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): August 1, 2024
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 August 1, 2024, PDS Biotechnology Corporation (the “Company”) issued a press release announcing that it has received the official minutes from its meeting with the U.S. Food and Drug Administration regarding next steps in the planned Phase 3 clinical trial of its Versamune^®^ based investigational immunotherapy designed to stimulate a targeted T cell attack against HPV16-positive head and neck squamous cell carcinoma. In addition, on August 1 2024, 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 August 1, 2024. |
| 99.2 | Corporate Presentation (August 2024). |
| 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: August 1, 2024 | By: | /s/ Frank Bedu-Addo, Ph.D. |
| Name: Frank Bedu-Addo, Ph.D. | ||
| Title: President and Chief Executive Officer |
Exhibit 99.1
PDS Biotech Aligns with FDA on Phase 3 Trial in HPV16-Positive
First-Line Recurrent or Metastatic Head and Neck Cancer
Company to initiate Phase 3 VERSATILE-003 trial in Q4 2024
Conference Call Today at 8:00 a.m. Eastern Time
PRINCETON, N.J., August 1, 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 it has received the official minutes from its meeting with the U.S. Food and Drug Administration (“FDA”) regarding next steps in its planned Phase 3 clinical trial of its Versamune^®^ based investigational immunotherapy designed to stimulate a targeted T cell attack against HPV16-positive head and neck squamous cell carcinoma (“HNSCC”). The Company will host a conference call today at 8:00 a.m. ET to discuss details of the anticipated Phase 3 clinical trial of Versamune^®^ HPV (formerly PDS0101) in this indication.
PDS Biotech presented the FDA with recent data from both the VERSATILE-002 study of Versamune^®^ HPV + pembrolizumab, and the triple combination of Versamune^®^ HPV + PDS01ADC + bintrafusp alfa. The Company also provided an updated design of the Phase 3 VERSATILE-003 trial of Versamune^®^ HPV + pembrolizumab which included updated statistical endpoints based on recent and more mature survival data. PDS Biotech proposed the addition of a third arm to the study which would be a triple combination of Versamune^®^ HPV + PDS01ADC + pembrolizumab. The first part of the study would therefore involve a dose optimization of PDS01ADC in the novel combination.
The FDA supported the strategy and development of the double and triple combinations. Also, the FDA requested additional safety analysis in the lead-in PDS01ADC dose optimization part of the study. To avoid potential delays in initiating the randomized trial, the FDA agreed that the dose optimization should be done separately and the registrational trial of the revised 2-arm double combination trial, VERSATILE-003, should proceed. The Versamune^®^ HPV + pembrolizumab combination has received Fast Track designation.
“We appreciate the FDA’s support in the development of both the double and triple Versamune^®^ HPV-based combinations. We are also pleased to have aligned on initiating the updated VERSATILE-003 study,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “The VERSATILE-002 results have matured significantly and positively over the last year, allowing us to revise the statistical endpoints of the study to provide additional robustness to the study design. We continue to believe that the combination, based on encouraging survival, disease control response rates and safety has the potential to significantly advance the treatment of HPV16-positive HNSCC. Our goal now is to investigate Versamune^®^ HPV + pembrolizumab’s potential as the first targeted immunotherapy for HPV16-positive HNSCC. The addition of PDS01ADC in the future has the potential to provide further clinical benefit to an effective targeted immunotherapy.”
Kirk Shepard, MD, Chief Medical Officer, continued, “We have contracted with a clinical research organization and the preparatory work is advancing to begin enrollment in the VERSATILE-003 Phase 3 clinical trial in first-line treatment of patients with recurrent or metastatic HPV16-positive HNSCC, with overall survival as the study’s primary endpoint. Our VERSATILE-003 trial has significant key opinion leader support, including from the investigators involved in VERSATILE-002, and we have lined up a significant number of the target sites that have indicated strong interest in participating in the trial.”
Conference Call Details
Date: August 1, 2024
Time: 8:00 a.m. ET
Dial-in: 1-877-704-4453 or 1-201-389-0920
Webcast Registration: Click Here
Call Me^TM^ Registration: Click Here (Available 15 minutes prior to call)
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.
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, 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, PDS0101, 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.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com
Exhibit 99.2
Transforming How the Immune System Targets and Fights Cancer to Promote Survival NASDAQ: PDSB August 2024 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 PDS01ADC, PDS0101 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 PDS01ADC, Versamune® HPV 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 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. 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.
Late-Stage Head and Neck Cancer Program as Value Catalyst Potent Long-Lasting “Memory” T Cells High-Value Lead Program with strong KOL support Promising Patient Survival Oncology Pipeline Consistent and compelling Phase 2 data demonstrate potential for safe and effective therapy that promotes patient survival Timing of Phase 3 start presents potential to be next standard of care FDA aligned on pivotal trial design with Fast-track designation Pivotal trial planned for Q4 2024 in first-line recurrent/metastatic HNSCC Versamune® HPV in multiple HPV+ cancers Versamune® platform + PDS01ADC in HNSCC and other indications Induction of right type and quantity of potent tumor-accumulating killer T cells demonstrated in comprehensive preclinical and human studies HNSCC - head and neck squamous cell carcinoma
Market Potential in HPV16-Positive HNSCC HPV16 will Continue to Drive Increased HNSCC Incidence Rates for Decades1 Current US annual incidence of HPV16+ HNSCC = 18,000 (40% of all HNSCC)4 Incidence of locally advanced, unresectable, metastatic HPV16+ HNSCC = 15,3004-7 Versamune® HPV US Market Potential = $2-3B* Majority of Oropharyngeal Cases HPV16-Positive2,3 *Independent Market Research, Triangle Research Group
A Significant Unmet Need Remains in R/M HNSCC KEYNOTE-0488 Pembrolizumab EGFR antibody (cetuximab) + chemotherapy LEAP-0109 Pembrolizumab Pembrolizumab + lenvatinib In Trials Improved ORR and PFS Have Not Resulted in Improved Overall Survival (OS) ORR = Objective Response Rate; PFS = Progression Free Survival; OS = Overall Survival
Promotes Right Type and Quantity of Effective CD8 Killer T Cells and “Memory” T Cells10,11 Versamune® Platform Enables Potent Long-Lasting T Cell Induction Water-insoluble fatty acids/ hydrocarbon chains Water-soluble, positively charged head-group coats particle surface Immunologically active R-enantiomer of 1,2-dioleoyl-trimethyl-ammonium (R-DOTAP) Versamune® Promotes Potent & Long-Lasting Tumor-Specific Memory T Cells: Generates active CD8 T cells for anti-tumor effect and memory T cells for potential prolonged survival effect10,11 Versamune® HPV = Versamune® + Proprietary multi-epitope HPV16 E6 and E7 peptides (HPV16-targeted immunotherapy)
Preclinical: Single Versamune® HPV Injection Eradicated Established HPV+ Cancer Day 0: HPV16+ TC1 tumor cells were injected into mice Day 12: Resulting tumors had a size of ~250mm3 (volume) Day 12 : A group of the mice received a single injection of Versamune® HPV Day 25: All treated mice had complete regression of their tumors Day 50: 2 sets of mice were injected with the TC1 tumor cells Set 1: Mice previously treated with Versamune® HPV Set 2: Naïve mice NOT previously treated with Versamune® HPV Only the mice that had been previously treated with Versamune® HPV were protected against the cancer with no tumor growth CD8 T Cells Attacked the Cancer Leading to Tumor Eradication & Memory T Cells Prevented Re-establishment3 Memory T cells Promoted Immune Surveillance and Prevented Re-establishment of Cancer Day 0 Day 12 Day 50
Clinical Proof-of-Concept: Versamune® HPV Promoted Tumor Shrinkage Stage III and IV locally advanced cervical cancer patients were treated with Versamune® HPV and chemoradiotherapy (CRT) Versamune® HPV induced active CD8+ killer T cells that targeted and accumulated in the patients’ tumors (activated CD8 T cells secrete Granzyme-B and the green bars represent the quantity of active CD8+ T cells in the tumor by quantifying Granzyme B) Increase in CD8 T cells in the tumor was seen from T0 to T5. The straight line measures the amount of circulating cancer cells in the blood by quantifying circulating tumor DNA (ctDNA) By T3 clearance of ctDNA is seen. 91.7% clearance of ctDNA at week 5 vs 53.1% clearance with CRT alone An ORR of 100% was reported in the first 8 patients, 0% disease recurrence or disease-related deaths in 1-yr follow-up 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)12 CD8+ T Cell Accumulation in the Tumor Occurred Long-Term; 100% (8/8) ORR Representative Plot from a Single Patient Day 170 Day 21 Baseline
VERSATILE-002: A Global Phase 2 Study of Versamune® HPV and Pembrolizumab in Subjects with HPV16+ Recurrent/Metastatic 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 Recurrent or metastatic 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 1.1 Key Secondary: Overall Survival (OS) Progression Free Survival (PFS) per RECIST 1.1 Safety and tolerability Endpoints Fast Track Designation Study Evaluating Effects of Versamune® HPV Attributes on Clinical Responses
VERSATILE-002: Most Patients Had CPS Score 1-19 Demographic mITT Population (N=53) Age, Median (Min, Max) 64.0 (46, 83) Sex, n (%) Male Female 49 (92.5) 4 (7.5) Race, n (%) American Indian or Alaska Native Asian Black or African American Pacific Islander White Other 0 1 (1.9) 1 (1.9) 0 50 (94.3) 1 (1.9) ECOG, n (%) 0 1 30 (56.6) 23 (43.4) CPS, n (%)* <1 1–19 ≥20 0 32 (60.4) 21 (39.6) Historical Responses Published data reports lower ORR, PFS and OS with pembrolizumab in patients with CPS 1-19 vs. CPS ≥ 20 Data on File: Data represents a 30Nov2023 data cut No controlled or comparative studies have been conducted between checkpoint inhibitors and Versamune® HPV Key Demographics and Treatment Exposure Lower pembrolizumab responses
Versamune® HPV + ICI Promoted Deep Tumor Regression in Several Patients Independent of CPS Score; Confirmed Disease Control Rate of 77.4% Confirmed Objective Response Rate (ORR) Based on Investigator Assessment Per RECIST v1.1 Data on File: Data represents a 30Nov2023 data cut Results According to RECIST 1.1 (CPS≥1) Complete Response (CR) 4/53 7.5% Partial Response (PR) 14/53 26.4% Stable Disease (SD) 23/53 43.4% Progressive Disease (PD) 9/53 17.0% Disease Control Rate (CR+PR+SD) 77.4% Non-Evaluable 3/53 – Not included in plot Best Percentage Change from Baseline in Target Lesions 11/53 (21%) of patients had 90-100% tumor shrinkage
Extended Disease Control Observed in Majority of Patients Confirmed Objective Response Rate (ORR) Based on Investigator Assessment Per RECIST v1.1 Data on File: Data represents a 30Nov2023 data cut Best Percentage Change from Baseline in Target Lesions Promising Long-Lasting Immune Response with CR, PR and SD Maintained Long-Term
Promising Survival in First Line HPV16-Positive R/M HNSCC (CPS Score ≥1) VERSATILE-002 (Versamune® HPV + pembrolizumab) KEYNOTE-0488 (pembrolizumab) CPS≥1 CPS≥20 CPS≥1 CPS≥20 Confirmed ORR (%) 34 48 19 23 Median PFS (months) 6.3 14.1 3.2 3.4 Median Overall Survival (months)* 30.0 30.0 12.3 14.9 Confirmed Objective Response Rate (ORR) and Progression-Free Survival (PFS) Based on Investigator Assessment Per RECIST v1.1 No controlled or comparative studies have been conducted between checkpoint inhibitors and Versamune® HPV * FDA-recommended clinical endpoint Data on File: Data represents 30Nov2023 data cut Study Met its Primary End Point of at Least 14 Confirmed Objective Responses
Data on File: Represents a 17May2024 data cut Discontinued: N=2 Lost to follow up; N=6 withdrawn consent; Ongoing: Patients ongoing and awaiting next clinical assessment Median Overall Survival of 30 Months Multiple Patients Approaching 3 Years of Survival Kaplan-Meier Analysis: Median Follow-up of 16 months N = 53 Events = 18 Median OS (Months) = 30 95% CI (Months) = (19.7, NE)
Versamune® HPV Plus Pembrolizumab Was Well Tolerated 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) TRAEs by Grade n (%) Any Combination TRAE 76 (87.4) Grade 1 40 (46.0) Grade 2 26 (29.9) Grade 3 9 (10.3) Grade 4 1 (1.1) Grade 5 0 Protocol stipulates 5 subcutaneous injections of Versamune® HPV. 4 injections over 2 months and a final injection after 6-months Grade 3 Combination-TRAE were: Fatigue (2), Colitis (2), Rash, Diarrhea, Vomiting, Alanine aminotransferase increased, Blood alkaline phosphatase increased, Lymphocyte count decreased, Autoimmune colitis, Headache, Acute kidney injury, Hyponatremia, Hyperglycemia Grade 4 Combination-TRAE: encephalitis (case recorded approx. one year after last Versamune® HPV dose – patient remained on pembrolizumab) * TRAE = Treatment Related Adverse Event Data on File: Data represents a 30Nov2023 data cut 8/87 (9.2%) Patients had a Grade 3 TRAE; 1/87 (1.1%) had a Grade 4 TRAE
VERSATILE-002 Conclusions VERSATILE-002 successfully met primary endpoint of 14 or more confirmed objective responses by RECIST v1.1 in ICI naïve patients with CPS ≥1 ORR by Investigator Assessment: 34% (CPS ≥1) and 48% (CPS ≥20) 21% of patients had >90% shrinkage of their tumors Versamune® HPV may significantly impact both disease control rate and survival in first line treatment of recurrent/metastatic HPV16 positive head and neck cancer Median OS of 30 months and 12-month OS rate of approx. 80% both exceed the best publicly reported survival results to date with both investigational and approved products in patients with CPS ≥1 Therapy appears to be well tolerated Biomarker and clinical data suggests that Versamune® HPV induces the right type and quantity of potent tumor targeting memory T cells that promote patient survival
VERSATILE-003 First Line Recurrent/Metastatic HNSCC Study Design Interim Analysis Possible Early Approval Versamune® HPV + PDS01ADC + pembrolizumab Q4 2024 Versamune® HPV + Pembrolizumab Pembrolizumab Aligned with FDA on Study Design and Initiation Patient Recruitment Patient Recruitment Survival Follow-up Survival Follow-up Key Eligibility Criteria CPS ≥1 HPV16-positive HNSCC ≥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 ≈ 400-450 2:1 randomization Primary Endpoint Overall Survival (OS) FinalAnalysis FutilityAnalysis
Enabling Q4-2024 Patient Enrollment CRO engaged in site selection and preparation, investigator agreements, etc. Approx. 130 sites Site locations: US, Canada, UK, EU, Latin America 18-24 months estimated time to full enrollment Interim analysis for OS following event trigger 18 months estimated time to futility analysis VERSATILE-003 Trial Implementation
PDS01ADC + Versamune® HPV + ICI Combination May Overcome Tumor Immune Suppression TME: Tumor microenvironment Versamune® HPV + PDS01ADC: Novel Anti-Tumor Mechanism Necrotic Core PDS01ADC binds to necrotic DNA Versamune® Activated Targeting CD8+ Killer T-Cell Inside PDS01ADC Infiltrates TME; Weakens Tumor’s Protection from Immune System13 Stimulates T Cells in TME to Promote Expansion + Prolonged, Effective Killing13 Outside Versamune® HPV Induces Right Type & Quantity of Potent Killer T Cells that Target and Infiltrate Tumor10 Immune Checkpoint Inhibitor Restores Pre-existing T Cell Responses Tumor Necrosis Targeting Ab (NHS76) – Binds to exposed DNA PDS01ADC IL-12 fused antibody drug conjugate
Addition of PDS01ADC to Versamune® HPV and a Checkpoint Inhibitor Presents Potential for Deeper Anti-Tumor Responses and Prolonged Survival Versamune® HPV + PDS01ADC + ICI (First Line) Versamune® HPV + PDS01ADC + ICI (Second Line) Number of patients 8 29 HPV Status HPV16-Positive HPV16-Positive ICI treatment Status ICI Naive ICI Resistant Types of Cancer Anal, cervical, HNSCC, vaginal/vulvar Anal, cervical, HNSCC, vaginal/vulvar Median OS 42 months 17 months ORR 75%* 63% (with published effective dose of PDS01ADC, N=8) Triple Combination appears to be well-tolerated Biomarker and clinical data suggest that PDS01ADC may be effective in targeting the tumor to overcome immune suppression National Cancer Institute. (2023). Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set] * Includes 1 subject with response by iRECIST
Inclusion of HPV16-Negative Patients Provided an Internal Study Control that Suggests Clinical Efficacy of Versamune® HPV in Advanced HPV16-Positive Cancers * 1 subject with response by iRECIST National Cancer Institute. (2023). Triple Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set] Objective Response Rate (ORR) Progression Free Survival (PFS) Versamune® HPV Appears to be an Effective HPV16-Targeting Immunotherapy N=8 N=8 N=6 N=6 *
Candidate/ Study Indication PC P1 P2 P3 Partner Versamune® Versamune® HPV + pembrolizumab Recurrent or metastatic HPV16-positive HNSCC Versamune® HPV + chemo (IMMUNOCERV)* 1st-line treatment of locally advanced(IB3-IVA) cervical cancer Versamune® HPV +/- pembrolizumab* Neo-adjuvant treatment of locally advanced HPV-positive oropharyngeal cancer (OPSCC) Versamune®+PDS01ADC Versamune® HPV + PDS01ADC + ICI* Recurrent or metastatic HPV16-positive HNSCC Versamune® MUC1 + PDS01ADC + ICI (Phase 1/2 anticipated 2024) Recurrent or metastatic MUC1+ cancer Pipeline Continues to Validate Platforms, Drive Future Opportunities Fast Track *Investigator Initiated Trials (IIT)
Upcoming Milestones 2024-2025 Q3 2024 Q4 2024 1H 2025 2H 2025 Regulatory Confirmation of VERSATILE-003 Study Design Initiate VERSATILE-003 Pivotal Study in HNSCC IMMUNOCERV Trial Update in Cervical Cancer Preliminary data readout: Neoadjuvant Study in Oral Cancer File IND for Versamune® MUC1 in MUC1+ Cancers Initiate MUC1 Study Data readouts: Multiple NCI Phase 2 studies of PDS01ADC þ
Candidate/ Study Indication PC P1 P2 P3 Partner PDS01ADC PDS01ADC Monotherapy Advanced/Recurrent Kaposi Sarcoma PDS01ADC + Hepatic Artery Infusion Pump (HAIP) Colon Cancer/Intrahepatic Cholangiocarcinoma PDS01ADC + Docetaxel Castration sensitive and castration resistant prostate cancer PDS01ADC + Enzalutamide PET-Positive Recurrent Prostate Cancer PDS01ADC + Stereotactic Body Radiation Therapy (SBRT) High and Intermediate Risk Prostate Cancer (PDS01ADC + Bintrafusp alfa) ± SBRT Metastatic Non-Prostate Genitourinary Malignancies PDS01ADC + Bintrafusp alfa + Entinostat Small Bowel cancer, Colon Cancer, HPV+ Malignancies PDS01ADC Being Extensively Studied in Multiple Indications
References Damgacioglu H., et al. The Lancet Regional Health – Americas. 2022;8:100143 https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.htm. Accessed January 30, 2024 Lechner M. et al. Nature Reviews Clinical Oncl. 2022, 19, 306-327 CDC.gov accessed January 2022; Saraiya, Mona et al. “US assessment of HPV types in cancers: implications for current and 9-valent HPV vaccines.” Journal of the National Cancer Institute vol. 107,6 djv086. 29 Apr. 2015, doi:10.1093/jnci/djv086; SEER, Accessed February 2024 Isayeva, et al., Human Papillomavirus in Non-Oropharyngeal Head and Neck Cancers: A Systematic Review (2012).; Mazul, A., et al., Disparities in head and neck cancer incidence and trends by race/ethnicity and sex Burtness B. et al. Lancet. 2019;394:1915-28 Licitra L. et al. 2024 Multidisciplinary Head and Neck Cancers Symposium. February 29-March 2, 2024 Gandhapudi et al; (2019) J. Immunology, June 15, 202 (12) 3524 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 Yoshida-Court et al: (2022) IMMUNOCERV an ongoing Phase 2 trial combining PDS0101 an HPV-specific T cell immunotherapy with chemotherapy and radiation for treatment of locally advanced cervical cancer, SITC (NCT04580771) Dr. Katharine Price, ASCO 2024, Session: Therapeutic Vaccines for Head and Neck Cancers Birch J, March 18 2022, Hollings clinical trial shows promise treating HPV-related head and neck cancers CM Minnar et al; (2024) Front. Oncol. 13:1321318.doi: 10.3389/fonc.2023.1321318
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