Nature of Operations

12 Months Ended

Dec. 31, 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 molecularly targeted immunotherapies designed to overcome the limitations of current immunotherapy and vaccine technologies. The Company’s proprietary T-cell activating platforms designed to train the immune system to better attack and destroy disease; Versamune^{, for treatments in oncology and Infectimune, for treatments in infectious disease  When paired with an antigen, which is a disease-related protein that is recognizable by the immune system, Versamune and Infectimune have both been shown to induce, in vivo, large quantities of high-quality, highly potent polyfunctional CD4+ helper and CD8+ killer T-cells, a specific sub-type of T-cell that is more effective at killing infected or target cells. Infectimune is also designed to promote the induction of disease-specific neutralizing antibodies.  The Company’s immuno-oncology product candidates are of potential interest for use as a component of combination product candidates (for example, in combination with other leading technologies such as checkpoint inhibitors) to provide more effective treatments across a range of advanced and/or refractory cancers. The Company is also evaluating our immunotherapies as monotherapies in early-stage disease.  PDS is developing targeted product candidates to treat several cancers including Human Papillomavirus (HPV)-associated cancers, melanoma, colorectal, lung, breast and prostate cancers. The Company infectious disease candidates are of potential interest for use in COVID-19 and universal influenza vaccines.}

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 still uncertainty related to the anticipated impact of the COVID-19 pandemic and its variants 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 and its variants are broad-reaching and continuing and the financial impacts associated with the COVID-19 pandemic and its variants are still uncertain.

Despite the economic uncertainty resulting from the COVID-19 pandemic, we intend to continue to focus on the development of our product candidates and we have expanded our infectious disease pipeline since the pandemic brought renewed resources and interest on technologies such as the Versamune platform in the context of research and development in prevention of COVID-19. We licensed Versamune to Farmacore in Brazil to develop PDS0203; a vaccine for the prevention of COVID-19.  The Secretary for Research and Scientific Training of The Ministry of Science, Technology and Innovation of Brazil provided a commitment to fund up to approximately US$60 million to support the clinical development and commercialization of a Versamune-based COVID-19 vaccine in Brazil. We have not received confirmation of the availability of financial resources within the MCTI to support the clinical development and commercialization of a Versamune-based COVID-19 vaccine in Brazil. Clinical development and commercialization of a Versamune-based COVID-19 vaccine in Brazil has not been initiated.

Due to delays in the program, in the fourth quarter of 2021, we met with Farmacore and performed a detailed program review.  As the result of that review, we extended the contract with Farmacore for six months through May 31,  2022.  This allows time for Farmacore to begin manufacturing and scale up of product for the use in clinical studies and further research and development.  We are continuing to monitor the status of the technical manufacturing activities with Farmacore.

PDS has developed numerous patents and patent applications and owns substantial know-how and trade secrets related to its Versamune ^{platform. As of December 31, 2021, PDS holds six (6) U.S. patents with granted claims directed to its platform technology and sixteen (16) pending U.S. patent applications. These issued patents will expire in 2028, 2029, 2031 and 2033. Should the more recently submitted patent applications currently in prosecution be issued, these will expire in 2033 through 2037 assuming no patent term extensions are granted. As of March 1, 2022, PDS holds seventy (70) issued foreign patents and thirty-eight (38) pending or published foreign patent applications.  Most of our international issued patents are issued in multiple countries including Europe, Japan and Australia, and all of which cover compositions of matter and methods of use related to its platform technology. These issued patents will expire in 2031-2037, or later if patent term extension applies. Most recently, the USPTO allowed an application for PDS’s HPV 16 immunotherapy which when granted will run until October 2037.}

Licensed patents

We have licensed patented antigens from the US government for use in our cationic lipid immunotherapies. We have licensed T-cell receptor gamma alternate reading frame protein (“TARP”) from the National Cancer Institute (“NCI”) to develop and commercialize TARP peptide-based therapies in combination with the Company’s Versamune ^{technology and any other of the Company’s proprietary technologies for prostate and breast cancers and Acute Myeloid Leukemia.  These patents are directed to Immunogenic Peptides and Peptide Derivatives for The Treatment of Prostate and Breast Cancer Treatment and Multi-Epitope TARP Peptide Vaccine and Uses Thereof. These antigens are incorporated in PDS0102 with Versamune.  We have licensed mucin-1 (“MUC1”) novel highly immunogenic agonist epitopes of MUC1 developed by the National Cancer Institute. MUC1 is highly expressed in multiple solid tumors and has been shown to be associated with drug resistance and poor disease prognosis in breast, colorectal, lung and ovarian cancers, for which PDS0103 is being developed.   We have been granted patents and are pursuing additional patents that cover compositions and methods of use of cationic lipid immunotherapies with each of the licensed technologies.}

We entered into a non-exclusive agreement to license Computationally Optimized Broadly Reactive Antigen (COBRA) with the University of Georgia Research Foundation. These antigens are developed by Dr. Ted Ross at the University of Georgia.  We believe that the combination of these antigens with our proprietary Versamune ^{technology has potential to induce a broad immune response as a universal flu vaccine.}