[8-K] LENZ Therapeutics, Inc. Reports Material Event

Rhea-AI Filing Summary

On 31 Jul 2025, LENZ Therapeutics, Inc. filed a Form 8-K to report a material corporate event under Item 8.01.

The filing states that the U.S. Food and Drug Administration has approved LNZ100 in the United States. Additional details are contained in the accompanying press release (Exhibit 99.1). No financial statements, earnings figures or guidance were provided. Exhibit 104 includes the Inline XBRL cover-page tags. The report was signed by Chief Financial Officer Daniel Chevallard.

• Event date: 31 Jul 2025
• Regulatory milestone: FDA approval of LNZ100
• No other items or financial disclosures reported

Positive

• FDA approval of LNZ100 marks a significant regulatory milestone satisfying the primary requirement for U.S. market entry.

Negative

• None.

Insights

Regulatory Affairs Analyst

TL;DR: FDA approval of LNZ100 is the sole focus of this 8-K and represents a clear positive regulatory milestone for LENZ.

LENZ’s disclosure is concise: Item 8.01 confirms U.S. approval of LNZ100 and attaches the press release as Exhibit 99.1. Although the filing omits commercial timelines or financial projections, FDA approval itself removes the principal regulatory hurdle for LNZ100’s U.S. launch. Such clearance typically accelerates market access and may trigger milestone payments or partnerships, but the company has not disclosed any related arrangements in this document. The absence of additional items keeps compliance risk low.

Equity Analyst

TL;DR: Regulatory win boosts LENZ narrative; lack of financial detail tempers near-term visibility.

Investors generally react favorably to FDA approvals, viewing them as catalysts for valuation re-rating. While the 8-K confirms the approval, it provides no data on pricing, launch timing or expected revenue, so the magnitude of financial impact remains unknown. Still, the event reduces development risk and could improve LENZ’s negotiating position with payors or strategic partners. The filing’s narrow scope suggests management is reserving commercial specifics for future communications.

FALSE0001815776Solana BeachCalifornia00018157762025-07-312025-07-31

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): July 31, 2025

LENZ THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-40532

84-4867570

(State or other jurisdiction of incorporation)

(Commission File Number)

(I.R.S. Employer Identification No.)

201 Lomas Santa Fe Dr., Suite 300
Solana Beach, California						92075
(Address of principal executive offices)						(Zip code)

(858) 925-7000

(Registrant’s telephone number, including area code)

Not Applicable

(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 $0.00001 per share

LENZ

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 8.01 Other Events.

On July 31, 2025, LENZ Therapeutics, Inc. issued a press release announcing the approval of LNZ100 in the United States by the U.S. Food and Drug Administration. The press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference, except that the information contained on the website referenced in the press release is not incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number						Description
99.1						Press Release, dated July 31, 2025.
104						Cover Page Interactive Data File (the cover page XBRL tags are 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: July 31, 2025

LENZ THERAPEUTICS, INC.
By:			/s/ Daniel Chevallard
Name:			Daniel Chevallard
Title:			Chief Financial Officer
			(Principal Financial and Accounting Officer)

FAQ

When did LENZ (LENZ) receive FDA approval for LNZ100?

The approval was announced and reported on July 31, 2025.

What SEC form did LENZ file to disclose the FDA approval?

LENZ filed a Form 8-K under Item 8.01 (Other Events).

Which exhibit contains the press release about LNZ100’s approval?

The press release is filed as Exhibit 99.1 to the Form 8-K.

Who signed the Form 8-K on behalf of LENZ Therapeutics?

The document was signed by Chief Financial Officer Daniel Chevallard.

Does the 8-K include any financial statements or guidance related to LNZ100?

No, the filing does not include financial statements, projections, or guidance.