PDS Biotechnology(PDSB) - 2024 Q1 - Quarterly Report

PART I — FINANCIAL INFORMATION 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) 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 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 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 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 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 This section provides detailed explanations and additional information supporting the condensed consolidated financial statements Note 1 – Nature of Operations 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] - The company's proprietary platforms include Versamune® and Versamune® in combination with PDS01ADC for oncology, and Infectimune® for infectious diseases[21] - Product candidates target various cancers (HPV-associated, melanoma, colorectal, lung, breast, prostate) and universal influenza vaccines[21] Note 2 – Summary of Significant Accounting Policies 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] - Research and development costs, including licensing fees and consultant fees, are expensed as incurred[27] - Stock-based compensation is recognized as an expense based on grant date fair values using the Black-Scholes option-pricing model[30] 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][64] - 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][38] Note 3 – Liquidity and Capital Resources 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] - 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][47][49] - Funding sources include an at-the-market offering program (Sales Agreement) and a venture loan and security agreement[40][41][42] 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][83] Note 4 – Fair Value of Financial Instruments 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] Note 5 – Leases 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] 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] Note 6 – Accrued Expenses 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 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] - 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][61] 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] Note 8 – Income Taxes 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][65] - 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] Note 9 – Commitments and Contingencies 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] - 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][69] - The Company is not currently a party to any material pending legal proceedings[70] Note 10 – Venture Loan and Security Agreement 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][72] - 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][74] - 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][78] - 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] 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 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 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] ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 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 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] - 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] Recent Developments 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] - 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] - 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] - Preclinical data for the universal flu vaccine candidate, PDS0202, demonstrated broad neutralization and protection across multiple influenza strains in animals (September 2023)[96] - 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] Clinical Candidate Pipeline This section details the company's ongoing clinical trials and investigational immunotherapies for various cancers and infectious diseases VERSATILE-002: PDS0101 + Keytruda® 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][105][108] - 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][117] - 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] - 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] National Cancer Institute: PDS0101+ M9241 (now PDS01ADC) +Bintrafusp Alfa 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][119] - Preclinical data showed synergistic activity of the triple combination, leading to superior tumor T cell responses and regression[116] - 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] - Objective response rates were 88% in ICI naïve patients and 63% in ICI resistant patients receiving the optimal dose of the triple combination[122] MD Anderson Cancer Center (IMMUNOCERV): PDS0101+ Chemoradiotherapy 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] - Patients treated with the combination achieved 89% 1-year disease-free survival and 1-year overall survival[123] - 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][130] Mayo Clinic: PDS0101 Monotherapy and in combination with Keytruda® 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] - 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] 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] 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] - Preclinical studies demonstrated PDS0103's ability to generate powerful MUC1-specific CD8 killer T cells[129] - 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] IL-12 Oncology Immunocytokine Pipeline 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] - 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][133] - 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] Infectimune® Development Strategy 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] - 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] - Preclinical data for PDS0202 (universal flu vaccine) demonstrated broad neutralization and protection against multiple influenza strains and lethal H1N1 challenge[136][138] SELECTED FINANCIAL OPERATIONS OVERVIEW This section provides an overview of the company's financial operations, including revenue and research and development expenses 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] Research and Development Expenses 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] - R&D expenses are expected to increase significantly as product candidates advance through clinical trials and regulatory approval processes[144] Results of Operations 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] - 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] Liquidity and Capital Resources 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] - 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][150][151][160] - 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][161] - 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] Cash Flows 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] - 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] Operating Capital Requirements 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] - Future funding requirements depend on factors such as clinical trial timing and costs, regulatory approvals, collaborations, intellectual property costs, and commercialization efforts[167][170] - 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] Purchase Commitments 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] Critical Accounting Policies and Estimates 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] Off-Balance Sheet Arrangements 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] Smaller Reporting Company 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] ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK This section details the company's exposure to market risks, including interest rate and inflation risks, and their historical impact Interest Rate Risk 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] - Historically, fluctuations in interest rates have not had a material impact on the Company[175] Inflation Risk 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] ITEM 4. CONTROLS AND PROCEDURES 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 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] Changes in Internal Control over Financial Reporting 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] PART II — OTHER INFORMATION This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and exhibits ITEM 1. LEGAL PROCEEDINGS 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] ITEM 1A. RISK FACTORS 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] - Any investment in the Company's business involves a high degree of risk[180] ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS 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] ITEM 3. DEFAULTS UPON SENIOR SECURITIES This section confirms the absence of any defaults upon senior securities during the reported period - There were no defaults upon senior securities[182] ITEM 4. MINE SAFETY DISCLOSURES This section states that mine safety disclosures are not applicable to the company's operations - Mine safety disclosures are not applicable[183] ITEM 5. OTHER INFORMATION This section indicates that there is no other information to report for the period - No other information to report[184] ITEM 6. EXHIBITS 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]