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): March 27, 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.)

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 2.02.
Results of Operations and Financial Condition.

On March 27, 2020, PDS Biotechnology Corporation (the “Company”) issued a press release announcing its financial results for the three months and fiscal year ended December 31, 2019, which is attached hereto as Exhibit 99.1.

In accordance with General Instruction B.2 of Form 8-K, the information set forth in this Current Report on Form 8-K (including Exhibit 99.1) is deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

Item 8.01.
Other Events.

On March 27, 2020, the Company updated its corporate presentation slide deck. A copy of the corporate presentation slide deck is attached hereto as Exhibit 99.2 and incorporated herein by reference

Item 9.01
Financial Statements and Exhibits.

(d)
Exhibits.

Exhibit
Number
 
Description

 
 
Press Release dated March 27, 2020.
 
Corporate Presentation dated March 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: March 27, 2020

By: /s/ Frank Bedu-Addo, Ph.D.


Name: Frank Bedu-Addo, Ph.D.


Title: President and Chief Executive Officer




Exhibit 99.1

PDS Biotechnology Reports Full Year 2019 Financial Results and Provides Business Update

Princeton, NJ, March 27, 2020 - PDS Biotechnology Corporation (“PDS Biotechnology”) (Nasdaq: PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on T-cell activating technology called Versamune® today announced its financial results for the full year ended December 31, 2019 and provided a business update.

Fourth Quarter 2019 and Recent Business Highlights


Reported promising Phase 1 clinical outcome data of PDS0101 in patients with cervical intraepithelial neoplasia (CIN) infected with multiple high-risk, cancer-causing types of human papillomavirus (HPV). Study demonstrated robust treatment-induced HPV16-specific killer T-cell (CD8+) responses as well as clearance of the disease and regression of lesions in the majority of evaluable patients;

Announced clinical collaboration with Merck to evaluate PDS0101 in combination with KEYTRUDA® (pembrolizumab) in first line treatment of metastatic head and neck cancer;

Selected Dr. Jared Weiss as Principal Investigator for Phase 2 Clinical Collaboration with Merck and formed an Independent Data Monitoring Committee;

Completed manufacturing of clinical batches of HPV mix component of PDS0101 for upcoming Phase 2 combination trials with Merck and National Cancer Institute;

Announced pre-clinical collaboration with Farmacore Biotechnology for tuberculosis

Granted U.S. and European Patents for Versamune® - GM-CSF Combination to Overcome Tumor Immune Suppression and US composition of matter patent for Versamune;

Appointed Kamil Ali-Jackson, Esq. to the Board of Directors; and

Successfully completed an underwritten public offering of its common stock with net proceeds of approximately $11.9 million after deducting underwriting discounts and commissions, not including other offering expenses in February 2020.
 
“We have made significant progress over the last year as we transitioned to a public company, strengthened our partnerships with leaders in immuno-oncology, such as Merck and National Cancer Institute and reported encouraging human data from our lead program, PDS0101,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotechnology. “As we forge ahead in 2020, we look forward to leveraging the highly encouraging Phase I human clinical outcome data, which demonstrated complete lesion regression in 60% of evaluable patients with cervical intraepithelial neoplasia (CIN) and human papillomavirus (HPV) within 1-3 months of treatment. These results support our combination approach in our upcoming clinical trials and provide evidence that PDS0101 could be essential in expanding the clinical efficacy of checkpoint inhibitors and improving clinical outcomes for patients.”

“With a strengthened balance sheet, we look forward to initiating three studies, including; a Phase 2 combination study to evaluate PDS0101 in combination with KEYTRUDA® in the first line treatment of metastatic head and neck cancer, a Phase 2 study to evaluate PDS0101 in combination with two promising immune-modulating agents in advanced HPV-associated cancers with the NCI and a Phase 2a study to evaluate the combination of PDS0101 and chemoradiation in patients with locally advanced cervical cancer. We remain committed to developing our novel Versamune platform in collaboration with our partners and would like to thank our shareholders for their continued support” concluded Dr. Bedu-Addo.


Full Year 2019 Financial Review

For the year ended December 31, 2019, the net loss was approximately $6.9 million, or $1.44 per basic and diluted share. This compares to a net loss of approximately $3.8 million, or $1.15 per basic and diluted share for the year ended December 31, 2018.

For the year ended December 31, 2019, research and development expenses increased approximately 634% to approximately $6.1 million compared to approximately $0.8 million in the prior year. The increase is primarily attributable to an increase in external expenses for clinical studies, internal R&D personnel costs, non-cash stock-based compensation and departmental costs.

For the year ended December 31, 2019, general and administrative expenses increased approximately 294% to approximately $11.0 million compared to approximately $2.8 million in the prior year.  The increase was due to increases in personnel costs, non-cash stock-based compensation, facilities costs, D&O insurance costs, legal fees, professional fees and other operating expenses.

For the year ended December 31, 2019, total operating expenses increased approximately 477% to approximately $21.0 million compared to approximately $3.6 million in the prior year.

As of December 31, 2019, the Company’s cash balance was approximately $12.2 million. This amount does not include the approximately $11.9 million in net proceeds after deducting underwriting discounts and commissions, not including other offering expenses from PDS Biotech’s underwritten public offering including the full exercise of the underwriters’ overallotment option, which closed in February.

About PDS Biotechnology
 
PDS Biotech is a clinical-stage immuno-oncology company developing multiple therapies based on the Company’s proprietary Versamune® T-cell activating technology platform. The Versamune® platform effectively delivers tumor-specific antigens for in vivo uptake and processing, while also activating a critical immunological pathway, the type 1 interferon pathway, thus resulting in the production of potent tumor-specific killer T-cells. Using Versamune®, PDS Biotech is engineering therapies designed to better recognize cancer cells and break down their defense systems to effectively attack and destroy tumors. PDS Biotech’s pipeline combines the Versamune® technology with tumor-specific antigens across several cancer types. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
 
About PDS0101
 
PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck, PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first line treatment of recurrent or metastatic head and neck cancer. In partnership with the National Cancer Institute (NCI), PDS Biotech is also advancing a combination of PDS0101 and two clinical stage immunotherapies to a Phase 2 study in advanced HPV-associated cancers. A third phase 2 study is to be performed in advanced localized cervical cancer combining PDS0101 with the chemoradiotherapy, which is the standard of care.


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 Company’s ability to protect its intellectual property rights; potential adverse reactions or changes to business relationships resulting from the resignation of the Company’s Chief Financial Officer or the Company’s ability to find a replacement Chief Financial Officer; 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 results 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, including any collaboration studies concerning PDS0101 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 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, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Tram Bui / Alexander Lobo
The Ruth Group
Phone: +1 (646) 536-7035 / +1 (646) 536-7037
Email: tbui@theruthgroup.com / alobo@theruthgroup.com


(Financial Statements to Follow)


PDS BIOTECHNOLOGY CORPORATION and Subsidiaries
 
Consolidated Balance Sheets
 
   
December 31,
2019
   
December 31,
2018
 
ASSETS
           
Current assets:
           
Cash and cash equivalents
 
$
12,161,739
   
$
103,695
 
Prepaid expenses and other
   
2,308,462
     
18,428
 
Total current assets
   
14,470,201
     
122,123
 
                 
Property and equipment, net
   
21,051
     
29,508
 
Other assets
   
     
12,800
 
                 
Total assets
 
$
14,491,252
   
$
164,431
 
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
               
LIABILITIES
               
Current liabilities:
               
Accounts payable
 
$
1,197,720
   
$
1,307,529
 
Accrued expenses
   
1,097,640
     
601,889
 
Restructuring reserve
   
498,185
     
 
Total current liabilities
   
2,793,545
     
1,909,418
 
                 
Noncurrent liability:
               
Warranty liability
   
     
291,225
 
Convertible promissory notes payable
   
     
30,000
 
Total liabilities
   
2,793,545
     
2,230,643
 
                 
STOCKHOLDERS' EQUITY
               
Common stock, $0.00033 par value, 75,000,000 shares authorized at December 31, 2019 and December 31, 2018, 5,281,237 shares and 3,417,187 shares issued and outstanding at December 31, 2019  and December 31, 2018, respectively
   
1,742
     
1,128
 
Additional paid-in capital
   
40,633,670
     
19,871,759
 
Accumulated deficit
   
(28,937,705
)
   
(21,939,099
)
Total stockholders' equity (deficit)
   
11,697,707
     
(2,066,212
)
                 
Total liabilities and stockholders' equity (deficit)
 
$
14,491,252
   
$
164,431
 


PDS BIOTECHNOLOGY CORPORATION and Subsidiaries
 
Consolidated Statements of Operations and Comprehensive Loss
 
   
Year Ended December 31,
 
   
2019
   
2018
 
Operating expenses:
           
Research and development expenses
 
$
6,099,580
   
$
830,744
 
General and administrative expenses
   
10,981,765
     
2,788,016
 
Impairment expense-IPRD
   
2,974,000
     
 
Lease termination costs
   
979,273
     
 
Depreciation and amortization
   
     
27,426
 
                 
Total operating expenses
   
21,034,618
     
3,646,186
 
                 
Loss from operations
   
(21,034,618
)
   
(3,646,186
)
                 
Other income (expense):
               
Gain on bargain purchase upon merger
   
13,334,568
     
 
Interest income
   
353,490
     
 
Interest expense
   
(33,559
)
   
(3,595
)
Other
   
     
(900
)
Loss on extinguishment of debt
   
     
(185,800
)
                 
Loss before income taxes
   
(7,380,119
)
   
(3,836,481
)
Income taxes (benefit)
   
(381,513
)
   
 
Net loss and comprehensive loss
 
$
(6,998,606
)
 
$
(3,836,481
)
                 
Net loss per share, basic and diluted
 
 
$
1.44
   
$
1.15
 
                 
Weighted average common shares outstanding basic and diluted
   
4,868,079
     
3,337,351
 




Exhibit 99.2

 CORPORATE PRESENTATION  Frank Bedu-Addo Ph.D.  President & CEO  MARCH 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  Frank Bedu-Addo, PhDChief Executive Officer  Lauren V. Wood, MDChief Medical Officer  Gregory Conn, PhDChief Scientific Officer   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)  >30 years of translational clinical research experienceFormer Director of Clinical Research at the 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       
 

 PDS Biotech is well-poised to transform cancer treatment by fulfilling the promise of immuno-oncology  4  Clinical studies in areas of high unmet medical need supported by leaders in the field  4  Diversified pipeline  3  Demonstrated potential for strong clinical efficacy and durability of the response with minimal toxicity  2  Powerful T-cell activating immunotherapy platform  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 validated induction of active antigen-specific killer and helper T-cells in vivoPromising clinical efficacy results in early trials of PDS0101 monotherapy with good safety and no dose limiting toxicities  Publicly listed via reverse merger with Edge Therapeutics in March 2019~15 employees with headquarters in Princeton, NJ14.5M shares outstanding with $21.7M in cash*  PDS0101 (Phase 2): HPV-associated cancers (Anal, head & neck, cervical etc.)PDS0102 (Formulation complete): Prostate, breast cancersPDS0103: Ovarian, breast, colorectal and lung cancersPDS0104: Melanoma    Pipeline      Versamune® Platform  Corporate Overview  * February 28, 2020 
 

 6  Reference: Data on file.  PDS Biotech’s pipeline combines the Versamune® platform with proprietary & validated tumor antigens across several cancer types 
 

 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® is a proprietary T-cell activating platform engineered to induce a robust, targeted anti-tumor response 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 necessary steps to induce a therapeutic T-cell response in-vivo    Versamune® design and novel immunological mechanisms of action promote a powerful anti-tumor T-cell response        Versamune® has demonstrated the potential to overcome the challenges of immunotherapy  9  Challenges of Immunotherapy  How Versamune® May Overcome the Challenge  Inability to alter the tumor’s immunosuppressive microenvironment limits T-cell efficacy    Ability to alter the tumor’s microenvironment de-camouflages the tumors allowing effective killing of the tumor by activated T-cells        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)        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, August 3, 27 (33): 5706 
 

 PDS0101 
 

 12  PDS0101 is designed to treat cancers caused by human papillomavirus (HPV)  Approximately 43,000 patients are diagnosed with HPV-associated cancers each year, a number unlikely to be impacted by increased use of HPV preventive vaccines in the next decade  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 the Versamune® platform 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) 
 

 13  The combination of Versamune® and a proprietary antigen is engineered 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 
 

 14  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 
 

 15  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 
 

 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 unique ability to generate large and superior numbers of CD8+ killer T-cells that effectively recognize and kill antigen-expressing cancer cells in pre-clinical and human clinical studies  PDS Biotech clinical strategy in advanced cancer is to focus on efficiency and risk mitigation to proof of concept  16  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 
 

 The robust T-cell response induced by Versamune® results in the potential for enhancement of efficacy of checkpoint inhibitors in immune suppressive B16 melanoma  17  Early clinical studies showed the checkpoint inhibitor to be ineffective in treating B16 melanoma, a notoriously difficult model to treat. Versamune® + TRP2 melanoma antigen (sub-optimal levels) promotes infiltration of active killer T-cells into tumors, strong synergy with the checkpoint inhibitor, and significantly enhanced anti-tumor efficacy  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.   CD4+ helper T-cell   CD8+ killer T-cell      
 

 18  PDS0101 is the only compound selected by Merck for evaluation in combination with KEYTRUDA® as first line cancer therapy  PDS0101 + KEYTRUDA®Keytruda® first immunotherapy approved as standard of care for first line treatment of cancer (recurrent or metastatic head and neck cancer)PDS0101 first T-cell activating immunotherapy to demonstrate both high levels of circulating CD8+ killer T-cells and therapeutic benefit as monotherapyUnique immuno-oncology combination addressing first-line treatment of cancerValidation of both efficacy and safety of PDS0101Anticipated advantages of combining PDS0101 with standard of care: Mitigated riskPotential enhanced rates of recruitmentPotential for rapid market penetration and market leadership  Initiate Phase 2 in 1H 2020 
 

 19  PDS Biotechnology-sponsored study with KEYTRUDA ® supplied by MerckPrimary endpoints: Efficacy, safety and tolerabilityStudy design: Phase 2 open-label studyInclusion criteria: Recurrent/metastatic head and neck cancer and HPV16 infectionClinical Trial Identifier: NCT04260126  A Phase 2 study of PDS0101 in combination with KEYTRUDA ® in first-line treatment of recurrent/metastatic head and neck cancer is planned for 1H 2020  Followed by open label SOC with KEYTRUDA® until disease progression or intolerance  patients = 96                                      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 data reads:Safety analysis of first 12 patients after Cycle 1: 4Q 2020Interim analysis planned: 2H 2021 
 

 20  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  Expected Initiation    Advanced HPV-associated malignancies – all typesTriple combination with EMD Serono’s M7824 and NHS-IL1229 subjectsClinical Trial Identifier: NCT04287868  NCI selection and confirmation of synergies with PDS0101All three agents have demonstrated efficacy as monotherapies in early trials  1H 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  1H 2020  Leading Cancer Research Institute: TBA 
 

 PDS0102 
 

 22  PDS0102 combines a proven NCI-developed TARP antigen with Versamune® to promote the robust induction of prostate- and breast-specific killer T-cells  PDS Biotech collaboration with the National Cancer Institute (NCI)The TARP antigen was discovered by the NCI to be present in over 85% of prostate cancers and 50% of breast cancersThe NCI demonstrated that the TARP antigen is recognized by T-cells of late-stage cancer patients, with vaccination resulting in a significant lowering of tumor growth rate*PDS Biotech is combining the TARP antigen with Versamune® (PDS0102) to potentially promote more effective induction of prostate and breast-specific killer T-cells and altering of the tumor microenvironmentIn on-going pre-clinical studies Versamune®, has demonstrated the ability to significantly enhance the immune system’s ability to generate TARP-specific killer T-cells  Reference: Wood LV et al, Oncoimmunology, 2016, Vol. 5 (8) 
 

 Intellectual Property and Financials 
 

 24  Intellectual property provides 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) 
 

 PDS Biotech is in a financial position to support critical near-term milestones  25  Nasdaq:  PDSB  Shares Outstanding*  14.5M  Cash*  $21.7M  Share Price**  $0.67  Market Cap**  $9.7M  Debt*  ---  1H 2020: Initiation of PDS Biotech-Merck Phase 2 combination study in head and neck cancer 1H 2020: Initiation of PDS Biotech-NCI Phase 2 combination study in advanced HPV-associated cancers1H 2020: Initiation of Partnered Phase 2 combination study in advanced cervical-cancer 3Q 2020: Complete formulation of PDS0102  *February 28, 2020 **March 20,2020 
 

 PDS Biotech is well-poised to transform cancer treatment by fulfilling the promise of immuno-oncology  26  Clinical studies in areas of high unmet medical need supported by leaders in the field  4  Diversified pipeline  3  Demonstrated potential for strong clinical efficacy and durability of the response with minimal toxicity  2  Powerful T-cell activating immunotherapy platform  1