PDS Biotechnology(PDSB) - 2025 Q2 - Quarterly Report

FORM 10-Q Filing Information This section provides details on the Form 10-Q filing for PDS Biotechnology Corporation, including its filer status and registered stock information Filing Details This document is a Quarterly Report on Form 10-Q for PDS Biotechnology Corporation, covering the period ended June 30, 2025. The company is a non-accelerated filer and a smaller reporting company - The report is a Quarterly Report on Form 10-Q for the period ended June 30, 2025[2] - PDS Biotechnology Corporation is a non-accelerated filer and a smaller reporting company[3][4] Title of each class | Title of each class | Trading symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, par value $0.00033 per share | PDSB | The Nasdaq Stock Market LLC | Table of Contents This section provides an organized list of all chapters and sub-sections within the report for easy navigation Part I — Financial Information This part presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis Item 1. Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements for PDS Biotechnology Corporation, including Balance Sheets, Statements of Operations and Comprehensive Loss, Statements of Changes in Stockholders' Equity, and Statements of Cash Flows, along with their accompanying notes Condensed Consolidated Balance Sheets Total assets decreased from $45.36 million at December 31, 2024, to $40.48 million at June 30, 2025, with notable decreases in cash and equity ASSETS | ASSETS | June 30, 2025 (unaudited) ($) | December 31, 2024 ($) | | :-------------------------------- | :------------- | :------------- | | Current assets: | | | | Cash and cash equivalents | $31,873,495 | $41,689,591 | | Prepaid expenses and other assets | $1,774,550 | $3,364,852 | | Total current assets | $33,648,045 | $45,054,443 | | Noncurrent assets: | | | | Prepaid expenses | $6,554,064 | - | | Property and equipment, net | $131,102 | $142,020 | | Financing lease right-to-use assets | $142,854 | $162,194 | | Total assets | $40,476,065 | $45,358,657 | LIABILITIES AND STOCKHOLDERS' EQUITY | LIABILITIES AND STOCKHOLDERS' EQUITY | June 30, 2025 (unaudited) ($) | December 31, 2024 ($) | | :-------------------------------- | :------------- | :------------- | | Current liabilities: | | | | Accounts payable | $4,497,434 | $1,684,868 | | Accrued expenses | $1,482,081 | $2,841,214 | | Note payable - short term | $5,500,000 | $12,500,000 | | Financing lease obligation-short term | $51,937 | $61,119 | | Total current liabilities | $11,531,452 | $17,087,201 | | Noncurrent liabilities: | | | | Note payable, net of debt discount | $12,943,656 | $9,204,755 | | Financing lease obligation-long term | $41,173 | $61,853 | | Total liabilities | $24,516,281 | $26,353,809 | STOCKHOLDERS' EQUITY | STOCKHOLDERS' EQUITY | June 30, 2025 (unaudited) ($) | December 31, 2024 ($) | | :-------------------------------- | :------------- | :------------- | | Common stock | $15,390 | $12,536 | | Additional paid-in capital | $215,978,568 | $201,103,311 | | Accumulated deficit | $(200,034,174) | $(182,110,999) | | Total stockholders' equity | $15,959,784 | $19,004,848 | | Total liabilities and stockholders' equity | $40,476,065 | $45,358,657 | - Cash and cash equivalents decreased by $9.8 million from $41.7 million at December 31, 2024, to $31.9 million at June 30, 2025[9] - Total stockholders' equity decreased by $3.0 million from $19.0 million at December 31, 2024, to $16.0 million at June 30, 2025[9] Condensed Consolidated Statements of Operations and Comprehensive Loss Net loss increased to $9.43 million for Q2 2025 but decreased to $17.92 million for H1 2025, influenced by lower operating expenses and higher interest expenses Operating expenses: | Operating expenses: | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------------- | :------------- | :------------- | :------------- | :------------- | | Research and development expenses | $4,212,918 | $4,527,698 | $10,043,918 | $11,231,862 | | General and administrative expenses | $3,410,433 | $4,156,606 | $6,685,191 | $7,550,069 | | Total operating expenses | $7,623,351 | $8,684,304 | $16,729,109 | $18,781,931 | | Loss from operations | $(7,623,351) | $(8,684,304) | $(16,729,109) | $(18,781,931) | | Interest income (expenses), net | $(1,810,857) | $(512,762) | $(2,363,886) | $(1,018,612) | | Benefit from income taxes | - | $869,169 | $1,169,820 | $869,169 | | Net loss and comprehensive loss | $(9,434,208) | $(8,327,897) | $(17,923,175) | $(18,931,374) | | Net loss per share, basic and diluted | $(0.21) | $(0.23) | $(0.41) | $(0.53) | | Weighted average common shares outstanding, basic, and diluted | 45,902,502 | 36,693,561 | 43,226,618 | 35,754,715 | - Net loss increased by 13% to $9.43 million for the three months ended June 30, 2025, compared to $8.33 million for the same period in 2024[11] - Net loss decreased by 5% to $17.92 million for the six months ended June 30, 2025, compared to $18.93 million for the same period in 2024[11] Condensed Consolidated Statements of Changes in Stockholders' Equity Stockholders' equity decreased from $19.00 million to $15.96 million by June 30, 2025, primarily due to a $17.92 million net loss, partially offset by stock and warrant issuances Stockholders' Equity Changes | | Common Stock ($) | Additional Paid-in Capital ($) | Accumulated Deficit ($) | Total Equity ($) | | :-------------------------------- | :------------- | :------------------------- | :------------------ | :----------- | | January 1, 2025 | $12,536 | $201,103,311 | $(182,110,999) | $19,004,848 | | Stock-based compensation expense | - | $1,253,882 | - | $1,253,882 | | Issuance of common stock for consulting agreement | $50 | $203,451 | - | $203,501 | | Issuances of common stock from the Sales Agreement, net | $68 | $306,047 | - | $306,115 | | Issuances of common stock, net of issuance costs | $2,111 | $6,919,908 | - | $6,922,019 | | Issuance of pre-funded warrants | - | $1,009,969 | - | $1,009,969 | | Issuance of warrants | - | $2,150,771 | - | $2,150,771 | | Exercise of pre-funded warrants | $233 | $(162) | - | $71 | | Net loss | - | - | $(8,488,967) | $(8,488,967) | | Balance - March 31, 2025 | $14,998 | $212,947,177 | $(190,599,966) | $22,362,209 | | Stock-based compensation expense | - | $448,029 | - | $448,029 | | Issuances of common stock from the Sales Agreement, net | $317 | $1,460,325 | - | $1,460,642 | | Issuances of common stock, net of issuance costs | - | $50,000 | - | $50,000 | | Issuance of warrants | - | $1,073,089 | - | $1,073,089 | | Exercise of pre-funded warrants | $75 | $(52) | - | $23 | | Net loss | - | - | $(9,434,208) | $(9,434,208) | | Balance - June 30, 2025 | $15,390 | $215,978,568 | $(200,034,174) | $15,959,784 | - Total stockholders' equity decreased by $3.0 million from $19.0 million at January 1, 2025, to $16.0 million at June 30, 2025[14] - The accumulated deficit increased to $200.0 million as of June 30, 2025, from $182.1 million at January 1, 2025, primarily due to net losses[14] Condensed Consolidated Statements of Cash Flows Net cash used in operating activities decreased to $18.13 million, while net cash provided by financing activities significantly decreased to $8.32 million, resulting in a $9.82 million net decrease in cash Cash flows from operating activities: | Cash flows from operating activities: | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------------- | :------------- | :------------- | | Net loss | $(17,923,175) | $(18,931,374) | | Net cash used in operating activities | $(18,133,379) | $(18,796,097) | | Net cash used in investing activities | - | $(28,999) | | Net cash provided by financing activities | $8,317,283 | $19,998,303 | | Net decrease in cash and cash equivalents | $(9,816,096) | $1,173,207 | | Cash and cash equivalents at beginning of period | $41,689,591 | $56,560,517 | | Cash and cash equivalents at the end of period | $31,873,495 | $57,733,724 | | Supplemental information of cash and non-cash transactions: | | | | Cash paid for interest | $1,581,846 | $2,362,716 | - Net cash used in operating activities decreased by $0.66 million (3.5%) for the six months ended June 30, 2025, compared to the same period in 2024[17] - Net cash provided by financing activities decreased by $11.68 million (58.4%) for the six months ended June 30, 2025, compared to the same period in 2024[17] Notes to Condensed Consolidated Financial Statements These notes detail the company's operations, accounting policies, liquidity, capital resources, fair value, leases, accrued expenses, stock-based compensation, income taxes, commitments, and debt agreements, including new financing and going concern assessment Note 1 – Nature of Operations PDS Biotechnology Corporation is a clinical-stage immunotherapy company developing targeted immunotherapies for oncology and infectious diseases using its proprietary Versamune®, PDS01ADC, and Infectimune® platforms - PDS Biotech is a clinical-stage immunotherapy company developing targeted immunotherapies for oncology and infectious diseases[19] - Key proprietary platforms include Versamune® (alone or with PDS01ADC for oncology) and Infectimune® (for infectious diseases), designed to induce potent T cell responses and neutralizing antibodies[19] - The company is developing product candidates for HPV-associated cancers, melanoma, colorectal, lung, breast, prostate cancers, and universal influenza vaccines[19] Note 2 – Summary of Significant Accounting Policies Unaudited interim financial statements adhere to U.S. GAAP, with R&D and patent costs expensed as incurred, stock-based compensation valued by Black-Scholes, and ASC 842 applied to leases, with ASU 2023-07 adopted retrospectively - Unaudited interim financial statements are prepared in U.S. dollars and in accordance with U.S. GAAP for interim reporting, consistent with annual policies[20] - Research and development costs and patent costs are expensed as incurred[25][27] - The company adopted ASU 2023-07, Segment Reporting, retrospectively for the annual period ended December 31, 2024, enhancing disclosures about significant segment expenses[34] Note 3 – Liquidity and Capital Resources As of June 30, 2025, cash and cash equivalents totaled $31.9 million; ongoing net losses and negative cash flows raise substantial doubt about the company's going concern, necessitating recent equity and debt financings - As of June 30, 2025, cash and cash equivalents totaled $31.9 million[38] - The company has experienced net losses and negative cash flows from operations since inception and expects this to continue, leading to substantial doubt about its ability to continue as a going concern[38][46][48] - Recent financing activities include: $1.5 million (Q2 2025) from the New Sales Agreement, $1.2 million from NJ NOL program (2025), $10.05 million net from February 2025 Offering, and $20.0 million total purchase price from April 2025 Securities Purchase Agreement (Debentures and Warrants), with $19 million used to retire previous debt[40][43][44][45] Note 4 – Fair Value of Financial Instruments Cash and cash equivalents are Level 1 fair value measurements, and the Debentures' carrying value approximated fair value due to their variable interest rate as of June 30, 2025 Fair Value Measurements | | Total ($) | Quoted Prices in Active Markets (Level 1) ($) | Quoted Prices in Inactive Markets (Level 2) ($) | Significant Unobservable Inputs (Level 3) ($) | | :-------------------------- | :------------ | :---------------------------------------- | :---------------------------------------- | :---------------------------------------- | | As of June 30, 2025: | | | | | | Cash and cash equivalents | $31,873,495 | $31,873,495 | $ - | $ - | | As of December 31, 2024: | | | | | | Cash and cash equivalents | $41,689,591 | $41,689,591 | $ - | $ - | - The carrying value of the Debentures approximated its fair value as of June 30, 2025, due to the variable interest rate[50] Note 5 – Leases The company holds a month-to-month operating lease for research facilities and financing leases for laboratory equipment, with total future minimum financing lease payments of $101,757, including $34,925 due in 2025 - The company maintains a month-to-month operating lease for its research facilities[51] Future Minimum Financing Lease Payments | Year ended December 31, | Amount ($) | | :---------------------- | :--------- | | 2025 | $34,925 | | 2026 | $40,108 | | 2027 and after | $26,724 | | Total future minimum lease payments | $101,757 | | Less imputed interest | $(8,647) | | Remaining lease liability | $93,110 | - Financing leases for laboratory equipment have a total cost of $251,959 with four to five-year terms and a 9.15% capitalized interest rate[53] Note 6 – Accrued Expenses Total accrued expenses decreased to $1.48 million at June 30, 2025, from $2.84 million at December 31, 2024, primarily due to reduced accrued research and development and professional fees Accrued Expenses | Accrued expenses | As of June 30, 2025 ($) | As of December 31, 2024 ($) | | :-------------------------- | :------------- | :------------- | | Accrued research and development | $178,192 | $1,267,627 | | Accrued professional fees | $315,420 | $657,498 | | Accrued compensation | $988,101 | $663,399 | | Accrued interest on debt | - | $252,322 | | Accrued rent | $368 | $368 | | Total | $1,482,081 | $2,841,214 | - Accrued research and development decreased significantly from $1.27 million to $0.18 million[54] - Accrued professional fees decreased from $0.66 million to $0.32 million[54] Note 7 – Stock-Based Compensation Equity incentive plans were amended to increase authorized shares; stock-based compensation expense for H1 2025 was $1.70 million, a decrease from $3.43 million in the prior year, with 6,397,184 options outstanding at a $5.88 weighted average exercise price - The Third Restated Plan was amended to increase authorized shares for issuance to 9,709,584 shares, with 3,409,087 shares available for grant as of June 30, 2025[58] - The Inducement Plan was amended to increase authorized shares to 2,100,000, with 957,407 shares available for grant as of June 30, 2025[60][61] Stock-Based Compensation | Stock-Based Compensation | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------- | :------------- | :------------- | :------------- | :------------- | | Research and development | $(316,466) | $609,828 | $204,061 | $1,161,746 | | General and administrative | $764,495 | $1,185,894 | $1,497,850 | $2,263,987 | | Total | $448,029 | $1,795,722 | $1,701,911 | $3,425,733 | Stock Option Activity (Six months ended June 30, 2025) | Stock Option Activity (Six months ended June 30, 2025) | Number of Options / Price ($) | | :-------------------------------- | :------------- | | Options outstanding at December 31, 2024 | 5,373,063 | | Granted options | 1,246,500 | | Forfeited and expired | (222,379) | | Options outstanding at June 30, 2025 | 6,397,184 | | Weighted average exercise price of all outstanding options | $5.88 | Note 8 – Income Taxes A full valuation allowance was recorded against net deferred tax assets, resulting in no income tax benefit for Q2 2025, but a $1.2 million income tax benefit was recognized for H1 2025 from selling New Jersey NOL carryforwards, up from $0.9 million in the prior year - The company recorded a full valuation allowance against net deferred tax assets due to expected operating losses, resulting in no income tax benefit for the three months ended June 30, 2025[65][66] - Income tax benefit from the New Jersey Technology Business Tax Certificate Transfer NOL program was $1.2 million for the six months ended June 30, 2025, compared to $0.9 million in 2024[68] Note 9 – Commitments and Contingencies The company has rent commitments and an exclusive global license agreement with Merck KGaA for PDS01ADC, involving potential milestone payments up to $116 million and a 10% royalty on net sales, with no material pending legal proceedings - Rent expense for the three and six months ended June 30, 2025, was $64,200 and $129,900, respectively[69] - Under the Merck KGaA License Agreement for PDS01ADC, the company may pay up to $11 million in development and first commercial sales milestones and up to $105 million for aggregate sales levels[70] - A 10% royalty on aggregate net sales of PDS01ADC is payable to Merck KGaA, subject to certain reductions[71] - The company is not a party to any material pending legal proceedings[72] Note 10 – Venture Loan and Security Agreement The August 2022 Venture Loan and Security Agreement was fully retired using proceeds from the April 2025 Securities Purchase Agreement; interest expense was $277,859 for Q2 2025 and $1,206,035 for H1 2025, including a $1,107,005 debt extinguishment expense in Q2 2025 - The Venture Loan and Security Agreement was fully satisfied and retired with proceeds from the April 2025 Securities Purchase Agreement[73][78] - Interest expense recognized for this loan was $277,859 for the three months ended June 30, 2025, and $1,206,035 for the six months ended June 30, 2025[74] - A $1,107,005 interest expense was recognized during Q2 2025 due to the extinguishment of this debt[75] Note 11 – Securities Purchase Agreement On April 30, 2025, the company sold $22.22 million in senior secured convertible debentures and warrants for 1 million common shares for $20 million, using $19 million to retire prior debt; debentures carry a coupon rate of prime plus 5.0% (minimum 11.0%) and an effective annual interest rate of approximately 24.1% - On April 30, 2025, the company sold $22,222,222 in senior secured convertible debentures and warrants to purchase 1,000,000 shares of common stock[76] - The total purchase price for these securities was $20,000,000[76] - Approximately $19 million of the proceeds were used to satisfy the previous Loan and Security Agreement[78] - The debentures have a coupon rate of prime plus 5.0% (minimum 11.0%) and an effective annual interest rate of approximately 24.1% as of June 30, 2025[79] - Interest expense of $757,257 was recognized for the debentures for the three and six months ended June 30, 2025[80] Note 12 – Retirement Plan The company contributed $51,293 to its 401(k) plan for Q2 2025 and $116,833 for H1 2025, a slight increase from the prior year 401(k) Employer Contributions | 401(k) Employer Contributions | Three Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2025 ($) | | :-------------------------- | :------------- | :------------- | | 2025 | $51,293 | $116,833 | | 2024 | $46,995 | $113,483 | Note 13 – Segment Reporting The company operates as a single reportable segment focused on developing immunotherapies, with performance measured by net income/loss attributable to shareholders and detailed operating and segment expenses - The company operates as a single reportable segment, developing targeted immunotherapies[82] - The Chief Executive Officer, as the chief operating decision maker, assesses performance and allocates resources based on consolidated financial statements[82][83] Segment expenses | Segment expenses | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------- | :------------- | :------------- | :------------- | :------------- | | Salaries and Benefits | $2,857,617 | $4,124,151 | $6,686,838 | $8,307,421 | | Professional fees | $1,278,581 | $1,688,412 | $2,405,627 | $2,765,678 | | Clinical development expenses | $2,017,145 | $1,004,848 | $2,455,049 | $2,846,909 | | Other development expenses | $1,082,111 | $1,487,988 | $4,449,344 | $4,118,356 | | Total operating and segment expenses | $7,623,351 | $8,684,304 | $16,729,109 | $18,781,931 | | Segment and consolidated net loss | $(9,434,208) | $(8,327,897) | $(17,923,175) | $(18,931,374) | Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and operational results, highlighting its clinical-stage immunotherapy focus, pipeline developments, financial performance, liquidity, capital resources, and going concern assessment Company Overview PDS Biotech is a clinical-stage immunotherapy company developing targeted cancer and infectious disease immunotherapies using its Versamune®, PDS01ADC, and Infectimune® platforms to induce potent T cell responses - PDS Biotech is a clinical-stage immunotherapy company developing targeted cancer and infectious disease immunotherapies[90] - The company's platforms, Versamune®, Versamune® in combination with PDS01ADC, and Infectimune®, are designed to induce high-quality CD4 helper and CD8 killer T cells and neutralizing antibodies[90][91] - PDS01ADC is an investigational tumor-targeting IL-12 fusion protein designed to enhance T cell proliferation, potency, and longevity in the tumor microenvironment[91] Recent Developments In March 2025, the VERSATILE-003 Phase 3 trial for PDS0101 in HPV16-positive HNSCC began, and in July 2025, a Phase 2 colorectal cancer cohort with PDS01ADC met expansion criteria - Initiation of VERSATILE-003 Phase 3 clinical trial for PDS0101 in HPV16-positive first-line recurrent/metastatic head and neck squamous cell carcinoma in March 2025[92] - Colorectal cancer cohort of a Phase 2 clinical trial with PDS01ADC met pre-defined criteria for expansion to stage 2 in July 2025, following positive stage 1 results[92] Clinical Candidate Pipeline The clinical pipeline includes Versamune® and PDS01ADC therapies, with VERSATILE-003 (Phase 3) and VERSATILE-002 (Phase 2) showing promising results for HPV16-positive HNSCC, alongside NCI and MD Anderson collaborations and advancements for other cancers VERSATILE-003: PDS0101 (Versamune® HPV) + pembrolizumab The VERSATILE-003 Phase 3 trial is enrolling 351 patients with HPV16-positive recurrent/metastatic HNSCC, evaluating PDS0101 with pembrolizumab, with median overall survival as the primary endpoint and interim data expected at 6 and 18 months - Phase 3 trial (VERSATILE-003) initiated for PDS0101 + pembrolizumab in HPV16-positive first-line recurrent/metastatic HNSCC, enrolling 351 patients[93] - Primary endpoint is median overall survival; secondary endpoints include objective response rate, disease control rate, duration of response, and progression-free survival[94] - Interim data readouts are estimated at 6 and 18 months, with final readout expected 24 months after full enrollment[94] VERSATILE-002: PDS0101 + Keytruda® The VERSATILE-002 Phase 2 trial for PDS0101 + Keytruda® in HPV16-positive HNC completed enrollment, showing promising interim overall survival (e.g., 30 months median OS, 74% 24-month OS in ICI naïve) and objective response rates (36% overall), leading to a two-part registrational trial strategy - VERSATILE-002 Phase 2 trial evaluating PDS0101 + Keytruda® for HPV16-positive recurrent/metastatic head and neck cancer has completed enrollment in both ICI naïve and ICI resistant arms[95][97] - Updated interim data (May 2024 cut-off) for ICI naïve cohort with CPS > 1 showed a median overall survival of 30 months (published ICIs: 7-18 months) and an objective response rate of 34% (published ICIs: <20%)[100][101] - Updated data (May 2024 cut-off) showed an overall median OS of 30.0 months, ORR of 35.8%, and DCR of 77.4%[107] - The company announced an updated clinical strategy for a two-part registrational trial focusing on the double combination of Versamune® HPV + pembrolizumab[102][103] National Cancer Institute: PDS0101 + PDS01ADC +Bintrafusp Alfa An NCI-led Phase 2 trial for PDS0101 + PDS01ADC + Bintrafusp Alfa in advanced HPV-positive cancers closed enrollment, showing promising preliminary efficacy in ICI-resistant patients, with 75% of ICI-naïve patients alive at 36 months and a 72% 12-month survival rate in ICI-resistant patients - NCI-led Phase 2 trial evaluating PDS0101 + PDS01ADC + Bintrafusp Alfa for advanced HPV-positive cancers has closed for enrollment, with evaluation of long-term patient survival ongoing[105] - Updated interim survival data (November 2023) showed 75% of ICI-naïve patients alive at 36 months (historical 7-11 months) and a 12-month survival rate of 72% in ICI-resistant patients (median OS ~20 months vs. historical 3.4 months)[110][112] - Preclinical data suggested synergistic activity of the triple combination, corroborated by Phase 2 trial results[108] MD Anderson Cancer Center (IMMUNOCERV): PDS0101 + Chemoradiotherapy A Phase 2 IIT at MD Anderson is investigating PDS0101 with standard-of-care chemoradiotherapy for locally advanced cervical cancer, with October 2023 data showing PDS0101 plus CRT associated with earlier and greater ctDNA clearance - Phase 2 IIT at MD Anderson is actively recruiting patients for PDS0101 in combination with standard-of-care chemo-radiotherapy for locally advanced cervical cancer[110] - Data from October 2023 demonstrated earlier and greater ctDNA clearance with PDS0101 plus CRT (81.3% clearance after 3 weeks vs. 30.3% with SOC) and 91.7% clearance at 5 weeks vs. 53.1% with SOC[111][113] Mayo Clinic: PDS0101 (Versamune® HPV) Monotherapy and in combination with Keytruda® An IIT (MC200710) at Mayo Clinic is evaluating PDS0101 alone or with Keytruda® as neoadjuvant treatment for HPV-positive oropharyngeal cancer patients at high risk of recurrence, aiming to assess HPV-specific anti-tumor responses, tumor shrinkage, and ctDNA decreases - IIT MC200710 initiated in February 2022 at Mayo Clinic for PDS0101 alone or with Keytruda® in HPV-positive oropharyngeal cancer patients at high risk of recurrence[111] - Treatment is administered as neoadjuvant therapy before transoral robotic surgery (TORS) with curative intent[114] - The trial will explore if the treatment increases HPV-specific anti-tumor responses, tumor shrinkage, pathologic regression, and decreases in circulating tumor DNA (ctDNA)[114] PDS0103 (Versamune® MUC1) PDS0103, an investigational immune therapy for MUC1-associated cancers, combines Versamune® with NCI-developed MUC1 agonist epitopes, with FDA IND clearance in March 2025 for combination with PDS01ADC in metastatic colorectal cancer - PDS0103 is an investigational immune therapy for MUC1-associated cancers (ovarian, breast, colorectal, lung)[115][116] - FDA cleared IND application for PDS0103 and PDS01ADC combination in metastatic colorectal cancer in March 2025[117] PDS0102 PDS0102 is an investigational immunotherapy utilizing TARP antigen from the NCI, designed to treat TARP-associated cancers, with preclinical work showing it induced large numbers of tumor-targeted killer T cells - PDS0102 is an investigational immunotherapy utilizing TARP antigen from the NCI, targeting AML, prostate, and breast cancer[118] - Preclinical studies demonstrated that PDS0102 (Versamune®+TARP antigen) induced large numbers of tumor-targeted killer T cells[118] IL-12 Oncology Immunocytokine Pipeline PDS01ADC is a novel IL-12 fused antibody drug conjugate designed to enhance T cell activity, with interim Phase 1/2 data for metastatic prostate cancer showing PSA level decreases and favorable immune changes - PDS01ADC is a novel investigational IL-12 fused antibody drug conjugate designed to enhance T cell proliferation, potency, and longevity in the tumor microenvironment[119] - Interim Phase 1/2 data for PDS01ADC with docetaxel in metastatic prostate cancer showed PSA level decreases in all patients (61% with ≥60% decrease) and favorable immune changes (decreased T reg cells, increased NK cells, memory CD8 T cells, proliferating CD4/CD8 T cells, and cytokines)[121][124] - PDS01ADC is being evaluated in several NCI-sponsored IIT Phase 2 trials, including combinations for HPV-positive malignancies, prostate cancer, and MUC1-positive cancers, as well as monotherapy for Kaposi Sarcoma[120] Infectimune® Development Strategy The Infectimune® platform aims to improve infectious disease treatments and prevention by inducing strong T cells and antibodies, with near-term focus on universal flu vaccines aligned with NIAID's CIVICs program, supported by preclinical data for broad and durable protection - Infectimune® platform aims to induce strong CD8 and CD4 T cells and antibodies for improved infectious disease treatment and prevention[126] - Near-term focus is on developing a universal seasonal flu vaccine and potentially a universal pandemic influenza vaccine, aligning with NIAID's CIVICs program[127] - Preclinical data published in Viruses (February 2023) demonstrated complete protection against sickness after lethal challenge with live SARS-CoV-2 or influenza viruses and dramatically enhanced CD4 T cell responses[128] - Preclinical data on investigational universal flu vaccine PDS0202 (September 2023) showed active neutralization across multiple influenza viruses and protection against infection and weight loss in animals[129] Selected Financial Operations Overview The company has not generated product revenue and anticipates increasing R&D expenses as clinical candidates advance, with uncertain project duration, completion costs, and no assurance of marketing approval or profitability - The company has not generated any revenues from commercial product sales and does not expect to in the near future[130] - Research and development expenses are expected to increase significantly as clinical trials advance and regulatory approvals are pursued[132] - The company is unable to determine the duration and completion costs of R&D projects or when revenue will be generated due to numerous risks and uncertainties[133] Results of Operations For Q2 2025, net loss increased by 13% to $9.43 million due to a 253% rise in net interest expense, despite a 12% operating expense decrease; for H1 2025, net loss decreased by 5% to $17.92 million due to 11% lower operating expenses and a 35% income tax benefit, offset by a 132% increase in net interest expense Three Months Ended June 30, 2025 vs. 2024 | Operating expenses: | 2025 (in thousands $) | 2024 (in thousands $) | Increase (Decrease) $ Amount (in thousands $) | Increase (Decrease) % | | :-------------------------------- | :------------------ | :------------------ | :--------------------------- | :-------------------- | | Research and development expenses | $4,213 | $4,528 | $(315) | (7)% | | General and administrative expenses | $3,410 | $4,156 | $(746) | (18)% | | Total operating expenses | $7,623 | $8,684 | $(1,061) | (12)% | | Loss from operations | $(7,623) | $(8,684) | $1,061 | (12)% | | Interest income (expense), net | $(1,811) | $(513) | $(1,298) | 253% | | Benefit from income taxes | - | $869 | $(869) | 100% | | Net loss and comprehensive loss | $(9,434) | $(8,328) | $(1,106) | 13% | Six Months Ended June 30, 2025 vs. 2024 | Operating expenses: | 2025 (in thousands $) | 2024 (in thousands $) | Increase (Decrease) $ Amount (in thousands $) | Increase (Decrease) % | | :-------------------------------- | :------------------ | :------------------ | :--------------------------- | :-------------------- | | Research and development expenses | $10,044 | $11,232 | $(1,188) | (11)% | | General and administrative expenses | $6,685 | $7,550 | $(865) | (11)% | | Total operating expenses | $16,729 | $18,782 | $(2,053) | (11)% | | Loss from operations | $(16,729) | $(18,782) | $2,053 | (11)% | | Interest income (expense), net | $(2,364) | $(1,019) | $(1,345) | 132% | | Benefit from income taxes | $1,170 | $869 | $301 | 35% | | Net loss and comprehensive loss | $(17,923) | $(18,932) | $1,009 | (5)% | - Research and development expenses decreased by $0.3 million (7%) for the three months ended June 30, 2025, primarily due to decreases in manufacturing and personnel costs, offset by increased clinical trial costs[135] - General and administrative expenses decreased by $0.8 million (18%) for the three months ended June 30, 2025, mainly due to lower personnel costs and professional fees[135] Liquidity and Capital Resources As of June 30, 2025, the company held $31.9 million in cash and cash equivalents, funding operations through various equity and debt financings, but recurring losses and capital needs raise substantial doubt about its going concern ability - As of June 30, 2025, the company had $31.9 million in cash and cash equivalents[149] - The company sold 1,165,861 shares of common stock for a net value of $1.8 million through the New Sales Agreement during the six months ended June 30, 2025[143] - Net proceeds of approximately $10.05 million were received from the February 2025 Offering of common stock and warrants[147] - The April 2025 Securities Purchase Agreement provided $20 million, with approximately $19 million used to retire previous debt[148] - Substantial doubt exists about the company's ability to continue as a going concern for at least 12 months due to recurring losses and the need for additional financing[152] Cash Flows Net cash used in operating activities decreased by $0.7 million to $18.1 million due to lower stock-based compensation and reduced net loss, while net cash provided by financing activities decreased by $11.7 million due to loan repayment and lower stock issuance proceeds, partially offset by new loan and warrant issuances Cash Flows (in thousands) | Cash Flows (in thousands) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------------- | :------------- | :------------- | | Net cash used in operating activities | $(18,133) | $(18,796) | | Net cash used in investing activities | - | $(29) | | Net cash provided by financing activities | $8,317 | $19,998 | | Net (decrease) increase in cash and cash equivalents | $(9,816) | $1,173 | - Net cash used in operating activities decreased by $0.7 million for the six months ended June 30, 2025, primarily due to a decrease in non-cash stock-based compensation expense and a decrease in net loss[154] - Net cash provided by financing activities decreased by $11.7 million, mainly due to a $22.8 million decrease from loan repayment and a $17.7 million decrease from common stock issuance via Sales Agreement, offset by $19.2 million from the Securities Purchase Agreement and $10.2 million from the February 2025 Offering[156] Operating Capital Requirements The company anticipates continued losses and substantial additional funding for R&D and clinical trials, planning to seek equity, debt, collaborations, or licenses, but faces risks of delays or termination if financing is inadequate, compounded by a minimum cash covenant in its Debentures - The company expects to incur additional costs associated with operating as a public company and anticipates substantial additional funding for continuing operations[157] - Future funding requirements depend on factors like timing and costs of clinical trials, regulatory approvals, and potential collaborations[159][166] - Failure to obtain adequate financing could lead to delays, reductions, or termination of product development, or granting rights to third parties[151] - The Securities Purchase Agreement allows lenders to call outstanding Debentures if minimum cash balances are not maintained[151][158] Critical Accounting Policies and Estimates Financial statements are prepared under U.S. GAAP, requiring management estimates and assumptions, with no material changes to critical accounting policies or estimates during the six months ended June 30, 2025, compared to the 2024 Annual Report on Form 10-K - Financial statements are prepared in accordance with U.S. GAAP, requiring management estimates and assumptions[162] - No material changes to critical accounting policies and estimates occurred during the six months ended June 30, 2025, compared to the Annual Report on Form 10-K for 2024[163] Off-Balance Sheet Arrangements The company did not have any material off-balance sheet arrangements during the periods presented and does not currently have any - The company did not have any off-balance sheet arrangements during the periods presented and does not currently have any[164] Smaller Reporting Company The company is a 'smaller reporting company' and intends to rely on exemptions from certain disclosure requirements applicable to larger public companies - The company is a 'smaller reporting company' as defined in Rule 12b-2 under the Securities Exchange Act of 1934[165] - It intends to rely on exemptions from certain disclosure requirements applicable to other public companies[165] Item 3. Quantitative and Qualitative Disclosures About Market Risk The company faces interest rate risk from cash equivalents and floating-rate debentures, though historical impact has been immaterial, and inflation has not materially affected its business during the six months ended June 30, 2025 - The company is exposed to interest rate risk from bank deposits, money market accounts, and floating-rate debentures (pegged to prime rate)[167] - Historically, the net impact of interest rate fluctuations has not been material[167] - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the six months ended June 30, 2025[168] Item 4. Controls and Procedures Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that disclosure controls and procedures were effective as of June 30, 2025[169] - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[170] Part II — Other Information This part covers legal proceedings, risk factors, unregistered sales of equity securities, defaults, and other miscellaneous information Item 1. Legal Proceedings The company is not a party to any material pending legal proceedings, as referenced in Note 9 to the Condensed Consolidated Financial Statements - The company is not a party to any material pending legal proceedings[172] - Information regarding legal proceedings is incorporated by reference from Note 9 to the Condensed Consolidated Financial Statements[172] Item 1A. Risk Factors Substantial doubt exists about the company's going concern ability, potentially impacting stock price and financing, with new risks including operating restrictions and repayment obligations under the April 2025 Debentures, global economic uncertainty, geopolitical conflicts, and changing regulatory policies - Substantial doubt exists about the company's ability to continue as a going concern, which may adversely affect its stock price and ability to obtain financing[174][176] - The April 2025 Debentures impose covenants restricting operations (e.g., incurring indebtedness, granting liens, paying dividends) and require maintaining a minimum cash balance, with potential for immediate repayment upon default[177][178][179] - Global economic uncertainty, geopolitical conflicts (e.g., Russia-Ukraine, Middle East), and changing U.S. administration policies (e.g., tariffs, drug pricing regulations) could adversely affect the company's business, financial condition, and results of operations[180][181][182][186] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds On April 30, 2025, the company sold $22,222,222 in Senior Secured Convertible Debentures and warrants for 1,000,000 common shares for a total of $20,000,000, exempt from registration under Section 4(a)(2) of the Securities Act - On April 30, 2025, the company sold $22,222,222 in Senior Secured Convertible Debentures and warrants to purchase 1,000,000 shares of common stock[189] - The total purchase price for these securities was $20,000,000[189] - The issuance was exempt from registration under the Securities Act pursuant to Section 4(a)(2)[189] Item 3. Defaults Upon Senior Securities There were no defaults upon senior securities during the reporting period - No defaults upon senior securities[190] Item 4. Mine Safety Disclosures This item is not applicable to the company - Mine Safety Disclosures are not applicable[191] Item 5. Other Information There is no other information to report under this item - No other information to report[192] Item 6. Exhibits This section lists all exhibits filed with the Form 10-Q, including the Securities Purchase Agreement, Amendment Agreement, Registration Rights Agreement, Security Agreement, Subsidiary Guarantee, amendments to the Equity Incentive Plan, certifications, and XBRL documents - Exhibits include the Securities Purchase Agreement, Amendment Agreement, Registration Rights Agreement, Security Agreement, and Form of Subsidiary Guarantee related to the April 30, 2025, financing[194] - An Amendment to the Third Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan is also filed[194] - Certifications of Principal Executive Officer and Principal Financial Officer (pursuant to Sections 302 and 906 of Sarbanes-Oxley Act) and Inline XBRL documents are included[194] Signatures This section contains the official signatures of the company's principal executive and financial officers, certifying the report's accuracy Signatures The report was duly signed on August 13, 2025, by Frank Bedu-Addo, Ph.D., President and Chief Executive Officer, and Lars Boesgaard, Chief Financial Officer - The report was signed on August 13, 2025[198] - Signatories include Frank Bedu-Addo, Ph.D., President and Chief Executive Officer, and Lars Boesgaard, Chief Financial Officer[198]