PDSB 8-K
PDS Biotechnology Corp (PDSB)
8-K
2022-05-11
For: 2022-05-11
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): May 11, 2022
(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 2.02 |
Results of Operation and Financial Condition.
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On May 11, 2022, PDS Biotechnology Corporation (the “Company”) issued a press release announcing its financial results for the
three months ended March 31, 2022 and provided an update on the business of the Company. 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 Item 2.02 of 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 the 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 May 11, 2022, the Company updated its corporate presentation slide deck. A copy of the slide deck is attached hereto as
Exhibit 99.2 and incorporated herein by reference.
With the cash balance available at March 31, 2022, the Company currently believes that the Company will have sufficient resources
to fund its current operations into 2024. This projection is based on the Company’s current estimates and there may be changes to the Company’s current plans that may change these estimates.
This Current Report on Form 8-K contains forward-looking statements, including statements regarding future results, performance
or achievements. All statements other than statements of historical facts included in this Current Report on Form 8-K 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 by the Company with the Securities and Exchange Commission from time to time, including the Company’s 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 hereof.
| 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 May 11, 2022.
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Corporate Presentation May 2022.
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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: May 11, 2022
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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 First Quarter 2022 Financial Results
Company to host conference call and webcast today, May 11, 2022, at 8:00 AM EDT
FLORHAM PARK, N.J., May 11, 2022 -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a
growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technologies, will discuss its financial results for the
quarter ended March 31, 2022, and provide a business update on its conference call today.
“2022 is shaping up to be an incredibly productive year for PDS Biotech,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of the Company. “As we
continue to make significant clinical progress on our lead oncology candidate, PDS0101, we’re looking ahead to presentations of preliminary data from our two most advanced Phase 2 clinical trials at this year’s ASCO meeting in early June. We believe
ASCO’s selection of the preliminary data from both trials for presentation at the June meeting is a testament to the quality of work being done by our team and our partners, as well as the potential demonstrated by PDS0101 in treating advanced
HPV-associated cancers. We look forward to sharing these efficacy and safety data in the near term. In addition, we continue to leverage our proprietary platforms to advance our pre-clinical pipeline into clinical studies, focused on a variety of
cancer targets and infectious diseases. Lastly, due to our partnering model and our financial discipline, we finished the quarter with a strong cash balance which we project to fund our current operations into 2024.”
Recent Business Highlights:
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Announced two abstracts accepted for poster presentation during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 3-7 in Chicago:
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| • |
The poster presentation of Abstract # 6041 will summarize updates to the preliminary efficacy and safety data from the PDS-sponsored VERSATILE-002 Phase 2 clinical trial, which is evaluating PDS0101 in combination with Merck’s anti-PD-1
therapy KEYTRUDA® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.
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The poster presentation of Abstract # 2518 will summarize updates from last year’s ASCO presentation to efficacy and survival data, as well as new findings from the ongoing National Cancer Institute (NCI)-led Triple Combination Phase 2
clinical trial. This trial is evaluating PDS0101 in combination with two investigational immune-modulating agents across the range of HPV16-positive advanced relapsed refractory cancers.
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In April, received $1.2 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate
Transfer Net Operating Loss (NOL) program for State Fiscal Year 2021.
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Announced that the NCI achieved the enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the Triple Combination Phase 2 clinical trial for PDS0101.
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First Quarter 2022 Financial Results
PDS Biotech reported a net loss of approximately $8.5 million, or $0.32 per basic share and diluted share, for the three months ended March 31, 2022
compared to a net loss of approximately $3.0 million, or $0.14 per basic share and diluted share, for the three months ended March 31, 2021.
Research and development (R&D) expenses increased to approximately $5.2 million for the three months ended March 31, 2022 from approximately $1.4 million for the three months ended March 31, 2021. The increase of approximately $3.7 million in 2022 was primarily attributable to an increase of $1.8 million
in manufacturing services and quality costs, $1.04 million in clinical study and regulatory costs, $0.8 million in personnel costs and $0.06 million in facilities.
General and administrative expenses increased to approximately $3.3 million for the three months
ended March 31, 2022 from approximately $1.6 million for the three months ended March 31, 2021. The increase of approximately $1.7 million is primarily attributable to an increase of $1.0 million in personnel costs, $0.6 million in legal fees and
$0.1 in marketing expenses.
Total operating expenses increased to approximately $8.5 million for the three months ended March 31, 2022 from approximately $3.0 million for the
three months ended March 31, 2021 for the reasons described above.
PDS Biotech’s cash balance as of March 31, 2022 was approximately $58.9 million.
Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM EDT on Wednesday, May 11, 2022. Participants should dial 877-407-3088 (United States) or
201-389-0927 (International) and reference conference ID 13728184. To access the webcast, please use the following link PDS Biotech Earnings Webcast. 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 molecularly targeted cancer and infectious disease
immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. 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
HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
Our Infectimune™ -based vaccines have 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. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
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 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; 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.
KEYTRUDA® is a registered trademark of Merck Sharp and Dohme Corp. a subsidiary of Meck & Co., Inc. Kenilworth, NJ USA.
Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
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March 31, 2022
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December 31,
2021
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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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58,881,101
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$
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65,242,622
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Prepaid expenses and other
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1,849,406
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1,597,569
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Total current assets
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60,730,507
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66,840,191
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Property and equipment, net
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-
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86
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Operating lease right-to-use asset
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308,327
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357,611
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Total assets
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$
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61,038,834
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$
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67,197,888
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LIABILITIES AND STOCKHOLDERS' EQUITY
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Current liabilities:
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Accounts payable
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$
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2,745,709
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$
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1,309,403
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Accrued expenses
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1,961,468
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2,187,704
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Operating lease obligation-short term
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311,311
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258,924
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Total current liabilities
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5,018,488
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3,756,031
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Noncurrent liability:
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Operating lease obligation-long term
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146,980
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231,430
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Total Liabilities:
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$
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5,165,468
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$
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3,987,461
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STOCKHOLDERS' EQUITY
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Common stock, $0.00033 par value, 75,000,000
shares authorized at March 31, 2022 and December 31, 2021, 28,450,894 shares and 28,448,612 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively
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9,388
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9,387
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Additional paid-in capital
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125,041,062
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123,904,602
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Accumulated deficit
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(69,177,084
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)
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(60,703,562
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)
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Total stockholders' equity
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55,873,366
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63,210,427
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Total liabilities and stockholders' equity
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$
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61,038,834
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$
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67,197,888
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PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
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Three Months Ended March 31,
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||||||||
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2022
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2021
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Operating expenses:
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Research and development expenses
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$
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5,161,315
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$
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1,413,057
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General and administrative expenses
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3,317,907
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1,636,216
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Total operating expenses
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8,479,222
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3,049,273
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Loss from operations
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(8,479,222
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)
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(3,049,273
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)
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Other income
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Interest income
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5,700
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655
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Net loss and comprehensive loss
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$
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(8,473,522
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)
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$
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(3,048,618
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)
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Per share information:
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Net loss per share, basic
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$
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(0.32
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)
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$
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(0.14
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)
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Net loss per share, diluted
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$
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(0.32
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)
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$
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(0.14
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)
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Weighted average common shares outstanding, basic
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26,161,156
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22,263,838
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Weighted average common shares outstanding, diluted
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26,161,156
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22,263,838
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PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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Three Months Ended March
31,
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2022
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2021
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Cash flows from operating activities:
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Net loss
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$
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(8,473,522
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)
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$
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(3,048,618
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)
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Adjustments to reconcile net loss to net cash used in operating activities:
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Stock-based compensation expense
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1,128,973
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257,622
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Stock-based 401K company common match
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-
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35,747
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Depreciation expense
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86
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1,860
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Operating lease expense
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60,257
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60,257
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Changes in assets and liabilities:
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||||||||
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Prepaid expenses and other assets
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(251,837
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)
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(721,849
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)
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Accounts payable
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1,436,306
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(464,626
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)
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|||||
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Accrued expenses
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(226,236
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)
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119,473
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|||||
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Operating lease liabilities
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(43,036
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)
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(42,057
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)
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Net cash used in operating activities
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(6,369,009
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)
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(3,802,191
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)
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Cash flow from financing activities:
Proceeds from exercise of stock options
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7,488
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-
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Net cash provided by financing activities
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7,488
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-
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||||||
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Net decrease in cash and cash equivalents
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(6,361,521
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)
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(3,802,191
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)
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||||
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Cash and cash equivalents at beginning of period
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65,242,622
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28,839,565
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||||||
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Cash and cash equivalents at end of period
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$
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58,881,101
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$
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25,037,374
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Exhibit 99.2
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | May 2022
2 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. Forward-Looking Statements
1 2 4 5 6 Company Overview Clinical-stage Company developing molecularly targeted immunotherapies
to treat cancer and infectious disease Versamune® and Infectimune™ platforms leverage the body’s own defense systems to induce disease-specific killer T-cells and antibodies to combat cancer and infectious disease Data accepted for two poster
presentations at ASCO – additional data anticipated in 2022 Clinical partnerships with Merck, MD Anderson Cancer Center, National Cancer Institute and Mayo Clinic Debt free with approximately $58.9M in cash (unaudited) as of March 31,
2022 3 The initial concept for Versamune® and Infectimune™ was developed by Prof. Leaf Huang PH.D., a world renowned pioneer in nanoparticle drug delivery 3
Versamune® Oncology Platform
Generate memory T-cells, to enhance durability of response Generate potency without serious systemic
side effects Generate the right type and quantity of effective CD8+ killer T-cells 15-30% Success in checkpoint inhibitor treatments due to low CD8+ T-cell response* Versamune® is designed to promote powerful, CD8+ killer T-cell responses
in vivo The PDS Biotech Differentiation Versamune®-based therapies also show promising potential to: *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. 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 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 Designed to Recruit, Train and Arm T-cells in the Body 6
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 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 Bintrafusp and M9241 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. 7 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
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 decades 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 PDS0101: Lead Asset Designed to treat human papillomavirus (HPV16)-associated cancers $6B Market Opportunity1 Reference: Data on file. 8
0 5 10 15 Median Survival In Patients Naïve Patients Refractory Patients 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. PDS0101: Triple Combination Promising survival of patients with advanced refractory HPV16-associated
cancers PDS0101 + Bintrafusp alfa + M9241 Indications targeted in study–cervical, anal, head and neck, vaginal, penile As of 12/31/21: 37 patients (30 HPV16 positive) evaluated Study progressing and recruiting; updates will be provided
in the future 3 – 4 mo. Survival: 7–11 mo. Survival: 12+ mo. 3:1 ratio refractory to naïve patients Check Point Inhibitor Patient Median Survival - Months 9 Data to be provided at ASCO 2022
*These numbers reflect data as of evaluation of 25 patients; numbers will change as more patients undergo
evaluation, includes both CPI refractory and naïve patients. PDS0101: Triple Combo Versamune® induced HPV-16 CD8+ killer T-cells 0% 25% 50% 75% HPV-16 Positive HPV-16 Negative Historical Check Point Inhibitor Efficacy 0%
(0/7) 12% -24% Triple Combo: PDS0101 + bintrafusp alfa + M9241 Advanced cancer patients with tumor shrinkage who had failed prior therapy 67% (12/18)* 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. 10 Percent of Patients
Phase 2: PDS0101 + KEYTRUDA® Company-sponsored trial for the treatment of HPV16-positive
metastatic/recurrent head and neck cancer (VERSATILE-002) Achieved Safety data presented at Head and Neck Symposium Q1 2022 Preliminary efficacy data released; achieved initial efficacy milestone Q1 2022 in Group 1 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 patients Group 2: ORR in patients who have failed checkpoint inhibitor therapy (CPI refractory) Trial
Partner Confirmation that PDS0101 enhances the therapeutic benefit of checkpoint inhibitors could expand evaluation of Versamune®-based therapies in multiple cancer indications 11 Timing Detail preliminary safety and efficacy data to be
presented at ASCO 2022
Phase 2: PDS0101 + Chemoradiotherapy Investigator-led trial evaluating the combination in patients with
locally advanced cervical cancer (IMMUNOCERV) Timing Preliminary data anticipated late Q3 2022 Indication Treatment of patients with locally advanced cervical cancer–Stages IB3-IVA Clinical Agents Chemoradiotherapy (CRT –Standard of
Care): Cisplatin and radiation therapy PDS0101: 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) Trial
Partner If successful, this study could support further investigation of Versamune®-based immunotherapies in combination with chemotherapy or CRT to treat multiple cancers 3 12
KEYTRUDA®: Cisplatin and radiation therapy 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 Approved by
the IRB and anticipate enrollment will begin in Q2 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 13
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 14
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 15
Projected Milestones Through 1Q 2023* *Based on current enrollment and forecast modeling as of March
2022. Subject to change. 16 1H21 2H21 1Q22 2Q22 3Q22 4Q22 PDS0101 Interim data from HPV-associated cancer trial ASCO - (NCI) Completed enrollment of HPV- associated cancer trial CPI refractory arm (NCI) Preliminary data from
VERSATILE- 002 (KEYTRUDA® combo) (go, no go) Anticipated preliminary data from IMMUNOCERV (MD Anderson) Estimated IND filing in MUC1-related cancers PDS0103 Anticipate preliminary efficacy data from Mayo Clinic IIT 1Q23 Updated
preliminary safety and updated efficacy data from NCI trial accepted at ASCO Preliminary safety and efficacy data (KEYTRUDA® combo) accepted at ASCO
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 18
PDS0202: Universal Prevention of Influenza Provided Effective Neutralization Against Multiple Strains
of Flu Viruses in Preclinical Study Reference: Ross T. and Woodward J. et al. evaluation of the PDS0202 (Infectimune™+ COBRA) Universal flu formulation. Average HAI Neutralization Titer Levels Induced by PDS0202 for Various Flu Strains vs
Required Levels 40 590 200 AVERAGE HAI NEUTRALIZATION INEFFECTIVE ZONE 760 800 8 10 10 7 H1 flu protein + Infectimune H1 flu protein Average HAI Titers A / California / 07 / 2009 A / Michigan / 15 / 2014 A / Brisbane / 02 / 2018
(BR18) A / Guangdong-Maonan / SWL1536 / 2019 (GD19) H1N1 Strains 19
Reference: Ross T. and Woodward J. et al. evaluation of the PDS0202 (Infectimune™+ COBRA) Universal flu
formulation. PDS0202: Universal Prevention of Influenza Provided Protection in Preclinical Study in Keeping Subjects 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 20 % of Protection of Subjects Challenged with the Flu
Virus Treatment Regimen
20 Infectimune™ Pipeline Highlights License agreement with University of Georgia for proprietary influenza
antigensPositive top-line preclinical data announced; effective delivery of flu proteins activate the critical immune signals necessary to generate powerful neutralizing antibody responses to all flu strains testedPreclinical data submitted
for peer-reviewed publication Decided to strategically shift focus to Universal Influenza VaccinesFarmacore licensing agreement expires May 31, 2022 Universal Influenza Vaccines COVID 21
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 22
1 2 4 5 6 Company Overview Clinical-stage Company developing molecularly targeted immunotherapies
to treat cancer and infectious disease Versamune® and Infectimune™ platforms leverage the body’s own defense systems to induce disease-specific killer T-cells and antibodies to combat cancer and infectious disease Data accepted for two poster
presentations at ASCO – additional data anticipated in 2022 Clinical partnerships with Merck, MD Anderson Cancer Center, National Cancer Institute and Mayo Clinic Debt free with approximately $58.9M in cash (unaudited) as of March 31,
2021 3 The initial concept for Versamune® and Infectimune™ was developed by Prof. Leaf Huang PH.D., a world renowned pioneer in nanoparticle drug delivery 23
Precision Designed Science INVESTOR PRESENTATIONNASDAQ: PDSB | May 2022