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): February 21, 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 5.02
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On February 21, 2020, the Board of Directors (the “Board”) of PDS Biotechnology Corporation (the “Company”) appointed Kamil Ali-Jackson, Esq., as a director and new member of the Board, effective February 21, 2020. Upon joining the Board, Ms. Ali-Jackson will also become a member of the Board’s Audit Committee (the “Audit Committee”).  Following the appointment of Ms. Ali-Jackson, the Audit Committee will consist of Stephen Glover, Kamil Ali-Jackson, and Gregory Freitag, J.D., CPA, with Mr. Freitag serving as the chair of the Audit Committee and its designated financial expert.

Kamil Ali-Jackson, Esq., age 60, has more than 30 years of experience as legal counsel in the life sciences industry with public and private specialty pharmaceutical, biotech and biopharmaceutical companies. Ms. Ali-Jackson has extensive domestic and international experience with strategic alliances, drug development and commercialization collaborations and M&A transactions. Ms. Ali-Jackson is the co-founder of Aclaris Therapeutics, Inc. and has served as its Chief Legal Officer since its inception in 2012. Ms. Ali-Jackson also serves as Chief Compliance Officer and Corporate Secretary of Aclaris. In addition, since 2013, Ms. Ali-Jackson has served as Chief Legal Officer of NeXeption II, LLC and its affiliates. From 2014 to 2015, Ms. Ali-Jackson served as Chief Legal Officer of Ralexar Therapeutics, Inc. (formerly known as Alexar Therapeutics Inc.). Previously, Ms. Ali-Jackson served as legal counsel and as a licensing business executive for a number of pharmaceutical companies, including Merck & Co. Inc., Dr. Reddy’s Laboratories Ltd. and Endo Pharmaceuticals, Inc. Ms. Ali-Jackson received her Juris Doctorate from Harvard Law School and Bachelor of Arts in politics from Princeton University. Ms. Ali-Jackson was a 2011 Philadelphia Business Journal Woman of Distinction winner.  Ms. Ali-Jackson has served on several nonprofit boards and is currently on the board of Rosemont College, a private liberal arts college located in Pennsylvania.

There are no arrangements or understandings between Ms. Ali-Jackson and any other persons pursuant to which she was chosen as a director of the Company. There are no family relationships between Ms. Ali-Jackson and any of the Company’s directors, executive officers, or persons nominated or chosen by the Company to become a director or executive officer. Ms. Ali-Jackson is not a party to any current or proposed transaction with the Company for which disclosure is required under Item 404(a) of Regulation S-K.

On February 21, 2020, Ms. Ali-Jackson was granted an option to purchase 9,000 shares of the Company’s common stock at an exercise price of $1.31 per share, which was the closing price of the Company’s common stock on the Nasdaq Capital Market on the date of grant. The option will vest in three equal annual installments of 3,000, each following the date of grant, subject to Ms. Ali-Jackson’s continuous service.

Item 8.01
Other Events.

On February 24, 2020, the Company issued a press release announcing the appointment of Ms. Ali-Jackson, Esq., as a director. The full text of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

On February 27, 2020, the Company issued a press release announcing the commencement of pre-clinical work under an Amended and Restated Material Transfer Agreement with Farmacore Biotechnology.  The full text of the press release is attached as Exhibit 99.2 and incorporated herein by reference.

Item 9.01
Financial Statements and Exhibits.

(d) Exhibits.

Exhibit
Number
 
Description
     
 
Press release dated February 24, 2020.
99.2
  Press release dated February 27, 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: February 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 Appoints Kamil Ali-Jackson, Esq. to Board of Directors
 
Princeton, NJ, February 24, 2020 - PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on the Company’s proprietary Versamune® T-cell activating technology, today announced that it has appointed Kamil Ali-Jackson, Esq. to its Board of Directors. Ms. Ali-Jackson will be a member of the Board’s audit committee.
 
“We are very pleased to welcome Kamil to the Board of Directors and look forward to her insights and contributions as we continue to progress the company’s Versamune®-based clinical and preclinical pipeline and grow PDS into a leading immuno-oncology company. Kamil’s extensive legal experience, particularly with financial transactions, strategic alliances, and development and commercialization transactions, will be an invaluable asset to the team and help guide the Company,” commented Steve Glover, Chairman of the Board of PDS. “With our successful financing complete we look forward to initiating three Phase 2 clinical trials for our lead product candidate PDS0101 over the coming months.”

Kamil Ali-Jackson, Esq. has more than 30 years of experience as legal counsel in the life sciences industry with public and private specialty pharmaceutical, biotech and biopharmaceutical companies. Ms. Ali-Jackson has extensive domestic and international experience with strategic alliances, drug development and commercialization collaborations and M&A transactions. She is a co-founder of Aclaris Therapeutics, Inc. and has served as Chief Legal Officer since its inception in 2012. In addition, since 2013, she has served as Chief Legal Officer of NeXeption II, LLC and its affiliates. Previously, Kamil served as Chief Legal Officer of Ralexar Therapeutics, Inc. (formerly known as Alexar Therapeutics Inc.). She has also served as legal counsel and as a licensing business executive for large pharmaceutical companies, including Merck & Co. Inc., Dr. Reddy’s Laboratories Ltd., and Endo Pharmaceuticals, Inc.

Ms. Ali-Jackson holds her Juris Doctorate from Harvard Law School in addition to a Bachelor of Arts degree in politics from Princeton University. She was a 2011 Philadelphia Business Journal Woman of Distinction winner. She has served on several nonprofit boards and is currently on the board of Rosemont College, a private liberal arts college located in Pennsylvania.

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 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 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. 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


Exhibit 99.2

PDS Biotechnology Announces Commencement of Work Under a Pre-Clinical Collaboration with Farmacore Biotechnology for Tuberculosis

Princeton, NJ, February 27, 2020 - PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on the Company’s proprietary Versamune® T-cell activating technology, today announced commencement of work under an Amended and Restated Material Transfer Agreement with Farmacore Biotechnology, experts in infectious diseases, to develop a novel tuberculosis (TB) immunotherapy based on Farmacore’s proprietary TB antigens and PDS Bio’s Versamune® platform technology. The prior Material Transfer Agreement under which preliminary work commenced was Amended and Restated in December 2019 due to promising early pre-clinical results and to progress this next phase of development.

In preliminary evaluations, Versamune® based product demonstrated highly promising in-vivo TB-specific T-cell induction. The collaboration will focus on evaluation and optimization of efficacy in in-vivo pre-clinical models. Under terms of the agreement, PDS Biotech will undertake product development and Farmacore will conduct studies to evaluate efficacy of the formulated product.

“Our goal for the collaboration is to explore the unique capabilities of our proprietary Versamune® technology to address critical unmet medical needs beyond oncology. The role of T-cells in the management of pathogen-induced diseases such as tuberculosis and influenza are well established, however, the development of vaccines and immunotherapies to address such diseases has been limited,” said Dr. Bedu-Addo, CEO of PDS Biotech. “Versamune® has demonstrated the ability to induce high levels of in-vivo disease specific CD8+ killer and CD4+ helper T-cells in humans without any significant side effects. We believe that there is an opportunity to leverage our Versamune® technology to overcome these major hurdles and develop effective immunotherapies to better manage and treat several deadly infectious diseases.”

Helena Faccioli Lopes, CEO of Farmacore added, “Farmacore focuses on developing immunotherapeutic products and vaccines for Infectious Diseases, specifically for Tuberculosis, where we have identified a great potential peptide-based vaccine. We believe that based on published data about Versamune® and our preliminary evaluation, the Versamune® platform technology is well-suited to effectively deliver the peptides to induce an immune response. We are very excited to have Versamune® available to support and potentially enhance our chances of success in the development of a new Tuberculosis vaccine.”

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 Farmacore

Farmacore Biotechnology is a privately held animal and human health research company focused on carrying out research and development of products and process with therapeutic and biotechnological potential in the areas of infectious diseases and oncology. The Company also acts in services (analytical methods, preclinical tests, upstream and downstream development methods), technology transfer, protection of intellectual property, management of innovation projects and evaluation of technological feasibility. To learn more, please visit www.farmacore.com.br.

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 ability to access capital markets, the timing for the Company to initiate two clinical trials for its lead asset, PDS0101; (and statements regarding 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; 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:

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