What is PDS Biotechnology's gross profit margin?

What is the market's earnings forecast for PDS Biotechnology next quarter?

What guidance did PDS Biotechnology's management provide for the next earnings period?

What were the key takeaways from PDS Biotechnology’s earnings call?

What factors drove the changes in PDS Biotechnology's revenue and profit?

Did PDS Biotechnology beat or miss consensus estimates last quarter?

What were the key takeaways from PDS Biotechnology's earnings call?

What is PDS Biotechnology's latest dividend and current dividend yield?

- **Clinical Milestone**: VERSATILE-002 trial reports unprecedented 39.3-month MOS and 6.3-month PFS in HPV16-positive patients, supporting PDS0101's potential as a chemotherapy-free option.
- **Strategic Trial Amendment**: Seeking FDA approval to add PFS as primary endpoint in VERSATILE-003 to accelerate regulatory timeline.
- **Financial Efficiency**: 21% year-over-year reduction in operating expenses to $8.1 million, with $26.2 million cash balance post-equity financing.
- **Pipeline Momentum**: PDS01ADC colorectal cancer trial expands to Stage 2, while collaborations advance immunotherapy platforms.

**【CEO Summary Section】**
- **VERSATILE-002 Trial Results**: Final data showed median overall survival (MOS) of 39.3 months and progression-free survival (PFS) of 6.3 months in HPV16-positive head and neck cancer patients. A sensitivity analysis confirmed no negative impact of 9 censored patients on PFS or MOS.
- **VERSATILE-003 Protocol Amendment**: Proposed to add PFS as a surrogate primary endpoint alongside MOS to potentially accelerate trial readout. FDA meeting requested to discuss amendment.
- **Pipeline Progress**: PDS01ADC colorectal cancer cohort expanded to Stage 2 after positive Stage 1 results. Collaborations with NCI, MD Anderson, and Mayo Clinic support pipeline development.

**【CFO Financial Commentary】**
- **Q3 2025 Financials**: Net loss of $9 million ($0.19 per share), down from $10.7 million ($0.29 per share) in Q3 2024. Operating expenses decreased 21% to $8.1 million due to lower R&D and G&A costs.
- **Cash Position**: $26.2 million as of September 30, 2025. Completed $5.3 million equity financing in October 2025.

**【Q&A Highlights】**
- **Patient Enrollment in VERSATILE-003**: Enrolled patients will continue treatment during the temporary pause. FDA discussions on new sample size and cost savings pending.
- **Control Arm PFS Assumptions**: Control arm PFS estimated at 3 months (based on KEYNOTE-048 and LEAP-010 studies), while PDS0101-treated patients achieved 6.3 months PFS in VERSATILE-002.
- **Competitive Landscape**: Focus on HPV16-positive head and neck cancer, a growing but underserved population (90% of oropharyngeal cancers are HPV16-positive).

PDS Biotechnology Corporation (PDSB) Q3 2025 Earnings Call Transcript

- **Phase III Trial Leadership**: First registrational trial targeting HPV16-positive head and neck cancer with 350-patient enrollment complete. Median OS of 30 months in Phase II trial underscores potential.
- **Colorectal Cancer Breakthrough**: NCI-led trial expands to Stage 2 after achieving 6/9 objective responses, addressing a critical unmet need.
- **Financial Discipline**: Q2 2025 net loss of $9.4M reflects controlled expenses (R&D/G&A down 7%/19%) despite higher interest costs.
- **Strategic Differentiation**: Unique focus on HPV16-positive population with tolerable, subcutaneous therapy; only competitor (BioNTech) trails in efficacy and progress.

**【CEO Summary Section】**
- **VERSATILE-003 Phase III Trial Progress**: Targeting HPV16-positive recurrent/metastatic head and neck cancer with a 2:1 randomization of PDS0101 + pembrolizumab vs. pembrolizumab alone. Primary endpoint: median overall survival (OS). Enrollment complete, 22 patients remain on follow-up. No new safety signals.
- **VERSATILE-002 Phase II Data**: Median OS of 30 months (95% CI lower limit 23.9 months), with 22 patients still alive. All data meet RECIST 1.1 criteria. Full dataset expected to publish by end-2025.
- **Colorectal Cancer Trial Expansion**: Phase II trial (NCI-led) met expansion criteria with 6/9 objective responses in metastatic colorectal cancer. Expansion to Stage 2 underway.
- **Universal Flu Vaccine Preclinical Data**: Positive efficacy and immune response in mice/ferrets, presented at AAI 2025. Collaboration with NIAID for high-risk populations.

**【CFO Financial Commentary】**
- **Q2 2025 Financials**: Net loss of $9.4M ($0.21/share) vs. $8.3M ($0.23/share) in Q2 2024. Key drivers:
  - **R&D Expenses**: $4.2M (down 7% vs. Q2 2024) due to lower personnel costs, offset by higher manufacturing costs.
  - **G&A Expenses**: $3.4M (down 19% vs. Q2 2024) due to reduced personnel and professional fees.
  - **Net Interest Expense**: $1.8M (up 260% vs. Q2 2024) due to debt repayment costs.
  - **Cash Balance**: $31.9M as of June 30, 2025 (down from $41.7M at year-end 2024).

**【Q&A Key Highlights】**
- **VERSATILE-003 Enrollment**: Sites actively recruiting with strong investigator engagement. BioNTech's competing Phase II trial reports lower median OS, reinforcing PDS0101's lead.
- **Mayo Clinic Neoadjuvant Trial**: 70% stable disease with PDS0101 alone, 100% stable/partial response with combination. Results support potential for earlier-line therapy.
- **Competitive Landscape**: Only BioNTech has a comparable trial, but slower progress and lower efficacy metrics.
- **Data Dissemination**: VERSATILE-002 full dataset expected Q4 2025. ASCO 2025 presentations highlighted durability and tolerability, driving enrollment momentum.


PDS Biotechnology Corporation (PDSB) Q2 2025 Earnings Call Transcript

- **VERSATILE 003 Phase 3 Launched**: First registrational trial for HPV16+ recurrent HNSCC with 350-patient, 2:1 randomized design targeting median OS.
- **ASCO 2025 Highlights**: Neoadjuvant data for Versamune HPV + pembrolizumab in locally advanced HPV16+ HNSCC and updated VERSATILE 002 durability (30M median OS vs. 12M standard care).
- **Financial Strength**: $40M cash balance, 19% YoY net loss reduction, and $11M equity raise to support Phase 3 execution.
- **MUC1 Differentiation**: NCI-designed antigens + IL-12 ADC tumor targeting; Phase 1 trial initiated with NCI collaboration.

**【CEO Summary Section】**
- Initiated VERSATILE 003 Phase 3 trial for Versamune HPV + pembrolizumab in recurrent/metastatic HPV16+ head and neck cancer (HNSCC). Trial includes ~350 patients randomized 2:1 (combination vs. pembrolizumab alone), with median overall survival as primary endpoint.
- Collaborated with Mayo Clinic on neoadjuvant study of Versamune HPV + pembrolizumab for locally advanced HPV16+ oropharyngeal cancer, with data to be presented at ASCO 2025.
- Expanded pipeline with FDA-cleared IND for Versamune MUC1 + IL-12 ADC for metastatic colorectal cancer, conducted under NCI collaboration.

**【CFO Financial Commentary】**
- Q1 2025 net loss of $8.5M ($0.21/share), down 19% YoY due to lower R&D expenses (-13%) and tax benefits.
- Cash balance of $40M as of March 31, 2025, supported by $11M equity raise and $11M warrant exercise potential, plus debt refinancing extending term to 36 months.
- Operating expenses decreased 9% YoY to $9.1M, driven by reduced clinical trial costs.

**【Q&A Key Takeaways】**
- VERSATILE 003 enrollment unaffected by Keynote 689 (97% HPV-negative), with ~3% HPV+ patients ineligible for surgery. PDS expects durable responses similar to VERSATILE 002 (30M median OS vs. 12M for standard care).
- MUC1 program differentiated by NCI-designed agonist epitopes and IL-12 tumor-targeting ADC, with NCI-led Phase 1 trial underway.
- Financial stability maintained with controlled expenses and $40M cash runway.

PDS Biotechnology Corporation (PDSB) Q1 2025 Earnings Call Transcript

- **Phase 3 Trial Launched**: VERSATILE-003 evaluating Versamune HPV + pembrolizumab in HNSCC with 350-patient target, powered for 30-month median OS vs. 17.9 months for pembrolizumab alone. First interim analysis at 6 months post-enrollment.
- **Strong Financial Position**: $11 million raised in Q1 2025, with $41.7 million cash balance. Plan to raise additional capital stepwise for trial completion.
- **Pipeline Progress**: NCI-led Phase 1/2 trial for Versamune MUC1 + PDS01ADC in mCRC; TARP program on hold. Focus on VERSATILE-003 with potential triple combination post-approval.

**【CEO Summary Section】**
- Initiated VERSATILE-003 Phase 3 trial for Versamune HPV + pembrolizumab in HPV16-positive head and neck cancer (HNSCC), targeting 350 patients in a 2:1 randomization. Primary endpoint: median overall survival (OS). Phase 2 data showed 30-month median OS (95% CI lower limit 20 months) vs. 17.9 months for pembrolizumab alone, with 36% objective response rate (ORR) vs. 19-25% for pembrolizumab. Safety profile: Grade 1-2 injection site reactions in most patients.
- FDA-cleared IND for Versamune MUC1 + PDS01ADC in metastatic colorectal cancer (mCRC), with Phase 1/2 trial led by the National Cancer Institute (NCI).
- IMMUNOCERV Phase 2 data in locally advanced cervical cancer showed promising survival and safety; IL-12 Fused ADC (PDS01ADC) trial with enzalutamide for prostate cancer presented at Cytokines 2024.

**【CFO Financial Commentary】**
- 2024 net loss: $37.6 million (-12.3% YoY), driven by $5.2 million R&D expense reduction (clinical costs down $4.1 million). Q4 2024 cash balance: $41.7 million, plus $11 million from Feb 2025 registered direct offering. Plan to raise additional capital stepwise for Phase 3 trial, balancing equity and non-dilutive debt.

**【Q&A Highlights】**
- Enrollment: 350 patients expected, with Phase 2 sites re-engaged to accelerate recruitment. First interim analysis at 6 months post-enrollment, second at 12 months, for potential accelerated approval.
- Funding: $11 million raised in Feb 2025, but additional capital needed for full trial. Will pursue equity and debt, prioritizing VERSATILE-003 while NCI leads other programs.
- Pipeline: MUC1 program in mCRC led by NCI; TARP program for prostate cancer on hold. Focus on VERSATILE-003, with potential triple combination (Versamune + PDS01ADC + pembrolizumab) post-approval.

PDS Biotechnology Corporation (PDSB) Q4 2024 Earnings Call Transcript

PDS Biotechnology (PDSB)-14 Nov 24-2024 Q3 Earnings call transcript

PDS Biotechnology Corporation (PDSB) Q4 2023 Earnings Call Transcript

- **Breakthrough Survival**: PDS-0101 + KEYTRUDA achieves 74% 2-year OS in ICI-naive head and neck cancer, vs. <30% for current therapies.
- **Triple Combination Power**: PDS-01ADC + PDS-0101 + ICI delivers 75% ORR in ICI-naive and 63% in ICI-resistant patients.
- **Financial Resilience**: $44.3M cash runway to Q3 2024; Phase III costs expected at $12-15M/year.
- **2024 Catalysts**: VERSATILE-003启动 (Q1), PDS-0103 trial start (Q1), and multiple data readouts across oncology pipeline.

**【CEO Summary Section】**
- **PDS-0101 Progress**: VERSATILE-002 trial shows 74% 24-month overall survival (OS) in ICI-naive head and neck cancer patients, vs. <30% for approved ICIs. Objective response rate (ORR) of 27% with minimal Grade 3+ toxicities (13%).
- **Triple Combination Trial**: PDS-01ADC + PDS-0101 + ICI achieves 75% ORR in ICI-naive patients and 63% ORR in ICI-resistant patients. 3-year OS of 75% in ICI-naive and 56% in ICI-resistant groups.
- **PDS-01ADC Expansion**: Phase II trial with docetaxel in prostate cancer shows 60% PSA reduction and tolerable safety profile. Monotherapy trial in Kaposi Sarcoma ongoing.
- **Phase III Readiness**: VERSATILE-003 expected to start Q1 2024 with 100 sites; interim data timeline dependent on enrollment rates.

**【CFO Financial Commentary】**
- **Q3 2023 Results**: Net loss of $10.8M ($0.35/share) vs. $7.4M ($0.26/share) in Q3 2022. R&D expenses +$2M (to $6.4M) due to clinical trials; G&A +$1.2M (to $4.1M) due to investor relations.
- **Cash Position**: $44.3M as of Sep 30, 2023. Anticipate Phase III costs of $12-15M/year, with current cash sufficient through Q3 2024.
- **OpEx Outlook**: Q4 2023 OpEx ~$10.5M, increasing in 2024 with Phase III启动.

**【Q&A Highlights】**
- **2024 Milestones**: Final VERSATILE-002 data (Q2 2024), PDS-0103 trial start (Q1 2024), and neoadjuvant oral cancer trial data (H1 2024).
- **Collaboration Strategy**: Exploring partnerships leveraging PDS-0101's survival data and PDS-01ADC's ORR in ICI-resistant patients.
- **Trial Design**: VERSATILE-003 powered for OS improvement vs. KEYTRUDA, with conservative assumptions for control arm performance.
- **Manufacturing Readiness**: PDS-0101 commercial-scale production complete; PDS-0102 and PDS-0103 in CMC development.


PDSB

PDSB fundamentals

Earnings Call

You can ask Aime