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 23, 2023
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 Stock Market LLC
|
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 ☐
On October 23, 2023, PDS Biotechnology Corporation (the “Company”) issued a press release announcing immune response data from a preliminary analysis of a subset of patients in VERSATILE-002, the Phase 2 clinical trial evaluating the safety and efficacy of PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with human papillomavirus (HPV)16-positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The data presented during the European Society for Medical Oncology Congress 2023 (ESMO Congress 2023) provided preliminary insight to the pre-existing immune responses in advanced HPV-positive HNSCC patients and potential changes to the immune profile after treatment.
The Company is filing a copy of the press release, which is attached hereto as Exhibit 99.1 and incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit Number | | Description |
| | | |
| | Press Release, dated October 23, 2023. |
| 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 23, 2023 |
| By: | /s/ Frank Bedu-Addo, Ph.D. |
|
| Name: Frank Bedu-Addo, Ph.D. |
|
| Title: President and Chief Executive Officer |
