CARLSBAD, CA - Palisade Bio, Inc. (NASDAQ:PALI), a biopharmaceutical company, has announced the successful production of the first Good Manufacturing Practice (GMP) batch of PALI-2108, a drug substance aimed at treating ulcerative colitis (UC). The company confirmed its readiness to begin Phase 1 human clinical trials by the end of the year.
PALI-2108, an orally administered prodrug designed to release specifically in the colon, has shown promise in preclinical studies. The drug is intended to alleviate symptoms of moderate-to-severe UC, a chronic inflammatory bowel disease. The GMP manufacturing, a critical regulatory requirement, was completed in collaboration with Eurofins, a global contract development and manufacturing organization.
The company has also achieved consistent and reliable drug release profiles with its enteric-coated tablet formulation of PALI-2108. This formulation is critical for protecting the drug from stomach acid and ensuring its release in the desired intestinal region.
In preclinical murine models, PALI-2108 demonstrated a significant reduction in the disease activity index (DAI) compared to controls, with some dosage groups showing attenuated body weight loss, suggesting targeted efficacy.
J.D. Finley, Chief Executive Officer of Palisade, expressed satisfaction with reaching this milestone and emphasized the company's commitment to advancing the clinical development of PALI-2108.
Palisade Bio specializes in novel therapeutics for autoimmune, inflammatory, and fibrotic diseases.
This announcement is based on a press release statement from Palisade Bio.
In other recent news, Palisade Bio, Inc. has made significant strides in its strategic collaboration with Strand Life Sciences, identifying potential PDE4-related biomarkers for ulcerative colitis (UC) treatment.
Financial services firm Ladenburg Thalmann has maintained a Buy rating for Palisade Bio, highlighting the potential of PALI-2108 to improve clinical remission rates.
Furthermore, Palisade Bio shareholders recently elected three directors and ratified the appointment of Baker Tilly US, LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2024. The company also announced the appointment of Margery Fischbein to its Board of Directors and secured approximately $4 million in a private placement agreement with an institutional investor.
These events underscore Palisade Bio's ongoing efforts in the biopharmaceutical space and are part of the recent developments within the company.
InvestingPro Insights
As Palisade Bio, Inc. (NASDAQ:PALI) forges ahead with the development of its ulcerative colitis treatment, PALI-2108, investors may find the company's financial health and market performance to be of interest. Here are some insights based on the latest data from InvestingPro:
InvestingPro Data indicates a challenging financial landscape for Palisade Bio. With a market cap of approximately $4.19 million USD and a negative P/E ratio of -0.19, reflecting investor concerns about profitability. The company's adjusted P/E ratio for the last twelve months as of Q1 2024 stands at -0.31, underscoring these challenges. Furthermore, Palisade Bio's price/book ratio during the same period is 0.42, which could suggest that the stock is undervalued relative to its assets.
Among the InvestingPro Tips, it's noted that Palisade Bio holds more cash than debt on its balance sheet, which could provide some financial flexibility as it moves into clinical trials. However, analysts do not anticipate the company will be profitable this year, and the company has been quickly burning through cash. Additionally, Palisade Bio's valuation implies a poor free cash flow yield.
For investors looking to delve deeper into Palisade Bio's prospects, InvestingPro offers more tips to consider. There are 11 additional InvestingPro Tips available for PALI, which can be accessed at https://www.investing.com/pro/PALI. Readers interested in a comprehensive analysis can use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription. These tips will provide a more nuanced view of the company's financial health and market potential.
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