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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 (PDSB) announced positive interim results from a phase 2 trial evaluating PDS0101 in patients with advanced HPV16-associated cancers. The trial showed an objective response rate of 71% in refractory patients, with tumor reduction observed in 83% of HPV16-positive relapsed patients who haven't previously received checkpoint inhibitors. This data will be presented at the 2021 ASCO Annual Meeting on June 7. The company’s innovative Versamune® technology is being combined with immune-modulating agents to enhance treatment efficacy.
PDS Biotechnology Corporation (Nasdaq: PDSB) has appointed Dr. Olivera Finn and Dr. Mark Frohlich to its Scientific Advisory Board, enhancing its leadership in cancer immunotherapy. Dr. Finn, a distinguished immunologist, brings over 30 years of experience, notably in T-cell research. Dr. Frohlich, a medical oncologist, has over 20 years in developing immunotherapies and contributed to the FDA approval of Provenge®. These appointments are poised to accelerate the development of PDSB's clinical programs, particularly PDS0101 for HPV-associated cancers and PDS0102 for prostate cancer.
PDS Biotechnology Corporation (Nasdaq: PDSB) has received $4.5 million from the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program. This funding will support the advancement of its immuno-oncology pipeline, including the lead candidate PDS0101, which is in Phase 2 clinical studies for HPV-associated cancers. The NOL program allows qualifying New Jersey-based biotechnology firms to convert tax losses into cash to enhance growth. PDS Biotech is among 49 companies benefiting from approximately $54.5 million approved for the 2020 period.
PDS Biotechnology Corporation (PDSB) reported a $3.0 million net loss for Q1 2021, down from $4.0 million in Q1 2020. R&D expenses decreased 28% to $1.4 million, and G&A expenses fell 21% to $1.6 million. Total operating expenses were 24% lower at $3.0 million. The company's cash balance stood at $25.0 million as of March 31, 2021. PDSB will present interim data of its PDS0101 Phase 2 clinical trial at the ASCO 2021 Annual Meeting on June 7.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced its participation in Noble Capital Markets' C-Suite Interview Series, where leadership discussed the company's pipeline and proprietary Versamune® technology. Key topics included the ongoing phase 2 trials of PDS0101 and the anticipated interim data readout from a National Cancer Institute-led trial at ASCO in June. The interview is available on Channelchek and PDS Biotech's website. PDS0101 is being evaluated in partnership with Merck for HPV-associated cancers.
PDS Biotechnology Corporation (PDSB) announced that efficacy and safety data from the NCI's Phase 2 study of PDS0101 for advanced HPV-associated cancers has been accepted for oral presentation at the ASCO 2021 Annual Meeting, scheduled for June 4-8. The trial demonstrated preliminary efficacy with a response from 3 of the first 8 patients, leading to expanded enrollment. The study focuses on a combination of PDS0101, M9241, and bintrafusp alfa. Dr. Lauren V. Wood expressed optimism regarding the study's potential in immunotherapy.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced the release of its financial results for Q1 2021 on May 13, 2021, prior to market open. Following this release, management will conduct a conference call at 8:00 am ET to discuss the results and provide a business update. The call will also be available as a live webcast, and an archived version will be accessible on the company’s website for six months. PDS Biotech focuses on developing cancer therapies and vaccines using its proprietary Versamune® T-cell activating technology.
PDS Biotechnology Corporation (Nasdaq: PDSB) will participate in Noble Capital Markets’ Virtual Road Show on April 21, 2021, at 1 PM EDT. The event includes a corporate presentation by CEO Dr. Frank Bedu-Addo, CMO Dr. Lauren Wood, and CFO Seth Van Voorhees, followed by a Q&A session. Registration is free for all investors. PDS Biotech focuses on developing cancer therapies and infectious disease vaccines using its proprietary Versamune® technology, which activates T-cells and enhances immune responses. For more information, visit their website.
PDS Biotechnology Corporation (Nasdaq: PDSB) reported its financial results for the year ending December 31, 2020, revealing a net loss of $14.8 million ($0.89 per share), a rise from a $7.0 million loss in 2019. R&D expenses increased to $7.9 million, while G&A expenses decreased to $7.0 million. Key developments include the initiation of Phase 2 trials for PDS0101 in combination with KEYTRUDA® and chemoradiotherapy. Additionally, PDSB received a $60 million commitment from Brazil’s Ministry of Science, Technology and Innovation for the development of its COVID-19 vaccine PDS0203.
PDS Biotech, along with Farmacore Biotechnology and Blanver Farmoquímica, announced a commitment of approximately US$60 million from Brazil's MCTI for the development of a second-generation COVID-19 vaccine utilizing the Versamune® technology. The funding will support a combined Phase 1/2 clinical trial expected to begin in Q2/3 2021, pending approval by Anvisa. The trial aims to enroll around 360 patients, focusing on the vaccine's safety and efficacy. The consortium plans to scale up manufacturing in anticipation of positive trial results.
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