PDS Biotechnology(PDSB)2024-08-13 20:06Clinical Trial Results and Efficacy - The company's Versamune® and PDS01ADC combination showed a median overall survival of approximately 20 months in a Phase 2 trial for ICI-resistant HPV-positive cancers, compared to historical median survival of 3-4 months with ICIs and 8.2 months with systemic therapy[78] - 75% survival rate at 36 months was observed in ICI-naïve patients treated with the triple combination of PDS0101, PDS01ADC, and an investigational ICI in a Phase 2 trial[83] - The VERSATILE-002 Phase 2 trial reported a 41.2% response rate (tumor shrinkage >30%) in 7/17 patients treated with PDS0101 and Keytruda®, compared to 19% with ICI monotherapy[88] - Clinical efficacy (ORR + stable disease) was observed in 76.5% of patients (13/17) in the VERSATILE-002 trial, with a progression-free survival rate of 55.2% and overall survival rate of 87.2% at 9 months[88] - Interim data from the VERSATILE-002 trial showed a rapid decline in ctHPV-DNA, a potential predictive biomarker, in patients treated with PDS0101 and standard-of-care chemoradiotherapy[81] - Estimated 12-month overall survival rate was 87.1% for PDS0101 and pembrolizumab in HPV16-positive HNSCC, compared to 36-50% with approved ICIs alone[90] - Median progression-free survival was 10.4 months for PDS0101 and pembrolizumab, compared to 2-3 months with approved ICIs[90] - Disease control rate of 70.6% (24/34) and confirmed objective response rate of 41.2% (14/34) for PDS0101 and pembrolizumab[91] - 24-month overall survival rate of 74% for PDS0101 and pembrolizumab, compared to less than 30% with approved ICIs[93] - Tumor shrinkage seen in 60% (31/52) of patients treated with PDS0101 and pembrolizumab[93] - Median overall survival of 30 months for PDS0101 and pembrolizumab, compared to 7-18 months with ICIs[94] - Confirmed overall response rate of 34% (18/53) for PDS0101 and pembrolizumab, compared to less than 20% with ICIs[94] - Objective response rate of 88% (7/8) for PDS0101, PDS01ADC, and bintrafusp alfa in ICI-naive patients[100] - Median overall survival of 21 months for PDS0101, PDS01ADC, and bintrafusp alfa in ICI-resistant patients, compared to 3-4 months with ICIs[103] - 75% of ICI-naive patients remain alive at 36 months with PDS0101, PDS01ADC, and bintrafusp alfa, compared to 7-11 months with ICIs[104] - PDS0101 combined with chemoradiotherapy showed 81.3% ctDNA clearance after 3 weeks vs. 30.3% with SOC alone (p=0.0018), and 91.7% clearance at 5 weeks vs. 53.1% with SOC (p=0.0179)[107] Regulatory and Trial Progress - The company completed enrollment in the ICI-naïve arm of the VERSATILE-002 trial in May 2023 and received FDA feedback on the amended IND in October 2023[89] - The company confirmed the required contents of a clinical protocol for a potential registrational trial for the triple combination of PDS0101, PDS01ADC, and an FDA-approved ICI in February 2023[79] - The combination of PDS0101 and Keytruda® received Fast Track designation from the FDA in June 2022[88] - PDS0101 monotherapy and in combination with Keytruda® trial initiated in February 2022 for HPV-positive oropharyngeal cancer at Mayo Clinic[107] - PDS0103, targeting MUC1-associated cancers, is in tech transfer and clinical scale-up, with IND submission planned by end of 2024[110][111] Preclinical Studies and Vaccine Development - PDS0202, the company's universal flu vaccine candidate, demonstrated broad neutralization across multiple influenza strains and provided protection against lethal doses of H1N1 in preclinical studies[81] - PDS0102 preclinical studies demonstrated induction of tumor-targeted killer T cells for TARP-associated cancers including AML, prostate, and breast cancer[109] - Infectimune® preclinical data demonstrated complete protection against SARS-CoV-2 and influenza, with enhanced CD4 T cell responses[119] Financial Performance and Expenses - Net losses were 163.4 million[120] - Cash and cash equivalents stood at 4.5 million for the three months ended June 30, 2024[126][127] - Total operating expenses decreased by 32% to 4.2 million for Q2 2024, down from 0.3 million decrease in personnel costs and a 0.9 million for Q2 2024 from 11.2 million for the six months ended June 30, 2024, compared to 7.6 million for the six months ended June 30, 2024, compared to 18.9 million for the six months ended June 30, 2024, compared to 19.5 million during the six months ended June 30, 2024, under the Sales Agreement[136] - As of June 30, 2024, the company had 18.8 million for the six months ended June 30, 2024, compared to 19.998 million for the six months ended June 30, 2024, primarily due to proceeds from the sale of common stock[147][149] Going Concern and Financial Risks - The company concluded that substantial doubt exists about its ability to continue as a going concern for at least 12 months due to uncertainties in securing additional financing[144] - The company has concluded that substantial doubt exists about its ability to continue as a going concern for at least 12 months from the issuance of the unaudited financial statements[151] - The company's future funding requirements depend on factors such as clinical trial progress, regulatory outcomes, and market developments[152] - The company has no material non-cancelable purchase commitments with service providers[154] - The company's cash equivalents as of June 30, 2024, consist of bank deposits and money market accounts, with exposure to interest rate risk[160] - The company does not believe inflation has had a material effect on its business, financial condition, or results of operations for the quarter ended June 30, 2024[161] Internal Controls and Reporting - The company's disclosure controls and procedures are effective as of the end of the reporting period[164] - There were no changes in the company's internal control over financial reporting during the quarter ended June 30, 2024[165] - The company remains a "smaller reporting company" and intends to rely on certain disclosure exemptions[159]