PDSB 8-K
PDS Biotechnology Corp (PDSB)
8-K
2021-08-12
For: 2021-08-12
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): August 12, 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 ☐
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Item 2.02
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Results of Operations and Financial Conditions.
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On August 12 2021, PDS Biotechnology Corporation (the “Company”) issued a press release announcing its financial results for the three months ended June 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.
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Other Events.
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On August 12, 2021, the Company updated its corporate
presentation slide deck. A copy of the slide deck is filed as Exhibit 99.2 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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| 99.1 | Press Release, dated August 12, 2021. | |
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Updated Corporate Presentation August 2021.
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104
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Cover Page Interactive Data File (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: August 12, 2021
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By: /s/ Frank Bedu-Addo, Ph.D.
Name: Frank Bedu-Addo, Ph.D.
Title: President and Chief Executive Officer
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Exhibit 99.1
PDS Biotech Provides Business Update and Reports Second Quarter 2021 Financial Results
FLORHAM PARK, N.J., August 12, 2021 (GLOBE NEWSWIRE) --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, will discuss its financial results for the quarter ended June 30, 2021 and provide a business update on its conference call today.
Recent Business Highlights:
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Presented interim Phase 2 clinical data for lead product PDS0101, in an oral presentation at the American Society for Clinical Oncology (ASCO) 2021 Annual Meeting. In the National Cancer Institute-led study, tumor reduction was observed
in 83% (5 of 6) of advanced HPV16-positive cancer patients who had relapsed or failed treatment with chemotherapy and radiation but had not been treated with checkpoint inhibitor therapy. Tumor reduction was reported in 58% (7 of 12) of
HPV16-positive patients who in addition had also failed checkpoint inhibitor therapy.
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Completed approximately $52 Million public offering that will support next phase of company growth through advancement of PDS0102 and PDS0103 into human clinical trials.
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Received $4.5 Million from the sale of Net Operating Loss tax benefits through the New Jersey Economic Development Program.
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Appointed immuno-oncology experts Dr. Olivera Finn and Dr. Mark Frohlich to Scientific Advisory Board.
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Expanded VERSATILE-002 study of PDS0101 and KEYTRUDA® in advanced head and neck cancer to include patients who have failed prior treatment with checkpoint
inhibitors.
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Added to Russell Microcap® Index as part of the 2021 annual reconstitution based on market-capitalization rankings and style attributes.
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“The second quarter has been quite significant for PDS Biotech in providing the first demonstration of the clinical potential of the Versamune®-based products in
treating advanced, treatment-resistant cancers. We believe the unprecedented objective responses and tumor reduction observed in our most advanced PDS0101 phase 2 clinical trial demonstrate the potential of the Versamune® platform to overcome one of the most significant limitations preventing broadly effective cancer immunotherapy. Versamune® has the potential to induce high levels of potent tumor-specific killer T-cells that may attack and eliminate the cancer,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “Our capital raise
of approximately $52M in June, further strengthens our balance sheet and provides us with the capital necessary to continue advancing our promising immuno-oncology pipeline. Renowned experts in fields of prostate and MUC1 associated cancers joined
our Scientific Advisory Board to facilitate development of our pipeline products. The Company is well positioned and now has the momentum to move quickly to the next phase of growth by accelerating advancement of PDS0102 and PDS0103 into clinical
trials.”
Interim Study Results in NCI-Led Phase 2 Clinical Study of PDS0101 Highlight Potential of Versamune®
In June, the Company reported interim Phase 2 clinical trial data from one of three ongoing PDS0101 Phase 2 trials at the American Society for Clinical Oncology (ASCO) 2021 Annual Meeting. This Phase 2 trial is studying PDS0101 (Versamune®-HPV16) in combination with two investigational immune-modulating agents: Bintrafusp alfa (M7824), a bifunctional “trap” fusion protein targeting TGF-β and PD-L1, and
NHS-IL12 (M9241), a tumor-targeting immunocytokine. PDS0101 is an investigational immunotherapy designed to treat cancers caused by infection with HPV16 (HPV16-positive cancers) by training and activating the immune system to produce large numbers
of in vivo CD8+ (killer) T-cells to target and kill tumors that are HPV16-positive.
Analysis of the interim clinical data showed that of the initial six HPV16-positive patients who had not been treated with checkpoint inhibitors, 83% (5 of 6) of the patients demonstrated an objective response (tumor reduction >30%). One
patient had achieved a complete response. The reported objective response rate with current standard of care checkpoint inhibitor treatment is 12-24%. It was also reported that 100% (6/6) of the patients were still alive (median 8 months). The
historical average (median) survival or life span for this patient population is 7-11 months.
Of the twelve HPV16-positive patients who had also failed treatment with checkpoint inhibitors after failing chemotherapy and radiation treatment, tumor reduction was observed in 58% (7/12). An objective response rate of 42% (5/12) and one
complete response had already been achieved at the time of reporting in June. The objective response rate reported with the standard of care in this population is 5-12%. It was also reported that 83% (10/12) were still alive (median 8 months). The
historical median survival or life span for this patient population is only 3-4 months.
Second Quarter 2021 Financial Results
PDS Biotech reported a net loss of approximately $0.6 million, or ($.03) per basic share and diluted share, for the three months ended June 30, 2021 compared to a net loss of approximately $2.9 million, or ($0.19) per basic share and diluted
share, for the three months ended June 30, 2020. The lower net loss reported for the three months ended June 2021 is primarily due to $4.5 million received from the sale of our NJ tax benefits pursuant to the
New Jersey Technology Business Tax Certificate Transfer Net Operating Loss program.
Research and development (R&D) expenses increased 95% to approximately $2.8 million for the three months ended June 30, 2021 from approximately $1.4 million for the three months ended June 30, 2020. A
significant portion of the increase is attributable to clinical expenses related to VERSATILE-002 which is enrolling and progressing according to schedule. Preliminary data on the trial is expected as previously projected in Q4 2021 or Q1 2022.
The increase of $1.3 million in 2021 was primarily attributable to an increase of $0.2 million in personnel costs, $1.0 in clinical studies and $0.1 million in manufacturing.
General and administrative expenses increased to $2.3 million for the three months ended June 30, 2021 from $1.5 million for the three months ended June 30, 2020. The increase of $0.8 million is
primarily attributable to an increase in personnel costs of $0.6 million and an increase in professional services of $0.2 million..
Total operating expenses increased 74% to approximately $5.1 million for the three months ended June 30, 2021 from approximately $2.9 million for the three months ended June 30, 2020.
PDS Biotech’s cash balance as of June 30, 2021 was approximately $74.7 million.
Conference Call and Webcast
The conference call is scheduled to begin at 8:00 am ET on Thursday, August 12, 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 13721612.
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.
PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.
Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended)
concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on
current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to
future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “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]
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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June 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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74,749,201
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$
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28,839,565
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Prepaid expenses and other
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2,185,189
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1,497,665
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Total current assets
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76,934,390
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30,337,230
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Property and equipment, net
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2,310
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5,443
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Operating lease right-to-use asset
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454,026
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547,706
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Total assets
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$
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77,390,726
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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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2,375,363
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$
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1,415,224
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Accrued expenses
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1,469,792
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1,735,322
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Operating lease obligation-short term
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157,663
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119,904
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Total current liabilities
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4,002,818
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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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395,314
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490,353
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Total Liabilities
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$
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4,398,132
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$
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3,760,803
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STOCKHOLDERS’ EQUITY
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Common stock, $0.00033 par value, 75,000,000 shares authorized at June 30, 2021 and December 31, 2020, 28,417,909
shares and 22,261,619 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively
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9,377
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7,346
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Additional paid-in capital
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120,405,851
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70,907,315
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Accumulated deficit
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(47,422,634
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)
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(43,785,085
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)
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Total stockholders’ equity
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72,992,594
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27,129,576
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Total liabilities and stockholders’ equity
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$
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77,390,726
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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 June 30,
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Six Months Ended June 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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2,764,195
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$
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1,414,225
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$
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4,177,252
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$
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3,385,904
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General and administrative expenses
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2,341,828
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1,521,736
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3,978,044
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3,581,884
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Total operating expenses
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5,106,023
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2,935,961
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8,155,296
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6,967,788
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Loss from operations
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(5,106,023
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)
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(2,935,961
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)
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(8,155,296
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)
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(6,967,788
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)
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Interest income
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604
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6,617
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1,259
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53,036
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Loss before income taxes
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(5,105,419
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)
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(2,929,344
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)
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(8,154,037
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)
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(6,914,752
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)
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Benefit for income taxes
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4,516,488
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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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(588,931
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)
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(2,929,344
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)
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(3,637,549
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)
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(6,914,752
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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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(0.03
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)
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$
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(0.19
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)
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$
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(0.16
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)
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$
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(0.54
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)
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Weighted average common shares outstanding, basic and diluted
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23,160,371
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15,357,199
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22,714,581
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12,835,980
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Exhibit 99.2
CORPORATE OVERVIEW Frank Bedu-Addo Ph.D. President & CEO AUGUST 2021
* 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’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:
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based
on the proprietary Versamune® platform * 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 Institute18 employees with headquarters in
Florham Park, NJDebt free with approximately $74.7M in cash as of June 30, 2021 PIPELINE VERSAMUNE® PLATFORM CORPORATE OVERVIEW
PDS Biotech executive team has demonstrated success in the development and commercialization of
leading pharmaceutical products * 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 Senior executive
experience with over 20 years of experience in high tech companiesIn-depth experience with M&A transactions, capital markets, business development and investor relations Seth Van Voorhees, PhDChief Financial Officer
PDS Biotech’s robust Versamune® -based pipeline is being developed in partnership with leaders in
immuno-oncology and infectious disease * 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
* Approximately 43,000 patients are diagnosed with HPV-associated cancers annually in the US
alone1Cancers caused by HPV include anal, cervical, head and neck, penile vaginal and vulvar cancersIncidence rate of HPV-related head and neck and anal cancer is growing and remains a significant unmet medical needExisting immunotherapies
cost $120,000+ annually per patient 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. PDS0101 is designed to treat advanced human papillomavirus (HPV)-16 cancers which represents 70-80% of the HPV-associated cancer market
Sub-cutaneous injection of PDS0101 monotherapy induced high quantity of potent HPV16-specific
CD8+T-cells in Phase 1 clinical trial * 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 *
Phase 2 NCI-led clinical trial evaluating the triple combination of PDS0101, Bintrafusp alfa and
M9241 in advanced HPV-associated cancer * 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
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 * 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
ASCO 2021: PDS0101 triple combination achieved 83% ORR among six advanced HPV16-positive CPI naive
patients, suggesting potential efficacy * 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 * 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)
* ASCO 2021: Triple combination shows promising durability of the 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 * 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
* 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 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
* 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
Development of PDS0102
* * 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
* * 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.
* * 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 August
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) * PDS Biotech Funded Clinical Trials Partner Co-Funded Clinical Trials 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
PDS Biotech’s robust Versamune® -based oncology pipeline is being developed in partnership with the
leaders in immuno-oncology * Reference: Data on file.
Versamune® is designed to induce a robust and targeted anti-tumor response in vivo when administered
with a tumor-associated antigen * 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. Promotes uptake of vaccine or immunotherapy and entry into
lymph nodes Promotes antigen processing and presentation to T-cells via MHC I and II pathways Activates Type I Interferon pathway, enabling a powerful anti-tumor killer CD8+ T-cell response Versamune® + Tumor-associated proteins
(antigens)
Greater quantity and quality of Versamune®-induced killer T-cells may result in unique ability to
eradicate HPV-positive tumors after a single dose * 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)
* 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
* 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
* Reference: Data on file. Versatility of Versamune®: Potent TRP2-specific CD8+ killer T-cells
break immune tolerance in difficult-to-treat B16 melanoma * 14 days after single injection treatment Potent activity with different tumor antigens
Immunotherapeutics ORR in HPV-associated malignancies * 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
* 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 * * 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.