1,500,000 | $ | 2,000,000 | |||||||
| Total | $ | 1,300,000 | $ | 1,900,000 | $ | 2,600,000 | ||||||||
Part V. Commercial License Terms (Global and Exclusive License)
Royalty: 2% of Net Sales of licensed AAVone-based commercial products
<Signature Page Follows>
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Signature Page
AVVnerGene, Inc. and Klotho Neurosciences, Inc. agree to the general terms of this term sheet Agreement. A final definitive License Agreement shall be drafted incorporating the terms of this Agreement.
| As agreed to on this date: July 16, 2025 | ||||
| Klotho Neurosciences, Inc. | AVVnerGene, Inc. | |||
| Signature: | Signature: | |||
| /s/ Joseph Sinkule | /s/ Daozhan Yu | |||
| Name: | Dr. Joseph Sinkule | Name: | Daozhan Yu | |
| Title: | CEO and Chairman | Title: | CEO and Founder | |
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Exhibit 99.1
Klotho Neurosciences, Inc. Partners with AAVnerGene Inc.
to Make Klotho’s Gene Therapy Assets.
July 22, 2025 – New York, NY - Cision PR NewsWire – Klotho Neurosciences, Inc. (NASDAQ: KLTO), announced that it is partnering with AAVnerGene Inc. (AAVnerGene), a Rockville, MD-based innovation-driven biotech renowned for its transformative technologies in AAV manufacturing and tissue-targeted delivery.
Dr. Joseph Sinkule, the CEO of KLTO stated “we announced previously that we have been looking for a more efficient, ‘next-generation’ method to manufacture several of our patented gene therapy candidates, and the two platform technologies offered by AAVnerGene will catapult our product candidates into the clinic at a faster pace, at a lower cost, a higher efficacy and purity compared to the current state-of-the-art AAV manufacturing processes. We are talking about KLTO-101 for Alzheimer’s and Parkinson’s diseases, KLTO-202 for ALS and other motor neuron diseases, and KLTO-303 for treatment of ageing-related pathologies resulting in a healthy, extended lifespan. I’m also looking at other complementary longevity-related assets that we may bring into KLTO”.
“AAV gene therapy has been proven to be a revolutionary one-time, life-changing treatment, however it is experiencing some crisis caused by high drug price and high dose-related toxicity.” said Dr. Daozhan Yu, Founder and CEO of AAVnerGene. “We envisioned these bottleneck problems six years ago and AAVnerGene was founded with the mission to solve them. With the two proprietary platforms, we can dramatically drive down the manufacture cost with the AAVone system and the dose required by the highly efficient and specific tissue-targeting AAVs developed with the ATHENA platform. It’s a perfect synergy to partner with Klotho, a neuroscience-driven pathfinder. Neurological disease drug development is always challenging and we need new approaches and mechanisms. Klotho’s data on neuron protection and longevity are very impressive and it holds the potential to treat so many devastating diseases. We are very glad to work with the passionate and highly executive team, and strongly believe that the collaboration can bring more affordable and innovative drugs for patients with rare and common diseases.”
Dr. Joseph Sinkule concluded “Klotho believes AAVnerGene has conceived a process method that is more cost effective, faster to make, has fewer impurities, shows higher efficacy and lower toxicity because of the higher targeted tissue delivery. KLTO hopes to work with AAVnerGene for manufacturing several of our product candidates composed of a tissue-specific promoter driving our Klotho gene to produce the Klotho protein and elevated concentrations of the protein in specific, targeted tissues and organs affected by these neurologic and neuromuscular diseases.”
About AAVnerGene, Inc. AAVnerGene is a creativity-powered biotechnology company pioneering next-generation AAV vector technologies. The company’s proprietary platforms include AAVone, a high-yield, single-plasmid AAV production system that dramatically reduces manufacturing costs, and ATHENA, an advanced capsid engineering platform enabling precise tissue targeting. AAVnerGene is dedicated to delivering affordable, scalable, and precision-engineered gene therapy solutions that accelerate clinical development across diverse therapeutic areas.
Investor Contact and Corporate Communications – Daozhan Yu, CEO
Website:www.aavnergene.com
About Klotho Neurosciences, Inc. Klotho Neurosciences, Inc. (NASDAQ: KLTO), is a biogenetics company focused on the development of innovative, disease-modifying cell and gene therapies using a protein derived from a patented form of the “anti-aging” human Klotho gene (s-KL), and it’s novel delivery systems to transform and improve the treatment of neurodegenerative and age-related disorders such as ALS, Alzheimer’s, and Parkinson’s disease. The company’s current portfolio consists of its proprietary cell and gene therapy programs using DNA and RNA as therapeutics and genomics-based diagnostic assays. The company is managed by a team of individuals and advisors who are highly experienced in biopharmaceutical product development and commercialization.
Investor Contact and Corporate Communications - Jeffrey LeBlanc, CFO
Website:www.klothoneuro.com
Forward-Looking Statements:
This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Without limiting the generality of the foregoing, the forward-looking statements in this press release include descriptions of the Company’s future commercial operations. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, such as the Company’s inability to implement its business plans, identify and realize additional opportunities, or meet or exceed its financial projections and changes in the regulatory or competitive environment in which the Company operates. You should carefully consider the foregoing factors and the other risks and uncertainties described in the documents filed or to be filed by the Company with the U.S. Securities and Exchange Commission (the “SEC”) from time to time, which could cause actual events and results to differ materially from those contained in the forward-looking statements. All information provided herein is as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law.