PDSB

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management successfully amended the VERSATILE-003 trial design to include progression-free survival (PFS) as an interim primary endpoint, aiming for an accelerated approval pathway. The trial redesign leverages robust PFS data and an increased median overall survival (approaching 40 months) to justify a more efficient regulatory timeline. PDS0101 is positioned as a unique late-stage candidate for HPV16-positive head and neck cancer, distinguished by its subcutaneous delivery and limited 5-dose regimen. Strategic focus remains on the growing unmet need in HPV16-positive cancers, driven by low vaccine uptake and a lack of approved targeted therapies. The PDS01ADC platform demonstrated cross-tumor potential with encouraging early results in metastatic prostate and colorectal cancers with liver metastasis. Intellectual property was significantly bolstered with new patents in the U.S. and Japan, extending market protection for PDS0101 into the 2040s. The company expects the amended VERSATILE-003 protocol to reduce both external clinical costs and internal operating expenses due to a shorter duration to interim readout. Management anticipates providing additional data on the full patient population for the colorectal cancer study by the end of 2026. CMC activities will run in parallel with the Phase III trial, focusing on process validation and potential scale-up required for a future BLA filing. The trial's patient enrollment target was reduced from approximately 350 to 250 patients following a shift to 1:1 randomization, further optimizing capital allocation. Net loss for Q1 2026 improved to $7.3 million compared to $8.5 million in the prior year, primarily due to reduced clinical and manufacturing costs. R&D expenses decreased to $3.5 million from $5.8 million, reflecting lower spending during the trial amendment and pause period. Cash and cash equivalents stood at $21.7 million as of March 31, 2026. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed that all clinical sites remained committed during the protocol amendment pause and are now moving toward re-enrollment. While the current study uses IV pembrolizumab, management noted that an...

Interested in PDS Biotechnology Corporation? Here are five stocks we like better. PDS Biotechnology amended its VERSATILE-003 late-stage head and neck cancer trial to add progression-free survival as an interim primary endpoint, which management says could speed an accelerated approval path while also lowering development costs. The company said the redesigned study will enroll fewer patients, dropping from about 350 to 250 after changing the randomization ratio from 2-to-1 to 1-to-1, which should reduce both external and internal trial expenses. Q1 losses narrowed to $7.3 million from $8.5 million a year earlier, helped by lower R&D and operating costs, while cash stood at $21.7 million at quarter-end. PDS Biotechnology (NASDAQ:PDSB) reported a smaller first-quarter loss and highlighted changes to its late-stage head and neck cancer trial that management said could shorten development timelines and reduce costs. On the company’s first quarter 2026 earnings call, Chief Executive Officer Dr. Frank Bedu-Addo said the company’s “major focus was on advancing our clinical programs,” and that PDS made “significant progress” during the quarter. Chief Medical Officer Dr. Kirk Shepard detailed updates across the company’s oncology pipeline, while Chief Financial Officer Lars Boesgaard reviewed financial results for the quarter ended March 31, 2026. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? Shepard said PDS adopted an amendment to its VERSATILE-003 trial, revising the design to incorporate progression-free survival, or PFS, as an interim primary endpoint. He said the company believes the change “has the potential to enable a more efficient path to accelerated approval,” while overall survival would remain the basis for full approval in line with FDA requirements. The trial is evaluating PDS0101 in combination with KEYTRUDA, also known as pembrolizumab, in HPV16-positive head and neck squamous cell carcinoma. Shepard described the disease as an area of “significant and growing unmet need,” and said PDS0101 remains a promising treatment option for those patients. → MercadoLibre Boldly Invests in Growth: Discount Deepens According to Shepard, PDS0101 in combination with KEYTRUDA is “the only late-stage investigational head and neck squamous cell carcinoma therapy that requires only full doses” and is also “the only subcutaneous therapy.” He...

This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. PDS Biotechnology Corp (NASDAQ:PDSB) has made significant progress in advancing its clinical programs, particularly with the Versatile 003 trial amendment to incorporate progression-free survival as an interim primary endpoint. The amendment to the Versatile 003 trial may shorten the trial's duration and reduce overall costs, potentially accelerating the availability of treatment for HPV-16 positive patients. PDS0101, in combination with Keytruda, is the only late-stage investigational therapy for head and neck squamous cell carcinoma that requires only five doses and is administered subcutaneously. PDS Biotechnology Corp (NASDAQ:PDSB) strengthened its intellectual property portfolio with new patents in the United States and Japan, extending market protection into the 2040s. The company reported promising results from ongoing trials for prostate and colorectal cancer with PDS01ADC, enhancing the efficacy of existing therapies across multiple solid tumor types. PDS Biotechnology Corp (NASDAQ:PDSB) reported a net loss of approximately $7.3 million for the quarter ended March 31, 2026. Research and development expenses decreased to $3.5 million from $5.8 million in the prior year, primarily due to lower clinical and manufacturing costs, which may indicate reduced activity or investment in these areas. General administrative expenses were slightly lower at $3.1 million compared to $3.3 million in the prior year, reflecting reduced professional fees. The company's cash balance as of March 31, 2026, was $21.7 million, which may limit its ability to fund extensive future research and development activities without additional financing. The landscape for HPV-16 positive head and neck cancer remains competitive, with BioNTech also conducting a phase three trial, posing potential challenges for PDS Biotechnology Corp (NASDAQ:PDSB) in securing market share. Warning! GuruFocus has detected 1 Warning Sign with PDSB. Is PDSB fairly valued? Test your thesis with our free DCF calculator. Q: On the Versatile 003 trial restart, what remains pending, and is there a consideration of including SubQ KEYTRUDA as a combination partner? A: (Dr. Kirk Shepherd, Chief Medical Officer) We are in the process of amending...

PDS Biotechnology (NASDAQ:PDSB) reported first-quarter financial results on Wednesday. The transcript from the company's first-quarter earnings call has been provided below. Benzinga APIs provide real-time access to earnings call transcripts and financial data. Visit https://www.benzinga.com/apis/ to learn more. The full earnings call is available at https://viavid.webcasts.com/starthere.jsp?ei=1761437&tp_key=6d561d3af2 PDS Biotechnology reported a net loss of $7.3 million for Q1 2026, an improvement from $8.5 million in Q1 2025, with reduced research and development and general administrative expenses. The company made significant progress in its clinical programs, notably amending the versatile 003 trial to include progression-free survival as a primary endpoint, potentially reducing trial duration and costs. PDS Biotechnology strengthened its intellectual property with new patents for PDS0101 in the US and Japan, extending market protection into the 2040s. Positive results were reported from trials involving PDS01 ADC in prostate and colorectal cancer, supporting its potential across multiple solid tumor types. Management highlighted the promising future outlook, focusing on advancing PDS0101 as a treatment for HPV 16 positive cancers, with late-stage trials in collaboration with key institutions. OPERATOR Greetings and welcome to The PDS Biotech first quarter 2026 earnings conference call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operating assistance, please press Star zero on your telephone keypad. It is now my pleasure to introduce your host, Dean Schwartz. Thank you. You may. Dean Schwartz (Moderator) Thank you, Operator. Good morning everyone and welcome to PDS Biotech's first quarter 2026 results and clinical programs. Update call I'm joined on the call today by the following members of the company's management team. Dr. Frank Baduodeau, Chief Executive Officer, Dr. Kirk Sheppard, Chief Medical Officer and Lars Bozgaard, Chief Financial Officer. Dr. Baduodeau and Dr. Sheppard will provide an overview of the company's recent highlights in its clinical development program, and Mr. Bozgaard will review the financial results for the quarter ended March 31, 2026. Following management's prepared remarks, we will take questions from covering analyst...

EAST PRINCETON, N.J. (AP) — EAST PRINCETON, N.J. (AP) — PDS Biotechnology Corporation (PDSB) on Wednesday reported a loss of $7.3 million in its first quarter. The East Princeton, New Jersey-based company said it had a loss of 13 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on PDSB at https://www.zacks.com/ap/PDSB

Investor Webcast Scheduled for 8:00 am ET PRINCETON, N.J., May 13, 2026 (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, today provided a business and clinical programs update and reported financial results for the quarter ended March 31, 2026. “During the first quarter, we made meaningful clinical and regulatory progress across our clinical pipeline,” said Frank Bedu-Addo, PhD, President and CEO of PDS Biotech. “We work towards restarting enrollment in the amended VERSATILE-003 Phase 3 trial. With regards to PDS01ADC, we have completed enrollment in the metastatic colorectal cancer trial, and the advanced castration resistant prostate cancer trial continues to recruit well”. Dr. Bedu-Addo continued: “We believe the progress achieved during the quarter reflects the continued advancement and maturation of our clinical portfolio. We remain focused on advancing potentially differentiated immunotherapy candidates designed to address significant unmet medical needs for patients with difficult-to-treat cancers”. Clinical and Corporate Update Amended VERSATILE-003 Phase 3 clinical trial protocol to incorporate progression-free survival (PFS) as an interim primary endpoint, creating a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival remains the primary endpoint for full FDA approval. The amendment also reduces the number of enrolled patients while maintaining statistical power. Patients already enrolled prior to the amendment remain on the trial and continue to receive treatment. Announced publication of positive clinical and immunological biomarker data from Stage 1 of NCI-led Metastatic Colorectal Cancer (mCRC) trial evaluating PDS01ADC, the Company’s tumor-targeted IL-12 immunocytokine. The results, published in the March issue of Journal of Clinical Oncology (JCO) Oncology Advances, included: Objective response rate (ORR) by RECIST v1.1: 77.8% (7/9) at six months; in the parallel trial without PDS01ADC, the ORR was 35% (7/20) 24-month survival rate approximately 85%; in the parallel trial without PDS01ADC, the 24-month survival rate was approximately 40% Extrahepatic progression-free survival (PFS): median not reac...

PRINCETON, N.J., May 06, 2026 (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, today announced that the Company will host a conference call and webcast to report financial results for the quarter ended March 31, 2026, and will provide a clinical programs and corporate update, on Wednesday, May 13, 2026 at 8:00 am Eastern Time. Conference Call Details Date: May 13, 2026 Time: 8:00 a.m. Eastern Time Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International) Conference I.D.: 13760368 CallMeTM: Click Here Webcast: Click Here (available 15 minutes prior to the call) After the live webcast, the event will be archived on PDS Biotech’s website for six months. About PDS Biotechnology PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy PDS0101 is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. PDS01ADC is being evaluated in multiple phase 2 trials in various cancer indications in combination with standard of care. For more information, please visit www.pdsbiotech.com Forward Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include...

Adopted a VERSATILE-003 protocol amendment to include progression-free survival (PFS) as an interim primary endpoint, aiming for a more efficient path to accelerated approval. Strategic shift was driven by VERSATILE-002 data showing median overall survival of 39.3 months, which would have significantly extended the original trial duration if left as the sole primary endpoint. PDS0101 demonstrated a durable clinical benefit in HPV16-positive head and neck cancer, reporting the first median overall survival of nearly 40 months in this population. Management emphasizes the competitive advantage of a subcutaneous, 5-dose regimen compared to standard therapies requiring over 20 doses. Early results for PDS01ADC in prostate cancer showed a median PFS of 9.6 months, reinforcing the platform's potential across multiple solid tumor types. Strengthened intellectual property with new U.S. and Japanese patents, extending market protection for PDS0101 into the 2040s. Anticipates the first interim PFS analysis will be available in approximately 1.5 years, potentially shortening the total trial duration by up to one year. Maintains median overall survival as the required endpoint for full FDA approval following any potential accelerated approval based on PFS. Expects R&D expenses to increase as the Phase III trial reinitiates, with costs scaling based on site openings and patient enrollment rates. Assumes a brisk recruitment pace as previous VERSATILE-002 sites transition to the Phase III study and competitive trial pressure remains low. The combination of subcutaneous PDS0101 with the recently approved subcutaneous KEYTRUDA is expected to further improve patient convenience and administration time. Reported a net loss of $34.5 million for 2025, a decrease from $37.6 million in 2024, driven by lower manufacturing and personnel costs. Cash balance of $26.7 million as of December 31, 2025, following a year of disciplined spending and debt extinguishment. The FDA raised no objections to the protocol amendment following the standard 30-day wait period, allowing the Phase III trial to proceed. A non-cash expense related to debt extinguishment contributed to a year-over-year increase in net interest expense to $4.1 million. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Mana...

This article first appeared on GuruFocus. Net Loss: $34.5 million or $0.74 per basic and diluted share for the year ended December 31, 2025. Net Loss Comparison: $37.6 million or $1.03 per basic and diluted share for the year ended December 31, 2024. Research and Development Expenses: $19 million for the year ended December 31, 2025. R&D Expenses Comparison: $22.6 million for the year ended December 31, 2024. General and Administrative Expenses: $12.5 million for the year ended December 31, 2025. G&A Expenses Comparison: $13.8 million for 2024. Total Operating Expenses: $31.5 million for the year ended December 31, 2025. Operating Expenses Comparison: $36.3 million for 2024. Net Interest Expense: $4.1 million for the year ended December 31, 2025. Interest Expense Comparison: $2.2 million for the year ended December 31, 2024. Cash Balance: $26.7 million as of December 31, 2025. Warning! GuruFocus has detected 1 Warning Sign with PDSB. Is PDSB fairly valued? Test your thesis with our free DCF calculator. Release Date: March 30, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. PDS Biotechnology Corp (NASDAQ:PDSB) has made significant progress in its clinical programs, particularly with the VERSATILE-003 trial amendment, which could lead to a more efficient path to accelerated approval. The company's investigational drug, PDS0101, shows promise as a treatment for HPV16-positive head and neck cancer, with compelling data from the VERSATILE-002 Phase II trial. Early results from the National Cancer Institute-led trial on PDS01ADC demonstrate encouraging progression-free survival and PSA declines in metastatic castration-resistant prostate cancer patients. PDS Biotechnology Corp (NASDAQ:PDSB) has strengthened its intellectual property portfolio with new patents in the United States and Japan, extending market protection into the 2040s. The company has managed to reduce its net loss and operating expenses compared to the previous year, demonstrating financial discipline. PDS Biotechnology Corp (NASDAQ:PDSB) reported a net loss of $34.5 million for the year ended December 31, 2025, indicating ongoing financial challenges. Research and development expenses remain high, although slightly reduced from the previous year, reflecting the significant costs associated with advancing clinical trials. The company's cash...

Filed Phase 3 Amendment Incorporates PFS as Interim Primary Endpoint Expected to Shorten Trial Duration and Reduce Costs Conference Call and Webcast Today at 8:00 am Eastern Time PRINCETON, N.J., March 30, 2026 (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, today provided a business and clinical programs update and reported financial results for the quarter and year ended December 31, 2025. "The fourth quarter capped a year of important progress for PDS Biotech, marked by meaningful advances across our clinical programs, financial discipline, and intellectual property portfolio," said Frank Bedu-Addo, PhD, President and CEO of PDS Biotech. "Building on the compelling topline data from our VERSATILE-002 Phase 2 trial, we believe the VERSATILE-003 protocol amendment has the potential to create a more efficient path to accelerated approval — shortening the trial's duration, reducing costs, and accelerating our timeline to regulatory submission — while preserving overall survival as the basis for full approval. For patients living with HPV16-positive head and neck cancer, a disease with significant and growing unmet need, we believe PDS0101 represents a promising treatment option, and we remain focused on advancing it as efficiently as possible." Dr. Bedu-Addo added: “Combined with early data from one of our PDS01ADC Phase 2 programs and expanded patent protections for the Versamune® platform extending into the 2040s, we believe we have meaningful opportunities ahead as we continue to execute against our priorities in 2026." Clinical and Corporate Update Amended the VERSATILE-003 Phase 3 clinical trial protocol to incorporate progression-free survival (PFS) as an interim primary endpoint, creating a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival remains the primary endpoint for full FDA approval. The amendment also reduces the number of enrolled patients while maintaining statistical power. Patients already enrolled prior to the amendment remain on the trial and continue to receive treatment. Presented encouraging early results from an NCI-led trial investigating PDS01ADC, the Company's investigational IL-12 tu...

EAST PRINCETON, N.J. (AP) — EAST PRINCETON, N.J. (AP) — PDS Biotechnology Corporation (PDSB) on Monday reported a loss of $7.6 million in its fourth quarter. The East Princeton, New Jersey-based company said it had a loss of 14 cents per share. For the year, the company reported a loss of $34.5 million, or 74 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on PDSB at https://www.zacks.com/ap/PDSB