8-K
PDS Biotechnology Corp (PDSB)
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): February 5, 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<br><br> <br>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 February 5, 2025, PDS Biotechnology Corporation (the “Company”) issued a press release announcing the reaffirmation of the Company’s guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune^®^ HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year. In addition, on February 5, 2025, the Company updated its corporate presentation deck.
A copy of the press release is filed herewith as Exhibit 99.1 and incorporated by reference herein. A copy of the corporate presentation deck is filed herewith as Exhibit 99.2 and incorporated by reference herein.
| Item 9.01 | Financial Statements and Exhibits. |
|---|
(d) Exhibits.
| Exhibit<br><br> <br>Number | Description |
|---|---|
| 99.1 | Press Release Dated February 5, 2025. |
| 99.2 | Corporate Presentation (February 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: February 5, 2025 | By: | /s/ Frank Bedu-Addo, Ph.D. |
| Name: Frank Bedu-Addo, Ph.D. | ||
| Title: President and Chief Executive Officer |
Exhibit 99.1
PDS Biotech Reaffirms Guidance for First Quarter Initiation of
VERSATILE-003 Phase 3 Clinical Trial in HPV16-Positive
Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
FDA-cleared amended trial design; First site initiation expected Q1 2025
PRINCETON, N.J., February 5, 2025 -- 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, today reaffirmed the Company’s guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune^®^ HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year.
PDS Biotech submitted its updated clinical protocol on November 15, 2024, amending the Investigational New Drug (IND) application. The window for comments from the U.S. Food and Drug Administration (FDA) has passed, and the Company is on track to initiate site activation in the first quarter of 2025. The Company has received Fast Track designation from the FDA for the combination of Versamune^®^ HPV and pembrolizumab in R/M HNSCC. (See VERSATILE-002 Phase 2 clinical results here.)
“The integral elements for trial initiation are ready, including alignment with the FDA,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We look forward to initiating VERSATILE-003 this quarter and advancing the combination of Versamune^®^ HPV plus pembrolizumab to potentially provide improved outcomes for patients with HPV16-positive R/M HNSCC.”
HPV16-positive patients represent a large, fast-growing subgroup in need of targeted therapies to treat the underlying cause of the cancer. A recently validated companion diagnostic to confirm HPV16-positive HNSCC will be utilized during the patient screening process of the VERSATILE-003 trial.
“HPV16-positive HNSCC is poised to become the dominant type of HNSCC in the US and EU,” said Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. “Confirming HPV16 status with a potentially commercializable test is essential to effectively identifying the patients suitable to receive Versamune HPV. This will be the first investigational use of this type of companion diagnostic in a Phase 3 clinical trial in HNSCC.”
For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966).
About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company plans to initiate a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational T-cell stimulating 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
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 Versamune^®^ HPV, PDS01ADC and other Versamune^®^ 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 Versamune^®^ HPV, PDS01ADC and other Versamune^®^ 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^®^ is a registered trademark of PDS Biotechnology Corporation.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
Janine McCargo
6 Degrees
Phone +1 (646) 528-4034
Email: jmccargo@6degreespr.com
Exhibit 99.2
Transforming How the Immune System Targets and Fights Cancer to Promote Survival NASDAQ: PDSB February 2025 Precision Designed Science For Immunotherapy
Forward-Looking Statements This communication contains forward-looking statements (including within the meaning of Section 27E 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 Versamune® HPV, PDS01ADC and other Versamune® and lnfectimune® 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 Versamune® HPV, PDS01ADC and other Versamune® and lnfectimune® 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; to aid in the development of the Versamune® platform; 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 risk factors included in the Company's annual, quarterly and periodic reports filed with the Securities and Exchange Commission (“SEC”). The forward-looking statements are made only as of the date of this presentation 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. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Versamune® and lnfectimune® are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Xtandi® is a registered trademark of Astellas Pharma Inc.
Late-Stage Head and Neck Cancer* Program as Value Catalyst Potential for Market Leadership Position High-Value Lead Program With Strong KOL support Growing Unmet Need Phase 3 HNSCC Trial Rapidly growing HPV16-positive indication 50%+ of HNSCC in US/EU Unique cancer with atypical presentation and physiology No current approved therapy for large HPV16-positive population Versamune® HPV is an HPV16-specific T cell stimulating immunotherapy Lead program addressing HPV16-positive recurrent and/or metastatic HNSCC $4-5B US & EU market potential for HPV16-positive HNSCC Phase 2 trial resulted in FDA Fast Track designation in R/M HNSCC Alignment with FDA on phase 3 trial design Trial planned to start in Q1 2025 Competing EGFR antibody approaches have reported weaker clinical responses in HPV-positive HNSCC compared to HPV-negative HNSCC Strong phase 2 trial safety, response and survival results warrant Phase 3 study Versamune® HPV is most clinically advanced HPV16 targeted program *Head and neck squamous cell carcinoma (HNSCC)
Upcoming Milestones 2025-2026 (Phase 2 and Phase 3 Trials) Q1 2025 Q2 2025 Q3 2025 Q4 2025 Q1 2026 Q2 2026 Q3 2026 Regulatory clearance to start VERSATILE-003 File IND for Versamune® MUC1 Initiate VERSATILE-003 (V-003) Data readout from VERSATILE-002 (V-002) Data readout: Versamune® HPV and Versamune® HPV + Pembrolizumab as neoadjuvant in HPV16+ oropharynx cancer Interim data readout: PDS01ADC + HAIP therapy in colorectal & gall bladder cancer Interim data readout: PDS01ADC + Xtandi® in recurrent PET+ prostate cancer Complete V-003 patient recruitment þ * Investigator initiated and funded trials. Trials not run by PDS Biotech; Completed * * * * þ
HPV-positive and HPV-negative HNSCC: Two Distinct Diseases1-3 HPV-negative HNSCC Alcohol & tobacco Causes mutations in oncogenic river genes HPV-positive HNSCC High-risk HPVViral oncoproteins E6/E7 degrade tumor suppressor proteins Low expression of viral genes & limited T cell infiltration Treatable with chemotherapy/radiation Difficult to Treat Disease recurrence or metastasis High rates of disease recurrence or metastasis High expression of viral genes & T cell presence in tumors Non-keratinizing, basaloid histopathological features and over-expression of p16 Keratinizing squamous cell carcinoma features and frequent TP53 mutations Most effective therapy will target E6 & E7 proteins
Significant and Growing Market Potential in HPV16-positive HNSCC HPV16 to Drive Increased HNSCC Incidence Rates & Exceed 50% of all HNSCC by mid 2030s4 Current estimated US annual incidence of HPV16-positive HNSCC ~ 21,000 (~40-50% of all HNSCC)5-8 Incidence of locally advanced, unresectable, metastatic HPV16-positive HNSCC = 13,6007-9 Versamune® HPV US market potential = $2-3B10 EU HPV+ HNSCC incidence and trends similar to US
Significant Unmet Needs Remain in Recurrent or Metastatic (R/M) HNSCC Pembrolizumab (KEYTRUDA®) Pembrolizumab Plus Chemo Chemotherapy + EGFR Inhibitor Objective Response Rate (ORR) 19% 36% 35% Progression Free Survival (PFS) 3.2 mos 5.0 mos 5.0 mos Median Overall Survival (OS) 12.3 mos 13.6 mos 10.3 mos Treatment Related Grade 3+ Toxicities 17% 72% 69% HPV-Specificity: Need targeted treatment option to address the growing population of HPV16-positive HNSCC and improve outcomes Improved Survival: Need novel MOA that provides enhanced survival Improved Durability: Need novel MOA that is clinically effective in broad patient population and provides more durable (long-term) responses. Improved Safety: Need safe treatments that may be used with or in place of current standard of care and chemotherapy Oncologist10 – Stated Unmet Medical Needs in HNSCC Survival on Current Therapies: Approx. 12 months (Published Results12)
FDA Views Overall Survival (OS) as Primary Endpoint for Approval in R/M HNSCC KEYNOTE-04812 Pembrolizumab EGFR antibody (cetuximab) + chemotherapy LEAP-01014 Pembrolizumab Pembrolizumab + lenvatinib Combination Drug Candidates Have Not Resulted in Improved (OS) over Pembrolizumab ORR = Objective Response Rate; PFS = Progression Free Survival; OS = Overall Survival
VERSATILE-002: A Global Phase 2 Study of Versamune® HPV and Pembrolizumab in Subjects with HPV16-positive R/M HNSCC Partner StudyDesign Open-label, non-randomized, adaptive design study 31 sites in US and EU 2 Cohorts: ICI Naïve ICI Resistant Enrollment complete Key Entry Criteria for ICI Naïve Subjects R/M HNSCC ≥18 years of age HPV16-positive tumor Combined positive score (CPS) ≥1 Versamune® HPV 5 doses: 1 mL Subcutaneous injection at Cycles 1, 2, 3, 4 & 12) Pembrolizumab (KEYTRUDA®) 200mg IV Q3W up to 35 Cycles (2 years) Study Treatment Primary: Best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1 Key Secondary: Overall Survival (OS) Progression Free Survival (PFS) per RECIST v1.1 Safety and tolerability Endpoints Fast Track Designation Study Evaluating Effects of Versamune® HPV Attributes on Clinical Responses
VERSATILE-002: Most Patients Had Recurrent Disease and Prior Treatment Historical Responses Published data reports lower ORR, PFS and OS with pembrolizumab in patients with CPS 1-19 vs. CPS ≥ 2016 Published data reports lower responses in patients with recurrent disease No controlled or comparative studies have been conducted between checkpoint inhibitors and Versamune® HPV Key Demographics and Treatment Exposure15 Demographic/Baseline Characteristic Efficacy Population (N=53) Age, Median (Min, Max) 64.0 (46, 83) Sex, n (%) Male Female 49 (92.5) 4 (7.5) Race, n (%) Asian Black or African American White Other 1 (1.9) 1 (1.9) 50 (94.3) 1 (1.9) ECOG, n (%) 0 1 30 (56.6) 23 (43.4) CPS, n (%) 1–19 ≥20 32 (60.4) 21 (39.6) Prior Therapy*, n (%) No Prior Therapy Chemotherapy Only Chemotherapy + Radiation Therapy 10 (18.9) 3 (5.7) 40 (75.5) Lower pembrolizumab responses 81.2% with prior treatment
Percent Change from Baseline in Target Lesions -50 -25 25 50 75 100 0 -75 -100 -125 CPS Group 1-19 ≥20 CPS Group Response Complete Response (CR) 5/53 9.4% Partial Response (PR) 14/53 26.4% Stable Disease (SD) 22/53 41.5% Progressive Disease (PD) 9/53 17.0% Treatment Ongoing Confirmed Objective Response Rate (ORR) Based on Investigator Assessment Per RECIST v1.1 Best Percentage Change from Baseline in Target Lesions (mITT population) 11/53 (21%) of patients had 90-100% tumor shrinkage Deep Tumor Regression Independent of Patient CPS Score 35.8% ORR Confirmed Disease Control Rate of 77.4%15
Extended Disease Control in Majority of Patients15 Based on Investigator Assessment Per RECIST v1.1 Best Percentage Change from Baseline in Target Lesions Spider plot: Sustained CR, PR, and SD responses. Median Duration of Response is 21.8 months Percent Change from Baselinein Target Lesions Time of Assessment (Months) 0 2 4 6 8 10 12 14 16 18 20 22 24 1 3 5 7 9 11 13 15 17 19 21 23 -125 -100 150 175 200 225 50 75 100 125 -50 -25 0 25 -75 Response Complete Response Partial Response Stable Disease Progressive Disease Treatment Ongoing
Survival Fraction 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 0.0 0.2 0.4 0.6 0.8 1.0 Censored ‒ Ongoing (N=27) Censored ‒ Discontinued (N=8) Discontinued: N=2 Lost to follow up; N=6 withdrawn consent; Ongoing: Patients ongoing and awaiting next clinical assessment Median Overall Survival of 30 Months15 Multiple Patients Approaching 3 Years of Survival 53 (0) 50 (3) 46 (6) 42 (8) 40 (8) 37 (10) 34 (11) 32 (11) 23 (13) 20 (13) 16 (15) 14 (15) 9 (16) 8 (16) 7 (16) 5 (18) 3 (18) 1 (18) 0 (18) Number at Risk Median OS, months (95% CI) = 30.0 (19.7, NE) Median follow up (months) = 16
Versamune® HPV plus Pembrolizumab Appears to be well Tolerated17 Protocol stipulates 5 subcutaneous injections of Versamune® HPV: 4 injections over 2 months and a final injection after an additional 6 months *Grade 3 Combination-TRAE were: Fatigue (2), Rash, Alanine aminotransferase increased, Blood alkaline phosphatase increased, Lymphocyte count decreased, Autoimmune colitis, Colitis, Headache, Acute kidney injury, Hyponatremia, Hyperglycemia, **Grade 4 Combination-TRAE: encephalitis (case recorded approx. one year after last Versamune® HPV dose) * TRAE = Treatment Related Adverse Event 8/87 (9%) Patients had a Grade 3 TRAE*; 1/87 (1%) had a Grade 4 TRAE** TRAEs by Grade n (%) Any Combination TRAE 76 (87.4) Grade 1 40 (46.0) Grade 2 26 (29.9) Grade 3 8 (9.2) Grade 4 1 (1.1) Grade 5 0 Non-Injection Site TRAEs ≥ 5% n (%) Fatigue 30 (34.5) Headache 13 (14.9) Diarrhea 10 (11.5) Pruritis 9 (10.3) Rash 7 (8.0) Malaise 6 (6.9) Pyrexia 6 (6.9) Pain 5 (5.7) Cough 5 (5.7)
VERSATILE-002 Summary of Results15 ESMO 2024* Published Results* VERSATILE-002 KEYNOTE-048 LEAP-010 CPS ≥ 1 CPS ≥ 20 CPS ≥ 1 CPS ≥ 20 CPS ≥ 1 Objective Response Rate (ORR) 36% 48% 19% 23% 25% Median Overall Survival (mOS) 30.0 months 30.0 months 12.3 months 14.9 months 17.9 months * Not a head-to-head comparison. No controlled or comparative studies have been conducted between Versamune® HPV and pembrolizumab Study has met primary ORR endpoint by RECIST v1.1 in ICI naïve patients Disease control rate (DCR) for CPS ≥ 1 was 77.4% 21% of patients had 90-100% tumor shrinkage The combination treatment was well tolerated Strong Clinical Responses and Patient Survival Warrant Registrational Trial
Durable Anti-Tumor Immune Response Observed Objective Response Rate (ORR) Patients with Tumor Shrinkage of 90-100% Patients with Complete Responses (CR) Disease Control Rate (DCR) Median Overall Survival May 2023 (N=34)15 26% 6% 3% 70% Not Estimable November 2023 (N=53)16 34% 21% 7.5% 77% 30 months May 2024 (N=53)12 36% 21% 9.4% 77% 30 months By promoting potent killer T cells and memory T cells, Versamune® HPV is designed to enable a durable attack on the cancer, leading to potential tumor shrinkage and survival Time Responses Improved with Time; Sustained Median OS of 30 Months
Corroborating Biomarker/Clinical Support for Versamune® HPV IMMUNOCERV Chemoradiotherapy + Versamune® HPV Published KEYNOTE-A18 Chemoradiotherapy + Pembrolizumab (KEYTRUDA®) 36-Month Survival Rate Number of Versamune® HPV doses 5 doses: 100% (N=8) ≥2 doses: 84.4% (N=17) 82.6% 36-Month Progression Free Survival (PFS) Rate Number of Versamune® HPV doses 5 doses: 100% (N=8) ≥2 doses: 74.9% (N=17) 69.3% Complete Response (Metabolic) 88% N/A * For illustrative purposes only. Not a head-to-head comparison. No controlled or comparative studies have been conducted between Versamune® HPV and pembrolizumab Results for IMMUNOCERV Phase 2 Trial Results and Published KEYNOTE A18 Results IMMUNOCERV Trial Provides Compelling Survival and PFS Results
Study in locally advanced cervical cancer patients treated with Versamune® HPV and chemoradiotherapy 91.7% clearance of ctDNA at Week 5 vs 53.1% clearance with CRT alone18 5/5 tested HPV16-positive patients had undetectable ctDNA at 3-4 months22 Undetectable ctDNA resulted in superior 2-year recurrence free survival (RFS) of 93% vs 30%22 Quantity of killer T cells that infiltrated the patient’s tumors Quantity of HPV+ tumor cell DNA circulating in patient blood Clinical: CD8 T Cell Accumulation in Tumor Correlated with Elimination of Circulating Cancer Cells (ctDNA)17 Representative Plot from a Single Versamune® HPV Treated Patient Week 24 Week 3 Baseline Radiation Oncology Dept. Univ. of Texas MD Anderson Cancer Center Corroborating Biomarker/Clinical Support for Versamune® HPV Elimination of Micro-Metastatic Tumors by Circulating Tumor DNA (ctDNA) Analysis25
Objective Response Rate (ORR) Progression Free Survival (PFS) N=8 N=8 N=6 N=6 Corroborating Biomarker/Clinical Support for Versamune® HPV Superior Survival and Response in HPV16-positive vs HPV16-negative R/M Cancers26 Study performed by National Cancer Institute
VERSATILE-003 First Line Recurrent/Metastatic HNSCC Trial Design Interim Analysis 1 Possible Early Approval Versamune® HPV + PDS01ADC + pembrolizumab Study Start Versamune® HPV + Pembrolizumab Pembrolizumab (KEYTRUDA®) Aligned with FDA on Study Design and Initiation in Q1 2025 Patient Recruitment Patient Recruitment Survival Follow-up Survival Follow-up Key Eligibility Criteria HPV16-positive HNSCC CPS ≥1 ≥18 years of age ECOG 0-1 Secondary Endpoints Objective Response Rate (ORR) Disease Control Rate (DCR) Duration of Response (DoR) Progression Free Survival (PFS) Randomized controlled trial N = 351 2:1 randomization Primary Endpoint Overall Survival (OS) FinalAnalysis Interim Analysis 2 Possible Early Approval
Late-Stage Head and Neck Cancer* Program as Value Catalyst Potential for Market Leadership Position High-Value Lead Program With Strong KOL support Growing Unmet Need Phase 3 HNSCC Trial Rapidly growing HPV16-positive indication 50%+ of HNSCC Unique cancer with atypical presentation and physiology No current approved therapy for large HPV16-positive population Versamune® HPV is an HPV16-specific T cell stimulating immunotherapy Lead program addressing HPV16-positive recurrent and/or metastatic HNSCC $4-5B US & EU market potential for HPV16-positive HNSCC Phase 2 trial resulted in FDA Fast Track designation in R/M HNSCC Alignment with FDA on phase 3 trial design Trial planned to start in Q1 2025 Competing EGFR antibody approaches have reported weaker clinical responses in HPV-positive HNSCC compared to HPV-negative HNSCC Strong phase 2 trial safety, response and survival results warrant Phase 3 study Versamune® HPV is most clinically advanced HPV16 targeted program *Head and neck squamous cell carcinoma (HNSCC)
Thank You NASDAQ: PDSB
References Tabatabaeian H et al, Navigating therapeutic strategies: HPV classification in head and neck cancer, British Journal of Cancer. (2024) 131: 220-230 Wang H, et al (2019) The Double-Edged Sword—How Human Papillomaviruses Interact With Immunity in Head and Neck Cancer, (2019). Front. Immunol. 10:653.doi: 10.3389/fimmu.2019.00653 https://sysmex-inostics.com/key-differences-between-hpv-positive-and-hpv-negative-head-and-neck-squamous-cell-carcinomas-hnscc/ Damgacioglu H, Sonawane K, Chhatwal J, et al. Long-term impact of HPV vaccination and COVID-19 pandemic on oropharyngeal cancer incidence and burden among men in the USA: A modeling Study. The Lancet Regional Health – Americas. 2022;8:100143. CDC. HPV and Oropharyngeal Cancer. September 17, 2024. Accessed November 10, 2024. https://www.cdc.gov/cancer/hpv/oropharyngeal-cancer.html. Saraiya M, Unger ER, Thompson TD, et al. US Assessment of HPV Types in Cancers: Implications for Current and 9-Valent HPV Vaccines. J Natl Cancer Inst. 2015;107(6):djv086. Isayeva T, Li Y, Mawahu D, Brandwein-Gensler M. Human Papillomavirus in Non-Oropharyngeal Head and Neck Cancers: A Systematic Literature Review. Head and Neck Pathol. 2012;6:S104–S120. Mazul AL, et al. Disparities in head and neck cancer incidence and trends by race/ethnicity and sex. Head Neck. 2023;45(1):75-84. Lechner M et al HPV-associated oropharyngeal cancer: epidemiology, molecular biol and clinical management. Nat Rev Clin Oncol. 2022;19(5),306-327. Triangle Research Group. PDS Proprietary Market Research Report. 2024. Trosman SJ, Koyfman SA, Ward MC et al. Effect of Human Papillomavirus on Patterns of Distant Metastatic Failure in Oropharyngeal Squamous Cell Carcinoma Treated With Chemoradiotherapy. JAMA Otolaryngol Head Neck Surg. 2015;141(5):457-462. doi:10.1001/jamaoto.2015.136 Burtness B, Harrington KJ, Greil R, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomized, open-label, phase 3 study. Lancet. 2019;394:1915-28. https://doi.org/10.1016/. Harrington, KJ, Burtness B, Greil R, et al. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. J Clin Oncol. 2022;41:790-802. https://doi.org/10.1200/JCO.21.02508. Licitra L, Tahara M, Harrington K, et al. Pembrolizumab With or Without Lenvatinib As First-Line Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC): Phase 3 LEAP-10 Study. Poster or Paper presented at: Multidisciplinary Head and Neck Cancers Symposium; February 29-March 2, 2024; Phoenix, AZ
References (continued) Weiss J et al. VERSATILE-002: Survival with First-Line Treatment with PDS0101 Therapeutic Vaccine and Pembrolizumab in HPV16-positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). Poster Presented: ESMO Congress 2024; September 13-17, 2024; Barcelona, Spain. Burtness B, Rischin D, Greil R, et al. Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score. J Clin Oncol. 2022;40:2321-2332. https://doi.org/10.1200/JCO.21.02198. PDSB Data on File: Data represents a 17May2024 data cut. Price KAR, Kaczmar JM, Worden FP, et al. Safety and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study of PDS0101 and Pembrolizumab in HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC). Poster Presented at: ASCO Annual Meeting; June 2-6, 2023; Chicago, IL. PDSB Data on File: Data represents a 30November2023 data cut. Yoshida-Court K, Gjyshi O, Lin L, et al. IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy with chemotherapy and radiation for treatment of locally advanced cervical cancers (NCT04580771). Poster Presented at: SITC; November 8-12, 2022; Boston MA. Xiao Q, Gjyshi O, Court K, et al. HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation. Poster Presented at: ASTRO 2023; October 1-4, 2023; San Diego, CA. Lorusso D, Xiang Y, Hasegawa K, et al. Pembrolizumab Plus Chemoradiotherapy for High Risk Locally Advanced Cervical Cancer: Overall Survival Results from the Randomized, Double Blind, Phase 3 ENGOT cx11/GOG 3047/KEYNOTE A18 Study. Poster Presented at: ESMO Congress 2024; September 13-17, 2024; Barcelona, Spain. Grippin AJ, Yoshida-Court K, O’Hara M, et al. IMMUNOCERV Phase II Trial Combining the HPV-specific T Cell Immunotherapy PDS0101 with Chemoradiation for Treatment of Locally Advanced Cervical Cancer. Poster Presented at: ASTRO 2024; September 29-October 2, 2024; Washington, DC. Gandhapudi SK, Ward M, Bush JPC, Bedu-Addo F, Conn G, Woodward JG. Antigen Priming with Enantiospecific Cationic Lipid Nanoparticles Induces Potent Antitumor CTL Responses through Novel Induction of a Type I IFN Response. J Immunol. 2019;202:3524-3536. Seo A., et al, Human Papilloma Virus Circulating Cell-Free DNA Kinetics in Patients with Cervical Cancer Undergoing Definitive Chemoradiation, Clinical Cancer Research, Jan. 10, 2025. National Cancer Institute (2023). Triple Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set] L. Wood et al. A Novel Enantio-Specific Cationic Lipid R-DOTAP + HPV16 E6 & E7 Antigens Induces Potent Antigen-Specific CD8+ T Cell Responses In-Vivo in Subjects with CIN and High-Risk Human Papillomavirus Infection. Nov 8, 2019. SITC. Presentation O17.