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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) 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.
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy firm, will announce its financial results for the year ended December 31, 2020, on March 18, 2021, before market opening. The announcement will be followed by a conference call at 8:00 am ET to discuss the results and provide a business update. PDS Biotech focuses on innovative cancer therapies and vaccines using its proprietary Versamune® technology, designed to activate immune responses effectively.
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company, announced that CEO Frank Bedu-Addo will present at the H.C. Wainwright Global Life Sciences Conference on March 9-10 and the 31st Annual Oppenheimer Healthcare Conference on March 16. Both events will be hosted virtually, with presentations available on-demand and live. Replays will be accessible on the company’s investor relations website for 90 days post-conference. PDSB develops innovative cancer therapies and vaccines utilizing their proprietary Versamune® technology.
PDS Biotechnology Corporation (PDSB) has announced a partnership with Blanver Farmoquímica e Farmacêutica S.A. and Farmacore Biotechnology to develop and commercialize a COVID-19 vaccine in Latin America. Blanver will handle the manufacturing and distribution of this Versamune®-based vaccine, while Farmacore will lead regulatory and clinical trial efforts in Brazil. The vaccine, which showed significant T-cell activation in preclinical studies, represents a promising approach to combat COVID-19 without using live viruses or traditional adjuvants. Clinical trials are expected to begin in the first half of 2021.
PDS Biotechnology (Nasdaq: PDSB) announced progress in its Phase 2 clinical study of PDS0101 for advanced HPV-associated cancers. Full enrollment was triggered by observing 3 objective responses in the initial cohort of 8 patients. The trial, led by the National Cancer Institute, evaluates PDS0101 in combination with the immune-modulating agents bintrafusp alfa and NHS-IL12. The study aims to assess efficacy in both checkpoint inhibitor-naïve and refractory patients. The company's proprietary Versamune® technology aims to enhance immune response against cancer.
PDS Biotechnology Corporation (Nasdaq: PDSB) released a white paper on its Versamune® T-cell activating technology, highlighting its potential in cancer treatment. The technology aims to enhance the body’s immune response against tumors, addressing limitations seen in existing immunotherapies. Versamune® has shown superior induction of tumor-recognizing T-cells in preclinical studies, promising a favorable safety profile. PDS Biotech's pipeline focuses on antigens for challenging solid tumors. CEO Dr. Frank Bedu-Addo emphasizes a commitment to developing innovative cancer therapies.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced the approval of inducement stock options covering 202,800 shares to newly appointed CFO Seth Van Voorhees. The options have an exercise price of $2.28, the closing stock price on January 4, 2021. Vested over four years, these awards align with PDSB’s 2019 Inducement Plan aimed at attracting new employees. PDS Biotechnology focuses on developing immunotherapies using its proprietary Versamune® technology to treat cancer and infectious diseases.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced that CEO Dr. Frank Bedu-Addo will present at H.C. Wainwright’s BioConnect virtual conference. The presentation will be available on-demand starting January 11, 2021, at 6:00 AM ET. PDS Biotech is focused on developing innovative immunotherapy treatments and vaccines utilizing its proprietary Versamune® technology, which aims to enhance the immune system's ability to recognize and destroy disease cells. A replay will be accessible in the investor relations section of the company's website.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced promising results from preclinical studies of its Versamune® T-cell activating platform, showing significant antibody induction against SARS-CoV-2 with low antigen doses. The research conducted by the Icahn School of Medicine indicates Versamune's potential for a cost-effective COVID-19 vaccine, PDS0203, which is in development with Farmacore. The study highlights rapid immune responses, including strong neutralizing antibodies and T-cell activation. This positions PDSB favorably in the competitive vaccine landscape.
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