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): March 27, 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)) |
| --- | --- |
| ☐ | 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 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<br> 2.02 | Results of Operation and Financial Condition. |
|---|
On March 27, 2024, PDS Biotechnology Corporation (the “Company”) issued a press release announcing an update to its clinical development strategy and its financial results for the year ended December 31, 2023. 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<br> 8.01 | Other Events. |
|---|
On March 27, 2024, the Company updated its corporate presentation deck. A copy of the corporate presentation deck is filed as Exhibit 99.2 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 March 27, 2024. |
| 99.2 | Corporate Presentation (March 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: March 27, 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 Announces Clinical Strategy Update and Reports
Full Year 2023 Financial Results
Unique mechanism of action of the combination of PDS01ADC and Versamune^®^ results in 3-year survival of 75% and 75% overall response rate in advanced head and neck cancer trial
As a result, Company to focus late-stage clinical strategy on triple combination of PDS01ADC, PDS0101 (Versamune^®^ HPV) and KEYTRUDA^®^ in advanced head and neck cancer
Strong safety profile of IL-12 fused antibody drug conjugate (PDS01ADC) demonstrated to date with data generated in >300 cancer patients; Versamune^®^ HPV tested in >110 HNSCC patients
Successful recent meeting with FDA provided clear guidance on trial design and regulatory pathway for pivotal randomized trial of triple combination in recurrent metastatic HPV-positive HNSCC
Company to host conference call and webcast today at 8:00 AM ET
Princeton, NJ, March 27, 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 announced an update to its clinical development strategy and reported its financial results for the year ended December 31, 2023.
“We have obtained compelling data from several Phase 2 trials in the fourth quarter of 2023, including long-term survival data from the National Cancer Institute (NCI)-led triple combination trial of PDS01ADC in combination with Versamune^®^ HPV (PDS0101) and an investigational immune checkpoint inhibitor (ICI), as well as our VERSATILE-002 study,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We now have a better understanding of how our drug platform technology works in advanced cancer, and we have therefore made the strategic, data-driven decision to add our novel, investigational IL-12 fused antibody drug conjugate, PDS01ADC, to the promising combination of Versamune^®^ HPV and KEYTRUDA^®^ to advance the triple combination as our top clinical development priority.”
“By initially addressing the rapidly growing unmet medical need in recurrent metastatic HPV+ head and neck squamous cell cancer (HNSCC), we strongly believe this approach may rapidly establish our proprietary combination of PDS01ADC and Versamune^®^ HPV as a transformative oncology treatment. The data suggest that the triple combination may result in a significant improvement in overall survival rates for patients who currently lack an effective treatment option. It may also significantly increase the rates of durable tumor shrinkage or overall responses,” said Dr. Bedu-Addo. “We are grateful to the patients and physicians who participated in the clinical trials which have helped inform our understanding of how the drug therapies may be used most effectively to safely address advanced cancer, and our decision to prioritize the triple combination.”
With the recent long-term survival Phase 2 data from the NCI-led triple combination trial, together with favorable safety and extended survival results seen in both ICI naïve and resistant patients in our VERSATILE-002 trial, PDS Biotech has decided to prioritize the triple combination in place of the VERSATILE-003 trial. This decision enables PDS Biotech to focus its resources on the drug regimen it believes has the highest potential to benefit patients with HNSCC and to drive shareholder value.
“We have had several discussions with key opinion leaders in HNSCC regarding the use of the triple combination in HNSCC. A clear unmet need is seen in HPV+ HNSCC with few agents being studied in this population due to the difficulty in treating advanced HNSCC,” said Kirk V. Shepard, M.D., Chief Medical Officer of PDS Biotech. “These discussions with expert HNSCC oncologists have guided our decision to prioritize the triple combination in our efforts to address the growing incidence of advanced HPV+ HNSCC.”
“Despite good outcomes in many patients with HPV-related HNSCC, approximately 20% of patients will develop recurrent, incurable disease, often in young individuals in the prime of their lives. HPV-related HNSCC that progresses after standard first-line chemotherapy is a devastating, hard-to-treat cancer with no HPV-related treatment currently approved. The NCI clinical trial data show significant promise in the use of PDS01ADC in combination with Versamune^®^ HPV,” said Katharine A. Price, M.D., Associate Professor of Oncology, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center and Principal Investigator of PDS Biotech’s upcoming triple combination trial. “A controlled randomized clinical trial that builds upon the current data is warranted, and I am intrigued by the potential of this unique combination to treat HNSCC.”
Clinical Strategy Update
Triple Combination Clinical Trial (PDS01ADC, Versamune^®^ HPV and KEYTRUDA^®^)
| • | Company in discussions with the U.S. Food and Drug Administration (FDA) on the design of potentially pivotal clinical trial to treat HPV+ HNSCC, with the trial<br> expected to start in 2024. |
|---|---|
| • | Previously announced data from Phase 2 NCI-led triple combination clinical trial for the treatment of recurrent/metastatic ICI naïve and ICI resistant<br> HPV16-positive cancers including head and neck, anal, cervical, vaginal and vulvar cancers support rationale: |
| --- | --- |
| • | ICI naïve group: 75% of patients remain alive at 36 months. The median OS was not reached. Published results show a 36-month survival rate of approximately 20%<br> with ICIs.^^ORR of 75% and complete response of 38% were seen in patients treated with the triple combination. Published ORR of <40% seen with immunotherapeutic agents. |
| --- | --- |
| • | ICI resistant group: 12-month overall survival (OS) rate of 72%, and 63% overall response rate<br> (ORR) in patients with optimal dose of PDS01ADC. Median OS approximately 20 months; published 12-month OS rate in HPV-positive ICI-resistant cancer is ~30%; published median OS in HPV-positive ICI-resistant cancer is 3.4 months. |
| --- | --- |
| • | Responses were seen in all HPV-positive tumor types. |
| --- | --- |
Leadership Appointments
| • | In January 2024, announced the appointment of Dr. Shepard as Chief Medical Officer. |
|---|---|
| • | In November 2023, announced the appointment of Lars Boesgaard as Chief Financial Officer. |
| --- | --- |
Full Year 2023 Financial Results
Net loss for the year ended December 31, 2023, was approximately $42.9 million, or $1.39 per basic and diluted share, compared to a net loss of $40.9 million, or $1.43 per basic share and diluted share, for the year ended December 31, 2022. The higher net loss was primarily the result of increased operating loss and increased net interest expense.
Research and development expenses for the year ended December 31, 2023, decreased to $27.8 million, compared to $29.4 million for the year ended December 31, 2022. The decrease of $1.7 million was primarily attributable to the $10 million purchase of the rights to PDS01ADC in 2022, partially offset by an increase in clinical costs of $6.1 million and an increase in personnel costs of $2.1 million.
General and administrative expenses for the year ended December 31, 2023, increased to $15.3 million compared to $12.2 million for the year ended December 31, 2022. The $3.1 million increase was primarily attributable to an increase in personnel costs of $1.5 million and an increase in professional fees of $1.6 million.
Total operating expenses for the year ended December 31, 2023, were $43.0 million, an increase of approximately 3.3% compared to $41.7 million total operating expenses for the year ended December 31, 2022.
Net interest expense increased to $1.3 million for the year ended December 31, 2023, compared to $0.4 million for the year ended December 31, 2022. The change was due to higher interest expense related to the Company’s notes payable, partially offset by higher interest income on bank deposits.
During the fourth quarter of 2023, the Company raised approximately $10.5 million in net proceeds from its “at-the-market” sales agreement.
The Company’s cash balance as of December 31, 2023, was $56.6 million.
Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM ET today, March 27, 2024. Participants should dial 877-704-4453 (United States) or 201-389-0920 (International) and reference conference ID 13745320. To access the webcast, please use the following link. The event will be archived on the Investor Relations section of PDS Biotech’s website for six months.
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 in 2024 to advance its lead program in advanced head and neck squamous cell cancers (HNSCC). PDS Biotech’s lead program is a proprietary dual-acting combination of antibody drug conjugate (ADC) PDS01ADC and T-cell activator Versamune^®^ HPV in regimen with a standard-of-care immune checkpoint inhibitor. Proof-of-concept long-term data have shown positive survival results and tumor shrinkage with this combination and indicate favorable tolerability.
With a novel investigational “inside-out” mechanism, the dual immunotherapy has shown compelling results with potential to successfully disrupt a tumor’s inside defenses, while also generating potent, targeted killer T-cells to attack the tumor from the outside. Robust data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the platforms and point to potential broad utility.
Our Infectimune^®^ based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses, including long-lasting memory T-cell responses in pre-clinical studies to date. 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 PDS01ADC, 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 PDS01ADC, 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 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.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Unaudited Consolidated Statements of Operations and Comprehensive Loss
| Year Ending December 31, | ||||||
|---|---|---|---|---|---|---|
| 2023 | 2022 | |||||
| Operating expenses: | ||||||
| Research and development expenses | $ | 27,762,784 | $ | 29,431,027 | ||
| General and administrative expenses | $ | 15,282,450 | $ | 12,241,394 | ||
| Total operating expenses | $ | 43,045,234 | $ | 41,672,421 | ||
| Loss from operations | $ | (43,045,234 | ) | $ | (41,672,421 | ) |
| Interest income (expense), net | ||||||
| Interest income | $ | 2,902,939 | $ | 935,180 | ||
| Interest expense | $ | (4,205,922 | ) | $ | (1,316,519 | ) |
| Interest income (expense), net | $ | (1,302,983 | ) | $ | (381,339 | ) |
| Loss before income taxes | $ | (44,348,217 | ) | $ | (42,053,760 | ) |
| Benefit from income taxes | $ | 1,406,021 | $ | 1,198,905 | ||
| Net loss and comprehensive loss | $ | (42,942,196 | ) | $ | (40,854,855 | ) |
| Per share information: | ||||||
| Net loss per share, basic and diluted | $ | (1.39 | ) | $ | (1.43 | ) |
| Weighted average common shares outstanding basic and diluted | 30,952,060 | 28,599,221 |
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Unaudited Selected Balance Sheet Data
| December 31, | December 31, | |||||
|---|---|---|---|---|---|---|
| 2023 | 2022 | |||||
| Cash and cash equivalents | $ | 56,560,517 | $ | 73,820,160 | ||
| Working Capital | $ | 45,425,100 | $ | 66,659,354 | ||
| Total assets | $ | 59,390,082 | $ | 77,007,923 | ||
| Long term Debt | $ | 19,506,183 | $ | 23,020,844 | ||
| Accumulated Deficit | $ | (144,500,613 | ) | $ | (101,558,417 | ) |
| Total stockholders’ equity | $ | 26,130,949 | $ | 44,002,030 |
Exhibit 99.2
Transforming How the Immune System Targets and Fights Cancer NASDAQ: PDSB March 2024
Forward-Looking Statement This communication contains forward-looking statements (including within the meaning of Section 27E of the United States Securities Exchange Act of 7934, as amended, and Section 27A of the United States Securities Act of 7933, 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, PDS0101 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, PDS0101 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 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® 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 Pivotal trial planned for PDS01ADC + Versamune® HPV (PDS0101) + KEYTRUDA® in head and neck cancer High-Value Lead Program PDS01ADC + Versamune® disrupts tumor’s inside defenses, and generates potent, targeted killer T-cell attack from outside Durable Phase 2 survival and ORR data Novel Investigational “Inside-Outside” MOA PDS01ADC safety demonstrated in >300 patients Versamune® HPV administered to >100 HNSCC patients Robust Phase 2 Data in 400+ Patients Cash runway into Q4 2025 (without pivotal trial)1 Financials 1. Company’s 10-K for year ended 12/31/2023 includes going concern opinion. Cash runway estimate based on currently available cash resources and cash flow projections and assumes no initiation of pivotal trial and Company debt not being called by lenders.
Strategy Addresses Why Immunotherapies Fail in Solid Tumors References: Darvin et al. Immune Checkpoint Inhibitors, Recent Progress and Potential Biomarkers; Experimental & Molecular Medicine (2018) 50:165. Chen, D. S. & Mellman, I. Elements of cancer immunity and the cancer–immune set point. Nature 541, 321 (2017). Two Critical Limitations Remain Inability to generate the right type and quantity of effective tumor-infiltrating and tumor-killing T cells Inadequate T Cell Response Immune-Desert Tumors: Lack T cells because T cells don’t get activated or recognize the cancer Immune-Excluded Tumors: Contain immune suppressive cytokines and inhibitory factors that prevent T cell infiltration TME Prevents Immunogenicity TME = Tumor Microenvironment
Infiltrates TME to Suppress the Tumor’s Defenses & Promotes T Cell Infiltration/Immunogenicity Combination Platform Enables Inside-Outside Attack to Address Limits Immuno-cytokine IL-12 Fused Antibody Drug Conjugate PDS01ADC First immuno-cytokine antibody drug conjugate NHS76 (Tumor Necrosis Targeting Ab – Binds to exposed DNA) De-immunized Junction IL-12 (p40 clipping-resistant) IL-12 (p40 clipping-resistant) IL-12 fused antibody drug conjugate TME = Tumor Microenvironment Induces Right Type & Quantity of Powerful Tumor-Targeting Killer T Cells Versamune® Water-insoluble fatty acids/ hydrocarbon chains Water-soluble, positively charged head-group coats particle surface Immunologically active R-enantiomer of 1,2-dioleoyl-trimethyl-ammonium (R-DOTAP) Inside Outside
PDS01ADC + Versamune® + ICI: Unique Combined Mechanism Mechanism Attacks the Tumor from Both the Inside (TME) and Outside of the Tumor Inside 1 PDS01ADC Infiltrates TME; Weakens Tumor’s Protection from Immune System StimulatesT Cells in TME to Promote Expansion + Prolonged, Effective Killing Versamune® Induces Right Type & Quantity of Potent Killer T Cells that Target and Infiltrate Tumor Outside 2 KEYTRUDA® Restores Pre-existing T Cell Responses 3 Potential first tumor-targeting immuno-cytokine antibody drug conjugate 1 2 3 Necrotic Core PDS01ADC binds to necrotic DNA Oxygenated Area Versamune® Activated HPV+ Targeting CD8+ Killer T-Cell
PDS01ADC and Versamune® Have Broad Therapeutic Potential Synergistic Effect With SoC Modalities Across a Spectrum of Tumors PDS01ADC Versamune® Conjugate limits systemic toxicity of IL-12 Activates/expands T cells in tumor & limits T cell exhaustion Changes tumor to become more permissive to T cell attack Designed to deliver and sustain IL-12 in tumor Activates the right type of multifunctional CD8 killer T cells Promotes the right quantity and potency of T cells Promotes a long-lasting memory T cell response Designed to train T cells to recognize the cancer
Patients Had Sustained Tumor Shrinkage, Objective Response Rate ICI Resistant Cancer 1. Burtness B et al., Lancet. 2019; 394:1915-1928. 2. Triple combination Phase 2 trial (NCT04287868, Investigator assessment (11/2023) 1. Strauss J et al, Journal for ImmunoTherapy of Cancer 2020;8:e001395. 2. INTERLINK-1 (NCT04590963) 3. Triple combination Phase 2 trial (NCT04287868), Investigator assessment (11/2023). ICI Naïve Cancer Optimal Dose PDS01ADC % of Patients with Sustained Tumor Shrinkage of ≥30% No controlled or comparative studies have been conducted between PDS0101 + PDS01ADC and checkpoint inhibitors or Chemotherapy. * *38% Complete Response (CR)
Triple Combination Has Shown Compelling Survival Data Proof-of-Concept in ICI-resistant Cancer Validates MOA and Preclinical Results One-Year Survival Median Overall Survival 1. Strauss J et al, Journal for ImmunoTherapy of Cancer 2020;8:e001395. 2. Pestana, et al. Oral Oncology. 2022:104523. 3. Triple combination Phase 2 trial (NCT04287868), Investigator assessment (11/2023). Bila M, et al. Frontiers in Oncology. Jan 2022;12:761428. Pestana, et al. Oral Oncology. 2022:104523. Triple combination Phase 2 trial (NCT04287868), Investigator assessment (11/2023). No controlled or comparative studies have been conducted between PDS0101 and checkpoint inhibitors or EGFR Inhibitor or Chemotherapy or PDS01ADC.
Compelling Long-Term Survival of ICI Naïve Advanced HNSCC Cancer Patients (Double & Triple Combinations) PDS01ADC and Versamune® HPV May Significantly Promote Patient Survival (N=53 HNSCC Patients) (HNSCC Patients) (HNSCC Patients) (N=29 Anal, cervical, HNSCC, Vaginal, Vulvar Patients) 1. Burtness B et al., Lancet. 2019; 394:1915-1928. 2. Triple combination Phase 2 trial (NCT04287868, Investigator assessment (11/2023) 3, Data on file. VERSATILE-002 8/2/23 data cut. No controlled or comparative studies have been conducted between PDS0101 + PDS01ADC and checkpoint inhibitors or Chemotherapy.
Proof-of-Concept Results Indicate Favorable Tolerability 48% Had Grade 3 TRAEs, 4% Grade 4 Safety Population: All enrolled subjects who received at least 1 dose of any drug National Cancer Institute. (2023). Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set] Preferred Term n (%) Myocarditis 1 (2) Anemia 15 (30) HLH* 1 (2) Flu-like Symptoms 1 (2) Lymphopenia 3 (6) CPK Elevation 1 (2) Preferred Term n (%) Leukopenia 1 (2) Neutropenia 1 (2)** Hematuria 5 (10) GI Bleeding 2 (4) AST/ALT Elevation 4 (8)*** Mucositis 1 (2) Grade 3/4 Adverse Events (AE) Grade 3/4 Adverse Events (cont.) *HLH, hemophagocytic lymphohistiocytosis **Grade 4 TRAE ***1 patient had Grade 4 TRAE
Program Is Supported and Validated by Robust Clinical Data Experience in More Than 430 Patients PDS01ADC + Versamune® HPV + Bintrafusp alfa (triple) and Versamune® HPV + KEYTRUDA® (double) administered to 110+ head & neck cancer patients to date HNSCC Patient Exposure Across Product Portfolio Well-tolerated to date at 3.0 mg per dose every 3 weeks 170+ Patients Treated to Date Versamune® HPV Acceptable tolerability and safety profile to date at 8.0, 12.0 and 16.8 ug/kg every 2 or 4 weeks 300+ Patients Treated to Date PDS01ADC
HNSCC: Devastating Cancers with High Prevalence and Mortality References: Johnson, D.E., Burtness, B., Leemans, C.R.et al.Head and neck squamous cell carcinoma.Nat Rev Dis Primers6, 92 (2020) Noseyaba et al. 2018. Cancer. Suicide Risk Among Cancer Survivors: Head and Neck Versus Other Cancers https://virologyj.biomedcentral.com/articles/10.1186/s12985-021-01688-9 https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.html *Human Papillomavirus Oral and PharyngealCancers (~40% of HNSCC) Genotype of *HPV-Positive Oral and Pharyngeal Cancer Paranasalsinuses Nasopharynx Oropharynx Hypopharynx Larynx Pharynx Tongue Salivaryglands OralCavity NasalCavity Increasing Incidence Driven Largely by HPV16+
Est. HPV16Locally Advanced,Unresectable andMetastatic HNSCC HPV16-positive HNSCC Presents Significant Initial Market Opportunity Epidemiology-Based Estimate of Addressable Population: HNSCC Company market research ~13,600 ~18,200 ~22,000 ~53,305 Est. U.S. HPV Positive HNSCC Est. U.S. HNSCC Est. HPV16 Genotype ~$2-3B Market Opportunity in US1 No approved HPV-specific cancer therapy Significant unmet need
Candidate/ Study Indication PC P1 P2 P3 Partner PDS01ADC + Versamune® HPV + ICI Recurrent or metastatic HPV16-positive HNSCC PDS01ADC + Versamune® MUC1 + ICI (Phase 1/2 anticipated 2024) Recurrent or metastatic colorectal cancer Versamune® HPV + ICI (KEYTRUDA) Recurrent or metastatic HPV16-positive HNSCC PDS01ADC + Versamune® Agent + SoC* Immune Deficiency and Infectious Diseases* Pipeline Continues to Validate Platforms, Drive Future Opportunities Versamune® Initiate pivotal study in HNSCC: PDS01ADC+Versamune® HPV+ KEYTRUDA® Triple Combination - 2024 Update on regulatory confirmation of potentially registrational study - Q2/Q3-2024 Readout of VERSATILE-002 Phase 2 in HNSCC (Versamune® HPV + KEYTRUDA®) – April 2024 Confirm path to triple combination Phase 1/2 study in r/m colorectal cancer to be performed under funded collaboration with NCI - Q4-2024 Upcoming Milestones
Veteran New Leadership to Execute Strategy Record of Execution in Development, Commercialization of Leading Pharmaceutical Products Frank Bedu-Addo, PhD Chief Executive Officer Senior executive experience with management of strategy and execution at both large pharma and biotechs Notable drug development: Abelcet® (Liposome Company/ Elan) PEG-Intron® (Schering-Plough/ Merck) Lars Boesgaard Chief Financial Officer 20 years of financial leadership roles in healthcare Former Chief Financial Officer of publicly traded healthcare and biotech companies Kirk Shepard, M.D. Chief Medical Officer US board-certified medical oncologist and hematologist 30+ years of experience in the pharmaceutical industry Gregory Conn, PhD Chief Scientific Officer Co-founder 35 years of drug development experience In-depth experience with biotech drug discovery, product development and manufacturing
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