PDS Biotechnology(PDSB)

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PDS Biotechnology(PDSB) - 2023 Q4 - Annual Results
2024-03-27 11:30
Exhibit 99.1 PDS Biotech Announces Clinical Strategy Update and Reports Full Year 2023 Financial Results Unique mechanism of action of the combination of PDS01ADC and Versamune® results in 3-year survival of 75% and 75% overall response rate in advanced head and neck cancer trial As a result, Company to focus late-stage clinical strategy on triple combination of PDS01ADC, PDS0101 (Versamune® HPV) and KEYTRUDA® in advanced head and neck cancer Strong safety profile of IL-12 fused antibody drug conjugate (PDS ...
PDS Biotechnology(PDSB) - 2023 Q3 - Quarterly Report
2023-11-14 21:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____________ Commission file number 001-37568 PDS Biotechnology Corporation (Exact name of registrant as specified in its charter) (State or ...
PDS Biotechnology(PDSB) - 2023 Q3 - Earnings Call Transcript
2023-11-14 17:17
PDS Biotechnology Corporation (NASDAQ:PDSB) Q3 2023 Earnings Call Transcript November 14, 2023 8:00 AM ET Company Participants Nicole Jones - Investor Relations Frank Bedu-Addo - Chief Executive Officer Matthew Hill - Chief Financial Officer Conference Call Participants Louise Chen - Cantor Fitzgerald Mayank Mamtani - B. Riley Securities Joe Pantginis - HC Wainwright Laura Suriel - Alliance Resource Partners Operator Greetings and welcome to the PDS Biotechnology Third Quarter 2023 Earnings Call and Webcast ...
PDS Biotechnology(PDSB) - 2023 Q2 - Quarterly Report
2023-08-14 17:10
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, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____________ Commission file number 001-37568 PDS Biotechnology Corporation (Exact name of registrant as specified in its charter) (State or othe ...
PDS Biotechnology(PDSB) - 2023 Q2 - Earnings Call Transcript
2023-08-14 15:52
PDS Biotechnology Corporation (NASDAQ:PDSB) Q2 2023 Earnings Conference Call August 14, 2023 8:00 AM ET Company Participants Frank Bedu-Addo - Chief Executive Officer Lauren Wood - Chief Medical Officer Matthew Hill - Chief Financial Officer Gabby DeGravina - Investor Relations Conference Call Participants Joe Pantginis - HC Wainwright Lucas Duffy - Cantor Fitzgerald Kalpit Patel - B. Riley Leland Gershell - Oppenheimer Robert LaBoyer - Noble Capital Laura Suriel - Alliance Global Partners Operator Hello a ...
PDS Biotechnology(PDSB) - 2023 Q1 - Quarterly Report
2023-05-15 20:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____________ Commission file number 001-37568 PDS Biotechnology Corporation (Exact name of registrant as specified in its charter) (State or oth ...
PDS Biotechnology(PDSB) - 2023 Q1 - Earnings Call Transcript
2023-05-15 14:33
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].
PDS Biotechnology(PDSB) - 2022 Q4 - Annual Report
2023-03-28 21:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________to ________ Commission file number 001-37568 PDS Biotechnology Corporation (Exact name of registrant as specified in its charter) Delaware 26-4231384 (State or other juri ...
PDS Biotechnology(PDSB) - 2022 Q4 - Earnings Call Transcript
2023-03-28 19:03
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 ...
PDS Biotechnology (PDSB) Investor Presentation - Slideshow
2023-01-20 14:42
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 ...