PDS Biotechnology (PDSB) requests FDA meeting on PDS0101 pathway

PDS Biotechnology (PDSB) filed an 8-K announcing a regulatory step for its lead immunotherapy.

Rhea-AI Filing Summary

PDS Biotechnology (PDSB) filed an 8-K announcing a regulatory step for its lead immunotherapy. The company said it has requested a meeting with the U.S. Food and Drug Administration to explore an expedited approval pathway for PDS0101 in HPV16+ head and neck cancer. The announcement was made via a press release furnished as Exhibit 99.1.

This update signals the company’s intent to discuss potential accelerated routes with regulators, which, if granted in the future, could affect how quickly PDS0101 reaches patients. The filing does not include additional program, timing, or financial details beyond the meeting request.

Insights

Biopharma regulatory analyst

Company seeks FDA meeting to discuss expedited path for PDS0101.

PDS Biotechnology disclosed it requested an FDA meeting to explore an expedited approval pathway for PDS0101 in HPV16+ head and neck cancer. A meeting request is an early regulatory step that frames what evidence the agency will consider for any accelerated route.

The impact depends on FDA feedback and alignment on data requirements. The disclosure does not cite clinical outcomes, designations, or timelines, so the near-term effect is informational.

Next clarity would come from FDA meeting outcomes or future company updates, which could outline the evidentiary path and whether expedited mechanisms are feasible.

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, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did PDS Biotechnology (PDSB) announce?

The company requested a meeting with the FDA to explore an expedited approval pathway for PDS0101 in HPV16+ head and neck cancer.

Which product is involved in the PDSB update?

PDS0101, the company’s immunotherapy candidate for HPV16+ head and neck cancer.

Is there FDA approval for PDS0101?

No. The update states a meeting request to explore an expedited approval pathway, not an approval.

Where can I find the full details of the announcement?

Details are in the press release furnished as Exhibit 99.1.

Does the filing include financial or timing details?

No. It discloses the meeting request without additional program, timing, or financial specifics.

What is the form of this disclosure?

An 8-K current report dated October 29, 2025.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 10/29/2025 - 08:45 AM Learn about SEC filing dates

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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): October 29, 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 October 29, 2025, PDS Biotechnology Corporation issued a press release announcing that the Company has requested a meeting with the Food and Drug Administration to explore an expedited approval pathway for PDS0101 in HPV16+ Head and Neck 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 October 29, 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:  October 29, 2025	By:	/s/ Frank Bedu-Addo, Ph.D.
	Name: Frank Bedu-Addo, Ph.D.
	Title: President and Chief Executive Officer