PDSB 8-K
PDS Biotechnology Corp (PDSB)
8-K
2021-11-10
For: 2021-11-05
View Original
Added on
April 06, 2026
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): November 5, 2021
(Exact Name of Registrant as Specified in Charter)
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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(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):
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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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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.
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Effective as November 5, 2021, PDS Biotechnology Corporation (the “Company”) entered into a Patent License Agreement (the
“Patent License Agreement”) with the U.S. Department of Health and Human Services, as represented by National Cancer Institute (“NCI”) of the National Institutes of Health (“NIH”). Pursuant to the Patent License Agreement, the Company obtained a
nonexclusive license to the patent rights for NCI’s T-cell receptor gamma alternate reading frame protein (“TARP”) to develop and commercialize TARP peptide-based therapies in combination with the Company’s Versamune® technology and any
other of the Company’s proprietary technologies for prostate and breast cancers and Acute Myeloid Leukemia. The Patent License Agreement expires when the last licensed patent expires if the Patent License Agreement is not terminated prior to that
date. NCI may terminate the Patent License Agreement if the Company is in default in the performance of any material obligation under the Patent License Agreement. The Company may unilaterally terminate the Patent License Agreement in any country
or territory upon sixty (60) days written notice. Under the Patent License Agreement the Company agreed to pay NCI certain non-creditable, nonrefundable license issue royalties, unreimbursed patent expenses for the licensed patent rights, a
nonrefundable minimum annual royalty, earned royalties as a percentage of net sales and benchmark royalties. (The foregoing description of the Patent License Agreement does not purport to be complete and is qualified in its entirety by reference
to the complete terms and conditions of the Patent License Agreement to be filed as an exhibit to the Company’s next Form 10-K to be filed with the U.S. Securities and Exchange Commission.)
| Item 2.02 |
Results of Operations and Financial Conditions.
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On November 10, 2021, the Company issued a press release announcing its financial results for the three months ended September 30,
2021 and provided an update on the Company’s operations. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information set forth in this Current Report on Form 8-K (including
Exhibit 99.1) is deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “exchange Act”), or otherwise subject to the liabilities of that section, nor
shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
| Item 8.01 |
Other Events.
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On November 8, 2021, the Company issued a press release announcing its entry into the Patent License Agreement. A copy of
the press release is filed as Exhibit 99.2 hereto and incorporated by reference herein.
On November 10, 2021, the Company updated
its corporate presentation slide deck. A copy of the slide deck is filed as Exhibit 99.3 hereto and incorporated herein by reference.
| Item 9.01 |
Financial Statements and Exhibits.
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(d) Exhibits.
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Exhibit
Number
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Description
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Press Release dated November 10, 2021.
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Press Release dated November 8, 2021.
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Updated Corporate Presentation November 2021.
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104
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Cover Page Interactive Data File - the cover page interactive date file does not appear in the Interactive Date File because its XBRL tags are
embedded within the Inline XBRL document.
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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.
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PDS BIOTECHNOLOGY CORPORATION
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Date: November 10, 2021
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By: /s/ Frank Bedu-Addo, Ph.D.
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Name: Frank Bedu-Addo, Ph.D.
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Title: President and Chief Executive Officer
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Exhibit 99.1
PDS Biotech Provides Business Update and Reports Third Quarter 2021 Financial Results
FLORHAM PARK, N.J., November 10, 2021 (GLOBE NEWSWIRE) -- 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, will discuss its financial results for the
quarter ended September 30, 2021 and provide a business update on its conference call today.
Recent Business Highlights:
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Achievement of the preliminary safety benchmark for the first 12 patients
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| o |
Completion of enrollment for the first stage of the checkpoint inhibitor naïve arm (1st line treatment of recurrent or metastatic head and neck cancer).
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Initiated enrollment of the second arm of the study addressing checkpoint inhibitor refractory patients (2nd line treatment of recurrent or metastatic head and neck cancer)
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Completed a licensing agreement with the National Cancer Institute (NCI) for intellectual property related to the NCI’s proprietary T-cell receptor gamma alternate reading frame
protein (TARP) tumor antigen for use in PDS0102.
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PDS0102 is being developed to treat prostate cancer, breast cancer and acute myeloid leukemia or AML.
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| o |
PDS0102 has demonstrated powerful induction of TARP-specific killer T-cells in preclinical studies.
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Entered agreement to license COBRA (Computationally Optimized Broadly Reactive Antigen) antigens from the University of Georgia for use in the development of PDS0202, a novel
Versamune®-based universal flu vaccine.
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Announced temporary administrative suspension of enrollment into the NCI-led study of the
PDS0101 triple combination. PDS Biotech continues to be in contact with the NCI. Treatment of already enrolled patients has continued without interruption.
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Announced the hiring of Matthew Hill as Chief Financial Officer, who has more than 20 years of experience in finance and operational leadership roles for life sciences companies.
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“PDS Biotech has continued to build on its momentum from the interim data of the last quarter in 2nd and 3rd line treatment of HPV16-positive anal, cervical, head and
neck, vaginal and vulvar cancers,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “We have achieved numerous clinical milestones, and formalized agreements with development partners to continue to progress both
our Versamune®-based oncology pipeline and our Versamune®-based infectious diseases
pipeline. We also welcomed Matthew Hill as our new Chief Financial Officer. Matt has decades of experience as a financial leader in publicly traded life sciences companies and will be a key player in our next phase of growth. The groundwork has
been laid for the execution of multiple pipeline development milestones in 2022 and into 2023.”
Third Quarter 2021 Financial Results
PDS Biotech reported a net loss of approximately $7.0 million, or $(0.24) per basic and diluted share, for the three months ended September 30, 2021, compared to a net
loss of approximately $3.9 million, or $(0.21) per basic and diluted share, for the three months ended September 30, 2020.
Research and development expenses increased to approximately $3.7 million for the three months ended September 30, 2021 from approximately $2.1 million for the three
months ended September 30, 2020. The increase of $1.6 million was primarily attributable to an increase of $0.7 million in personnel costs of which $0.5 million was stock compensation costs, and $0.9 million in costs related to clinical studies.
General and administrative expenses increased to approximately $3.2 million for the three months ended September 30, 2021 from approximately $1.8 million for the three
months ended September 30, 2020. The increase of $1.4 million is primarily attributable to an increase in personnel costs of $1.6 million, of which $1.0 million was stock compensation costs and $0.4 million was severance, partially offset by a
decrease in professional fees of $0.2 million.
PDS Biotech’s cash and cash equivalents as of September 30, 2021, were approximately $69.7 million.
Conference Call and Webcast
The conference call is scheduled to begin at 8:00 am ET on Wednesday, November 10, 2021. Participants should dial 877-407-3088
(United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company's corporate website at www.pdsbiotech.com.
After the live webcast, the event will be archived on PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months.
The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13722558.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer
T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to
better recognize diseased cells and effectively attack and destroy them. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers. 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 & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior
checkpoint inhibitor therapy. PDS Biotech is also conducting a Phase 2 clinical study in both second- and third-line treatment of multiple advanced HPV-associated cancers with the National Cancer Institute (NCI). A third phase 2 clinical trial in
first line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.
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® based products; 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® based products and the Company’s or monitoring committees’ or other third parties’ 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, significance of milestones, and completion of the trials (including our ability to fully fund our 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 results, 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 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: [email protected]
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
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September 30,
2021
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December 31,
2020
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ASSETS
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(unaudited)
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Current assets:
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Cash and cash equivalents
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$
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69,744,004
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$
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28,839,565
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Prepaid expenses and other
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1,596,810
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1,497,665
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Total current assets
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71,340,814
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30,337,230
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Property and equipment, net
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1,037
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5,443
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Operating lease right-to-use asset
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406,171
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547,706
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Total assets
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$
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71,748,022
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$
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30,890,379
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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LIABILITIES
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Current liabilities:
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Accounts payable
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$
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1,445,585
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$
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1,415,224
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Accrued expenses
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1,923,846
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1,735,322
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Operating lease obligation-short term
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207,717
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119,904
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Total current liabilities
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3,577,148
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3,270,450
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Noncurrent liability:
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Operating lease obligation-long
term
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313,976
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490,353
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Total Liabilities
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$
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3,891,124
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$
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3,760,803
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STOCKHOLDERS’ EQUITY
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Common stock, $0.00033 par value, 75,000,000 shares authorized at September 30, 2021 and December
31, 2020, 28,435,067 shares and 22,261,619 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively
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9,383
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7,346
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Additional paid-in capital
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122,231,115
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70,907,315
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Accumulated deficit
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(54,383,600
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)
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(43,785,085
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)
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Total stockholders’ equity
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67,856,898
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27,129,576
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Total liabilities and stockholders’ equity
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$
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71,748,022
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$
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30,890,379
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PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
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Three Months Ended September 30,
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Nine Months Ended September 30,
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2021
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2020
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2021
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2020
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Operating expenses:
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Research and development expenses
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$
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3,687,999
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$
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2,060,815
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$
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7,865,249
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$
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5,446,718
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General and administrative expenses
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3,274,325
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1,846,214
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7,252,371
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5,428,098
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Total operating expenses
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6,962,324
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3,907,029
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15,117,620
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10,874,816
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Loss from operations
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(6,962,324
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)
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(3,907,029
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(15,117,620
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)
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(10,874,816
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)
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Other income:
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Interest income
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1,358
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1,207
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2,617
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54,242
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Loss before income taxes
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(6,960,966
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)
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(3,905,822
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)
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(15,115,003
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)
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(10,820,574
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)
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Benefit from income taxes
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–
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–
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4,516,488
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–
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Net loss and comprehensive loss
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(6,960,966
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)
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(3,905,822
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)
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(10,598,515
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)
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(10,820,574
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)
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Per share information:
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Net loss per share, basic and diluted
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$
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(0.24
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)
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$
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(0.21
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)
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$
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(0.43
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)
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$
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(0.73
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)
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Weighted average common shares outstanding, basic and diluted
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28,425,850
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18,961,619
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24,639,299
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14,892,764
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Exhibit 99.2
PDS Biotechnology Licenses Protein for the Treatment of Acute Myeloid Leukemia, Prostate and Breast Cancers from National Cancer
Institute
Advances Next Phase of Versamune® Oncology Pipeline
Florham Park, NJ, November 8, 2021 - PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer
therapies based on the Company’s proprietary Versamune® T-cell activating technology, today announced a licensing agreement with the National Cancer Institute (NCI)
for intellectual property related to the NCI’s proprietary tumor-associated and immunologically active T-cell receptor gamma alternate reading frame protein (TARP).
Approximately 470,000 patients are diagnosed annually with TARP-associated cancers, including acute myeloid leukemia (AML), prostate, and breast cancer
according to the National Cancer Institute. In preclinical studies performed by PDS Biotech, the administration of PDS0102, the Versamune®-TARP tumor antigen
combination, led to the induction of large numbers of tumor targeted killer T-cells. It is important to note, the TARP tumor antigen alone has already been studied at the NCI in men with prostate cancer and been shown to be safe, immunogenic, and
associated with slowing tumor growth rates (NCT00972309).
“The highly promising proof-of-concept data presented earlier this year in the advanced HPV cancer trial solidifies our confidence in the Versamune® technology to rapidly advance our pipeline into other types of debilitating cancers,” said Dr. Lauren V. Wood, PDS Biotech’s Chief Medical Officer. “We are excited
about the potential of PDS0102, which leverages the Versamune® platform to improve on the results reported in humans with the NCI’s TARP antigen alone.”
The worldwide, non-exclusive license secures rights for the proprietary TARP antigen from the NCI with patent protection through 2034.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary
Versamune® T-cell activating technology platform. Our Versamune®-based products have
demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly
potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and
disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian
cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
About PDS0102
PDS0102 combines the utility of the Versamune® platform with the
proprietary T-cell receptor gamma alternate reading frame protein (TARP), a tumor antigen identified by the National Cancer Institute (NCI) which is strongly associated with acute myeloid leukemia (AML), breast and prostate cancers. Approximately
470,000 patients are projected to be diagnosed with AML, prostate, or breast cancer this year, most of which are associated with TARP.
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®
based products; 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® based products 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 our ability to fully fund our 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 results, 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 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: [email protected]
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]
Exhibit 99.3
CORPORATE OVERVIEW Frank Bedu-Addo Ph.D. President & CEO NOVEMBER 2021
2 Forward-Looking Statements This presentation contains forward-looking statements about PDS
Biotechnology Corporation (“PDSB”), and its businesses, business prospects, strategies and plans, including but not limited to statements regarding anticipated pre-clinical and clinical drug development activities and timelines and market
opportunities. All statements other than statements of historical facts included in this presentation are forward-looking statements. The words “anticipates,” “may,” “can,” “plans,” “believes,” “estimates,” “expects,” “projects,” “intends,”
“likely,” “will,” “should,” “to be,” and any similar expressions or other words of similar meaning are intended to identify those assertions as forward-looking statements. These forward-looking statements involve substantial risks and
uncertainties that could cause actual results to differ materially from those anticipated.Factors that may cause actual results to differ materially from such forward-looking statements include those identified under the caption “Risk
Factors” in the documents filed with the Securities and Exchange Commission (“SEC”) from time to time, including its Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. You are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the date of this presentation. Except to the extent required by applicable law or regulation, PDSB undertakes no obligation to update the forward-looking statements
included in this presentation to reflect subsequent events or circumstances.
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on
the proprietary Versamune® platform 3 Interim data from NCI-led PDS0101 Phase 2 trial showed tumor reduction in ~70% of patients who had failed prior treatmentNo new or elevated toxicities observed from the addition of PDS0101 to
combination therapyPre-clinical studies demonstrate potency and versatility of Versamune® in oncology and infectious diseaseMultiple composition and application patents valid through mid-2030s Biopharma developing novel T-cell activating
cancer treatment candidates Three phase 2 oncology clinical trials in progress with multiple near-term readoutsClinical partnerships with Merck, MD Anderson Cancer Center and National Cancer InstituteDebt free with approximately $69.7M in
cash as of September 30, 2021 Pipeline Versamune® Platform Corporate Overview
4 PDS Biotech’s Versamune®-based immunotherapies are designed to promote a powerful in vivo
tumor-specific CD8+ killer T-cell response Generate the right type and quantity of effective CD8+ killer T-cells Generate potency without systemic side effects Generate memory T-cells, to enhance durability of response A significant
barrier to effective immunotherapy has been the inability to promote adequate CD8+ killer T-cell responses in vivo70-90% of cancer patients fail check point inhibitor therapy Versamune®-based therapies also show promising potential to:
Versamune® is designed to induce a robust and targeted anti-tumor response in vivo when administered
with a tumor-associated antigen 5 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 Rumfield C et al. 2020. Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine. J. for ImmunoTherapy of Cancer 8:e000612. Recruits T-cells to lymph nodes: Promotes uptake of immunotherapy and
entry into lymph nodes. Signals T-cells to infiltrate lymph nodes. Trains T-cells to target tumors: Promotes antigen processing and presentation to T-cells via MHC I and II pathways Arms T-cells to kill tumor cells: Activates Type I
Interferon pathway, enabling a powerful antigen-specific (tumor) killer CD8+ T-cell response Versamune® + Tumor-associated proteins (antigens)
PDS Biotech executive team has demonstrated success in the development and commercialization of
leading pharmaceutical products 6 Senior executive experience with management of strategy and execution at both large pharma and biotechsNotable drug development:Abelcet® (Liposome Company/ Elan)PEG-Intron® (Schering-Plough/ Merck) Frank
Bedu-Addo, PhDChief Executive Officer Co-founder>35 years of drug development experience In-depth experience with biotech drug discovery, product development and manufacturing Gregory Conn, PhDChief Scientific Officer >30 years
of translational clinical research experienceFormer Director of Clinical Research at National Cancer Institute Center for Cancer Research (Cancer Vaccine Branch) Lauren V. Wood, MDChief Medical Officer >20 years of financial and
operational leadership roles for life sciences companiesFormer Chief Financial Officer of several publicly traded companies Matthew HillChief Financial Officer
PDS Biotech’s robust Versamune® -based oncology pipeline is being developed in partnership with the
leaders in immuno-oncology 7 Reference: Data on file.
PDS Biotech’s Versamune® -based pipeline is being developed in partnership with leaders in infectious
disease 8 Reference: Data on file. *Consortium of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquimica. Funding provided by The Ministry of Science, Technology and Innovation of Brazil (“MCTI”)
Introduction to PDS0101
10 Approximately 43,000 patients are diagnosed with HPV-associated cancers annually in the US1Cancers
caused by HPV include anal, cervical, head and neck, penile vaginal and vulvar cancersIncidence rate of HPV-related anal and head and neck cancer is growing and remains a significant unmet medical needExisting immunotherapies cost $120,000+
annually per patient2 1Markowitz et al. 2016. Centers for Disease Control and Prevention. 2018.2Hernandez et al. 2018. American Journal of Managed Care Volume 24, Issue 2; Company Research Females (24,391) Males (18,280) US annual
HPV-associated cancer incidence1 PDS0101 is designed to treat cancers caused by human papillomavirus (HPV)-16, which represents 70-80% of the HPV-associated cancer market
11 References: Markowitz et al. 2016. Centers for Disease Control and Prevention. 2018. Hernandez et
al. 2018. American Journal of Managed Care Volume 24, Issue 2; Company Research, Strauss J. et al. 2021 ASCO Annual Meeting Abstract: 2501. human papillomavirus (HPV)-16 cancers represents 70-80% of the HPV-associated cancer market
Greater quantity & quality of Versamune®-induced killer (CD8+) T-cells may result in unique ability
to eradicate HPV-positive tumors after a single dose 12 Induced a >10-fold number of highly potent T-cells and eradication of HPV-positive tumors after a single dose in preclinical studies Single treatment dose Results typical of
current topclinical-stage HPV cancer vaccines Tumor rechallenge at Day 60; complete and sustained cure of cancer *Adjuvant = cytokine GM-CSFReferences: 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. (PDS0101) HPV-Specific CD8+ Killer T-CellsINF-γ SFCs/1x106 spleen
cells
Sub-cutaneous injection of PDS0101 monotherapy induced high quantity of potent HPV16-specific
CD8+T-cells in Phase 1 clinical trial 13 2-4 Patient 2-5 3-1 3-2 5-7 2-7 High HLA Type A2 A2 A3 A74 A2 HPV-specific T-cell ResponseIFN-γ ELISPOT Patient 5-1 5-4 2-1 2-3 Low Medium HLA Type A2 A1, A2, A3,
30 HPV-specific T-cell ResponseIFN-γ ELISPOT Responses were evaluated on Days 14-19 after SC injection Predominant CD8+ T-cell responses confirmed by Granzyme-b
ELISPOT Pre-treatment Post-treatment Lesion regression in 8/10 CIN patients within 3 months of treatment (Retrospective analysis)No recurrence within 2-year evaluation period may suggest durable
immune responses 13
Phase 2 NCI-led clinical trial evaluating the triple combination of PDS0101, Bintrafusp alfa and M9241
in advanced HPV-associated cancer 14 Indication Patients with advanced HPV-associated cancer who have failed prior treatment Clinical Agents Bintrafusp alfa: Bifunctional checkpoint inhibitor-“TGF-β trap” fusion proteinM9241:
Antibody-conjugated immuno-cytokinePDS0101: Versamune®-based immunotherapy generating HPV-specific CD8+ T-cells Study goals Group 1: Objective response rate (ORR) in checkpoint inhibitor (CPI) naïve patientsGroup 2: ORR in patients who have
failed checkpoint inhibitor therapy (CPI refractory) Timing Full enrollment of 56 patientsComplete enrollment expected by Q1 2022 Trial Sponsor The objective of this trial is to evaluate the potential of the triple combination to
provide an effective therapy for patients with advanced and untreatable cancer
ASCO 2021: PDS0101 triple combination achieved 83% ORR among six advanced HPV16-positive CPI naive
patients, suggesting potential efficacy 15 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 2021 Annual Meeting; June 4-8, 2021; Virtual. Abstract: 2501. * These numbers reflect data as of evaluation of 25 patients at a median of 8 months; numbers will change as more patients undergo evaluation
ASCO 2021: Triple combination achieved 58% tumor reduction among 12 HPV16 checkpoint inhibitor
refractory patients 16 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 2021
Annual Meeting; June 4-8, 2021; Virtual. Abstract: 2501. * These numbers reflect data as of evaluation of 25 patients at a median of 8 months; numbers will change as more patients undergo evaluation 5 patients had already achieved an
objective response (>30% tumor reduction)
17 ASCO 2021: Triple combination shows promising durability of potential for anti-cancer efficacy in
HPV16-positive checkpoint inhibitor naïve patients PDS0101 + Bintrafusp alfa + M9241 Standard of Care(Checkpoint Inhibitors) HPV16-positive Number of checkpoint inhibitor naïve patients 6 Ongoing objective responses at median of
8 months 80% (4/5) Survival at median of 8 months 100% (6/6) Historical is 7-11 months Number of checkpoint inhibitor refractory patients 12 Ongoing tumor reduction at median of 8 months 86% (6/7) Ongoing objective responses at
median of 8 months 80% (4/5) Survival at median of 8 months 83% (10/12) Historical is 3-4 months 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 2021 Annual Meeting; June 4-8, 2021; Virtual. Abstract: 2501. Preliminary results suggest PDS0101 induction of in vivo highly active tumor-attacking HPV16 killer
(CD8+) T-cells even in extensively treated and immunologically limited patients have the potential for effective disease reduction and ongoing responses * These numbers reflect data as of evaluation of 25 patients; numbers will change as
more patients undergo evaluation
ASCO 2021: Results in HPV16-negative patients suggests critical role of PDS0101-induced HPV16-specific
CD8+ T-cells in promoting tumor reduction 18 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 2021 Annual Meeting; June 4-8, 2021; Virtual. Abstract: 2501. * These numbers reflect data as of evaluation of 25 patients; numbers will change as more patients undergo evaluation Preliminary results suggest that
HPV16-specific CD8+ and CD4+ T-cell induction by PDS0101 as predicted by preclinical studies may promote enhanced clinical benefit of the triple combination
19 Phase 2 trial evaluating the combination of PDS0101/KEYTRUDA® for treatment of HPV16-positive
metastatic/recurrent head and neck cancer (VERSATILE-002) Indication Treatment of patients with HPV16-positive head and neck cancer whose cancer has spread or returned Clinical Agents KEYTRUDA® (Standard of Care): Anti-PD1 checkpoint
inhibitor (ORR ~20%)PDS0101: Versamune®-based immunotherapy generating HPV-specific CD8+ and CD4+ T-cells Study goals Group 1: Objective response rate (ORR) as first-line treatment in checkpoint inhibitor (CPI) naïve patientsGroup 2: ORR in
patients who have failed checkpoint inhibitor therapy (CPI refractory) Timing Preliminary efficacy data anticipated Q4 2021/Q1 2022 Trial Partner Confirmation that PDS0101 enhances the therapeutic benefit of checkpoint inhibitors could
expand evaluation of Versamune®-based therapies in multiple cancer indications
20 Phase 2 investigator-led trial evaluating the combination of PDS0101 and chemoradiation in patients
with locally advanced cervical cancer (IMMUNOCERV) Indication Treatment of patients with locally advanced cervical cancer – Stages IB3-IVA Clinical Agents Chemoradiotherapy (CRT – Standard of Care): Cisplatin and radiation therapyPDS0101:
Versamune®-based immunotherapy generating HPV-specific CD8+ and CD4+ T-cells Study goals Safety, rate of regression and local control in patients with primary tumor ≥5cm (n=35 patients) Timing Preliminary data anticipated 1H 2022 – Rate
of complete response by PET-CT at 6 months and rate of tumor volume reduction by MRI at 30-40 days from start of treatment Trial Sponsor If successful, this study could support further investigation of Versamune®-based immunotherapies in
combination with chemotherapy or CRT to treat multiple cancers
Preclinical Pipeline Data
22 Reference: Data on file. In preclinical studies, Versamune® has demonstrated potential for potent
CD8+ (killer) T-cell responses with different tumor antigens 22 PDS0101 Phase 2 interim results demonstrate promising link between targeted CD8+ killer T-cell response and anti-tumor response Versamune®-induced T-cellsHigh quantityRight
phenotype (high quality)Strong killing potency
Development of PDS0102
24 24 Approximately 470,000 patients are diagnosed annually with AML, prostate or breast cancer, most
of which are associated with target T-cell receptor gamma alternate reading frame protein (TARP) Acute Myeloid Leukemia (AML)Almost 20,000 cases in the US annuallyTARP expressed in 100% of AML Prostate cancerAlmost 175,000 US cases
annuallyThe immunogenic TARP protein is expressed in about 90% of prostate cancers at all stages of the disease^Breast cancerMore than 270,000 US cases annuallyTARP expressed in about 50% of breast cancers at all stages of the
disease References: Fritzche FR et al. Histol Histopathol 2010 Jun; 25 (6): 733-9 doi: 10.14670/HH-25.733, Cancer Facts & Figures, American Cancer Society, 2019, LV Wood, et al. Oncoimmunology, 2016. Vol 5. No 8. e1197459. Prostate
Cancer (174,650) Breast Cancer (271,270) AML(19,970) PDS0102 is designed to treat cancers caused by T-cell receptor gamma alternate reading frame protein (TARP), including AML, prostate and breast cancers
25 25 PDS0102 may provide superior induction of TARP-specific tumor attacking CD8+ killer
T-cells 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 PRE-CLINICAL OPTIMIZATION STUDIES: TARP-Specific
T-cell Induction after 2 injections of PDS0102
Development of PDS0103
Clinical trial design will seek to evaluate PDS0103 in tumor types with the highest expression of MUC1
and the greatest differences in MUC1 expression between malignant and healthy tissue PDS0103 is designed to treat cancers caused by mucin-1 (MUC1), which is highly expressed in solid tumors and is associated with poor prognosis Reference:
M. Uhlen, et al. A pathology atlas of the human cancer transcriptome. Science.18 Aug 2017. MUC1 protein expression overview data available from https://www.proteinatlas.org/ENSG00000185499-MUC1/tissue.
28 28 Greater quantity and quality of Versamune®-induced CD8+ killer T-cells may result in ability to
eradicate MUC1-positive tumors Induced a >10-fold number of polyfunctional MUC1 specific CD8+ T-cells *Adjuvant = cytokine GMCSFReferences: J. Immunology, 2019 (202), 1215; Studies in TC-1 tumor model with other immunotherapies reported
in: Vaccine 2009, January 14, 27 (3): 431; Science Translational Medicine 2016, 13 April, Vol 8 Issue 334; Vaccine 2009, September 25, 27 (42): 5906.
PDS0101 Near-Term Milestones and Market Opportunities
Projected milestones through 2022* *Based on current enrollment and forecast modeling as of November
2021. Subject to change. 4Q22 3Q22 2Q22 1Q22 4Q21 3Q21 2Q21 1Q21 Preliminary efficacy data from advanced HPV-associated cancer trial (NCI) Interim data from HPV-associated cancer trial (NCI) Preliminary data from ImmunoCerv (MD
Anderson) expected Preliminary data from VERSATILE-002 (KEYTRUDA® combo) expected Expected completion of HPV-associated cancer trial (NCI) PDS0101 30 PDS Biotech Funded Clinical Trials Partner Co-Funded Clinical
Trials PDS0102 PDS0103 Planned initiation of Phase 1/2 clinical trial in TARP-related cancers Planned initiation of Phase 1/2 clinical trial in MUC1-related cancers
Appendix
33 Bintrafusp alfa (M7824 - bi-functional checkpoint inhibitor) Tumor Regression: 0/16 (0%)T-cell
Clones: 22 PDS0101 + Bintrafusp alfa + M9241 (NHS IL-12) Tumor Regression: 13/16 (81%)T-cell Clones: 3 *Reference: Smalley Rumfield C, Pellom ST, Morillon II YM, et al; Journal for ImmunoTherapy of Cancer 2020; 8:e000612. doi:
10.1136/jitc-2020-000612 Red – CD8+ (killer) T-cellsGreen – CD4 + (helper) T-cells T-cell clones per 25% of TCR repertoire (Average) Combination of PDS0101 with M9241 or Bintrafusp alfa generated superior targeted T-cell response; triple
combination demonstrated superior efficacy T-cell induction levels Preclinical study: Triple combination of PDS0101, Bintrafusp alfa (M7824) and M9241 (NHS-IL12) demonstrated higher targeted T-cell response
34 Reference: Data on file. Versamune® induces high quantity and quality of CD8+ killer T-cells that
infiltrate the tumors and make them more susceptible to killing Minimizes the presence of immune suppressive regulatory T-cells (Treg) within the tumor microenvironment PDS0101 treatment alters the tumor from having >250-fold more immune
repressive Treg cells than CD8+ (killer) T-cells to having about 10-fold higher CD8+ T-cells than Treg cells within 10 days of treatment A-antigen, R-Versamune® (R-DOTAP); G-GM-CSF; S-Sucrose; N-Naive
35 Reference: Data on file. PDS0104 preclinical studies: Potent TRP2-specific CD8+ killer T-cells
demonstrate potential to break immune tolerance in difficult-to-treat B16 melanoma 35 14 days after single injection treatment Potential potent activity with different tumor antigens
Immunotherapeutics ORR in HPV-associated malignancies 36 Taken from J. Strauss, ASCO 2021 (Revised to
show CPI status) Agents(s) Cervical (CPI Naïve) H&N SCC (CPI Naïve) All HPV (CPI Naïve) All HPV (CPI refractory) References Pembroluzimab (Keytruda®) 14% 24% Keynote 012, Siewert TY, 2016 Nivolumab
(Opdivo®) 13% Checkmate 154, Ferris RL, 2018 Atezolizumab (Tecentriq®) 22% Colevas AD, Ann Oncol 2018 Opdivo + ISA 101 33% Massarelli, JAMA Oncol 2019 Bintrafusp-α 30.5% 10% Strauss, JITC 2020 PDS0101 +
Bintrafusp-α + M9241 83% (ORR) 58% (reduction)42% (ORR) Strauss, ASCO 2021
37 Adverse Event Summary All patientsN=25* Grade ≥2 Treatment-related adverse events (TRAEs) 23
(92%) TRAEs leading to discontinuation of ≥ 1 drug(s) 5 (20%) Treatment-related serious AEs 7 (28%) TRAEs in ≥5% of patients Anemia 12 (48%) Lymphocyte decrease 7 (28%) Flu like symptoms 6 (24%) Injection site reactions 5
(20%) Hematuria 4 (16%) AST/ ALT/ Alk phos elevation 4 (16%) Keratoacanthomas 4 (16%) Leukocyte decrease 3 (12%) Maculopapular rash 3 (12%) Pruritis 3 (12%) Nausea/ vomiting 3 (12%) Mucositis 3 (12%) Hypothyroidism 3
(12%) Peripheral motor neuropathy 2 (8%) Fatigue 2 (8%) Grade 3 TRAEs occurred in 10 (40%) patientsAnemia due to gross hematuria (n=4), AST/ALT elevation (n=2); flu like symptoms (n=1), nausea/ vomiting (n=1), leukopenia (n=1),
lymphopenia (n=2), HLH (n=1)One patient with transient grade 3 leukopenia and lymphopenia also had transient grade 4 neutropenia4 patients who originally had grade 3 toxicities with the triple combo including M9241 at 16.8 mcg/kg tolerated
the triple combo with M9241 at 8 mcg/kg w/o any further grade ≥3 toxicitiesNo treatment-related deaths occurred No new or elevated toxicities observed from the addition of PDS0101 to the combination; PDS0101 only caused transient injection
site reactions 37 * These numbers reflect data as of evaluation of 25 patients; numbers will change as more patients undergo evaluation 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 2021 Annual Meeting; June 4-8, 2021; Virtual. Abstract: 2501.
Percentages of HPV-related cancers (anal, cervical, head and neck, vaginal and vulvar cancers) included
in the interim data study population PDS0101 interim Phase 2 trial data presented by the NCI at ASCO 2021: Most HPV-associated cancers are represented - >95% of all US cases 38 Cervical(40%) Anal(24%) Vaginal/Vulvar(12%) Head &
Neck(24%) 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 2021 Annual
Meeting; June 4-8, 2021; Virtual. Abstract: 2501. * These numbers reflect data as of evaluation of 25 patients; numbers will change as more patients undergo evaluation