Release Date: August 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- The ASPIRE trial for ivospemin in combination with gemcitabine and nab-paclitaxel has received its third consecutive positive safety review from the DSMB.
- ASPIRE trial enrollment is progressing faster than anticipated, with full enrollment expected by Q1 2025.
- The company has successfully monetized assets from the eflornithine pediatric neuroblastoma program, receiving an additional $775,000.
- Panbela Therapeutics Inc (PBLA, Financial) has entered into a clinical trial agreement for a Phase 2 study of eflornithine in castration-resistant metastatic prostate cancer.
- The company is planning a Phase 2 trial to assess ivospemin in platinum-resistant ovarian cancer, with collaboration from Johns Hopkins University School of Medicine.
Negative Points
- General and administrative expenses were approximately $1.1 million in Q2 of 2024, indicating a decrease but still a significant cost.
- Research and development expenses increased to $7 million in Q2 of 2024, up from $4.2 million in the prior year quarter.
- Net loss for the quarter was $7.1 million, compared to a net loss of $5.8 million in Q2 of 2023.
- Total cash as of June 30, 2024, was approximately $59,000, indicating a tight cash position.
- Current liabilities were $16.8 million at quarter end, significantly higher than current assets of $0.8 million.
Q & A Highlights
Q: Can you provide an update on the pediatric neuroblastoma program with US WorldMeds?
A: US WorldMeds has FDA approval in the maintenance setting, and a trial through Children's Oncology Group in the first-line setting has completed enrollment. The trial is now running its course, and US WorldMeds is actively commercializing the approved indication from December of last year. - Jennifer Simpson, CEO
Q: What is the current status of the ASPIRE trial for ivospemin in metastatic pancreatic ductal adenocarcinoma?
A: The ASPIRE trial has reached 395 patients in its safety database, with full enrollment of approximately 600 patients expected by Q1 2025. Interim analysis is now projected for early 2025 due to prolonged patient survival, suggesting potential benefits of ivospemin. - Jennifer Simpson, CEO
Q: Can you elaborate on the financial results for Q2 2024?
A: General and administrative expenses were $1.1 million, down from $1.6 million in Q2 2023. Research and development expenses increased to $7 million from $4.2 million due to higher ASPIRE trial enrollment. Net loss was $7.1 million or $1.47 per diluted share. - Susan Horvath, CFO
Q: What are the upcoming milestones for Panbela in the second half of 2024?
A: Key milestones include enrolling the first patient in the non-small cell lung cancer Phase 1 trial, opening the neoadjuvant pancreatic cancer trial, initiating the Phase 2 ovarian trial, and publishing final Phase 2b metastatic pancreatic trial data. - Jennifer Simpson, CEO
Q: How is the PACES trial for Flynpovi progressing?
A: Enrollment for the PACES trial has concluded, and the study passed its planned futility analysis. Data readout is expected by the second half of 2026. - Jennifer Simpson, CEO
Q: Can you provide details on the recent financial agreement with US WorldMeds?
A: Panbela signed an amendment with US WorldMeds for a nonrefundable payment of $0.8 million, giving up two future milestone payments. The company also entered a loan agreement for $1.5 million to fund the ASPIRE trial. - Susan Horvath, CFO
Q: What is the status of the Phase 2 study of eflornithine in castration-resistant metastatic prostate cancer?
A: The Phase 2 study is actively recruiting patients. - Jennifer Simpson, CEO
Q: What are the financial highlights for Panbela as of June 30, 2024?
A: Total cash was approximately $59,000, with current assets at $0.8 million and current liabilities at $16.8 million. Noncurrent assets were $8.6 million. - Susan Horvath, CFO
Q: What are the plans for the Phase 2 trial of ivospemin in platinum-resistant ovarian cancer?
A: The Phase 2 trial is planned to initiate in collaboration with Johns Hopkins University School of Medicine in the latter half of this year. - Jennifer Simpson, CEO
Q: How is Panbela progressing with its preclinical development efforts?
A: Panbela is collaborating with MD Anderson Cancer Center to investigate combining polyamine metabolic inhibitor treatment with CAR T cell therapy and bispecific monoclonal antibodies using preclinical models. - Jennifer Simpson, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
