PDS Biotech Corporation (NASDAQ:PDSB) is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on its Versamune® and Infectimune® platforms. The company has made significant advancements in its PDS01ADC, an IL-12 Fused Antibody Drug Conjugate, as well as its PDS0101 Phase 2 programs.

Financials

In 2023, PDS Biotech reported a net loss of $42.9 million, or $1.39 per basic and diluted share, compared to a net loss of $40.9 million, or $1.43 per basic and diluted share, in 2022. The company did not generate any revenue in 2023 or 2022. Operating cash flow was negative $33.6 million in 2023, while free cash flow was also negative $33.6 million.

For the fourth quarter of 2023, the company reported a net loss of $10.8 million, compared to a net loss of $7.4 million in the prior year period. Research and development expenses increased to $6.4 million from $4.4 million, while general and administrative expenses rose to $4.1 million from $2.9 million.

Recent Developments

The company's decision to prioritize the development of the triple combination of PDS0101, PDS01ADC, and an FDA-approved immune checkpoint inhibitor (ICI) for the treatment of recurrent/metastatic HPV-positive, ICI-resistant head and neck cancer is a strategic move driven by compelling clinical data.

The National Cancer Institute-led Phase 2 trial of this triple combination demonstrated a 12-month overall survival rate of 72% and a median overall survival of approximately 20 months in the ICI-resistant group. In comparison, current approaches have shown a 12-month overall survival rate of only around 30% and a median overall survival of just 3.4 months in this patient population. Additionally, the triple combination achieved a 63% overall response rate in the ICI-resistant group, significantly higher than the less than 20% response rates reported with current therapies.

In the ICI-naive group, 75% of patients remained alive at 36 months, with the median overall survival not yet reached. This compares favorably to published results showing a 36-month survival rate of approximately 20% with immune checkpoint inhibitors alone.

The company's decision to prioritize the triple combination is further supported by the robust clinical data set of over 430 patients treated with either Versamune-based or PDS01ADC-based therapies, including more than 110 head and neck cancer patients. Importantly, the safety profile of these treatments has been acceptable, with no significant toxicity concerns observed in over 300 patients treated with PDS01ADC and 170 patients with Versamune-based therapies.

PDS Biotech's strategic focus on the triple combination of PDS0101, PDS01ADC, and an ICI for recurrent/metastatic HPV-positive, ICI-resistant head and neck cancer is a well-informed decision based on the compelling clinical data and the significant unmet medical need in this patient population. The company has engaged the FDA, obtained clear guidance on the clinical study design and regulatory pathway, and secured the commitment of a leading investigator, Dr. Katharine Price from Mayo Clinic, to lead the planned pivotal trial.

The company's decision to prioritize this triple combination program over the previously planned VERSATILE-003 trial is a prudent move that aligns with the data and the potential to rapidly establish the combination of PDS01ADC and Versamune as a transformative oncology platform. By initially addressing the rapidly growing unmet medical need in recurrent metastatic HPV-16 positive head and neck cancer, PDS Biotech believes this approach has the potential to significantly improve overall survival rates for patients who currently lack an effective treatment option.

In addition to the focus on the triple combination, PDS Biotech continues to advance other programs in its pipeline. This includes the IMMUNOCERV Phase 2 trial evaluating PDS0101 in combination with standard-of-care chemoradiotherapy in patients with locally advanced cervical cancer, as well as the investigator-initiated trial at Mayo Clinic exploring PDS0101 alone or in combination with KEYTRUDA® in patients with HPV-positive oropharyngeal cancer.

The company's Infectimune platform is also being evaluated, with preclinical data on the universal flu vaccine candidate, PDS0202, demonstrating broad neutralization across multiple influenza strains and providing protection against infection after challenging animals with lethal doses of the pandemic H1N1 flu virus.

Conclusion

PDS Biotech's strong clinical data, strategic focus, and diversified pipeline position the company well for continued advancement and potential value creation. With the decision to prioritize the triple combination program, the company is poised to make significant strides in addressing the unmet needs of patients with recurrent/metastatic HPV-positive, ICI-resistant head and neck cancer, a rapidly growing and underserved market. Investors should closely monitor the company's progress as it moves this transformative oncology platform into a pivotal trial.