Palisade Bio, Inc. (PALI): Business Model Canvas [Dec-2025 Updated]

You're staring down the financials of a clinical-stage biotech, trying to map out where the money actually goes before a product hits the market. For Palisade Bio, Inc., the Business Model Canvas clearly shows a high-stakes gamble: advancing PALI-2108, a novel, gut-restricted therapy for IBD, through expensive trials. Honestly, the near-term reality is stark: they are forecasting a net loss of about -$158.6 million for the 2025 fiscal year, with their main 'revenue' coming from capital raises, like that recent $138 million gross public offering. So, how does this model actually work, and what are the partnership plays that could de-risk this defintely capital-intensive path? Dive into the nine blocks below to see the full picture.

Palisade Bio, Inc. (PALI) - Canvas Business Model: Key Partnerships

You're looking at the core alliances that fund and advance Palisade Bio, Inc.'s pipeline, especially as they push PALI-2108 toward Phase 2. These aren't just names on a slide; they represent tangible financial commitments and scientific milestones.

The licensing deal with Giiant Pharma, Inc. is foundational, securing exclusive worldwide rights to their precision delivery technology platform and multiple product candidates. This includes the lead asset, GT-2108 (which Palisade Bio calls PALI-2108), an orally administered, gut-restricted, colon-specific phosphodiesterase 4 (PDE4) inhibitor prodrug targeting moderate-to-severe ulcerative colitis (UC). The agreement also covers GT-1908, targeted for fibro stenotic Crohn's Disease. Financially, Palisade Bio assumed responsibility for all development, manufacturing, and commercialization costs after the first approval of an Investigational New Drug (IND) application or a Canadian Clinical Trial Application (CTA). Before that point, Palisade Bio paid a portion of the development costs. The structure also mandates Palisade Bio pay certain milestone payments (in cash or stock at their election) and royalty payments based on sales. The Inflammatory Bowel Disease (IBD) market opportunity is noted as a multi-billion dollar space where current therapies achieve less than a 20% average clinical remission rate.

The strategic collaboration with Strand Life Sciences, announced in April 2024, centers on bioinformatics to sharpen the precision medicine approach for UC therapy. This partnership gave Palisade Bio access to advanced tools to analyze their curated pipeline of 1600 UC patient samples, which include transcriptomics and clinical outcomes data. The immediate goal was to identify predictive biomarkers, specifically PDE4-related biomarkers, to guide the development of PALI-2108.

Funding from institutional investors is a critical component, validated by the October 2025 public offering. Palisade Bio closed this underwritten public offering, raising gross proceeds of approximately $138 million before expenses, priced at $0.70 per share. This capital is earmarked to support the upcoming Phase 2 clinical development program for PALI-2108. Key participants in this financing included Adage Capital Partners LP and RA Capital Management.

Specifically, RA Capital Management, L.P. executed a noteworthy transaction on October 2, 2025, acquiring 9,935,761 shares at $1.70 per share. This move increased their total holdings to 9.90% of Palisade Bio, Inc.'s outstanding shares, signaling strong conviction from a major healthcare-focused firm.

Regulatory bodies form the gatekeepers for market entry. Palisade Bio received a No Objection Letter from Health Canada to commence the Phase 1 clinical study for PALI-2108 in UC. To be fair, the regulatory environment itself is shifting; Health Canada's Report on Red Tape Reduction, published in September 2025, signaled modernization initiatives, including establishing a modern, flexible regulatory framework for clinical trials proportionate to risk, with a public comment period for clinical trial framework modernization expected in spring 2025.

Managing global trials necessitates partnerships with Clinical Research Organizations (CROs). While specific CRO names aren't public in this data, the Giiant agreement structure dictates that Palisade Bio assumes all development costs, including those associated with CRO management, after the initial IND/CTA filing. This transition point shifts a significant financial burden onto Palisade Bio's balance sheet, which was bolstered by the $138 million raise in October 2025.

Here's a quick look at the key partnership data points:

The reliance on external expertise and capital is clear:

• Exclusive rights to GT-2108 and GT-1908 from Giiant Pharma, Inc.
• Analysis of 1600 patient samples via Strand Life Sciences collaboration.
• $138 million gross proceeds secured in the October 2025 offering.
• RA Capital Management, L.P. stake reached 9.90% post-offering.
• Health Canada clearance received for Phase 1 trial initiation.

Finance: review the cash burn rate against the $138 million Q4 2025 financing runway by next Tuesday.

Palisade Bio, Inc. (PALI) - Canvas Business Model: Key Activities

You're managing a clinical-stage biopharma, so your key activities revolve around the science, the regulators, and the bank account. Here's the breakdown of what Palisade Bio, Inc. (PALI) was actively executing as of late 2025.

Executing Phase 1b/2 clinical trials for PALI-2108 in IBD

The core activity here is pushing PALI-2108 through human trials for Inflammatory Bowel Disease (IBD), specifically targeting fibrostenotic Crohn's disease (FSCD) and building on prior Ulcerative Colitis (UC) data. This is where the science meets the patient.

The Phase 1b study in FSCD received Health Canada clearance on September 5, 2025, for its Clinical Trial Application. This open-label study is set to enroll approximately 6-12 patients to evaluate safety, pharmacokinetics (PK), and pharmacodynamics (PD). Patient dosing for the FSCD study began in the second half of 2025, with the exploratory cohort starting on October 16, 2025. You're looking for topline safety, PK, and PD readouts from this FSCD trial in the first quarter of 2026.

The prior Phase 1b UC cohort data provided some compelling early signals:

• Achieved a 100% clinical response rate in all five patients with moderate-to-severe UC.
• Demonstrated a mean 62.8% reduction in modified Mayo score.
• 2 of 5 patients achieved clinical remission after only seven days.
• Tissue analyses confirmed a 40% decrease in tissue lymphocytes and a 51% reduction in PDE4B expression.

Also, the Phase 1a multiple ascending dose cohort successfully dosed 89 subjects.

Research and development (R&D) of novel therapeutics

R&D is the engine, but you have to manage the burn rate as you transition from early-stage work to active clinical execution. The spending profile reflects this shift.

For the quarter ended September 30, 2025 (Q3 2025), Research and Development expenses were reported at $1.39 million. This was an improvement compared to the $2.13 million reported in Q3 2024, showing a planned decrease as the focus moved from preclinical work to clinical trial execution. To give you a look at the quarterly spend earlier in the year, the operating expenses for the quarter ending March 31, 2025, included R&D expenditures of approximately $950K. The total operating expenses for Q3 2025 were $2.92 million.

Securing regulatory approvals (INDs, NDAs) from FDA and global agencies

This activity is about translating positive clinical data into permission to proceed to the next, larger trial phase. The immediate goal is the Phase 2 Investigational New Drug (IND) application.

Palisade Bio, Inc. is on track to submit its Phase 2 IND application to the U.S. Food and Drug Administration (FDA) in the first half of 2026, contingent on successful outcomes from the ongoing clinical trials. This submission will leverage data from the completed UC trials and the ongoing FSCD Phase 1b study.

Protecting and expanding intellectual property (IP) portfolio globally

Securing the exclusivity window is non-negotiable for future valuation. You need to lock down the asset.

A key development was the introduction of a new Canadian patent for PALI-2108, which provides protection for the therapeutic until the year 2041.

Raising capital through equity and debt financings

Cash runway is lifeblood, so capital raising is a constant, critical activity. You successfully executed a major equity event in the fall of 2025 to fund the next stage of development.

The financing landscape for Palisade Bio, Inc. in late 2025 involved significant equity issuance and warrant restructuring:

The proceeds from the October offering are specifically earmarked to support the upcoming Phase 2 clinical development program for PALI-2108. As of the October 17, 2025 record date, there were 148,964,572 shares of common stock outstanding. Institutional investors and hedge funds collectively held 11.79% of the company as of November 2025.

Palisade Bio, Inc. (PALI) - Canvas Business Model: Key Resources

You're looking at the core assets that Palisade Bio, Inc. (PALI) is counting on to drive value, especially after that big capital raise late last year. These aren't just line items; they are the engines for their next phase of clinical execution.

Lead Drug Candidate: PALI-2108

The primary asset is PALI-2108, which you know is their oral, gut-restricted phosphodiesterase-4 B/D (PDE4 B/D) inhibitor. This is designed specifically to target the terminal ileum and colon, positioning it as a first-in-class therapy for fibrostenotic Crohn's disease (FSCD) and ulcerative colitis (UC). As of late 2025, PALI-2108 was being evaluated in a Phase 1b/2a clinical trial. The potential market size in China alone for Inflammatory Bowel Disease (IBD) treatments is projected to approach $1 billion in total revenues by 2030.

Financial Capital

The balance sheet got a significant boost by the closing of an upsized underwritten public offering on October 2, 2025. This transaction generated gross proceeds of approximately $138 million, before deducting underwriting discounts and expenses. This capital raise, which involved the sale of 197,154,844 shares of common stock (or equivalents) at a price of $0.70 per share, is earmarked to support the upcoming Phase 2 clinical development program for PALI-2108 in Ulcerative Colitis. To give you a snapshot of the prior cash position, as of June 30, 2025, Palisade Bio, Inc. reported cash and cash equivalents of $14.1 million. For context on recent operational burn, the net loss for the third quarter ended September 30, 2025, was $2.87 million, leading to a trailing twelve-month net loss of $11.2 million ending the same date.

This financing definitely changes the near-term runway. Here's the quick math: that $138 million gross raise provides a substantial buffer against the recent quarterly losses.

Proprietary Technology and Intellectual Property

Palisade Bio, Inc. relies on its Proprietary Precision Delivery technology platform. This platform is what enables PALI-2108 to be a gut-restricted prodrug, activated by the colonic bacterium enzyme $\beta$-glucuronidase to facilitate colon-specific distribution while limiting systemic absorption. This mechanism is protected by a growing Global patent portfolio. Specifically, the company secured a Notice of Allowance from the China National Intellectual Property Administration for a composition of matter patent covering PALI-2108, which extends protection into 2045, subject to regulatory extension requirements.

Leadership Expertise

The execution of the clinical strategy hinges on Key scientific and clinical leadership expertise. This team is responsible for advancing PALI-2108 through its current Phase 1b/2a trial and preparing for the planned Phase II investigational new drug application submission to the US FDA in the first half of 2026. The company expects multiple clinical milestones and data readouts in the next 12-18 months following the financing.

• PALI-2108 development stage: Phase 1b/2a clinical trial.
• Planned FDA submission for Phase II: First half of 2026.
• China Patent Term (Base): Extends into 2045.
• Projected clinical milestones/data readouts: Next 12-18 months.

Finance: review the pro-forma cash runway post-October 2025 financing by next Tuesday.

Palisade Bio, Inc. (PALI) - Canvas Business Model: Value Propositions

You're looking at the core reason why Palisade Bio, Inc. (PALI) is pursuing this path, which really boils down to a differentiated approach for patients with serious gut inflammation. The value proposition centers entirely on PALI-2108, their lead candidate.

Novel, Gut-Restricted Therapy for Inflammatory Bowel Disease (IBD)

The main draw here is the precision. PALI-2108 is an orally administered prodrug engineered specifically for gut-restricted delivery of PDE4 B/D inhibition, targeting the terminal ileum and colon. It's designed to be activated only by bacterial enzymes once it reaches the lower intestine. This localized activation is key; it means the drug gets where it needs to go, which is a big step up from older systemic approaches. For context, the IBD market is a multi-billion-dollar opportunity, but current therapies often only achieve a clinical remission rate of less than 20% on average. Palisade Bio is betting that this targeted delivery will change that math.

Potential to Minimize Systemic Side Effects Versus Current Treatments

Because PALI-2108 is designed for local action, the goal is to maximize anti-inflammatory and anti-fibrotic effects while minimizing systemic exposure. This is how you address the class-related tolerability issues, like nausea and headache, that have historically limited systemic PDE4 inhibitors. The preclinical data supported this, showing a colon/plasma AUC ratio exceeding 200, which confirms its preference for the colon. The company's financial position, with a market capitalization of $265.97 million as of late 2025, is entirely dependent on proving this safety profile translates into the clinic, especially given the high cash burn-trailing 12-month earnings ending September 30, 2025, were -$11.2M.

Targeting High-Unmet-Need Conditions like Fibrostenotic Crohn's Disease (FSCD)

Palisade Bio isn't just aiming for general inflammation; they are specifically targeting fibrostenotic Crohn's Disease (FSCD). This is a critical distinction because PALI-2108 is positioned as the first dual-acting anti-inflammatory and anti-fibrotic candidate in development for FSCD, a condition that currently has no approved medical therapies. The Phase 1b FSCD study, which began dosing in the second half of 2025, is designed to enroll approximately 6 to 12 patients. Success here opens up a significant, unaddressed patient population.

Promising Early Data Showing a 100% Clinical Response in a UC Cohort

The clinical validation for the mechanism came from the Phase 1b Ulcerative Colitis (UC) cohort. While the study was short and not powered for efficacy, the signals were defintely strong. You need to see the numbers to appreciate the early activity:

These early clinical improvements were backed up by histology and biomarker changes, confirming local PDE4 engagement. The company is using this data, alongside the Phase 1a safety data from 84 healthy volunteers, to support their planned Phase 2 Investigational New Drug (IND) submissions to the FDA in the first half of 2026.

The value proposition is clear: a targeted, potentially safer, first-in-class therapy for severe IBD, supported by compelling, albeit early, human data. Finance: draft 13-week cash view by Friday.

Palisade Bio, Inc. (PALI) - Canvas Business Model: Customer Relationships

You're looking at how Palisade Bio, Inc. manages its crucial connections with the scientific community, investors, and ultimately, the patients their science aims to help. For a clinical-stage company, these relationships are the lifeblood, translating data into dollars and hope into trials.

High-touch, collaborative relationships with scientific partners are built on sharing early data and aligning on development pathways. The company's lead asset, PALI-2108, is being advanced through dual Phase 1b studies in Ulcerative Colitis (UC) and Fibrostenotic Crohn's Disease (FSCD). Scientific validation is key, evidenced by the abstract acceptance for poster presentation at the Crohn's & Colitis Congress held February 6-8, 2025. Furthermore, data on PALI-2108 was presented at Digestive Disease Week (DDW) 2025. This level of scientific engagement suggests close collaboration with the investigators running these trials and the academic bodies reviewing the science.

Direct engagement with key opinion leaders (KOLs) and clinical investigators is a deliberate strategy to build credibility for PALI-2108, which is a gut-restricted PDE4 inhibitor prodrug. Palisade Bio released a Virtual Investor KOL Connect segment on August 25, 2025, featuring Dr. Brian G. Feagan, MD, FRCPC. Dr. Feagan is a Professor of Medicine at Western University and Senior Scientific Director at Alimentiv, Inc.. To give you a sense of his standing, Dr. Feagan has directed more than 140 randomized controlled trials in Crohn's disease and ulcerative colitis. This direct outreach to a leading authority helps shape the perception of the drug's novel approach targeting both inflammation and fibrosis in FSCD.

Transparent investor relations through SEC filings and presentations is how Palisade Bio, Inc. keeps its financial customers informed. You can track their required disclosures, such as the Form 10-Q for the 2025 Q3 period, which was filed on November 10, 2025. The company actively engages the investment community, presenting at events like the Piper Sandler 37th Annual Healthcare Conference on December 4, 2025. Financially, the company reported raising $138 million from institutional healthcare investors to fund milestones. On September 24, 2025, the last reported sale price for common stock (PALI) was $0.68 per share. They also recently secured approximately $3.9 million in gross proceeds from an agreement to exercise existing warrants at a reduced price of $0.9047 per share. Analyst coverage is maintained by firms including Brookline Capital Markets, Ladenburg Thalman & Co. Inc., and Maxim Securities.

Patient-centric communication via clinical trial sites is grounded in the progress of PALI-2108. The UC cohort in the Phase 1b trial showed a 100% clinical response with no serious adverse events reported. The company announced dosing the first patients in the FSCD Phase 1b study on October 20, 2025. This trial is exploring safety, PK (pharmacokinetics), and PD (pharmacodynamics) endpoints. The company is currently conducting this Phase 1 clinical trial of PALI-2108 in Canada. The next major step for the UC indication is the expected start of Phase 2 in 2026.

Here's a quick look at the recent investor-facing structural changes and key personnel updates:

• Stockholders approved increasing authorized common shares from 280,000,000 to 300,000,000 on December 3, 2025.
• As of the October 17, 2025 record date, there were 148,964,572 shares of common stock outstanding.
• The company appointed James Izanec, MD, AGAF, as Vice President, Clinical Development on December 2, 2025.
• Sharon Skare was appointed Vice President, Global Head of Clinical Operations on October 28, 2025.

The relationship with the financial community is further detailed by the recent capital raise activity:

The clinical investigators and sites are directly engaged in the PALI-2108 program, which is described as the only PDE4 inhibitor prodrug in development for terminal ileum and colon.

• PALI-2108 is a locally-bioactivated PDE4 inhibitor prodrug.
• UC Phase 1b achieved 100% clinical response.
• FSCD Phase 1b study is ongoing, with first subject dosed expected in Q4 2025.
• Phase 2 IND clearance for UC is a key upcoming milestone for 2026.

Finance: review the impact of the December 3rd authorized share increase on the current share count for the next 10-Q filing due in February 2026.

Palisade Bio, Inc. (PALI) - Canvas Business Model: Channels

You're building a clinical-stage biopharma company, so your channels for data dissemination, site activation, and future commercial reach are critical. For Palisade Bio, Inc. (PALI) as of late 2025, these channels are heavily weighted toward the scientific and investment communities while clinical operations ramp up.

Clinical trial sites and contract research organizations (CROs)

Executing clinical development requires a network of external partners to manage the actual patient interactions. Palisade Bio, Inc. relies on outside consultants, Contract Research Organizations ('CROs'), clinical sites, contract manufacturing organizations ("CMOs") and research laboratories for its pre-clinical, process development, manufacturing, clinical development, and regulatory activities.

The company is actively managing multiple trials, which dictates channel activity:

• Phase 1b/2 Proof-of-Concept (POC) trial in Ulcerative Colitis (UC) patients was planned to initiate in the second half of 2025.
• An open-label Phase Ib study of PALI-2108 for fibrostenotic Crohn's disease (FSCD) received a no-objection letter from Health Canada, with subject dosing scheduled to commence in the latter half of 2025.
• One subject had completed the screening and dosing portion of the Phase 1b UC patient cohort study as of April 2025.

This clinical channel is the primary conduit for generating the safety, pharmacokinetic (PK), and pharmacodynamic (PD) data needed for the next stage of development.

Scientific publications and medical conferences (e.g., DDW 2025)

Presenting at key medical forums is how Palisade Bio, Inc. validates its science to peers and potential partners. The Digestive Disease Week (DDW) 2025 was a major channel for PALI-2108 data presentation, held May 3-6 in San Diego, California.

The specific engagements at DDW 2025 included:

Also, the company used investor conferences to communicate progress. Palisade Bio, Inc. leadership participated in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Thursday, December 4th at 10:30 AM ET.

Furthermore, clinical leadership brings established scientific channels. The newly appointed Vice President of Clinical Development, Dr. James Izanec, has authored over 100 peer-reviewed publications and abstracts and is a frequent invited speaker at global medical congresses including DDW, ECCO, ACG, and UEGW.

Investor relations platforms (NASDAQ, press releases, webcasts)

The primary channel for financial and corporate updates is the public market disclosure system. Palisade Bio, Inc. is listed on NASDAQ under the ticker PALI.

Key investor communication channels utilized in late 2025 include:

• Press Releases (GLOBE NEWSWIRE): Used for major announcements like leadership appointments (e.g., James Izanec on Dec 2, 2025) and clinical milestones (e.g., First Patients Dosed in FSCD study on Oct 20, 2025).
• SEC Filings: The source for official financial data, including 10-K and 10-Q reports. The 10-K for fiscal year ended December 31, 2024, was filed on March 24, 2025.
• Conference Webcasts: Live webcasts are used for investor conferences, such as the Piper Sandler event on December 4, 2025, at 10:30 AM ET.
• Financing Activities: Capital raising is a direct channel to investors, evidenced by the closing of an upsized $138 Million Public Offering on October 2, 2025.

Analyst coverage is another key channel, with firms like Brookline Capital Markets, Ladenburg Thalman & Co. Inc., and Maxim Securities following the stock as of mid-2025.

Future channel: Global pharmaceutical licensing partners for commercialization

While Palisade Bio, Inc. currently holds the rights to its pipeline, the ultimate commercialization channel will likely involve strategic partnerships. The company already has a foundational agreement in place that defines this future path.

This is established through the exclusive worldwide licensing agreement with Giiant Pharma, Inc., announced in September 2023, which grants Palisade the rights to develop, manufacture, and commercialize the proprietary targeted prodrug platform for all indications worldwide.

The structure of this existing agreement dictates the future licensing terms:

• Palisade assumes all development, manufacturing, and commercialization costs after the first IND or CTA approval.
• Palisade will pay Giiant royalty payments based on sales.
• Palisade will pay certain milestone payments (in cash or stock at Palisade's election).

The next major milestone that will inform future licensing discussions is the planned US Food and Drug Administration (FDA) Phase II Investigational New Drug (IND) submission, anticipated in the first half of 2026, following the completion of the FSCD trial.

Palisade Bio, Inc. (PALI) - Canvas Business Model: Customer Segments

You're looking at the core groups Palisade Bio, Inc. (PALI) targets to validate its science and fund its journey through clinical development. For a clinical-stage company like Palisade Bio, these segments are the lifeblood, driving both clinical proof and capital formation.

Patients with moderate-to-severe Ulcerative Colitis (UC)

This group represents the initial, most immediate patient population for PALI-2108, the company's lead candidate. The data from the early clinical work is what speaks loudest here, showing the potential for a differentiated, locally-acting therapy.

The Phase 1b Ulcerative Colitis (UC) cohort, though small, provided compelling early signals for PALI-2108:

• 5 patients were in the Phase 1b UC cohort.
• 100% clinical response rate was observed.
• 40% (or 2 out of 5) patients achieved remission after just seven days.
• The treatment resulted in a 62.8% mean reduction in modified Mayo score.
• Biomarker analysis showed an approximate 70% reduction in fecal calprotectin.

Palisade Bio is now advancing towards a Phase 2 clinical study in UC designed to evaluate clinical remission and response over 12 weeks.

Patients with Fibrostenotic Crohn's Disease (FSCD)

This segment is critical because it addresses a significant unmet need-a condition where few non-surgical options exist. PALI-2108's potential anti-fibrotic activity, suggested by biomarker data from the UC study, makes this a high-value target segment.

Here's what the timeline shows for this patient group:

• PALI-2108 is being developed for FSCD, a condition with no current approved medical therapies.
• The Phase 1b exploratory study for FSCD was designed to enroll approximately 6 to 12 patients.
• Patient dosing for the Phase 1b FSCD study was planned to begin in the second half of 2025 (2H 2025).
• Topline data for the FSCD study is anticipated in the first quarter of 2026 (Q1 2026).

The company is using data from both UC and FSCD studies to inform its planned Phase 2 IND submissions, anticipated in the first half of 2026 (1H 2026).

Biopharmaceutical companies seeking to license late-stage assets

While Palisade Bio, Inc. is currently focused on advancing PALI-2108 internally, the successful navigation of clinical milestones positions the company as a potential partner or acquisition target. The interest from the investment community underscores the perceived value of their late-stage asset.

The financial validation from the October 2025 offering suggests external confidence in the asset's progression:

These capital events are directly tied to the perceived value of PALI-2108 progressing toward Phase 2, which is a key inflection point for potential licensing discussions.

Institutional and retail investors funding clinical development

This segment provides the necessary runway for Palisade Bio, Inc. to execute its development plan. The company relies on capital markets to bridge the gap between research and potential commercialization, especially given its current operating losses.

The investor base and recent capital activity are concrete metrics for this segment:

• Palisade Bio has total 3 institutional investors, including the HHS, which made its first investment in 2017.
• The October 2025 public offering was led by B Group Capital and Columbia Threadneedle Investments, with participation from firms like Adage Capital Partners LP and Perceptive Advisors.
• The offering price for the October 2025 raise was $0.70 per share.
• For the trailing 12 months ending September 30, 2025, the company reported earnings of -$11.2 million.
• The net loss for Q3 2025 was $2.86 million, an improvement from $3.48 million in Q3 2024.

Individual investors were noted as the biggest owners after a market cap rise in November 2025. Honestly, for a company burning cash, the confidence shown by institutional participation in a $138 million raise is a major vote of confidence in the management's strategy.

Palisade Bio, Inc. (PALI) - Canvas Business Model: Cost Structure

You're looking at the cost side of Palisade Bio, Inc. (PALI) as they push PALI-2108 through critical clinical stages. Honestly, for a company like this, the cost structure is almost entirely dictated by the science and the regulatory hurdles ahead.

The business is heavily driven by Research and Development (R&D) expenses. This is where the bulk of your cash burn is going, funding the science that might become a future revenue stream. To give you a sense of scale, R&D expenses for the full year ending December 31, 2024, were $9,063 thousand. Then, looking at the most recent quarter, Q3 2025 R&D spend was $1.39 million, which was actually a decrease from $2.13 million in Q3 2024, reflecting a shift in focus from earlier preclinical work to active clinical trials.

The next big ticket item is the significant clinical trial costs for PALI-2108 Phase 2. You can see the capital need directly reflected in their financing activities. Palisade Bio closed a public offering in October 2025, bringing in approximately $138 million in gross proceeds, with the explicit goal of funding the Phase 2 clinical development of PALI-2108 for Ulcerative Colitis. Plus, earlier in 2025, they received CAD$1.39 million in non-dilutive funding from Canada's SR&ED program to reimburse prior pre-clinical costs for the same candidate. These are the direct costs of proving the drug works safely in humans.

Then there's the General and Administrative (G&A) overhead you have to cover just to keep the lights on and the lawyers busy. For the year ended December 31, 2024, Sales, General and Admin expenses totaled $5,796 thousand. In Q3 2025, the narrative noted that G&A saw a minor increase due to rising employee-related costs and, definitely, high legal fees, which is standard when managing clinical programs and corporate financing activities.

You also have to account for licensing fees and intellectual property maintenance costs. While I don't have the exact 2025 figures for IP maintenance, the structure relies on maintaining exclusivity for PALI-2108, which involves ongoing legal and filing expenses to protect those assets. Remember, they have a co-development agreement with Giiant Pharma, Inc., which implies ongoing contractual obligations that factor into the cost base.

All these expenditures lead to the bottom line. The forecasted 2025 net loss is around -$158.6 million, based on the average analyst consensus estimate of -$158,569,216 for the full year. That number is the net result of zero expected revenue and the heavy operational spending detailed above.

Here's a quick look at some of those key cost components:

The main cost drivers you need to track are:

• Funding the PALI-2108 Phase 2 clinical program.
• Managing G&A, especially legal and employee-related costs.
• Maintaining the intellectual property estate.
• Covering ongoing operational burn rate until potential financing events.

Finance: draft 13-week cash view by Friday.

Palisade Bio, Inc. (PALI) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Palisade Bio, Inc. (PALI) as of late 2025. For a clinical-stage company like this, revenue streams are often less about selling products and more about fueling the clinical engine through capital markets and strategic non-dilutive sources. Honestly, the current picture is entirely focused on financing the development of PALI-2108.

The forecast for the current fiscal year is clear: $0 in product revenue is projected for the 2025 fiscal year. On average, 5 Wall Street analysts forecast PALI's revenue for 2025 to be $0. This is typical for a company deep in clinical trials, where the focus is on data milestones, not sales.

The primary stream keeping the lights on and funding the Phase 2 program is equity financing. This is where you see the big, lumpy cash infusions. Most recently, Palisade Bio, Inc. closed an upsized underwritten public offering in October 2025, raising approximately $138 million in gross proceeds before fees, which included the full exercise of the underwriter's over-allotment option. This financing validates the science, but it definitely dilutes existing shareholders.

Here's a quick look at the major capital raises identified through late 2025 filings:

Also contributing to the cash runway is non-dilutive funding. This is the good stuff because it doesn't require selling more shares. Palisade Bio, Inc. secured a notable amount from Canadian tax incentives related to prior work on PALI-2108.

These non-dilutive sources include:

• Receipt of CAD$1.39 million in Scientific Research and Experimental Development (SR&ED) tax credits from Canada in February 2025.
• Reimbursement for prior pre-clinical costs associated with PALI-2108 incurred under the joint development plan with Giiant Pharma, Inc.

The future potential revenue streams are tied directly to the success of PALI-2108 in the clinic. If the drug candidate proves effective in its ongoing Phase 1b and upcoming Phase 2 studies for Ulcerative Colitis and Fibrostenotic Crohn's Disease, the company will look to strategic out-licensing partnerships. These deals are structured to bring in immediate, non-dilutive cash via upfront payments, followed by potential milestone payments upon hitting specific clinical or regulatory achievements, plus eventual royalties on future net sales. Right now, those are just potential figures on a term sheet, but they represent the next logical step in the revenue model post-Phase 2 data.

Finance: draft 13-week cash view by Friday.