Core Viewpoint - PDS Biotechnology (PDSB) has received a Zacks Rank 1 (Strong Buy) upgrade, indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][2]. Earnings Outlook - The Zacks rating upgrade reflects optimism regarding PDS Biotechnology's earnings outlook, which is expected to create buying pressure and potentially increase its stock price [2]. - For the fiscal year ending December 2024, PDS Biotechnology is projected to earn -$1.24 per share, representing a 10.8% change from the previous year's reported figure [5]. Earnings Estimate Revisions - Analysts have consistently raised their earnings estimates for PDS Biotechnology, with the Zacks Consensus Estimate increasing by 15.4% over the past three months [5]. - The correlation between earnings estimate revisions and near-term stock movements is strong, suggesting that tracking these revisions can be beneficial for investment decisions [4]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [4]. - PDS Biotechnology's upgrade to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [6].

Clinical Trial Results and Efficacy - The company's Versamune® and PDS01ADC combination showed a median overall survival of approximately 20 months in a Phase 2 trial for ICI-resistant HPV-positive cancers, compared to historical median survival of 3-4 months with ICIs and 8.2 months with systemic therapy[78] - 75% survival rate at 36 months was observed in ICI-naïve patients treated with the triple combination of PDS0101, PDS01ADC, and an investigational ICI in a Phase 2 trial[83] - The VERSATILE-002 Phase 2 trial reported a 41.2% response rate (tumor shrinkage >30%) in 7/17 patients treated with PDS0101 and Keytruda®, compared to 19% with ICI monotherapy[88] - Clinical efficacy (ORR + stable disease) was observed in 76.5% of patients (13/17) in the VERSATILE-002 trial, with a progression-free survival rate of 55.2% and overall survival rate of 87.2% at 9 months[88] - Interim data from the VERSATILE-002 trial showed a rapid decline in ctHPV-DNA, a potential predictive biomarker, in patients treated with PDS0101 and standard-of-care chemoradiotherapy[81] - Estimated 12-month overall survival rate was 87.1% for PDS0101 and pembrolizumab in HPV16-positive HNSCC, compared to 36-50% with approved ICIs alone[90] - Median progression-free survival was 10.4 months for PDS0101 and pembrolizumab, compared to 2-3 months with approved ICIs[90] - Disease control rate of 70.6% (24/34) and confirmed objective response rate of 41.2% (14/34) for PDS0101 and pembrolizumab[91] - 24-month overall survival rate of 74% for PDS0101 and pembrolizumab, compared to less than 30% with approved ICIs[93] - Tumor shrinkage seen in 60% (31/52) of patients treated with PDS0101 and pembrolizumab[93] - Median overall survival of 30 months for PDS0101 and pembrolizumab, compared to 7-18 months with ICIs[94] - Confirmed overall response rate of 34% (18/53) for PDS0101 and pembrolizumab, compared to less than 20% with ICIs[94] - Objective response rate of 88% (7/8) for PDS0101, PDS01ADC, and bintrafusp alfa in ICI-naive patients[100] - Median overall survival of 21 months for PDS0101, PDS01ADC, and bintrafusp alfa in ICI-resistant patients, compared to 3-4 months with ICIs[103] - 75% of ICI-naive patients remain alive at 36 months with PDS0101, PDS01ADC, and bintrafusp alfa, compared to 7-11 months with ICIs[104] - PDS0101 combined with chemoradiotherapy showed 81.3% ctDNA clearance after 3 weeks vs. 30.3% with SOC alone (p=0.0018), and 91.7% clearance at 5 weeks vs. 53.1% with SOC (p=0.0179)[107] Regulatory and Trial Progress - The company completed enrollment in the ICI-naïve arm of the VERSATILE-002 trial in May 2023 and received FDA feedback on the amended IND in October 2023[89] - The company confirmed the required contents of a clinical protocol for a potential registrational trial for the triple combination of PDS0101, PDS01ADC, and an FDA-approved ICI in February 2023[79] - The combination of PDS0101 and Keytruda® received Fast Track designation from the FDA in June 2022[88] - PDS0101 monotherapy and in combination with Keytruda® trial initiated in February 2022 for HPV-positive oropharyngeal cancer at Mayo Clinic[107] - PDS0103, targeting MUC1-associated cancers, is in tech transfer and clinical scale-up, with IND submission planned by end of 2024[110][111] Preclinical Studies and Vaccine Development - PDS0202, the company's universal flu vaccine candidate, demonstrated broad neutralization across multiple influenza strains and provided protection against lethal doses of H1N1 in preclinical studies[81] - PDS0102 preclinical studies demonstrated induction of tumor-targeted killer T cells for TARP-associated cancers including AML, prostate, and breast cancer[109] - Infectimune® preclinical data demonstrated complete protection against SARS-CoV-2 and influenza, with enhanced CD4 T cell responses[119] Financial Performance and Expenses - Net losses were $18.9 million for the six months ended June 30, 2024, with an accumulated deficit of $163.4 million[120] - Cash and cash equivalents stood at $57.7 million as of June 30, 2024[120] - Research and development expenses decreased by 43% to $4.5 million for the three months ended June 30, 2024[126][127] - Total operating expenses decreased by 32% to $8.7 million for the three months ended June 30, 2024[127] - General and administrative expenses decreased to $4.2 million for Q2 2024, down from $4.7 million in Q2 2023, primarily due to a $0.3 million decrease in personnel costs and a $0.2 million decrease in professional fees[129] - Income tax benefit decreased to $0.9 million for Q2 2024 from $1.4 million in Q2 2023, driven by a reduction in New Jersey NOL carryforwards sold[130] - Research and development expenses decreased by 19% to $11.2 million for the six months ended June 30, 2024, compared to $13.8 million in the same period in 2023, primarily due to reduced clinical studies and manufacturing costs[131][132] - General and administrative expenses decreased by 9% to $7.6 million for the six months ended June 30, 2024, compared to $8.3 million in 2023, driven by lower personnel and legal fees[131][133] - Net loss decreased by 11% to $18.9 million for the six months ended June 30, 2024, compared to $21.2 million in 2023, reflecting reduced operating expenses[131] - The company sold 3,428,681 shares of common stock with a net value of $19.5 million during the six months ended June 30, 2024, under the Sales Agreement[136] - As of June 30, 2024, the company had $57.7 million in cash and cash equivalents, primarily used to fund operating expenses, including research and development[141] - Net cash used in operating activities increased to $18.8 million for the six months ended June 30, 2024, compared to $18.0 million in 2023, driven by a decrease in accounts payable and accrued expenses[145] - Net cash provided by financing activities was $19.998 million for the six months ended June 30, 2024, primarily due to proceeds from the sale of common stock[147][149] Going Concern and Financial Risks - The company concluded that substantial doubt exists about its ability to continue as a going concern for at least 12 months due to uncertainties in securing additional financing[144] - The company has concluded that substantial doubt exists about its ability to continue as a going concern for at least 12 months from the issuance of the unaudited financial statements[151] - The company's future funding requirements depend on factors such as clinical trial progress, regulatory outcomes, and market developments[152] - The company has no material non-cancelable purchase commitments with service providers[154] - The company's cash equivalents as of June 30, 2024, consist of bank deposits and money market accounts, with exposure to interest rate risk[160] - The company does not believe inflation has had a material effect on its business, financial condition, or results of operations for the quarter ended June 30, 2024[161] Internal Controls and Reporting - The company's disclosure controls and procedures are effective as of the end of the reporting period[164] - There were no changes in the company's internal control over financial reporting during the quarter ended June 30, 2024[165] - The company remains a "smaller reporting company" and intends to rely on certain disclosure exemptions[159]

PRINCETON, N.J., Aug. 05, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that an abstract presenting updated data from the VERSATILE-002 trial evaluating first-line treatment with Versamune® HPV (formerly PDS0101) in combination with KEYTRUDA® (pembrolizumab) in patients with HPV1 ...

Company to initiate Phase 3 VERSATILE-003 trial in Q4 2024 Conference Call Today at 8:00 a.m. Eastern Time PRINCETON, N.J., Aug. 01, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that it has received the official minutes from its meeting with the U.S. Food and Drug Administration ...

PRINCETON, N.J., July 29, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Monday, August 5, 2024, at 10:00 a.m. ET. P ...

Core Insights - PDS Biotechnology Corporation is advancing its VERSATILE-002 Phase 2 clinical trial, focusing on the combination of Versamune® HPV and KEYTRUDA® for treating HPV16-positive head and neck squamous cell cancer (HNSCC) [1][3][6] Clinical Trial Updates - As of May 17, 2024, the trial has enrolled 53 patients, with updated survival data expected to be announced in Q3 2024 [2] - The median overall survival (mOS) for patients remains at 30 months, with a 95% confidence interval lower limit of 19.7 months [7][8] - The trial includes a three-arm registrational study for first-line treatment of HPV16-positive recurrent/metastatic HNSCC, featuring both double and triple combination therapies [3][6] Treatment Mechanism and Efficacy - The combination of PDS01ADC and Versamune® HPV is believed to effectively disrupt tumor defenses while generating targeted T-cells to attack tumors [10] - The company asserts that the current standard of care for recurrent/metastatic HNSCC has survival rates below 18 months, highlighting the potential of their investigational therapies [9]

[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]

Cancer Immunotherapy Development - The company is developing a pipeline of targeted cancer immunotherapies, including Versamune® and PDS01ADC, aimed at enhancing T cell responses in the tumor microenvironment [18]. - In a Phase 2 trial, the combination of PDS0101 and PDS01ADC resulted in a median overall survival of approximately 20 months for ICI-resistant patients, compared to historical median survival of 3-4 months [21]. - The company presented data at the 2023 ASCO conference showing safety and efficacy in an immune checkpoint inhibitor naïve cohort for HPV16-positive head and neck cancer [23]. - Interim data from the VERSATILE-002 Phase 2 trial indicated promising immune response results when combining PDS0101 with Merck's Keytruda® [26]. - The company announced a successful Type B meeting with the FDA regarding a registrational trial for the triple combination therapy for recurrent/metastatic HPV-positive head and neck cancer [22]. - In October 2023, data showed that PDS0101 in combination with SOC chemoradiotherapy led to a rapid decline in ctHPV-DNA, a potential predictive biomarker of treatment response [25]. - The proprietary combination of Versamune® and PDS01ADC is designed to overcome tumor immune suppression, which is patented by the company [21]. - Versamune® has shown the potential to promote efficient activation and robust expansion of polyfunctional CD8 killer T cells and CD4 helper T cells in lymph nodes [47]. - In preclinical studies, Versamune® demonstrated a reduction in the Treg/CD8 T cell ratio, enhancing tumor susceptibility to destruction by killer T cells [49]. - PDS0101, a Versamune® based immunotherapy, induced complete regression of tumors after a single subcutaneous injection in preclinical studies [62]. - In a Phase 1 clinical trial, PDS0101 was immunologically active at all doses studied, leading to clinical regression of cervical lesions in patients [62]. - In a Phase 2 clinical trial, 75% of ICI naïve patients treated with PDS0101 and PDS01ADC were still alive at 36 months, with median overall survival not yet reached [68]. - The combination therapy of PDS0101 and PDS01ADC showed an objective response rate (OR) of 88% in ICI naïve patients, with 4 out of 7 patients' responses ongoing at a median of 17 months [81]. - In ICI resistant patients, 63% (5 out of 8) achieved an OR with PDS01ADC at 16.8 mcg/kg compared to 7% (1 out of 14) at 8 mcg/kg [81]. - The median overall survival (OS) for ICI resistant patients receiving the triple combination was reported at 21 months, significantly higher than the historical median OS of 3-4 months [85]. - The objective response rate (ORR) in ICI naïve patients with the triple combination was reported as 88%, compared to less than 25% with FDA-approved ICIs in HPV-positive cancers [85]. Vaccine Development - The company presented data on its investigational universal flu vaccine, PDS0202, demonstrating broad neutralization across multiple influenza strains [24]. - The company is developing a universal influenza vaccine using the Infectimune® platform, aiming for long-lasting protection against multiple strains of the virus [73]. - A second preclinical publication in February 2023 demonstrated complete protection in animal studies with PDS0202, a novel recombinant investigational protein-based universal flu vaccine [75]. - PDS0202, a universal influenza vaccine candidate, demonstrated significant hemagglutinin inhibition titer levels ranging from 28x to 62x compared to COBRA antigens alone in preclinical studies [112]. Clinical Trial Results - In June 2023, the company presented data showing a progression-free survival (PFS) rate of 55.2% and an overall survival (OS) rate of 87.2% at 9 months follow-up in the ICI naïve cohort [91]. - Estimated 12-month overall survival rate for PDS0101 in combination with Keytruda® is 87.1%, compared to published results of 36-50% for approved ICIs used alone [92]. - Median progression-free survival (PFS) for PDS0101 is 10.4 months, significantly higher than the published median PFS of 2-3 months for approved ICIs [92]. - Disease control rate for PDS0101 is 70.6%, with a confirmed and unconfirmed objective response rate of 41.2% [92]. - 24-month overall survival rate for PDS0101 is 74%, compared to less than 30% for approved ICIs [97]. - 12-month overall survival rate for PDS0101 is 80%, while published results for approved ICIs range from 30-50% [97]. - 60% of patients treated with PDS0101 experienced tumor shrinkage, with a confirmed overall response rate of 27% [97]. - PDS0101 treatment resulted in 81.3% clearance of circulating tumor DNA (ctDNA) after 3 weeks, compared to 30.3% with standard-of-care [103]. Product Pipeline and Development - The current development pipeline includes PDS01ADC + Versamune® HPV for recurrent or metastatic HPV16-positive HNSCC, with Phase 1/2 trials anticipated in 2024 for colorectal cancer [117]. - The company plans to seek marketing authorization from the FDA for its product candidates through the Biologics License Application pathway [130]. - The company plans to progress its preclinical product candidate PDS0103 to an IND submission in 2024 and advance to first-in-human trials [130]. - The company has engaged with the FDA for initial feedback on the clinical trial design for the PDS0103 program, which will influence its regulatory submission strategy [130]. - The company has identified over 75 tumor antigens and is exploring the expansion of its Versamune® based pipeline to develop additional product candidates [67]. Financial and Regulatory Considerations - The company has not generated any product revenue to date and has incurred net losses each year since its inception [116]. - The company relies on third-party contract manufacturing organizations for the production of its product candidates necessary for preclinical research and clinical studies [126]. - The company does not intend to incur costs for building its own manufacturing facilities in the near term, relying instead on external contract manufacturers [128]. - The company has developed a scalable manufacturing process for its product candidates, ensuring reproducibility and efficiency [126]. - The FDA's approval process includes multiple stages, such as preclinical tests, IND submission, and clinical trials, which can take many years [158]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to ensure the safe use of a biological product, which can affect market potential [178]. - The approval of a BLA may be limited to specific diseases and dosages, impacting the commercial value of the product [181]. - The FDA may impose restrictions on product distribution and prescribing based on post-marketing studies or surveillance programs [182]. Collaborations and Agreements - The company executed an exclusive global license agreement with Merck KGaA for the tumor targeting IL12 fused antibody drug conjugate, M9241, which is now part of its pipeline [21]. - The company made a one-time cash payment of $5.0 million and issued 378,787 shares valued at $5.0 million to Merck KGaA for exclusive rights to develop and commercialize NHS-IL12 fusion protein (PDS01ADC) [136]. - Milestone payments to Merck KGaA could total up to $11 million upon achieving specific milestones, including the dosing of the fifth patient in a Phase 3 trial [137]. - The company has a Patent License Agreement with NIH for a therapeutic cancer vaccine using Versamune® technology, with various royalty obligations including a minimum annual royalty of $5,000 and 2% on net sales [142]. - The NCI Patent License Agreement allows the company to develop TARP peptide-based therapies, with royalties and benchmark payments tied to clinical milestones [143]. - A cost reimbursement agreement with the University of Kentucky Research Foundation was renewed for an anticipated cost of $628,171, terminating on June 30, 2024 [146]. - The company is collaborating with MSD International GmbH in a Phase 2 clinical trial to evaluate the combination of PDS0101 and Merck's pembrolizumab for treating head and neck cancer [148]. Competitive Landscape - The biotechnology and pharmaceutical industries are characterized by intense competition, with major companies such as Johnson & Johnson, Sanofi-Aventis, and Pfizer involved in similar research and development [153]. - The company anticipates facing increasing competition as new immunotherapies enter the market, which may affect its market position [155]. Compliance and Regulatory Challenges - Regulatory approval processes for biological products require substantial time and financial resources, with potential delays due to FDA holds [157]. - The FDA requires a significant application fee of $3,242,026 for each BLA requiring clinical data for fiscal year 2023 [175]. - Annual program fees for approved BLAs are set at $393,933 per eligible product for fiscal year 2023 [175]. - Fast track, breakthrough therapy, and priority review designations are available for products addressing unmet medical needs, facilitating expedited review [184][186][187]. - The FDA can withdraw approval if post-approval studies are not conducted or if clinical benefits are not confirmed [191]. - The Drug Supply Chain Security Act imposes obligations on manufacturers for product tracing and compliance within the drug supply chain [195]. - Non-compliance with FDA requirements can lead to severe enforcement actions, including product recalls and fines [198].

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]