Exhibit 99.1
Precision Designed Science For Immunotherapy Post-ASCO Presentation NASDAQ: PDSB | June 7, 2022
2 Certain information in this presentation may include forward-looking statements (including within the
meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These
statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and
information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,”
“would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions. Forward-looking statements are based on current beliefs and assumptions that are
subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the
Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity
financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s
operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s
prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other
Versamune® and Infectimune™-based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning
PDS0101, PDS0203 and other Versamune® and Infectimune™-based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future
success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of
initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations
at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing
clinical trials; 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, PDS0101, PDS0203 and other Versamune® and
Infectimune™-based product candidates; 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 of
PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Forward-Looking Statements 2
More than 46,0002 patients were estimated to have been diagnosed last year with HPV-associated cancers in
the US1,2 HPV vaccination is not expected to impact the rate of HPV-related cancer incidence for decades3 Existing immunotherapies cost $150,000+ annually per patient1 US HPV-associated cancer incidence2 1Company estimates based on CDC
data. Assessments have not been adjusted to reflect HPV16-expression 2CDC website 3 Projected Association of Human Papillomavirus Vaccination with Oropharynx Cancer in the US 2020-2045, JAMA Oncology, September 2021 PDS0101: Lead
Asset Designed to treat human papillomavirus (HPV16)-associated cancers $6B Market Opportunity1 Reference: Data on file. 3
Lesion regression in 8/10 CIN patients within 3 months of treatment (retrospective analysis) No
recurrence within 2-year evaluation period suggests durable immune responses Phase 1 Trial: PDS0101 Monotherapy CD8+ T cell induction with memory T cell response demonstrated 4 PDS0101 T cell induction on Days 14-19 after SC injection
Predominant HPV16-specific CD8+ T cell responses confirmed by Granzyme-b ELISPOT 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 Response IFN-γ
ELISPOT Patient 5-1 5-4 2-1 2-3 Low Medium HLA Type A2 A1, A2, A3, 30 HPV-specific T cell Response IFN-γ ELISPOT Pre-treatment Post-treatment *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.
Phase 2: PDS0101 in Combination with KEYTRUDA® Company-sponsored trial for the treatment of
HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002) Status Fast Track designation Q2 2022 Efficacy and safety data presented on first 19 patients at ASCO Q2 2022 Safety data presented at Head and Neck Symposium Q1
2022 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 1st 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 5
Phase 2: PDS0101 + KEYTRUDA® Company-sponsored trial for the treatment of HPV16-positive
metastatic/recurrent head and neck cancer (VERSATILE-002) 6 Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) N=17 Subjects w/Imaging Data OR (2 CR + 5PR) 7 (41.2%) SD (reduction in 4/6) 6
(35.3%) PD 4 (23.5%) CR+PR+SD 13 (76.5%) *Reference: Weiss J. et al. Phase II study VERSATILE-002 evaluation of PDS0101 and KEYTRUDA® in treatment of CPI naïve and CPI refractory patients with recurrent or metastatic HPV16-related HNSCC..
Presented at: American Society of Clinical Oncology 2022 Annual Meeting; June 3-7, 2022; Virtual. Abstract: 6041.
Phase 2: PDS0101 + KEYTRUDA® Company-sponsored trial for the treatment of HPV16-positive
metastatic/recurrent head and neck cancer (VERSATILE-002) 7 Treatment Emergent Adverse Events (TEAEs) Safety Population (N=19) CPI Naïve Subjects (N=19) N (%) : Events Subjects with any TEAEs Grade 1 Grade 2 Grade 3 Grade 4 Grade
5 18 (94.7%) : 371 3 (15.8%) : 3038 (42,1%) : 51 5 (26.3%) : 110 (0.0%) : 4 2 (10.5%) : 2 ≥ Grade 3 TEAEs Attributed to Study Treatment by Investigator No subjects met this criteria 0 Grade 3 & 4 Treatment Related TEAEs No
subjects met this criteria 0 At 9 Months of Follow Up (Median PFS not yet Achieved) % of Patients Alive at Median 9 Months 89% Progression Free Survival Rate (PSF) 55.2% Overall Survival Rate (OS) 87.2% *Reference: Weiss J. et al.
Phase II study VERSATILE-002 evaluation of PDS0101 and KEYTRUDA® in treatment of CPI naïve and CPI refractory patients with recurrent or metastatic HPV16-related HNSCC.. Presented at: American Society of Clinical Oncology 2022 Annual Meeting;
June 3-7, 2022; Virtual. Abstract: 6041.
Phase 2: PDS0101 + Bintrafusp alfa + M9241 (Triple Combination) NCI-led trial for the treatment of
HPV16-positive anal, cervical, head and neck, penile, vaginal, vulvar cancers Status Updated efficacy and safety data released at ASCO Q2 2022 Preliminary efficacy and safety data released at ASCO Q2 2021 Indication Treatment of patients
with advanced refractory HPV16-associated cancers Clinical Agents Bintrafusp alfa: Bifunctional checkpoint inhibitor (PD-L1/ TGF-β) M9241 (NHS-IL12): Tumor-targeting IL-12 (immunocytokine) PDS0101: Versamune®-based immunotherapy generating
HPV-specific CD8+ and CD4+ T cells Study Goals Group 1: Objective response rate (ORR) as 2nd line treatment in checkpoint inhibitor (CPI) naïve patients Group 2: ORR in patients who have failed CPI 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 8
PDS0101 Designed to Promote Efficacy in HPV16 Cancers Studies show key contributions of PDS0101, M9241
& Bintrafusp alfa* to clinical response to date 9 *Bintrafusp alfa monotherapy showed 30% ORR in CPI naïve and 10% ORR in CPI refractory HPV-positive cancers (Strauss et al, 2020, Dec 8(2) **All HPV16 negative and 80% of HPV16 positive
patients had high dose M9241 Tumor reduction only seen in HPV16-positive patients P<0.001 High dose M9241 provides superior ORR vs. low dose P<0.01 Reference: Strauss J. et al. Phase II evaluation of the triple combination of
PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malignancies. Presented at: American Society of Clinical Oncology 2022 Annual Meeting; June 3-7, 2022; Virtual. Abstract: 2518.
Best Overall Response Active Against Diverse HPV16 Cancers PDS0101: Triple Combination Active Against
HPV16 Cancer Responses to date across tumor types and higher NHS-IL12 dose show the potential to result in greater clinical efficacy 10 *HNSCC – head and neck squamous cell carcinomas Higher M9241
Dose Cervical Vaginal/Vulvar Anal HNSCC* Percentage Change Weeks Baseline Responses Occurred Irrespective of Tumor Type Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa
in patients with HPV 16 positive malignancies. Presented at: American Society of Clinical Oncology 2022 Annual Meeting; June 3-7, 2022; Virtual. Abstract: 2518.
Phase 2: Triple Combination May Extend Patient Survival High dose M9241 may provide improved synergy
with PDS0101 11 CPI Naïve Subjects CPI Refractory Subjects Objective Response Rate (ORR) > 30% tumor shrinkage High Dose M9241 - 83% Low Dose M9241 (2/2) - 100% Overall - 88% High Dose M9241 - 63% Low Dose M9241 - 7% Overall -
27% Tumor shrinkage 88% High Dose M9241 - 63% Low Dose M9241 - 36% Overall - 45% Patient survival at median 12 months NA High Dose - 77% Low Dose - 77% Patient survival at median 17 months 75% NA Reference: Strauss J. et al. Phase
II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malignancies. Presented at: American Society of Clinical Oncology 2022 Annual Meeting; June 3-7, 2022; Virtual. Abstract: 2518.
Versamune® + M9241 May Overcome CPI-Independent Tumor T Cell Evading Mechanisms Potential to advance
cancer immunotherapy 12 Tumors blocking T cell attack using immune checkpoints Tumors blocking T cell attack using alternative immune suppressive mechanisms KEYTRUDA® unlocks checkpoint-dependent immune suppressive mechanism – PDS0101
primes T cells to attack and kill the cancers Tumors blocking T cell attack using immune checkpoints Tumors blocking T cell attack using alternative immune suppressive mechanisms Versamune® + M9241 may unlock checkpoint-independent immune
suppressive mechanisms* and M9241 may induce tumor inflammation – PDS0101 primes T cells to attack and kill the cancers exposed by both CPI and Versamune® + M9241 PDS0101 + KEYTRUDA® PDS0101 + M9241 + Bintrafusp alfa (41% ORR) (88%
ORR) *Johnson K. et al; PDS Biotech US Patent #10,828,364
Next Steps 13 Align with FDA on regulatory pathway, timing and trial design for pivotal
trials VERSATILE-002: PDS0101 + KEYTRUDA® Fast track designation successfully granted by FDA on 06/01/2022 Triple combination: PDS0101 + high dose M9241 + Bintrafusp alfa Anticipate discussions with the FDA in Q3 2022 Expansion of
VERSATILE-002 to Europe: If pivotal trial is initiated, we will facilitate recruitment and execution of the trial Could facilitate EU product registration Cost estimates already included in previously announced cash burn projections
Conclusions 14 We believe Versamune® proof-of-concept data has been successfully demonstrated In vivo
CD8+ T cell induction may promote synergy with CPI and enhanced clinical efficacy Lack of severe adverse events to date may represent an advantage for PDS0101 combination therapy Versamune® and M9241 may overcome additional immune suppressive
mechanisms May result in broader patient responses and survival May result in effective treatment of CPI refractory patients No control or comparative studies have been conducted between checkpoint inhibitors and PDS0101
Precision Designed Science For Immunotherapy Q&A Session NASDAQ: PDSB | June 7, 2022