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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 a public offering of 5,294,118 shares at a price of $8.50 per share, aiming to raise approximately $45.0 million before expenses. The offering is expected to close around June 17, 2021, with Cantor Fitzgerald & Co. as the sole bookrunner. Proceeds will support the clinical pipeline development and general corporate needs. Additionally, underwriters can purchase an extra 794,117 shares within 30 days. This follows a previous shelf registration effective since July 31, 2020.
PDS Biotechnology Corporation (PDSB) announced an underwritten public offering of its common stock, with an option for underwriters to purchase an additional 15% of shares. The offering is subject to market conditions, with no guarantee on completion or specific terms. Proceeds from this offering will support the development of its clinical pipeline and general corporate purposes, including working capital. The registration statement for this offering was effective as of July 31, 2020, with preliminary prospectus materials filed with the SEC.
PDS Biotechnology Corporation (Nasdaq: PDSB) will host an Oncology R&D Day on June 16, 2021, at 8:00 am ET, aimed at analysts, investors, and the scientific community. The event will showcase advancements in the company's cancer immunotherapy pipeline utilizing the proprietary Versamune® technology. Key presentations will feature several experts, including company executives and researchers from the National Cancer Institute. A live webcast will be available, along with presentations published on the company’s website the following day.
PDS Biotechnology Corporation announced interim data from its Phase 2 trial (NCT04287868) of PDS0101 (Versamune®-HPV16) at the ASCO 2021 Annual Meeting. The trial shows promising results: 83% tumor reduction in checkpoint inhibitor naïve patients and 58% in checkpoint inhibitor refractory patients. Among the 25 patients, 100% failed chemotherapy, 96% failed both chemotherapy and radiation, and 56% were checkpoint inhibitor refractory. Notably, the overall response rate compares favorably with current standards, highlighting PDS0101's potential for advanced HPV16-associated cancers.
PDS Biotechnology Corporation (Nasdaq: PDSB) will join the Russell Microcap Index effective June 28, following the annual reconstitution. This inclusion enhances the company's visibility within the investment community and offers advantages for shareholder value. The company is progressing its Phase 2 clinical programs, especially for its lead product, PDS0101, targeting HPV-associated cancers. With approximately $10.6 trillion in assets benchmarked to Russell indexes, this membership provides a significant opportunity for PDSB to attract new investments.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced an amendment to its Phase 2 VERSATILE-002 study, expanding to include checkpoint inhibitor-refractory patients with HPV-associated head and neck cancer. The study evaluates PDS0101 combined with KEYTRUDA® at around 20 US clinical sites. The trial’s new arm will assess approximately 40 patients who have previously failed treatments, aiming for improved clinical outcomes. Interim data from a related NCI trial showed a 63% objective response rate in similar patients, highlighting the potential of this therapeutic strategy.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced it will host an Oncology R&D Day on June 16th, 2021, from 8:00 – 10:00 AM ET, focusing on advancements in cancer immunotherapy. Key speakers include Dr. Frank Bedu-Addo and Dr. Lauren V. Wood. Presentations will be available on June 17th on PDS Biotech's website. Registration is open for the live webcast, which will be accessible in the investor relations section for 90 days post-event. PDS Biotech focuses on innovative immunotherapies using its Versamune technology to enhance T-cell response against cancers.
PDS Biotechnology Corporation (Nasdaq: PDSB) and the Head and Neck Cancer Alliance (HNCA) have partnered to raise awareness about treatment options for patients with HPV-attributed head and neck cancer. This collaboration aims to inform clinicians and patients about clinical trials and emerging therapies, including PDSB's leading candidate, PDS0101, which utilizes the Versamune® technology to activate T-cells against HPV-associated cancer cells. The partnership reflects an increased focus on collaborative efforts in biotechnology to improve patient outcomes in a growing cancer demographic.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced a conference call on June 8, 2021, at 8:00 am ET, following the presentation of preliminary data of PDS0101 at the 2021 ASCO Annual Meeting. The call will review data from a phase 2 trial involving PDS0101 for advanced HPV-associated cancers. Registration for the call is open, and a live webcast will be available. The full abstract and presentation will be accessible on ASCO's website and PDS Biotech's site, respectively.
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