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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 a net loss of $8.5 million, or $0.32 per share, for Q1 2022, compared to $3.0 million, or $0.14 per share, in Q1 2021. R&D expenses surged to $5.2 million, up from $1.4 million, attributed mainly to higher manufacturing and clinical costs. Despite the loss, the company ended the quarter with $58.9 million in cash, enough to fund operations into 2024. PDS Biotech plans to present preliminary data from two Phase 2 trials for its leading candidate, PDS0101, at the upcoming ASCO Annual Meeting in June.
PDS Biotechnology Corporation (Nasdaq: PDSB) will release its first quarter 2022 financial results on May 11, 2022, before market opening. Management will host a conference call at 8:00 AM EDT to discuss results and provide a business update. PDS Biotech focuses on developing molecularly targeted cancer therapies and infectious disease vaccines using its proprietary Versamune® and Infectimune™ technologies. The company aims to enhance T-cell responses to effectively target and destroy diseased cells.
PDS Biotechnology Corporation (PDSB) announced updates on two clinical trials for PDS0101, focusing on HPV-positive cancers. The first abstract, presented at ASCO 2022, details a Phase 2 trial combining PDS0101 with KEYTRUDA® for recurrent/metastatic HPV16-positive head and neck cancer, achieving preliminary efficacy milestones. The second abstract discusses a National Cancer Institute-led trial combining PDS0101 with other immune therapies in HPV-associated malignancies. Enrollment is ongoing, aiming for a total of 56 participants in the refractory arm.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced that Dr. Lauren V. Wood will chair Day 2 of the Cancer and Immunotherapy Vaccines Conference at the World Vaccine Congress in Washington, DC. The conference will feature sessions focused on precision oncology, cancer vaccines, and novel immunotherapy approaches. PDS Biotech develops immunotherapies using its proprietary Versamune® and Infectimune™ technologies, aimed at enhancing immune responses against various cancers and infectious diseases. Their pipeline includes therapies targeting HPV16-associated cancers and other solid tumors.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced on April 18, 2022, the receipt of $1.2 million from the sale of tax benefits to a profitable New Jersey corporation through the state's Technology Business Tax Certificate Transfer NOL program. This funding supports the company's ongoing Phase 2 trials for PDS0101 and upcoming human trials for PDS0103. The NOL program allows eligible NJ-based tech companies to convert tax credits into necessary funds for operational growth and development.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced the granting of stock options to key personnel as an inducement for their employment. On April 6, 2022, the company granted 70,000 options to Dr. Robert Imani and 50,000 options to Paul Ivany, with an exercise price set at $6.09, the closing stock price on that date. The options will vest over four years, contingent on continued employment. PDS Biotech focuses on developing cancer immunotherapies and infectious disease vaccines using its proprietary technologies, Versamune® and Infectimune™.
PDS Biotechnology Corporation (Nasdaq: PDSB) reported a net loss of approximately $16.9 million for 2021, compared to $14.8 million in 2020. The increase in losses was driven by higher research and development costs of $11.3 million and general and administrative expenses of $10.2 million. The company achieved significant clinical milestones, including progress on PDS0101 in ongoing Phase 2 trials and encouraging preclinical data for its flu vaccine. With a cash balance of $65.2 million, PDSB expects to fund operations through 2023.
PDS Biotechnology Corporation (Nasdaq: PDSB) has rescheduled its 2021 fourth quarter and full-year earnings release and conference call to March 31, 2022, at 8:00 AM EDT. The delay is attributed to the need for additional time to complete its audit and file the Annual Report on Form 10-K for the fiscal year ending December 31, 2021. The conference call will review financial results and provide a business update. Investors can access the call via a live webcast on PDS Biotech’s website.
PDS Biotechnology Corporation (Nasdaq: PDSB) announced that the National Cancer Institute (NCI) has enrolled 30 patients in the checkpoint inhibitor (CPI) refractory arm of a Phase 2 clinical trial for PDS0101 targeting advanced HPV-associated cancers. The study aims for a total of 56 participants, evaluating efficacy in both CPI refractory and CPI naïve patients. Promising survival data was previously reported, with median survival now exceeding 12 months. An update from the NCI is anticipated soon.
PDS Biotechnology Corporation (Nasdaq: PDSB) will release financial results for the year ended December 31, 2021, on March 23, 2022, before market opening. The company specializes in immunotherapy, utilizing proprietary Versamune® and Infectimune™ technologies to develop cancer therapies and infectious disease vaccines. Following the release, a conference call will occur at 8:00 AM EDT for a financial review and business updates. Investors can join via phone or a live webcast available on the company's website.
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