8-K: Candel Therapeutics Announces Positive Survival Data and First Quarter 2024 Financial Results

Candel Therapeutics reported positive survival data from a phase 2 trial of CAN-2409 in pancreatic cancer and announced first quarter 2024 financial results.

Summary

• Candel Therapeutics announced its financial results for the first quarter ended March 31, 2024, and provided a corporate update.
• The company reported positive survival data from an ongoing phase 2 clinical trial of CAN-2409 in borderline resectable pancreatic cancer, showing a significant improvement in overall survival compared to the control group.
• Topline overall survival data for CAN-2409 in non-small cell lung cancer (NSCLC) is scheduled to be presented at ASCO on June 3, 2024.
• The company is on track to release topline disease-free survival data from a CAN-2409 phase 3 clinical trial in localized intermediate/high risk prostate cancer in Q4 2024.
• Research and development expenses for the first quarter of 2024 were $4.1 million, down from $5.5 million in the same period of 2023.
• General and administrative expenses were $3.8 million for the first quarter of 2024, compared to $4.2 million for the first quarter of 2023.
• The net loss for the first quarter of 2024 was $8.2 million, compared to a net loss of $8.8 million for the first quarter of 2023.
• As of March 31, 2024, the company had $25.7 million in cash and cash equivalents, compared to $35.4 million as of December 31, 2023.
• The company expects its existing cash to fund operations into the fourth quarter of 2024.

Sentiment

Score: 7

Explanation: The document presents positive clinical trial results and regulatory achievements, but also highlights financial losses and a limited cash runway, resulting in a moderately positive sentiment.

Positives

• The CAN-2409 pancreatic cancer trial showed a significant improvement in overall survival, with a median of 28.8 months compared to 12.5 months in the control group.
• The survival rates at 24 and 36 months were significantly higher in the CAN-2409 treatment group.
• CAN-2409 received Orphan Drug Designation for pancreatic cancer, which can provide regulatory and financial benefits.
• CAN-3110 received Fast Track Designation for recurrent high-grade glioma, which can expedite the development and review process.
• The company is advancing multiple clinical programs and has a novel discovery platform.
• The company has reduced operating expenses compared to the same quarter last year.

Negatives

• The company experienced a net loss of $8.2 million in the first quarter of 2024.
• Cash and cash equivalents decreased from $35.4 million at the end of 2023 to $25.7 million as of March 31, 2024.
• The company's cash runway is expected to last only into the fourth quarter of 2024.

Risks

• The company's ability to continue as a going concern is dependent on securing additional funding.
• Clinical trial results may differ from reported interim data.
• The company faces risks related to the timing and advancement of development programs.
• There are risks associated with obtaining and maintaining regulatory approval of product candidates.
• The company's intellectual property may not be adequately protected.

Future Outlook

The company expects to release additional preclinical and clinical data in the coming year and anticipates that its existing cash will fund operations into the fourth quarter of 2024.

Management Comments

• It was a catalyst-rich first quarter for Candel, marked by significant advances across both our clinical and preclinical programs, said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel.
• Notably, as our clinical data mature with long-term follow up, we are beginning to observe highly differentiated results in long-term survival of patients treated with our viral immunotherapies.
• We are also excited to announce that topline overall survival data from our phase 2 clinical trial of CAN-2409 in patients with stage III/IV non-small cell lung cancer and an inadequate response to immune checkpoint inhibitors will be presented at the upcoming ASCO meeting in Chicago on Monday, June 3, 2024.
• We believe this preclinical candidate offers groundbreaking potential in the treatment of cancer, continued Dr. Tak.

Industry Context

The announcement highlights Candel's progress in the competitive field of cancer immunotherapy, with a focus on viral immunotherapies. The positive survival data in pancreatic cancer and the upcoming presentation of lung cancer data at ASCO are significant milestones in this space.

Comparison to Industry Standards

• The median overall survival of 28.8 months for CAN-2409 in pancreatic cancer is a significant improvement compared to standard treatments, which typically have a median survival of around 12 months.
• The 71.4% survival rate at 24 months in the CAN-2409 group is also notably higher than what is typically seen with standard of care.
• Companies like BioNTech and Moderna have also been developing mRNA-based cancer vaccines, but Candel's approach using viral immunotherapies is a different modality.
• The Fast Track and Orphan Drug Designations for CAN-2409 and CAN-3110 are similar to those obtained by other companies in the oncology space, which can help expedite the regulatory process.

Stakeholder Impact

• Shareholders may react positively to the clinical trial results and regulatory achievements.
• Employees may be encouraged by the progress of the company's programs.
• Patients with pancreatic cancer, NSCLC, and prostate cancer may benefit from the company's therapies.
• The company's financial situation may impact suppliers and creditors.

Next Steps

• Presentation of topline overall survival data for CAN-2409 in NSCLC at ASCO on June 3, 2024.
• Release of updated Phase 1b data (Arm C) for CAN-3110 in rHGG expected in H2 2024.
• Release of Phase 2 topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer expected in Q4 2024.
• Release of Phase 3 topline disease-free survival data for CAN-2409 in localized intermediate/high-risk prostate cancer expected in Q4 2024.

Key Dates

Keywords

CAN-2409, CAN-3110, Pancreatic Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Recurrent High-Grade Glioma, Immunotherapy, Clinical Trial, Orphan Drug Designation, Fast Track Designation, enLIGHTEN Discovery Platform, Financial Results