PDS Biotechnology Corporation (PDSB) is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The company's proprietary Versamune® platform has demonstrated promising results in clinical trials, positioning it as a potential game-changer in the rapidly evolving field of cancer immunotherapy.
Company History and Overview PDS Biotech was founded in 2014 with the mission of developing innovative cancer immunotherapies. The company is headquartered in Princeton, New Jersey, and focuses on developing targeted cancer and infectious disease immunotherapies. PDS Biotech's pipeline is based on its proprietary Versamune and Infectimune platforms, which 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, allowing PDS Biotech to grant up to 91.37K shares as incentive stock options, non-qualified stock options, and restricted stock units. This plan was later amended and restated in 2019, increasing the number of shares authorized for issuance.
In 2020, PDS Biotech entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to clinically and preclinically develop its Versamune HPV (formerly PDS0101) and PDS0103 product candidates. The same year, the company initiated a Phase 2 investigator-initiated trial evaluating Versamune HPV with an IL-12 antibody drug conjugate and an immune checkpoint inhibitor in patients with advanced HPV-positive cancers.
2022 saw PDS Biotech file a shelf registration statement with the SEC for the issuance of up to $150 million in securities. Additionally, the company entered into a $24.6 million venture loan and security agreement with Horizon Technology Finance Corporation, providing six separate and independent term loans to the company. Throughout its history, PDS Biotech has faced challenges, including net losses each fiscal year since inception and the ongoing need to fund its operations through equity and/or debt financings.
The company's lead product candidate, Versamune® HPV (formerly PDS0101), is an investigational immunotherapy designed to treat cancers associated with the human papillomavirus (HPV), including head and neck, cervical, and other HPV-positive malignancies.
The Versamune® platform is a novel T-cell activator that has shown the ability to induce a potent and durable immune response against targeted antigens, such as those expressed by HPV-positive cancers. When paired with an antigen, Versamune® has demonstrated the capacity to generate large quantities of high-quality, highly potent polyfunctional CD4 helper and CD8 killer T cells, which are crucial for effective anti-tumor immunity.
Financial Performance and Liquidity As a clinical-stage company, PDS Biotech has not yet generated any commercial revenue, with its financial performance primarily driven by research and development (R&D) expenses and general and administrative (G&A) costs.
Financials For the fiscal year ended December 31, 2023, the company reported a net loss of $42.9 million, or $1.39 per diluted share, compared to a net loss of $40.9 million, or $1.43 per diluted share, in the prior year. In the most recent quarter, PDS Biotech reported a net loss of $10.7 million, which represents a decrease of $122,000 or 1% compared to the prior year quarter. This decrease in net loss was primarily due to lower operating expenses, partially offset by higher net interest expenses.
Liquidity The company's cash and cash equivalents totaled $56.6 million as of December 31, 2023, compared to $73.8 million as of December 31, 2022. The decrease in cash was primarily due to the company's ongoing clinical trials and other operational expenses. As of September 30, 2024, PDS Biotech had $49.8 million in cash and cash equivalents on its balance sheet.
PDS Biotech has demonstrated the ability to raise additional capital through equity financings, including its at-the-market (ATM) offering program, to support its clinical development efforts. The company has a $50 million at-the-market equity offering program and a $24.6 million venture loan and security agreement with Horizon Technology Finance Corporation, under which the company had $24.5 million in principal outstanding as of September 30, 2024.
Key financial ratios for PDS Biotech include: - Debt/Equity ratio: 1.12 - Current ratio: 2.84 - Quick ratio: 2.84
These ratios indicate that the company has a moderate level of debt relative to equity and maintains a strong short-term liquidity position.
Clinical Pipeline and Milestones PDS Biotech's lead product candidate, Versamune® HPV, is currently being evaluated in several clinical trials, including the ongoing VERSATILE-002 Phase 2 study in recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and the IMMUNOCERV Phase 2 trial in locally advanced cervical cancer.
The VERSATILE-002 study has demonstrated encouraging results, with the combination of Versamune® HPV and the PD-1 inhibitor pembrolizumab (KEYTRUDA®) showing improved median overall survival (mOS) and objective response rates (ORR) compared to historical data for pembrolizumab alone in this patient population. The latest data presented at the European Society for Medical Oncology (ESMO) Congress in September 2024 highlighted a mOS of 30 months and an ORR of 36% in the Versamune® HPV plus pembrolizumab arm, which represent significant improvements over the published results for pembrolizumab monotherapy.
In the IMMUNOCERV study, the combination of Versamune® HPV and standard-of-care chemoradiotherapy (CRT) in patients with locally advanced cervical cancer demonstrated a 36-month overall survival rate of 100% in those who received all five doses of Versamune® HPV, compared to a published 36-month OS rate of 82.6% for CRT plus the PD-1 inhibitor KEYTRUDA®.
Building on these promising results, PDS Biotech is now preparing to initiate the VERSATILE-003 Phase 3 clinical trial evaluating Versamune® HPV in combination with pembrolizumab as a first-line treatment for recurrent/metastatic HPV16-positive HNSCC. The company has made updates to the study design, which now includes approximately 350 patients, down from the previous plan, while maintaining statistical power and a 2:1 randomization. Median overall survival remains the primary endpoint. PDS Biotech expects to submit the updated protocol to the FDA this week and receive a clearance decision by mid-December 2024. The company plans to initiate the first site for the VERSATILE-003 trial in the first quarter of 2025, starting with a targeted subset of sites that can be financed from existing resources, and then ramping up the number of sites as additional capital becomes available.
Product Segments and Key Products PDS Biotechnology's product segments include:
Oncology Segment: - Versamune Platform: The company's proprietary T-cell activator platform, which includes: - Versamune HPV (PDS0101): An investigational immunotherapy targeting HPV-associated cancers. - PDS0102: An investigational immunotherapy for TARP-associated cancers. - PDS0103: An investigational immunotherapy for MUC1-positive cancers. - PDS01ADC: A novel investigational IL-12 fused antibody drug conjugate licensed globally from Merck KGaA in 2022.
Infectious Disease Segment: - Infectimune Platform: The company's proprietary T-cell activator platform for infectious diseases, which includes: - PDS0202: An investigational universal flu vaccine.
Competitive Landscape and Risks The immunotherapy market for HPV-positive cancers is highly competitive, with established players like Merck (KEYTRUDA®) and Bristol-Myers Squibb (OPDIVO®) offering PD-1/PD-L1 inhibitors. However, PDS Biotech's Versamune® platform has demonstrated the potential to overcome the limitations of current immunotherapies by effectively converting the tumor microenvironment from an immunosuppressive to an immunogenic state and inducing a robust and durable T-cell response.
Some of the key risks facing PDS Biotech include the inherent uncertainties of clinical development, potential regulatory hurdles, competition from larger pharmaceutical companies, and the company's ability to secure additional funding to support its pipeline advancement. Additionally, the company's reliance on the successful development and commercialization of its lead candidate, Versamune® HPV, poses a concentration risk.
Outlook and Conclusion PDS Biotech's Versamune® platform has shown promising results in clinical trials, particularly in the treatment of HPV-positive cancers. The company's upcoming VERSATILE-003 Phase 3 trial in recurrent/metastatic HNSCC, coupled with the positive data from its earlier studies, positions Versamune® HPV as a potential game-changer in the competitive landscape of cancer immunotherapy.
As PDS Biotech continues to advance its clinical pipeline and navigates the regulatory environment, investors will closely monitor the company's ability to execute on its strategic priorities and deliver meaningful clinical outcomes. The successful development and potential commercialization of Versamune® HPV could significantly transform the treatment landscape for HPV-associated cancers and solidify PDS Biotech's position as a leader in the field of immuno-oncology.
The company's focus on capital-efficient development, as evidenced by the updated VERSATILE-003 trial design, demonstrates a strategic approach to advancing its pipeline while managing financial resources. With no reported scandals, short seller reports, or CEO departures, PDS Biotech appears to maintain a stable corporate environment as it progresses through this critical phase of clinical development.