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): September 11, 2023
PDS BIOTECHNOLOGY CORPORATION
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-37568 | 26-4231384 |
|---|---|---|
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
303A College Road East,
Princeton, NJ 08540
(Address of Principal Executive Offices, and Zip Code)
(800) 208-3343
Registrant’s Telephone Number, Including Area Code
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions \(see General Instruction A.2. below\):
| ☐ | Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.00033 per share | PDSB | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Yes ☐ No ☐
| Item 8.01 | Other Events. |
|---|
On September 11, 2023, PDS Biotechnology Corporation updated its corporate presentation deck. A copy of the corporate presentation is filed as Exhibit 99.1 and incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
|---|
(d) Exhibits.
| Exhibit<br><br> <br>Number | Description |
|---|---|
| 99.1 | Corporate Presentation (September 2023). |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| PDS BIOTECHNOLOGY CORPORATION | ||
|---|---|---|
| Date: September 11, 2023 | By: | /s/ Frank Bedu-Addo, Ph.D. |
| Name: | Frank Bedu-Addo, Ph.D. | |
| --- | --- | |
| Title: | President and Chief Executive Officer |
Exhibit 99.1
Developing Transformational Immunotherapies for Cancer NASDAQ: PDSB September 2023
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 PDS0101 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 PDS0101 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; 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 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. Versamune® and Infectimune® 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
PDS0101 to enter Phase 3 registrational trial in 2023 to treat recurrent or metastatic, HPV16-positive head and neck squamous cell cancer (HNSCC) Fast Track Designation PDS0101 addresses large and growing market with significant unmet need Transformational data generated with PDS0101 and PDS0301 in multiple Phase 2 clinical studies Financial: Cash as of June 30, 2023 - $60.6M- Adequate cash runway for the next 12 months with initiation of a registrational trial in 2023 Executive Summary: Positioned for Market Leadership Company Overview T cell activating platforms and antibody conjugated immuno-cytokine platform to develop safer, more effective and longer lasting cancer immunotherapies 1 2 3 4
Experienced Management Team Historical success in development and commercialization of leading pharmaceutical products Frank Bedu-Addo, PhD Chief Executive Officer Senior executive experience with management of strategy and execution at both large pharma and biotechs Notable drug development: Abelcet® (Liposome Company/ Elan) PEG-Intron® (Schering-Plough/ Merck) Matthew Hill Chief Financial Officer 20 years of financial and operational leadership roles for life sciences companies Former Chief Financial Officer of several publicly traded companies Lauren V. Wood, MD Chief Medical Officer 30 years of translational clinical research experience Former Vaccine Branch Clinical Director at National Cancer Institute Center for Cancer Research Gregory Conn, PhD Chief Scientific Officer Co-founder 35 years of drug development experience In-depth experience with biotech drug discovery, product development and manufacturing
PDS Biotech Versamune® Overview Designed to address limitations of current immunotherapy PLATFORM: Induces powerful, long-lasting anti-tumor response by promoting uptake of tumor-specific proteins by the immune system and activates a specific signaling pathway that promotes the production of active tumor-infiltrating multifunctional CD8 killer and CD4 helper T cells Versamune® PDS0101 PDS0102 PDS0103 PDS0104 Product Candidates
Versamune® Induces the Right Type, Potency and Quantity of Multifunctional Killer and Helper T Cells Comprised of positively charged lipid (R-DOTAP) co-administered with proprietary tumor-specific proteins, delivered via subcutaneous injection Delivers antigen to CD4 and CD8 T cells. Activates the Type I Interferon pathway, leading to potent, multifunctional, antigen specific T cell responses Human clinical trials confirm induction and accumulation of multifunctional T cells in the tumor, which correlated with clinical response and elimination of circulating tumor DNA and clinical response (SITC 2022) Recruits T cells to lymph nodes Trains T cells to target tumors Arms T cells to kill tumor cells 1 2 3 Injection Site Lymph Node Tumor Site References: Gandhapudi SK, et al. 2019. Antigen priming with enantiospecific cationic lipid nanoparticles induces potent antitumor CTL responses through novel induction of a Type I IFN response. J Immunol. 202 (12): 3524-3536. Smalley Rumfield C et al. 2020. Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine. J. for ImmunoTherapy of Cancer 8:e000612.
IMMUNOCERV: PDS0101 Appears to Induce Clinically Beneficial Killer (CD8) T Cells PDS0101 activates the immune system to generate active killer T cells (CD8 T) cells that induce a critical mediator of the T cell’s tumor-killing function called granzyme-B Multifunctional killer T cells target, infiltrate and eliminate the cervical cancer tumors HPV16 tumor DNA in the blood circulation declines by day 170 (T5) Quantity of tumor cell DNA circulating in the blood Killer T cells that infiltrated the tumors Representative Subject IMMUNOCERV (PDS0101+Chemoradiation) Trial1: Predominantly stage III and IV cervical cancer Locally advanced cancer with tumors > 5cm (high-risk patients) 100% (9/9) clinical response rate with 60 days No evidence of cancer in 89% (8/9) by Day 170 Induction of activated CD8 T cells correlates with elimination of circulating tumor DNA1 1Yoshida-Court 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); SITC 2022
HPV16-Positive Head and Neck Squamous Cell Cancer (HNSCC) Disease Overview and Market Size
Est. HPV16Locally Advanced,Unresectable andMetastatic HPV16-positive HNSCC Presents a Significant Market Opportunity Largely Attributed to the High Rate of Oral HPV Infections in Men Data sources: 1 PD-L1 negative and PD-L1 positive populations (> 9000 incidence PD-L1 Positive) https://seer.cancer.gov/statfacts/html/oralcav.html; https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.htm; https://virologyj.biomedcentral.com/articles/10.1186/s12985-021-01688-9; https://seer.cancer.gov/statistics-network/explorer/application.html?site=3&data_type=1&graph_type=4&compareBy=sex&chk_sex_1=1&race=1&age_range=1&advopt_precision=1&hdn_view=0; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5002133/ ~18,300 ~34,000 ~38,100 ~54,400 Est. U.S. HPV Positive Oral and Pharyngeal Cancer Est. U.S. Oral and Pharyngeal Cancer Est. HPV16 Genotype $2-3B Market Opportunity in US1 HPV cancer incidences continue to increase despite preventive HPV vaccine HPV vaccination is not expected to impact the rate of HPV-positive cancer incidence for the near-term Existing immunotherapies cost $150,000+ annually per patient1 No available HPV specific therapy Initial commercial opportunity for PDS0101
Targeted treatment option to address the growing population of HPV16-positive HNSCC and improve outcomes Novel MOA that is clinically effective in a broader patient population and provides more durable responses. Safer and more effective treatments that may be used with or in place of current standard of care Better tolerability and less toxic alternatives to chemotherapy Despite the Availability of Treatments, Significant Unmet Needs Remain in Recurrent or Metastatic HNSCC KEYTRUDA® KEYTRUDA® 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 12-Month Survival Rate 50% 55% 44% Median Overall Survival (OS) 12.3 mos 13.6 mos 10.3 mos Key Toxicities Anemia Fatigue Weight loss Hypokalemia Additional to KEYTRUDA®: Neutropenia Mucosal inflammation Thrombocytopenia Stomatitis Neutropenia Anemia Thrombocytopenia Nausea/vomiting Hypokalemia Rash Fatigue Mucosal inflammation Treatment Related Grade 3+ Toxicities 17% 72% 69% Oncologist2 – Stated Unmet Medical Needs in HNSCC Standard of Care for Recurrent or Metastatic HNSCC – Published Results*1 1KEYNOTE-048 Study Burtness B et al, Lancet 2019 2Primary Market Research 2022 * No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101
PDS0101 for HPV16-Positive HNSCC
VERSATILE-002 Phase 2 Clinical Trial Objective: To assess the combination of PDS0101 and KEYTRUDA® in ICI naïve subjects with recurrent or metastatic HPV-positive HNSCC KEYTRUDA® (pembrolizumab) FDA Approved Standard of Care Partner Study Design Open-label, non-randomized, adaptive design study N=54 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 Pembrolizumab 200mg IV Q3W up to 35 Cycles (2 years) PDS0101 1 mL subcutaneous injection at Cycles 1, 2, 3, 4 and 12 Study Treatment Primary: Best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST 1.1 Key Secondary: Progression Free Survival (PFS) per RECIST 1.1 Overall Survival (OS) Safety and tolerability Achievement of Statistical Threshold for efficacy Endpoints Fast TrackDesignation
To Date 70.6% of Patients have Achieved Disease Stabilization or Tumor Shrinkage Confirmed best overall response was determined based on confirmed CR or confirmed PR per RECIST 1.1 per investigator assessment. One subject (NE) died prior to target lesion measurement and is included in the mITT population denominator. Four subjects experienced unconfirmed tumor shrinkage and subsequently experienced progressive disease. 30%Shrinkage 14/34 (41.2%) Confirmed and Unconfirmed Objective Response 9/34 (26.5%) Confirmed Partial and Complete Response 15/34 (44.1%) Stable Disease 9/34 (26.5%) Progressive Disease 1/34 (2.9%) Not Evaluable (not included in Waterfall plot) 23/34 (67.6%) Tumor Reduction Statistically significant improvement in the Response Rate of PDS0101+ KEYTRUDA vs. KEYTRUDA monotherapy confirmed
The Addition of PDS0101 to KEYTRUDA® Does not Appear to Compound Toxicity Only 4 subjects (8%) had Grade 3 PDS0101-KEYTRUDA® TRAEs: fatigue, injection site reaction, blood alkaline phosphatase increased, hyperglycemia, colitis, and rash No subjects had Grade 4 or 5 TRAEs No subject came off study due to toxicity PDS0101+KEYTRUDA® Treatment Related Adverse Events (TRAE) >5% (ITT Population) Safety data in approximately 120 patients to date across multiple Phase 1 and 2 Studies Safety data, anti-tumor responses and patient survival suggest that the Versamune® based therapies such as PDS0101 could be ideal candidates for combination oncology treatments
Data Suggests Prolonged Responses (Durability) and Patient Survival PDS0101 + KEYTRUDA® Data – Median PFS and 12 Month OS *median OS for PDS0101 + KEYTRUDA® not yet reached KEYNOTE-048: Burtness B et al. Lancet 2019;394:1915-28, Published results for reference only 15 10.4 months 3.2 months 5.0 months 55% 87.1% 50% Median Progression Free Survival (Months) 12-Month OS Rate (%)* ® ® ® ® ® ® No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101
Several Patients Approaching Two Years of Survival Overall response: CR=Complete Response; PR=Partial Response; SD=Stable Disease; PD=Progressive Disease; NE=Not Evaluable. Overall response was based on investigator assessment per RECIST v1.1. Survival status: A=Alive; D=Deceased. Alive subjects were based on the last contact date. Complete Response Partial Response Stable Disease Progressive Disease Demonstrated objective response rate of 41% (confirmed and unconfirmed) No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101
VERSATILE-003 Timeline to Registrational Trial Initiation Worldwide Randomized, Controlled Clinical Study to Be Initiated Q4 2023 with an Overall Estimated 90–100 Sites PDS0101 + KEYTRUDA® in Recurrent or Metastatic HPV16-Positive HNSCC 2Q 2022 3Q 2022 1Q 2023 2Q 2023 3Q 2023 4Q 2023 FDA Fast Track designation for PDS0101 + KEYTRUDA® Successful EOP2 meeting with FDA Initiated PDS0101 tech-transfer, scale up at selected Phase 3 clinical/commercial manufacture Completed Phase 3 clinical manufacturing of PDS0101 Obtained visibility to potential OS and PFS information for VERSATILE-002 trial needed to finalize VERSATILE-003 trial design Completed CMC-related activities for PDS0101 Obtained feedback from EU regulatory agencies on protocol Submitted amended IND with FDA for registrational trial Initiate site activation and related clinical, operational activities (4- to 6-month process) InitiateVERSATILE-003 Phase 3 Trial VERSATILE-002 Phase 2 Trial Progressing
Versamune® Based Oncology Pipeline Partnerships with World Class Institutions in Immuno-Oncology Reference: Data on file. PDS Biotech Funded Candidate/ Study Indication Combination PC P1 P2 P3 R Partner(s) Clinical (Lead) PDS0101 (HPV)/ VERSATILE-002 Recurrent or metastatic HPV16-positive head and neck cancer Arm 1: ICI naïve Arm 2: ICI refractory KEYTRUDA® (standard of care) IIT Studies PDS0101 (HPV)/ IMMUNOCERV 1st-line treatment of locally advanced (IB3-IVA) cervical cancer Chemo-radiation (standard of care) PDS0101 (HPV)/ Mayo Clinic Pre-metastatic HPV-positive oropharyngeal cancer (OPSCC) Arm 1: PDS0101 monotherapy Arm 2: PDS0101 + KEYTRUDA® KEYTRUDA® (standard of care) Preclinical Candidates PDS0102(TARP) TARP-positive AML, prostate and breast cancers TBD PDS0103 (MUC1) MUC1-positive breast, colon, lung, ovarian and other cancers TBD PDS0104(TRP2) Melanoma TBD Partner Co-Funded Fast Track Designation
Antibody-Conjugated IL-12 (PDS0301)
PDS Biotech Antibody-Conjugated IL-12 (PDS0301) Overview Antibody-Conjugated IL-12 Opportunities PDS0301 is a novel investigational tumor-targeting IL-12 that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment Monotherapy Combinations: Versamune® Based Immunotherapies Chemotherapy Radiation HDAC Inhibitors* *Histone Deacetylase Inhibitor
NCI-led Triple Combination: PDS0301 + PDS0101 + ICI Advanced HPV16-Positive Anal, Cervical, Head and Neck, Penile, Vaginal, Vulvar Cancer Patients Who Are ICI Refractory 172% grade 3 and higher adverse events reported in KEYNOTE-048 Burtness 2019 https://doi.org/10.1016/S0140-6736(19)32591-7 Goswami 2022 http://dx.doi.org/10.1136/jitc-2022-SITC2022.0695 Partner FDA Approved Standard of Care None Immunology/Immune Correlates SITC, November 2022: Greater than two-fold increase in HPV16-specific T cells in the blood of 11/14 (79% ) of the evaluated patients Induction of multifunctional killer (CD8) T cells Increases in granzyme B (associated with active killer T cells), IFN-γ, TNF-α, etc., signal a pro-inflammatory response and role in overcoming tumor immune suppression Safety Safety results (Arms 1 & 2)1 24/50 (48%) of patients experienced grade 3 and higher adverse events 2/50 (4%) experienced grade 4 adverse events
Phase 2 Results in Recurrent Metastatic ICI Refractory HPV-Positive Cancer (CPS>0; PD-L1 agnostic) Plot Includes Published Data in HSNCC NCI-led Triple Combination: PDS0301 + PDS0101 + ICI Advanced HPV16-Positive ICI Refractory Cancer Patients 1Published results for ICI monotherapy <10%, Strauss J, et al. J Immunother Cancer 2020;8:e001395. doi:10.1136/jitc-2020-001395 2Pestana RC et al. Oral Oncology 2020;101:104523. https://doi.org/10.1016/j.oraloncology.2019.104523 N=29 Best published median OS data to date in ICI refractory head and neck cancer population is 8.2 months2 Objective Response (ORR) in High Dose PDS0301 Group = 63% (5/8)* 1 No controlled or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101
Antibody-Conjugated IL-12 (PDS0301) Regimens Reference: Data on file. Candidate/ Study Indication Combination PC P1 P2 P3 R Partner(s) IIT Studies PDS0301/ NCI-led Triple Combination HPV-positive anal, cervical, head and neck, penile, vaginal, vulvar cancers Arm 1: ICI naive Arm 2: ICI refractory PDS0101 & ICI IIT Studies PDS0301 Advanced Kaposi Sarcoma Monotherapy PDS0301 Metastatic Castration sensitive and Castration Resistant Prostate Cancer Docetaxel PDS0301 Localized High and Intermediate Risk Prostate Cancer Radiation Therapy PDS0301 ICI Refractory HPV-related, colon and small-bowel cancer HDAC Inhibitor Partner Co-Funded
3Q23 4Q23 1Q24 2Q24 3Q24 PDS0101 Anticipate ICI naïve/refractory data – KOL Event (VERSATILE-002) Submit IND with FDA for registrational trial for PDS0101 (VERSATILE-003) Updated OS data from NCI-led triple combination Immune response data (VERSATILE-002) (ESMO 2023) Initiate registrational trial for PDS0101 (VERSATILE-003) Anticipate preliminary efficacy data from Mayo Clinic IIT Anticipate updated data (IMMUNOCERV) (ASTRO 2023) Final data VERSATILE-002 PDS0301 Interim safety and immune data (PDS0301 + docetaxel) PDS0103 Estimated IND filing in MUC1-related cancers Projected Milestones Through 3Q24 Trials are investigator-initiated trials and data read-outs are outside the control of the Company
3Q23 4Q23 1Q24 2Q24 3Q24 PDS0101 Submit IND with FDA for registrational trial (VERSATILE-003) Anticipate ICI naïve/refractory data – KOL Event (VERSATILE-002) Updated OS data from PDS0101-PDS0301 based triple combination Immune response data (VERSATILE-002) (ESMO 2023) Initiate registrational trial (VERSATILE-003) Anticipate updated data (IMMUNOCERV) (ASTRO 2023) Anticipate preliminary efficacy data (Mayo Clinic) Final data VERSATILE-002 PDS0301 Interim safety and immune data (PDS0301 + docetaxel) (Cytokines 2023) PDS0103 Estimated IND filing in MUC1-related cancers PDS0202 Universal flu preclinical ferret data (ESWI 2023) Projected Milestones Through 3Q24 Investigator-initiated trials and data read-outs are outside the control of the Company.
PDS0101 to enter Phase 3 registrational trial in 2023 to treat recurrent or metastatic, HPV16-positive head and neck squamous cell cancer (HNSCC) Fast Track Designation PDS0101 addresses large and growing market with significant unmet need Transformational data generated with PDS0101 and PDS0301 in multiple Phase 2 clinical studies Financial: Cash as of June 30, 2023 - $60.6M cash runway for the next 12 months with initiation of a registrational trial in 2023 Executive Summary: Positioned for Market Leadership Company Overview T cell activating platforms and antibody conjugated immuno-cytokine platform to develop safer, more effective and longer lasting cancer immunotherapies 1 2 3 4
Thank you
Appendix
License agreement with University of Georgia for proprietary influenza antigens Top-line preclinical data announced; effective delivery of flu proteins activate the critical immune signals necessary to generate neutralizing antibody responses to all flu strains tested in animals Preclinical data presented at the 41st Annual meeting of the American Society Virology Meeting Universal Flu Market Opportunity in 2021 PDS0202: Universal Prevention of Influenza PDS0202 Provided Full Protection Against Lethal Challenge with H1N1 Pandemic Strain in Preclinical Study Reference: Ross T. and Woodward J. et al. evaluation of the PDS0202 (Infectimune® + COBRA) Universal flu formulation. Proprietary Computationally Designed Influenza Protein % survival Day post infection Universal Influenza Vaccines $7 Billion
Infectimune® Infectious Disease Platform
Several Key Opinion Leaders Involved with PDS Biotech’s VERSATILE-002 Head and Neck Cancer Trial Katharine A. Price, MD Associate Professor, Oncology Mayo Clinical (Presented ASCO data) Jared Weiss, MD Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine UNC Lineberger Comprehensive Cancer Center(Lead Investigator) John Kaczmar, MD Associate Professor, Oncology MUSC Hollings Cancer Center (Published Article on PDS0101-KEYTRUDA patient) Kevin J. Harrington, MBBS, PhD Professor in Biological Cancer Therapies The Institute of Cancer Research, London (Key investigator on Merck KEYNOTE-048 trial with KEYTRUDA)
Expanding Evidence of Consistent and Durable PDS0101 Clinical Results Across Multiple Phase 2 Trial Indications PDS0101 is an HPV16-targeted immunotherapy PDS0101 is providing strong proof of concept data for the Versamune® technology platform Efficacy data in >90 patients to date Strong agreement between preclinical and clinical results Versamune® mechanism of action shows clear translation between preclinical and human results Anti-tumor responses and biomarker data show strong correlation across all types of HPV-positive cancer and at all stages of the disease Safety data in approximately 120 patients to date Safety data, anti-tumor responses and patient survival suggest that the Versamune® based therapies such as PDS0101 could be ideal candidates for combination oncology treatments
HNSCC is a Devastating Group of Cancers Reference: Noseyaba et al. 2018. Cancer. Suicide Risk Among Cancer Survivors: Head and Neck Versus Other Cancers https://virologyj.biomedcentral.com/articles/10.1186/s12985-021-01688-9 https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.html *Human Papillomavirus Oral and PharyngealCancers Genotype of *HPV-Positive Oral and Pharyngeal Cancer Paranasalsinuses Nasopharynx Oropharynx Hypopharynx Larynx Pharynx Tongue Salivaryglands OralCavity NasalCavity
Antibody-Conjugated IL-12: PDS0301 Targets Tumors and Enhances T Cell Infiltration and Proliferation in the Tumor Tumor Site Injection Site Non-Immunogenic (Cold Tumor) Immunogenic (Hot Tumor) Tumor Site PDS0301 travels direct to tumor Increased tumor inflammation from PDS0301 PDS0301 increases T cell infiltration and expansion in tumor CD8 T cells kill tumor cells 1 2 3 4
Demographics of the ITT (Safety) and mITT (Efficacy) Populations Demographics and Baseline Characteristics Demographic or Baseline Characteristic ITT Population (N=48) mITT Population (N=34) Age, Median (Min, Max) 62.5 (45, 83) 63.5 (46, 83) Sex, n (%) Male Female 45 (93.8) 3 (6.3) 32 (94.1) 2 (5.9) Race, n (%) American Indian or Alaska Native Asian Black or African American Pacific Islander White Multiple Other 0 1 (2.1) 1 (2.1) 0 45 (93.8) 0 1 (2.1) 0 0 0 0 33 (97.1) 0 1 (2.9) ECOG, n (%) 0 1 30 (62.5) 18 (37.5) 20 (58.8) 14 (41.2) CPS, n (%)* <1 1-19 ≥20 1 (2.1) 27 (56.3) 20 (41.7) 0 17 (50.0) 17 (50.0) Summary of Exposure Exposure ITT Population (N=48) PDS0101 doses, Median (Min, Max) 4.0 (1, 5) PDS0101 doses, n, (%) ≥1 dose ≥2 doses ≥3 doses ≥4 doses 5 doses 46 (95.8) 40 (83.3) 36 (75.0) 27 (56.3) 11 (22.9) Pembrolizumab doses, Median (Min, Max) 5.0 (1, 29) Pembrolizumab doses, n (%) ≥1 dose ≥2 doses ≥3 doses ≥4 doses ≥5 doses ≥6 doses ≥7 doses ≥8 doses ≥9 doses ≥10 doses 48 (100) 40 (83.3) 36 (75.0) 28 (58.3) 27 (56.3) 23 (47.9) 20 (41.7) 16 (33.3) 15 (31.3) 13 (27.1) Duration of treatment (months), Median (Min, Max) 3.5 (0.0, 19.5)
PDS0101: A Novel Investigational HPV-Targeted Immunotherapy PDS0101 is given by subcutaneous injection and stimulates a potent targeted T cell attack against HPV-positive cancers Interim VERSATILE-002 data suggests PDS0101 generates clinically effective immune responses The combination of PDS0101 with KEYTRUDA® has demonstrated a favorable safety profile to date PDS0101 with KEYTRUDA® demonstrates significant disease control by shrinking tumors, delaying disease progression and prolonging survival
Compelling Durability of the Anti-Tumor Response Progressive Free Survival (PFS) per Investigator Assessment (mITT Population) Number of Subjects at Risk (Events) CPI Naïve 34 (0) 33 (1) 32 (2) 27 (6) 25 (7) 16 (11) 14 (12) 12 (12) 12 (12) 10 (12) 9 (13) 8 (14) 6 (15) 4 (15) 4 (15) 3 (16) 1 (18) 1 (18) 1 (18) 0 (18) N Events Median (Months) 95% CI(Months) 34 18 10.4 (4.2, 15.3) PFS = 10.4 months Demonstrated median PFS of 10.4 months; published results of 2-3 months for approved immune checkpoint inhibitors* * No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101; Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B 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(10212):1915-1928https://www.opdivo.com/head-and-neck-cancerhttps://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/
Promising Survival Benefit Overall Survival (OS) (ITT Population) Number of Subjects at Risk (Events) CPI Naïve 47 (0) 41 (1) 36 (1) 31 (1) 29 (1) 26 (1) 23 (2) 19 (2) 17 (2) 16 (2) 13 (3) 13 (3) 13 (3) 13 (3) 12 (3) 11 (3) 6 (4) 5 (4) 4 (4) 3 (4) 2 (4) 0 (4) N Events Median (Months) 95% CI(Months) 48 4 NE (15.3, NE) 12-month OS rate = 87.1%** Demonstrated 12-month OS rate of 87.1%; published results of 35-50% for approved immune checkpoint inhibitors* *No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101; Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B 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(10212):1915-1928https://www.opdivo.com/head-and-neck-cancerhttps://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/ **All subjects either alive, lost to follow up, or who have left the trial are censored at the last known date of contact, or at Day 1, if they do not have any post-baseline visits or assessments. The 12-month OS rate for the mITT population, excluding the 14 most recently enrolled patients, is 86.5%.
Several Patients Approaching Two Years of Survival Blue Dot: Timing of last scan demonstrating PD; Red Bars – PD, Grey Bars – SD, Green Bars – PR, Black Bar – CR, Orange Bars – survival period through last known date alive Days on Treatment and Survival Grouped by Best Overall Response mITT Population (n=34) with at least 1 scan No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101
Tumor Reduction, ORR and OS Remain Consistent Comparison: ASCO 2022 & 2023 PDS0101 + KEYTRUDA® Clinical Results *9-Month OS in 2022; 12-Month OS in 2023 ASCO 2022 vs ASCO 2023 Data 87.1% 87.2% 67.6% 64.7% 26.5% 29.4% 41.2% 41.2%
Antibody-Conjugated IL-12 (PDS0301) A novel investigational tumor-targeting Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment Together with Versamune® based immunotherapies PDS0301 works synergistically to promote a targeted T cell attack against cancers PDS0301 is given by a simple subcutaneous injection Clinical data suggest the addition of PDS0301 to Versamune® based immunotherapies demonstrate disease control by shrinking tumors and prolonging survival in recurrent or metastatic cancers with poor survival prognosis