CARLSBAD, CA - Palisade Bio, Inc. (NASDAQ:PALI), a biopharmaceutical company, announced today that the European Patent Office (EPO) has decided to grant a patent for its novel therapeutics targeting inflammatory bowel diseases (IBD).
The patent, numbered 4,157,853, encompasses Composition of Matter claims for the company's PALI-2108 and PALI-1908 programs, as well as related Gut Microbiota Bioactivated PDE4 Inhibitor Precursors.
The granted patent is expected to be issued on July 31, 2024, and will extend the company's intellectual property coverage beyond 2042. This patent protection is part of Palisade Bio's strategy to strengthen its global patent estate, which includes a recently allowed Canadian patent and additional planned submissions.
PALI-2108, an orally administered, colon-specific Phosphodiesterase-4 (PDE4) inhibitor prodrug, is being developed for patients with moderate-to-severe Ulcerative Colitis (UC). Its design aims to ensure localized bioactivation and limited systemic exposure, a feature supported by tissue distribution studies. The company is preparing to initiate a Phase 1 clinical study for PALI-2108 before the end of 2024.
The PALI-1908 candidate, also a microbiota-activated PDE4 inhibitor prodrug, is being developed for the treatment of fibrostenotic Crohn’s Disease (CD). It leverages advancements made with PALI-2108, aiming to provide a targeted therapeutic option for this chronic condition.
J.D. Finley, Chief Executive Officer of Palisade Bio, expressed confidence in the potential of PALI-2108 as a next-generation treatment for IBD and reiterated the company's commitment to advancing its development pathway.
Palisade Bio focuses on creating novel therapeutics for autoimmune, inflammatory, and fibrotic diseases, with the goal of transforming treatment landscapes. The company's efforts in expanding its intellectual property portfolio underscore its dedication to innovation and patient care in the biopharmaceutical sector.
This announcement is based on a press release statement and contains forward-looking statements subject to risks and uncertainties. These include the company's ability to advance its clinical programs, navigate the regulatory approval process, and obtain necessary financing. Palisade Bio's future results may differ materially from current expectations due to these risks and uncertainties.
In other recent news, Palisade Bio has made significant strides in its drug development efforts. The biopharmaceutical company has successfully produced the first Good Manufacturing Practice batch of PALI-2108, a drug aimed at treating ulcerative colitis, and is ready to begin Phase 1 human clinical trials.
The drug has shown promise in preclinical studies, demonstrating a significant reduction in disease activity index and attenuated body weight loss.
Palisade Bio has also made notable advancements in its strategic collaboration with Strand Life Sciences, identifying potential PDE4-related biomarkers for ulcerative colitis treatment. This progress aligns with the company's commitment to developing precision medicine solutions for inflammatory diseases.
In terms of financial developments, Palisade Bio has secured approximately $4 million in a private placement agreement with an institutional investor. Furthermore, the company has seen changes in its leadership, with the appointment of Margery Fischbein to its Board of Directors.
Ladenburg Thalmann, a financial services firm, has maintained a Buy rating for Palisade Bio, emphasizing the potential of PALI-2108 to improve clinical remission rates.
Finally, Palisade Bio shareholders have 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. These are the recent developments within the company.
InvestingPro Insights
As Palisade Bio, Inc. (NASDAQ:PALI) continues to make strides in the biopharmaceutical arena with its latest patent grant for IBD therapeutics, investors and stakeholders may find the financial health and market performance of the company equally important.
According to InvestingPro metrics, PALI holds a market capitalization of $4.07 million, which reflects the current market value of the company's outstanding shares. Despite the anticipation of sales growth in the current year, as highlighted by an InvestingPro Tip, analysts are not expecting the company to be profitable within this timeframe.
Moreover, the company's P/E ratio stands at -0.18, with an adjusted P/E ratio for the last twelve months as of Q1 2024 at -0.31, signaling that investors are wary of the company's earnings potential. Palisade Bio's Price / Book ratio for the same period is 0.4, which could suggest that the stock is currently undervalued relative to its assets.
Investors should note that while Palisade Bio has more cash than debt on its balance sheet, an important indicator of financial stability, the company is rapidly burning through cash. This could be a concern for long-term viability, especially considering the company's weak gross profit margins and poor free cash flow yield. For those interested in further insights, there are additional InvestingPro Tips available, offering a deeper analysis of Palisade Bio's financial outlook.
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