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PDS Biotechnology Corporation (Nasdaq: PDSB) is a clinical stage biopharmaceutical company focused on developing next-generation immunotherapies for cancer and infectious diseases. The company's proprietary Versamune® platform leverages synthetic and biodegradable lipids to form nanoparticles that are readily taken up by the immune system. These nanoparticles are designed to activate and direct the immune system to target and eliminate disease-causing cells.
PDS Biotech's lead product candidates include PDS0101, targeting HPV-related cancers, and PDS01ADC, an IL-12 fused antibody drug conjugate. These candidates are part of the company's broader strategy to treat a range of cancers, including head and neck, prostate, breast, cervical, and anal cancers.
Recent achievements include the completion of a Phase 1 clinical trial for PDS0101 and ongoing Phase 2 trials demonstrating positive survival results and tumor shrinkage. The company is preparing to initiate a pivotal clinical trial in advanced head and neck cancers in 2024.
Financially, PDS Biotech reported a net loss of $10.8 million for Q3 2023, primarily due to increased R&D and administrative expenses. Despite this, the company remains focused on advancing its pipeline and has several key partnerships to support its research and development efforts.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced that its VERSATILE-002 Phase 2 study for treating advanced HPV16-associated head and neck cancer reached a preliminary safety benchmark. No dose-limiting toxicities were observed in the initial 12 patients. The trial will continue enrollment for efficacy evaluation among 17 checkpoint inhibitor (CPI) naïve patients and 21 CPI refractory patients. The study aims to advance based on tumor response criteria. PDS0101, in combination with KEYTRUDA, targets an unmet medical need in advanced cancer treatment.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced an equity award to Gregory Reid, its new VP of Program Development, as an inducement for joining the company. This award includes 63,800 shares with an exercise price of $14.99, vesting over four years. Reid brings over 30 years of pharmaceutical industry experience, particularly in oncology product development. His expertise aims to advance PDS Biotech's innovative cancer immunotherapy pipeline, leveraging its proprietary Versamune® technology, which targets various cancers effectively.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced its participation in the virtual Oppenheimer Fall Healthcare Life Sciences & MedTech Summit from September 21-23, 2021. The management will present updates on three ongoing Phase 2 clinical trials for PDS0101 and developments of PDS0102 and PDS0103 in human clinical trials. The presentation is scheduled for September 21, 2021, at 3:45 PM EDT. A webcast will follow on the company's investor website. PDSB focuses on innovative cancer therapies utilizing its proprietary Versamune® T-cell activating technology.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced the completion of enrollment in the lead-in safety cohort for its VERSATILE-002 Phase 2 study. This trial evaluates the efficacy and safety of the combination of PDS0101 and KEYTRUDA® for treating HPV16-associated head and neck cancer. The study includes approximately 100 patients across 25 centers in the U.S. Preliminary data shows promising responses, with 83% of CPI naïve patients showing tumor reduction. The company aims to address the significant unmet medical needs in advanced HPV-related cancers.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced its participation in the HC Wainwright 23rd Annual Global Investment Conference, set for September 13-15, 2021. The management will present updates on three ongoing Phase 2 clinical trials for PDS0101, along with progress on PDS0102 and PDS0103, which are entering human clinical trials. The presentation will be available on demand starting September 13 at 7:00 am EDT on the company’s website. PDS Biotech specializes in immunotherapy based on its Versamune® technology, targeting various cancers including breast and lung cancer.
PDS Biotechnology Corporation (Nasdaq: PDSB) reported a net loss of $0.6 million, or ($0.03) per share, for Q2 2021, a reduction from $2.9 million in Q2 2020, primarily due to $4.5 million from NJ tax benefit sales. Significant clinical results were highlighted, showing tumor reduction in 83% of HPV16-positive patients not previously treated with checkpoint inhibitors and 58% in those who had. The company completed a $52 million public offering to advance its pipeline and appointed new experts to its Scientific Advisory Board.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced presentations at various investor conferences in Q3 2021, highlighting interim data on its lead asset, PDS0101. At the ASCO 2021 Meeting, results showed tumor reduction in 83% of advanced cancer patients who failed prior treatments, and 58% in those who also failed checkpoint inhibitors. PDS0101 targets HPV16-positive cancers and is involved in ongoing Phase 2 studies. Upcoming conferences include BTIG on August 10, HC Wainwright on September 14, and Cantor on September 27.
PDS Biotechnology Corporation (Nasdaq: PDSB) will release its Q2 2021 financial results on August 12, 2021, before the market opens. Following the release, a conference call will be held at 8:00 am ET to review the results and provide a business update. PDS Biotech is focused on developing novel cancer therapies using its proprietary Versamune T-cell activating technology, with its lead product PDS0101 currently in three Phase 2 clinical studies targeting HPV-associated cancers. Interim results have shown strong efficacy in advanced, treatment-resistant cancers.
PDS Biotechnology Corporation (Nasdaq: PDSB) was added to the Russell Microcap® Index as of June 28, 2021. This inclusion enhances visibility among investors and confirms the company's progress in developing its lead HPV-cancer immunotherapy, PDS0101, currently in three Phase 2 trials. The Russell indexes, which benchmark approximately $10.6 trillion in assets, inform investment strategies globally. Dr. Frank Bedu-Addo emphasized that this recognition underscores the potential to improve cancer therapy effectiveness and increase shareholder value.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced the closing of its public offering of 6,088,235 shares at $8.50 each, raising approximately $51.7 million before expenses. The offering saw participation from insiders, including board members and executives. Cantor Fitzgerald & Co. managed the offering, which was made under a previously filed registration statement. PDS Biotech focuses on developing cancer immunotherapies using its proprietary Versamune® technology, with ongoing clinical studies for its lead product, PDS0101, in various cancers.
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