Palisade Bio Q2 2024 Financial Results and Business Update

Palisade Bio, Inc., a biopharmaceutical company headquartered in Carlsbad, CA, focuses on creating innovative treatments for autoimmune, inflammatory, and fibrotic diseases. Recently, the company announced its financial results for the second quarter of 2024 and shared significant updates on its business operations.

One of the most exciting developments is the progress towards the initiation of a Phase 1 clinical study for their lead product candidate, PALI-2108, designed to treat Ulcerative Colitis (UC). The company aims to begin this study by the end of the year. PALI-2108 is a locally acting, colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug, administered orally, with promising preclinical data suggesting it could become the first approved PDE4 inhibitor for UC.

The company highlighted several recent achievements, including the completion of a microbiome study that confirmed the role of bacterial enzymes in the local bioactivation of PALI-2108. Additionally, they have finished nonclinical studies necessary for Investigational New Drug (IND) and Clinical Trial Application (CTA) submissions.

Palisade Bio has also expanded its global intellectual property portfolio for PALI-2108 and PALI-1908, receiving a notice to grant a patent from the European Patent Office. Furthermore, the company successfully completed its first batch of Good Manufacturing Practice (GMP) drug substance for PALI-2108, a crucial step in its development process.

Collaborating with Strand Life Sciences, Palisade Bio has identified promising PDE4-related biomarkers associated with UC pathology, which could lead to more targeted therapeutic interventions. They also received a notice of allowance for a Canadian patent covering the proprietary composition of PALI-2108, titled "Gut Microbiota Bioactivated PDE4 Inhibitor Precursors."

In terms of preclinical data, PALI-2018 has shown to be safe, effective, and well-tolerated in mouse models, as presented at Digestive Disease Week (DDW) 2024.

CEO J.D. Finley expressed optimism about the company's progress, highlighting the growing body of data and the successful completion of the first GMP batch for PALI-2108. He believes that the preclinical data suggests PALI-2108 has the potential to become a significant treatment option for UC patients.

Looking ahead, the company aims to complete the analysis of ongoing toxicology studies by the end of the third quarter of 2024 and submit the initial IND/CTA within the same timeframe. They plan to initiate Phase 1a studies with a UC patient cohort before year-end.

Palisade Bio is also developing a precision medicine approach, working on a genetic- or biomarker-based patient selection method. This strategy, if successful, would help clinicians identify patients likely to respond to PALI-2108 therapy. The company has curated a robust pipeline of clinical and biomarker data from over 1,600 UC patients and is in talks with potential partners to access additional patient data, aiming to develop an FDA-approved test.

Financially, as of June 30, 2024, Palisade Bio reported cash and cash equivalents of $11.4 million, which they believe will fund operations through the first quarter of 2025. The net loss for the quarter was $4.1 million, up from $3.4 million in the same period of the previous year. This increase is largely due to higher research and development expenses, which rose to $2.6 million from $2.2 million, reflecting the intensified efforts on PALI-2108's development.

General and administrative expenses also saw an increase, rising by $0.2 million to $1.6 million compared to the same quarter last year.

In conclusion, Palisade Bio is making significant strides in developing PALI-2108 for UC, supported by robust preclinical data and strategic collaborations. The company is well-positioned to advance its clinical program and achieve regulatory milestones in the coming quarters, with a solid financial footing to support its ambitious goals.