PDS Biotechnology (NASDAQ: PDSB) shares VERSATILE-002 Phase 2 survival data

Rhea-AI Filing Summary

PDS Biotechnology Corporation filed a report describing that it has issued a press release with final topline survival data from its VERSATILE-002 Phase 2 clinical trial. This study evaluated its immunotherapy candidate PDS0101 (Versamune® HPV) in combination with Keytruda® (pembrolizumab) for patients with HPV16-positive, first-line recurrent or metastatic head and neck squamous cell cancer. The company has attached the full press release as Exhibit 99.1 for more detailed clinical results.

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): August 25, 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 August 25, 2025, PDS Biotechnology Corporation issued a press release announcing final topline survival data from its VERSATILE-002 Phase 2 clinical trial. VERSATILE-002 evaluated PDS0101 (Versamune^® HPV) + Keytruda^® (pembrolizumab) in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer.

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 August 25, 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:  August 25, 2025	By:	/s/ Frank Bedu-Addo, Ph.D.
	Name: Frank Bedu-Addo, Ph.D.
	Title: President and Chief Executive Officer

FAQ

What did PDSB disclose in this Form 8-K filing?

PDS Biotechnology Corporation disclosed that it issued a press release announcing final topline survival data from its VERSATILE-002 Phase 2 clinical trial and filed the press release as Exhibit 99.1.

What is the focus of PDSB's VERSATILE-002 Phase 2 trial?

The VERSATILE-002 Phase 2 trial focuses on PDS0101 (Versamune® HPV) in combination with Keytruda® (pembrolizumab) in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer.

Which therapy from PDSB is being evaluated in VERSATILE-002?

The trial evaluates PDS Biotechnology Corporation's immunotherapy candidate PDS0101, also referred to as Versamune® HPV, in combination with Keytruda®.

What kind of data did PDSB announce for VERSATILE-002?

PDS Biotechnology announced final topline survival data from the VERSATILE-002 Phase 2 clinical trial, as described in the press release attached as Exhibit 99.1.

Where can investors find the detailed VERSATILE-002 results from PDSB?

Detailed results are contained in the press release dated August 25, 2025, which PDS Biotechnology filed as Exhibit 99.1 to this report.

Which patient population is targeted in PDSB's VERSATILE-002 study?

VERSATILE-002 targets patients with HPV16-positive, first-line recurrent and/or metastatic head and neck squamous cell cancer.