UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

June 22, 2020
Date of Report (Date of earliest event reported)
PDS Biotechnology Corporation
(Exact name of registrant as specified in its charter)

Delaware
 
001-37568
 
26-4231384
(State or other jurisdiction of incorporation)
 
(Commission File Number
 
(IRS Employer Identification No.)

25B Vreeland Road
Florham Park, NJ
 
07932
(Address of Principal Executive Offices)
 
(Zip Code)

(800) 208-3343
Registrant’s telephone number, including area code
 
(Former name or former address if changed since last report,)

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

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:

 
Written communications 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 communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
Pre-commencement communications pursuant to Rule 13e-4© under the Exchange Act (17 CFR 240.13e-4©)

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§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 5.02
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On June 23, 2020, the Board of Directors of PDS Biotechnology Corporation (the “Company”) appointed Michael King as interim Chief Financial Officer.  Mr. King will replace Janetta Trochimiuk as interim Principal Accounting Officer and Frank Bedu- Addo, Ph.D., as interim Principal Financial Officer.

Mr. King, age 50, joined the Company in 2014 as the Chief Financial Officer. Mr. King helped take the Company public via a reverse merger with Edge Therapeutics, Inc. in March 2019 and has continued to serve as a financial consultant to the Company since that time.  Mr. King is the former long-time Chief Business Officer and Chief Financial Officer of Aprecia Pharmaceuticals, LLC, a specialty pharmaceuticals company that develops branded specialty products using three-dimensional printing, a unique pharmaceutical manufacturing technology. Mr. King has served as a senior advisor to a number of early-stage public and private biotechnology and biopharmaceutical companies. Mr. King was Chief Business Officer of Atrin Pharmaceuticals, Chief Commercial Officer of Belrose Pharma, as well as Head of US Product Portfolio & Strategy, and a member of the U.S. Executive Committee, for Sandoz GmbH, the $10 billion subsidiary of Novartis AG. A former management consultant with McKinsey & Company, Mr. King has a diverse background in corporate finance and sell-side analyst research, with deep knowledge of the pharmaceutical/biotechnology industry.  Mr. King holds a Masters of Business Administration with Honors from the Columbia Graduate School of Business and a Bachelor of Arts from Wesleyan University.

There are no family relationships between Mr. King and any of the Company’s directors or other executive officers. There are no arrangements or understandings between Mr. King and any other persons or entities pursuant to which he has been appointed as interim Chief Financial Officer and Mr. King has no direct or indirect interest in any transaction or proposed transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.

Mr. King will receive a consulting fee of $17,000 per month. Mr. King did not receive any equity awards in connection with his appointment. A copy of Mr. King’s consulting agreement with the Company is filed as Exhibit 10.1 hereto and incorporated by reference herein.

Item 5.07
Submission of Matters to a Vote of Security Holders.

At the 2020 annual meeting of stockholders (the “Annual Meeting”) of the Company held on June 23, 2020, the following proposals were submitted to the stockholders of the Company:

Proposal 1:
The election of Kamil Ali-Jackson, Esq. and Ilian Iliev, Ph.D. to serve as Class B directors until the Company’s 2023 annual meeting of stockholders and until their successors are duly elected and qualified.

Proposal 2:
The ratification of the appointment of KPMG US LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2020.

For more information about the foregoing proposals, see the Company’s definitive proxy statement on Schedule 14A filed with the United States Securities and Exchange Commission on April 29, 2020 (the “Proxy Statement”). Of the 15,350,445 shares of the Company’s common stock entitled to vote at the Annual Meeting, 10,786,524 shares, or approximately 70.26%, were represented at the meeting in person or by proxy, constituting a quorum. The number of votes cast for, against or withheld, as well as abstentions and broker non-votes, if applicable, in respect of each such proposal is set forth below:

Proposal 1:
Election of Class B Directors.

The Company’s stockholders elected the following directors to serve as Class B directors until the 2023 annual meeting of stockholders and until their successors are duly elected and qualified. The votes regarding the election of the director were as follows:

Director
 
Votes For
   
Votes Withheld
   
Broker Non-Votes
 
Kamil Ali-Jackson, Esq.
   
5,547,733
     
66,470
     
5,172,321
 
Ilian Iliev, Ph.D.
   
5,549,506
     
64,697
     
5,172,321
 


Proposal 2:
Ratification of Appointment KPMG US LLP.

The Company’s stockholders ratified the appointment of KPMG US LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2020. The votes regarding this proposal were as follows:

Votes For
 
Votes Against
 
Votes Abstaining
 
Broker Non-Votes
10,688,544
 
78,764
 
19,216
 
0

Item 8.01
Other Events.

On June 22, 2020, the Company announced the publication of data generated by the National Cancer Institute. The full text of the press release is filed as Exhibit 99.1 hereto and incorporated herein by reference.

Item 9.01
Financial Statements and Exhibits.

(d) Exhibits.

Exhibit
Number
 
Description
     
 
Consulting Agreement (Michael King).
 
Press release dated June 22, 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: June 24, 2020
By:
 
/s/ Frank Bedu-Addo, Ph.D.
     
Name: Frank Bedu-Addo, Ph.D.
     
Title: President and Chief Executive Officer




Exhibit 10.1

PDS Biotechnology Corporation
 
Consulting Agreement
 
This Consulting Agreement (the “Agreement”), made as of June 23, 2020 (the “Effective Date”), is entered into by and between PDS Biotechnology Corporation a Delaware corporation with a principal place of business at 25B Vreeland Road, Suite 300, Florham Park NJ 07932 (“PDS”), and King Partners II, a limited liability corporation with an address at 6200 Maiden Lane, Bethesda, MD 20817 (the “Consultant”).

WHEREAS, PDS and Consultant desire to establish the terms and conditions under which Consultant will provide services to PDS.
 
NOW, THEREFORE, in consideration of the mutual covenants and promises contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by the parties hereto, the parties agree as follows:
 
1.1         Services.  Consultant agrees to perform such consulting, advisory and related services to and for PDS as may be reasonably requested from time to time in writing by PDS, including, but not limited to, the services specified on Schedule A to this Agreement. Consultant shall not engage the services of third party subcontractors in the performance of the services.
 
2.          Term.  This Agreement shall commence on the Effective Date and shall continue until the 6 month anniversary of the Effective Date or until a (such period, as it may be extended or sooner terminated in accordance with the provisions of Section 4, being referred to as the “Consultation Period”).
 
3.           Compensation.
 
3.1         Consulting Fees.  PDS shall pay to Consultant the consulting fees set forth on Schedule A to this Agreement.  Payment for any partial month shall be prorated.  A detailed invoice for services shall be prepared and submitted electronically to the PDS portal, [e-mail redacted], for review and approval by the third (3rd) business day following the month during which services were provided.  Payment terms are 30 days from receipt of invoice. Except as set forth in Section 3.2, such payment includes all taxes, fees, duties and other costs associated with the services to be performed hereunder.
 
3.2         Expenses. Unless otherwise expressly set forth in this Agreement, Consultant shall furnish at its own expense all resources, equipment, tools, and supplies necessary for the performance of its obligations under this Agreement.  PDS shall reimburse Consultant for all reasonable and necessary documented out of pocket expenses incurred or paid by Consultant in connection with, or related to, the performance of its services under this Agreement, consistent with PDS’s travel and expense policies, which may be amended from time to time, and which shall be made available to Consultant at its request.  Consultant shall submit to PDS itemized monthly statements, in a form satisfactory to PDS, of such expenses incurred in the previous month, along with proper documentation of such expenses.  PDS shall pay to Consultant amounts shown on each such statement within thirty (30) days after receipt thereof.  Notwithstanding the foregoing, Consultant shall not incur total expenses in excess of $500.00 per month without the prior written approval of PDS.
 
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3.3       Benefits.  Consultant shall not be entitled to any benefits, coverages or privileges, including, without limitation, health insurance, social security, unemployment, medical or pension payments, made available to employees of PDS.
 
4.          Termination.  This Agreement may be terminated prior to its expiration under Section 2 in the following manner: (a) by either PDS or Consultant upon not less than thirty (30) days prior written notice to the other party; (b) by the non-breaching party, upon twenty-four (24) hours prior written notice to the breaching party if one party has materially breached this Agreement; or (c) at any time upon the mutual written consent of the parties hereto.  Notwithstanding the foregoing, PDS may terminate this Agreement effective immediately by giving written notice to Consultant if Consultant breaches or threatens to breach any provision of Section 6.  In the event of termination, Consultant shall be entitled to payment for services performed and (subject to the Section 3.2) for expenses paid or incurred prior to the effective date of termination that have not been previously paid.  Unless otherwise instructed in writing by PDS, Consultant will cease providing services on the date of any notice of termination and shall be entitled to payment for all pre-approved services provided prior to the date of termination.
 
5.          Cooperation.  Consultant shall use reasonable efforts in the performance of its obligations under this Agreement.  PDS shall provide such access to its information and property as may be reasonably required in order to permit Consultant to perform its obligations hereunder, but Consultant’s sole remedy for PDS’s failure to do so shall be to terminate this Agreement.  Consultant shall cooperate with PDS’s personnel, shall not interfere with the conduct of PDS’s business and shall observe all rules, regulations and security requirements of PDS concerning the safety of persons and property.
 
6.           Proprietary Information and Inventions.
 
6.1          Proprietary Information.
 
(a)        Consultant acknowledges that its relationship with PDS is one of high trust and confidence and that in the course of its service to PDS it will have access to and contact with Proprietary Information.  Consultant will not disclose any Proprietary Information to any person or entity other than employees of PDS or use the same for any purposes (other than in the performance of the services) without written approval by an officer of PDS, either during or after the Consultation Period.
 
(b)        For purposes of this Agreement, “Proprietary Information” shall mean all information disclosed by PDS to Consultant or that is otherwise learned, developed or acquired by Consultant in the course of its service as a consultant to PDS, whether or not in written, oral, electronic, tangible, visual or other form, as well as any information or analysis provided by Consultant to PDS under this Agreement.
 
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(c)         Consultant’s obligations under this Section 6.1 shall not apply to any information that (i) is or becomes known to the general public under circumstances involving no breach by Consultant; (ii) is in Consultant's possession at the time of disclosure, as evidenced by Consultant’s written records; or (iii) becomes known to Consultant through disclosure by sources other than PDS without any obligation of confidentiality.  Notwithstanding the foregoing, Consultant may disclose Proprietary Information pursuant to a court order or as otherwise required by law.  In the event Consultant is asked or subpoenaed by a court of law or governmental agency to provide Proprietary Information, Consultant will promptly inform PDS and will reasonably cooperate with PDS to obtain any protection that may be afforded such Proprietary Information.
 
(d)      Consultant agrees that all files, documents, letters, memoranda, reports, records, data sketches, drawings, models, laboratory notebooks, program listings, computer equipment or devices, computer programs or other written, photographic, or other tangible material containing Proprietary Information, whether created by Consultant or others, which shall come into its custody or possession, shall be and are the exclusive property of PDS to be used by Consultant only in the performance of its duties for PDS and shall not be copied or removed from PDS’s premises except in the pursuit of the business of PDS.  All such materials or copies thereof and all tangible property of PDS in the custody or possession of Consultant shall be delivered to PDS, upon the request of PDS.  After such delivery, Consultant shall not retain any such materials or copies thereof or any such tangible property.
 
(e)      Consultant agrees that its obligations in this Section 6.1  extend to information, materials and tangible property provided by third parties to Consultant for the benefit of PDS.
 
6.2          Inventions.
 
(a)        All inventions, ideas, creations, discoveries, computer programs, works of authorship, data, developments, technology, designs, innovations and improvements thereto (whether or not patentable and whether or not copyrightable) which are made, conceived, reduced to practice, created, written, designed or developed by Consultant, solely or jointly with others or under its direction and whether during normal business hours or otherwise, (i) during the Consultation Period if within the scope of the services provided to PDS and related to the business of PDS, or (ii) after the Consultation Period if resulting or directly derived from Proprietary Information (collectively under clauses (i) and (ii), “Inventions”), shall be the sole property of PDS.  Consultant hereby assigns to PDS all Inventions and any and all related patents, copyrights, trademarks, trade names, and other industrial and intellectual property rights and applications therefor, in the United States and elsewhere and appoints any officer of PDS as its duly authorized attorney to execute, file, prosecute and protect the same before any government agency, court or authority.  However, this paragraph shall not apply to Inventions that do not relate to the business or research and development conducted or planned to be conducted by PDS at the time such Invention is created, made, conceived or reduced to practice and which are made and conceived by Consultant not during the hours worked for PDS, not on PDS’s premises and not using PDS’s tools, devices, equipment or Proprietary Information.  Consultant further acknowledges that each original work of authorship that is made by Consultant (solely or jointly with others) within the scope of the Agreement and that is protectable by copyright is a “work made for hire,” as that term is defined in the United States Copyright Act.
 
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(b)       Consultant will not incorporate any invention, improvement, development, concept, discovery or other proprietary information owned by Consultant or any third party into any Invention without PDS’s prior written permission.
 
(c)      Upon the reasonable request of PDS and at PDS’s expense, Consultant shall execute such further assignments, documents and other instruments as may be necessary or desirable to fully and completely assign all Inventions to PDS and to assist PDS in applying for, obtaining and enforcing patents or copyrights or other rights in the United States and in any foreign country with respect to any Invention.  Consultant also hereby waives all claims to moral rights in any Inventions.
 
(d)        Consultant shall promptly disclose to PDS all Inventions and will maintain adequate and current written records (in the form of notes, sketches, drawings and as may be specified by PDS) to document the conception and/or first actual reduction to practice of any Invention.  Such written records shall be available to and remain the sole property of PDS at all times.
 
7.           Other Agreements.Consultant represents that its performance of all the terms of this Agreement and the performance of the services as a consultant of PDS do not and will not breach any agreement with any third party to which Consultant is a party (including, without limitation, any nondisclosure or non-competition agreement), and that Consultant will not disclose to PDS or induce PDS to use any confidential or proprietary information or material belonging to any current or previous employer or others.
 
8.           Independent Contractor Status.
 
8.1          Consultant shall perform all services under this Agreement as an “independent contractor” and not as an employee or agent of PDS.  Consultant is not authorized to assume or create any obligation or responsibility, express or implied, on behalf of, or in the name of, PDS or to bind PDS in any manner without authorization from PDS’s CEO or a majority of PDS’s Board.
 
8.2        Consultant shall have the right to control and determine the time, place, methods, manner and means of performing the services.  However, upon reasonable notice, Consultant shall meet with representatives of PDS at a location to be designated by PDS.
 
8.3          Consultant shall not use PDS's trade names, trademarks, service names or service marks without the prior approval of PDS.
 
8.4         Consultant shall be solely responsible for all state and federal income taxes, unemployment insurance and social security taxes in connection with this Agreement.
 
9.          Remedies.  Consultant acknowledges that any breach of the provisions of Section 6 of this Agreement shall result in serious and irreparable injury to PDS for which PDS cannot be adequately compensated by monetary damages alone.  Consultant agrees, therefore, that, in addition to any other remedy it may have, PDS shall be entitled to enforce the specific performance of this Agreement by Consultant and to seek both temporary and permanent injunctive relief (to the extent permitted by law) without the necessity of proving actual damages or posting a bond.
 
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10.         Indemnification.  Company shall indemnify Consultant from any loss, damage, cost or expense (including reasonable attorney's fees) (“Loss”) arising from or related to a third party claim, demand, assessment, action, suit or proceeding (“Claim”), including without limitation, any Claim arising from or related to Consultant’s services to the Company.  Notwithstanding the foregoing, Company shall not be liable for Losses to the extent such Losses are caused by the negligence, recklessness or misconduct of Consultantor breach of any of the terms of this Agreement by Consultant.  Consultant shall be solely liable for, and shall indemnify, defend and hold harmless PDS and its successors and assigns from and against any Loss (including penalties, fees or charges) arising from or related to a Claim resulting from Consultant's failure to pay the taxes, penalties, and payments referenced in Section 8 of this Agreement.
 
11.         Representations, Warranties and Covenants.  Consultant hereby represents, warrants and covenants that it has the skills and experience necessary to perform the services, that it will perform said services in a professional, competent, ethical, and timely manner, that it has the power to enter into this Agreement and that its performance hereunder will not infringe upon or violate the rights of any third party or violate any federal, state or municipal laws.
 
12.         Notices.  All notices required or permitted under this Agreement shall be in writing and shall be deemed effective upon personal delivery or upon deposit in the United States Post Office, by registered or certified mail, postage prepaid, addressed to the other party at the address shown above, or at such other address or addresses (including any email address) as either party shall designate to the other in accordance with this Section 12.
 
13.         Pronouns.  Whenever the context may require, any pronouns used in this Agreement shall include the corresponding masculine, feminine or neuter forms, and the singular forms of nouns and pronouns shall include the plural, and vice versa.
 
14.         Entire Agreement.  This Agreement constitutes the entire agreement between the parties and supersedes all prior negotiations, representations, agreements and understandings, whether written or oral, relating to the subject matter of this Agreement.
 
15.         Amendment.  This Agreement may be amended or modified only by a written instrument executed by both PDS and Consultant.
 
16.         Non-Assignability of Contract.  Consultant shall not have the right to assign any of its rights or delegate any of its duties without the express written consent of PDS.  Any non-consented-to assignment or delegation, whether express or implied or by operation of law, shall be void and shall constitute a breach and a default by Consultant.
 
17.         Governing Law.  This Agreement shall be governed by and construed in accordance with the laws of the State of New Jersey without giving effect to any choice or conflict of law provision or rule that would cause the application of laws of any other jurisdiction.
 
18.         Successors and Assigns.  This Agreement shall be binding upon, and inure to the benefit of, both parties and their respective successors and assigns, including any corporation with which, or into which, PDS may be merged or which may succeed to its assets or business, provided, however, that the obligations of Consultant are personal and shall not be assigned by Consultant.
 
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19.        Interpretation.  If any restriction set forth in Section 6 is found by any court of competent jurisdiction to be unenforceable because it extends for too long a period of time or over too great a range of activities or in too broad a geographic area, it shall be interpreted to extend only over the maximum period of time, range of activities or geographic area as to which it may be enforceable with the exception of the protections applicable to any trade secrets that may be disclosed by PDS, which shall extend until such time as such information ceases to hold the status of a trade secret.
 
20.         Survival.  Sections 4, 6, 8, 9, 10, and 12 through 21 shall survive the expiration or termination of this Agreement.
 
21.         Miscellaneous.
 
21.1       No delay or omission by a party in exercising any right under this Agreement shall operate as a waiver of that or any other right.  A waiver or consent given by a party on any one occasion shall be effective only in that instance and shall not be construed as a bar or waiver of any right on any other occasion.
 
21.2       The captions of the sections of this Agreement are for convenience of reference only and in no way define, limit or affect the scope or substance of any section of this Agreement.
 
21.3       In the event that any provision of this Agreement shall be invalid, illegal or otherwise unenforceable, the validity, legality and enforceability of the remaining provisions shall in no way be affected or impaired thereby, and the unenforceable provision shall be deemed modified to the limited extent required to permit its enforcement in a manner most closely approximating the intention of the parties as expressed herein.
 
For the convenience of the parties, this Agreement may be executed in counterparts, each of which shall be deemed to be an original, and both of which taken together, shall constitute one agreement binding on both parties.  Signatures of either party transmitted electronically (including, without limitation, via electronic mail as a pdf) shall be treated as and deemed to be original signatures for all purposes, and shall have the same binding effect as if they were original, signed instruments delivered in person.
IN WITNESS WHEREOF, the parties hereto have executed this Consulting Agreement as of the date and year first above written.

 
PDS Biotechnology Corporation
   
 
By:
/s/ Frank Bedu-Addo
 
   
Name:
Frank Bedu-Addo
 
   
Title: 
Chief Executive Officer
 
         
 
King Partners II
 
 
By: /s/ Michael King
 
 
Name: Michael King
 
 
Title:   Managing Member
 

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Schedule A
 
Description of Services
 
Consultant shall assume the role of Chief Financial Officer of the Company on an interim basis while the Company searches for a permanent Chief Financial Officer.
 
In recognition of Consultant’s ongoing non-Company consulting requirements, Consultant’s required working time commitment to Company shall be limited to a maximum of 50% in any given week.
 
Consultant shall perform the duties of Interim Chief Financial Officer and Principal Accounting Officer including but not limited to the following, in descending order of time commitment priority:
Miscellaneous near-term objectives in mutual agreement with Company’s CEO and/or Board of Directors
Manage Company’s overall Finance and Accounting functions

o
Review and approval of all SEC-mandated reports and disclosures that require input from the Interim Chief Financial Officer.  Sign financial filings as Principal Accounting Officer

o
Prepare and present applicable materials to Company’s Board of Directors

o
Manage and oversee Janetta Trochimuick, Company’s Controller

o
Oversee creation of new Company top-level financial / cash flow forecasting tool
Business Development

o
Continuing general involvement in COVID-19 business development activities, including securing relationships and potential non-dilutive funding or funding-equivalent contributions from BARDA, CEPI, PATH and the Brazilian federal government
Investor relations/press releases – input as appropriate and requested
Clinical operations

o
Supporting other members of senior management in overseeing or participating in a range of analytical activities, including :

Support with Budget forecasting, modeling and advance cash burn projections for Clinical Operations budget

Support with software integration, use and adoption (WRIKE, Box and other)

Support with managing change orders

Description of Consulting Fees
 

Consultant shall be paid $17,000 per calendar month, starting as of June 1, 2020

Consultant shall receive option grant package appropriate to executive level, role and 50% working status, vesting monthly for duration of contract, as per determination and approval by Company Board of Directors.


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Exhibit 99.1


PDS Biotech Announces Publication of Preclinical Results of PDS0101 Combination by the National Cancer Institute in the Journal for ImmunoTherapy of Cancer

NCI-led Phase 2 clinical trial of this reported combination was initiated in June 2020

Florham Park, NJ, June 22, 2020 - PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, today announced the publication of data generated by the National Cancer Institute (NCI) based on preclinical studies of PDS Biotech’s lead clinical program, PDS0101, in combination with two other investigational anti-cancer agents.  The article “Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine” by Rumfield et al. was published in the Journal for ImmunoTherapy for Cancer, and provides strong rationale for clinical evaluation of this three-component treatment combination in a recently initiated NCI-led Phase 2 clinical trial.

The results of the NCI’s preclinical study indicated that PDS0101 generated both human papillomavirus (HPV)-specific T-cells and an associated antitumor response when used as a monotherapy.  When PDS0101 was combined with two other development-stage anti-cancer agents, Bintrafusp alfa (M7824) and NHS-IL12, the data suggest the agents worked synergistically to provide enhanced tumor regression and T-cell response as compared to the agents alone.

Dr. Frank Bedu-Addo, PDS Biotech’s Chief Executive Officer, commented, "The results of this preclinical study highlight the potential of PDS0101, Bintrafusp alfa (M7824) and NHS-IL12 when administered in combination, to improve treatment outcomes in patients with advanced HPV-associated cancers such as anal, cervical, head and neck and vulvar cancers.  We look forward to progressing development of this triple therapeutic combination in the upcoming Phase 2 study in patients with HPV-associated cancers.”

The studies detailed in the Journal for ImmunoTherapy for Cancer were conducted under an existing Cooperative Research and Development Agreement (CRADA) between PDS Biotech and the NCI. The CRADA includes collaborative development work on both PDS0101 and a second development stage compound, PDS0103.

The full publication can be accessed here.

About PDS Biotechnology
 
PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. 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 and Co., 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 separate partnership with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, PDS Biotech is conducting additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer respectively.

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; 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 asset PDS0101; 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