Early certepetide results for metastatic PDAC disclosed by Lisata

Rhea-AI Filing Summary

Lisata Therapeutics (Nasdaq:LSTA) filed an 8-K (Item 7.01 Regulation FD) announcing preliminary cohort B data from its Phase 2 ASCEND trial evaluating certepetide plus standard chemotherapy in metastatic pancreatic ductal adenocarcinoma. The company furnished a press release (Ex. 99.1) and investor slide deck (Ex. 99.2); the 8-K itself contains no numerical efficacy or safety results. Because the information is furnished, it is not deemed “filed” under the Exchange Act and carries no Section 18 liability. The disclosure is potentially material given certepetide’s status as the lead asset targeting a high-mortality cancer, yet the market impact depends on data contained only in the exhibits.

Positive

• Disclosure of preliminary Phase 2 ASCEND cohort B data for certepetide in metastatic pancreatic ductal adenocarcinoma, advancing the program toward potential pivotal testing

Negative

• None.

Insights

Clinical Trial Analyst

TL;DR: Preliminary Phase 2 data could de-risk lead asset but lack of numbers limits conclusions.

Releasing cohort B results signals management’s confidence in certepetide’s activity and safety profile against metastatic PDAC, a notoriously difficult indication. However, the 8-K omits response rates, progression-free survival or adverse-event details, forcing investors to consult the exhibits and judge credibility. Until quantitative endpoints are disclosed, the risk-adjusted NPV of certepetide remains unchanged. Watch for objective response ≥20% or PFS >6 months versus historical ~3 months to justify upside. Furnishing, rather than filing, also shields the company from potential liability, hinting data may still be maturing.

Portfolio Manager

TL;DR: Event is potentially price-moving but information asymmetry persists; maintain neutral stance.

Pipeline-centric micro-caps like Lisata trade on clinical catalysts. A Phase 2 read-out, even preliminary, often prompts sharp re-pricing. Yet with no metrics in the core filing, capital markets must parse a press release that may emphasize best-case signals. Position sizing should reflect binary outcomes: positive efficacy can accelerate partnering or a secondary equity raise; disappointing data risks cash burn and dilution. Until hard numbers are vetted, volatility elevates and discount rate stays high. Neutral rating pending fuller data.

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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

June 26, 2025

Date of Report (date of earliest event reported)

LISATA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-33650

22-2343568

(State or other jurisdiction of incorporation or organization)

(Commission File Number)

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

110 Allen Road, Second Floor, Basking Ridge, NJ 07920

(Address of Principal Executive Offices) (ZipCode)

(908) 842-0100

Registrant's telephone number, including area code

(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 (see General Instruction A.2. below):

☐ 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 $0.001 per share			LSTA			The Nasdaq Capital Market

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

o 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 7.01 Regulation FD Disclosure.

On June 26, 2025, Lisata Therapeutics, Inc. (the “Company”) issued a press release announcing preliminary cohort B data from the Phase 2 ASCEND trial (the “ASCEND Data”) evaluating certepetide with standard-of-care chemotherapy in metastatic pancreatic ductal adenocarcinoma. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.

A copy of a slide presentation that the Company will use at investor and industry conferences and presentations is attached to this Current Report as Exhibit 99.2 and is incorporated herein solely for purposes of this Item 7.01 disclosure.

The information in this Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, except as otherwise expressly stated in such filing.

Item 9.01. Financial Statement and Exhibits.

Exhibit No.			Description
99.1			Press Release, dated June 26, 2025
99.2			Corporate Presentation, dated June 26, 2025

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

LISATA THERAPEUTICS, INC.

By: /s/ David J. Mazzo            

Name: David J. Mazzo, PhD

Title: President & Chief Executive Officer

Dated: June 26, 2025

FAQ

What did LSTA announce in its June 26 2025 8-K filing?

The company furnished preliminary cohort B Phase 2 ASCEND data for its drug candidate certepetide in metastatic pancreatic cancer, along with a press release and slides.

Does the 8-K provide efficacy outcomes for certepetide?

No. The core document omits numerical efficacy or safety results; investors must review Exhibit 99.1 and 99.2 for details.

Which exhibits were attached to Lisata's 8-K?

Exhibit 99.1 is the press release dated June 26 2025; Exhibit 99.2 is a corporate presentation summarizing the ASCEND data.

Is the furnished information subject to Section 18 liability?

Because the ASCEND data is furnished under Item 7.01, it is not deemed filed and therefore not subject to Section 18 liabilities.

Why is the ASCEND trial important for LSTA investors?

Certepetide is the company's lead clinical asset; positive Phase 2 data in metastatic pancreatic cancer could unlock partnering options and value inflection.