PDSBMEDIUM SIGNALOPERATIONAL10-K

PDSB advanced multiple clinical trials through 2025 with positive Phase 2 results leading to expansion and initiation of Phase 3 trials, while experiencing significant cash burn and deteriorating net income.

The company achieved important clinical milestones including positive colorectal cancer results that met expansion criteria and final survival data from VERSATILE-002, positioning them for potential FDA discussions on expedited pathways. However, the substantial increase in net losses and declining cash position raise concerns about funding runway for these advancing trials.

Comparing 2026-03-30 vs 2025-03-27View on EDGAR →
FINANCIAL ANALYSIS

PDSB's financial position deteriorated significantly with net income declining 283% to -$34.5M despite reduced R&D spending, driven primarily by a 220% increase in interest expense to $4.2M. The company's cash position weakened substantially, falling 36% to $26.7M alongside a 37% decline in current assets, though current liabilities also decreased 45% to $9.5M. The overall picture shows accelerating cash burn despite operational improvements, suggesting potential near-term funding needs as clinical programs advance.

FINANCIAL STATEMENT CHANGES
Net Income
P&L
-282.9%
-$9.0M-$34.5M

Net income declined 282.9% — review whether driven by operations, interest costs, or non-recurring items.

Interest Expense
P&L
+219.5%
$1.3M$4.2M

Interest expense surged 219.5% — significant debt increase or rising rates materially impacting earnings.

Current Liabilities
Balance Sheet
-44.5%
$17.1M$9.5M

Current liabilities reduced — improved short-term financial position and working capital health.

Current Assets
Balance Sheet
-37.3%
$45.1M$28.3M

Current assets declined 37.3% — monitor working capital adequacy and short-term liquidity.

Cash & Equivalents
Balance Sheet
-35.9%
$41.7M$26.7M

Cash declined 35.9% — significant cash burn or deployment; verify adequacy of remaining liquidity runway.

Total Assets
Balance Sheet
-32.8%
$45.4M$30.5M

Total assets contracted 32.8% — asset sales, write-downs, or balance sheet optimization underway.

Operating Cash Flow
Cash Flow
+20.8%
-$35.0M-$27.8M

Operating cash flow grew 20.8% — strong conversion of earnings to cash, healthy business fundamentals.

Total Liabilities
Balance Sheet
-19.4%
$26.4M$21.2M

Liabilities reduced 19.4% — deleveraging improves balance sheet strength and financial flexibility.

R&D Expense
P&L
-15.7%
$22.6M$19.0M

R&D spending cut 15.7% — could signal cost discipline or concerning reduction in innovation investment.

Operating Income
P&L
+13.2%
-$36.3M-$31.5M

Operating income improving — cost discipline or growing revenue base absorbing fixed costs.

LANGUAGE CHANGES
NEW — 2026-03-30
PRIOR — 2025-03-27
ADDED
In March 2025, we announced the initiation of our VERSATILE-003 Phase 3 clinical trial evaluating PDS0101 (PDS0101) in HPV16-positive first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma.
In July 2025, we announced that the colorectal cancer cohort of a phase 2 clinical trial with PDS01ADC met the pre-defined criteria for expansion to stage 2 following positive stage 1 results.
In August 2025, we announced final topline survival data from our VERSATILE-002 Phase 2 trial evaluating PDS0101 in HPV16-positive first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma.
In September 2025, we announced final topline survival data for the low-CPS patient population from our VERSATILE-002 Phase 2 trial evaluating PDS0101 in HPV16-positive first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma.
In October 2025, we announced our request for a Type C meeting with the FDA to discuss a proposed expedited pathway for our VERSATILE-003 Phase 3 clinical trial, based on a proposed amendment to the trial s design to include progression-free survival as an interim primary endpoint, in addition to median overall survival.
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REMOVED
In December 2022, we executed an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor targeting IL-12 fused antibody drug conjugate, M9241, which joined our pipeline as PDS01ADC.
PDS01ADC is a novel investigational tumor-targeting fusion protein of IL-12 that enhances the proliferation, potency, infiltration and longevity of T cells in the tumor microenvironment and is therefore designed to overcome the limitations of cytokine therapy which today have resulted in high toxicity and limited therapeutic potential.
The proprietary combination of Versamune HPV and PDS01ADC is designed to overcome tumor immune suppression utilizing a different mechanism from immune checkpoint inhibitors (ICI).
The combination of Versamune and PDS01ADC to overcome immune suppression is patented by us, and we believe our ownership of both assets will streamline the clinical development, registrational process and their potential therapeutic use.
In a Phase 2 National Cancer Institute (NCI)-led clinical trial in ICI-resistant patients, the combination of Versamune HPV and PDS01ADC administered with an investigational bi-functional ICI resulted in a median overall survival of approximately 20 months.
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