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

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

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

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

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

PDS Biotechnology Corporation (NASDAQ:PDSB) Q3 2022 Results Conference Call November 14, 2022 8:00 AM ET Company Participants Gabrielle DeGravina - Investor Relations, CG Capital Frank Bedu-Addo - Chief Executive Officer Lauren Wood - Chief Medical Officer Matt Hill - Chief Financial Officer Conference Call Participants Carvey Leung - Cantor Fitzgerald Laura Suriel - Alliance Global Partners Robert LeBoyer - Noble Capital Operator Greetings. Welcome to PDS Biotech's Third Quarter 2022 Earnings Conference Ca ...

PDS Biotechnology Corporation (NASDAQ:PDSB) Q2 2022 Results Earnings Conference Call August 8, 2022 8:00 AM ET Company Participants Gabrielle DeGravina - Investor Relations, CG Capital Frank Bedu-Addo - Chief Executive Officer Lauren Wood - Chief Medical Officer Matthew Hill - Chief Financial Officer Conference Call Participants Louise Chen - Cantor Fitzgerald James Molloy - Alliance Global Partners Leland Gershell - Oppenheimer & Co. Joseph Pantginis - H. C. Wainwright & Co. Robert LeBoyer - Noble Capital ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____________ Commission file number 001-37568 PDS Biotechnology Corporation (Exact name of registrant as specified in its charter) (State or othe ...

Company Overview - PDS Biotechnology has approximately $58.9 million in cash as of March 31, 2022, projected to fund operations into 2024[4] - PDS0101 has been granted Fast Track designation from the FDA[4] PDS0101 Clinical Trials - In the VERSATILE-002 trial, the Objective Response (OR) was 41.2% (7 out of 17 subjects with imaging data), including 2 Complete Responses (CR) and 5 Partial Responses (PR)[21] - In the VERSATILE-002 trial, Stable Disease (SD) was observed in 35.3% (6 out of 17) of subjects with imaging data, with reduction in 4 out of 6 cases[21] - In the VERSATILE-002 trial, the Progression Free Survival Rate (PSF) was 55.2% at 9 months of follow-up[25] - In the VERSATILE-002 trial, the Overall Survival Rate (OS) was 87.2% at 9 months of follow-up[25] - In the NCI-led triple combination trial, the Objective Response Rate (ORR) in CPI Refractory patients was 63% with high dose M9241[29] - In the NCI-led triple combination trial, tumor reduction was only seen in HPV16-positive patients (P<0.001)[30] - In the NCI-led triple combination trial, the Objective Response Rate (ORR) in CPI Naïve subjects was 83% with high dose M9241[36] - In the NCI-led triple combination trial, patient survival at median 17 months was 75% in CPI Naïve subjects[36] Market Opportunity - PDS0101 targets a $6 billion market opportunity in HPV16-associated cancers[14]

PDS Biotechnology Corporation. (NASDAQ:PDSB) Q1 2022 Earnings Conference Call May 11, 2022 8:00 AM ET Company Participants Gabrielle DeGravina - Investor Relations, CG Capital Frank Bedu-Addo - Chief Executive Officer Lauren Wood - Chief Medical Officer Matthew Hill - Chief Financial Officer Conference Call Participants Louise Chen - Cantor Fitzgerald Leland Gershell - Oppenheimer Laura Suriel - Alliance Global Partners Robert LeBoyer - Noble Capital Operator Hello and welcome to PDS Biotechnology First Qua ...