[8-K] ANEW MEDICAL, INC. Common Stock Reports Material Event

Rhea-AI Filing Summary

Klotho Neurosciences entered a Letter Agreement with AAVnerGene to manufacture and develop its KLTO-202 gene therapy candidate using AAVnerGene platform technology. The Company will pay an initial fee of $250,000, additional fees tied to clinical trial stages, and a 2% royalty on revenue from products created using the referenced platform. The agreement is filed as an exhibit to the 8-K and the company furnished a related press release.

The filing discloses the commercial terms but does not quantify expected costs, timelines, or projected revenue impact; it includes customary forward-looking statement cautions.

Positive

• Executed a Letter Agreement with AAVnerGene to manufacture and develop the KLTO-202 gene therapy candidate
• Upfront payment disclosed as $250,000, providing clarity on initial cash commitment
• Long-term commercial terms defined with a 2% royalty on revenue from products using the platform

Negative

• 2% royalty obligation will reduce future product revenue available to the company
• Additional stage-based fees may increase development costs; total program cost and timeline are not disclosed

Insights

Financial Analyst

TL;DR: Agreement establishes manufacturing path for KLTO-202 with known upfront cost and a 2% royalty; material financial impact remains unclear.

The Letter Agreement specifies an $250,000 initial fee, stage-based additional fees, and a 2% royalty on product revenue. From a financial viewpoint, these terms create clear cost and future-royalty obligations but the filing does not disclose estimated total program costs, anticipated revenue, or how royalties compare to expected product economics. Without revenue or budget context, investors cannot assess whether fees or royalty materially change valuation or cash-flow projections.

Biotech Manufacturing Specialist

TL;DR: Securing a manufacturing and development partner for KLTO-202 is operationally significant and supports clinical advancement.

The agreement formally engages AAVnerGene for manufacturing and development of KLTO-202, which is an important step toward enabling clinical manufacturing scale-up. The disclosed $250,000 upfront payment and stage-based fees reflect typical early-stage service arrangements, and the 2% product revenue royalty aligns long-term partner incentives. The filing does not provide process, capacity, or timeline details, so operational readiness and potential bottlenecks cannot be evaluated from this disclosure alone.

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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).

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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: August 12, 2025	KLOTHO NEUROSCIENCES, INC.
	By:	/s/ Joseph Sinkule
	Name:	Joseph Sinkule
	Title:	Chief Executive Officer

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FAQ

What did Klotho Neurosciences announce about KLTO-202's manufacturing?

The company entered a Letter Agreement with AAVnerGene to manufacture and develop KLTO-202 using AAVnerGene platform technology.

How much is the initial fee Klotho will pay under the agreement?

The initial fee disclosed in the filing is $250,000.

Are there ongoing payments or royalties in the agreement?

Yes. The Company will pay additional fees based on clinical trial stage and a 2% royalty on revenue from products created using the platform.

Did Klotho provide financial projections or timelines for KLTO-202 in this filing?

No. The filing discloses fees and royalty terms but does not provide cost estimates, revenue projections, or development timelines.

Where can investors find the full agreement details?

The Letter Agreement is filed as Exhibit 4.1 to the 8-K and the related press release is furnished as Exhibit 99.1.