[PART I — FINANCIAL INFORMATION](index=3&type=section&id=Part%20I%20%E2%80%94%20Financial%20Information) This section presents PDS Biotechnology Corporation's unaudited condensed consolidated financial statements and related notes for the quarter ended March 31, 2024 [ITEM 1. FINANCIAL STATEMENTS (UNAUDITED)](index=3&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) This section presents PDS Biotechnology Corporation's unaudited condensed consolidated financial statements and related notes for the quarter ended March 31, 2024 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position at specific dates, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheet Highlights | Metric | March 31, 2024 (Unaudited) | December 31, 2023 | | :----------------------------- | :--------------------------- | :------------------ | | Cash and cash equivalents | $66,634,417 | $56,560,517 | | Total current assets | $68,685,765 | $59,055,075 | | Total assets | $69,006,366 | $59,390,080 | | Total current liabilities | $15,063,690 | $13,629,977 | | Total liabilities | $31,823,321 | $33,259,133 | | Total stockholders' equity | $37,183,045 | $26,130,947 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines the company's financial performance over a period, showing revenues, expenses, and net loss Condensed Consolidated Statements of Operations and Comprehensive Loss Highlights | Metric (Three Months Ended March 31) | 2024 | 2023 | | :----------------------------------- | :------------ | :------------ | | Research and development expenses | $6,704,164 | $5,843,686 | | General and administrative expenses | $3,393,463 | $3,578,728 | | Total operating expenses | $10,097,627 | $9,422,414 | | Loss from operations | $(10,097,627) | $(9,422,414) | | Interest income (expense), net | $(505,850) | $(237,504) | | Net loss and comprehensive loss | $(10,603,477) | $(9,659,918) | | Net loss per share, basic and diluted| $(0.30) | $(0.32) | | Weighted average common shares outstanding basic and diluted | 34,815,870 | 30,428,053 | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) This section details the changes in the company's equity accounts over a period, including net loss and stock issuances Changes in Stockholders' Equity (Q1 2024 vs. Q1 2023) | Item | March 31, 2024 | January 1, 2024 | March 31, 2023 | January 1, 2023 | | :--------------------------------------- | :------------- | :-------------- | :------------- | :-------------- | | Total Equity (End of Period) | $37,183,045 | $26,130,947 | $41,010,953 | $44,002,030 | | Stock-based compensation expense | $1,630,011 | - | $2,080,319 | - | | Issuances of common stock (net) | $19,494,473 | - | $4,588,522 | - | | Issuances of common stock (stock options)| $531,091 | - | - | - | | Net loss | $(10,603,477) | - | $(9,659,918) | - | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section reports the cash generated and used by the company during a period, categorized into operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows Highlights (Three Months Ended March 31) | Cash Flow Activity | 2024 | 2023 | | :----------------- | :------------- | :------------- | | Net loss | $(10,603,477) | $(9,659,918) | | Net cash used in operating activities | $(9,938,189) | $(13,188,636) | | Net cash provided by financing activities | $20,012,089 | $4,567,855 | | Net increase in cash and cash equivalents | $10,073,900 | $(8,620,781) | | Cash and cash equivalents at end of period | $66,634,417 | $65,199,379 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the condensed consolidated financial statements [Note 1 – Nature of Operations](index=8&type=section&id=Note%201%20%E2%80%93%20Nature%20of%20Operations) This note describes PDS Biotechnology Corporation's business, focusing on its clinical-stage immunotherapy development - PDS Biotechnology Corporation is a clinical-stage immunotherapy company focused on developing molecularly targeted immunotherapies to overcome limitations of current treatments[21](index=21&type=chunk) - The company's proprietary platforms include Versamune® and Versamune® in combination with PDS01ADC for oncology, and Infectimune® for infectious diseases[21](index=21&type=chunk) - Product candidates target various cancers (HPV-associated, melanoma, colorectal, lung, breast, prostate) and universal influenza vaccines[21](index=21&type=chunk) [Note 2 – Summary of Significant Accounting Policies](index=8&type=section&id=Note%202%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements - Unaudited interim financial statements are prepared in accordance with U.S. GAAP for interim reporting, consistent with policies used for the audited 2023 annual statements[22](index=22&type=chunk) - Research and development costs, including licensing fees and consultant fees, are expensed as incurred[27](index=27&type=chunk) - Stock-based compensation is recognized as an expense based on grant date fair values using the Black-Scholes option-pricing model[30](index=30&type=chunk) Potentially Dilutive Securities Excluded from EPS Calculation | Security Type | As of March 31, 2024 | As of March 31, 2023 | | :-------------------------------- | :------------------- | :------------------- | | Stock options to purchase Common Stock | 5,314,661 | 5,295,911 | | Warrants to purchase Common Stock | 466,112 | 506,229 | | Total | 5,780,773 | 5,802,140 | - A full valuation allowance is recorded against deferred tax assets due to the anticipation of future operating losses, resulting in no income tax benefit[33](index=33&type=chunk)[64](index=64&type=chunk) - New accounting standards ASU 2023-07 (Segment Reporting) and ASU 2023-09 (Income Tax Disclosures) are being evaluated, with ASU 2023-07 not expected to have a material impact due to having one reportable segment[37](index=37&type=chunk)[38](index=38&type=chunk) [Note 3 – Liquidity and Capital Resources](index=11&type=section&id=Note%203%20%E2%80%93%20Liquidity%20and%20Capital%20Resources) This note discusses the company's cash position, funding strategies, and ability to meet its financial obligations - As of March 31, 2024, the Company had **$66.6 million in cash and cash equivalents**[39](index=39&type=chunk) - The Company has experienced net losses and negative cash flows from operations since inception and expects this to continue, raising substantial doubt about its ability to continue as a going concern for at least 12 months[39](index=39&type=chunk)[47](index=47&type=chunk)[49](index=49&type=chunk) - Funding sources include an at-the-market offering program (Sales Agreement) and a venture loan and security agreement[40](index=40&type=chunk)[41](index=41&type=chunk)[42](index=42&type=chunk) Proceeds from Common Stock Sales via Sales Agreement | Period (Ended March 31) | Shares Sold | Net Value (Millions) | | :------------------------ | :---------- | :------------------- | | 2024 | 3,428,681 | $19.5 | | 2023 | 553,293 | $4.6 | - The Company received approximately **$0.9 million in April 2024** from the sale of tax benefits under the New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2022[46](index=46&type=chunk)[83](index=83&type=chunk) [Note 4 – Fair Value of Financial Instruments](index=13&type=section&id=Note%204%20%E2%80%93%20Fair%20Value%20of%20Financial%20Instruments) This note details the fair value measurements of the company's financial assets and liabilities Fair Value Measurements of Cash and Cash Equivalents (Level 1) | Asset | As of March 31, 2024 | As of December 31, 2023 | | :-------------------- | :------------------- | :---------------------- | | Cash and cash equivalents | $66,634,417 | $56,560,517 | - There were no transfers among Level 1, 2, or 3 fair value hierarchy during the three months ended March 31, 2024 or 2023[50](index=50&type=chunk) [Note 5 – Leases](index=14&type=section&id=Note%205%20%E2%80%93%20Leases) This note provides information on the company's lease arrangements and associated liabilities - An operating sublease for office space expired on August 31, 2023, and was not renewed, with the Company maintaining a month-to-month lease for its research facilities[52](index=52&type=chunk) Financing Lease Liabilities Maturity | Year ended December 31, | Amount | | :---------------------- | :----------- | | 2024 | $52,387 | | 2025 | $69,850 | | 2026 | $40,108 | | 2027 | $26,721 | | 2028 and after | $1 | | Total future minimum lease payments | $189,067 | | Less imputed interest | $(23,775) | | Remaining lease liability | $165,292 | - The Company has four financing leases for laboratory equipment with 4-5 year terms and a **9.15% capitalized interest rate**, with aggregate monthly payments of approximately **$6,000**[55](index=55&type=chunk) [Note 6 – Accrued Expenses](index=14&type=section&id=Note%206%20%E2%80%93%20Accrued%20Expenses) This note breaks down the company's accrued expenses into various categories Accrued Expenses Breakdown | Accrued Expense | As of March 31, 2024 | As of December 31, 2023 | | :-------------------------- | :------------------- | :---------------------- | | Accrued research and development | $457,229 | $- | | Accrued professional fees | $531,294 | $827,863 | | Accrued compensation | $418,449 | $1,289,690 | | Accrued interest on debt | $306,771 | $306,771 | | Accrued rent | $368 | $368 | | Total | $1,714,111 | $2,424,692 | [Note 7 – Stock-Based Compensation](index=15&type=section&id=Note%207%20%E2%80%93%20Stock-Based%20Compensation) This note explains the company's stock-based compensation plans and related expenses - The Third Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (Third Restated Plan) authorizes **6,565,535 shares**, with **2,645,723 shares available for grant** as of March 31, 2024[58](index=58&type=chunk) - The 2019 Inducement Plan was amended in January 2024 to increase shares reserved for issuance from **1,100,000 to 2,100,000**, with **1,232,200 shares available for grant** as of March 31, 2024[60](index=60&type=chunk)[61](index=61&type=chunk) Stock-Based Compensation Expense (Three Months Ended March 31) | Category | 2024 | 2023 | | :------------------------ | :----------- | :----------- | | Research and development | $551,918 | $800,764 | | General and administrative| $1,078,093 | $1,279,555 | | Total | $1,630,011 | $2,080,319 | - As of March 31, 2024, there was approximately **$15.1 million of unamortized stock option compensation expense**, expected to be recognized over an average vesting period of **2.95 years**[63](index=63&type=chunk) [Note 8 – Income Taxes](index=16&type=section&id=Note%208%20%E2%80%93%20Income%20Taxes) This note discusses the company's income tax position, including deferred tax assets and valuation allowances - The Company records a full valuation allowance against its deferred tax assets due to the expectation of a loss for 2024, resulting in no current income tax expense or benefit[64](index=64&type=chunk)[65](index=65&type=chunk) - In April 2024, the Company received approximately **$0.9 million** from the sale of its New Jersey state net operating losses for tax year 2022[66](index=66&type=chunk) [Note 9 – Commitments and Contingencies](index=17&type=section&id=Note%209%20%E2%80%93%20Commitments%20and%20Contingencies) This note outlines the company's contractual commitments and potential contingent liabilities - Rent expense for month-to-month arrangements was **$66,000** for both the three months ended March 31, 2024 and 2023[67](index=67&type=chunk) - The Company entered into an exclusive global license agreement with Merck KGaA for PDS01ADC, involving potential development and commercial sales milestone payments up to **$116 million** and a **10% royalty** on aggregate net sales[68](index=68&type=chunk)[69](index=69&type=chunk) - The Company is not currently a party to any material pending legal proceedings[70](index=70&type=chunk) [Note 10 – Venture Loan and Security Agreement](index=17&type=section&id=Note%2010%20%E2%80%93%20Venture%20Loan%20and%20Security%20Agreement) This note details the terms and conditions of the company's venture loan agreement - The Company entered into a venture loan and security agreement with Horizon Technology Finance Corporation in August 2022, providing for four term loans (A, B, C, D) totaling **$25 million**, with Loans E and F (**$10 million**) having expired[71](index=71&type=chunk)[72](index=72&type=chunk) - Loans mature on the 48-month anniversary of funding, with principal payments beginning October 1, 2024, and bearing a floating interest rate (prime rate + **5.75%**, minimum **4.00%**)[73](index=73&type=chunk)[74](index=74&type=chunk) - The Company's obligations are secured by a security interest in all assets, excluding intellectual property, and the Company was in compliance with all covenants as of March 31, 2024[77](index=77&type=chunk)[78](index=78&type=chunk) - Warrants to purchase **381,625 shares of common stock** were issued in connection with the loan, classified as equity, and a debt discount of **$1,994,412** remained unamortized as of March 31, 2024[80](index=80&type=chunk) Interest Expense and Debt Discount Amortization (Three Months Ended March 31) | Expense Type | 2024 | 2023 | | :--------------------- | :----------- | :----------- | | Total Interest Expense | $1,170,758 | $961,753 | | Amortization of Debt Discount | $270,236 | $121,997 | [Note 11 – Retirement Plan](index=18&type=section&id=Note%2011%20%E2%80%93%20Retirement%20Plan) This note provides information on the company's 401(k) retirement plan and employer contributions 401(k) Employer Contributions (Three Months Ended March 31) | Year | Employer Contributions | | :--- | :--------------------- | | 2024 | $66,488 | | 2023 | $94,907 | [Note 12– Subsequent Events](index=18&type=section&id=Note%2012%E2%80%93%20Subsequent%20Events) This note reports significant events that occurred after the balance sheet date - In April 2024, the Company received approximately **$0.9 million** from the net sale of tax benefits under the New Jersey Technology Business Tax Certificate Transfer of Net Operating Loss (NOL) program for tax year 2022[83](index=83&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of the company's financial condition, operational results, and strategic developments for the quarter ended March 31, 2024 [Company Overview](index=21&type=section&id=Company%20Overview) This section introduces PDS Biotech as a clinical-stage immunotherapy company developing targeted cancer and infectious disease treatments - PDS Biotech is a clinical-stage immunotherapy company developing targeted cancer and infectious disease immunotherapies based on Versamune® T cell activator and PDS01ADC[91](index=91&type=chunk) - The company's platforms aim to induce potent CD4 helper and CD8 killer T cells and disease-specific neutralizing antibodies to overcome current immunotherapy limitations[92](index=92&type=chunk) [Recent Developments](index=21&type=section&id=Recent%20Developments) This section highlights key milestones and progress in the company's clinical trials and product development - In December 2022, PDS Biotech licensed M9241 (now PDS01ADC) from Merck KGaA, a tumor-targeting IL-12 fused antibody drug conjugate, designed to enhance T cell activity and overcome cytokine therapy limitations[93](index=93&type=chunk) - A Phase 2 NCI-led trial of PDS0101 and PDS01ADC with an investigational bi-functional ICI in ICI-resistant HPV-positive cancers showed a median overall survival of approximately **20 months**, significantly higher than historical data[93](index=93&type=chunk) - The company announced successful completion of a Type B meeting with the FDA in February 2023 for a triple combination therapy for recurrent/metastatic, ICI resistant head and neck cancer[94](index=94&type=chunk) - Preclinical data for the universal flu vaccine candidate, PDS0202, demonstrated broad neutralization and protection across multiple influenza strains in animals (September 2023)[96](index=96&type=chunk) - Updated survival data from the NCI-led Phase 2 trial (November 2023) showed **75% survival** of ICI naïve patients at **36 months** for HPV16-positive cancers[101](index=101&type=chunk) [Clinical Candidate Pipeline](index=22&type=section&id=Clinical%20Candidate%20Pipeline) This section details the company's ongoing clinical trials and investigational immunotherapies for various cancers and infectious diseases [VERSATILE-002: PDS0101 + Keytruda®](index=22&type=section&id=VERSATILE-002%3A%20PDS0101%20%2B%20Keytruda%C2%AE) This section describes the Phase 2 clinical trial evaluating PDS0101 in combination with Keytruda® for HPV16-positive HNSCC - The Phase 2 clinical trial (VERSATILE-002) evaluating PDS0101 + Keytruda® for recurrent/metastatic HPV16-positive HNSCC has completed enrollment in both ICI naïve and ICI resistant arms[103](index=103&type=chunk)[105](index=105&type=chunk)[108](index=108&type=chunk) - Updated interim data (May 2024) for the ICI naïve cohort (CPS > 1) showed an estimated **12-month overall survival rate of 87.1%** (vs. 36-50% for approved ICIs alone) and a confirmed overall response rate of **34%**[113](index=113&type=chunk)[117](index=117&type=chunk) - The combination was well tolerated, with **11% of patients experiencing Grade 3 TRAEs** and **2% experiencing Grade 4 or 5 TRAEs**, which is comparable to or better than approved ICI monotherapy[117](index=117&type=chunk) - An updated clinical strategy (May 2024) focuses on a two-part registrational trial for the triple combination of Versamune® HPV + PDS01ADC + pembrolizumab as a first-line treatment in HPV16-positive recurrent/metastatic HNSCC[114](index=114&type=chunk) [National Cancer Institute: PDS0101+ M9241 (now PDS01ADC) +Bintrafusp Alfa](index=24&type=section&id=National%20Cancer%20Institute%3A%20PDS0101%2B%20M9241%20%28now%20PDS01ADC%29%20%2BBintrafusp%20Alfa) This section outlines the NCI-led Phase 2 trial for a triple combination therapy in advanced HPV-positive cancers - The NCI-led Phase 2 trial evaluating PDS0101 with PDS01ADC and Bintrafusp Alfa in advanced HPV-positive cancers has closed for enrollment, with evaluation of long-term patient survival ongoing[115](index=115&type=chunk)[119](index=119&type=chunk) - Preclinical data showed synergistic activity of the triple combination, leading to superior tumor T cell responses and regression[116](index=116&type=chunk) - Interim data (November 2023) showed **75% of ICI naïve patients alive at 36 months** (vs. historical 7-11 months) and a median OS of approximately **20 months** in ICI resistant patients (vs. historical 3-4 months)[122](index=122&type=chunk) - Objective response rates were **88% in ICI naïve patients** and **63% in ICI resistant patients** receiving the optimal dose of the triple combination[122](index=122&type=chunk) [MD Anderson Cancer Center (IMMUNOCERV): PDS0101+ Chemoradiotherapy](index=25&type=section&id=MD%20Anderson%20Cancer%20Center%20%28IMMUNOCERV%29%3A%20PDS0101%2B%20Chemoradiotherapy) This section presents results from the IMMUNOCERV Phase 2 trial for PDS0101 with chemoradiotherapy in cervical cancer - The IMMUNOCERV Phase 2 IIT for PDS0101 + standard-of-care chemoradiotherapy in locally advanced cervical cancer showed **100% objective response** and **89% complete response rates** on Day 170 by PET CT[123](index=123&type=chunk) - Patients treated with the combination achieved **89% 1-year disease-free survival** and **1-year overall survival**[123](index=123&type=chunk) - The combination was associated with earlier and greater ctDNA clearance (**81.3% after 3 weeks** vs. **30.3% with SOC CRT alone**) and activated HPV16-specific CD8 T cells and the Type 1 interferon pathway[124](index=124&type=chunk)[130](index=130&type=chunk) [Mayo Clinic: PDS0101 Monotherapy and in combination with Keytruda®](index=27&type=section&id=Mayo%20Clinic%3A%20PDS0101%20Monotherapy%20and%20in%20combination%20with%20Keytruda%C2%AE) This section details the Investigator-Initiated Trial at Mayo Clinic for PDS0101 in HPV-positive oropharyngeal cancer - An Investigator-Initiated Trial (ITT) for PDS0101 alone or in combination with Keytruda® has been initiated at Mayo Clinic for HPV-positive oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence[125](index=125&type=chunk) - This trial explores neoadjuvant treatment to increase HPV-specific anti-tumor responses, potentially leading to tumor shrinkage, pathologic regression, and decreases in circulating tumor DNA (ctDNA)[126](index=126&type=chunk) [PDS0102](index=27&type=section&id=PDS0102) This section introduces PDS0102, an investigational immunotherapy targeting TARP-associated cancers - PDS0102 is an investigational immunotherapy targeting TARP-associated cancers (AML, prostate, breast cancer), which has shown induction of large numbers of tumor-targeted killer T cells in preclinical studies[127](index=127&type=chunk) [PDS0103](index=27&type=section&id=PDS0103) This section describes PDS0103, an investigational immunotherapy for MUC1-associated cancers, and its development status - PDS0103 is an investigational immunotherapy for MUC1-associated cancers (ovarian, breast, colorectal, lung), combining Versamune® with novel MUC1 epitopes[128](index=128&type=chunk) - Preclinical studies demonstrated PDS0103's ability to generate powerful MUC1-specific CD8 killer T cells[129](index=129&type=chunk) - A pre-IND meeting with the FDA was held in Q1 2022, with IND package submission anticipated by the end of 2024, potentially impacted by resource allocation for PDS0101 pivotal trials[130](index=130&type=chunk) [IL-12 Oncology Immunocytokine Pipeline](index=28&type=section&id=IL-12%20Oncology%20Immunocytokine%20Pipeline) This section focuses on PDS01ADC, a novel IL-12 fused antibody drug conjugate, and its potential in cancer therapy - PDS01ADC is a novel IL-12 fused antibody drug conjugate designed to enhance T cell proliferation, potency, and longevity in the tumor microenvironment, working synergistically with Versamune®[131](index=131&type=chunk) - PDS01ADC has significant potential as a cytokine therapy independent of Versamune®, with several NCI-sponsored Phase 2 trials underway for various cancers, including prostate, Kaposi Sarcoma, and colon/bladder cancers[132](index=132&type=chunk)[133](index=133&type=chunk) - Interim data from a Phase 1/2 trial of PDS01ADC + docetaxel for metastatic prostate cancer showed PSA level decreases in all patients, with **61% achieving at least a 60% decrease**, and favorable immune response changes[133](index=133&type=chunk) [Infectimune® Development Strategy](index=28&type=section&id=Infectimune%C2%AE%20Development%20Strategy) This section outlines the Infectimune® platform's approach to infectious disease treatments, particularly universal flu vaccines - The Infectimune® platform aims to improve infectious disease treatments and prevention by inducing strong CD8 and CD4 T cells, as well as antibodies[134](index=134&type=chunk) - The company is focusing near-term infectious disease activities on developing a universal seasonal flu vaccine and potentially a universal pandemic influenza vaccine, aligning with NIAID interests[135](index=135&type=chunk) - Preclinical data for PDS0202 (universal flu vaccine) demonstrated broad neutralization and protection against multiple influenza strains and lethal H1N1 challenge[136](index=136&type=chunk)[138](index=138&type=chunk) [SELECTED FINANCIAL OPERATIONS OVERVIEW](index=30&type=section&id=SELECTED%20FINANCIAL%20OPERATIONS%20OVERVIEW) This section provides an overview of the company's financial operations, including revenue and research and development expenses [Revenue](index=30&type=section&id=Revenue) This section discusses the company's revenue generation strategy and expectations - The Company has not generated any revenues from commercial product sales and does not expect to in the near future, anticipating future revenue from R&D payments, license fees, and milestone payments[142](index=142&type=chunk) [Research and Development Expenses](index=30&type=section&id=Research%20and%20Development%20Expenses) This section details the components of research and development expenses and future expectations - R&D expenses include employee-related costs, licensing fees, clinical trial materials, and consultant fees, and are expensed as incurred[143](index=143&type=chunk) - R&D expenses are expected to increase significantly as product candidates advance through clinical trials and regulatory approval processes[144](index=144&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance for the reported period, highlighting key expense changes and net loss Results of Operations (Three Months Ended March 31, in thousands) | Metric | 2024 | 2023 | $ Amount Change | % Change | | :-------------------------- | :-------- | :-------- | :-------------- | :------- | | Research and development expenses | $6,704 | $5,844 | $860 | 15% | | General and administrative expenses | $3,393 | $3,579 | $(186) | (5)% | | Total operating expenses | $10,097 | $9,423 | $674 | 7% | | Loss from operations | $(10,097) | $(9,423) | $(674) | 7% | | Interest income (expense), net | $(506) | $(237) | $(269) | 114% | | Net loss and comprehensive loss | $(10,603) | $(9,660) | $(943) | 10% | - Research and development expenses increased by **$0.9 million (15%)** primarily due to a **$1.2 million increase** in clinical studies and medical affairs, partially offset by decreases in personnel, professional fees, and manufacturing costs[147](index=147&type=chunk) - General and administrative expenses decreased by **$0.2 million (5%)** mainly due to a **$0.5 million decrease** in personnel costs, partially offset by a **$0.3 million increase** in professional fees[148](index=148&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's current cash position, funding strategies, and ability to sustain operations - As of March 31, 2024, the Company had **$66.6 million in cash and cash equivalents**[158](index=158&type=chunk) - The Company continues to fund operations through existing cash and additional equity/debt financing, including an at-the-market offering program (Sales Agreement) and a venture loan agreement[149](index=149&type=chunk)[150](index=150&type=chunk)[151](index=151&type=chunk)[160](index=160&type=chunk) - The Company concluded that substantial doubt exists about its ability to continue as a going concern for at least 12 months due to recurring net losses and negative cash flows from operations[159](index=159&type=chunk)[161](index=161&type=chunk) - Proceeds from the sale of common stock under the Sales Agreement were **$19.5 million for Q1 2024**, compared to **$4.6 million for Q1 2023**[150](index=150&type=chunk) [Cash Flows](index=33&type=section&id=Cash%20Flows) This section summarizes the company's cash inflows and outflows from operating, investing, and financing activities Summary of Cash Flows (Three Months Ended March 31, in thousands) | Cash Flow Activity | 2024 | 2023 | | :-------------------------------- | :-------- | :-------- | | Net cash used in operating activities | $(9,938) | $(13,189) | | Net cash provided by financing activities | $20,012 | $4,568 | | Net increase (decrease) in cash and cash equivalents | $10,074 | $(8,621) | - Net cash used in operating activities decreased by **$3.3 million**, primarily due to a **$0.5 million decrease** in non-cash stock-based compensation expense, offset by a **$1.0 million increase** in net loss and changes in working capital[163](index=163&type=chunk) - Net cash provided by financing activities increased significantly, mainly due to higher net proceeds from the sale of common stock under the Sales Agreement (**$19.5 million in 2024** vs. **$4.6 million in 2023**)[164](index=164&type=chunk) [Operating Capital Requirements](index=34&type=section&id=Operating%20Capital%20Requirements) This section discusses the company's future funding needs and the factors influencing capital requirements - The Company has not generated product revenue and anticipates continued losses, requiring substantial additional funding for development, regulatory approvals, and potential commercialization[165](index=165&type=chunk) - Future funding requirements depend on factors such as clinical trial timing and costs, regulatory approvals, collaborations, intellectual property costs, and commercialization efforts[167](index=167&type=chunk)[170](index=170&type=chunk) - The Company reiterates substantial doubt about its ability to continue as a going concern, emphasizing the uncertainty of obtaining additional financing on acceptable terms[166](index=166&type=chunk) [Purchase Commitments](index=34&type=section&id=Purchase%20Commitments) This section clarifies the company's non-cancelable purchase commitments with service providers - The Company has no material non-cancelable purchase commitments with service providers, as contracts are generally on a cancelable, purchase order basis[169](index=169&type=chunk) [Critical Accounting Policies and Estimates](index=35&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section confirms the consistency of critical accounting policies and estimates with previous reports - There have been no material changes to the Company's critical accounting policies and estimates during the three months ended March 31, 2024, from those disclosed in its Annual Report on Form 10-K for 2023[172](index=172&type=chunk) [Off-Balance Sheet Arrangements](index=35&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of any off-balance sheet arrangements for the company - The Company did not have, and does not currently have, any off-balance sheet arrangements[173](index=173&type=chunk) [Smaller Reporting Company](index=35&type=section&id=Smaller%20Reporting%20Company) This section clarifies the company's status as a smaller reporting company and its implications for disclosure requirements - As of January 1, 2021, the Company ceased to be an 'emerging growth company' but remains a 'smaller reporting company,' allowing it to rely on exemptions from certain disclosure requirements[174](index=174&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section details the company's exposure to market risks, including interest rate and inflation risks, and their historical impact [Interest Rate Risk](index=35&type=section&id=Interest%20Rate%20Risk) This section explains the company's exposure to interest rate fluctuations on its cash equivalents and floating-rate debt - The Company is exposed to interest rate risk due to its cash equivalents (bank deposits and money market accounts) and its floating-rate Loan and Security Agreement, which is pegged to the prime rate[175](index=175&type=chunk) - Historically, fluctuations in interest rates have not had a material impact on the Company[175](index=175&type=chunk) [Inflation Risk](index=35&type=section&id=Inflation%20Risk) This section assesses the impact of inflation on the company's costs and overall financial performance - Inflation affects the Company by increasing labor costs and contract pricing, but it has not had a material effect on its business, financial condition, or results of operations during the three months ended March 31, 2024[176](index=176&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of disclosure controls and procedures and reports no material changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=35&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section reports management's conclusion on the effectiveness of the company's disclosure controls and procedures - Management, including the CEO and CFO, concluded that the Company's disclosure controls and procedures were effective as of March 31, 2024[177](index=177&type=chunk) [Changes in Internal Control over Financial Reporting](index=36&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section addresses any material changes in the company's internal control over financial reporting during the quarter - There were no changes in internal control over financial reporting during the quarter ended March 31, 2024, that materially affected or are reasonably likely to materially affect the Company's internal control over financial reporting[178](index=178&type=chunk) [PART II — OTHER INFORMATION](index=36&type=section&id=Part%20II%20%E2%80%94%20Other%20Information) This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and exhibits [ITEM 1. LEGAL PROCEEDINGS](index=36&type=section&id=Item%201.%20Legal%20Proceedings) This section confirms the absence of any material pending legal proceedings involving the company - There are no material pending legal proceedings to which the Company is a party[179](index=179&type=chunk) [ITEM 1A. RISK FACTORS](index=36&type=section&id=Item%201A.%20Risk%20Factors) This section reiterates that there have been no material changes to previously reported risk factors, emphasizing the high investment risk - There have been no material changes to the Company's risk factors as previously reported in its Annual Report on Form 10-K for the year ended December 31, 2023[180](index=180&type=chunk) - Any investment in the Company's business involves a high degree of risk[180](index=180&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports that there were no unregistered sales of the company's equity securities during the reported period - There were no unregistered sales of the Company's equity securities during the three months ended March 31, 2024[181](index=181&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=36&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section confirms the absence of any defaults upon senior securities during the reported period - There were no defaults upon senior securities[182](index=182&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=36&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable to the company's operations - Mine safety disclosures are not applicable[183](index=183&type=chunk) [ITEM 5. OTHER INFORMATION](index=36&type=section&id=Item%205.%20Other%20Information) This section indicates that there is no other information to report for the period - No other information to report[184](index=184&type=chunk) [ITEM 6. EXHIBITS](index=36&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report, including key agreements and certifications - Exhibits include executive employment agreements (e.g., Kirk V. Shephard, Stephan F. Toutain), the PDS Biotechnology Corporation 2019 Inducement Plan, and certifications from principal executive and financial officers[187](index=187&type=chunk)

Financial Performance - Reported net loss for Q1 2024 was approximately $10.6 million, or $0.30 per share, compared to a net loss of $9.7 million, or $0.32 per share in Q1 2023[5] - General and administrative expenses decreased to approximately $3.4 million in Q1 2024 from $3.6 million in Q1 2023[7] - Total operating expenses rose to approximately $10.1 million in Q1 2024 from $9.4 million in Q1 2023[9] - Cash and cash equivalents as of March 31, 2024, totaled approximately $66.6 million, up from $56.6 million at the end of 2023[10][20] Research and Development - Research and development expenses increased to approximately $6.7 million in Q1 2024 from $5.8 million in Q1 2023, primarily due to a $1.2 million increase in clinical studies[6] Clinical Trial Results - Updated results from the VERSATILE-002 trial showed a median overall survival of 30 months for patients treated with Versamune® HPV + KEYTRUDA®, compared to published results of 7-18 months for immune checkpoint inhibitors[3] - The best overall response rate (BOR) was 34% for CPS ≥1 and 48% for CPS ≥20, significantly higher than published results for immune checkpoint inhibitors[3] - Progression-free survival was reported at 6.3 months for CPS ≥1 and 14.1 months for CPS ≥20, compared to 2-3 months for immune checkpoint inhibitors[3] Regulatory and Patent Developments - The company announced a two-part registrational trial for a triple combination treatment in HPV16-positive recurrent or metastatic head and neck cancer[8] - The company received patents extending protections for the Versamune® platform through December 2038 and November 2036, respectively[8]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT UNDER 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) Delaware 26-4231384 (State or other juri ...

Financial Data and Key Metrics Changes - The net loss for the year ended December 31, 2023, was approximately $42.9 million, or $1.39 per share, compared to a net loss of $40.9 million, or $1.43 per share, for the year ended December 31, 2022, indicating a slight increase in net loss primarily due to increased operating loss and net interest expense [22][23][24] - Total operating expenses for the year ended December 31, 2023, were $43 million, an increase of approximately 3.3% compared to $41.7 million in 2022 [24] - Research and development expenses decreased to $27.8 million in 2023 from $29.4 million in 2022, while general and administrative expenses increased to $15.3 million from $12.2 million [50][51] Business Line Data and Key Metrics Changes - The company is prioritizing the PDS01ADC triple combination study over the previously planned VERSATILE-003 trial, focusing resources on what is believed to be the highest potential benefit for patients with head and neck cancer [14][20] - The triple combination of Versamune HPV, PDS01ADC, and KEYTRUDA is expected to significantly improve overall survival rates for patients lacking effective treatment options [48] Market Data and Key Metrics Changes - The company is conducting rigorous evaluations of the competitive landscape in both ICI-naive and ICI-resistant head and neck cancer, indicating a strategic focus on addressing unmet needs in these patient populations [20][38] - The overall response rate (ORR) for the triple combination was reported at 75%, with a complete response rate of 38%, compared to published ORR of less than 40% for other immunotherapeutic agents [45][46] Company Strategy and Development Direction - The company aims to advance the triple combination into a pivotal trial, focusing initially on recurrent metastatic HPV-16 positive head and neck cancer before potentially expanding to other HPV-associated cancers [48][68] - The management has engaged with the FDA for guidance on clinical study design and regulatory pathways for the triple combination, indicating a proactive approach to regulatory compliance [19][87] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the long-term survival data from the triple combination, highlighting a 72% overall survival rate at 12 months for ICI-resistant patients, compared to approximately 30% with current approaches [44] - The company anticipates updates on the VERSATILE-002 trial in the second or early third quarter of 2024, with hopes for preliminary data from ongoing trials at the Mayo Clinic later in the year [28][29] Other Important Information - The company raised approximately $10.5 million in net proceeds from an at-the-market sales agreement during the fourth quarter of 2023, with a cash balance of $56.6 million as of December 31, 2023 [25][83] - The annual report will contain a going concern opinion, reflecting substantial doubt about the company's ability to meet obligations for 12 months following the filing [25] Q&A Session Summary Question: How is the company managing operating expenses differently due to the prioritization of the PDS01ADC triple combo study? - The management indicated that the operating burn is approximately $8 million per quarter and is expected to continue through the first two to three quarters of 2024, with a slight decrease anticipated thereafter [31][32] Question: What are the biggest milestones or data readouts expected in the next 12 to 18 months? - Key updates expected include results from the IMMUNOCERV trial at MD Anderson and the filing of the IND for the PDS0103 program in the second half of the year [58][59] Question: Is the VERSATILE-003 trial still ongoing? - The management confirmed that VERSATILE-003 is not moving forward, as the focus has shifted to the triple combination, which is believed to provide the best opportunity for patients [72][73] Question: What is the focus of the company's initial trials? - The initial focus is on head and neck cancer, guided by FDA recommendations, before potentially expanding to other HPV-associated cancers [68][69]

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 ...

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 September 30, 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 ...

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].