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 (PDS ...

Part I — Financial Information [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents unaudited condensed consolidated financial statements, covering balance sheets, operations, cash flows, and notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets | Metric | September 30, 2023 ($) | December 31, 2022 ($) | Change ($) | Change (%) | | :-------------------------- | :------------------- | :------------------ | :--------- | :--------- | | Cash and cash equivalents | $54,251,387 | $73,820,160 | $(19,568,773) | -26.5% | | Total current assets | $56,838,412 | $76,480,390 | $(19,641,978) | -25.7% | | Total assets | $57,187,821 | $77,007,923 | $(19,820,102) | -25.7% | | Accounts payable | $5,366,564 | $1,219,287 | $4,147,277 | 340.1% | | Accrued expenses | $3,732,727 | $8,313,708 | $(4,580,981) | -55.1% | | Total current liabilities | $9,153,828 | $9,821,036 | $(667,208) | -6.8% | | Total liabilities | $32,703,993 | $33,005,893 | $(301,900) | -0.9% | | Total stockholders' equity | $24,483,828 | $44,002,030 | $(19,518,202) | -44.4% | | Accumulated deficit | $(133,602,399) | $(101,558,417) | $(32,043,982) | 31.5% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations and Comprehensive Loss (Three Months Ended Sep 30) | Metric | Three Months Ended Sep 30, 2023 ($) | Three Months Ended Sep 30, 2022 ($) | Change ($) | Change (%) | | :----------------------------------- | :------------------------------ | :------------------------------ | :--------- | :--------- | | Research and development expenses | $6,448,528 | $4,352,987 | $2,095,541 | 48.1% | | General and administrative expenses | $4,071,158 | $2,926,209 | $1,144,949 | 39.1% | | Total operating expenses | $10,519,686 | $7,279,196 | $3,240,490 | 44.5% | | Loss from operations | $(10,519,686) | $(7,279,196) | $(3,240,490) | 44.5% | | Interest income (expenses), net | $(329,483) | $(145,254) | $(184,229) | 126.8% | | Net loss and comprehensive loss | $(10,849,169) | $(7,424,450) | $(3,424,719) | 46.1% | | Net loss per share, basic and diluted| $(0.35) | $(0.26) | $(0.09) | 34.6% | Condensed Consolidated Statements of Operations and Comprehensive Loss (Nine Months Ended Sep 30) | Metric | Nine Months Ended Sep 30, 2023 ($) | Nine Months Ended Sep 30, 2022 ($) | Change ($) | Change (%) | | :----------------------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Research and development expenses | $20,297,066 | $13,275,947 | $7,021,119 | 52.9% | | General and administrative expenses | $12,341,207 | $9,575,122 | $2,766,085 | 28.9% | | Total operating expenses | $32,638,273 | $22,851,069 | $9,787,204 | 42.8% | | Loss from operations | $(32,638,273) | $(22,851,069) | $(9,787,204) | 42.8% | | Interest income (expenses), net | $(811,730) | $(65,008) | $(746,722) | 1148.7% | | Benefit for income taxes | $1,406,021 | $1,198,905 | $207,116 | 17.3% | | Net loss and comprehensive loss | $(32,043,982) | $(21,717,172) | $(10,326,810) | 47.5% | | Net loss per share, basic and diluted| $(1.04) | $(0.76) | $(0.28) | 36.8% | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Condensed Consolidated Statements of Changes in Stockholders' Equity | Metric | January 1, 2023 ($) | September 30, 2023 ($) | Change ($) | Change (%) | | :-------------------------- | :-------------- | :----------------- | :--------- | :--------- | | Total Stockholders' Equity | $44,002,030 | $24,483,828 | $(19,518,202) | -44.4% | | Accumulated Deficit | $(101,558,417) | $(133,602,399) | $(32,043,982) | 31.5% | | Additional Paid-in Capital | $145,550,491 | $158,075,994 | $12,525,503 | 8.6% | - During the nine months ended September 30, 2023, the company recognized **$6,259,464** in stock-based compensation expense and received **$5,647,467** from the net issuance of common stock through the Sales Agreement[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows | Metric | Nine Months Ended Sep 30, 2023 ($) | Nine Months Ended Sep 30, 2022 ($) | Change ($) | Change (%) | | :-------------------------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Net cash used in operating activities | $(25,178,960) | $(18,180,773) | $(6,998,187) | 38.5% | | Net cash provided by financing activities | $5,610,187 | $24,580,588 | $(18,970,401) | -77.2% | | Net increase (decrease) in cash and cash equivalents | $(19,568,773) | $6,399,815 | $(25,968,588) | -405.8% | | Cash and cash equivalents at end of period | $54,251,387 | $71,642,437 | $(17,391,050) | -24.3% | - Cash paid for interest increased significantly to **$3,031,129** for the nine months ended September 30, 2023, from **$62,500** in the prior year[17](index=17&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - PDS Biotechnology Corporation is a clinical-stage immunotherapy company developing targeted cancer and infectious disease immunotherapies based on its Versamune, Versamune plus PDS01ADC, and Infectimune T cell-activating platforms[20](index=20&type=chunk) - The company has no commercially approved products and expects to incur operating losses for the foreseeable future, with substantial doubt existing about its ability to continue as a going concern[25](index=25&type=chunk)[36](index=36&type=chunk)[45](index=45&type=chunk) - In January 2023, the company entered into an exclusive global license agreement with Merck KGaA for PDS01ADC (M9241), involving potential milestone payments up to **$116 million** and a **10% royalty** on net sales[65](index=65&type=chunk)[66](index=66&type=chunk) - Total stock-based compensation expense for the nine months ended September 30, 2023, was **$6,259,464**, an increase from **$3,821,923** in the prior year[56](index=56&type=chunk) - The company recognized an income tax benefit of **$1.4 million** for the nine months ended September 30, 2023, from the sale of New Jersey NOL carryforwards[63](index=63&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, liquidity, and operations, highlighting increased expenses, net losses, and critical financing needs [Cautionary Note Regarding Forward-Looking Statements](index=18&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) - The report contains forward-looking statements that are subject to known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from expectations[80](index=80&type=chunk)[82](index=82&type=chunk) - Key risks include the company's ability to protect intellectual property, anticipated capital requirements, dependence on additional financing, limited operating history, and the success, timing, and cost of clinical trials and regulatory approvals[81](index=81&type=chunk) [Company Overview](index=19&type=section&id=Company%20Overview) - PDS Biotech is a clinical-stage immunotherapy company developing targeted cancer and infectious disease immunotherapies based on its Versamune, Versamune plus PDS01ADC, and Infectimune T cell-activating platforms[84](index=84&type=chunk) - The company aims to overcome limitations of current immunotherapy approaches by activating high-quality, potent polyfunctional CD4 helper and CD8 killer T cells[84](index=84&type=chunk) [Recent Developments](index=19&type=section&id=Recent%20Developments) - In December 2022, PDS Biotech executed an exclusive global license agreement with Merck KGaA for PDS01ADC (M9241), a tumor-targeting IL-12 fused antibody drug conjugate[85](index=85&type=chunk) - In February 2023, the company completed a successful Type B meeting with the FDA for a triple combination therapy (PDS0101, PDS01ADC, and an FDA-approved immune checkpoint inhibitor) for recurrent/metastatic, ICI resistant HPV-positive head and neck cancer[86](index=86&type=chunk) - In September and October 2023, data on the investigational universal flu vaccine PDS0202 and PDS0101 in combination with chemoradiotherapy for cervical cancer were presented, showing promising results[88](index=88&type=chunk)[89](index=89&type=chunk) - Updated interim survival data from the NCI-led Phase 2 triple combination study in November 2023 showed a median overall survival of approximately **20 months** in ICI resistant HPV-positive patients[93](index=93&type=chunk) [Clinical Candidate Pipeline](index=20&type=section&id=Clinical%20Candidate%20Pipeline) - The VERSATILE-002 Phase 2 clinical trial (PDS0101 + KEYTRUDA®) for recurrent/metastatic HPV16-positive head and neck cancer has completed enrollment in the ICI naïve arm, with a Phase 3 trial (VERSATILE-003) planned for Q1 2024[94](index=94&type=chunk)[101](index=101&type=chunk) VERSATILE-002 (ICI Naïve Cohort) Interim Data (Oct 2023) | Metric | Result | Comparison to Approved ICI | | :-------------------------- | :----- | :------------------------- | | 24-month Overall Survival (OS) Rate | 74% | Less than 30% | | 12-month OS Rate | 80% | 30-50% | | Tumor Shrinkage | 60% | - | | Confirmed Overall Response Rate (ORR) | 27% | - | | Median Progression-Free Survival (PFS) | 8.1 months | 2-3 months | | Grade 3 TRAE | 13% | 13-17% Grade 3-5 | - The NCI-led Phase 2 triple combination study (PDS0101 + PDS01ADC + Bintrafusp Alfa) in ICI resistant HPV-positive patients showed a median OS of approximately **20 months**, compared to historical median OS of **3-4 months**[111](index=111&type=chunk)[116](index=116&type=chunk) - The IMMUNOCERV Phase 2 trial (PDS0101 + Chemoradiotherapy) for locally advanced cervical cancer demonstrated a **100% objective response rate** and **89% complete response rate** by PET CT, along with rapid ctDNA clearance[117](index=117&type=chunk) - PDS0103 (MUC1-positive cancers) is in tech transfer and clinical scale-up, with IND submission planned for H1 2024, potentially delayed by resource allocation to PDS0101's pivotal trial[120](index=120&type=chunk)[121](index=121&type=chunk) [IL-12 Oncology Immunocytokine Pipeline](index=26&type=section&id=IL-12%20Oncology%20Immunocytokine%20Pipeline) - PDS01ADC is a novel investigational IL-12 fused antibody drug conjugate designed to enhance T cell proliferation, potency, and longevity in the tumor microenvironment, working synergistically with Versamune-based immunotherapies[123](index=123&type=chunk) - A Phase 1/2 clinical trial evaluating PDS01ADC in combination with docetaxel for metastatic prostate cancer showed PSA level decreases in all patients (**61% with at least a 60% decrease**) and was well-tolerated[125](index=125&type=chunk) - The combination therapy was associated with favorable immune response changes, including decreases in T reg cells and increases in activated NK cells, memory CD8 T cells, proliferating CD4/CD8 T cells, and cytokines INF-γ and IL-10[125](index=125&type=chunk) [Infectimune Development Strategy](index=27&type=section&id=Infectimune%20Development%20Strategy) - The Infectimune platform aims to develop improved treatments and preventive options for infectious diseases, focusing on strong induction of CD8 and CD4 T cells as well as antibodies[128](index=128&type=chunk) - The company is focusing its near-term infectious disease activities on developing universal seasonal and pandemic flu vaccines, aligning with the NIAID's CIVICs program[129](index=129&type=chunk) - Preclinical data for the investigational universal flu vaccine PDS0202 demonstrated broad neutralization across multiple influenza strains and protection against lethal H1N1 challenge[132](index=132&type=chunk) [Liquidity](index=28&type=section&id=Liquidity) - The company has never been profitable and has incurred net losses in each year since inception, with an accumulated deficit of **$133.6 million** as of September 30, 2023[134](index=134&type=chunk) - As of September 30, 2023, the company had **$54.3 million** in cash and cash equivalents[135](index=135&type=chunk) - Future funding requirements are substantial and depend on the timing and costs of clinical trials, regulatory approvals, and potential collaborations, with significant uncertainty regarding the availability of additional capital[140](index=140&type=chunk) [SELECTED FINANCIAL OPERATIONS OVERVIEW](index=28&type=section&id=SELECTED%20FINANCIAL%20OPERATIONS%20OVERVIEW) - The company has not generated any revenues from commercial product sales and does not expect to in the near future[136](index=136&type=chunk) Operating Expenses (Nine Months Ended Sep 30) | Expense Category | 2023 ($M) | 2022 ($M) | Change ($M) | Change (%) | | :----------------------- | :-------- | :-------- | :---------- | :--------- | | Research and Development | 20.3 | 13.3 | 7.0 | 53% | | General and Administrative | 12.3 | 9.6 | 2.7 | 29% | | Total Operating Expenses | 32.6 | 22.9 | 9.7 | 43% | - The increase in R&D expenses was primarily due to higher personnel costs (**$2.0 million**, including **$1.0 million** stock-based compensation), clinical trials (**$3.4 million**), and manufacturing expenses (**$1.4 million**)[145](index=145&type=chunk) - The increase in G&A expenses was mainly driven by higher personnel costs (**$2.0 million**, including **$1.4 million** stock-based compensation) and investor relations costs (**$0.7 million**)[146](index=146&type=chunk) - Income tax benefit increased to **$1.4 million** for the nine months ended September 30, 2023, from **$1.2 million** in 2022, due to an increase in New Jersey NOL carryforwards sold[147](index=147&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2023, the company had **$54.3 million** in cash and cash equivalents, with primary uses of cash being operating expenses, particularly research and development[156](index=156&type=chunk) - Funding sources include proceeds from the sale of tax benefits (**$1.4 million** in April 2023), a **$150 million** shelf registration statement, and an at-the-market offering program which generated **$5.7 million** net value in 9M 2023[148](index=148&type=chunk)[149](index=149&type=chunk)[150](index=150&type=chunk)[155](index=155&type=chunk) - The company entered into a venture loan and security agreement in August 2022 for **$25 million** (Loans A-D funded), with Loans E and F (totaling **$10 million**) having expired[151](index=151&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern for at least 12 months due to ongoing losses and uncertainty in securing additional financing on acceptable terms[158](index=158&type=chunk) [Cash Flows](index=32&type=section&id=Cash%20Flows) Summary of Cash Flows (Nine Months Ended Sep 30) | Cash Flow Activity | 2023 ($M) | 2022 ($M) | Change ($M) | | :------------------------------- | :-------- | :-------- | :---------- | | Net cash used in operating activities | (25.2) | (18.2) | (7.0) | | Net cash provided by financing activities | 5.6 | 24.6 | (19.0) | | Net increase (decrease) in cash and cash equivalents | (19.6) | 6.4 | (26.0) | - The increase in net cash used in operating activities was primarily due to a **$10.3 million** increase in net loss, partially offset by a **$2.4 million** increase in non-cash stock-based compensation expense[161](index=161&type=chunk) - Net cash provided by financing activities decreased significantly in 2023 due to proceeds from common stock sales (**$5.6 million**) compared to the prior year's venture loan proceeds (**$24.6 million**)[162](index=162&type=chunk) [Operating Capital Requirements](index=32&type=section&id=Operating%20Capital%20Requirements) - The company anticipates continued losses and increasing operating costs as it develops and seeks regulatory approval for its vaccine candidates, requiring substantial additional funding[163](index=163&type=chunk) - Future funding requirements depend on the initiation, progress, timing, and costs of clinical trials, regulatory requirements, intellectual property costs, and commercialization efforts[165](index=165&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern due to the uncertainty of securing adequate financing[164](index=164&type=chunk) [Purchase Commitments](index=33&type=section&id=Purchase%20Commitments) - The company has no material non-cancelable purchase commitments with service providers, as contracts are generally on a cancelable, purchase order basis[167](index=167&type=chunk) [Critical Accounting Policies and Estimates](index=33&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - The financial statements are prepared in accordance with U.S. GAAP, requiring management to make estimates and assumptions that affect reported amounts[168](index=168&type=chunk) - There have been no material changes to the company's critical accounting policies and estimates during the nine months ended September 30, 2023, from those disclosed in the 2022 Annual Report on Form 10-K[169](index=169&type=chunk) [Off-Balance Sheet Arrangements](index=33&type=section&id=Off-Balance%20Sheet%20Arrangements) - The company did not have any material off-balance sheet arrangements during the periods presented and does not currently have any[170](index=170&type=chunk) [Smaller Reporting Company](index=33&type=section&id=Smaller%20Reporting%20Company) - The company remains a 'smaller reporting company' and intends to rely on exemptions from certain disclosure requirements[171](index=171&type=chunk) - It will cease to be a smaller reporting company if its non-affiliate public float exceeds **$250 million** with annual revenues over **$100 million**, or if its non-affiliate public float exceeds **$700 million**[171](index=171&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the company's exposure to market risks, focusing on interest rate fluctuations and the impact of inflation on operations [Interest Rate Risk](index=34&type=section&id=Interest%20Rate%20Risk) - The company is exposed to market risks from changes in the interest rate on its variable-rate debt borrowings and interest income sensitivity from cash equivalents[172](index=172&type=chunk) - Due to the short-term nature of its investment portfolio and debt agreement, an immediate **100 basis point** increase in interest rates is not expected to have a material effect on the fair market value of the portfolio or operating results/cash flows[172](index=172&type=chunk) [Inflation Risk](index=34&type=section&id=Inflation%20Risk) - Inflation generally affects the company by increasing labor costs and contract pricing[173](index=173&type=chunk) - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the three months ended September 30, 2023[173](index=173&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) This section reports on the effectiveness of disclosure controls and procedures and changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=34&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of September 30, 2023[174](index=174&type=chunk) [Changes in Internal Control over Financial Reporting](index=34&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - There were no changes in internal control over financial reporting identified during the quarter ended September 30, 2023, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[175](index=175&type=chunk) Part II — Other Information [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material pending legal proceedings - The company is not currently a party to any material pending legal proceedings[176](index=176&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section highlights significant risks, including substantial doubt about the company's ability to continue as a going concern due to ongoing losses and financing uncertainty - The company has identified conditions and events that raise substantial doubt regarding its ability to continue as a going concern[178](index=178&type=chunk) - As of September 30, 2023, the company had **$54.3 million** in cash and cash equivalents and used **$18.2 million** in operations during the nine months ended September 30, 2023, expecting continued significant cash outflows and losses[178](index=178&type=chunk) - The uncertainty in securing additional funding means the company may need to delay, reduce, or eliminate research and development programs, or cease operations, which could materially and adversely affect its stock price and ability to obtain financing[178](index=178&type=chunk)[181](index=181&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - None to report[182](index=182&type=chunk) [Item 3. Defaults Upon Senior Securities](index=35&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - None to report[182](index=182&type=chunk) [Item 4. Mine Safety Disclosures](index=35&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company's operations - Not applicable[183](index=183&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, terminated, or modified Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted, terminated, or modified Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended September 30, 2023[184](index=184&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including the Equity Incentive Plan, certifications, and XBRL documents - The exhibits include the Third Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan, certifications of principal executive and financial officers, and XBRL Instance Document and Taxonomy Extension Documents[187](index=187&type=chunk) [SIGNATURES](index=37&type=section&id=SIGNATURES) This section contains the official signatures of the President, CEO, and CFO, certifying the report filing - The report was signed on November 14, 2023, by Frank Bedu-Addo, President and Chief Executive Officer, and Matthew Hill, Chief Financial Officer[191](index=191&type=chunk)

Financial Data and Key Metrics Changes - The net loss for Q3 2023 was approximately $10.8 million, or $0.35 per share, compared to a net loss of approximately $7.4 million, or $0.26 per share, for the same period in 2022, primarily due to increased research and development costs [83][84] - Research and development costs increased to approximately $6.4 million in Q3 2023 from $4.3 million in Q3 2022, driven by higher clinical trial costs and personnel expenses [24] Business Line Data and Key Metrics Changes - The combination of PDS0101 and KEYTRUDA demonstrated a 24-month overall survival rate of 74% in the ICI naive group, indicating significant potential in treating HPV16 positive cancers [10][15] - The triple combination of PDS0101, PDS01ADC, and KEYTRUDA showed a 75% overall survival rate at three years, suggesting strong efficacy in advanced cancer treatment [15][75] Market Data and Key Metrics Changes - The overall survival rate for patients treated with PDS0101 in the ICI resistant group was reported at 72% at 12 months, compared to a median overall survival of only three to four months for standard therapies [76][78] - The safety profile of PDS01ADC was favorable, with only 48% of patients experiencing Grade 3 treatment-related adverse events, compared to 72% for KEYTRUDA plus chemotherapy [78] Company Strategy and Development Direction - The company aims to initiate the Phase III VERSATILE-003 trial in Q1 2024, focusing on expanding the application of PDS0101 and PDS01ADC in various cancer indications [13][88] - The strategy includes exploring the use of PDS01ADC in combination with standard chemotherapy and radiation therapy for advanced tumors, indicating a broadening of treatment approaches [20][80] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming milestones in 2024, including data readouts from ongoing trials and the initiation of new clinical studies [88][95] - The company is focused on maintaining a prudent cash management strategy, with available cash resources expected to sustain operations into Q3 2024 [25][91] Other Important Information - The company has safety data from over 250 patients treated with PDS01ADC, supporting its continued development [19] - Preliminary biomarker data from the VERSATILE-002 trial indicated a strong correlation between the elimination of circulating tumor DNA and improved patient outcomes [103] Q&A Session Summary Question: What are the key milestones and catalysts for 2024? - Management highlighted the initiation of the VERSATILE-003 trial and expected final data readouts from VERSATILE-002 in Q2 2024 as significant milestones [88][95] Question: How will operating expenses change in Q4 2023 and 2024? - Operating expenses are expected to increase as the company prepares for the Phase III clinical trial, with a ramp-up in costs anticipated [30][97] Question: What is the expected timeline for data from VERSATILE-003? - The timeline for data readouts will depend on the number of sites opened and enrollment rates, with management working aggressively to provide updates soon [96][88] Question: How does the company view the positioning of PDS0101 and PDS01ADC? - Management indicated that both assets have shown promising survival data and are being considered for broader applications beyond HPV positive cancers [100][100]

[Part I — Financial Information](index=3&type=section&id=Part%20I%20%E2%80%94%20Financial%20Information) [Financial Statements (Unaudited)](index=4&type=section&id=Item%201%2E%20Financial%20Statements%20%28Unaudited%29) PDS Biotechnology reported a $21.2 million net loss for H1 2023, with cash and assets declining due to R&D investment [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $60,624,991 | $73,820,160 | | Total current assets | $63,350,949 | $76,480,390 | | **Total assets** | **$63,754,250** | **$77,007,923** | | **Liabilities & Equity** | | | | Total current liabilities | $7,904,189 | $9,821,036 | | Note payable, net of debt discount | $23,254,367 | $23,020,844 | | **Total liabilities** | **$31,310,061** | **$33,005,893** | | Accumulated deficit | $(122,753,230) | $(101,558,417) | | **Total stockholders' equity** | **$32,444,189** | **$44,002,030** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (Unaudited) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $8,004,852 | $3,761,646 | $13,848,538 | $8,922,961 | | General and administrative expenses | $4,691,321 | $3,331,006 | $8,270,049 | $6,648,913 | | Loss from operations | $(12,696,173) | $(7,092,652) | $(22,118,587) | $(15,571,874) | | **Net loss and comprehensive loss** | **$(11,534,895)** | **$(5,819,200)** | **$(21,194,813)** | **$(14,292,722)** | | Net loss per share, basic and diluted | $(0.37) | $(0.20) | $(0.69) | $(0.50) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (Unaudited) | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(18,003,030) | $(12,287,867) | | Net cash provided by financing activities | $4,807,861 | $29,917 | | **Net increase in cash and cash equivalents** | **$(13,195,169)** | **$(12,257,950)** | | Cash and cash equivalents at end of period | $60,624,991 | $52,984,672 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company is a clinical-stage immunotherapy firm developing treatments for cancer and infectious diseases using its Versamune, Infectimune, and PDS0301 platforms, which are designed to activate potent T cells[20](index=20&type=chunk) - As of June 30, 2023, the company had **$60.6 million** in cash and cash equivalents, and management believes these funds are sufficient to continue operations and R&D programs for at least 12 months from the filing date of this report[36](index=36&type=chunk)[44](index=44&type=chunk) - In August 2022, the company entered into a venture loan agreement for up to six term loans, receiving funds from Loans A, B, C, and D on August 24, 2022, with floating interest rates and a 48-month maturity[40](index=40&type=chunk)[71](index=71&type=chunk) - In January 2023, the company entered into an exclusive global license agreement with Merck KGaA for the tumor-targeting antibody M9241 (now PDS0301), with potential milestone payments up to **$11 million** for development/first commercial sale and up to **$105 million** based on sales levels, plus a **10% royalty** on net sales[67](index=67&type=chunk)[68](index=68&type=chunk) - The company sold New Jersey Net Operating Loss (NOL) carryforwards, resulting in an income tax benefit of **$1.4 million** and **$1.2 million** for the six months ended June 30, 2023 and 2022, respectively[65](index=65&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202%2E%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management highlights clinical pipeline progress and increased R&D expenses, ending Q2 2023 with **$60.6 million** cash deemed sufficient for 12 months [Company Overview and Recent Developments](index=19&type=section&id=Company%20Overview%20and%20Recent%20Developments) - PDS Biotech is a clinical-stage immunotherapy company focused on activating T cells to treat cancer and infectious diseases through its Versamune®, Infectimune®, and PDS0301 platforms[87](index=87&type=chunk) - In June 2022, the FDA granted Fast Track designation to the lead candidate, PDS0101, in combination with Merck's KEYTRUDA® for treating recurrent/metastatic HPV16-positive head and neck cancer[88](index=88&type=chunk) - In December 2022, the company executed an exclusive global license agreement with Merck KGaA for the tumor-targeting IL-12 agent M9241, now designated PDS0301[92](index=92&type=chunk) - In February 2023, the company successfully completed a Type B meeting with the FDA regarding a potential registrational trial for the triple combination of PDS0101, PDS0301, and an approved checkpoint inhibitor for ICI-refractory head and neck cancer[93](index=93&type=chunk) [Clinical Candidate Pipeline](index=20&type=section&id=Clinical%20Candidate%20Pipeline) - **VERSATILE-002 (PDS0101 + KEYTRUDA®):** Enrollment in the ICI-naïve arm was completed in May 2023, with plans to initiate a Phase 3 trial (VERSATILE-003) in Q4 2023[95](index=95&type=chunk)[102](index=102&type=chunk) VERSATILE-002 ICI-Naïve Cohort Data (ASCO June 2023) | Metric | Result | | :--- | :--- | | Estimated 12-month overall survival rate | 87.1% | | Median progression-free survival | 10.4 months | | Objective response rate (confirmed & unconfirmed) | 41.2% (14/34 patients) | | Disease control rate | 70.6% (24/34 patients) | | Grade 3 treatment-related adverse events | 8.3% (4/48 patients) | - **NCI Triple Combination Trial (PDS0101 + PDS0301):** In ICI-refractory patients, the trial demonstrated a median overall survival of **21 months**, significantly better than the historical 3-4 months, with an objective response rate of **63%** at the optimal dose[106](index=106&type=chunk)[110](index=110&type=chunk) - **IMMUNOCERV Trial (PDS0101 + Chemoradiotherapy):** In patients with locally advanced cervical cancer, **100% (9/9)** showed an objective response, with **89% (8/9)** achieving a complete response, and the 1-year disease-free and overall survival was **89%**[111](index=111&type=chunk)[113](index=113&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Comparison of Operating Results (in thousands) | Period | Research & Development (in thousands) | General & Administrative (in thousands) | Net Loss (in thousands) | | :--- | :--- | :--- | :--- | | **Three Months Ended June 30, 2023** | **$8,005** | **$4,691** | **$(11,535)** | | Three Months Ended June 30, 2022 | $3,762 | $3,331 | $(5,819) | | **Six Months Ended June 30, 2023** | **$13,849** | **$8,270** | **$(21,195)** | | Six Months Ended June 30, 2022 | $8,923 | $6,649 | $(14,293) | - R&D expenses for the three and six months ended June 30, 2023 increased by **$4.2 million** and **$4.9 million** YoY, respectively, driven by higher costs for clinical trials, personnel (including stock-based compensation), and manufacturing[138](index=138&type=chunk)[142](index=142&type=chunk) - G&A expenses for the three and six months ended June 30, 2023 increased by **$1.4 million** and **$1.6 million** YoY, respectively, primarily due to increased personnel costs (including stock-based compensation) and professional fees[139](index=139&type=chunk)[143](index=143&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) - The company had **$60.6 million** in cash and cash equivalents as of June 30, 2023[153](index=153&type=chunk) - Management believes existing cash is sufficient to fund operations and R&D programs for 12 months following the filing of this report[154](index=154&type=chunk)[160](index=160&type=chunk) - During the six months ended June 30, 2023, the company sold **576,462 shares** of common stock for net proceeds of **$4.8 million** under its At Market Issuance Sales Agreement[148](index=148&type=chunk) - In April 2023, the company received approximately **$1.4 million** from the net sale of tax benefits through the New Jersey NOL program for tax year 2021[152](index=152&type=chunk) Summary of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(18,003) | $(12,288) | | Net cash provided by financing activities | $4,808 | $30 | | Net increase in cash and cash equivalents | $(13,195) | $(12,258) | [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203%2E%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuation, though management expects no material impact from rate changes or inflation - The company is exposed to market risk from interest rate fluctuations on its cash equivalents and variable interest rate debt[169](index=169&type=chunk) - Management does not expect operating results or cash flows to be materially affected by a sudden change in market interest rates[169](index=169&type=chunk) - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the quarter[170](index=170&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204%2E%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2023, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[171](index=171&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[173](index=173&type=chunk) [Part II — Other Information](index=34&type=section&id=Part%20II%20%E2%80%94%20Other%20Information) [Legal Proceedings](index=34&type=section&id=Item%201%2E%20Legal%20Proceedings) The company is not currently a party to any material pending legal proceedings - The company is not a party to any material pending legal proceedings[69](index=69&type=chunk)[174](index=174&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A%2E%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2022 - No material changes have occurred in the company's risk factors since the filing of its Annual Report on Form 10-K for the year ended December 31, 2022[175](index=175&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202%2E%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In April 2023, the company issued **100,000** unregistered common shares valued at **$659,000** to DC Consulting LLC for services - In April 2023, the company issued **100,000** unregistered shares of common stock to DC Consulting LLC for consulting services, with a fair value of approximately **$659,000** at issuance[176](index=176&type=chunk) [Other Information](index=34&type=section&id=Item%205%2E%20Other%20Information) During the quarter ended June 30, 2023, no directors or officers adopted, terminated, or modified a Rule 10b5-1 trading arrangement - No directors or officers adopted, terminated, or modified a Rule 10b5-1 trading arrangement during the quarter[179](index=179&type=chunk) [Exhibits](index=34&type=section&id=Item%206%2E%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act of 2002, and XBRL data files - The report includes required certifications from the CEO and CFO under Sections 302 and 906 of the Sarbanes-Oxley Act[183](index=183&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____________ Commission file number 001-37568 PDS Biotechnology Corporation (Exact name of registrant as specified in its charter) (State or oth ...

Financial Data and Key Metrics Changes - The net loss for Q1 2023 was approximately $9.7 million or $0.32 per share, compared to a net loss of $8.5 million or $0.32 per share for the same period in 2022, attributed to increased personnel costs, clinical studies costs, and medical affairs expenses [20][21]. - Total operating expenses for Q1 2023 were approximately $9.4 million, up from approximately $8.5 million in Q1 2022 [21]. - The company ended the quarter with approximately $65.2 million in cash, with cash burn impacted by a $5 million payment to Merck KGaA for the in-license of PDS0301 [22]. Business Line Data and Key Metrics Changes - Research and development expenses for Q1 2023 increased to approximately $5.8 million from $5.2 million in Q1 2022, primarily due to increased clinical studies and personnel costs [43]. - General and administrative expenses for Q1 2023 increased slightly to approximately $3.6 million from $3.3 million in Q1 2022, mainly due to higher personnel costs [97]. Market Data and Key Metrics Changes - The company is preparing to initiate the Phase 3 VERSATILE-003 trial, which will study PDS0101 in combination with KEYTRUDA against KEYTRUDA monotherapy in HPV-positive cancers [5][39]. - The Phase 2 results of PDS0101 have shown consistent anti-tumor activity across various HPV-positive cancers, with substantial biomarker data indicating the induction of HPV16-specific killer T cells [38]. Company Strategy and Development Direction - The company aims to commercialize PDS0101 for first-line treatment of recurrent or metastatic HPV-positive head and neck cancer, addressing a significant unmet medical need [14]. - The strategic focus includes the development of a triple combination therapy involving PDS0101, PDS0301, and a commercial immune checkpoint inhibitor, with promising results in both ICI naive and refractory cancers [17][55]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, emphasizing the potential of PDS0101 to revolutionize cancer treatment and the importance of upcoming milestones [14][87]. - The company is awaiting feedback from the FDA regarding the VERSATILE-003 trial design and anticipates that initial data from the refractory arm of the VERSATILE-002 study will inform the registrational study design [40][77]. Other Important Information - The company has monetized its net operating loss carryforwards in New Jersey, receiving $1.4 million as part of a tax benefits program [44]. - The company plans to present updated interim results for the Phase 2 VERSATILE-002 trial at the ASCO conference, which has been accepted for a poster presentation [37][72]. Q&A Session Summary Question: Can you provide more thoughts on the expert panel reviewing the VERSATILE-002 study at ASCO? - Management indicated that the expert panel will assess the data presented, including interim data points for progression-free survival (PFS) and overall survival (OS) [23][26]. Question: What are the expectations for interim analysis in the VERSATILE-003 trial? - Management stated that interim analysis criteria will be established in alignment with the FDA, and they are designing the trial based on observed enrollment rates from VERSATILE-002 [46][68]. Question: Can you discuss the partnership environment and ongoing discussions? - Management confirmed that partnership discussions are ongoing and are facilitated by the progress into Phase 3 trials, which potential partners find attractive [82]. Question: What is the anticipated cash burn for the remainder of the year? - Management projected a cash burn ramp-up to approximately $12 million to $13 million per quarter, primarily driven by R&D expenses [94]. Question: What CMC-related work is still needed before filing an amended IND? - Management highlighted the need for proper characterization of the manufacturing and release processes, as well as stability program requirements before filing the IND in Q3 [73][74].

Immunotherapy Development - The company is developing a pipeline of targeted cancer and infectious disease immunotherapies based on proprietary platforms Versamune® and Infectimune™, aiming to induce large quantities of high-quality CD4 and CD8 T cells[17]. - The company aims to address a wide range of cancers, including HPV-positive cancers and various solid tumors[17]. - The company is focused on overcoming challenges in immunotherapy, such as generating adequate quantities of high-quality T cells and minimizing systemic toxicities[23]. - The combination of Versamune and IL-12 is patented by the company, streamlining the registrational process for its therapies[21]. - Versamune has shown the ability to reduce the Treg to CD8 T cell ratio, enhancing tumor susceptibility to immune destruction[39]. - In preclinical studies, Versamune-based therapy resulted in complete tumor regression after a single subcutaneous injection[52]. - PDS0101 demonstrated immunological activity at all three doses studied, leading to clinical regression of cervical lesions in patients[52]. - PDS0301, when combined with Versamune, has shown potential for significant disease control by shrinking tumors and prolonging patient survival[58]. - PDS0102 is designed to treat TARP-associated cancers, showing safety and immunogenicity in preclinical studies[87]. - PDS Biotech is developing a universal influenza vaccine using the Infectimune platform, aiming for broad protection against multiple strains[63]. - PDS0201 is in preclinical development targeting tuberculosis, a leading cause of death from a single infectious agent, with 1.5 million deaths reported in 2020[66]. Clinical Trials and Results - In a Phase 2 clinical trial, the combination of PDS0101 and PDS0301 resulted in a median overall survival of 21 months for ICI refractory head and neck cancer patients, compared to a historical median survival of 3-4 months with checkpoint inhibitors[21]. - The VERSATILE-002 Phase 2 clinical trial is actively recruiting patients to evaluate the combination of PDS0101 and KEYTRUDA® for recurrent/metastatic head and neck cancer[71]. - Preliminary efficacy data from the VERSATILE-002 trial showed an objective response rate of at least 23.5% in the ICI refractory group[79]. - In the NCI-led Phase 2 trial, 41.2% of patients achieved tumor shrinkage greater than 30% with the triple combination therapy[78]. - The median overall survival for ICI refractory patients receiving the triple combination therapy was reported at 21 months, compared to historical data of 3-4 months[82]. - In ICI naïve patients, the objective response rate with the triple combination was 88%, significantly higher than the less than 25% reported with FDA-approved ICIs[82]. - The ongoing Phase 2 trial with MD Anderson Cancer Center is investigating the combination of PDS0101 with standard-of-care chemoradiotherapy for locally advanced cervical cancer[84]. - PDS0101 treatment resulted in 100% objective response rate and 89% complete response rate in patients treated with combination therapy[88]. - 1-year disease-free survival and overall survival rates were both 89% in patients receiving PDS0101 combined with CRT[88]. - Safety data from the trials indicate that 48% of patients experienced Grade 3 treatment-related adverse events, with no Grade 5 events reported[82]. Regulatory and Financial Aspects - The FDA granted Fast Track designation to PDS0101 in combination with KEYTRUDA® to expedite its development for serious conditions[18]. - The next step for PDS0101 is transitioning into Phase 3 clinical development, with an amended IND filing planned for Q3 2023[108]. - The company plans to progress PDS0102 and PDS0103 to IND submissions in 2023 for first-in-human trials[109]. - The company has not generated any product revenue to date and has incurred net losses each year since inception[100]. - The biotechnology and pharmaceutical industries are characterized by intense competition, with established companies and development-stage biotechnology companies competing in immunotherapies and vaccines[134]. - PDS anticipates facing increasing competition as new immunotherapies enter the market, which may affect its ability to compete based on efficacy, safety, and pricing[136]. - The FDA approval process for biological drug products requires substantial time and financial resources, with various regulatory steps that must be completed before marketing[138]. - The FDA may impose a clinical hold or partial clinical hold on clinical trials, which delays or suspends investigations, with a written explanation provided within 30 days[143]. - The company is seeking nondilutive financing to support the next stage of clinical development for its product candidates[97]. Intellectual Property and Agreements - As of December 31, 2022, the company holds seven (7) U.S. patents and nineteen (19) pending U.S. patent applications related to its Versamune platform, with issued patents expiring between 2026 and 2033[111]. - The company has an exclusive worldwide license from Merck & Cie for (R)-DOTAP and its related pharmaceutical compositions, which are significant for its immunotherapy products[112]. - The company has licensed patented antigens from the U.S. government for use in cationic lipid immunotherapies, including TARP peptide-based therapies for prostate and breast cancers[113]. - A non-exclusive agreement was entered into with the University of Georgia Research Foundation to develop COBRA universal influenza antigens for a clinical trial of a universal influenza vaccine[114]. - On December 30, 2022, the company entered into a License Agreement with Merck KGaA, which includes a one-time cash payment of $5.0 million and the issuance of 378,787 shares valued at $5.0 million[116]. - The company agreed to make milestone payments totaling up to $11 million upon achieving certain development milestones and up to $105 million based on aggregate sales levels of the product under the Merck KGaA License Agreement[117]. - A royalty of 10% on aggregate net sales of the product is to be paid to Merck KGaA, applicable for ten years after the first commercial sale or until the expiration of the licensed patents[118]. - The company has a Patent License Agreement with NIH, which includes a nonrefundable minimum annual royalty of $5,000 and earned royalties of 2% on net sales[122]. - Under the NCI Patent License Agreement, the company obtained a nonexclusive, worldwide license to develop TARP peptide-based therapies, with royalties and benchmark payments required[123]. - The Cooperative Research and Development Agreement with NCI includes a commitment of up to $1,000,000 for the first year and a minimum of $750,000 per year for subsequent years to support clinical research activities[126]. Market and Compliance Challenges - Coverage and reimbursement for PDS's product candidates depend on third-party payors, with significant uncertainty regarding approval and pricing processes[211]. - The Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into national rebate agreements to receive federal matching funds[204]. - PDS may face civil, criminal, and administrative penalties if found in violation of healthcare laws, which could adversely affect its operations and financial results[207]. - The marketability of PDS's products may suffer if adequate coverage and reimbursement are not provided by government and third-party payors[213]. - Increased scrutiny of pharmaceutical companies by federal and state enforcement bodies may lead to investigations and compliance challenges for PDS[208]. - PDS expects ongoing pricing pressures due to managed healthcare trends and legislative changes impacting reimbursement rates[214]. - Future state and federal privacy legislation may arise, potentially impacting PDS's operations and compliance costs[210]. - Recent healthcare reforms in the U.S. may delay marketing approval for product candidates and affect sales capabilities[216]. - The Patient Protection and Affordable Care Act (PPACA) has significantly impacted healthcare financing and delivery[216].

PDS Biotechnology Corporation (NASDAQ:PDSB) Q4 2022 Results Earnings Conference Call March 28, 2023 8:00 AM ET Company Participants Gabrielle DeGravina - Investor Relations, CG Capital Frank Bedu-Addo - Chief Executive Officer Lauren Wood - Chief Medical Officer Matthew Hill - Chief Financial Officer Conference Call Participants Leland Gershell - Oppenheimer & Co. Louise Chen - Cantor Fitzgerald Andrew Fleszar - B. Riley Securities James Molloy - Alliance Global Partners Robert LeBoyer - Noble Capital Marke ...

CFA + TARP (1-20) X Versamune® + TARP (1-20) 1 Reference: Wood LV et al, Oncoimmunology, 2016, Vol. 5 (8) CFA –Complete Freund's Adjuvant a highly potent immune activator not used in humans due to potentially lethal toxicity *Reference: Surveillance Research Program, National Cancer Institute SEER Assumes $150K for annual course of therapy; in line with current immunotherapy treatment.Assessments have not been adjusted to reflect TARP expression, which is currently unknown by tumor type 243 PDS0103: MUC1 An ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION PDS Biotechnology Corporation Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____________ Commission file number 001-37568 Securities registered pursuant to Section 12(b) of the Act: | Ti ...