8-K
PDS Biotechnology Corp (PDSB)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 14, 2024
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.) |
303A College Road East,
Princeton, NJ 08540
(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)) |
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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:
| Title of each class | Trading Symbol(s) | Name of each exchange on which<br><br> <br>registered |
|---|---|---|
| Common Stock, par value $0.00033 per share | PDSB | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Yes ☐ No ☐
| Item 2.02 | Results of Operation and Financial Condition. |
|---|
On November 14, 2024, PDS Biotechnology Corporation (the “Company”) issued a press release announcing a business update and its financial results for the quarter ended September 30, 2024. 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 the section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
| Item 8.01 | Other Events. |
|---|
On November 14, 2024, the Company updated its corporate presentation deck. A copy of the corporate presentation deck is filed as Exhibit 99.2 hereto and incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
|---|
(d) Exhibits.
| Exhibit<br><br> <br>Number | Description |
|---|---|
| 99.1 | Press Release dated November 14, 2024. |
| 99.2 | Corporate Presentation (November 2024). |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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: November 14, 2024 | 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 Clinical Programs Update and Reports Third Quarter 2024 Financial Results
Conference call and webcast today at 8:30 a.m. Eastern Time
PRINCETON, N.J., November 14, 2024 -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today provided a business update and reported financial results for the third quarter of 2024.
“Since our last update in August, we have been actively engaged with investors and clinicians to discuss our strategy and funding requirements for our VERSATILE-003 Phase 3 trial of Versamune^®^ HPV + pembrolizumab compared to pembrolizumab as a potential treatment for first-line recurrent/metastatic HPV16-positive head and neck squamous cell cancer (HNSCC),” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. Dr. Bedu-Addo further noted that “based on investor feedback, discussions with key opinion leaders involved with the study and other experts, we have made minor modifications to the VERSATILE-003 trial design to reduce the overall cost and time required to achieve an interim data readout and trial completion.”
With submission of the updated Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) this week, the Company expects the FDA clearance decision by mid-December, allowing the Company to initiate site activation in the first quarter of 2025.
“Elsewhere in our pipeline, we were pleased with the data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune^®^ HPV with chemoradiation to treat locally advanced cervical cancer presented at the American Society for Radiation Oncology (ASTRO) annual meeting. The presented data demonstrated promising clinical activity and a compelling safety profile. Based on continued research in various HPV-positive cancers conducted by PDS Biotech and independent researchers who recognize its potential, Versamune^®^ HPV appears to work in combination with a variety of therapeutic agents to generate clinical responses and promote improved survival in patients with favorable toxicity. We are exploring the next steps in the development of Versamune^®^ HPV for cervical cancer,” concluded Dr. Bedu-Addo.
Recent Developments
| • | Update to Phase 3 VERSATILE-003 Trial Design in HPV16-positive first-line recurrent and/or metastatic HNSCC |
|---|
| • | Updated trial design to include approximately 350 patients |
|---|---|
| • | VERSATILE-002 results have shown broadly improving clinical responses across multiple parameters with increases in patient size and duration of patient follow up over the last year,<br> demonstrating durability of the anti-tumor responses |
| --- | --- |
| • | The design, which is informed by the observed durability of the clinical responses, retains statistical power and remains within the confines of our agreement with the FDA on<br> registrational design |
| --- | --- |
| • | Design maintains 2:1 randomization and median overall survival as primary endpoint |
| --- | --- |
| • | Design imparts potential for earlier interim readouts and study completion |
| --- | --- |
| • | Design presents potential for reduced execution costs |
| --- | --- |
| • | Amended IND (updated design) submitted November 2024 |
| --- | --- |
| • | In September 2024, we provided updated results from our VERSATILE-002 Phase 2 clinical trial in recurrent and/or metastatic HPV16-positive HNSCC patients treated with the combination of<br> Versamune^®^ HPV and pembrolizumab presented at European Society for Medical Oncology (ESMO) Congress 2024 by Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at the University of North<br> Carolina, and principal investigator of the VERSATILE-002 clinical trial. Press release here. |
| --- | --- |
| • | In October 2024, we provided updated results from our IMMUNOCERV Phase 2 clinical trial in locally advanced cervical cancer patients treated with Versamune^®^ HPV and<br> chemoradiotherapy presented at the ASTRO Annual Meeting by Adam Grippin, M.D., Ph.D., The University of Texas MD Anderson Cancer Center. Press release here. |
| --- | --- |
| • | Ravi A. Madan, M.D., Head, Prostate Cancer Clinical Research Section, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, part of the U.S. National<br> Institutes of Health presented the rationale and design of recurrent prostate cancer trial combining Xtandi^®^ + PDS01ADC vs Xtandi^®^ alone during an oral presentation at the 12^th^ Annual Meeting of the<br> International Cytokine and Interferon Society, October 2024. Press release here . |
| --- | --- |
Third Quarter 2024 Financial Results
Reported net loss was approximately $10.7 million, or $0.29 per basic share and diluted share, for the three months ended September 30, 2024, compared to a net loss of $10.8 million, or $0.35 per basic share and diluted share, for the three months ended September 30, 2023. The decrease was primarily due to lower operating expenses.
Research and development expenses increased to approximately $6.8 million for the three months ended September 30, 2024, from $6.4 million for the three months ended September 30, 2023. The increase of $0.4 million was primarily attributable to higher manufacturing expenses, partially offset by lower clinical costs and personnel expenses.
General and administrative expenses decreased to approximately $3.4 million for the three months ended September 30, 2024, from approximately $4.1 million for the three months ended September 30, 2023. The decrease of $0.7 million was primarily attributable to lower personnel costs and professional fees.
Total operating expenses decreased to approximately $10.2 million for the three months ended September 30, 2024, from $10.5 million for the three months ended September 30, 2023.
Net interest expenses increased to approximately $0.5 million for the three months ended September 30, 2024, from $0.3 million for the three months ended September 30, 2023.
Cash and cash equivalents as of September 30, 2024 totaled approximately $49.8 million.
Conference Details
Date: November 14, 2024
Time: 8:30 a.m. ET
Dial-in 1-877-704-4453 or 1-201-389-0920
Webcast Registration: Click Here
Call Me^TM^ Registration: Click Here (Available 15 minutes prior to call)
About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune^®^ HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.
For more information, please visit www.pdsbiotech.com
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 Versamune^®^ HPV, PDS01ADC 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 Versamune^®^ HPV, PDS01ADC 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 the Company’s 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; 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 Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. 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 other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. 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^®^ and Infectimune^®^ are registered trademarks of PDS Biotechnology Corporation.
Keytruda^®^ is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.
Xtandi^®^ is a registered trademark of Astellas Pharma Inc.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
Janine McCargo
6 Degrees
Phone +1 (646) 528-4034
Email: jmccargo@6degreespr.com
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
| Three Months Ended Sep 30, | Nine Months Ended Sep 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Operating expenses: | ||||||||||||
| Research and development expenses | $ | 6,803,900 | $ | 6,448,528 | $ | 18,035,762 | $ | 20,297,066 | ||||
| General and administrative expenses | $ | 3,374,794 | $ | 4,071,158 | $ | 10,924,863 | $ | 12,341,207 | ||||
| Total operating expenses | $ | 10,178,694 | $ | 10,519,686 | $ | 28,960,625 | $ | 32,638,273 | ||||
| Loss from operations | $ | (10,178,694 | ) | $ | (10,519,686 | ) | $ | (28,960,625 | ) | $ | (32,638,273 | ) |
| Interest income (expense), net | ||||||||||||
| Interest income | $ | 666,770 | $ | 739,404 | $ | 2,010,874 | $ | 2,219,399 | ||||
| Interest expense | $ | (1,214,734 | ) | $ | (1,068,887 | ) | $ | (3,577,450 | ) | $ | (3,031,129 | ) |
| Interest income (expense), net | $ | (547,964 | ) | $ | (329,483 | ) | $ | (1,566,576 | ) | $ | (811,730 | ) |
| Loss before income taxes | $ | (10,726,658 | ) | $ | (10,849,169 | ) | $ | (30,527,201 | ) | $ | (33,450,003 | ) |
| Benefit for income taxes | $ | 869,169 | $ | 1,406,021 | ||||||||
| Net loss and comprehensive loss | $ | (10,726,658 | ) | $ | (10,849,169 | ) | $ | (29,658,032 | ) | $ | (32,043,982 | ) |
| Per share information: | ||||||||||||
| Net loss per share, basic and diluted | $ | (0.29 | ) | $ | (0.35 | ) | $ | (0.82 | ) | $ | (1.04 | ) |
| Weighted average common shares outstanding basic and diluted | 36,806,592 | 30,910,520 | 36,107,900 | 30,715,458 |
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Unaudited Selected Balance Sheet Data
| Sep 30, | December 31, | |||||
|---|---|---|---|---|---|---|
| 2024 | 2023 | |||||
| Cash and cash equivalents | $ | 49,751,252 | $ | 56,560,517 | ||
| Working capital | $ | 33,791,108 | $ | 45,425,098 | ||
| Total assets | $ | 52,450,653 | $ | 59,390,080 | ||
| Long term debt | $ | 12,031,986 | $ | 19,506,183 | ||
| Accumulated deficit | $ | (174,158,647 | ) | $ | (144,500,615 | ) |
| Total stockholders’ equity | $ | 22,000,805 | $ | 26,130,947 |
Exhibit 99.2
1 © 2024 PDS Biotechnology. All Rights Reserved. Transforming How the Immune System Targets and Fights Cancer to Promote Survival Precision Designed Science For Immunotherapy NASDAQ: PDSB November 2024
Forward-Looking Statements 2 This communication contains forward-looking statements (including within the meaning of Section 27E 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 PDS01ADC, Versamune® HPV and other Versamune® and lnfectimune® 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 PDS01ADC, Versamune® HPV and other Versamune® and lnfectimune® 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 the Company's 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; 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; to aid in the development of the Versamune® platform; and other factors, including legislative, regulatory, political and economic developments not within the Company's control. 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, quarterly and periodic reports filed with the Securities and Exchange Commission (“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. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer to sell or the solicitation of an offer to buy any securities of the Company will be made by means of a prospectus supplement. This presentation may not be reproduced, forwarded to any person or published, in whole or in part. The Company has filed a registration statement on Form S-3 on August 24, 2022. The offering will be made only by means of a prospectus supplement that forms a part of such registration statement. A prospectus supplement relating to the offering will be filed by the Company with the SEC. You can obtain these documents, when available, for free by visiting EDGAR on the SEC's website at www.sec.gov. Versamune® and lnfectimune® are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Late-Stage Head and Neck Cancer Program as Value Catalyst Potent Long-Lasting “Memory” T Cells High-Value Lead Program with strong KOL support Promising Multi-Country Phase 2 Data Phase 3 Study 30 months Overall Survival (mOS) 77% Disease Control Rate (DCR) Well Tolerated: 9% Grade 3, 1% Grade 4 Treatment Related AE Targeted immunotherapy in HPV16-positive Recurrent and/or Metastatic Head & Neck Squamous Cell Carcinoma (R/M HNSCC) Fast Track designation for Versamune® HPV in R/M HNSCC Alignment with FDA on Phase 3 study design Study targeted to start in Q1 2025 2 Induction of right type and quantity of potent tumor-accumulating killer T cells observed in comprehensive preclinical and human studies
Significant and Growing Market Potential in HPV16-positive HNSCC HPV16 to Drive Increased HNSCC Incidence Rates & Exceed 50% of all HNSCC by mid 2030s1 Current US annual incidence of HPV16+ HNSCC = 18,200 (~35-40% of all HNSCC)2-3 Incidence of locally advanced, unresectable, metastatic HPV16+ HNSCC = 13,6004-6 Versamune® HPV US Market Potential = $2-3B7 EU HPV+ HNSCC incidence and trends similar to US 2
Approx. 13,600 US Patients Annually with Advanced HPV16+ HNSCC Epidemiology-Based Estimate of Addressable Population: HNSCC*7 U.S. Other Head and Neck Cancers U.S. HPV Positive ~5,900 (82%) HPV16 Genotype ~3,300 (56%) Locally Advanced, Unresectable and Metastatic ~7,200 (22%) ~32,500 U.S. Oropharyngeal Cancer in 2024 U.S. HPV Positive Locally Advanced, Unresectable and Metastatic ~10,300 (84%) ~12,300 (83%) HPV16 Genotype ~14,800 (70%) ~20,805 Oropharyngeal Cancer (OPC) Growing Market – Key Opportunity Other HNSCC (non-OPC)** Focus of bi-specific EGFR Inhibitors *ICD-O-3 site codes C01.9, C02.4, C02.8, C05.1, C05.2, C09.0, C09.1, C09.8, C09.9, C10.0, C10.1, C10.2, C10.3, C10.4, C10.8, C10.9, C14.0, C14.2, and C14.8; **Other head and neck cancers include sinonasal, oral cavity, laryngeal, and nasopharyngeal with calculations based on weighted average with share of total head and neck cancers 2
HPV16-Positive HNSCC Virally driven HNSCC increasingly seen as a distinct and rapidly growing type of cancer 2 HPV16 virus integrated into the human genome HPV-positive HNSCC has different presentation and tumor physiology8 Recurrent patients have distant metastases at multiple sites and poor clinical outcomes HPV16 infection may lead to persistent expression of oncoproteins E6 and E7 causing cancer Targeting HPV16 virally infected tumor cells is a potentially effective therapeutic strategy Versamune® HPV designed to generate T cells to target HPV16 E6 and E7
Significant Unmet Needs Remain in Recurrent or Metastatic HNSCC KEYTRUDA® KEYTRUDA® Plus Chemo Chemotherapy + EGFR Inhibitor Objective Response Rate (ORR) 19% 36% 35% Progression Free Survival (PFS) 3.2 mos 5.0 mos 5.0 mos Median Overall Survival (OS) 12.3 mos 13.6 mos 10.3 mos Treatment Related Grade 3+ Toxicities 17% 72% 69% HPV-Specificity: Need Targeted treatment option to address the growing population of HPV16- positive HNSCC and improve outcomes Improved Survival: Need Novel MOA that provides enhanced survival Improved Durability: Need Novel MOA that is clinically effective in broad patient population and provides more durable (long-term) responses. Improved Safety: Need Safe treatments that may be used with or in place of current standard of care and chemotherapy 2 Oncologist7 – Stated Unmet Medical Needs in HNSCC Standard of Care for Recurrent or Metastatic HNSCC – Published Results9
Controlled Clinical Study Treatment Outcomes in Recurrent and/or Metastatic HNSCC Similar Between HPV+ and HPV- Patients KEYNOTE-048: Similar OS hazard ratio reported in HPV+ & HPV- patients10 2
9 Versamune® HPV may Address Significant Unmet Need in R/M HNSCC 19% 35% 0% 20% 10% 30% 40% ORR PFS OS 3.2 5.1 6.0 5.0 4.0 3.0 2.0 1.0 0.0 Months 12.3 10.4 0.0 5.0 10.0 15.0 Months KEYNOTE-0489 Pembrolizumab EGFR antibody (cetuximab) + chemotherapy 25% 46% 8.0 50% 40% 30% 20% 10% 0% ORR 2.8 7.0 0.0 2.0 6.0 4.0 PFS Months 15.0 20.0 17.9 15.0 10.0 0.0 5.0 OS Months LEAP-01011 Pembrolizumab Pembrolizumab + lenvatinib Improved ORR and PFS Have Not Resulted in Improved Patient Survival ORR = Objective Response Rate; PFS = Progression Free Survival; OS = Overall Survival
10 VERSATILE-002: A Global Phase 2 Study of Versamune® HPV and Pembrolizumab in Subjects with HPV16+ Recurrent/Metastatic HNSCC Partner Study Design Open-label, non- randomized, adaptive design study 31 sites in US and EU 2 Cohorts: ICI Naïve ICI Resistant Enrollment complete Key Entry Criteria for ICI Naïve Subjects Recurrent or metastatic HNSCC ≥18 years of age HPV16-Positive tumor Combined positive score (CPS) ≥1 Versamune® HPV 5 doses: 1 mL Subcutaneous injection at Cycles 1, 2, 3, 4 & 12) Pembrolizumab (KEYTRUDA®) 200mg IV Q3W up to 35 Cycles (2 years) Study Treatment Primary: Best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1 Key Secondary: Overall Survival (OS) Progression Free Survival (PFS) per RECIST v1.1 Safety and tolerability Endpoints Fast Track Designation Study Evaluating Effects of Versamune® HPV Attributes on Clinical Responses
11 VERSATILE-002: Most Patients Had Recurrent Disease and CPS Score 1-19 Historical Responses Published data reports lower ORR, PFS and OS with pembrolizumab in patients with CPS 1-19 vs. CPS ≥ 2013 Published data reports lower responses in patients with recurrent disease Lower pembrolizumab responses No controlled or comparative studies have been conducted between checkpoint inhibitors and Versamune® HPV Key Demographics and Treatment Exposure12 Demographic/Baseline Characteristic Efficacy Population (N=53) Age, Median (Min, Max) 64.0 (46, 83) Sex, n (%) Male Female 49 (92.5) 4 (7.5) Race, n (%) Asian Black or African American White Other 1 (1.9) 1 (1.9) 50 (94.3) 1 (1.9) ECOG, n (%) 0 1 30 (56.6) 23 (43.4) CPS, n (%) 1–19 32 (60.4) ≥20 21 (39.6) Prior Therapy*, n (%) No Prior Therapy Chemotherapy Only Chemotherapy + Radiation Therapy 10 (18.9) 3 (5.7) 40 (75.5)
12 Percent Change from Baseline in Target Lesions 25 0 -25 -50 -75 50 75 100 -100 CPS Group 1-19 ≥20 -125 CPS Group 9.4% 26.4% 41.5% 17.0% Response Complete Response (CR) 5/53 Partial Response (PR) 14/53 Stable Disease (SD) 22/53 Progressive Disease (PD) 9/53 Treatment Ongoing Confirmed Objective Response Rate (ORR) Based on Investigator Assessment Per RECIST v1.1 Best Percentage Change from Baseline in Target Lesions (mITT population) 11/53 (21%) of patients had 90-100% tumor shrinkage Versamune® HPV: Deep Tumor Regression Occurred Independent of Patient CPS Score; Confirmed Disease Control Rate was 77.4%12
13 Extended Disease Control Observed in Majority of Patients12 Based on Investigator Assessment Per RECIST v1.1 Best Percentage Change from Baseline in Target Lesions Promising Long-Lasting Immune Response with CR, PR and SD Maintained Long-Term Percent Change from Baseline in Target Lesions 0 2 4 6 8 16 18 20 22 24 1 3 5 7 9 10 11 12 13 14 Time of Assessment (Months) 15 17 19 21 23 25 0 -25 -50 -75 -100 -125 200 175 150 225 100 75 50 125 Response Complete Response Partial Response Stable Disease Progressive Disease Treatment Ongoing
14 Survival Fraction 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 0.4 0.6 0.8 1.0 Censored ‒ Discontinued (N=8) Censored ‒ Ongoing (N=27) 0.2 Median OS, months (95% CI) = 30.0 (19.7, NE) Median follow up (months) = 16 0.0 Discontinued: N=2 Lost to follow up; N=6 withdrawn consent; Ongoing: Patients ongoing and awaiting next clinical assessment Median Overall Survival of 30 Months12 Multiple Patients Approaching 3 Years of Survival 53 (0) 50 (3) 46 (6) 42 (8) 40 (8) 37 (10) 34 (11) 32 (11) 23 (13) 20 (13) 16 (15) 14 (15) 9 (16) 8 (16) 7 (16) 5 (18) 3 (18) 1 (18) 0 (18) Number at Risk
15 Versamune® HPV plus pembrolizumab Appears to be well Tolerated14 Protocol stipulates 5 subcutaneous injections of Versamune® HPV: 4 injections over 2 months and a final injection after an additional 6 months *Grade 3 Combination-TRAE were: Fatigue (2), Rash, Alanine aminotransferase increased, Blood alkaline phosphatase increased, Lymphocyte count decreased, Autoimmune colitis, Colitis, Headache, Acute kidney injury, Hyponatremia, Hyperglycemia, **Grade 4 Combination-TRAE: encephalitis (case recorded approx. one year after last Versamune® HPV dose) * TRAE = Treatment Related Adverse Event 8/87 (9%) Patients had a Grade 3 TRAE*; 1/87 (1%) had a Grade 4 TRAE** TRAEs by Grade n (%) Any Combination TRAE 76 (87.4) Grade 1 40 (46.0) Grade 2 26 (29.9) Grade 3 8 (9.2) Grade 4 1 (1.1) Grade 5 0 Non-Injection Site TRAEs ≥ 5% n (%) Fatigue 30 (34.5) Headache 13 (14.9) Diarrhea 10 (11.5) Pruritis 9 (10.3) Rash 7 (8.0) Malaise 6 (6.9) Pyrexia 6 (6.9) Pain 5 (5.7) Cough 5 (5.7)
VERSATILE-002 Summary of Results12 16 Study has met primary ORR endpoint by RECIST v1.1 in ICI naïve patients ORR by Investigator Assessment: 36% (CPS ≥1) and 48% (CPS ≥20) 21% of patients had 90-100% shrinkage of their tumors Versamune® HPV + KEYTRUDA® may significantly impact DCR and OS in first line treatment of recurrent/metastatic HPV16 positive head and neck cancer Median OS of 30 months in patients with CPS ≥1 DCR of 77.4% in patients with CPS ≥1 Therapy appears to be well tolerated Biomarker and clinical data suggests that Versamune® HPV induces the right type and quantity of potent tumor targeting memory T cells that promote patient survival
VERSATILE-003 First Line Recurrent/Metastatic HNSCC Study Design Interim Analysis 1 Possible Early Approval Study Start Versamune® HPV + Pembrolizumab Pembrolizumab Aligned with FDA on Study Design and Initiation Patient Recruitment Patient Recruitment Survival Follo w-up Survival Follo w-up Key Eligibility Criteria HPV16-positive HNSCC CPS ≥1 ≥18 years of age ECOG 0-1 Secondary Endpoints Objective Response Rate (ORR) Disease Control Rate (DCR) Duration of Response (DoR) Progression Free Survival (PFS) Randomized controlled trial N = 351 2:1 randomization Primary Endpoint Overall Survival (OS) 16 Final Analysis Interim Analysis 2 Possible Early Approval
CRO engaged in site selection and preparation, investigator agreements, etc. Approximately 100 sites Site locations: US, UK, EU, Latin America 18 months estimated time to full enrollment 2 interim analyses for OS following event triggers 16 VERSATILE-003 Trial Implementation
VERSATILE-002: Durable Anti-Tumor Immune Response Observed Improving Responses with Time and Sustained Survival Objective Response Rate (ORR) Patients with Tumor Shrinkage of 90- 100% Patients with Complete Responses (CR) Disease Control Rate (DCR) Median Overall Survival May 2023 (N=34)15 26% 6% 3% 70% Not Estimable November 2023 (N=53)16 34% 21% 7.5% 77% 30 months May 2024 (N=53)12 36% 21% 9.4% 77% 30 months By promoting potent killer T cells and memory T cells, Versamune® HPV is designed to enable a durable attack on the cancer, leading to potential tumor shrinkage and survival Time 16
20 Versamune® HPV Biomarker Studies (CD8+ T Cells) Long-Term Tumor Infiltration and Accumulation of Multi-functional CD8+ T Cells Stage III and IV locally advanced cervical cancer patients treated with Versamune® HPV and chemoradiotherapy Increase in CD8 T cells in the tumor observed Day 0 to Week 24 - Supports durable responses 91.7% clearance of ctDNA at Week 5 vs 53.1% clearance with CRT alone18 - Supports long-term benefit ORR of 100% reported in the first 8 patients, 0% disease recurrence or disease-related deaths in 1-year follow-up 40 35 30 25 20 15 10 5 0 0 5 10 15 20 25 30 T0 T1 T2 T3 T4 T4B T5 Brush Granzyme B (% CD8) HPV16 Copies/ml Plasma Week 3 Time Brush GrsnB+ % CD8 HPV16 Copies/ml Plasma Quantity of killer T cells that infiltrated the patient’s tumors Quantity of HPV+ tumor cell DNA circulating in patient blood Clinical: CD8 T Cell Accumulation in Tumor Correlated with Elimination of Circulating Cancer Cells (ctDNA)17 Representative Plot from a Single Patient Week 24 Baseline Radiation Oncology Dept. Univ. of Texas MD Anderson Cancer Center
21 KEYTRUDA® & Versamune® HPV Were Both Independently Studied in Locally Advanced Cervical Cancer in Combination with CRT Versamune® HPV: Compelling Evidence of Survival Benefit *No head-to-head studies have been done between Keytruda and Versamune® HPV 3 C (P KEYTRUDA® Published KEYNOTE-A1819 Versamune® HPV IMMUNOCERV Trial20 6-months OS Rate 82.6% 100% with 5/5 doses 84.2% with ≥ 2/5 doses omplete Response ET Scan) N/A 88% with ≥ 2/5 doses
Versamune® HPV Treated Secondary Tumor Primary Tumor 22 njected Time (Days) Day 0: HPV16+ TC1 tumor cells were injected into mice Day 12: Resulting tumors had a size of ~250mm3 (volume) Day 12 : A group of the mice received a single injection of Versamune® HPV Day 25: All treated mice had complete regression of their tumors Day 50: 2 sets of mice were injected with the TC1 tumor cells Set 1: Mice previously treated with Versamune® HPV Set 2: Naïve mice NOT previously treated with Versamune® HPV Only the mice that had been previously treated with Versamune® HPV were protected against the cancer with no tumor growth Day 12 Treatment Day 50 TC-1 HPV16+ Tumor Cells Injected CD8 T Cells Attacked the Cancer Leading to Tumor Eradication & Memory T Cells Prevented Re-establishment21 Versamune® HPV Biomarker Preclinical Studies (Memory T Cells) Memory T cells Promoted Immune Surveillance and Prevented Re-establishment of Cancer Day 0
NCI-Led Triple Combination Trial: Inclusion of HPV16-Negative Patients Provided Internal Study Control & Demonstrated Versamune HPV Specificity22 Objective Response Rate (ORR) Progression Free Survival (PFS) Versamune® HPV May be Effective HPV16-targeted Immunotherapy 80 70 60 50 40 30 20 10 0 HPV16-Positive HPV16-Negative % of Patients 75% 17% 20 18 16 14 12 10 8 6 4 2 0 HPV16-Positive HPV16-Negative 19.0 Mos 2.3 Mos Time (Months) N=8 22 N=8 N=6 N=6
Upcoming Milestones 2024-2025 22 Q3 2024 Q4 2024 1H 2025 2H 2025 Regulatory Confirmation of VERSATILE-003 Study Design Initiate VERSATILE-003 Phase 3 Trial in HNSCC IMMUNOCERV Trial Update in Cervical Cancer Preliminary data readout: Neoadjuvant Study in Oral Cancer File IND for Versamune® MUC1 in MUC1+ Cancers Initiate MUC1 Study Data readouts: Multiple NCI Phase 2 studies of PDS01ADC
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References 26 1. 2. 3. 4. 5. 6. 7. 8. 9. Damgacioglu H, Sonawane K, Chhatwal J, et al. Long-term impact of HPV vaccination and COVID-19 pandemic on oropharyngeal cancer incidence and burden among men in the USA: A modeling Study. The Lancet Regional Health – Americas. 2022;8:100143. CDC. HPV and Oropharyngeal Cancer. September 17, 2024. Accessed November 10, 2024. https://www.cdc.gov/cancer/hpv/oropharyngeal-cancer.html. Saraiya M, Unger ER, Thompson TD, et al. US Assessment of HPV Types in Cancers: Implications for Current and 9-Valent HPV Vaccines. J Natl Cancer Inst. 2015;107(6):djv086. Isayeva T, Li Y, Mawahu D, Brandwein-Gensler M. Human Papillomavirus in Non-Oropharyngeal Head and Neck Cancers: A Systematic Literature Review. Head and Neck Pathol. 2012;6:S104–S120. Mazul AL, Chidambaram S, Zevallos JP, Massa ST. Disparities in head and neck cancer incidence and trends by race/ethnicity and sex. Head Neck. 2023;45(1):75-84. Lechner M, Liu J, Masterson L, Fenton TR. HPV-associated oropharyngeal cancer: epidemiology, molecular biology and clinical management. Nat Rev Clin Oncol. 2022;19(5),306-327. Triangle Research Group. PDS Proprietary Market Research Report. 2024. Trosman SJ, Koyfman SA, Ward MC et al. Effect of Human Papillomavirus on Patterns of Distant Metastatic Failure in Oropharyngeal Squamous Cell Carcinoma Treated With Chemoradiotherapy. JAMA Otolaryngol Head Neck Surg. 2015;141(5):457-462. doi:10.1001/jamaoto.2015.136 Burtness B, Harrington KJ, Greil R, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomized, open-label, phase 3 study. Lancet. 2019;394:1915-28. https://doi.org/10.1016/. Harrington, KJ, Burtness B, Greil R, et al. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. J Clin Oncol. 2022;41:790-802. https://doi.org/10.1200/JCO.21.02508. Licitra L, Tahara M, Harrington K, et al. Pembrolizumab With or Without Lenvatinib As First-Line Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC): Phase 3 LEAP-10 Study. Poster or Paper presented at: Multidisciplinary Head and Neck Cancers Symposium; February 29-March 2, 2024; Phoenix, AZ
References (continued) 26 Weiss J, Kaczmar JM, Harrington K, et al. VERSATILE-002: Survival with First-Line Treatment with PDS0101 Therapeutic Vaccine and Pembrolizumab in HPV16-positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). Poster Presented at: ESMO Congress 2024; September 13-17, 2024; Barcelona, Spain. Burtness B, Rischin D, Greil R, et al. Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score. J Clin Oncol. 2022;40:2321-2332. https://doi.org/10.1200/JCO.21.02198. PDSB Data on File: Data represents a 17May2024 data cut. Price KAR, Kaczmar JM, Worden FP, et al. Safety and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study of PDS0101 and Pembrolizumab in HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC). Poster Presented at: ASCO Annual Meeting; June 2-6, 2023; Chicago, IL. PDSB Data on File: Data represents a 30November2023 data cut. Yoshida-Court K, Gjyshi O, Lin L, et al. IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy with chemotherapy and radiation for treatment of locally advanced cervical cancers (NCT04580771). Poster Presented at: SITC; November 8-12, 2022; Boston MA. Xiao Q, Gjyshi O, Court K, et al. HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation. Poster Presented at: ASTRO 2023; October 1-4, 2023; San Diego, CA. Lorusso D, Xiang Y, Hasegawa K, et al. Pembrolizumab Plus Chemoradiotherapy for High Risk Locally Advanced Cervical Cancer: Overall Survival Results from the Randomized, Double Blind, Phase 3 ENGOT cx11/GOG 3047/KEYNOTE A18 Study. Poster Presented at: ESMO Congress 2024; September 13-17, 2024; Barcelona, Spain. Grippin AJ, Yoshida-Court K, O’Hara M, et al. IMMUNOCERV Phase II Trial Combining the HPV-specific T Cell Immunotherapy PDS0101 with Chemoradiation for Treatment of Locally Advanced Cervical Cancer. Poster Presented at: ASTRO 2024; September 29-October 2, 2024; Washington, DC. Gandhapudi SK, Ward M, Bush JPC, Bedu-Addo F, Conn G, Woodward JG. Antigen Priming with Enantiospecific Cationic Lipid Nanoparticles Induces Potent Antitumor CTL Responses through Novel Induction of a Type I IFN Response. J Immunol. 2019;202:3524-3536. National Cancer Institute (2023). Triple Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set]