PDS Biotechnology Corporation (PDSB) is a late-stage immunotherapy company at the forefront of transforming how the immune system targets and kills cancers. The company's pipeline of investigational therapies, based on its proprietary Versamune and PDS01ADC platforms, holds immense promise in the fight against various forms of cancer as well as the development of infectious disease vaccines.
Business Overview and History: PDS Biotech was founded in 2014 as a clinical-stage immunotherapy company developing targeted cancer and infectious disease immunotherapies. The company's proprietary platforms, Versamune and Infectimune, are designed to train and enable the immune system to attack and destroy disease. In 2014, the company's stockholders approved the 2014 Equity Incentive Plan, which allowed PDS Biotech to grant up to 91,370 shares as stock options, restricted stock units, and other equity awards. This plan was amended and restated several times over the following years to increase the total shares authorized.
In 2019, PDS Biotech began developing its lead product candidate, Versamune HPV (formerly PDS0101), for the treatment of HPV-associated cancers. The company entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to evaluate Versamune HPV in combination with other agents in clinical trials.
The first patient was dosed in 2020 in the NCI-led Phase 2 trial evaluating the triple combination of Versamune HPV, PDS01ADC (an IL-12 fusion protein), and bintrafusp alfa in patients with advanced HPV-positive cancers. PDS Biotech also initiated its own Phase 2 IMMUNOCERV trial evaluating Versamune HPV in combination with chemoradiation for locally advanced cervical cancer.
Despite facing challenges in 2021 and 2022 due to the COVID-19 pandemic's impact on clinical trial enrollment and operations, PDS Biotech adapted its protocols and continued advancing its pipeline. In 2022, the company entered into a venture loan agreement to secure additional financing for its clinical development programs and expanded its licensing agreement with the NCI to include the development of PDS0103, an investigational therapy targeting the MUC1 tumor antigen.
Financial Performance and Ratios: For the nine months ended September 30, 2024, PDS Biotech reported a net loss of $29.7 million, compared to a net loss of $32.0 million in the same period of the prior year. The company's research and development expenses decreased to $18.0 million from $20.3 million, while general and administrative expenses decreased to $10.9 million from $12.3 million.
For the most recent fiscal year (2023), PDS Biotech reported no revenue, a net loss of $42.94 million, and operating cash flow (OCF) and free cash flow (FCF) of -$33.64 million. In the most recent quarter (Q3 2024), the company reported no revenue, a net loss of $10.73 million, and OCF and FCF of -$7.99 million. The net loss decreased by $0.12 million or 1% year-over-year from Q3 2023 to Q3 2024, while OCF and FCF decreased by $7.67 million during the same period.
Financials: As of September 30, 2024, PDS Biotech had $49.8 million in cash and cash equivalents, compared to $56.6 million as of December 31, 2023. The company operates primarily in the United States.
Liquidity: The company's debt-to-equity ratio stood at 1.12, indicating a balanced capital structure. PDS Biotech has a $25 million venture loan and security agreement with Horizon Technology Finance Corporation, with $12.03 million outstanding as of September 30, 2024. The company's current ratio and quick ratio were both reported as 0.00, which may indicate potential liquidity concerns.
Product Segments and Pipeline: PDS Biotech's product pipeline is divided into two main segments: Oncology and Infectious Diseases.
In the Oncology segment, the company's lead candidate is Versamune HPV, which is being developed for HPV-associated cancers. The VERSATILE-2 Phase 2 clinical trial is evaluating the combination of Versamune HPV with Merck's Keytruda (pembrolizumab) in patients with recurrent/metastatic head and neck cancer. Preliminary data has shown an objective response rate of 41.2% and a disease control rate of 76.5%, comparing favorably to historical results with Keytruda alone. The trial has also demonstrated a 24-month overall survival rate of 74% in the immune checkpoint inhibitor (ICI) naïve cohort.
Recent updates from the VERSATILE-002 study showed that the median overall survival remained at 30 months over the last two data cuts, with the lower limit of the 95% confidence interval improving to approximately 20 months. The objective response rate improved from 26% to 36%, and the disease control rate improved from 70% to 77%. The number of patients with 90-100% tumor shrinkage increased from 6% to 21%, with 9% having a complete response.
PDS Biotech is also evaluating Versamune HPV in combination with its novel IL-12-based immunocytokine, PDS01ADC, and an investigational checkpoint inhibitor in an NCI-led Phase 2 trial for advanced HPV-positive cancers. Interim data from this trial has shown a median overall survival of approximately 20 months in ICI-resistant patients.
In the Infectious Diseases segment, PDS Biotech is developing its Infectimune platform, with PDS0202, an investigational universal flu vaccine, as the lead candidate. Preclinical data on PDS0202 has demonstrated the ability to generate broad neutralizing antibodies and provide protection against multiple influenza strains in animal models.
Risks and Challenges: PDS Biotech, like many biotechnology companies, faces the inherent risks of drug development, including the uncertainties of clinical trials, regulatory approvals, and commercialization. The company's heavy reliance on its Versamune and PDS01ADC platforms means that any setbacks in the development or approval of these technologies could have a significant impact on its future prospects.
Additionally, the competitive landscape in the oncology and infectious disease immunotherapy space is rapidly evolving, with established players and well-funded competitors vying for market share. PDS Biotech's ability to differentiate its therapies and maintain its position as a leader in the field will be crucial to its long-term success.
The company has concluded that substantial doubt exists about its ability to continue as a going concern for at least the next 12 months, and it plans to continue to fund its operations through equity or debt financings, collaborations, and other strategic arrangements.
Outlook and Catalysts: Looking ahead, PDS Biotech is poised for several important clinical and regulatory milestones. The company has updated the design of their VERSATILE-003 Phase 3 trial evaluating Versamune HPV + pembrolizumab vs. pembrolizumab alone. The trial size has been reduced to approximately 350 patients while retaining a 2:1 randomization and median overall survival as the primary endpoint. PDS Biotech expects an FDA clearance decision on the updated protocol by mid-December 2024 and plans to initiate the first site in Q1 2025, with a ramp-up of sites as additional capital becomes available.
Furthermore, the company continues to explore the potential of its PDS01ADC immunocytokine, both as a monotherapy and in combination with Versamune-based therapies, in various cancer indications. Positive data from these studies could unlock additional opportunities for PDS Biotech to expand its pipeline and address unmet medical needs.
PDS Biotech is also exploring next steps for the development of Versamune HPV for cervical cancer, based on promising data from the IMMUNOCERV Phase 2 trial. In the infectious disease space, the company is evaluating the next steps in the clinical development and funding for its universal influenza vaccine program.
Conclusion: PDS Biotechnology Corporation is navigating the evolving immunotherapy landscape with a diversified pipeline of innovative investigational therapies. The company's lead asset, Versamune HPV, has demonstrated impressive clinical results in head and neck cancer, while the PDS01ADC platform holds promise for enhancing the efficacy of Versamune-based combinations. With ongoing clinical trials, strategic partnerships, and a focus on advancing its pipeline, PDS Biotech is well-positioned to continue its journey in transforming the treatment of cancer and infectious diseases, despite facing financial challenges and the inherent risks of drug development.