Nature of Operations

9 Months Ended

Sep. 30, 2021

Nature of Operations [Abstract]

Nature of Operations

Note 1 – Nature of Operations

PDS Biotechnology Corporation, a Delaware corporation (the “Company” or “PDS”), is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines designed to overcome the well-established limitations of current immunotherapy technologies. PDS owns Versamune®, a proprietary T-cell activating platform designed to train the immune system to better attack and destroy disease. When paired with an antigen, which is a disease-related protein that is recognizable by the immune system, Versamune® has been shown to induce, in vivo, large quantities of high-quality, highly potent polyfunctional CD8+ killer T-cells, a specific sub-type of CD8+ killer T-cell that is more effective at killing infected or target cells.

The Company’s immuno-oncology products can potentially be used as a component of combination products with other leading technologies to provide effective treatments across a range of advanced cancer types. Currently, the Company believes its product candidates are of interest for potential combination treatments in relation to Human Papillomavirus (HPV)-associated cancers, melanoma, colorectal, lung, breast and prostate cancers and potentially as monotherapies in early-stage cancers. In addition, PDS is working to progress its infectious disease development program, which includes novel vaccines for COVID-19 and universal influenza.

From the Company’s inception, it has devoted substantially all of its efforts to drug development, business planning, engaging regulatory, manufacturing and other technical consultants, acquiring operating assets, planning and executing clinical trials and raising capital.

In December 2019, a novel (new) coronavirus known as SARS-CoV-2 was first detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease, known as COVID-19, that has now spread globally. On January 30, 2020, the World Health Organization (WHO) declared COVID-19 a public health emergency. The Secretary of Health and Human Services declared a public health emergency on January 31, 2020, under section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to the COVID-19 outbreak. On March 11, 2020, the WHO declared COVID-19 a pandemic and on March 13 the President declared a national emergency in response to the pandemic. PDS continues to learn more about the full impact of the COVID-19 pandemic which has continued to evolve due to the emergence of variants of concern, resulting in new waves of infection regionally and globally. The COVID-19 pandemic has and could continue to negatively affect the Company’s liquidity and operations.  To date, the start of two of the three initiated PDS0101 clinical trials were delayed, specifically as a result of the adverse impact the COVID-19 pandemic has had on clinical trial operations for cancer indications in the United States. The FDA has continued to update its guidance assisting sponsors in assuring the safety of trial participants, maintaining compliance with Good Clinical Practice (GCP) and minimizing risks to trial integrity.  Clinical trial sites have implemented institution-specific measures securing the safety of patients and staff to ensure the integrity of the trials in the face of the ongoing pandemic. All three studies have since been initiated despite the pandemic challenges; however, the evolving COVID-19 pandemic has impacted the pace of enrollment in clinical trials in general and the Company may be negatively affected with its trials. COVID-19 related travel and other restrictions may also impact the potential for on-site monitoring visiting and audits and inspections by Company personnel, third parties, and government regulators. There may be shortages of site personnel and equipment necessary for the timely completion of the clinical trials. The Company is providing support to address these challenges, but these mitigation measures may not overcome the obstacles that the pandemic has wrought which continue to impede progress of clinical trials.

Although there is uncertainty related to the anticipated impact of the COVID-19 pandemic on the Company’s future results, management believes the Company’s current cash reserves leave us well-positioned to manage the business through this crisis as it continues to unfold. However, the impacts of the COVID-19 pandemic and its variants are broad-reaching and continuing and the financial impacts associated with the COVID-19 pandemic are still uncertain.