Form 8-K - Current report

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

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FORM 8-K

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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 2, 2024

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PDS BIOTECHNOLOGY CORPORATION

(Exact Name of Registrant as Specified in Charter)

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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)

[phone]

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):

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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

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

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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 ☐

 

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Item 7.01

Regulation FD Disclosure.

On October 2, 2024, PDS Biotechnology Corporation (the “Company”) issued a press release announcing that updated data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune^® HPV (formerly PDS0101) with chemoradiation to treat locally advanced cervical cancer were presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2024 in an oral presentation by Adam Grippin, M.D., Ph.D., of The University of Texas MD Anderson Cancer Center. The abstract was granted Basic/Translational Science Award from the ASTRO Annual Meeting Steering Committee. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.

The information in this Item 7.01 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing..

Item 8.01

Other Events.

The information set forth in the press release referred to in Item 7.01 above, other than the second and fourth paragraphs thereof, is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.

In addition, on October 2, 2024, the Company added the presentation from the ASTRO meeting to its corporate website. A copy of the presentation is filed herewith as Exhibit 99.2 and incorporated by reference herein.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number		Description
99.1		Press Release dated October 2, 2024
99.2		ASTRO Presentation
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

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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 2, 2024		By:	/s/ Frank Bedu-Addo, Ph.D.
		Name: Frank Bedu-Addo, Ph.D
		Title: President and Chief Executive Officer

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Exhibit 99.1

PDS Biotech Announces 36-Month Overall Survival Rate of 84.4% in Locally Advanced Cervical Cancer Patients Treated with Versamune^® HPV and Chemoradiation

 

100% 36-month overall survival (OS) and progression-free survival (PFS) rates in patients fully treated with Versamune^® HPV combined with chemoradiation (N=8)

88% (15/17) of patients had a complete metabolic response

IMMUNOCERV Phase 2 clinical trial results presented at ASTRO Annual Meeting 2024

PRINCETON, N.J., October 2, 2024 -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that updated data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune^® HPV (formerly PDS0101) with chemoradiation to treat locally advanced cervical cancer were presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2024 in an oral presentation by Adam Grippin, M.D., Ph.D., of The University of Texas MD Anderson Cancer Center. The abstract was granted Basic/Translational Science Award from the ASTRO Annual Meeting Steering Committee.

“HPV is responsible for virtually all cervical cancers and presents an opportunity for immunologic targeting¹. However, there are currently no FDA-approved HPV-targeted immunotherapies to treat cervical cancer,” said Ann Klopp, M.D., Ph.D., Professor of Radiation Oncology and Head of the Gynecologic Section at MD Anderson. “These data suggest that further investigation is warranted into the safety and efficacy of Versamune^® HPV in combination with standard of care in the treatment of locally advanced cervical cancer.”

The IMMUNOCERV Phase 2 clinical trial (NCT04580771) evaluated the efficacy, safety and tolerability of Versamune^® HPV in combination with standard-of-care chemoradiotherapy for the treatment of locally advanced cervical cancer. The investigator-initiated study enrolled 17 newly diagnosed high-risk patients with large tumors of at least 5 cm in size. Highlights from the presentation include:

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All patients received at least 2 doses of Versamune® HPV

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Median follow-up was 19 months

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36-month overall survival (OS) rate was 84.4%, and 100% for the eight patients who received all five doses of Versamune® HPV. Historical published data show 36-month OS rate with chemoradiation in this population of approximately 64%.2

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36-month progression free survival (PFS) rate was 74.9%, among all patients and 100% for the eight patients who received all five doses of Versamune® HPV. Historical published data show 36-month PFS rate with chemoradiation in this population of approximately 61%.2

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Complete metabolic response (CMR) was achieved in 15/17 (88%) patients

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Versamune® HPV appeared to be safe and well-tolerated. The most common treatment-related toxicities were injection site reactions in twelve patients (71%).

“We are pleased that data from the Phase 2 IMMUNOCERV trial demonstrate compelling clinical activity and a promising safety profile,” said Frank Bedu-Addo, Ph.D., President and Chief Executive Officer of PDS Biotech. “Based on our continued research in various HPV-positive cancers, Versamune^® HPV appears to work in combination with a variety of therapeutic agents to generate clinical responses and promote improved survival in patients with minimal toxicity. We look forward to the next steps in the development of Versamune^® HPV for locally advanced cervical cancer.”

1.

National Cancer Institute, Cervical Cancer Causes, Risk Factors and Prevention. https://www. https://www.cancer.gov/types/cervical/causes-risk-prevention

2.

Rose PG, et al. Concurrent Cisplatin-Based Radiotherapy and Chemotherapy for Locally Advanced Cervical Cancer. N Engl J Med. 1999;340:1144-53.

About PDS Biotechnology

PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune^® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

For more information, please visit www.pdsbiotech.com.

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Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, Versamune^® HPV (formerly PDS0101), PDS0203 and other Versamune^® and Infectimune^® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, Versamune^® HPV, PDS0203 and other Versamune^® and Infectimune^® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  

Versamune^® and Infectimune^® are registered trademarks of PDS Biotechnology Corporation.

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Investor Contact:

Mike Moyer

LifeSci Advisors

Phone [phone]

Email: [e-mail]

Media Contact:

Janine McCargo

6 Degrees

Phone [phone]

Email: [e-mail]

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Exhibit 99.2

 IMMUNOCERV Phase II Trial Combining the HPV-specific T Cell Immunotherapy PDS0101 with Chemoradiation for Treatment of Locally Advanced Cervical Cancer   Adam J Grippin1, Kyoko Yoshida-Court1, Madison O’Hara1, Olsi Gjyshi2, Geena Mathew1, Maliah Domingo1, Lilie Lin1, Anuja Jhingran1, Melissa Joyner1, Tatiana Cisneros Napravnik1, Kathleen Schmeler1, Michael Hernandez1, Erica Lynn1, Aaron Seo1, Sage Copling1, Lauren Colbert1, Jagannadha K Sastry1 and Ann Klopp1  1The University of Texas MD Anderson Cancer Center, 2Department of Radiation Oncology, Saint Elizabeth Cancer Center, Edgewood, KY  

 

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 Disclosure  Employed by The University of Texas MD Anderson Cancer Center.  Inventor on a patent application related to cancer vaccines  This presentation discusses investigational use of PDS0101 in a clinical trial sponsored by PDS Biotechnology.  

 

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 Rationale  Although they express virus-associated antigens, there are currently no HPV-targeted therapies to treat HPV-related cancers.1   PDS0101 is a novel, subcutaneously administered Type I interferon and CD8 T-cell activating immunotherapy containing peptide pools encoding HPV antigens E6/E7.2  The IMMUNOCERV trial was designed to test the hypothesis that PDS0101 would be safe and effective in combination with standard of care chemoradiation for locally advanced HPV-related cervical cancer.   1Schwartz, JNCI, 1998; Gillison, JNCI, 2000; Burd, Clin Micro Rev, 2003  2Price, ASCO, 2023 

 

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 Trial Design  Primary Endpoint:   Clinically significant grade ≥3 acute toxicities from first vaccine injection up to 30 days following completion of chemoradiation (Day -10 to day 80)  Prespecified secondary endpoints:  Complete metabolic response (CMR) on Day 170 PET CT (± 14 days)  ≥90% gross tumor volume reduction (GTVR) on Day 35 MRI (± 5 days)  Progression-free survival (PFS)  Overall survival (OS) at 12 and 18 months 

 

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 Patient Enrollment and Demographics  n (%)  Age, median (range), years  Age, median (range), years  40 (26-79)  Ethnicity  Native Hawaiian or Other Pacific Islander  1 (5.8)  White or Caucasian  11 (64)  Other  1 (5.8)  Patient Refused  1 (5.8)  Black or African American  2 (11)  Clinical Stage  IB3  1 (5.8)  IIB  4 (23.5)  IIIC1  9 (52.9)  IIIC2  1 (5.8)  IVA  2 (11.7)  HPV Serotype  16  9 (52.9)  18  4 (23.5)  59  1 (5.8)  45  2 (11.7)  Negative  1 (5.8)  *Trial was closed early due to a change in the standard of care. Median follow up at time of analysis was 575 days.   n (%)  Highest Positive Clinical Node  Internal Iliac  3 (18)  External Iliac  9 (53)  Common Iliac  2 (12)  Para-aortic  2 (12)  Inguinal  1 (6)  Tumor Diameter (cm), median (Range)  6 (2.2-9.8)  Tumor Size (cm3), median (Range)  56.5 (4.5-251) 

 

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 PDS0101 was well-tolerated  Acute grade 3+ adverse events occurred in eight patients (47%), approximating the expected rate of Grade 3+ adverse events among patients receiving chemoradiation and brachytherapy boost of 46% (Rose, NEJM 1999; Rose, JCO 2007; Keys, NEJM 1999; Morris, JCO 1999; Eifel, JCO 2004).   Adverse events likely related to PDS0101 injection included injection site reaction (n=12, 71%), Grade 3 urticarial allergic reaction (n=1, 5.8%) and Grade 2 pain (n=1, 5.8%).   Grade 3+ Adverse Event  Frequency, n (%)  Nausea  2 (12%)  Vomiting  2 (12%)  Hydronephrosis  2 (12%)  Urinary tract infection  1 (6%)  Diarrhea  1 (6%)  Thromboembolic event  1 (6%)  Vaginal hemorrhage  1 (6%)  Renal insufficiency  1 (6%)  Hematuria  1 (6%)  Urticaria  1 (6%) 

 

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 Complete metabolic response* at 4 months**  GTV Reduction at Day 35 MRI  Radiographic Response  *Maximum SUV<4 on PET.  ** CMR ultimately achieved in 15/17 (88%) patients 

 

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 Patients in this high-risk cohort demonstrated promising survival outcomes  36 month OS = 84.4%  36 month PFS = 74.9%  *Both deaths occurred in patients with Stage IVA disease. One death was related to disease and the other was caused by cardiac arrest in a disease-free patient.  

 

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 Receipt of all five planned doses of PDS0101 was associated with improved PFS 

 

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 >75% volume reduction at Day 35 MRI was associated with improved PFS 

 

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 Conclusions  In this final report of the IMMUNOCERV clinical trial, PDS0101 was safe and well-tolerated, and receipt of all prescribed doses of PDS0101 was associated with improved PFS.   Further investigation of PDS0101 in cervical cancer in combination with pembrolizumab is warranted.  

 

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 Acknowledgements  MD Anderson Department of Radiation Oncology  Kyoko Yoshida-Court, PhD Kathleen Schmeler   Geena Mathew Erica Lynn   Maliah Domingo Aaron Seo, MD, PhD  Lilie Lin, MD, PhD Sage Copling  Anuja Jhingran, MD Lauren Colbert, MD  Melissa Joyner, MD Ann Klopp, MD  Tatiana Cisneros Napravnik  Saint Elizabeth Cancer Center Department of Radiation Oncology  Olsi Gjyshi, MD, PhD  MD Anderson Department of Immunology  Madison O’Hara, PhD  Jagannadha K Sastry, PhD  MD Anderson Department of Biostatistics  Michael Hernandez, PhD  MD Anderson/RICE University T32 in Cancer Nanotechnology  Gang Bao PhD Konstantin Sokolov PhD     This work was supported in whole or in part by:  PDS Biotechnologies  MD Anderson/RICE University T32 in Cancer Nanotechnology  Radiological Society of North America Resident Research Award 

 

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Document and Entity Information	Oct. 02, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Oct. 02, 2024
Entity File Number	001-37568
Entity Registrant Name	PDS BIOTECHNOLOGY CORPORATION
Entity Central Index Key	0001472091
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	26-4231384
Entity Address, Address Line One	303A College Road East
Entity Address, City or Town	Princeton
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08540
City Area Code	800
Local Phone Number	208-3343
Title of 12(b) Security	Common Stock, par value $0.00033 per share
Trading Symbol	PDSB
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false

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