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): May 17, 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.) |
25B Vreeland Road, Suite 300, Florham Park, NJ 07932
(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 May 17, 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 (May 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: May 17, 2023 | By: /s/ Frank Bedu-Addo, Ph.D. |
| Name: Frank Bedu-Addo, Ph.D. | |
| Title: President and Chief Executive Officer |
Exhibit 99.1
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | May 2023
2 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® is a registered trademark, and Infectimune™ is a trademark of PDS Biotechnology Corporation KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA
3 About PDS Biotechnology Company Overview T cell activating platforms and antibody conjugated immuno-cytokine platform to develop safer, more effective and longer lasting immunotherapies to treat cancer and infectious disease 1 3 Clinical Partnerships: Merck, National Cancer Institute, MD Anderson Cancer Center, Mayo Clinic Financial: Cash as of March 31, 2023 $65.2M cash runway into Q3 2024 with initiation of a registrational trial in 2023 2 PDS0101 to enter Phase 3 registrational trial in 2023 to treat recurrent or metastatic, HPV-positive head and neck cancer VERSATILE-002 Abstract was accepted as a Poster Discussion and a featured poster to be reviewed by an expert panel in the Head and Neck Cancer Discussion Session 4
4 Experienced Management Team Historical success in development and commercialization of leading pharmaceutical products Timing Safety data confirmed and released Q4 2021 Preliminary efficacy data anticipated Q1 2022 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 Director of Clinical Research at National Cancer Institute Center for Cancer Research (Cancer Vaccine Branch) 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
5 Platform Overview Versamune® 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 killer T cells Overcomes tumor’s ability to suppress attack by T cells. PDS0301 is a novel investigational tumor-targeting IL-12 that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment Designed to address limitations of current immunotherapy with potential efficacy over immune checkpoint inhibitors (ICI) and ICIs in combination with chemotherapy Infectimune™ Generates broad and robust antibody and T cell responses that provide durable protection against infectious disease in preclinical studies Versamune® + Antibody-Conjugated IL-12
6 Pipeline: Versamune® Based Oncology Developed in partnership with leaders in immuno-oncology Reference: Data on file. PDS Biotech Funded Partner Co-Funded Combination PDS0104 (TRP2) TBD Arm 1: ICI naïve 1st line treatment Arm 2: ICI refractory 2nd or 3rd line treatment VERSATILE-002 IMMUNOCERV PDS0102 (TARP) PDS0103 (MUC1) Candidate/ Trial Indication PC P1 P2 P3 R Partner(s) Recurrent/metastatic HPV16-positive head and neck cancer KEYTRUDA(® (standard of care) HPV-positive anal, cervical, head and neck, penile, vaginal, vulvar cancers Arm 1: ICI naive 2nd line treatment Arm 2: ICI refractory 3rd line treatment PDS0301 & ICI 1st line treatment of locally advanced (IB3-IVA) cervical cancer TARP-associated AML, prostate and breast cancers MUC-1 associated breast, colon, lung, ovarian and other cancers Chemo-radiation (standard of care) TBD TBD Neoadjuvant Trial Pre-metastatic HPV-associated oropharyngeal cancer (OPSCC) Arm 1: PDS0101 monotherapy Arm 2: PDS0101 + KEYTRUDA KEYTRUDA® (standard of care) NCI-led Triple Combination Melanoma PDS0101 Clinical Preclinical Fast Track Designation
1 Clinical Pipeline: PDS0301 Focused Oncology Investigator initiated trials with National Cancer Institute Localized High and Intermediate Risk Prostate Cancer PDS0301 (Combination Radiation Therapy) Candidate Indication PC P1 P2 P3 R Partner Advanced Kaposi Sarcoma PDS0301 (Monotherapy) PDS0301 (Combination Docetaxal) Metastatic Castration sensitive and Castration Resistant Prostate Cancer PDS0301 (Combination HDAC Inhibitor) ICI Refractory MUC1-positive Colon, Bladder etc. Additional trials ongoing at the NCI 7
Versamune® Oncology Platform
9 Versamune® Based Immunotherapy Versamune® is based on proprietary, positively charged and immune-activating lipids that form spherical nanoparticles in aqueous media* The nanoparticles are sized to mimic viruses, which promotes uptake by dendritic cells of the immune system Activates the important Type I interferon immunological signaling pathway Due to its composition destabilizes cell endosomes and promotes antigen entry into the correct processing and presentation pathways to prime tumor-specific killer (CD8) and helper (CD4) T cells A novel investigational platform that promotes tumor-antigen uptake into preferred immunological pathways and activates a critical immunological pathway - Promotes a powerful anti-cancer immune response Versamune® Water-insoluble Fatty acids/hydrocarbon chains Water-soluble and positively charged head-group coats the particle surface R-enantiomer of 1,2-dioleoyl-trimethyl-ammonium-propane (R-DOTAP) *Versamune® protected by 6 issued PDS-owned patents in various countries - Protection through June 2033; More recently developed patents in prosecution R-DOTAP used under exclusive worldwide license of 2 additional patents from Merck KGaA, Darmstadt, Germany
10 Versamune® Mechanism of Action Comprised of cationic lipids (R-DOTAP) co-administered with proprietary HPV16-specific tumor antigens, delivered via subcutaneous injection Delivers antigen to CD4 and CD8 T cells. Activates the Type I Interferon pathway, leading to potent, multifunctional T cell responses Human clinical trials confirm induction and accumulation of multifunctional T cells in the tumor, which correlated with elimination of circulating tumor DNA and clinical response (SITC 2022) 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. 1 Recruits T cells to lymph nodes 2 Trains T cells to target tumors 3 Arms T cells to kill tumor cells
11 PDS0101: Lead Asset Designed to treat human papillomavirus (HPV16)-positive cancers More than 54,4002 patients were estimated to have been diagnosed last year with HPV16-positive cancers in the US1,2. This represents 70-80% of all HPV-positive cancers. HPV vaccination is not expected to impact the rate of HPV-positive cancer incidence for decades Existing immunotherapies cost $150,000+ annually per patient1 1Company estimates based on CDC data. Assessments have not been adjusted to reflect HPV16-expression 2CDC website $7B Market Opportunity1 Reference: Data on file. U.S. HPV-associated Cancer Incidence2
12 PDS0101 Phase 1 Monotherapy Data In vivo CD8 T cell responses appear to correlate with regression of CIN cervical lesions supporting preclinical studies CIN Lesion Regression at 1-3 Months (Retrospective) 60% 20% 20% Phase 1 trial results showed no serious or dose-limiting toxicities All patients infected with high-risk, cancer-causing strains of HPV that are more resistant to spontaneous regression * When treated with selected human clinical trial dosage (1mg and 3mg Versamune®) References: 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. Potentially overcomes key limitation of immuno-oncology: > 20-fold increase in circulating dual INF-γ & Granzyme-B inducing killer T cells at selected doses vs. pre-treatment at Day 14*
13 IMMUNOCERV Phase 2 Clinical Trial: PDS0101 + CRT Cervical Cancer 13 Timing Safety data confirmed and released Q4 2021 Preliminary efficacy data anticipated Q1 2022 Partner FDA approved standard of care Chemo-radiotherapy (CRT) Preliminary Efficacy Preliminary efficacy data (Society for Immunotherapy of Cancer (SITC) Conference, November 2022): Clinical response with tumor shrinkage of over 60% at 1 month - 100% (9/9) Complete response (No evidence of cancer) by day 170 - 89% (8/9)1 Majority of patients have Stage III and Stage IV cancer 1-year overall survival – No patients have died from the cancer or treatment. One patient has died from an unrelated cause/event 100% (9/9) clinical response in locally advanced cervical cancer patients having tumors > 5 cm 1Residual traces of the cancer were detected in one patient who only received 3 of the schedule 5 doses of PDS0101 2In agreement with published preclinical findings that Versamune® promotes in vivo induction of the more potent, polyfunctional (multi-cytokine inducing) and tumor infiltrating killer T cells – J. Immunology 2019; 202 (12): 3524-3536
14 IMMUNOCERV: PDS0101 Appears to Induce Clinically Beneficial T Cells Induction of activated CD8 killer 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 PDS0101 activates the immune system to generate active killer T cells (CD8 T cells that induce 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
15 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 Genotype of HPV+ Oral and Pharyngeal Cancer Oral and Pharyngeal Cancers
16 The Incidence of Head and Neck Squamous Cell Carcinoma (HNSCC) is Sizeable and Growing Largely attributed to the high rate of oral HPV infections in men HPV cancer incidences continue to increase despite preventive HPV vaccine Est. U.S. Oral and Pharyngeal Cancer Est. U.S. HPV Positive Oral and Pharyngeal Caner Est. HPV16 Genotype Est. HPV16 Locally Advanced, Unresectable and Metastatic ~18,300 ~34,000 ~38,100 ~54,400 $2.3B Market Opportunity1 Initial commercial opportunity for PDS0101 Data sources: 1PDL-1 negative and PDL01 positive populations (> 9000 incidence PDL-1 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/
17 Standard of Care for Recurrent/Metastatic HNSCC – Published Results Significant unmet needs remain KEYTRUDA® KEYTRUDA® plus chemo Chemotherapy +/- EGFR Route of Administration IV IV IV Objective Response Rate (ORR) 19% 36% 41% Progression Free Survival (PFS) 3.2 mos 5.0 mos 5.0 mos Median Overall Survival (OS) 12.3 mos 13.6 mos 11.0 mos Key Toxicities Immune-mediated adverse reactions Infusion-related reactions Complications of allogeneic HSCT Immune-mediated adverse reactions Infusion-related reactions Complications of allogeneic HSCT Liver toxicity Nausea/vomiting Peripheral neuropathy Bone marrow suppression Hair loss Cardiotoxicity Hypersensitivity reaction Treatment Related Grade 3+ AEs 17% 72% 69% Oncologist - stated unmet medical needs in HNSCC: Lack of effective targeted therapies for HPV-positive cancers Less toxic treatment options without long-term side effects Better quality of life for patients undergoing treatment
18 VERSATILE-002 Phase 2 Clinical Trial: PDS0101 + KEYTRUDA® Recurrent or metastatic HPV16-positive head and neck cancer 18 Timing Safety data confirmed and released Q4 2021 Preliminary efficacy data anticipated Q1 2022 Partner FDA-Approved Standard of Care KEYTRUDA® (pembrolizumab) owned by Merck1,2 Preliminary Efficacy Objective response (% of patients with ≥ 30% tumor shrinkage) – 7/17 (41.1%)1 confirmed and unconfirmed Clinical benefit (stable disease + objective response) – 13/17 (76.5%) 9-month overall survival rate – 87.2%2 In first 43 patients, no treatment related grade 3 and higher (serious) adverse events - 0/43 (0%)3 Preliminary Safety Fast Track Designation Initiation of registrational trial in 2023 based on successful FDA meeting 119% objective response rate with KEYTRUDA® monotherapy reported in KEYNOTE-048 study 212-month with KEYTRUDA® monotherapy reported in KEYNOTE-048 study 317% of patients had treatment overall survival of 49% elated grade 3 and higher adverse events with KEYTRUDA® monotherapy reported in KEYNOTE-048 study
19 VERSATILE-002 Phase 2: PDS0101 + KEYTRUDA® Company-sponsored trial in HPV16-positive metastatic or recurrent head and neck cancer Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) N=17 Subjects w/imaging data – confirmed and unconfirmed OR (2 CR + 5PR) 7 (41.2%) SD (reduction in 4/6) 6 (35.3%) PD 4 (23.5%) CR+PR+SD 13 (76.5%) *Reference: Weiss J. et al. Phase II study VERSATILE-002 evaluation of PDS0101 and KEYTRUDA® in treatment of CPI naïve and ICI refractory patients with recurrent or metastatic HPV16-related HNSCC. Presented at: American Society of Clinical Oncology 2022 Annual Meeting; June 3-7, 2022; Virtual. Abstract: 6041.
20 VERSATILE-003 Phase 3 Study Design World-wide Randomized, Controlled Clinical Study– Potential for Accelerated Approval – Potential for Accelerated Approval Primary endpoints Progression free survival (PFS) and overall survival (OS) Planned Interim Analysis: PFS and OS Planned Interim Analysis: OS + Final PFS Final Analysis: OS Targeted Indication For the treatment of recurrent/metastatic HPV16-positive HNSCC
21 VERSATILE-003 Timeline to Registrational Trial Initiation World-wide randomized, controlled clinical study to be initiated Q4 2023 with an overall estimated 90-100 sites Q 2022 FDA Fast Track designation for PDS0101 + KEYTRUDA® Q1 2023 Complete Phase 3 clinical manufacturing of PDS0101 Obtain visibility to potential OS and PFS information for VERSATILE-002 trial needed to finalize VERSATILE-003 trial design Q2 2023 Complete CMC-related activities for PDS0101 Obtain feedback from EU regulatory agencies on protocol Q3 2023 File amended IND with FDA for registrational trial Initiate site activation and related clinical operational activities (4-6 month process) Q4 2023 Initiate VERSATILE-003 Phase 3 Trial VERSATILE-002 Phase 2 Trial Progressing Q3 2022 Successful EOP2 meeting with FDA Initiate PDS0101 tech-transfer, scale up at selected Phase 3 clinical/commercial manufacture PDS0101 + KEYTRUDA® in Recurrent or Metastatic Head and Neck Cancer
Versamune® + Antibody-Conjugated IL-12 Oncology Platform
23 PDS0301 Promotes IL-12 Accumulation in Tumors PDS0301 turns tumors more immunogenic (“hot”) after subcutaneous injection Panel A shows superior targeting and accumulation of fluorescence-conjugated PDS0301 (NHS-muIL12) into lung cancer tumors in athymic mice, turning tumors “hot” compared to traditional IL-12 (BC1-muIL12). Circles represent the area of the tumor. Panel B shows PDS0301 binding to exposed cell nuclei within the tumor necrotic regions: arrows indicate NHS-muIL12 deposition. Circles represent the area of the tumor. PDS0301 consists of IL-12 conjugated to a tumor necrosis targeting (TNT) antibody that has been clinically validated for its ability to target tumors following administration. Panel C shows that in humans the TNT antibody targets exposed DNA/histone sites thereby directing the proinflammatory cytokine IL-12 to intratumoral necrotic regions. Image shows biodistribution and tumor-accumulation of the radio-labelled TNT antibody in a patient with lung cancer. Arrows identify a tumor lesion. Panel A Panel B Panel C JW Greiner et al; ImmunoTargets and Therapy 2021:10 155–169
24 PDS0301 + PDS0101 + ICI: Promotes Tumor Shrinkage & Survival Preclinical data translated to Phase 2 human results in advanced HPV-positive cancer Immune checkpoint inhibitor (ICI) PDS0301+ICI PDS0301 + PDS0101 + ICI Mouse HPV-positive tumors CD8 T cells CD4 T cells Treatment Tumor Vol. <300mm3 0/16 (0%) 8/16 (50%) 13/17 (73%) Phase 2 Human Clinical Trial Results ICI naïve patients: 88% ORR (7/8) & 75% alive at 27 months ICI refractory patients: 63% ORR (5/8) at high dose PDS0301 & median OS of 21 months (N=29) Multifunctional HPV16-positive CD8 T cells Paoloni M, et al. (2015) PLoS ONE 10(6): e0129954. doi:10.1371/ journal.pone.0129954
25 PDS0301 + HDAC Inhibitor Effective in aPD-L1 Resistant Tumors Potent CD8+ T cells and Natural Killer cells demonstrated in tumors in preclinical studies Phase 2 Study in Progress Preclinical study provides rationale for combining PDS0301 with a histone deacetylase (HDAC) inhibitor for patients unresponsive to checkpoint inhibitors (aPD-1/aPD-L1) Mouse tumors used in study: TC-1/a: HPV16 E6/E7 MHC-class I deficient lung cell line CMT.64: Lung cancer cell line RVP3: Rous sarcoma virus-induced sarcoma cell line Minnar CMet al. Journal for ImmunoTherapy of Cancer 2022;10:e004561. doi:10.1136/ jitc-2022-004561
26 Versamune® + Antibody-Conjugated IL-12 Oncology Platform PDS0301 targets tumors and enhances T cell infiltration and proliferation in the tumor Tumor Site PDS0301 travels direct to tumor 1 Increased tumor inflammation from PDS0301 2 PDS0301 increases T cell infiltration and expansion in tumor 3 CD8 T cells kill tumor cells 4 Injection Site Non-Immunogenic (Cold Tumor) Immunogenic (Hot Tumor) Tumor Site
27 NCI-led Triple Combination: PDS0101 + PDS0301 + ICI Advanced HPV16-positive anal, cervical, head and neck, penile, vaginal, vulvar cancer patients who are ICI refractory Timing Safety data confirmed and released Q4 2021 Preliminary efficacy data anticipated Q1 2022 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 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 Safety 173% 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
28 NCI-led Triple Combination: PDS0101 + PDS0301 + ICI Advanced HPV16-positive ICI refractory cancer patients Phase 2 Results in Recurrent Metastatic ICI Refractory HPV-Positive Cancer (CPS>0; PD-L1 agnostic) Plot Includes Published Data in HSNCC *Strauss J, et al. J Immunother Cancer 2020;8:e001395. doi:10.1136/jitc-2020-001395 **No tumor shrinkage in HPV16-negative subjects (ASCO 2021) – Suggests critical role of PDS0101-induced HPV16-specific CD8+ T cells No head-to-head studies have been completed Objective Response (ORR) in high dose PDS0301 Group = 63% (5/8) N=29 Best published median OS data to date in ICI refractory head and neck cancer population is 8.2 months
29 NCI-led Triple Combination: PDS0101 + PDS0301 + ICI Advanced HPV16-positive ICI naïve cancer patients Phase 2 Results in Recurrent Metastatic ICI Naïve HPV Positive Cancer (CPS>0; PD-L1 agnostic) Plots Include Published Data in HPV Positive Cancer (Head and Neck) Median OS not yet reached *Data from KEYNOTE-048 STUDY; No head-to-head studies have been completed N =8
Infectimune™ Infectious Disease Platform
31 InfectimuneTM Pipeline Developed in partnership with leaders in infectious disease Prevention of tuberculosis PDS0201 (M-tuberculosis) Candidate Indication PC P1 P2 P3 R Partner Universal prevention of influenza PDS Biotech Funded Partner Co-Funded PDS0202 (influenza) PDS0203 (SARS-CoV-2) Prevention of COVID-19
32 InfectimuneTM Pipeline Highlights Universal Influenza Vaccines 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 $7 Billion Universal flu market opportunity in 2021
33 PDS0202: Universal Prevention of Influenza 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. Flu Protein 3ug + Infectimune™ Flu Protein 0.6ug + Infectimune™ Flu Protein 0.1ug + Infectimune™ Flu Protein 3ug Unvaccinated Proprietary Computationally Designed Influenza Protein
34 Projected Milestones Through 3Q24 Trials are investigator-initiated trials and data read-outs are outside the control of the Company. 2Q23 3Q23 4Q23 1Q24 PDS0101 Anticipate preliminary efficacy data from Mayo Clinic IIT 2Q24 Initiate registrational trial for PDS0101 (VERSATILE-003) 3Q24 File amended IND with FDA for registrational trial for PDS0101 (VERSATILE-003) Anticipate updated data (IMMUNOCERV) Anticipate updated data (VERSATILE-002) Completion of enrollment (VERSATILE-002) Final data VERSATILE-002 Estimated IND filing in MUC1-related Cancers PDS0103 PDS Biotech Funded
35 About PDS Biotechnology Company Overview T cell activating platforms and antibody conjugated immuno-cytokine platform to develop safer, more effective and longer lasting immunotherapies to treat cancer and infectious disease 1 3 Clinical Partnerships: Merck, National Cancer Institute, MD Anderson Cancer Center, Mayo Clinic Financial: Cash as of December 31, 2022- $65.2M cash runway into Q3 2024 with initiation of a registrational trial in 2023 2 PDS0101 to enter Phase 3 registrational trial in 2023 to treat recurrent or metastatic, HPV-positive head and neck cancer VERSATILE-002 Abstract was accepted as a Poster Discussion and a featured poster to be reviewed by an expert panel in the Head and Neck Cancer Discussion Session 4
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | May 2023 Appendix
CFA + TARP (1-20) X PDS0102: TARP Antigen Versamune® induced CD8+ killer T cells may result in the ability to treat TARP positive AML and prostate cancers Preclinical Optimization Studies1: TARP-Specific T cell Induction after 2 injections of PDS0102 1 Reference: Wood LV et al, Oncoimmunology, 2016, Vol. 5 (8) CFA –Complete Freund’s Adjuvant a highly potent immune activator not used in humans due to potentially lethal toxicity *Reference: Surveillance Research Program, National Cancer Institute SEER Assumes $150K for annual course of therapy; in line with current immunotherapy treatment.Assessments have not been adjusted to reflect TARP expression, which is currently unknown by tumor type $40B TARP Total Market Opportunity* Announced license with NCI TARP antigens Number of TARP-Specific T cells (Interfer on-y spot forming cells per million splenocytes) 0 100 200 300 400 500 600 700 800 900 1000 100 spots/million cells Strong T cell response level Range of observed T cell responses with PDS0102 IFN-γ ELISPOT Study Versamune® + TARP (1-20) X 3 37
Induced a >10-fold number of polyfunctional (highly potent) MUC1 specific CD8+ T cells PDS0103: MUC1 Antigen Greater quantity and quality of Versamune® induced CD8+ killer T cells may result in the ability to treat breast, ovarian, lung, colon and other cancers *References: Surveillance Research Program, National Cancer Institute SEER, Cancer Institute SEER, Assumes $150K for annual course of therapy; in line with current immunotherapy treatment, Assessments have not been adjusted to reflect MUC1-expression, which is currently unknown by tumor type Adjuvant = cytokine GMCSF J. Immunology, 2019 (202),1215; Studies in TC-1 tumor model with other immunotherapies reported in: Vaccine 2009, January 14, 27 (3): 431; Science Translational Medicine 2016, 13 April, Vol 8 Issue 334; Vaccine 2009, September 25, 27 (42):5906. IFN-γSpot Forming Cells/1X106Spleen Cells Polyfunctional T Cells Monofunctional T Cells 4-Combo Adjuvant + MUC1 Antigen Versamune® + MUC1 Antigen (PDS0103) # of Antigen-Recognizing CD8+ T Cells $100B MUC1 Total Market Opportunity* Adjuvant* + MUC1 Antigen 38
39 Mayo Clinic: PDS0101 Monotherapy & in Comb. with KEYTRUDA® HPV-associated oropharyngeal cancer with high risk of recurrence Timing Safety data confirmed and released Q4 2021 Preliminary efficacy data anticipated Q1 2022 Partner FDA Approved Standard of Care Study Goals Safety, rate of regression and local control in patients transoral robotic surgery Potential treatment of patients with oropharyngeal cancer prior to transoral robotic surgery Targeted Indication Chemoradiation and resection
40 PDS0301 + Chemo or Radiation Promotes Tumor Shrinkage Preclinical models of lung cancer (LLC) and colon cancer (MC38) PDS0301 (NHS-muIL12) with radiotherapy enhances the anti-tumor response. Beginning on day 0, LLC tumor-bearing mice were randomized (n = 9 mice per group) and treated with PBS, fractionated radiotherapy alone (360 cGy on days 0-4), NHS-muIL12 alone (10 μg s.c. on day 0), or the combination of fractionated radiotherapy plus NHS-muIL12. ***P<0.001 PDS0301 with Docetaxel enhances the anti-tumor response. Mice bearing MC38 tumors were randomized (n = 12 mice per group) and treated with saline (closed circle), 3x0.5 mg docetaxel (closed square) on days 11, 13 and 15 (blue arrows), 1x50 μg NHS-muIL12 (closed triangle) on day 18 (red arrow), or the sequential combination of both (closed inverted triangle). **P<0.0001 Phase 2 Clinical Studies in Progress (Prostate Cancer) Fallon J. et al, Oncotarget 2014; Vol. 5, No. 7, 1869