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): October 1, 2019


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 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. ☒

Item 8.01
Other Events.

On October 1, 2019, PDS Biotechnology Corporation announced certain clinical development updates.  The full text of the press release is filed as Exhibit 99.1 hereto and incorporated herein by reference.

Also, on October 1, 2019, PDS Biotechnology Corporation updated its corporate presentation. A copy of the presentation slide deck is attached as Exhibit 99.2 hereto and incorporated herein by reference.

Item 9.01
Financial Statements and Exhibits.

(d)
Exhibits.

Exhibit
Number
 
Description
     
 
Press release dated October 1, 2019.
 
Corporate Presentation dated October 2019.

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: October 1, 2019
   
By: /s/ Frank Bedu-Addo, Ph.D.
   
Name: Frank Bedu-Addo, Ph.D.
   
Title: President and Chief Executive Officer


Exhibit 99.1

PDS Biotechnology Prioritizes Development of PDS0101 in Advanced Cancers Following Promising Phase 1 Clinical Outcome Data

Data demonstrated regression of lesions in 60% of patients

Berkeley Heights, NJ, October 1, 2019 - PDS Biotechnology Corporation (“PDS Biotechnology”) (Nasdaq: PDSB), a clinical-stage immuno-oncology company pioneering the development of multi-functional immunotherapeutic products, today announced it will prioritize clinical development of PDS0101 in advanced cancers following its recent reporting of promising PDS0101 Phase 1 clinical trial outcome data.

On September 19, 2019, PDS reported clinical outcome data from a Phase 1 clinical trial of PDS0101 in patients with cervical intraepithelial neoplasia (CIN) infected with multiple high-risk, cancer-causing types of human papillomavirus (HPV). The study demonstrated robust treatment-induced HPV16-specific killer T-cell (CD8+) responses as well as clearance of the disease and regression of lesions in 60% of patients. These in-vivo PDS0101-induced T-cells were demonstrated to induce granzyme-b thus confirming their cytolytic/killing potency. This clinical data supports the superior CD8+ T-cell induction and anti-tumor efficacy of the Company’s Versamune® platform, as published based on the results of preceding preclinical studies in the June 2019 Issue of the Journal of Immunology.

“Our intent is to continue to advance our previously announced combination studies with PDS0101 in various advanced HPV-associated cancers.  These phase 2 clinical studies are partnered with top leaders in the field.  We also intend to rapidly progress PDS0102 (targeting prostate and breast cancers), PDS0103 (targeting colon, lung, ovarian cancers) and PDS0104 (targeting melanoma) into human clinical trials in combination with checkpoint inhibitors.  This approach has been recently supported by promising Phase 1 clinical outcome data,” said Dr. Frank Bedu-Addo, CEO of PDS. “The unique ability of PDS0101 to promote in-vivo induction of high levels of CD8+ T-cells overcomes a significant limitation of many current immunotherapy approaches such as checkpoint inhibitors. Checkpoint inhibitors have a proven ability to induce effective anti-tumor responses in approximately 20% of patients by “releasing the brakes” of the immune system that have been activated by cancer. It has been reported that there is a strong correlation between the presence of tumor-targeting CD8+ T-cells and the efficacy of checkpoint inhibitors. We believe that the Versamune® platform, by promoting induction of these tumor-specific cytolytic CD8+ killer T cells, could be critical to substantially expanding clinical efficacy of checkpoint inhibitors into a larger percentage of the population, which could address unmet patient needs for improved treatment options across a range of advanced cancer indications.”

As a result of the recent data showing strong CD8+ T-cell induction and the subsequent decision to prioritize the platform’s application in combination therapies addressing advanced cancer, the Company no longer anticipates starting a Phase 2 study to evaluate PDS0101 monotherapy in CIN2/3 as previously reported.

About the Versamune® Platform Technology
Versamune® is a proprietary, synthetic lipid-based T-cell activating platform. PDS Biotechnology’s pipeline of Versamune®-based products, which are administered by subcutaneous injection, provides strong activation of type I interferon genes. The Versamune® mechanism of action also involves effective presentation of tumor antigens via the MHC Class I and Class II pathways. These mechanisms together promote strong in-vivo induction of polyfunctional tumor-targeting CD8+ T-cells. Versamune®-based immunotherapies have been demonstrated to alter the tumor micro-environment in preclinical mechanism of action studies, thus further enhancing the ability of Versamune®-induced T-cells to effectively kill tumor cells.  Preclinical data demonstrating the novel multi-functional mechanism of action of the Versamune® platform technology and the resulting superior T-cell induction and unique regression of advanced tumors were published in the Journal of Immunology (Journal of Immunology, Vol. 202, Issue 1215 June 2019).   

About PDS Biotechnology and PDS0101
PDS Biotechnology is a clinical stage immuno-oncology company with a growing pipeline of clinical-stage immunotherapies to treat various HPV-associated cancers, including head and neck cancer, cervical and anal cancers. PDS0101 includes the Versamune® immune-activating platform and a mixture of HPV16 E6 and E7 peptide antigens designed to induce cytolytic T-cell responses against HPV expressed in patients with HPV-associated cancers. Clinical outcome findings from the PDS0101 Phase 1 clinical study demonstrated unique in-vivo systemic induction of high levels of granzyme-b inducing HPV-specific killer T-cells associated with observed clinical responses (regression and elimination of pre-cancerous lesions) in  the majority of evaluable patients treated with PDS0101 monotherapy, and a lack of dose limiting toxicities at all tested doses.

Versamune® is a registered trademark of PDS Biotechnology Corporation, Berkeley Heights, NJ, USA.

For additional information about PDS, 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,” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 ability of the Company to integrate Edge and PDS Biotechnology following the merger; the Company’s ability to protect its intellectual property rights; competitive responses to the completion of the merger; potential adverse reactions or changes to business relationships resulting from the completion of the merger; 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 timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101 and PDS0102; the Company’s interpretation of the results of its Phase 1 trial for PDS0101 and whether such are sufficient to support additional trials or the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; 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 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.

Media & Investor Relations Contact:
Tram Bui / Alexander Lobo
The Ruth Group
Phone: +1-646-536-7035 / +1-646-536-7037
Email: tbui@theruthgroup.com / alobo@theruthgroup.com


Exhibit 99.2

 Corporate PresentationSeptember 2019Frank Bedu-Addo Ph.D.President & CEO 
 
 Forward-Looking Statements  2  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 preclinical and clinical drug development activities and timelines and market opportunities. All statements other than statements of historical facts included in this presentation are forward-looking statements. The words “anticipates,” “may,” “can,” “plans,” “believes,” “estimates,” “expects,” “projects,” “intends,” “likely,” “will,” “should,” “to be,” and any similar expressions or other words of similar meaning are intended to identify those assertions as forward-looking statements. These forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those anticipated.Factors that may cause actual results to differ materially from such forward-looking statements include those identified under the caption “Risk Factors” in the documents filed with the Securities and Exchange Commission from time to time, including its Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this presentation. Except to the extent required by applicable law or regulation, PDS undertakes no obligation to update the forward-looking statements included in this presentation to reflect subsequent events or circumstances. 
 
 Investment Highlights  3  Versamune® Platform  Versatile T-cell-activating platform developed to treat early- & late-stage cancersEarly clinical data and preclinical studies suggest potential for best-in-class combination of potency and safetyStrong induction of CD8+ and CD4+ T-cells demonstrated in Phase 1 study  Lead program PDS0101 targeting multiple indications in >$6 billion HPV cancer market e.g. head and neck cancer, anal, cervical, CIN2/3*PDS0101 clinical studies projected to initiate in 1Q 2020Phase 2 combination therapy with KEYTRUDA in head and neck cancerPhase 2 combination study with 2 clinically tested immunotherapeutic agentsPipeline includes melanoma, prostate, breast, colon, lung cancers  Product Pipeline  Clinical stage biotechnology company developing pipeline of novel cancer immunotherapies based on proprietary Versamune® platform  * Cervical cancer treatment market size, Share & Trends Analysis Report, Dec. 2018, Grand View Research* Head and neck cancer market size, March 2018, Grand View Research   PDS Biotechnology 
 
 Current State of Immuno-Oncology (I-O)  4  The Promise of I-O  Durability of anti-tumor responses in some patientsDisease control for many years, resulting in improvements in duration of overall survival  Only minority of patients respond (15-25% on average) Additive toxicities of different I-O agents in combination, without significant corresponding clinical benefitCritical unmet ability to activate the necessary immunological events/pathways to induce robust in-vivo T-cell responseTrain right phenotype of CD8+ killer T-cellsActivate signaling mechanisms that activate CD8+ T-cellsOvercome tumors’ ability to evade attack by T-cells  The Frustration of I-O 
 
 Multi-Functional Versamune® Platform Overcomes Key I-O Limitations  5  Engineered to promote in-vivo induction of tumor-recognizing and attacking killer (CD8+) T-cells*  Trains killer T-cells to recognize & attack cancer  Activates powerful T-cells to attack cancer cells  Makes tumors more susceptible to T-cell attack  Positively charged nano-particles engineered to access critical MHC Class I pathway  Activates stimulation of type I interferon (IFN) genes within lymph nodes  Significantly increases ratio of killer T-cells to immune-suppressive regulatory T-cells  Induces memory immune response  Body generates tumor-attacking T-cells for extended period after treatment  Potent poly-functional T-cells  De-camouflaged tumor  Robust / lasting effect  1  2  3  4  *Mechanism of Action: Journal of Immunology, Vol. 202, Issue 1215 June 2019 
 
 6           500  1,000  1,500  2,000  PDS0101* GM-CSF/E7* DNA-Vaccine# Live Vector Vaccine##  # of HPV-Recognizing T-CellsIFN-γ Spot Forming Cells/1X106 Spleen cells   Versamune® Mechanisms of Action: Promote Superior Quantity & Quality of HPV-Specific Tumor-Attacking Killer T-Cells In-Vivo  Versamune® induces superior levels of CD8+ T-Cells versus competing approaches (analysis by interferon gamma ELISPOT)  **P<0.05  *J. Immunology, 2019 (202), 1215Studies in TC-1 tumor model with other immunotherapies reported in: #Vaccine 2009, January 14, 27 (3): 431;##Journal for Immunotherapy of Cancer, 2013 (1) 15   Superior/polyfunctionalT-cells   
 
 PDS0101: Multi-Functional Mechanism Promotes Superior Ability to Eliminate HPV-Positive TC-1 Tumors & Generates Sustained T-Cell Response  7  In vivo induction of superior quantity & quality of tumor-specific CD4+ and CD8+ T-cells result in complete regression & effective T-cell memory after a single dose*    *J. Immunology, 2019 (202), 1215Studies 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, August 3, 27 (33): 5706  Single treatment dose                50  55  60  80    Inject TC-1 Tumor Cells 
 
 Unique Formulations Present Advantages in Potency, Manufacturing, and Administration  8    Versamune®  Proprietary AntigenDesign                  Potential best-in-class simplicity, ease of administration and cost of goods 
 
 PDS0101 Mechanism Leads to Potent in-vivo Killer T-cell Response in Humans: Phase 1 Dose Escalating Study Showed Potent CD8+ T-Cell Induction  14x  24x   IFN-γ: Total T-Cells 26x  >20-Fold Increase in HPV-Specific CD8+ T-Cell ResponsesVs. Pre-Treatment Levels at Recommended Clinical Doses    9  Order of Magnitude Inc. Over Baseline   R-DOTAP Dosage  Strong & Measurable In-Vivo Induction of HPV-Specific Killer T-cells by ELISPOT 14 Days Post TreatmentDefined Dose for Phase 2 and Registration Studies  Clinical Study Design12 patient open-label study (3 cohorts, each 3-6 subjects)Cervical Intraepithelial Neo-plasia (CIN) & high-risk HPVEvaluated safety, tolerability & pharmacodynamics 
 
 PDS0101 Phase 1 Follow-up Data Supports Observed Strong Killer T-Cell Induction:Demonstrated Clearance of CIN Lesions in 60% of Evaluable Patients  10  PDS0101 was immunologically active at all three doses resulting in 5 to 73-fold increase in circulating HPV disease-attacking T-cells in 10/12 subjectsClearance of the CIN (lesion regression) was observed in 60% of evaluable patients across the three tested dosesRegression of the lesions was seen as early as 1-3 months after treatment in some patients, suggests potential correlation of immunologic and clinical responses with the administration of PDS0101  Dose Cohort  Evaluable Patients*  Clearance of Lesions 12 Months Post Treatment**      N =   N =  % of Evaluable  1mg  3 of 3  2  67%  3mg  2 of 3  1  50%  10mg  5 of 6  3  60%  Total  10  6  60%  *Two of twelve patients were not evaluable: one patient, who demonstrated a strong immune response, was lost to follow up and another received LEEP excision therapy (standard of care)         **Two of ten evaluable patients who had clearance of CIN by cytology were not considered as clinical responders: one patient regressed from CIN to atypical squamous cells of undetermined significance (ASCUS) with detectable virus, and the other showed consistent disease elimination by cytology, but showed residual disease by colposcopy        
 
 PDS0101 + KEYTRUDA® Clinical Study in HPV-Associated Head and Neck Cancer  11  Primary Efficacy EndpointObjective Response Rate (ORR) at 9 months following the initial dose of combination treatment.NoteMerck received FDA approval for KEYTRUDA® (checkpoint inhibitor) alone or with chemotherapy on 06/10/2019 in the first line treatment of recurrent/metastatic HNC with tumor PD-L1 expression  Open Label, Single Arm, Non-Randomized Study   TOTAL  Study Sample Size   N = 96  Anticipated # of Study Sites  ~20  First Line Treatment of HPV16 Positive Recurrent/Metastatic Head and Neck Cancer(Study Initiation in 1Q 2020)  
 
 PDS0101 Clinical Combination Study in Advanced HPV-Associated Cancers  12  Combination with two novel & clinically tested (large pharma owned) immunotherapiesPrimary Efficacy EndpointPercentage of subjects that achieve an objective confirmed complete or partial response using RECIST 1.1.Regulatory StrategyPhase 2 trial in HPV-positive all-comers.  Open Label, Single Arm, Non-Randomized Study   TOTAL  Study Sample Size  N = 30  Anticipated # of Study Sites  1 (NCI Bethesda, MD)  Treatment of Advanced HPV-Associated Cancers (PDS-NCI Collaboration)(Study Initiation in 1Q 2020)  
 
 Developing Broad Product Pipeline with Leaders in I-O  13  Product  Indication  Partner  Combination  Status  PDS0101(HPV-Cancer)   Head & neck cancer First line treatment Recurrent/metastatic    KEYTRUDA®  Initiate Phase 2 1Q 2020*    Advanced HPV cancers    NovelImmunotherapies  Initiate Phase 2 1Q 2020*    Cervical cancerStage IIb-IVa    Chemo-radiotherapy  Phase 2 ready  PDS0102(TARP)  Prostate and breast cancers    Immunotherapy  Preclinical studies ongoing  PDS0103(MUC-1)  Ovarian, colorectal, lung, breast cancers    Immunotherapy  Preclinical studies ongoing  PDS0104(Melanoma)  Melanoma    Immunotherapy  Preclinical studies ongoing  * These clinical studies are expected to be initiated with current funding  
 
 PDS0104: Powerful In-Vivo Killer T-Cell Induction Results in Unique Ability to Regress B16 Melanoma Lung Metastasis Tumors (Preclinical)  14  In vivo induction of superior quantity and quality of tumor-specific CD4+ and CD8+ T-cells results in regression of metastatic tumors in lungs after a single dose    14 days after treatment 
 
 Intellectual Property (Versamune® -Related Products)  15  Versamune® and associated patents 100% owned by PDSFive issued US patents valid from 2025 – 2034Five issued international patent families (including Europe & Japan)10 total patent families – provides possible protection of products through 2038Patents cover compositions/formulations and methods of use  IP strategy intended to provide multiple layers of technology & product protection 
 
   16  3Q 2019: Release available patient outcome data from Phase 1 clinical study1Q 2020: Initiation of PDS-Merck Phase 2 combination study in head and neck cancer 1Q 2020: Initiation of PDS-NCI Phase 2 combination study in advanced HPV-cancers 2Q 2020: Publication of PDS0101 Phase 1 clinical study results in peer reviewed journal2Q 2020: Complete formulation of lead preclinical product  Projected Near-Term Milestones / Catalysts   
 
 Financial Information  17  1 June 30, 2019 2 September 30, 2019   Nasdaq:  PDSB  Shares Outstanding1  5.2M  Cash1  $21.7M  Share Price2  $3.33  Market Cap2  $17.3M  Debt1   --- 
 
 Wrap-Up  18  Powerful and safe T-cell-activating immunotherapy platform  Versatility: Potential to transform treatment of early- & late-stage cancers  Validation: Superior preclinical and clinical data Clinical partnerships with both Big Pharma and NCI  Upcoming Phase 2 clinical studies  1    2    3    4   
 
 Management Team  19  Frank Bedu-Addo, PhDChief Executive Officer  Gregory Conn, PhDChief Science Officer   Lauren V. Wood, MDChief Medical Officer        Andrew SaikChief Financial Officer    Strategy & managed execution at both large pharma & biotechsNotable drug development:Abelcet® (Liposome Company/ Elan)PEG-Intron® (Schering-Plough/ Merck)  Co-founder>35 years of drug development experience In-depth experience with biotech drug discovery, product development and manufacturing  >30 years of translational clinical research experienceFormer Clinical Director of the Vaccine Branch within the Center for Cancer Research, National Cancer Institute  >20 years of experience in pharma & drug developmentIn-depth experience with M&A transactions, capital markets, and investor relations 
 
 Corporate PresentationOctober 2019Frank Bedu-Addo Ph.D.President & CEO