Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (June 2021)
35 slides from Pds Biotechnology's investor presentation, Jun 8, 2021
Slide 1: Corporate Overview
CORPORATE OVERVIEW Frank Bedu-Addo Ph.D. President & CEO JUNE 2021
Slide 2: Forward-Looking Statements
2 Forward-Looking Statements This presentation contains forward-looking statements about PDS Biotechnology Corporation (“PDSB”), and its businesses, business prospects, strategies and plans, including but not limited to statements regarding anticipated pre-clinical and clinical drug development acti
Slide 3: Versamune-based immunotherapies promote tumor-specific CD8+ killer T-cell response
3 PDS Biotech’s Versamune®-based immunotherapies are designed to promote a powerful in vivo tumor-specific CD8+ killer T-cell response Generate the right type and quantity of effective CD8+ killer T-cells Generate potency without systemic side effects Generate memory T-cells, to enhance durability o
Slide 4: PDS Biotech is a clinical stage biotechnology company with Versamune platform
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on the proprietary Versamune® platform 4 NCI-initiated phase 2 combination trial of PDS0101 in advanced HPV-cancer reported strong potential clinical benefitNo new or elevated toxicities observed fro
Slide 5: Versamune-based pipeline developed in partnership with leaders in immuno-oncology
PDS Biotech’s robust Versamune® -based pipeline is being developed in partnership with leaders in immuno-oncology and infectious disease 5 Reference: Data on file. * *Consortium of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquimica. Funding provided by The Ministry of Science, Technology
Slide 6: PDS Biotech executive team
PDS Biotech executive team has demonstrated success in the development and commercialization of leading pharmaceutical products 6 Senior executive experience with management of strategy and execution at both large pharma and biotechsNotable drug development:Abelcet® (Liposome Company/ Elan)PEG-Intro
Slide 7: Introduction to the Versamune Platform
Introduction to the Versamune® Platform
Slide 8: Versamune designed to induce robust targeted anti-tumor response in vivo
Versamune® is designed to induce a robust and targeted anti-tumor response in vivo when administered with a tumor-associated antigen 8 References: Gandhapudi SK, et al. 2019. Antigen priming with enantiospecific cationic lipid nanoparticles induces potent antitumor CTL responses through novel induct
Slide 9: Versamune-induced killer T-cells may eradicate HPV-positive tumors after a single dose
Greater quantity and quality of Versamune®-induced killer T-cells may result in unique ability to eradicate HPV-positive tumors after a single dose 9 Induced a >10-fold number of highly potent T-cells and eradication of HPV-positive tumors after a single dose in preclinical studies Single treatment
Slide 10: PDS0101 Phase Clinical Development
PDS0101 Phase 2 Clinical Development
Slide 11: Combinations of PDS0101 with standard of care and novel agents
Combinations of PDS0101 with FDA-approved standard of careFirst line treatment of recurrent/metastatic HPV-positive head and neck cancerCombination with KEYTRUDA®Treatment of locally advanced cervical cancerCombination with chemoradiotherapy 11 Novel combinations of PDS0101 with promising, investiga
Slide 12: NCI-led trial of triple combination of PDS0101, Bintrafusp alfa and M9241
Phase 2 NCI-led clinical trial evaluating the triple combination of PDS0101, Bintrafusp alfa and M9241 in advanced HPV-associated cancer 12 Indication Patients with advanced HPV-associated cancer who have failed prior treatment Clinical Agents Bintrafusp alfa: Bifunctional “trap” fusion proteinM9241
Slide 13: Preclinical triple combination tumor regression and T-cell response
13 Bintrafusp alfa (M7824 - bi-functional checkpoint inhibitor) Tumor Regression: 0/16 (0%)T-cell Clones: 22 PDS0101 + Bintrafusp alfa + M9241 (NHS IL-12) Tumor Regression: 13/17 (76%)T-cell Clones: 3 *Reference: Smalley Rumfield C, Pellom ST, Morillon II YM, et al; Journal for ImmunoTherapy of Canc
Slide 14: PDS0101 phase 1 trial: CD8+ T-cell response and CIN lesion regression
PDS0101 Phase 1 clinical trial: Powerful CD8+ T-cell response resulted in regression of CIN cervical lesions & supported continued clinical studies 14 * When treated with selected human clinical trial dosage (1mg and 3mg Versamune®)References: L. Wood et al. A Novel Enantio-Specific Cationic Lipid R
Slide 15: PDS0101 used in combination resulting in multifunctional therapy
PDS0101 is used in combination with other immunotherapies resulting in a multifunctional therapy 15 Bintrafusp alfa exposes the tumor to attack and M9241 issues a signal calling T-cells to the tumor Reference: Smalley Rumfield C, Pellom ST, Morillon II YM, et al; Journal for ImmunoTherapy of Cancer
Slide 16: Objective response rate and phase 2 triple combination trial rationale
Objective response rate is measured by RECIST 1.1 and represents at least a 30% reduction in tumor sizeAdvanced HPV-related cancer that is checkpoint inhibitor naïve:Patients who fail chemotherapy and/or radiation progress to checkpoint inhibitor therapy12-24% ORR with standard of care checkpoint in
Slide 17: Triple combination achieved 83% objective response in checkpoint inhibitor naive patients
Triple combination achieved 83% objective response among 6 HPV16-positive checkpoint inhibitor naive patients, suggesting potential efficacy 17 Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malignanc
Slide 18: Durability in HPV16-positive checkpoint inhibitor naive patients
18 Triple combination shows promising durability in HPV16-positive checkpoint inhibitor naïve patients, suggesting potential efficacy PDS0101 + Bintrafusp alfa + M9241 Standard of Care(Checkpoint Inhibitors) HPV16-positive Number of subjects 6 Ongoing responses at median of 8 months 80% (4/5)1 patie
Slide 19: 58% tumor reduction among checkpoint inhibitor refractory patients
Triple combination achieved 58% tumor reduction among 12 HPV16 checkpoint inhibitor refractory patients 19 Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malignancies. Presented at: American Society o
Slide 20: Durability in HPV16-positive checkpoint refractory patients
20 Triple combination shows promising durability in HPV16-positive checkpoint refractory patients PDS0101 + Bintrafusp alfa + M9241HPV16 positive Standard of Care(Checkpoint Inhibitors) Number of patients 12 Number of patients with ongoing tumor reduction at a median of 8 months 86% (6/7) Number of
Slide 21: Results in seven HPV16-negative patients
Results in seven (7) HPV16-negative patients suggests critical role of PDS0101-induced HPV16-specific CD8+ T-cells in promoting tumor reduction 21 Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malign
Slide 22: VERSATILE-002: PDS0101 and KEYTRUDA in head and neck cancer
22 PDS Biotech-sponsored phase 2 trial evaluating the combination of PDS0101 and KEYTRUDA for first-line treatment of HPV-associated metastatic/recurrent head and neck cancer (VERSATILE-002) Indication First line treatment of patients with HPV-associated head and neck cancer whose cancer has spread
Slide 23: IMMUNOCERV: PDS0101 with chemoradiation in cervical cancer
23 A Phase 2, investigator-initiated clinical trial evaluating PDS0101 in combination with chemoradiation therapy in patients with locally advanced cervical cancer (IMMUNOCERV) Indication Treatment of patients with locally advanced cervical cancer – Stages IB3-IVA Clinical Agents Chemoradiotherapy (
Slide 24: Studies designed to demonstrate efficacy and broad applicability of PDS0101
Studies are designed to demonstrate efficacy and broad applicability of PDS0101 and the Versamune® T-cell activating platform 24 Potential to enhance anti-cancer efficacy of various cancer treatments: Combinations with checkpoint inhibitors, chemoradiotherapy and novel therapies may further demonstr
Slide 25: PDS0101 Near-Term Milestones and Market Opportunities
PDS0101 Near-Term Milestones and Market Opportunities
Slide 26: Projected PDS0101 milestones through 2022
Projected PDS0101 milestones through 2022* *Based on current enrollment and forecast modeling as of June 2021. Subject to change. 4Q22 3Q22 2Q22 1Q22 4Q21 3Q21 2Q21 1Q21 Preliminary efficacy Data from advanced HPV-associated cancer trial (NCI) Interim data from HPV-associated Cancer trial (NCI) expe
Slide 27: Approximately 43,000 patients diagnosed with HPV-associated cancers annually in US
27 Approximately 43,000 patients are diagnosed with HPV-associated cancers annually in the US1Existing immunotherapies cost $120,000+ annually per patient2Incidence rate of HPV-related anal and head and neck cancer is growing and remains a significant unmet medical need 1Markowitz et al. 2016. Cente
Slide 28: Versamune compatible with a wide array of tumor and pathogenic antigens
Versamune® has demonstrated the potential for immunological compatibility with a wide array of tumor and pathogenic antigens Reference: Clin Cancer Res. 2009 Sep 1;15(17):5323-37. doi: 10.1158/1078-0432.CCR-09-0737 Versamune®’s unique flexibility means it may work well with a wide range of identifie
Slide 29: Oncology pipeline developed in partnership with leaders in immuno-oncology
PDS Biotech’s robust Versamune® -based oncology pipeline is being developed in partnership with the leaders in immuno-oncology 29 Reference: Data on file.
Slide 30: Farmacore License Agreement for Versamune-Based COVID Vaccine
Farmacore License Agreement for Versamune® -Based COVID Vaccine
Slide 31: PDS0203 may offer advantages as second generation COVID-19 vaccine
Development of PDS0203, if successful, may offer potential advantages as a second generation COVID-19 vaccine May be effective against multiple COVID-19 variantsDemonstrated induction of killer CD8+ and helper CD4+ T cells that can target less variable regions of the SARS-CoV-19 virus and may be eff
Slide 32: Consortium commitment of up to ~US$60 million from MCTI, Brazil
Consortium has received a commitment of up to ~US$60 million from MCTI, Brazil to support phase 1-3 clinical development and manufacturing scale-upPDS Biotech has licensed Versamune® technology to Farmacore to develop a COVID-19 vaccine candidate Farmacore is responsible for antigen manufacturing an
Slide 33: Final Comments
Final Comments
Slide 34: Investment Highlights
Investment Highlights 34 Promising early data in both oncology and infectious disease: Early clinical data and preclinical data suggest potential efficacy, safety and versatility of the Versamune® platformNear-term milestones: Preliminary data from MD Anderson-led study and PDS Biotech-led VERSATILE
Slide 35: PDS Biotechnology
®) PDS Biotechnology Nasdaq: PDSB Developing powerful, safe, versatile immunotherapies
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