PDS Biotech (NASDAQ: PDSB) revises Phase 3 VERSATILE-003 for earlier readout

Rhea-AI Filing Summary

PDS Biotechnology Corporation reported that it has submitted a protocol amendment to the U.S. Food and Drug Administration for its Phase 3 VERSATILE-003 clinical trial of PDS0101. The amendment would make progression free survival the primary endpoint that can be evaluated earlier with significant statistical power, which may provide a basis for accelerated approval of PDS0101. Median overall survival remains the primary endpoint for full approval, consistent with the FDA’s original recommendation.

Insights

Biotech clinical development analyst

PDS Biotech is revising its Phase 3 trial to pursue an earlier accelerated approval readout while keeping overall survival for full approval.

PDS Biotechnology Corporation is adjusting its Phase 3 VERSATILE-003 trial of PDS0101 so that progression free survival becomes the primary endpoint for an earlier evaluation. The company states this endpoint can be assessed earlier with significant statistical power, which aligns with a common strategy to obtain preliminary regulatory decisions before long-term survival data mature.

Despite the shift, median overall survival still remains the primary endpoint for full approval, as originally recommended by the U.S. Food and Drug Administration. This structure separates the potential accelerated approval decision, based on progression free survival, from the confirmatory overall survival outcome that would support traditional approval. Future updates about FDA feedback on the protocol amendment and eventual progression free survival and overall survival results from VERSATILE-003 will be important to understand how the program advances.

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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): January 9, 2026

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 January 9, 2026, PDS Biotechnology Corporation (the “Company”) issued a press release announcing that the Company has submitted a protocol amendment to the U.S. Food and Drug Administration (the “FDA”) for its Phase 3 VERSATILE-003 clinical trial. The proposed amendment to the VERSATILE-003 Phase 3 trial changes the progression free survival endpoint to a primary endpoint that can be evaluated earlier with significant statistical power, potentially providing the basis for accelerated approval of PDS0101. Median overall survival remains the primary endpoint for full approval as originally recommended by FDA.

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 January 9, 2026.
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:  January 9, 2026	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) change in the VERSATILE-003 Phase 3 trial?

PDS Biotechnology submitted a protocol amendment so that progression free survival becomes the primary endpoint in the VERSATILE-003 Phase 3 clinical trial, allowing it to be evaluated earlier with significant statistical power.

How could the new primary endpoint affect PDS0101 approval for PDSB?

By making progression free survival the primary endpoint that can be evaluated earlier, the amended trial design may provide the basis for accelerated approval of PDS0101, while median overall survival remains tied to full approval.

Does overall survival still matter in PDS Biotechnology’s VERSATILE-003 trial?

Yes. Median overall survival remains the primary endpoint for full approval of PDS0101 in the VERSATILE-003 Phase 3 trial, as originally recommended by the FDA.

What is the role of the FDA in PDS Biotechnology’s protocol amendment?

PDS Biotechnology has submitted the VERSATILE-003 protocol amendment to the U.S. Food and Drug Administration, which will review the proposed change of the primary endpoint to progression free survival.

What product is being studied in PDS Biotechnology’s VERSATILE-003 Phase 3 trial?

The VERSATILE-003 Phase 3 clinical trial is evaluating PDS0101, a product candidate being developed by PDS Biotechnology.

Where can investors find more details on PDSB’s Phase 3 trial update?

Additional details are provided in a press release dated January 9, 2026, which is included as Exhibit 99.1 to the company’s report.