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 15, 2020



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, 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 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 September 15, 2020, PDS Biotechnology Corporation updated its corporate presentation slide deck. A copy of the corporate presentation slide deck is attached hereto as Exhibit 99.1 and incorporated herein by reference.

Item 9.01
Financial Statements and Exhibits.

(d) Exhibits.

Exhibit
Number
 
Description
     
 
Corporate Presentation dated September 2020.


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 15, 2020
By:
/s/ Frank Bedu-Addo, Ph.D.
 
Name: Frank Bedu-Addo, Ph.D.
 
Title: President and Chief Executive Officer




Exhibit 99.1

 CORPORATE PRESENTATION  Frank Bedu-Addo Ph.D.  President & CEO  SEPTEMBER 2020 
 

 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 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, PDSB undertakes no obligation to update the forward-looking statements included in this presentation to reflect subsequent events or circumstances. 
 

 PDS Biotechnology leadership team has demonstrated success in the development and commercialization of leading pharmaceutical products  3        Senior executive experience with management of strategy and execution at both large pharma and biotechsNotable drug development:Abelcet® (Liposome Company/ Elan)PEG-Intron® (Schering-Plough/ Merck)  Senior executive experience with over 20 years of experience in pharma and drug developmentIn-depth experience with M&A transactions, capital markets, and investor relations  >30 years of translational clinical research experienceFormer Director of Clinical Research at National Cancer Institute Center for Cancer Research (Cancer Vaccine Branch)   Co-founder>35 years of drug development experience In-depth experience with biotech drug discovery, product development and manufacturing  Frank Bedu-Addo, PhDChief Executive Officer    Gregory Conn, PhDChief Scientific Officer     Lauren V. Wood, MDChief Medical Officer    Michael KingChief Financial Officer (Interim)      
 

 PDS Biotech is well-poised to transform vaccines and cancer treatment by delivering promising immunotherapies  4  Clinical studies in areas of high unmet medical need supported by leaders in the field  4  Diversified pipeline focused on oncology and infectious disease   3  Demonstrated potential for strong clinical efficacy and durability of response with minimal toxicity  2  Powerful immunotherapy platform that activates therapeutic and preventive immunological pathways  1 
 

 PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on the proprietary Versamune® platform  5  Versatile and potent T-cell-activating platformClinically supported induction of active antigen-specific killer and helper T-cells in vivoPromising clinical efficacy demonstrated in early trials of PDS0101 monotherapy with favorable safety profile and no dose limiting toxicities  Publicly listed on NASDAQ: PDSB~15 employees with headquarters in Florham Park and Princeton, NJ22.3M shares outstanding with approximately $34.0M in cash*  Pipeline      Versamune® Platform  Corporate Overview  * September 11, 2020 
 

 6  Reference: Data on file.  PDS Biotech’s pipeline combines the Versamune® platform with proprietary antigens across immuno-oncology and infectious disease 
 

 Versamune® Platform 
 

   v  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 excellent uptake by dendritic cells of the immune systemActivates the important Type I interferon immunological signaling pathwayVersamune® promotes the activation and maturation of dendritic cells, which then migrate to the lymph nodes  Versamune®: proprietary T-cell activating platform Engineered to induce robust, targeted anti-tumor responses in vivo  8  Water-insolubleFatty 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)  
 

 Inability to perform the necessary steps to induce a strong therapeutic killer T-cell response in-vivo    Versamune® design and novel immunological mechanisms of action promote a powerful disease-specific killer T-cell response        Versamune® has demonstrated potential to overcome well-established challenges of immunotherapy in oncology and infectious disease   9  Challenges of Immunotherapy  How Versamune® May Overcome the Challenges  Mechanistic limitations have resulted in lack of therapeutic benefit in human studies    Mechanism of action associated with regression of disease in human studies (PDS0101 monotherapy)        Potential for systemic toxicities    Mechanism of action results in a lack of clinically relevant toxicities, even at the highest dose, in human studies        Reference: Gandhapudi SK, Ward M, Bush JPC, Bedu-Addo F, Conn G, Woodward JG. 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.  
 

 Greater quantity and quality of Versamune®-induced killer T-cells may result in unique ability to eradicate HPV-positive tumors after a single dose  10    Produces > 10-fold number of highly potent (polyfunctional) killer T-cells vs. other T-cell technologies  Single treatment dose  Results typical of current topclinical-stage HPV cancer vaccines  Tumor rechallenge at Day 60; complete and sustained cure of cancer      *Adjuvant = cytokine GMCSFReferences: 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. 
 

 11  Combination of Versamune® and a proprietary antigenEngineered for simplicity and ease of administration      Vials of HPV16 mix (L)and Versamune® (R)  Versamune® formulationis mixed before injection*  Delivered viasubcutaneous injection  *Electron microscopy picture 
 

 Oncology 
 

 Checkpoint inhibitors have shown confirmed clinical efficacy and have demonstrated clinical benefit in late stage cancerCheckpoint inhibitors block a key immunological defense mechanism for cancer cells, and are reported to work primarily in patients whose immune systems are already generating tumor-attacking CD8+ killer T-cells pre-treatmentUsing various tumor-specific proteins (antigens), Versamune® has demonstrated the ability to generate large and superior numbers of CD8+ killer T-cells relative to other immunotherapies, that effectively recognize and kill antigen-expressing cancer cells in pre-clinical and human clinical studies  Clinical strategy in advanced cancer:Focus on efficiency and risk mitigation to proof of concept  13  Versamune®-based immunotherapies are being developed as combination therapies to exploit the demonstrated synergies between Versamune® and other anti-cancer agents  PDS Biotech is developing a new generation of advanced cancer treatments combining Versamune®-based immunotherapies with checkpoint inhibitors and other standard of care therapies 
 

 Versamune®-based immunotherapy + checkpoint inhibitors: Strong synergy leads to enhanced anti-tumor efficacy  14  Preclinical studies: Checkpoint inhibitor ineffective in treating B16 melanoma, a notoriously difficult modelPDS0104 promotes infiltration of active killer T-cells into tumors + Checkpoint inhibitor blocks tumor immune suppressive mechanism = Enhanced anti-tumor efficacy  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. Vasievich EA et al. 2012. Trp2 peptide vaccine adjuvanted with (R)-DOTAP inhibits tumor growth in an advanced melanoma model. Mol Pharmaceutics. 9(2): 261-268.  CD4+ helper T-cell   CD8+ killer T-cell      
 

 15  PDS0101 designed to treat cancers caused by human papillomavirus (HPV)  Approximately 43,000 patients are diagnosed with cancers where HPV is often found each year in US; approximately 35,000 cases are caused directly by HPV  References: Markowitz et al. 2016. Centers for Disease Control and Prevention. 2018.   Oropharyngeal (head & neck) cancers >18,000 cases annuallyMost common HPV-cancer in men,90% of cases are HPV16-specificIncidence increasingCervical cancer~12,000 cases annuallyMost common HPV-cancer in women,50-60% of cases are HPV16-specificIncidence steadyInitial market research suggests market penetration of ~20% is reasonable for PDS0101  PDS0101 combines the utility of Versamune® with a proprietary mix of HPV16 antigens, the most virulent high-risk HPV type, and by far the most prevalent in patients with HPV-associated cancer  Females (24,391)  Males (18,280) 
 

 16  PDS0101 Phase 1 clinical trial: Unique in vivo demonstration of high levels of HPV-specific killer T-cells in circulating blood   14x   24x   Total Activated T-Cells 26x    Order of magnitude increase over baseline  Versamune® Dose  Reference: Data on file.  INF-γ Elispot Granzyme-b Elispot      Clinical Study Results in Patients with CINImmunogenicity at Day 14Defined dose for Phase 2 studies (3mg)No dose-limiting toxicities  Clinical study results successfully demonstrate translation of Versamune®’s multi-functional mechanism of action between pre-clinical models and humans 
 

 17  Follow-up of patients in PDS0101 Phase 1 study demonstrated promising clinical responses at all three tested doses    A post-hoc, retrospective analysis, demonstrated complete lesion regression in at least 60% of evaluable patients (6/10) as early as 1-3 months after treatmentNo lesion recurrence occurred within the 2-year evaluation periodSpontaneous regression of CIN1 occurs in about 44% of patients over a 2-year duration* These results were remarkably positive as most patients were infected with multiple high-risk HPV typesTwo patients who had regression by cytology were not considered clinical responders:The first regressed to atypical cells of undetermined significance at the first post-treatment evaluation (3 months) but HPV detectedThe second had complete regression by cytology at the first post-treatment evaluation (3 months) but had residual CIN by colposcopy   Reference: Stefani C. et al, 2014, European Review for Medical and Pharmacological Sciences, 18: 728-733 
 

 18  Investigator-Led Phase 2 studies of PDS0101 in combination therapy will evaluate efficacy and safety in treatment of advanced HPV cancers  Funded By  Phase 2 Open Label Study (Safety and Efficacy)  Important Considerations  Initiation    Advanced HPV-associated malignancies – all typesTriple combination with EMD Serono’s M7824 and NHS-IL1228 subjectsClinical Trial Identifier: NCT04287868  NCI selection and confirmation of synergies with PDS0101All three agents have demonstrated efficacy as monotherapies in early trials  Initiated in June 2020    Advanced, localized cervical cancer (Stage IIb-IVa)Combination with chemo-radiotherapy (CRT-standard of care) 35 subjects  T-cell induction has strong potential to enhance CRT anti-cancer efficacyMitigated riskPotential for rapid market penetration and market leadership  Planned to be initiated Q4 2020 
 

 19  Unique triple combination including PDS0101 shows promising anti-tumor immune responses  CD4 T-cells – GreenCD8 T-cells – RedDAPI - Blue     PDS0101 promotes enhanced T-cell clonality  Immunohistochemistry for CD4+ and CD8+ T cells in HPV-Positive tumors   Reference: Smalley Rumfield C, Pellom ST, Morillon II YM, et alImmunomodulation to enhance the efficacy of an HPV therapeutic vaccine. Journal for ImmunoTherapy of Cancer 2020; 8:e000612. doi: 10.1136/jitc-2020-000612 
 

 20  PDS Biotechnology-sponsored Phase 2 study with KEYTRUDA® supplied by MerckKeytruda®: first immunotherapy approved as SOC for first line treatment of recurrent HNCPDS0101 monotherapy demonstrated high levels of circulating CD8+ killer T-cells and therapeutic benefitUnique immuno-oncology combination addressing first-line treatment of cancerStudy design: Phase 2 open-label studyPrimary endpoints: Efficacy, safety and tolerabilityInclusion criteria: Recurrent/metastatic head and neck cancer and HPV16 infectionPDS0101 dosed every 3 weeks for 4 doses (1st 4 cycles) with booster dose at cycle 12Keytruda dosed every 3 weeks (1st 4 in combo w/ PDS0101) until disease progression, intolerance or 2 yrsClinical Trial Identifier: NCT04260126  Planned Phase 2 study of PDS0101 in combination with KEYTRUDA® in first-line treatment of recurrent/metastatic head and neck cancer (HNC)  Followed by open label SOC with KEYTRUDA® until disease progression or intolerance                                      KEYTRUDA® alone  Combination of PDS0101 and KEYTRUDA®  200 mg IV KEYTRUDA® every 21 days in combinationwith 3 mg SC PDS0101 at cycles 1, 2, 3, 4 and 12  Expected initiation: Q4 2020 based on current COVID-19-related restrictions on health system operations 
 

 Infectious Disease 
 

 22  The addition of Versamune® to Fluzone®, a seasonal influenza vaccine, resulted in a 40-fold increase in protective HAI titers – achieving superior levels of HAI titers with 5-fold lower doses of Fluzone®  PDS0202: Versamune® dramatically enhances neutralizing antibody levels against various influenza strains and enables significant dose sparing 
 

 Preclinical testing of Versamune®-based COVID-19 vaccine candidates ongoing with a clear target profile   23  Ideal for rapid commercial scale up  4  No safety signals  3  Demonstrate high levels of both SARS-CoV-2-specific T-cell and antibody response after a single dose   2  Induction of highly-potent, SARS-CoV-2-specific killer T-cells   1 
 

           24    PDS0203: Versamune®-based COVID-19 vaccine induces rapid and potent antibody responses to SARS-CoV-2 in two weeks  *Mice were immunized with two doses (day 0 and day 7) of vaccine, data collected 14- and 30-days post vaccination  Initial preclinical data suggest Versamune® induces antibodies at a level equivalent to those observed in hospitalized COVID-19 patients within 2 weeks of vaccination 
 

           25    PDS0203: Versamune®-based COVID vaccine uniquely induces strong T-cell responses against SARS-CoV-2 in two weeks  Mice were immunized with two doses (day 0 and day 7) of vaccine, data collected 14 days post vaccination. T-cells were measured by ELISPOT and CD8+ killer T-cells were measured by flow cytometry*Data for CD4+ T-cell response on file  Preclinical data suggest Versamune® induces T-cells – including polyfunctional CD4+ (helper) & CD8+ (killer) T-cells - against SARS-CoV-2 when combined with either the Spike S1 protein or the full S-proteinStrong T-cell responses confirmed at 60 days: Long-lasting (memory T-cells) 
 

 Intellectual Property and Financials 
 

 27  Multiple layers of technology and product protection for Versamune®-related products through mid-2030s  Versamune® and associated patents are owned and licensed by PDS BiotechPatents cover methods and compositions stimulating/promoting an immune response with Versamune® technology in various forms and mechanisms through 2034Use of specific cationic lipids to induce an immune responseCompositions and use of any cationic lipid to activate MAP kinaseCompositions and use of R-DOTAP to induce immune responseMicellar antigen + cationic lipids compositions (US still ongoing) Compositions of R-DOTAP with GM-CSF to reduce immune suppressive myeloid derived suppressor cells in the tumorFive issued international patent families (including Europe and Japan) 
 

 Strong financial position to support near-term milestones  28  Nasdaq  PDSB  Shares Outstanding*  22.3M  Cash*  $34.0M  Share Price*  $2.16  Market Cap*  $48.2M  Debt*  ---  PDS0101 (HPV): Initiation of NCI-led Phase 2 combination study in advanced HPV-associated cancersPDS0203 (SARS-CoV-2): Complete preclinical formulation development and feasibility testingPDS0101 (HPV): Initiation of MD Anderson-led Phase 2 combination study in advanced cervical-cancerPDS0101 (HPV): Initiation of VERSATILE-002 Phase 2 study of first line treatment of recurrent/ metastatic head and neck cancer in combination with KEYTRUDA®PDS0202 (influenza): Generate initial feasibility data on universal flu vaccinePDS0204 (SARS-CoV-2): Complete preclinical formulation development and feasibility testing  Timing of 2020 milestones will be impacted by the COVID-19 pandemic   * September 11, 2020 
 

 PDS Biotech poised to transform vaccines and cancer treatment by fulfilling the promise of immunotherapy  29  Clinical studies in areas of high unmet medical need supported by leaders in the field  4  Diversified pipeline focused on oncology and infectious disease  3  Demonstrated potential for strong clinical efficacy and durability of response with minimal toxicity  2  Powerful immunotherapy platform that activates therapeutic and preventive immunological pathways  1