Chemomab Therapeutics Ltd. (CMMB): 5 FORCES Analysis [Nov-2025 Updated]

As a seasoned analyst, I see Chemomab Therapeutics Ltd. at a pivotal moment: its first-in-class drug, nebokitug, has the regulatory green light for a single Phase 3 trial in Primary Sclerosing Cholangitis (PSC), a huge win against the Threat of Substitutes and Competitive Rivalry in that rare disease space. But here's the reality check for late 2025: this nano-cap firm, valued around $14.9 million as of November, has an uphill battle against its Bargaining Power of Suppliers and its urgent need to secure a partner to fund that trial, despite having cash runway through the end of Q4 2026 and only reporting $1 million in R&D expenses in Q3 2025. Dive in to see how these five forces define the path for this rare disease asset.

Chemomab Therapeutics Ltd. (CMMB) - Porter's Five Forces: Bargaining power of suppliers

You're a seasoned analyst looking at Chemomab Therapeutics Ltd. (CMMB), a clinical-stage biotech firm, and the supplier landscape is definitely a key risk area. For a company developing a monoclonal antibody like nebokitug (CM-101), the power held by specialized external partners is substantial, directly impacting timelines and burn rate.

The bargaining power of suppliers for Chemomab Therapeutics Ltd. is assessed as High. This stems from the highly specialized, capital-intensive nature of biopharmaceutical development and manufacturing, where the company has outsourced nearly all critical operational components.

The reliance on specialized Contract Manufacturing Organizations (CMOs) for monoclonal antibody production is absolute for a company of this scale. Manufacturing a biologic requires validated, Good Manufacturing Practice (GMP) compliant facilities, which Chemomab Therapeutics Ltd. does not own. This means the few qualified CMOs capable of handling complex monoclonal antibody production hold significant leverage over scheduling and per-batch costs.

Similarly, as a clinical-stage company advancing its lead candidate, CM-101, through late-stage development-currently advancing three Phase 2 clinical trials in parallel and preparing for a potential Phase 3 trial in Primary Sclerosing Cholangitis (PSC)-the dependence on Contract Research Organizations (CROs) is total for trial execution. CROs that specialize in running complex, multi-site, orphan-disease trials dictate terms, especially when securing slots for large-scale Phase 3 work.

The company's small size further erodes its ability to command favorable terms. As of late 2025, Chemomab Therapeutics Ltd. has a market capitalization hovering around $14.1M to $15.63M. This Nano-Cap status means it lacks the volume commitment to negotiate aggressively with multi-billion dollar CROs or CMOs, who prioritize larger, more stable clients.

The supply chain for raw materials necessary for biologics production also presents concentrated risk. Unlike small molecule synthesis, biologics rely on living cells and complex media components, increasing vulnerability to variability and contamination.

Here is a breakdown of the key supplier categories and their associated power dynamics:

The leverage held by raw material suppliers is amplified by the inherent complexity and regulatory scrutiny in this sector. Regulators emphasize stringent supplier qualification and raw material control within GMP frameworks. This necessity limits the pool of acceptable vendors, even for basic inputs.

Specific risks associated with raw material suppliers include:

• Limited manufacturers for key components create supply chain vulnerabilities.
• Need for rigorous testing of each component to manage quality attributes (CQAs).
• Risk of contamination from animal-derived components if used in cell culture media.
• Requirement for comprehensive risk assessments covering bioburden and change management systems.

To mitigate this, Chemomab Therapeutics Ltd. must focus on robust supplier evaluation and change control protocols, which is tough when you only have a market cap of about $14.1M. Finance: draft a risk mitigation budget for dual-sourcing critical raw materials by next Wednesday.

Chemomab Therapeutics Ltd. (CMMB) - Porter's Five Forces: Bargaining power of customers

The bargaining power of customers for Chemomab Therapeutics Ltd. (CMMB) is a dynamic tension between the high unmet need in their target indications and the payers' inherent drive to control spending on high-cost specialty medicines.

Target indications (PSC, SSc) are rare diseases, reducing customer price sensitivity post-approval.

Targeting Primary Sclerosing Cholangitis (PSC) and Systemic Sclerosis (SSc) places Chemomab Therapeutics Ltd. (CMMB) squarely in the orphan drug space, which generally translates to lower volume but higher price tolerance from the ultimate end-users-the patients.

• The Rare Disease Treatment Market size is projected to be USD 242.50 billion in 2025.
• Biologics, the class nebokitug belongs to, accounted for 51.23% of the rare disease market size in 2024.
• The Systemic Sclerosis Treatment Market alone is valued at USD 1,164.2 Million in 2025.
• Treatments for rare diseases represented 72% of new drug launches in 2024.

Customers (payers/insurers) will still exert high pressure due to the high cost of specialty biologics.

Payers, the direct customers for reimbursement decisions, face escalating costs across the board, meaning any new specialty biologic from Chemomab Therapeutics Ltd. (CMMB) will face intense scrutiny, regardless of the indication's rarity. You know this pressure well; it's the same battle every specialty pharma company fights.

Here's the quick math on the cost environment you are entering:

Still, payers have mechanisms to push back, demanding evidence that justifies the price tag, especially for a first-in-class drug.

Prescribing physicians have limited alternatives, as PSC has no FDA-approved therapies.

This is where Chemomab Therapeutics Ltd. (CMMB) gains significant leverage. For PSC, the lack of an approved disease-modifying therapy means physicians are currently forced to manage symptoms or use off-label treatments, giving nebokitug a strong position if approved.

• Chemomab Therapeutics Ltd. (CMMB)'s nebokitug is positioned to potentially become the first FDA-approved PSC treatment.
• The FDA and EMA have backed a single Phase 3 registration trial using a composite clinical event endpoint, streamlining the path to approval.

When a drug is the first to address a critical, unaddressed clinical need, the prescribing physician's power to recommend it is high, which shifts some leverage back toward the manufacturer against the payer.

Payers will demand strong health economic data to justify the price of a first-in-class drug.

Because nebokitug is poised to be a first-in-class therapy, payers will not rely on comparative effectiveness data against existing treatments; instead, they will focus heavily on the absolute value proposition.

They will require robust data demonstrating that the long-term cost of managing untreated or sub-optimally treated PSC-including liver transplants or other complications-is significantly higher than the acquisition cost of nebokitug. The Institute for Clinical and Economic Review (ICER) benchmarks for high-value treatments often exceed $1 million for one-time therapies, setting a high, though not absolute, bar for justification. Chemomab Therapeutics Ltd. (CMMB) must deliver clear, compelling health economic outcomes research (HEOR) data to secure favorable formulary placement and avoid restrictive utilization management tools from payers.

Finance: draft the initial budget impact model for nebokitug launch scenarios by next Wednesday.

Chemomab Therapeutics Ltd. (CMMB) - Porter's Five Forces: Competitive rivalry

You're assessing Chemomab Therapeutics Ltd.'s position in the Primary Sclerosing Cholangitis (PSC) market as of late 2025. The competitive rivalry here is unique because, frankly, there are no approved disease-modifying treatments yet, which is a massive opportunity.

Low rivalry exists in the approved product space because nebokitug is positioned to be the first FDA-approved therapy for PSC, assuming the upcoming Phase 3 trial is successful. Chemomab Therapeutics Ltd. has secured alignment with both the FDA and EMA that a single Phase 3 registration trial, using a composite clinical event endpoint, could support full regulatory approval. This regulatory clarity, along with nebokitug's FDA Fast Track designation, significantly derisks the final development hurdle relative to competitors who might face longer pathways.

Rivalry is currently focused on companies whose products are still in clinical trials, not on the market. This means competition is about execution, data readout, and securing capital to cross the finish line first. For instance, Dr. Falk Pharma reported that its norucholic acid (NCA) achieved statistically significant improvements over placebo in its pivotal Phase III NUC-5 trial. Also, Pliant Therapeutics, Inc. has PLN-74809 (bexotegrast), which has already reported Phase 2a data.

Still, the competition isn't just PSC-specific. Competition exists in the broader fibro-inflammatory space, which can divert R&D talent and investment dollars toward other indications or diseases. Chemomab Therapeutics Ltd. itself has an open U.S. Investigational New Drug (IND) for nebokitug in systemic sclerosis, showing this broader focus.

The need for external validation and funding to launch the final trial is clear, which directly impacts competitive positioning. Chemomab Therapeutics Ltd. is actively seeking a strategic partner for the Phase 3 program. As of September 30, 2025, the company held $10.2 million in cash, cash equivalents, and short-term deposits, with a runway expected through the end of the fourth quarter of 2026. This level of liquidity requires a partner to fully fund and execute a global Phase 3 study efficiently against well-capitalized rivals. Their Research and Development (R&D) expenses were approximately $1 million in the third quarter of 2025.

Here's a look at where the PSC pipeline stands in late 2025, showing the active competitive front:

The race is on to translate clinical promise into regulatory approval. Chemomab Therapeutics Ltd. has the regulatory clarity advantage, but the need for a partner to fund the final leg is a near-term operational focus.

• Nebokitug has FDA Fast Track designation for PSC.
• PSC affects an estimated 30,000 patients in the U.S..
• The company's Q3 2025 net loss was $1.74 million.
• Discussions with potential strategic collaborators are advancing.
• Other pipeline candidates include PLN-74809 and Volixibat.

Finance: finalize the strategic partner outreach list by next Wednesday.

Chemomab Therapeutics Ltd. (CMMB) - Porter's Five Forces: Threat of substitutes

You're analyzing the competitive landscape for Chemomab Therapeutics Ltd. (CMMB) as of late 2025, and the threat of substitutes is a critical area to watch, especially given the unmet need in their target indications.

For Primary Sclerosing Cholangitis (PSC), the threat from the standard of care is high because there are currently no FDA-approved disease-modifying treatments, meaning the default options are procedures or off-label use. Liver transplantation (LT) remains the ultimate procedure for end-stage disease. Data from a Mayo Clinic cohort showed that the 1-, 5-, 10-, and 15-year cumulative incidence of recurrent PSC after LT was 1.0%, 8.0%, 23.5%, and 34.3%, respectively. Furthermore, recurrence (REC) of PSC after a first transplant occurs in up to 20% of LT recipients within 5 years.

Regarding nebokitug, which blocks the activity of the protein CCL24, you should note that as of late 2025, no direct drug substitutes targeting this specific mechanism are on the market. This unique mechanism gives nebokitug a potential first-in-class advantage, assuming Phase 3 success. Chemomab Therapeutics Ltd. has received FDA and EMA Orphan Drug designations for nebokitug for PSC.

Still, the pipeline competition is real. Other late-stage investigational drugs in PSC could launch near or before nebokitug's potential Phase 3 readout and subsequent approval. For instance, Volixibat's Phase 2b VISTAS trial enrolled 182 participants, with top-line results anticipated between April and June 2026. Also, Norucholic acid (NCA) reported statistically significant improvements over placebo in its Phase III NUC-5 trial (NCT03872921).

For Systemic Sclerosis (SSc), established immunosuppressants and antifibrotics serve as current, albeit inadequate, substitutes. For SSc-ILD, Cyclophosphamide (CYC) showed a modest but statistically significant benefit in FVC of a mean difference of 2.53% at 12 months in the Scleroderma Lung Study I. Antifibrotic agents like Nintedanib and Pirfenidone, initially approved for Idiopathic Pulmonary Fibrosis (IPF), validate the concept of directly targeting fibrogenic signaling cascades. The Global Antifibrotic Drug Market size was estimated at USD 2.15 billion in 2025. The SSc drug market is moderately concentrated, with major players including Allergan Plc, Bayer AG, Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company, and F. Hoffmann-La Roche Ltd..

Here is a quick comparison of the competitive landscape for PSC:

The key substitutes and competitive factors for Chemomab Therapeutics Ltd. are:

• Liver transplant is the end-stage procedure for PSC.
• Recurrent PSC after transplant is a known risk, occurring in up to 20% within 5 years.
• Established immunosuppressants like CYC showed a 2.53% FVC benefit at 12 months in SSc-ILD.
• The antifibrotic market was valued at USD 2.15 billion in 2025.
• Multiple late-stage PSC candidates, like Volixibat (Phase 2b) and NCA (Phase III complete), pose a near-term threat.

Chemomab Therapeutics Ltd. (CMMB) - Porter's Five Forces: Threat of new entrants

You're assessing the barriers for a new player to jump into the primary sclerosing cholangitis (PSC) space against Chemomab Therapeutics Ltd. Honestly, the deck is stacked against them right out of the gate because of the sheer scale of investment required for drug development.

The extreme capital requirements for biotech R&D form a high wall. For Chemomab Therapeutics Ltd., Research and Development (R&D) expenses were only $1 million in Q3 2025, down from $2.8 million in Q3 2024, largely due to the completion of Phase 2 activities. Still, getting a novel biologic like nebokitug to this stage costs serious money, and new entrants face that initial burn rate without any established pipeline or cash flow.

Here's a quick look at Chemomab Therapeutics Ltd.'s recent financial footing, which shows the kind of capital base a new entrant would need to match or surpass to compete effectively:

What this estimate hides is the massive, multi-year investment needed before reaching this late-stage clinical point. If onboarding takes 14+ days, churn risk rises, but for a new entrant, the risk is simply not securing enough capital to even start the race.

Significant regulatory hurdles are also firmly in place, which acts as a major deterrent. Chemomab Therapeutics Ltd. has successfully navigated early discussions, achieving alignment with both the FDA and the EMA on a single Phase 3 registration trial design for nebokitug. This streamlined path is itself a hard-won advantage. The planned pivotal trial is set to enroll approximately 350 PSC patients.

The regulatory advantages Chemomab Therapeutics Ltd. currently holds provide a temporary shield against immediate competition:

• FDA and EMA Orphan Drug designations secured for nebokitug in PSC.
• FDA Fast Track designation granted for nebokitug in PSC.
• Single Phase 3 trial design agreed upon by FDA and EMA.
• Primary endpoint focuses on clinically relevant events, avoiding liver biopsies.

Finally, developing a first-in-class monoclonal antibody demands specialized, proprietary intellectual property and manufacturing expertise that new firms simply do not possess. Nebokitug is defined as a first-in-class dual activity monoclonal antibody that neutralizes CCL24. This unique mechanism of action, targeting both inflammatory and fibrotic pathways, is protected by a growing portfolio of patents. Chemomab Therapeutics Ltd. has reported patent protections in the U.S., Europe, and Japan, and recently added coverage in Russia and China for the use of nebokitug in liver diseases. That IP moat is deep.

Finance: draft 13-week cash view by Friday.