PDS Biotechnology (PDSB) Files 8-K on CPS 1-19 Sub-analysis

Rhea-AI Filing Summary

PDS Biotechnology Corporation filed an 8-K stating that on September 18, 2025 it issued a press release detailing a sub-analysis of the cohort of patients with low PD-L1 expression (CPS 1-19) drawn from the final data of its VERSATILE-002 Phase 2 clinical trial. The filing itself does not include the press release text or any efficacy, safety, or numerical outcome data; it only identifies the press release as Exhibit 99.1 and incorporates it by reference. This disclosure notifies investors that the company is reporting subgroup findings for a defined low PD-L1 population but provides no performance metrics, so readers must consult the Exhibit for results.

Positive

• PDSB disclosed a targeted sub-analysis for the low PD-L1 cohort (CPS 1-19) from the final VERSATILE-002 Phase 2 dataset
• Formal filing of a press release as Exhibit 99.1 ensures the disclosure is part of the public record

Negative

• No efficacy or safety results are included in the 8-K text itself
• Key investor metrics are missing—the filing does not state response rates, survival data, or sample sizes for the CPS 1-19 cohort

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): September 18, 2025

PDS BIOTECHNOLOGY CORPORATION

(Exact Name of Registrant as Specified in Charter)

Delaware	001-37568	26-4231384
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

303A College Road East, Princeton, NJ 08540

(Address of Principal Executive Offices, and Zip Code)

(800) 208-3343

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 communication 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 communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communication 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 $0.00033 per share	PDSB	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 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §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. Yes ☐ No ☐

Item 8.01 Other Events.

On September 18, 2025, PDS Biotechnology Corporation issued a press release announcing details of a sub-analysis of the cohort of patients with low PD-L1 expression (CPS 1-19) from the final data for its recently completed VERSATILE-002 Phase 2 clinical trial.

A copy of the press release is filed herewith as Exhibit 99.1 and incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number		Description
99.1		Press Release Dated September 18, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL Document).

Signature

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.

		PDS BIOTECHNOLOGY CORPORATION
	Date:  September 18, 2025	By:	/s/ Frank Bedu-Addo, Ph.D.
		Name: Frank Bedu-Addo, Ph.D.
		Title: President and Chief Executive Officer

FAQ

What did PDS Biotechnology (PDSB) disclose in the 8-K on September 18, 2025?

The company announced a press release detailing a sub-analysis of the low PD-L1 expression cohort (CPS 1-19) from the final data of the VERSATILE-002 Phase 2 trial; the full press release is filed as Exhibit 99.1.

Does the 8-K include results for the CPS 1-19 cohort?

No. The 8-K notes the sub-analysis and references a press release but does not include any efficacy, safety, or numerical outcome data in the filing text.

Where can investors find the detailed data referenced in the 8-K?

The detailed information is contained in the press release filed as Exhibit 99.1; investors should review that exhibit for results and metrics.

Which clinical trial is referenced in the filing?

The filing references the VERSATILE-002 Phase 2 clinical trial.

What patient subgroup is the sub-analysis focused on?

The sub-analysis focuses on patients with low PD-L1 expression, defined in the filing as CPS 1-19.