PDSB 8-K
PDS Biotechnology Corp (PDSB)
8-K
2021-05-13
For: 2021-05-13
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 13, 2021
PDS BIOTECHNOLOGY CORPORATION
(Exact Name of Registrant as Specified in Charter)
|
Delaware
|
001-37568
|
26-4231384
|
||
|
(State or Other Jurisdiction of Incorporation)
|
(Commission File Number)
|
(I.R.S. Employer Identification No.)
|
25B Vreeland Road, Suite 300, Florham Park, NJ 07932
(Address of Principal Executive Offices, and Zip Code)
(800) 208-3343
Registrant’s Telephone Number, Including Area Code
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
|
☐
|
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
|
☐
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
☐
|
Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
☐
|
Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
|
Common Stock, par value $0.00033 per share
|
PDSB
|
The Nasdaq Capital Market
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act
of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange
Act. Yes ☐ No ☐
| Item 2.02 |
Results of Operations and Financial Conditions.
|
On May 13, 2021, PDS Biotechnology Corporation (the “Company”) issued a press release announcing its financial results for the three months ended March 31, 2021 and provided an update on the
Company’s operations. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information set forth in this Current Report on Form 8-K (including Exhibit 99.1) is deemed to be “furnished” and shall not be deemed to
be “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the
Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
| Item 8.01 |
Other Events.
|
On May 13, 2021, 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.
| Item 9.01 |
Financial Statements and Exhibits.
|
(d) Exhibits.
|
Exhibit Number
|
Description
|
|
|
Press Release, dated May 13, 2021.
|
||
| 99.2 |
PDS Corporate Presentation May 2021 |
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
PDS BIOTECHNOLOGY CORPORATION
|
||
|
Date: May 13, 2021
|
By: |
/s/ Frank Bedu-Addo, Ph.D.
|
|
Name: Frank Bedu-Addo, Ph.D.
Title: President and Chief Executive Officer
|
||
Exhibit 99.1
PDS Biotech Provides Business Update and Reports First Quarter 2021 Financial Results
FLORHAM PARK, N.J., May 13, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and
infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, will discuss its financial results for the quarter ended March
31, 2021 and provide a business update on its conference call today.
Recent Business Highlights:
|
•
|
National Cancer Institute to present interim efficacy and safety data of PDS0101 Phase 2 clinical trial in an oral presentation at the American Society of Clinical Oncology
(ASCO) 2021 Annual Meeting on June 7, 2021. This trial is evaluating PDS0101 with two clinical stage immunotherapies from EMD Serono, a first in class bifunctional checkpoint inhibitor Bintrafusp Alfa (M7824) and an antibody
conjugated cytokine M9241 (NHS-IL12), in patients with all types of advanced HPV-associated cancers, whose cancer has returned or spread after treatment.
|
|
•
|
COVID-19 consortium received a commitment from the Secretary for Research and Scientific Training of The Ministry of Science, Technology and Innovation of Brazil (MCTI) to fund up to
approximately US$60 million to support the clinical development and commercialization of a Versamune®-based COVID-19 vaccine by Farmacore in Brazil.
|
“We look forward to the presentation of preliminary efficacy and safety data from the National Cancer Institute (NCI)-led Phase 2 combination study of PDS0101 at the ASCO conference
in early June. ASCO provides an important opportunity to present the potential of PDS0101 and the Versamune® platform in oncology to the research and medical
community,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech, “The presentation of the human clinical efficacy data at ASCO is an important milestone both for PDS0101 and our entire Versamune®-based oncology pipeline.”
First Quarter 2021 Financial Results
PDS Biotech reported 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 compared to a net loss of
approximately $4.0 million, or $0.39 per basic share and diluted share, for the three months ended March 31, 2020.
Research and development (R&D) expenses decreased 28% to approximately $1.4 million for the three months ended March 31, 2021 from approximately $2.0 million for the three months
ended March 31, 2020. The decrease of approximately $0.6 million in 2021 was primarily attributable to a decrease of $0.3 million in professional services and $0.3 million in clinical studies.
General and administrative expenses decreased 21% to approximately $1.6 million for the three months ended March 31, 2021 from approximately $2.1 million for the three months ended
March 31, 2020. The decrease of approximately $0.5 million is primarily attributable to a decrease in professional services of approximately $0.7 million which includes legal fees of approximately $0.2 million, offset by an increase of
approximately $0.2 million in personnel costs.
Total operating expenses decreased 24% to approximately $3.0 million for the three months ended March 31, 2021 from approximately $4.0 million for the three months ended March 31,
2020.
PDS Biotech’s cash balance as of March 31, 2021 was approximately $25.0 million.
Conference Call and Webcast
The conference call is scheduled to begin at 8:00 am ET on Thursday, May 13, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention
PDS Biotech. Participants can also access the conference call via webcast on the investor relations page of the Company’s corporate website (link).
The event will be archived in the investor relations section of 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 13716518.
About PDS Biotech
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s
proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products 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. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The Company’s lead investigational
cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. 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® 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; 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 Biotechnology
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
|
March 31, 2021
|
December 31, 2020
|
|||||||
|
ASSETS
|
(unaudited)
|
|||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$
|
25,037,374
|
$
|
28,839,565
|
||||
|
Prepaid expenses and other
|
2,219,514
|
1,497,665
|
||||||
|
Total current assets
|
27,256,888
|
30,337,230
|
||||||
|
Property and equipment, net
|
3,583
|
5,443
|
||||||
|
Operating lease right-to-use asset
|
501,194
|
547,706
|
||||||
|
Total assets
|
$
|
27,761,665
|
$
|
30,890,379
|
||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
|
LIABILITIES
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
950,598
|
$
|
1,415,224
|
||||
|
Accrued expenses
|
1,854,795
|
1,735,322
|
||||||
|
Operating lease obligation-short term
|
123,654
|
119,904
|
||||||
|
Total current liabilities
|
2,929,047
|
3,270,450
|
||||||
|
Noncurrent liability:
|
||||||||
|
Operating lease obligation-long term
|
458,291
|
490,353
|
||||||
|
Total Liabilities:
|
$
|
3,387,338
|
$
|
3,760,803
|
||||
|
STOCKHOLDERS' EQUITY
|
||||||||
|
Common stock, $0.00033 par value, 75,000,000 shares authorized at March 31, 2021 and December 31, 2020, 22,278,261 shares and 22,261,619 shares issued and outstanding at March 31, 2021 and
December 31, 2020, respectively
|
7,346
|
7,346
|
||||||
|
Additional paid-in capital
|
71,200,684
|
70,907,315
|
||||||
|
Accumulated deficit
|
(46,833,703
|
)
|
(43,785,085
|
)
|
||||
|
Total stockholders' equity
|
24,374,327
|
27,129,576
|
||||||
|
Total liabilities and stockholders' equity
|
$
|
27,761,665
|
$
|
30,890,379
|
||||
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
|
Three Months Ended March 31,
|
||||||||
|
2021
|
2020
|
|||||||
|
Operating expenses:
|
||||||||
|
Research and development expenses
|
$
|
1,413,057
|
$
|
1,971,679
|
||||
|
General and administrative expenses
|
1,636,216
|
2,060,148
|
||||||
|
Total operating expenses
|
3,049,273
|
4,031,827
|
||||||
|
Loss from operations
|
(3,049,273
|
)
|
(4,031,827
|
)
|
||||
|
Other income
|
||||||||
|
Interest income
|
655
|
46,419
|
||||||
|
Net loss and comprehensive loss
|
$
|
(3,048,618
|
)
|
$
|
(3,985,408
|
)
|
||
|
Per share information:
|
||||||||
|
Net loss per share, basic
|
$
|
(0.14
|
)
|
$
|
(0.39
|
)
|
||
|
Net loss per share, diluted
|
$
|
(0.14
|
)
|
$
|
(0.39
|
)
|
||
|
Weighted average common shares outstanding, basic
|
22,263,838
|
10,314,761
|
||||||
|
Weighted average common shares outstanding, diluted
|
22,263,838
|
10,314,761
|
||||||
Exhibit 99.2
CORPORATE OVERVIEW Frank Bedu-Addo Ph.D. President & CEO MAY 2021
2 Forward-Looking Statements This presentation contains forward-looking statements about PDS
Biotechnology Corporation (“PDSB”), and its businesses, business prospects, strategies and plans, including but not limited to statements regarding anticipated pre-clinical and clinical drug development activities and timelines and market
opportunities. All statements other than statements of historical facts included in this presentation are forward-looking statements. The words “anticipates,” “may,” “can,” “plans,” “believes,” “estimates,” “expects,” “projects,” “intends,”
“likely,” “will,” “should,” “to be,” and any similar expressions or other words of similar meaning are intended to identify those assertions as forward-looking statements. These forward-looking statements involve substantial risks and
uncertainties that could cause actual results to differ materially from those anticipated.Factors that may cause actual results to differ materially from such forward-looking statements include those identified under the caption “Risk
Factors” in the documents filed with the Securities and Exchange Commission 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.
3 PDS Biotech’s Versamune®-based immunotherapies promote a powerful in vivo tumor-specific CD8+
killer T-cell response Generate a strong CD8+ T-cell memory response resulting in long-lasting efficacy Are versatile and shown to be effective on their own or in combination with other drugs to improve their efficacy Generate potency
without systemic side effects The most significant barrier to effective immunotherapy has been their inability to promote adequate CD8+ killer T-cell responses in vivo resulting in diminished efficacy Versamune®-based therapies also:
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on
the proprietary Versamune® platform 4 NCI-initiated phase 2 HPV-cancer trial surpassed initial efficacy requirement prompting expansion to full enrollmentNovel COVID-19 vaccine being developed in Brazil with consortium partnersMCTI, Brazil
to fund COVID-19 vaccine manufacturing scale up and clinical trialsDemonstrated to work with a wide array of oncogenes and viral antigensMultiple composition and application patents valid through mid-2030s Biopharma developing novel cancer
treatments and T-cell-activating vaccine candidates for infectious diseasesThree phase 2 oncology clinical trials in progress to initial data releases in 2021Clinical partnerships with Merck, MD Anderson and National Cancer Inst.~15 employees
with headquarters in Florham Park, NJDebt free with approximately $25.0M in cash as of 3/31/21 Pipeline Versamune® Platform Corporate Overview
PDS Biotech’s robust Versamune®-based pipeline is being developed in partnership with the leaders in
immuno-oncology and infectious disease 5 Reference: Data on file. * *Consortium of PDS Biotech, Farmacore and Blanver. Funding provided by The Ministry of Science, Technology and Innovation of Brazil (MCTI)
PDS Biotech executive team has demonstrated success in the development and commercialization of leading
pharmaceutical products 6 Senior executive experience with management of strategy and execution at both large pharma and biotechsNotable drug development:Abelcet® (Liposome Company/ Elan)PEG-Intron® (Schering-Plough/ Merck) Frank
Bedu-Addo, PhDChief Executive Officer Co-founder>35 years of drug development experience In-depth experience with biotech drug discovery, product development and manufacturing Gregory Conn, PhDChief Scientific Officer >30 years
of translational clinical research experienceFormer Director of Clinical Research at National Cancer Institute Center for Cancer Research (Cancer Vaccine Branch) Lauren V. Wood, MDChief Medical Officer 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
Introduction to the Versamune® Platform
Versamune® is designed to induce a robust and targeted anti-tumor response in vivo when administered
with a tumor-associated antigen 8 Reference: 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 9 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 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)
Phase 1 clinical trial: Powerful in-vivo CD8+ T-cell response resulted in regression of CIN cervical
lesions & supported continued clinical studies 10 * When treated with selected human clinical trial dosage (1mg and 3mg Versamune®)References: L. Wood et al. A Novel Enantio-Specific Cationic Lipid R-DOTAP + HPV16 E6 & E7 Antigens
Induces Potent Antigen-Specific CD8+ T Cell Responses In-Vivo in Subjects with CIN and High-Risk Human Papillomavirus Infection. Nov 8, 2019. SITC. Presentation O17. Most patients infected with multiple strains of HPV CIN lesion regression
at 1-3 months 60% 20% 20% Phase 1 trial results showed no serious or dose-limiting toxicities Overcomes key limitation of immuno-oncology: > 20-fold increase in circulating dual INF-γ & Granzyme-b inducing killer T-cells vs.
pre-treatment at day 14 led to rapid clearance of lesions*
Versamune®-basedImmunotherapies* Checkpoint Inhibitors Traditional Cancer
Vaccines CAR-T Induction of high levels of active CD8+ (killer) T-cells Induction of high levels of CD4+ (helper) T-cells Ability to overcome tumor immune suppression Induction of long-term memory CD8+
T-cells No dose limiting toxicities Initial data suggests Versamune® possesses the key characteristics of a safe and effective immunotherapeutic treatment *Reference: J. Immunology, 2019 (202), 1215; PDS0101 clinical
trial report (CSR U10-02-11-001) 11
PDS0101 Phase 2 Clinical Development
Combinations of PDS0101 with FDA-approved standard of careFirst line treatment of recurrent/metastatic
HPV-positive head and neck cancerCombination with Keytruda®Treatment of advanced localized cervical cancerCombination with chemoradiotherapy 13 Novel combinations of PDS0101 with promising, investigational immunotherapeutic agentsTreatment
of advanced HPV-associated cancers (anal, cervical, vaginal, head and neck etc.)Triple combination with Bintrafusp-alpha (bi-functional checkpoint inhibitor - M7824) and NHS-IL12 (antibody conjugated immuno-cytokine) Clinical strategy:
Develop PDS0101 in combination with established therapies for rapid proof-of-concept and risk mitigation
Phase 2 investigator-initiated clinical trial evaluating the combination of PDS0101, M7824 and NHS-IL12
in advanced HPV-associated cancer 14 Indication Patients with advanced HPV-associated cancer who have failed prior treatment Clinical Agents Bintrafusp alfa (M7824): Bifunctional “trap” fusion protein (ORR ~30%)M9241 (NHS-IL12):
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 45 patients triggered following achievement of objective response in ≥ 3 checkpoint inhibitor naive patientsTrial completion expected in Q1 2022 Trial
Sponsor Confirmation that PDS0101 enhances the therapeutic benefit of Bintrafusp alfa and M9241 may lead to expanded evaluation in several cancers with PDS0102, PDS0103 and PDS0104
15 Bintrafusp alfa (bi-functional checkpoint inhibitor)+ M9241 (immuno-cytokine) Tumor Regression:
8/16 (50%)T-cell Clones: 18 PDS0101 + Bintrafusp alfa + M9241 Tumor Regression: 13/17 (76%)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 In a preclinical model, PDS0101 demonstrated enhanced ability to train tumor-specific T-cells to be effective in infiltrating and killing tumors 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
Relapsed or refractory advanced HPV-related cancer presents a high bar for evaluation and significant
unmet medical needPatients who fail chemotherapy and/or radiation progress to checkpoint inhibitor therapy12-24% reported efficacy of standard of care checkpoint inhibitorsAn experimental immunotherapy (Bintrafusp alfa) has reported the
highest ORR to date in advanced HPV-associated cancer patients who are checkpoint inhibitor naive of 30%Few treatment options exist for patients who have also failed checkpoint inhibitor therapy The experimental immunotherapy (Bintrafusp
alfa) has demonstrated an ORR of 10% reported in advanced HPV-associated checkpoint inhibitor refractory cancer PDS0101 phase 2 triple combination trial: evaluates observation of superior preclinical tumor regression in advanced HPV-related
cancer 16 The most critical limitation of immunotherapy is the inability to induce large numbers of powerful tumor-attacking CD8+ (killer) T-cells within the body, that can result in tumor reduction or elimination in a significant number of
advanced cancer patients Strauss J, et al. J Immunother Cancer. 2020 Dec;8(2):e001395
17 PDS Biotech-sponsored phase 2 trial evaluating the combination of PDS0101 and KEYTRUDA for
first-line treatment of HPV-associated metastatic/recurrent head and neck cancer Indication First line treatment of patients with HPV-associated 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 Objective response rate (ORR) and overall survival (OS) Timing Preliminary data – Q4
2021/Q1 2022, ORR in first 20 patients (efficacy in 7 of 38 required to enroll all 96 patients) Trial Partner Confirmation that PDS0101 enhances the therapeutic benefit of checkpoint inhibitors could expand evaluation of Versamune®-based
therapies in multiple cancer indications
18 A Phase 2, investigator-initiated clinical trial evaluating PDS0101 in combination with
chemoradiation therapy in patients with advanced cervical cancer Indication Treatment of patients with locally advanced cervical cancer – Stages IB3-IVA Clinical Agents Chemoradiotherapy (CRT – Standard of Care): Cisplatin & radiation
therapyPDS0101: Versamune®-based immunotherapy generating HPV-specific CD8+ and CD4+ T-cells Study goals Rate of regression in patients with primary tumor ≥5cm Timing Preliminary data – Q4 2021/Q1 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 Safety and enhanced efficacy could lead to broad applications of Versamune®-based immunotherapies in combination with
chemotherapy or CRT to treat multiple cancers
Studies are designed to demonstrate efficacy and broad applicability of PDS0101 and the Versamune®
T-cell activating platform 19 Potential to enhance anti-cancer efficacy of various cancer treatments: Combinations with checkpoint inhibitors, chemotherapy and novel therapies may demonstrate Versamune®’s versatility. Broad potential for
additional partnerships: Successful phase 2 studies with PDS0101 and PDS0203 could enable a broad pipeline of Versamune®-based products containing various antigens. Potential to treat all types of HPV-cancer: PDS0101 Phase 2 clinical studies
address all types of HPV-associated cancers. Potential applications beyond oncology: PDS0203 COVID-19 phase 1/2 trials may demonstrate protection and induce durable T-cell responses against conserved regions of mutating viruses.
PDS0203 Phase 1/2 Clinical Development
Mt. Sinai data shows Versamune® promotes induction of neutralizing antibodies with lowest doses of
SARS-CoV-2 antigen1 21 1Reference: Sun et al. 2020. Vaccines Volume 8, Issue 42Reference: Data on file PDS Biotech generated data shows induction of SARS-CoV-2 specific CD8+ T-cells with Versamune®2 Preclinical studies show powerful
induction of long-lasting polyfunctional CD8+ and CD4+ anti-SARS-CoV-2 T-cells Developing a Versamune®-based COVID-19 vaccine candidate with the goal of promoting CD8+ T-cell responses and neutralizing antibodies
Development of PDS0203 may offer potential advantages as a second generation COVID-19 vaccine May be
effective against multiple COVID-19 variantsDemonstrated induction of killer CD8+ and helper CD4+ T cells that can target less variable regions of the SARS-CoV-19 virus and may be effective against currently circulating variants.May grant
long-lasting immunityDemonstrated induction of long-lasting, virus-specific memory T-cells necessary for longer term protection.High potential for safetyPDS0203 is a subunit vaccine, and does not require the use of attenuated viruses,
traditional adjuvants, DNA or RNA. Versamune®-based vaccines have shown no serious or dose limiting reactions. 22
Looking Forward
24 Approximately 43,000 patients are diagnosed with HPV-associated cancers annually in the USIncidence
rate is growing despite increased use of HPV preventative vaccinesSignificant unmet medical need across the spectrum of HPV-associated cancerExisting immunotherapies cost $120,000+ annually per patient2 1Markowitz et al. 2016. Centers for
Disease Control and Prevention. 2018.2Hernandez et al. 2018. American Journal of Managed Care Volume 24, Issue 2; Company Research Females (24,391) Males (18,280) US annual HPV-associated cancer incidence1 PDS0101 is designed to treat
cancers caused by human papillomavirus (HPV)
Consortium has received a commitment of up to ~US$60 million from MCTI, Brazil to support phase 1-3
clinical development and manufacturing scale-upPhase 1/2 study anticipated to start in Q2/Q3 of 2021 pending approval from Anvisa, Brazilian regulatory agencyPending results, PDS0203 could be commercially available in Brazil in 2023Initial
target market – Latin America ~ 650 million people (Brazil ~213 million people)1Based on public information, COVID-19 vaccine prices range from $20-74 for a two-dose regimen2 PDS0203 may offer another option to address the COVID-19 global
health crisis 1The World Population Review. 2021.2Comparing COVID-19 Vaccines: Timelines, Types and Prices, BioSpace, 2/8/21; Company Research 25
Projected milestones through 2022* *Based on current enrollment and forecast modeling as of April
2021. Subject to change.**Consortium funding provided by MCTI, Brazil 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) expected Preliminary Data from ImmunoCerv combo trial (MD Anderson) expected Potential interim data from VERSATILE-002 (Keytruda combo) Initiation of Phase 1/2 COVID clinical trial of PDS0203 Initiation of Phase 3 COVID clinical
trial of PDS0203 Efficacy data from Phase 3 COVID clinical trial of PDS0203 Completion of HPV-associated cancer trial (NCI) PDS0101 PDS0203** 26 PDS Biotech Funded Clinical Trials Partner Co-Funded Clinical Trials
Versamune® has demonstrated the potential for immunological compatibility with a wide array of tumor
and pathogenic antigens Reference: Clin Cancer Res. 2009 Sep 1;15(17):5323-37. doi: 10.1158/1078-0432.CCR-09-0737 Versamune®’s unique flexibility means it may work well with a wide range of identified tumor and infectious disease
antigensToday, 4 tumor antigens are being utilized with the Versamune® platform, more than 75 tumor antigens have been identified in oncologyToday, 3 infectious disease antigens are being developed with the Versamune® platform, more than 12
infectious disease antigens have been identified as potential targetsProof of concept data from ongoing clinical trials will trigger development activities for Versamune®-based products through partnerships and licensing 27
Rapid commercialization strategy 28 Promising early data in both oncology and infectious disease:
Early clinical data and preclinical data suggest potential efficacy, safety and versatility of the Versamune® platformNear-term milestones: PDS0101 preliminary efficacy data anticipated in Q2 2021 and PDS0203 safety and immunogenicity data
projected in Q4 2021/Q1 2022Validation of approach: All three on-going phase 2 clinical trials supported and partnered with leading and top-tier institutions in the field of cancer and immuno-oncologyCommercialization path: Anticipated
commercialization of PDS0203 in Brazil in 2023 and clinical studies demonstrating enhancement of FDA-approved anti-cancer products may offer rapid path to marketRapid adoption strategy: Evaluation of PDS0101 in combination with standard of
care in multiple HPV-associated cancers Potential Advantages and Differentiators
