PDSB

PRINCETON, N.J., Aug. 13, 2026 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a clinical-stage biotechnology company focused on developing targeted immunotherapies for cancer, today provided a business and clinical programs update and reported financial results for the quarter ended June 30, 2026. Clinical and Corporate Update Announced publication of positive clinical and immunological biomarker data from Stage 1 of the NCI-led metastatic colorectal cancer (mCRC) Phase 2, open-label, single-center, non-randomized clinical trial evaluating PDS0301 (formerly PDS01ADC), the Company’s tumor-targeted IL-12 immunocytokine. The clinical trial results, published in the March 2026 issue of the Journal of Clinical Oncology (JCO) Oncology Advances, included: On August 11, 2026, the Company issued a shareholder letter outlining its strategic refocus to prioritize PDS0301, its tumor-targeted IL-12 immunocytokine, as its lead development program. As part of this strategy, the Company will cease further internal investment in PDS0101, including the discontinuation of the VERSATILE-003 Phase 3 trial, and intends to pursue strategic partnerships or other externally funded opportunities for the continued development of PDS0101. The Company believes that concentrating its capital and development resources on PDS0301, while maintaining financial discipline and preserving the potential value of PDS0101 through partnerships, may provide the strongest path toward creating long-term value for patients and shareholders. Second Quarter 2026 Financial Results Reported net loss was $9.8 million, or $0.18 per basic and diluted share, for the three months ended June 30, 2026, compared to $9.4 million, or $0.21 per basic and diluted share, for the three months ended June 30, 2025. Research and development expenses were $3.3 million for the three months ended June 30, 2026, compared to $4.2 million for the three months ended June 30, 2025. The decrease was primarily attributable to lower clinical trial costs, manufacturing costs and personnel costs, partially offset by higher stock-based compensation expense. General and administrative expenses were $3.2 million for the three months ended June 30, 2026, compared to $3.4 million for the three months ended June 30, 2025. The decrease was primarily attributable to a decrease in professional fees. Total operating expenses were $6.5 million for the three months ended June 30, 2026, compared to $7.6 million for the three months ended June 30, 2025. Net interest expenses were $3.3 million for the three months ended June 30, 2026, compared to $1.8 million for the three months ended June 30, 2025. The increase was primarily due to a non-cash charge for loss on retirement of debt, partially offset by lower cash interest payments. The Company’s cash balance as of June 30, 2026, was $5.6 million. About PDS Biotechnology PDS Biotechnology is a clinical-stage biotechnology company focused on developing targeted immunotherapies for cancer. Following a strategic review, the Company has prioritized PDS0301, its investigational tumor-targeted interleukin-12 (IL-12) immunocytokine, as its lead development program. PDS0301 is designed to deliver IL-12 preferentially to the tumor microenvironment, with the goal of enhancing anti-tumor immune activity while limiting systemic exposure. PDS0301 has been clinically evaluated across multiple solid tumors, including metastatic colorectal cancer and prostate cancer. The Company is focused on advancing PDS0301 in indications where its tumor-targeted mechanism and potential to modify the tumor microenvironment may complement established and emerging cancer therapies and help address mechanisms of treatment resistance. PDS Biotechnology also owns the Versamune® platform, including PDS0101, which has been evaluated in HPV16-positive cancers. Following its strategic review, the Company decided to prioritize its capital and development resources toward PDS0301 and intends to pursue strategic partnerships or other externally funded opportunities for the continued development of PDS0101. 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 words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to conduct clinical trials for PDS0301 (formerly PDS01ADC), PDS0103 (Versamune® MUC1) and other Versamune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0301, PDS0103 and other Versamune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding response rates, the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; the anticipated benefits of the Company strategic refocus on PDS0301; the Company's ability to identify, negotiate and consummate strategic partnerships or other externally funded opportunities for PDS0101; the Company's ability to preserve, realize or enhance the value of its development programs; the Company's expectations regarding the timing, availability and sufficiency of capital resources to execute its business strategy; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. Versamune® is a registered trademark of PDS Biotechnology Corporation. Investor Contact:Mike MoyerLifeSci AdvisorsPhone +1 (617) 308-4306 Email: [email protected] Media Contact:Jude Gorman / Kiki TorpeyCollected [email protected]

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 entirely subcutaneous regimen remains a future possibility. Management identified BioNTech as the only other player with a late-stage study in this specific space, characterizing it as a relatively open market. The company believes PDS0101's unique pathophysiology targeting and dosing profile provide a competitive advantage. The shift from 2:1 to 1:1 randomization allowed for a reduction of approximately 100 patients from the total enrollment target. Lars Boesgaard noted this reduction directly lowers the external costs required to complete the trial and reach the interim readout.

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 said those characteristics, along with tolerability and survival data reported to date, could make the regimen a compelling option for patients. During the question-and-answer session, analyst Mayank Mamtani of B. Riley Securities asked about the restart of enrollment activity for VERSATILE-003. Shepard said that, now that the company has alignment with the FDA, it is moving through the process of amending the protocol and returning to trial sites to begin the study “in the near future.” → MP Materials Is Quietly Building a Rare Earth Powerhouse “We’re happy to say that the sites all stayed with us during that period of pause while we did the amendment and discussed it with the FDA,” Shepard said. Shepard also said the company’s current research remains focused on intravenous pembrolizumab, though the potential future use of subcutaneous pembrolizumab could remain open as a possibility for an entirely subcutaneous regimen. In response to a question from Joe Pantginis of H.C. Wainwright, Shepard said the amended trial design followed a final data cut in September 2025, when the company saw overall survival increase from roughly 30 months to nearly 40 months. He said that longer survival raised questions about how long the trial would take to complete, while the company also observed what he called robust PFS data. Boesgaard said the protocol amendment is expected to reduce financial requirements for the trial, particularly by shortening the time to the interim readout. He said that could reduce both external costs and internal operating expenses. Boesgaard also said the company changed the randomization ratio from 2-to-1 to 1-to-1, which lowered the number of patients in the trial from approximately 350 to approximately 250. He said that change is also expected to lower external costs associated with completing the trial. Shepard also discussed PDS01ADC, which he described as the company’s novel investigational interleukin-12, or IL-12, fused antibody drug conjugate designed to enhance the proliferation, potency and longevity of T cells in the tumor microenvironment. The company recently reported results from ongoing trials in prostate and colorectal cancer. Shepard said the Journal of Clinical Oncology JCO Oncology Advances published clinical and immunological biomarker data from stage I of a phase II trial evaluating PDS01ADC in colorectal cancer with liver metastasis. Earlier in the first quarter, PDS also announced early results from a National Cancer Institute-led trial evaluating PDS01ADC at the AACR Special Conference on Prostate Cancer Research. Shepard said that in patients with metastatic castration-resistant prostate cancer, most of whom received the therapy as a third-line option, the combination of PDS01ADC and docetaxel showed “encouraging results.” Bedu-Addo said stage 2 of the colorectal cancer cohort is fully enrolled and that the company anticipates having additional data on the full population of patients in the colorectal cancer study by the end of the year. Shepard said the company is encouraged by stage 1 results and is looking to move the therapy into a controlled trial. Bedu-Addo said PDS also strengthened the intellectual property estate for PDS0101 during the first quarter through new patents granted in the United States and Japan. He said the new U.S. patent, combined with anticipated biologics exclusivity, extends market protection into the 2040s. The Japanese patent adds broad composition-of-matter claims to existing protections across major markets. Asked about manufacturing needs, Bedu-Addo said the company has a “pretty straightforward manufacturing process” and that the commercial process is already established. He said the remaining work in parallel with phase III will involve traditional chemistry, manufacturing and controls activities, including validation batches ahead of a potential biologics license application filing. PDS reported a net loss of approximately $7.3 million, or $0.13 per basic and diluted share, for the quarter ended March 31, 2026. That compared with a net loss of $8.5 million, or $0.21 per basic and diluted share, in the prior-year quarter. Research and development expenses were $3.5 million, down from $5.8 million a year earlier, primarily due to lower clinical and manufacturing costs. General and administrative expenses were $3.1 million, compared with $3.3 million in the prior-year period, primarily due to lower professional fees. Total operating expenses were $6.5 million, down from $9.1 million a year earlier. Net interest expense was $0.8 million, compared with $0.6 million in the prior-year quarter. The company’s cash balance was $21.7 million as of March 31, 2026. In closing remarks, Bedu-Addo said the company sees “meaningful opportunities ahead” as it continues to execute against its priorities for 2026, citing early PDS01ADC data and expanded patent protections for PDS0101. PDS Biotechnology Group, Inc is a clinical‐stage immunotherapy company focused on the development of targeted treatments for oncology and infectious diseases. The company's proprietary Amplivant™ adjuvant platform leverages Toll-like receptor 3 activation to prime antigen‐presenting cells, directing robust immune responses against defined tumor and viral antigens. Its lead therapeutic vaccine candidate, PDS‐0101, is designed to treat HPV16‐positive cancers and is being evaluated both as a monotherapy and in combination with checkpoint inhibitors in ongoing Phase 1/2 clinical trials. Beyond its HPV‐focused program, PDS Biotechnology is advancing a diversified pipeline of immunotherapies incorporating its Amplivant platform. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "PDS Biotechnology Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

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 the protocol and preparing to restart the study soon. The sites have remained with us, maintaining momentum. While using SubQ pembrolizumab is a possibility, our current research focuses on the IV administration. Q: Are there any emerging updates in the HPV16 positive head and neck cancer landscape, and when can we expect data from the colorectal cancer cohort stage 2? A: (Dr. Frank Bedouadeau, CEO) BioNTech is also in a phase three trial, but options remain limited. We expect additional data from the colorectal cancer study by the end of the year. Q: Can you elaborate on the benefits of the recent amendment to the Versatile 003 trial and its financial impact? A: (Dr. Kirk Shepherd, Chief Medical Officer) The amendment allows for a co-primary endpoint with progression-free survival, potentially accelerating approval. (Lars Bosegaard, CFO) This reduces costs by shortening the trial duration and lowering patient numbers from 350 to 250. Q: What are your manufacturing needs for Versimmune and the pipeline as you approach potential commercialization? A: (Dr. Frank Bedouadeau, CEO) Our manufacturing process is straightforward and established. We will focus on validation processes and additional scale-up as needed, ensuring a smooth path to BLA filing. Q: How do you plan to allocate resources between the filing path and the ADC platform? A: (Lars Bosegaard, CFO) The amendment's cost savings will support both the filing path and further development of the ADC platform, optimizing our financial strategy. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

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 analysts. As a reminder, during this call, we will be making forward looking statements which are subject to various risks and uncertainties that could cause our actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in our filings with the SEC, including our quarterly reports on Form 10Q and annual report on Form 10K and cautionary statements made during this call. We assume no obligation to update any of these forward looking statements or information. Now I'd like to turn the call over to Dr. Baduodeau, Frank. Frank Baduodeau Thank you, Dean and good morning everyone. It's our pleasure to speak with you again and to provide this brief update on our progress in advancing our clinical programs. This past quarter, our major focus was on advancing our clinical programs and we made significant progress. So I will hand the call over to our Chief Medical Officer, Dr. Kirk Sheppard to provide an update. Kirk? Kirk Sheppard Thank you, Frank. During our first quarter, we adopted an amendment to our versatile 003 trial, revising the design to incorporate progression free survival as an interim primary endpoint, which we believe has the potential to enable a more efficient path to accelerated approval. We also believe this amendment may shorten the trial's duration and reduce the overall costs, all while retaining overall survival as the basis for full approval in accordance with FDA requirements. Additionally, this approach may also accelerate the availability of this promising treatment to the rapidly growing population of HPV 16 positive patients in dire need of effective treatment. For patients living with HPV 16 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. PDS0101, in combination with keytruda or pembrolizumab is the only late stage investigational head and neck squamous cell carcinoma therapy that requires only five doses and also the only subcutaneous therapy. These characteristics of PDS0101, together with the tolerability and survival data reported to date, make PDS0101 a potential compelling option for these patients. Key opinion leaders at institutions such as Mayo Clinic, Dana Farber, and Yale Cancer Institute are involved in our trial. HPV 16 positive cancers are rapidly increasing in the US and EU due to poor uptake of the human papillomavirus vaccine and other factors. Along with the unique pathophysiology of HPV16 cancers and the absence of approved targeted therapies, there's a significant unmet need we believe that PDS0101 is uniquely positioned to address elsewhere in our program. We recently reported promising results from ongoing trials for the treatment of prostate and colorectal cancer with PDS01 ADC, our novel investigational interleukin 12 or IL12 fused antibody drug conjugate that enhances the proliferation, potency, and longevity of T cells in tumor microenvironment. In March, the Journal of Clinical Oncology, JCO Oncology Advances published clinical and immunological biomarker Data from stage 1 of a phase 2 trial evaluating PDS01 ADC and colorectal cancer with liver metastasis. We refer you to these press releases issued this morning. Earlier in our first quarter, we also announced early results from the NCI led trial investigating PDS01ADC at the AACR Special Conference on Prostate Cancer Research in Patients with Metastatic Castration Resistant Prostate Cancer, the majority of whom received this therapy as a third line option. The combination of PDS01 ADC and docetaxel demonstrated encouraging results included in our press release this morning. The Results from these two trials reinforce the potential of PDS01 ADC to enhance the efficacy of existing therapies across multiple solid tumor types. We remain focused on advancing PDS01ADC as a key component of our immuno oncology pipeline. I will now hand the call back to Frank. Frank Baduodeau Thank you, Kirk. Finally, during our first quarter, we also strengthened the intellectual property estate for PDS0101 with new patents granted in the United States. In Japan, the new US patent combined with anticipated biologics exclusivity for PDS0101 extends our market protection into the 2040s. The Japanese patent adds broad composition of matter claims to existing protections across major markets. Now I will turn it over to Lars for a review of our results for the 2026 first quarter. Lars Bozgaard (Chief Financial Officer) thanks Frank, and good morning everyone. We reported a net loss for the quarter ended March 31, 2026 of approximately $7.3 million, or $0.13 per basic and diluted share. That compares to a net loss of $8.5 million, or $0.21 per basic and diluted share for the quarter ended March 31, 2025. Research and development expenses for the first quarter were $3.5 million compared to 5.8 million for the prior year period. Decrease was primarily due to lower clinical and manufacturing costs. General administrative expenses for the first quarter were $3.1 million compared to 3.3 million for the prior year period. The decrease was primarily due to lower professional fees. Total operating expenses for the first quarter were $6.5 million compared to 9.1 million for the prior year period. Net interest expense for the first quarter were 0.8 million dollars compared to 0.6 million for the prior year period. The company's cash balance as of March 31, 2026 was $21.7 million dollars and with that operator we can open the call to questions from analysts. OPERATOR Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press Star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press Star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing these star keys. One moment please While we poll for questions, Our first question comes from the line of Mayank Montani with Bally Securities. Please proceed with your question. Mayank Montani Yes Good morning team. Thanks for taking our questions and appreciate the updates on the versatile 003 restart enrollment activity. Could you remind us what remains sort of pending there and is there a consideration also maybe of including subcutaneous pembrolizumab as a combination partner? And I don't think fully follow what would be the procurement of pembrolizumab considerations that were there last year versus what you have today for versatile and then I have a follow up. Frank Baduodeau Hi Mayank, Thanks a lot for your questions. I'll hand over to Kirk. Kirk, why don't you go ahead. Kirk Sheppard Thank you Frank yes, regarding the enrollment, now that we have alignment with the FDA that we are going through the procedures of amending the protocol and going back to the sites to begin the study in the near future. We're happy to say that the sites all stayed with us during that period of a pause while we did the amendment and discussed it with the FDA. So we're very happy that we still have the momentum with us regarding the possibilities of using the drug with the subcutaneous pembrolizumab in the future. That's something that would be a possibility, but it's certainly not the target now of our research. Our research is with the pembrolizumab given IV in the usual amount that it has been in the past. But that option would remain open in the future for an entirely sub Q regimen. Mayank Montani Thank you. And then on the landscape external to you within HPV 16 positive head and neck, you know, it still seems like a relatively open white space or swim lane. Are there any emerging updates you've seen recently or you're expecting, you know, particularly from the EGFR bispecific class that, you know, you might be watching for? And then I also noticed the colorectal cancer cohort, you know, stage two is now fully enrolled and you obviously publish data from the stage one cohort. Maybe just remind us, when do you expect to have the next data update for Cohort 2? That would be very helpful Frank Baduodeau start and I'll hand over to Kirk to add anything to it. But in terms of the HPV 16 landscape, you're correct. Know that Biontech is also in a phase three trial, but both PDS and BioNTech remain the two late stage studies in the space. So you are correct, there are very few potential opportunities for these patients at this present time. And in terms of the colorectal cancer, yes, you are correct that we have completed enrollment into that colorectal cancer cohort of that study and we are anticipating that by the end of the year we should have some additional data on the full population of patients in the colorectal cancer study. Kirk, anything you'd want to add to that? Kirk Sheppard No, I would just refer them again to the article that was just published in our press release. But also we're very encouraged by the stage one of the phase two trial with the NCI. So we're anxious to move it on to the next trial, a controlled trial with this therapy. Mayank Montani Thanks so much, team. OPERATOR Thank you. Our next question comes from the line of Joe Pantogenis with A.C. wainwright. Please proceed with your question. Joe Pantogenis (Equity Analyst at A.C. Wainwright) Hey guys, good morning. Thanks for taking the questions and great to see the recent amendment. So I wanted to actually dive into that a little bit. If you could talk about maybe a little more color on the benefits here. Obviously Kirk, you mentioned about acceleration of the clinical timelines. I'm hoping you could hit that a little more with regard to attracting patients anecdotes you may be getting from doctors to be able to quickly get to those re enrolling quicker. And then next, sort of the second part of that is, from Lars standpoint, what, what do you believe the financial impact positively for these changes could be? And obviously would you then look to put, you know, keep that money towards the filing path or you know, put it towards a pathway sort of the ADC platform? Kirk Sheppard Yes. Thank you for your question regarding the amendments. As far as the protocol, of course this all started when we did our final data cut back in September of last year and we were very encouraged by those results. If anything though, we needed to consider how long the trial would take because the median overall survival, I think, you know, increased from around 30 months out to almost 40 months. And the trial would take a long time to complete. At the same time too, we saw the robustness of our pfs. So we went to the FDA to discuss the possibility of a CO primary which we have right now, having the PFS as a CO primary along with the median overall survival which would be needed for full approval. But we'd have a chance for an accelerated review with the pfs. So we're very happy with that as far as the trial design that has come as a result of the latest results as well as discussions with the fda. Lars Bozgaard (Chief Financial Officer) Hey Joe, this is Lars here. So to answer your question about the, the potential financial impact, the way we expect the amendment to the protocol to affect really the financial requirements for the trial is one, in terms of time and in terms of time to the interim readout in particular, so that we expect that to reduce costs, both external costs, but also our internal operating expenses, simply due to that shorter time period. Another aspect to bear in mind, Joe, is that we did as part of the amendment, we changed the randomization and the ratio from two to one to one to one. And so that also allowed us to essentially lower the number of patients from approximately 350 to approximately 250 patients. So that also in and of itself will drive lower external costs associated with completing the trial. Joe Pantogenis (Equity Analyst at A.C. Wainwright) Helpful details, thank you. And then just a quick follow up question. So look, things are late stage, they're progressing very quickly. Can you talk about your manufacturing needs for versimmune and the pipeline in the near term? And then heading beyond potential early commercialization. Lars Bozgaard (Chief Financial Officer) Yes, Joe, I can talk a little bit about that. So as you know, we have a pretty straightforward manufacturing process. So in terms of scale up in commercialization, some scale up has been done already by the commercialization. Commercial process is already established. And so what we anticipate doing is once in parallel with the phase three, doing the traditional CMC activities which involve validation of those processes. There may be some additional scale up required, but since the process is now fixed, fixed and established, we would look at the validation process. We need to do a number of those validation batches heading into the BLA filing. So those are really the major CMC activities remaining for the program. But in terms of manufacturing itself, the processes are completed and established. So pretty straightforward path to the BLA filing as pertains to the manufacturing specifically. Joe Pantogenis (Equity Analyst at A.C. Wainwright) Thanks for all the details, guys. Lars Bozgaard (Chief Financial Officer) No problem. OPERATOR Thank you. And we have reached the end of the question and answer session. I would like to turn the floor back to Frank Beruado for closing remarks. Frank Baduodeau Thank you, operator. Combined with early data from our PDS01ADC program and expanded patent protections extending into the 2040s for PDS0101, we believe we have meaningful opportunities ahead as we continue to execute against our priorities for 2026. We look forward to updating you on our progress and thank you very much again. Have a great day. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice. Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. This article PDS Biotechnology Q1 2026 Earnings Call: Complete Transcript originally appeared on Benzinga.com ﾩ 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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 reached at minimum follow-up of 13.1 months; in the parallel trial without PDS01ADC, the PFS was 8.1 months Presented encouraging early results from an NCI-led trial investigating PDS01ADC at the AACR special conference on prostate cancer research. In patients with metastatic castration-resistant prostate cancer (mCRPC) the majority of whom received third-line treatment options — the combination of PDS01ADC and docetaxel demonstrated encouraging median PFS of 9.6 months and a median PSA decline of 40%, with 6 of 16 patients achieving greater than 50% decline. Strengthened the intellectual property estate for PDS0101 with new patents granted in the U.S. and Japan. The new U.S. patent, combined with anticipated biologics exclusivity, extends market protection into the 2040s. The Japanese patent adds broad composition of matter claims to existing protections across major markets. First Quarter 2026 Financial Results Reported net loss for the quarter ended March 31, 2026, was approximately $7.3 million, or $0.13 per basic and diluted share, compared to a net loss of $8.5 million, or $0.21 per basic and diluted share for the quarter ended March 31, 2025. Research and development expenses for the quarter ended March 31, 2026, were $3.5 million, compared to $5.8 million for the quarter ended March 31, 2025. The decrease was primarily due to lower clinical and manufacturing costs. General and administrative expenses for the year ended March 31, 2026, were $3.1 million, compared to $3.3 million for the year ended March 31, 2025. The decrease was primarily due to lower professional fees. Total operating expenses for the year ended March 31, 2026, were $6.5 million compared to $9.1 million for the quarter ended March 31, 2025. Net interest expense was $0.8 million for the quarter ended March 31, 2026, compared to $0.6 million for the quarter ended March 31, 2025. The Company’s cash balance as of March 31, 2026, was $21.7 million. 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 Webcast: Click Here CallMeTM: 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 words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to conduct clinical trials for PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) and other Versamune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS01ADC, PDS0103 and other Versamune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding response rates, the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. Versamune® is a registered trademark of PDS Biotechnology Corporation. Investor Contact: Mike Moyer LifeSci Advisors Phone +1 (617) 308-4306 Email: [email protected] Media Contact: Jude Gorman / Kiki Torpey Collected Strategies [email protected] ---tables to follow---

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 words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to conduct clinical trials for PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) and other Versamune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) and other Versamune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding response rates, the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. Versamune® is a registered trademark of PDS Biotechnology Corporation. Investor Contact: Mike Moyer LifeSci Advisors Phone +1 (617) 308-4306 Email: [email protected] Media Contact: Jude Gorman / Kiki Torpey Collected Strategies [email protected]

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. Management confirmed the amendment could shorten the time to final results by as much as a year. The first interim PFS analysis is expected in about 1.5 years to support an accelerated review filing. Patients enrolled before the pause will continue treatment as indicated by the protocol. These patients will likely be included in a special subset for safety and intent-to-treat data analysis rather than the primary efficacy cohort. Management declined to disclose the specific new sample size publicly at this time. Confirmed the trial is powered to detect statistically significant differences in PFS at two points: completion of recruitment and six months thereafter. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

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 balance as of December 31, 2025, was $26.7 million, which may limit its financial flexibility moving forward. There is uncertainty regarding the exact enrollment target and sample size for the amended VERSATILE-003 trial, which could impact the trial's timeline and outcomes. The company has not provided specific financial guidance for 2026, creating uncertainty about future research and development expenses and overall financial performance. Q: Could you share what the revised enrollment target is going to look like and how that reduction compares to the original design? A: With the revised protocol and increased median survival, we had a productive meeting with the FDA. We were able to shorten the trial duration to about a year for final results, with progression-free survival (PFS) as the interim analysis available in about 1.5 years. This allows for accelerated review and a smaller trial size. Q: How should we expect R&D expenses to be for 2026 with the smaller trial design? A: While we are not providing specific financial guidance, we expect R&D costs to increase once the trial is reinitiated. The increase will depend on the number of sites opened and patient enrollment. Q: Could you touch on your plans for patients already enrolled prior to the 003 pause and any changes in enrollment pace? A: Patients already enrolled will continue their treatment as per the protocol. The enrollment pace is expected to be robust due to positive site responses and less competition. We retained all sites during the FDA dialogue pause, and they are eager to resume. Q: Can you share the new sample size for the Phase III and details on the interim PFS analysis? A: We have not made the sample size public yet. The PFS is highly powered to detect statistically significant changes, with two analyses planned: one at recruitment completion and another six months later. Q: What are the powering assumptions for the interim PFS and the new sample size for the Phase III? A: The PFS analyses are designed with high power to detect statistically significant differences between the two arms, but specific sample size details have not been disclosed. For the complete transcript of the earnings call, please refer to the full earnings call transcript.