Palisade Bio, Inc. Announces Receipt of Cash Proceeds from Canada’s SR&ED Tax Incentive Program for Reimbursement of Development Costs of PALI-2108 for Treatment of Ulcerative Colitis (UC) 

Rhea-AI Summary

Palisade Bio (NASDAQ: PALI) has received CAD$1.39 million from Canada's Scientific Research and Experimental Development (SR&ED) Tax Credit Program through its co-development partner, Giiant Pharma. The funds reimburse pre-clinical development costs for PALI-2108, a treatment for Ulcerative Colitis (UC).

The company is currently conducting a Phase 1a/b single-center, double-blind, placebo-controlled study evaluating PALI-2108's safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, along with an open-label study in UC patients. Topline data from this study is expected in the first half of 2025.

Positive

• Receipt of CAD$1.39 million in non-dilutive funding from SR&ED tax credits
• Ongoing Phase 1a/b clinical trial progress for PALI-2108

Negative

• None.

Insights

Financial Analyst

The receipt of CAD$1.39 million in SR&ED tax credits represents a significant financial boost for Palisade Bio, particularly given their micro-cap status with a market capitalization of just $2.89 million. This non-dilutive funding is especially valuable as it reimburses previously incurred pre-clinical development costs without requiring additional share issuance, effectively preserving shareholder value.

The timing of this cash injection is strategically important as the company progresses through its Phase 1a/b trial of PALI-2108 for Ulcerative Colitis. The study's dual-arm design - incorporating both healthy volunteers and UC patients - provides a comprehensive early-stage evaluation of the drug's safety profile and potential efficacy signals. The expected topline data readout in H1 2025 represents a important catalyst that could significantly impact the company's trajectory.

The SR&ED program's support demonstrates government confidence in the scientific merit of PALI-2108's development program. This type of non-dilutive funding is particularly valuable for micro-cap biotechs as it helps extend operational runway while maintaining focus on clinical development milestones. The collaboration with Giiant Pharma also suggests a strategic approach to resource optimization and risk sharing in drug development.

However, investors should note that while this funding provides immediate financial relief, the company's long-term success remains heavily dependent on positive clinical trial outcomes. The upcoming Phase 1a/b results will be important in determining whether PALI-2108 can advance to later-stage development and potentially address the significant unmet needs in UC treatment.

Company through its co-development partner, Giiant Pharma, Inc. (“Giiant”), receives funding from Canadian Scientific Research and Experimental Development (SR&ED) Tax Credit Program for PALI-2108

Ongoing progress of Palisade Bio’s Phase 1a/b UC study of PALI-2108 with topline data expected in the first half of 2025

Carlsbad, CA, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio”, or the “Company”), a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced the receipt of CAD$1.39 million Canadian SR&ED credits for reimbursement of prior pre-clinical costs for PALI-2108 incurred under the company’s joint development plan with Giiant.

“This non-dilutive funding, which resulted from our pre-clinical studies previously conducted in Montreal under our co-development agreement with Giiant, bolsters our efforts to potentially bring a solution to patients,” said JD Finley, Chief Executive Officer of Palisade Bio, “We are pleased with the continued progress made with our PALI-2108 program and look forward to reporting topline data in the first half of 2025 from our ongoing Phase 1a/b study.”

The Company is currently conducting a Phase 1a/b single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, alongside an open-label study involving a patient cohort with UC. For more information about the Phase 1a/b clinical study, visit clinicaltrials.gov and reference identifier NCT06663605.

About Palisade Bio 

Palisade Bio is a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to www.palisadebio.com.

Forward Looking Statements

Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding the safety and tolerability, PK and drug release characteristics of PALI-2108 based on the Company’s preclinical studies and preliminary data from the SAD portion of the Company’s Phase 1b/2a clinical study, indications and anticipated benefits of PALI-2108 and the expected timing of the release of topline data from the Phase 1b/2a clinical study. These forward-looking statements are based on the Company’s current expectations. Forward-looking statements involve risks and uncertainties. The Company’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the Company is heavily dependent on the success of PALI-2108, which is in the early stages of clinical development and may not successfully progress through clinical development or receive regulatory approval; preliminary clinical study results or the results from earlier preclinical studies may not be predictive of final or future results and unexpected adverse side effects or inadequate efficacy of PALI-2108 may limit its development, regulatory approval and/or commercialization; the Company needs to raise significant additional funds to support its operations and the continued development of PALI-2108; the timing and outcome of the Company’s current and anticipated clinical studies related to its product candidates; indications of use and estimates about the size and growth potential of the markets for the Company’s product candidates, and its ability to serve those markets, including any potential revenue generated; the Company’s ability to maintain the Nasdaq listing of its securities; the Company’s ability to compete effectively in a competitive industry; the Company’s ability to identify and qualify manufacturers to provide API and manufacture drug product; the Company’s ability to enter into commercial supply agreements; the Company’s ability to attract and retain key scientific or management personnel; the accuracy of the Company’s estimates regarding expenses, future revenues, capital requirements and needs for additional financing; and the impact of any global event on the Company’s business, and operations, and supply. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2024, and the Quarterly Reports on Form 10-Q or other SEC filings that are filed thereafter. Investors are cautioned not to put undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Investor Relations Contact
JTC Team, LLC
Jenene Thomas
908-824-0775
PALI@jtcir.com

FAQ

How much funding did Palisade Bio (PALI) receive from Canada's SR&ED program?

Palisade Bio received CAD$1.39 million from Canada's SR&ED Tax Credit Program as reimbursement for pre-clinical development costs of PALI-2108.

When will Palisade Bio release topline data for PALI-2108 Phase 1a/b trial?

Palisade Bio expects to release topline data from the Phase 1a/b trial of PALI-2108 in the first half of 2025.

What type of clinical trial is Palisade Bio conducting for PALI-2108?

Palisade Bio is conducting a Phase 1a/b single-center, double-blind, placebo-controlled study, along with an open-label study in UC patients.

What is the purpose of Palisade Bio's PALI-2108 clinical trial?

The trial aims to evaluate PALI-2108's safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and patients with Ulcerative Colitis (UC).