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): December 30, 2022


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, Suite 300, 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. Yes ☐ No ☐

Item 1.01
Entry into a Material Definitive Agreement.

Exclusive License Agreement

On December 30, 2022, PDS Biotechnology Corporation (the “Company”) entered into a License Agreement (the “License Agreement”) with Merck KGaA, Darmstadt, Germany, pursuant to which Merck KGaA, Darmstadt, Germany has granted the Company an exclusive (even as to Merk KGaA), worldwide, sublicensable, milestone and royalty-bearing right and license to certain patent rights and certain related data (the “Licensed Technology”) to develop, manufacture, use, commercialize and otherwise exploit any product containing NHS-IL12 fusion protein known as M9241 (the “Compound”). Merck KGaA, Darmstadt, Germany retains the right under the Licensed Technology in connection with certain existing collaborations between Merck KGaA, Darmstadt, Germany and academic institutions to allow such academic institutions to exercise their rights granted under such collaborations. The Company agreed to use commercially reasonable efforts to develop, manufacture and commercialize at least one pharmaceutical preparation, substance, or formulation, comprising or employing, the Compound (the “Product”).

In consideration for the rights granted by Merck KGaA, Darmstadt, Germany, the Company (i) agreed to make a one-time up-front cash payment of $5.0 million to Merck KGaA, Darmstadt, Germany, and (ii) entered into a Share Transfer Agreement dated December 30, 2022  (the “Share Transfer Agreement”), pursuant to which the Company issued 378,787 shares of its common stock (the “Shares”) to Merck KGaA, Darmstadt, Germany in a private placement for an aggregate value of $5.0 million, as measured by the closing price of the Company’s common stock on the Nasdaq Capital Market as of December 30, 2022. The Share Transfer Agreement is described in additional detail below under the caption “Share Transfer Agreement.”

Pursuant to the License Agreement, the Company agreed to make (i) development and first commercial sale milestone payments totaling up to $11 million upon the achievement of certain milestones, including the dosing of the fifth patient in a phase III trial of the Product and first commercial sale of the Product for a first and second indications in a major market, and (ii) up to $105 million upon achieving certain aggregate sales levels of the Product.

The Company also agreed to pay Merck KGaA, Darmstadt, Germany a royalty of 10% on aggregate net sales of Product as specified in the License Agreement on a Product-by-Product and country-by-country basis until the later of: (i) ten years after the first commercial sale of a Product in a given country; and (ii) the expiration or invalidation of the licensed patents covering the Compound or Product in such country (collectively, the “Royalty Term”). The royalty rate is subject to reduction in that event that a Product is not covered by a valid patent claim, a biosimilar to the Compound or the Product comes on the market in a particular country, or if the Company obtains a license to any intellectual property owned or controlled by a third-party which but for such license would be infringed by making, using or selling the Compound.

The License Agreement will expire on a Product-by-Product and country-by-country basis upon expiration of the last-to-expire Royalty Term for such Product. On expiration (but not earlier termination), the Company will have a fully paid-up, royalty-free, non-exclusive, transferable, perpetual and irrevocable license under the licensed patent rights and related data to develop, manufacture, use, commercialize and otherwise exploit the Compound. Either party may terminate the License Agreement for the other party’s material breach following a cure period. The License Agreement may not be terminated upon certain insolvency events relating to the Company. The Company may terminate the License Agreement for any reason upon ninety days written notice to Merck KGaA, Darmstadt, Germany.

The License Agreement also includes indemnification obligations of each party. The foregoing description of the terms of the License Agreement is not complete and is qualified in its entirety by reference to the full text of the License Agreement, which will be filed as an exhibit to the Company’s next Annual Report on Form 10-K.

Share Transfer Agreement

On December 30, 2022, the Company entered into the Share Transfer Agreement with Merck KGaA, Darmstadt, Germany, pursuant to which the Company issued the Shares to Merck KGaA, Darmstadt, Germany in a private placement.

The Shares are subject to lock-up restrictions, which, without prior approval of the Company, prohibit Merck, Darmstadt, Germany from selling the Shares for a period of up to six months after the effective date of the Share Transfer Agreement. The Share Transfer Agreement contains certain other customary terms and conditions, including mutual representations, warranties and covenants.

The foregoing description of the terms of the Share Transfer Agreement is not complete and is qualified in its entirety by reference to the full text of the Share Transfer Agreement, a copy of which is filed herewith as Exhibit 10.1 and incorporated herein by reference.

Item 3.02
Unregistered Sales of Equity Securities.

The description of the issuance of the Shares pursuant to the Share Transfer Agreement set forth under Item 1.01 above under the caption “Share Transfer Agreement” is incorporated by reference into this Item 3.02. The issuance and sale of the Shares has not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws. The Company has relied on the exemption from the registration requirements of the Securities Act under Section 4(a)(2) thereof, for a transaction by an issuer not involving any public offering.

Item 8.01
Other Events.

On January 3, 2023, the Company issued a press release announcing the License Agreement.  A copy of the press release is filed herewith as Exhibit 99.1 and incorporated by reference herein.

On January 3, 2023, the Company updated its corporate presentation.  A copy of the presentation is filed herewith as Exhibit 99.2 and incorporated by reference herein.

Item 9.01
Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit
Number
Description
 
 

Share Transfer Agreement by and between PDS Biotechnology Corporation and Merck KGaA, Darmstadt, Germany.

Press Release Dated January 3, 2023.

Corporate Presentation (January 2023).
104
Cover Page Interactive Data File (embedded within the Inline XBRL Document).
 
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: January 3, 2023
 By:
/s/ Frank Bedu-Addo, Ph.D.

Name: Frank Bedu-Addo, Ph.D. 

Title: President and Chief Executive Officer 


Exhibit 10.1

Execution Version

SHARE TRANSFER AGREEMENT
 
This Share Transfer Agreement (this “Agreement”) is made effective as of December 30, 2022 (the “Effective Date”), by and between PDS Biotechnology Corporation, a Delaware corporation (the “Company”), and Merck KGaA, Darmstadt, Germany, a corporation with general partners organized under German law (the “Investor”).

WHEREAS, simultaneously with the execution of this Agreement, the Company and the Investor are entering into a License Agreement dated as of the Effective Date (the “License Agreement”) under which the Company is licensing certain technology from the Investor;

WHEREAS, the Company and the Investor are executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Rule 506 of Regulation D as promulgated by the United States Securities and Exchange Commission (the “Commission”) under the Securities Act; and

WHEREAS, the License Agreement provides that, among other things, the Company will issue to the Investor shares of common stock, par value $0.00033 per share (the “Common Stock”), of the Company upon the terms and conditions stated in this Agreement.

NOW, THEREFORE, in consideration of the mutual covenants set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which is acknowledged, and intending to be legally bound hereby, the parties hereto agree as follows:

1. Issuance of Shares.

1.1. Shares; Number of Shares. In consideration of the licenses and rights granted to the Company under the License Agreement, and subject to the terms and conditions of this Agreement and in reliance on the representations and warranties of the Investor set forth herein, the Company hereby agrees to issue to the Investor, and the Investor hereby agrees to acquire from the Company, such number of shares of the Common Stock (the “Shares”) equal to the quotient of US $5,000,000.00 divided by the closing price of a share of the Common Stock on the Nasdaq Capital Market on the Effective Date, rounded down to the nearest whole share. The Company shall not issue to Investor any number of shares that would exceed four point ninety-nine percent (4.99%) of the total outstanding shares in the Company.

1.2. Closing; Delivery of Shares. The issuance of the Shares shall take place on the Effective Date, remotely via the exchange of documents and signatures, or at such other time, date and place as the Company and the Investor mutually agree upon in writing (which time and place are designated as the “Closing”). On or before the Closing, the Company will cause the transfer agent for the Common Stock (the “Transfer Agent”) to issue the Shares to the Investor and to hold the Shares in book-entry form for the account of the Investor. The book entry for the Shares will be subject to a stop transfer order reflecting such the transfer restrictions referred to in Sections 3.4 and 3.5 of this Agreement. At the Closing, the Company will deliver to Investor a copy of Company’s irrevocable instructions to its Transfer Agent for the Common Stock instructing such Transfer Agent to register the issuance of the Shares to the Investor via book-entry.

2.     Representations and Warranties of the Company. The Company hereby represents and warrants to the Investor that:

2.1. Organization, Good Standing and Qualification. The Company is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware and has all requisite corporate power and authority to carry on its business as presently conducted or proposed to be conducted and to own or lease the properties and assets it now owns or holds under lease. The Company is duly qualified to transact business and is in good standing in each jurisdiction in which the failure so to qualify would, individually or in the aggregate, have a material adverse effect upon the general affairs, business, management, properties, operations, financial condition or results of operations of the Company. Assuming the accuracy of the representations of the Investor in Section 3 of this Agreement, the Shares will be issued in compliance with all applicable federal and state securities laws.

1
Execution Version

2.2. Valid Issuance of Shares. The Shares to be issued hereunder by the Company have been duly authorized and, when issued and delivered in accordance with the terms of this Agreement, will have been validly issued and will be fully paid and nonassessable, will not be subject to preemptive rights or other similar rights of stockholders of the Company, and will be free and clear of all liens (except for restrictions on transfer imposed by applicable securities laws or contained herein) and the holder thereof will not be subject to personal liability by reason of being such holder.

2.2. Authorization; No Conflicts; Authority. This Agreement has been duly authorized, executed and delivered by the Company, and constitutes a valid, legal and binding obligation of the Company, enforceable in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization or similar laws affecting the rights of creditors generally and subject to general principles of equity.

3. Representations and Warranties of the Investor. The Investor hereby represents and warrants to the Company that:

3.1. Authorization. This Agreement has been duly authorized, executed and delivered by the Investor, and constitutes a valid, legal and binding obligation of the Investor, enforceable in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization or similar laws affecting the rights of creditors generally and subject to general principles of equity.

3.2. Purchase Entirely for Own Account. The Investor is acquiring the Shares for investment, and not with a view to the resale or distribution of any part thereof, and the Investor has no present intention of selling, granting any participation in, or otherwise distributing the same. The Investor does not presently have any contract, undertaking, agreement or arrangement with any person to sell, transfer or grant participations to such person or to any third person, with respect to any of the Shares.

3.3. Accredited Investor. The Investor is an accredited investor as defined in Rule 501(a) of Regulation D promulgated under the Securities Act.

3.4. Restricted Securities. The Investor understands that the Shares have not been registered under the Securities Act, by reason of a specific exemption from the registration provisions of the Securities Act which depends upon, among other things, the bona fide nature of the investment intent and the accuracy of the Investor’s representations as expressed herein. The Investor understands that the Shares are “restricted securities” under applicable U.S. federal and state securities laws and that, pursuant to these laws, the Investor must hold the Shares indefinitely unless they are registered under the Securities Act and qualified by state authorities, or an exemption from such registration and qualification requirements is available.

3.5. Legends. The Investor understands that the Shares may bear one or all of the following legends:

(a) “THE SHARES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AND HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF. NO SUCH TRANSFER MAY BE EFFECTED WITHOUT AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL IN A FORM SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933.”

(b) Any legend required by the securities laws of any state to the extent such laws are applicable to the Shares represented by the certificate, instrument, or book entry so legended.

2
Execution Version

4. Miscellaneous.

4.1. Entire Agreement; Amendments; Waivers. This Agreement, together with the License Agreement, constitutes the entire agreement between the parties hereto pertaining to the subject matter hereof, and any and all other prior or contemporaneous written or oral agreements relating to the subject matter hereof existing between the parties hereto are expressly canceled. This Agreement may not be amended, modified or waived except by an instrument in writing signed by each of the parties hereto.

4.2. Successors and Assigns. Neither this Agreement nor any of the rights or obligations hereunder may be assigned by either party without the prior written consent of the non-assigning party. The terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective successors and assigns of the parties hereto. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.

4.3. Further Assurances. The parties shall execute and deliver all such further instruments and documents and take all such other actions as may reasonably be required to carry out the transactions contemplated hereby and to evidence the fulfillment of the agreements herein contained.

4.4. Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State of Delaware, without regard to the principles of conflicts of law thereof.

4.5. Counterparts. This Agreement may be executed and delivered by facsimile, by electronic mail attaching a portable document file (.pdf) or any electronic signature complying with the U.S. federal ESIGN Act of 2000 (e.g., www.docusign.com). This Agreement may be executed in one or more counterparts and, if executed in more than one counterpart, the executed counterparts shall each be deemed to be an original and all such counterparts shall together constitute one and the same instrument.

4.6. Severability. If any provision of this Agreement should be held invalid, illegal or unenforceable in any jurisdiction, the parties will negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the parties and all other provisions hereof will remain in full force and effect in such jurisdiction and will be liberally construed in order to carry out the intentions of the parties hereto as nearly as may be possible. Such invalidity, illegality or unenforceability will not affect the validity, legality or enforceability of such provision in any other jurisdiction.

4.7. No Strict Construction. The language used in this Agreement is deemed to be the language chosen by the parties to express their mutual intent, and no rules of strict construction will be applied against a party.

4.8.   Rule 144; Registration Statement. The Investor understands that the Shares must be held indefinitely unless such Shares are registered under the Securities Act or an exemption from registration is available. The Investor acknowledges that it is familiar with Rule 144 of the rules and regulations of the Commission, promulgated pursuant to the Securities Act (“Rule 144”), and that the Investor has been advised that Rule 144 permits resales under certain circumstances. The Investor understands that to the extent that Rule 144 is not available, the Investor will be unable to sell any Shares without either registration under the Securities Act or the existence of another exemption from such registration requirement.  The Company shall (i) make and keep available adequate current public information, as those terms are defined in Rule 144; (ii) use commercially reasonable efforts to file with the Commission in a timely manner all reports and other documents required of the Company under the Securities Act and the Securities Exchange Act of 1934, as amended (the “Exchange Act”); and (iii) furnish to the Investor forthwith upon request (a) to the extent accurate, a written statement by the Company that it has complied with the reporting requirements of Rule 144 and (b) such other information as may be reasonably requested to avail the Investor of any rule or regulation of the Commission that permits the selling of the Shares without registration.  Following expiration of the 180-day lock up period under the License Agreement (the “Lockup Period”), the Company shall promptly (within two (2) business days) have its legal counsel deliver an opinion to the Transfer Agent requesting removal of the stop transfer order and restrictive legend(s) appended to Investor’s book-entry statement(s). If, after the expiration of the Lockup Period, the Shares are not available for resale under Rule 144, the Company shall prepare and file, as promptly as practicable, with the Commission a registration statement of the Company filed under the Securities Act that covers the resale of the Shares for an offering to be made on a continuous basis pursuant to Rule 415 promulgated by the Commission pursuant to the Securities Act as such rule may be amended from time to time or any similar rule or regulation hereafter adopted by the Commission having substantially the same effect as such rule (“Rule 415”) or, if Rule 415 is not available for offers and sales of the Shares, by such other means of distribution of the Shares as the Investor may reasonably specify (the “Initial Registration Statement”). The Initial Registration Statement shall be on Form S-3, or if the Company is ineligible to register the Shares on Form S-3, such other form available to register for resale the Shares as a secondary offering.

[Signature page follows]

3
IN WITNESS WHEREOF, the parties have executed this Share Transfer Agreement as of the Effective Date.

THE COMPANY:
PDS BIOTECHNOLOGY CORPORATION




By:
/s/ Frank Bedu-Addo
  

Name:
Frank Bedu-Addo, Ph.D.

Title:
Chief Executive Officer


  INVESTOR:
Merck KGaA, Darmstadt, Germany
 
 
 
 
 
 
By:  
/s/ Matthias Mullenbeck
 
 
Name:  
Dr. Matthias Mullenbeck, MBA
 
 
Title:  
SVP, Head Global Business Development & Alliance Management
 
       
 
By:
/s/ Jens Eckhardt
  
 
Name:
Jens Eckhardt
  
 
Title:
Authorized Representative
  


Exhibit 99.1


PDS Biotech Announces Exclusive Global License Agreement for Investigational IL-12 Tumor-Targeted Cytokine from Merck KGaA, Darmstadt, Germany

PDS Biotech bolsters immuno-oncology portfolio with a clinical-stage product synergistic with its Versamune® platform

PDS Biotech to host conference call and webcast on Tuesday, January 3, 2023, at 8:00 AM EST

FLORHAM PARK, N.J., January 3, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor-targeting IL-12 fusion protein M9241 (formerly known as NHS-IL12), which will join the pipeline as PDS0301. M9241 appears to enhance the proliferation, potency and longevity of T cells in the tumor.  The combination of Versamune® and IL-12 is patented by PDS Biotech and is designed to overcome tumor immune suppression utilizing a different mechanism from checkpoint inhibitors.

Under the terms of the agreement, PDS Biotech will receive from Merck KGaA, Darmstadt, Germany an exclusive license to M9241.  PDS Biotech will assume responsibility for future development, commercialization, and manufacturing of M9241.

Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will receive an upfront cash payment of $5 million and will be entitled to up to $11 million in development and regulatory milestone payments including first commercial sales for the first 2 indications, and up to $105 million in commercial milestones, and a 10% royalty on future sales of M9241 with standard step-down provisions.  Merck KGaA will receive 378,787 shares of PDS Biotech’s common stock having a value of $5 million, based on the closing price of PDS Biotech’s common stock on December 30, 2022.

“We are pleased to have partnered with Merck KGaA, Darmstadt, Germany to advance the development of M9241, a highly innovative cytokine therapy,” said Dr. Frank Bedu-Addo, PDS Biotech CEO. “Under the licensing arrangement between Merck KGaA, Darmstadt, Germany and PDS Biotech, assumption of an equity stake by Merck KGaA, Darmstadt, Germany in PDS Biotech further confirms the potential of the Versamune® platform and the data generated to date with this combination therapy. I’d like to thank the Merck KGaA, Darmstadt, Germany team for their support of PDS Biotech’s mission to potentially offer more cancer patients improved treatment options.”

M9241 was studied in a novel triple combination at the National Cancer Institute in a Phase 2 trial (NCT04287868) in combination with PDS0101, a Versamune® based HPV16-targeted immunotherapy, and bintrafusp alfa, a bifunctional fusion protein targeting two independent immunosuppressive pathways (PD-L1 and TGF-β). The triple combination was studied in checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy.

Data highlights for patients who had failed prior treatments including CPIs:

 •
Median overall survival for treated patients is 21 months in 29 CPI refractory patients.  The reported historical median OS in patients with CPI refractory disease is 3-4 months.


•
63% (5/8) of treated patients with the optimal dose combination had significant tumor shrinkage of over 30% (objective response). With the standard of care, the reported percentage of patients having an objective response is less than 10%.

•
79% (11/14) of treated patients demonstrated a greater than two-fold increase in HPV16-targeted T cells.

Results for patients who had failed prior treatments but were CPI-naïve also continue to appear to be encouraging:

 •
88% (7/8) of CPI naïve patients had an objective response.

•
38% (3/8) of responders had a complete response.

•
In CPI naïve subjects, 75% (6/8) remain alive at a median follow-up of 27 months.  As a result, median OS has not yet been reached.  Historically median OS for similar patients with platinum experienced CPI naïve disease is 7-11 months.

PDS Biotech has a scheduled meeting with the Food and Drug Administration (FDA) to discuss a registrational trial for investigating the triple combination of M9241, PDS0101 and a checkpoint inhibitor in recurrent/metastatic HPV-positive cancers.

Dr. Lauren V. Wood, Chief Medical Officer at PDS Biotech, commented, “M9241 seems to be unique in its ability to target the tumor’s microenvironment and appears to further promote proliferation of Versamune®-induced T cells in the tumors while also potentially enhancing the killing potency of the T cells. With the addition of M9241 to our Versamune®-based pipeline products, our goal is to develop and achieve checkpoint inhibitor-agnostic and independent combinations in advanced cancers. We look forward to expanding clinical development of our novel investigational combination products.”
 
Conference Call and Webcast
PDS Biotech will host a conference call and webcast on Tuesday, January 3, 2023, beginning at 8:00 AM EST. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13734890. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months.
 
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0301
PDS0301 is a tumor-targeting IL-12 that enhances the proliferation, potency and longevity of T cells in the tumor. Together with Versamune® based immunotherapies, PDS0301 works to promote a targeted T cell attack against cancers and also overcome tumor-induced immune suppression. Clinical data suggest this combination may demonstrate significant disease control by shrinking tumors and/or prolonging survival in recurrent/metastatic cancers with poor survival prognosis. A National Cancer Institute-supported Phase 2 clinical study of PDS0301 in a triple combination therapy is being conducted in checkpoint inhibitor refractory patients with multiple advanced HPV-associated cancers.

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,” “forecast,” “guidance”, “outlook” and other similar expressions among others. 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 Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; 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, PDS0203 and other Versamune® and Infectimune™ based product candidates 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 success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the success of the Company’s license agreements, including the potential for the clinical and nonclinical data available under the Company’s exclusive license agreement with Merck KGaA to aid in the development of the Versamune® platform; 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.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

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

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts:
Bill Borden
Tiberend Strategic Advisors
Phone: +1 (732) 910-1620
Email: bborden@tiberend.com

Dave Schemelia
Tiberend Strategic Advisors
Phone: +1 (609) 468-9325
Email: dschemelia@tiberend.com
 
Exhibit 99.2

 Precision Designed Science For Immunotherapy  INVESTOR   PRESENTATION  NASDAQ: PDSB | January 2023 
 
 2  Certain information in this presentation may include 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,” “forecast,” “guidance”, “outlook” and other similar expressions among others. 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 Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; 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, PDS0203 and other Versamune® and Infectimune™ based product candidates 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 success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the success of the Company’s license agreements, including the potential for the clinical and nonclinical data available under the Company’s exclusive license agreement with Merck KGaA to aid in the development of the Versamune® platform; 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.  Versamune® is a registered trademark, and Infectimune™ is a trademark of PDS Biotechnology Corporation  KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA  Opdivo® is a registered trademark of Bristol-Myers Squib Company.   Forward-Looking Statements  2 
 
 1  2  4  5  6  Company Overview  Clinical-stage Company developing proprietary targeted immunotherapies to treat cancer and infectious disease  Versamune® based platforms leverage the body’s own defense systems to induce tumor-specific killer T cells to overcome immune suppression and attack cancer  Exclusive global license with Merck KGaA, Darmstadt, Germany for tumor targeting IL-12 fusion protein (PDS0301)  Clinical partnerships with Merck, MD Anderson Cancer Center, National Cancer Institute and Mayo Clinic  Cash as of September 30, 2022 - $71.6M cash runway to Q2 2024 with a potential registrational trial in 2023  3  Infectimune™ activates the immune system to induce pathogen-specific T cells and antibodies to protect against infectious disease  3  PDS0101 granted FDA Fast Track designation. Four Phase 2 clinical trials addressing multiple HPV-positive cancers. Safety and efficacy data have been reported in over 100 and 60 patients, respectively  7 
 
 Versamune® is designed to promote CD8+ killer T cell responses in vivo  Top Line Phase 2 Clinical Data  4  Versamune® Technology Platform: In-vivo tumor-specific killer (CD8+) T cell induction  HPV-positive head and neck cancer: PDS0101 + KEYTRUDA® (standard of care) in patients whose cancer has returned or spread after treatment  41% (7/17) Objective response rate (ORR)1  89% survival at 9 months  Cervical cancer: PDS0101 + Chemoradiotherapy (standard of care) in patients with large localized tumors >5cm in the cervix and lymph nodes  100% (9/9) >60% shrinkage at midpoint  89% (8/9) complete response (CR)  0% deaths from cancer or treatment at 1 year  Versamune® IL-12 Technology Platform: Overcomes cancer-induced immune suppression  HPV-Associated cancers: PDS0101 + NHS-IL12 + Checkpoint inhibitor in patients who have failed all treatment options including checkpoint inhibitors (median survival reported 3-4 months)  63% (5/8) ORR in optimal dose group2   21-month OS (all dose groups)2  HPV-Associated cancers: PDS0101 + NHS-IL12 + Checkpoint inhibitor in patients whose cancer has returned or spread after treatment  88% (7/8) ORR3  38% (3/8) CR  75% (6/8) survival at 27 months  119% response rate with Keytruda monotherapy reported in KEYNOTE-048 study (CPS >1)  2 Objective response rates in CPI refractory cancer reported to be <10%, and historical median survival is 3-4 months  3Obective response rates in HPV-positive cancer with pembrolizumab and nivolumab is <25% and overall survival of <12 months 
 
 More than 46,0002 patients were estimated to have been diagnosed last year with HPV-associated cancers in the US1,2  HPV vaccination is not expected to impact the rate of HPV-related cancer incidence for decades3  Existing immunotherapies cost $150,000+ annually per patient1  US HPV-associated cancer incidence2  1Company estimates based on CDC data. Assessments have not been adjusted to reflect HPV16-expression  2CDC website  3 Projected Association of Human Papillomavirus Vaccination with Oropharynx Cancer in the US 2020-2045, JAMA Oncology, September 2021  PDS0101: Lead Asset  Designed to treat human papillomavirus (HPV16)-positive cancers  $6B Market Opportunity1  Reference: Data on file.  5 
 
 Versamune®   Oncology Platform 
 
 Designed to address limitations of current immunotherapy  Versamune® based Immunotherapies  7  PDS Biotech believes that there are 2 key obstacles that limit broad efficacy of immunotherapy in the treatment of cancer   Limited ability to induce the type of immune response that promotes the production of active tumor-targeting killer T cells within the patient’s body.  Limited ability to overcome tumor’s ability to evade detection by the immune system. FDA approved checkpoint inhibitors, such as KEYTRUDA®, block immune checkpoints that some tumors use to evade detection  PDS Biotech’s proprietary Versamune® based platforms are specifically designed to address these two limitations of current immunotherapeutic approaches 
 
 Locally advanced cervical cancer: Tumor size > 5cm and/or spread to lymph nodes  Phase 2 Clinical Trial: PDS0101 + Chemo-Radiotherapy  1Residual traces of the cancer were detected in one patient who only received 3 of the schedule 5 doses of PDS0101   2In agreement with published preclinical findings that Versamune® promotes in vivo induction of the more potent, polyfunctional (multi-cytokine inducing) and tumor infiltrating killer T cells – J. Immunology 2019; 202 (12): 3524-3536  8  Partner:  FDA approved standard of care: Chemo-radiotherapy (CRT)  Preliminary Results  Preliminary efficacy data (Society for Immunotherapy of Cancer (SITC) Conference, November 2022):   Clinical response with tumor shrinkage of over 60% at 1 month - 100% (9/9)   Complete response (No evidence of cancer) by day 170 - 89% (8/9)1   Majority of patients have Stage III and Stage IV cancer  1-year overall survival – No patients have died from the cancer or treatment. One patient has died from an unrelated cause/event 
 
 Induction of activated CD8+ killer T cells correlates with elimination of circulating tumor DNA1  PDS0101 Appears to Induce Clinically Beneficial T Cells   1Yoshida-Court et al,, IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers (NCT04580771); SITC 2022     9  PDS0101 activates the immune system to generate killer T cells (CD8+ T cells that induce granzyme-B)  The killer T cells target, infiltrate and eliminate the cervical cancer tumors  HPV16 tumor DNA in the blood circulation declines by day 170 (T5)  Quantity of tumor cells  circulating in the blood  at start of treatment  Killer T cells that infiltrated  the tumors 
 
 Potential Treatment for Recurrent or metastatic HPV16-positive head and neck cancer  Phase 2 Clinical Trial: PDS0101 + KEYTRUDA®  119% objective response rate with KEYTRUDA® monotherapy reported in KEYNOTE-048 study  212-month overall survival of 49% with KEYTRUDA® monotherapy reported in KEYNOTE-048 study   317% of patients had treatment related grade 3 and higher adverse events with KEYTRUDA® monotherapy reported in KEYNOTE-048 study  10  Partner:   FDA approved standard of care: KEYTRUDA® (Pembrolizumab) owned by Merck1,2  Preliminary Results  PDS0101+KEYTRUDA® Fast Track Designation awarded by FDA  Preparing to progress to registrational trial based on successful FDA meeting  Preliminary data (American Society of Clinical Oncology (ASCO) Conference, June 2022):   Objective response (% of patients with ≥ 30% tumor shrinkage) - 7/17 (41.1%)1  Clinical benefit (stable disease + objective response) – 13/17 (76.5%)  9-month overall survival rate – 87.2%2  Safety   To date, no treatment related grade 3 and higher (serious) adverse events - 0/43 (0%)3  
 
 Phase 2: PDS0101 + KEYTRUDA®  Company-sponsored trial for the potential treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002)  11  Complete Response (CR)  Partial Response (PR)  Stable Disease (SD)  Progressive Disease (PD)  N=17 Subjects w/Imaging Data  OR (2 CR + 5PR)  7 (41.2%)  SD (reduction in 4/6)  6 (35.3%)  PD  4 (23.5%)  CR+PR+SD  13 (76.5%)  *Reference: Weiss J. et al. Phase II study VERSATILE-002 evaluation of PDS0101 and KEYTRUDA® in treatment of CPI naïve and CPI refractory patients with recurrent or metastatic HPV16-related HNSCC. Presented at: American Society of Clinical Oncology 2022 Annual Meeting; June 3-7, 2022; Virtual. Abstract: 6041.   As of last DMC meeting – to date 43 patients treated had zero grade 3 or higher treatment related adverse events 
 
 KEYTRUDA®  PDS0101: Versamune® based immunotherapy generating HPV-specific CD8+ and CD4+ T cells  3  Phase 2: PDS0101 Monotherapy and in Comb. with KEYTRUDA®  Investigator-led trial evaluating treatments in patients with HPV-associated oropharyngeal cancer with high risk of recurrence  Timing  Enrollment ongoing  Indication  Treatment of patients with oropharyngeal cancer prior to transoral robotic surgery  Clinical Agents  Study Goals  Safety, rate of regression and local control in patients transoral robotic surgery  Trial Partner  If successful, this study could support the expansion of PDS0101 to earlier stage disease   12 
 
 Versamune® IL-12   Oncology Platform 
 
 Synergy with Versamune® by promoting T cell infiltration and expansion in the tumor  PDS0301 (Tumor Targeted IL-12 Immunotherapy)  14  IL-12 is a well-documented T cell stimulating cytokine, which can enhance growth and function of T cells  PDS0301 is a fusion protein of IL-12 that targets the tumor, enhances the infiltration of T cells into the tumor and expansion of the T cells in the tumor  Favorable preliminary data to date in NCI-led triple combination therapy   Potential uses with other pipeline candidates  Exclusive worldwide license from Merck KGaA, Darmstadt, Germany  $5 million up front cash payment  Up to $11 million in development and regulatory milestone payments and up to $105 million in commercial milestones for first two indications  10% royalty with typical step-downs  $5 million in PDSB common stock based on closing price of PDS Biotech’s common stock on December 30, 2022 
 
 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. Smalley R  umfield C et al. 2020. Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine. J. for ImmunoTherapy of Cancer 8:e000612.  Versamune® Platform  Versamune® generates right type, potency and quantity of killer T cells  15 
 
 Versamune® IL-12 Oncology Platform  PDS0301 targets tumors and enhances T cell infiltration and proliferation in the tumor  16 
 
 1Objective response rates with standard of care < 10%  2No tumor shrinkage in HPV16-negative subjects (ASCO 2021) – Suggests critical role of PDS0101-induced HPV16-specific CD8+ T cells   3Historical median overall survival in the population is 3-4 months  17  Phase 2 Trial Interim Results  Efficacy data in HPV16-positive patients, (ASCO) June 2021 & June 2022, updated December 2022):   Objective response in optimal dose group - 5/8 (62.5%)1,2  Median overall survival (OS) is 21 months (all dose groups)3  Immunology/immune correlates, (SITC), November 2022:   Greater than two-fold increase in HPV16-specific T cells in the blood of 11/14 (79% ) of the evaluated patients  Increases in granzyme B (associated with active killer T cells), IFN-γ, TNF-α, etc., signal a pro-inflammatory response and role in overcoming tumor immune suppression   PDS0101 HPV16-Targeted Immunotherapy  Triple Combination: PDS0101 + PDS0301 + Checkpoint Inhibitor  Advanced HPV16-positive cancer patients who are checkpoint inhibitor refractory  Partner:   Types of cancer included in the trial: Anal, cervical, head and neck, penile, vaginal, vulvar  FDA approved standard of care: None 
 
 136% objective response with Keytruda + chemotherapy reported in KEYNOTE-048 study  212-month overall survival of 51% with KEYTRUDA® + chemotherapy reported in KEYNOTE-048 study  373% treatment related grade 3 and higher adverse events with KEYTRUDA® + chemotherapy reported in KEYNOTE-048 study  18  Partner:   Types of cancer included in the trial: Anal, cervical, head and neck, penile, vaginal, vulvar  FDA approved standard of care: Checkpoint inhibitors e.g. OPDIVO ® (nivolumab), KEYTRUDA® (Pembrolizumab)1 and Checkpoint inhibitors plus chemotherapy2  Phase 2 Trial Interim Results  Preliminary data (ASCO), June 2022, (updated September 2022):   Objective response - 7/8 (87.5%)1  Percent of patients alive at median follow-up of 27 months – 6/8 (75.0%)2  Safety results (Arms 1 & 2)3  24/50 (48%) of patients experienced grade 3 and higher adverse events  2/50 (4%) experienced grade 4 adverse events  Advanced HPV16-positive cancer patients who are checkpoint inhibitor naive  Triple Combination: PDS0101 + PDS0301 + Checkpoint Inhibitor 
 
 Induction of activated HPV16-specific CD8+ killer T cells correlates with clinical efficacy1  PDS0101 Immune Correlates in Advanced HPV Cancer Patients  1M. Goswami et al; Immune correlates associated with clinical benefit in patients with immune checkpoint refractory HPV-associated malignancies treated with triple combination immunotherapy; SITC 2022     19  Group  Developed HPV16-Specific T cell Responses  All Patients  11/14 (79%)  Responders (n=5)  5/5 (100%)  Non-Responders (n=9)  6/9 (67%)  Includes optimal and sub-optimal doses  ORR with optimal dose combination - 63% (5/8) 
 
 PDS0101 Designed to Promote Efficacy in HPV16 Cancers  Studies appear to show key contributions of PDS0101, PDS0301 & Bintrafusp alfa* to clinical response to date  20  *Bintrafusp alfa monotherapy showed 30% ORR in CPI naïve and 10% ORR in CPI refractory HPV-positive cancers (Strauss et al, 2020, Dec 8(2)  **All HPV16 negative and 80% of HPV16 positive patients had high dose M9241  Tumor reduction only seen in HPV16-positive patients  P<0.001  High dose PDS0301 (M9241) provides increased ORR vs. low dose P<0.01  Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, PDS0301, and Bintrafusp alfa in patients with HPV 16 positive malignancies. Presented at: American Society of Clinical Oncology 2022 Annual Meeting; June 3-7, 2022; Virtual. Abstract: 2518.  
 
 Best Overall Response  Active Against Diverse HPV16 Cancers   PDS0101: Triple Combination Active Against HPV16 Cancer  Responses to date across tumor types and higher PDS0301 dose show the potential to result in greater clinical efficacy  21  *HNSCC – head and neck squamous cell carcinomas  Higher PDS0301 Dose  Cervical  Vaginal/Vulvar  Anal  HNSCC*  Percentage Change  Weeks  Baseline  Responses Occurred Irrespective of Tumor Type  Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malignancies. Presented at: American Society of Clinical Oncology 2022 Annual Meeting; June 3-7, 2022; Virtual. Abstract: 2518.   Best Overall Response is defined by RECIST 1.1 
 
 Potential for best-in class immunotherapy  Versamune® IL-12 platform in combination with Checkpoint Inhibitor*  22  Improved Safety & Tolerability  Enhanced Efficacy  Potential for increased efficacy and safety over CPI’s and CPI’s plus chemo  CPI plus   chemo  CPI monotherapy  Demonstrated efficacy against recurrent/metastatic HPV-positive head and neck cancer   PDS0101 +PDS0301+ CPI  PDS0101 + CPI  Standard of care for head and neck cancers   * Based on interim data generated to date in VERSATILE-002 and NCI-led Triple Combination Trials   PDS0101 & PDS0301 results in HPV-positive head and neck cancer 
 
 Combination  PDS Biotech Funded  Partner Co-Funded  Versamune® Platform  Versamune® based oncology pipeline is being developed in partnership with the leaders in immuno oncology  PDS0104 (TRP2)  TBD  Arm 1: CPI naïve 1st line treatment  Arm 2: CPI refractory 2nd or 3rd line treatment  PDS0101 (HPV16) VERSATILE-002  Fast Track Designation  PDS0101 (HPV16) IMMUNOCERV  PDS0102 (TARP)  PDS0103 (MUC1)  Candidate  Indication  PC  P1  P2  P3  R  Partner(s)  Recurrent/metastatic HPV16-positive head and neck cancer  KEYTRUDA(®  (standard of care)  HPV-positive anal, cervical, head and neck, penile, vaginal, vulvar cancers  Arm 1: CPI naive 2nd line treatment  Arm 2: CPI refractory 3rd line treatment  CPI and PDS0301  1st line treatment of locally advanced (IB3-IVA) cervical cancer  TARP-associated AML, prostate and breast cancers  MUC-1 associated breast, colon, lung, ovarian and other cancers  Chemo-radiation (standard of care)  TBD  TBD  Reference: Data on file.  23  PDS0101 (HPV16)  Mayo Clinic  Pre-metastatic HPV-associated oropharyngeal cancer (OPSCC)  Arm 1: PDS0101 monotherapy  Arm 2: PDS0101 + KEYTRUDA  KEYTRUDA®   (standard of care)  PDS0101 (HPV16) NCI-led Triple Combination  Melanoma 
 
 CFA + TARP (1-20)  X  PDS0102: TARP Antigen   Versamune® induced CD8+ killer T cells may result in the ability to treat TARP positive AML and prostate cancers  Pre-Clinical Optimization Studies1:   TARP-Specific T cell Induction after 2 injections of PDS0102  1 Reference: Wood LV et al, Oncoimmunology, 2016, Vol. 5 (8)  CFA –Complete Freund’s Adjuvant a highly potent immune activator not used in humans due to potentially lethal toxicity   *Reference: Surveillance Research Program, National Cancer Institute SEER  Assumes $150K for annual course of therapy; in line with current immunotherapy treatment.Assessments have not been adjusted to reflect TARP expression, which is currently unknown by tumor type  $40B   TARP Total Market Opportunity*  Announced license with NCI TARP antigens  Number of TARP-Specific T cells  (Interfer on-y spot forming cells   per million splenocytes)  0  100  200  300  400  500  600  700  800  900  1000  100 spots/million cells   Strong T cell response level  Range of observed T cell responses with PDS0102  IFN-y ELISPOT Study  Versamune® + TARP (1-20)  X  3  24 
 
 Induced a >10-fold number of polyfunctional (highly potent) MUC1 specific CD8+ T cells  PDS0103: MUC1 Antigen  Greater quantity and quality of Versamune® induced CD8+ killer T cells may result in the ability to treat breast, ovarian, lung, and colon cancers  *References: Surveillance Research Program, National Cancer Institute SEER, Cancer Institute SEER, Assumes $150K for annual course of therapy; in line with current immunotherapy treatment, Assessments have not been adjusted to reflect MUC1-expression, which is currently unknown by tumor type  Adjuvant = cytokine GMCSF  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.  IFN-γSpot Forming Cells/1X106Spleen Cells  Polyfunctional T Cells  Monofunctional T Cells  4-Combo Adjuvant + MUC1 Antigen  Versamune® + MUC1 Antigen (PDS0103)  # of Antigen-Recognizing CD8+ T Cells  $100B   MUC1 Total Market Opportunity*  Adjuvant* + MUC1 Antigen  25 
 
 Projected Milestones Through 3Q 2023*  *Based on current enrollment and forecast modeling as of December 2022. Subject to change.  26  1Q22  2Q22  3Q22  4Q22  1Q23  2Q23  PDS0101  Completed enrollment of HPV-  associated cancer trial CPI refractory arm (NCI)  Preliminary data from IMMUNOCERV (MD Anderson)  Estimated IND filing in MUC1-related cancers  PDS0103  Anticipate preliminary efficacy data from Mayo Clinic IIT   3Q23  Updated preliminary safety and updated efficacy data from NCI trial presented at ASCO  Preliminary safety and efficacy data (KEYTRUDA® combo) presented at ASCO – FAST TRACK DESIGNATION GRANTED  Anticipate discussion with the FDA on Pivotal Trial (NCI)  Discussions with the FDA on Pivotal Trial (VERSATILE-002)  Initiate registrational trial for PDS0101 
 
 Infectimune™   Infectious Disease Platform 
 
 PDS Biotech’s Infectimune™ Pipeline   Developed in partnership with leaders in infectious disease  Prevention of tuberculosis  PDS0201   (M-tuberculosis)  Candidate  Indication  PC  P1  P2  P3  R  Partner(s)  Universal prevention of influenza  PDS Biotech Funded  Partner Co-Funded  PDS0202 (influenza)  PDS0203   (SARS-CoV-2)  Prevention of COVID-19  28 
 
 20  Infectimune™   Pipeline Highlights  License agreement with University of Georgia for proprietary influenza antigens  Top-line preclinical data announced; effective delivery of flu proteins activate the critical immune signals necessary to generate neutralizing antibody responses to all flu strains tested in animals  Preclinical data presented at the 41st Annual meeting of the American Society Virology Meeting  Universal Influenza Vaccines  29 
 
 Reference: Ross T. and Woodward J. et al. evaluation of the PDS0202 (Infectimune™+ COBRA) Universal flu formulation.   PDS0202 Universal Prevention of Influenza   Appeared to Provide Protection in Preclinical Study in Keeping Animals Alive and Healthy Against Challenge with Flu Virus  Control  High-Dose Flu Proteins  PDS0202  (Low-Dose)  PDS0202  (High-Dose)  Alive  Healthy  Alive  Healthy  Alive  Healthy  Alive  Healthy  0%  0%  0%  30%  100%  100%  100%  100%  % of Protection  30  % of Protection of Subjects Challenged with the Flu Virus  Treatment Regimen 
 
 PDS Biotech Management  Historical success in the development and commercialization of leading pharmaceutical products  Timing  Safety data confirmed and released Q4 2021  Preliminary efficacy data anticipated Q1 2022  Frank Bedu-Addo, PHD  Chief Executive Officer  Senior executive experience with management of strategy and execution at both large pharma and biotechs  Notable drug development:   Abelcet® (Liposome Company/ Elan)   PEG-Intron® (Schering-Plough/ Merck)  Matthew Hill  Chief Financial Officer  20 years of financial and operational leadership roles for life sciences companies  Former Chief Financial Officer of several publicly traded companies  Lauren V. Wood, MD  Chief Medical Officer  30 years of translational clinical research experience  Former Director of Clinical Research at National Cancer  Institute Center for Cancer Research (Cancer Vaccine Branch)   Gregory Conn, PHD  Chief Scientific Officer  Co-founder  35 years of drug development experience   In-depth experience with biotech drug discovery, product development and manufacturing  31 
 
 1  2  4  5  6  Company Overview  Clinical-stage Company developing proprietary targeted immunotherapies to treat cancer and infectious disease  Versamune® based platforms leverage the body’s own defense systems to induce tumor-specific killer T cells to overcome immune suppression and attack cancer  Exclusive global license with Merck KGaA, Darmstadt, Germany for tumor targeting IL-12 fusion protein (PDS0301)  Clinical partnerships with Merck, MD Anderson Cancer Center, National Cancer Institute and Mayo Clinic  Cash as of September 30, 2022 - $71.6M cash runway to Q2 2024 with a potential registrational trial in 2023  3  Infectimune™ activates the immune system to induce pathogen-specific T cells and antibodies to protect against infectious disease  32  PDS0101 granted FDA Fast Track designation. Four Phase 2 clinical trials addressing multiple HPV-positive cancers. Safety and efficacy data have been reported in over 100 and 60 patients, respectively  7 
 
 Precision Designed Science For Immunotherapy  INVESTOR   PRESENTATION  NASDAQ: PDSB | January 2023