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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): August 6, 2025
Klotho Neurosciences, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
| 001-41340 | 86-2727441 | |
| (Commission File Number) |
(IRS Employer Identification No.) |
13576 Walnut Street, Suite A
Omaha, NE 68144
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code (833) 931-6330
(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 | KLTO | The Nasdaq Stock Market LLC | ||
| Warrants | KLTOW | 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 or Amendment of a Material Definitive Agreement.
On August 6, 2025, Klotho Neurosciences, Inc. (the “Company”) entered into a Letter Agreement (“Agreement:”) with AAVnerGene Inc. (“AAVnerGene”) for the manufacturing and development of its KLTO-202 gene therapy candidate using the AAVnerGene’s AAVnerGene platform technology. The initial fees to be paid by the Company are $250,000. 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 August 12, 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 | Letter Agreement | |
| 99.1 | Press Release | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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: August 12, 2025 | KLOTHO NEUROSCIENCES, INC. | |
| By: | /s/ Joseph Sinkule | |
| Name: | Joseph Sinkule | |
| Title: | Chief Executive Officer | |
Exhibit 4.1
Binding Letter Agreement
between
AAVnerGene Inc. and Klotho Neurosciences, Inc.
Effective Date: August 6, 2025
This Binding Letter Agreement (“Agreement”) is entered into as of the Effective Date by and between Klotho Neurosciences, Inc. (“Klotho”) and AAVnerGene Inc. (“AAVnerGene”) (collectively, the “Parties”), and sets forth the initial terms governing their collaboration related to AAVnerGene’s proprietary AAVone platform technologies for the development of Klotho’s gene therapy programs.
This Agreement is entered into in reliance on and subject to the terms outlined in the Term Sheet executed by the Parties on July 16, 2025, which is attached hereto as Appendix A and incorporated herein by reference. The Parties acknowledge and agree that this Agreement is legally binding and intended to serve as an interim framework to initiate development activities, facilitate payments, and enable the negotiation of a definitive License and Supply Agreement.
Phase 1 – Delivery and Evaluation (Binding)
| 1. | Initiation of Work. Upon execution of this Letter Agreement, AAVnerGene shall commence the production and delivery of the second-generation AAV construct, designated AAVone, for KLTO-101 and KLTO-202, in accordance with the Scope of Work set forth in the Term Sheet attached hereto as Appendix A. The Parties shall jointly prepare and execute a detailed Work Order outlining the specific activities to be performed by AAVnerGene for Klotho. Such Work Order shall be incorporated into this Agreement as Appendix B, and shall specify the responsibilities of each Party, the scope of services to be provided by AAVnerGene, and the associated deliverables. Additionally, Klotho shall provide a copy of its Certificate of Analysis (“COA”), which shall be attached hereto as Appendix C. |
| 2. | Payments. Klotho shall pay to AAVnerGene (i) the Part I service fees outlined in the Term Sheet (Appendix A) for the scope of work detailed in the Work Order (Appendix B) and (ii) the full Upfront License Payment associated with KLTO-101 and KLTO-202, as defined in the Term Sheet. These payments shall be made within ten (10) business days of the Effective Date. |
| 3. | Option to License. AAVnerGene hereby grants to Klotho an exclusive option to enter into a License and Supply Agreement covering the AAVnerGene AAVone technology for the development, manufacture, and commercialization of KLTO-101, KLTO-202, and KLTO-303. |
| 4. | Evaluation Period. Upon delivery of the KLTO-101 and KLTO-202 constructs and all associated deliverables specified in the Work Order, Klotho shall have fifteen (15) days to evaluate the materials and notify AAVnerGene in writing of its decision to exercise the License Option. |
| 5. | Refund Provision. If Klotho does not exercise the License Option during the Evaluation Period for any reason other than failure to meet agreed product specifications in the Work Order, AAVnerGene shall refund 40% of the Upfront License Payment to Klotho within thirty (30) days of receiving written notice of non-exercise. If Klotho does not exercise its License Option due to the failure to deliver product meeting specifications as outlined in the Work Order, AAVnerGene shall refund 80% of the Upfront License Payment to Klotho within thirty (30) days of receiving written notice of non-exercise. |
| 6. | Negotiation of Definitive Agreement. Upon execution of this Letter Agreement, the Parties shall immediately commence good faith negotiations of a definitive License and Supply Agreement, which shall incorporate the terms set forth in the Term Sheet (Appendix A). The Parties shall use commercially reasonable efforts to finalize such agreement within ninety (90) days of the Effective Date of this Letter Agreement, so that it is fully negotiated and in final form for execution immediately upon Klotho’s notice of whether it elects to exercise its exclusive license option. Once the negotiated, the mutually agreed and negotiated License and Supply Agreement will be attached as Appendix D. |
Phase 2 – License Execution and Launch Preparation
If Klotho exercises its license option and executes the definitive License and Supply Agreement:
| 1. | The Parties shall be bound by the terms of such agreement, including the scope of work outlined in Parts II, III, and IV of the Term Sheet. |
| 2. | As described in the Term Sheet and the License and Supply Agreement, AAVnerGene will complete all required technology transfer activities to Klotho’s designated CDMO and support Klotho’s transition to clinical development. |
Phase 3 – Commercialization
Upon successful development and regulatory approval:
| 1. | AAVnerGene shall manufacture and supply licensed AAVone-based materials for commercial use. |
| 2. | Klotho (or its designated commercialization partner) shall market and sell finished gene therapy products. |
| 3. | Klotho shall pay to AAVnerGene royalties on net sales of licensed products, as specified in Part V of the Term Sheet and incorporated into the License and Supply Agreement. |
General Provisions
This Agreement shall be binding and enforceable upon execution by both Parties and shall remain in effect unless terminated by mutual written agreement or superseded by the definitive License and Supply Agreement.
This Agreement may be executed in counterparts, including via electronic signature, each of which shall be deemed an original and all of which together shall constitute one and the same instrument.
Any notices under this Agreement shall be sent to the respective addresses of the Parties as set forth below or as otherwise designated in writing.
Signature Page
IN WITNESS WHEREOF, the Parties have executed this Binding Letter Agreement as of the Effective Date.
| By: | AAVnerGene Inc. Dr. Daozhan Yu |
By: | Klotho Neurosciences, Inc. Dr. Joseph Sinkule |
|
| Signature: | /s/ Dr. Daozhan Yu | Signature: | /s/ Joseph Sinkule | |
| Title: | CEO and Founder | Title: | CEO and Founder | |
| Date: | August 6, 2025 | Date: | August 6, 2025 |
Appendix A – Executed Term Sheet between Klotho and AAVnerGene (Dated July 16, 2025)
Appendix B – Detailed Work Order
Appendix C – Klotho Certificate of Analysis
Appendix D – License and Supply Agreement
Exhibit 99.1
Klotho Neurosciences, Inc. (KLOTHO) Initiates Manufacturing of KLTO-202 Product Candidate Using AAVnerGene’s Platform Technology
NEW YORK, Aug. 12, 2025 /PRNewswire/ -- Klotho Neurosciences, Inc. (Nasdaq: KLTO), announces that it signed a binding agreement to initiate manufacturing and development of its KLTO-202 gene therapy candidate using the AAVnerGene Inc. (AAVnerGene) platform technology. As previously announced, AAVnerGene is an innovation-driven biotech renowned for its transformative technologies in adeno-associated viruses (AAV) manufacturing and tissue-targeted delivery. KLOTHO is a biotechnology company focused on the development of groundbreaking, disease-modifying cell and gene therapies using a human gene and protein derived from its patented form of the “anti-aging” Klotho gene.
Dr. Joseph Sinkule, KLOTHO CEO, stated, “The AAVnerGene technology is a game-changer in manufacturing AAV vectors for intracellular delivery of genes. The initiation of manufacturing is a key milestone in the development of any biotech product, and the manufacturing of gene therapy products presents particular complications. KLOTHO is using AAVnerGene’s cutting-edge ‘AAVone’ platform technology and engineered HEK293 cell line to introduce the plasmid DNA containing our Klotho gene, so that the AAV particles containing our gene are at a higher-than-normal titer concentration, have fewer impurities, and can be optimized and produced faster than the old standard method. We believe that working with AAVnerGene as our development partner has the potential to launch our product candidates into the clinic at a faster pace, lower cost, higher efficacy, and higher purity compared to the current ‘triple transfection’ manufacturing method.”
One of the major challenges facing AAV-vectored gene therapies is the propensity of the AAVs to home in on the liver and induce an inflammatory response that causes life-threatening side effects and even death. AAVnerGene created a series of specific tissue-targeting AAVs developed with its ‘ATHENA’ platform technology. Using the ATHENA system and tissue-specific targeting of the KLTO gene therapy product candidates containing KLTO’s tissue-specific promoters will be proven to be highly beneficial and likely safer than the AAV vectors that traffic to the liver.
AAVnerGene and Complexity of AAV-vectored Cell Lines.
Over the past 20 years of gene therapy, investigators and companies used a process called “triple transfection” whereby three DNA plasmids are transfected, or inserted, into the cell line called HEK293. The three plasmids contain sequences of the ‘gene-of-interest’, Rep/Cap sequences from AAV and ‘Helper’ sequences from Adenovirus to provide essential viral genes to enable replication and packaging of the AAV. As the HEK293 cells replicate and produce the viral proteins, the HEK293 cells assemble the proteins required to make the AAV particles containing the gene-of-interest inside the AAV particle. This is a complicated, tedious, labor-intensive process requiring optimization that may take several months or a year to complete. AAVnerGene developed a one-plasmid AAV packaging system called “AAVone,” which dramatically increased the production efficiency, simplified the process, reduced the impurity, shortened the time and lowered the development cost.
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 its novel delivery systems to transform and improve the treatment of neurodegenerative and age-related disorders such as ALS, Alzheimer’s disease, 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. KLOTHO 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
ir@klothoneuro.com
Website:www.klothoneuro.com.
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
daozhan.yu@aavnergene.com
Website: www.aavnergene.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.