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

You're looking at Chemomab Therapeutics Ltd. (CMMB) and wondering if their regulatory wins translate into investment security. Honestly, the PESTLE analysis for 2025 shows a high-stakes pivot: they've successfully aligned with the FDA and EMA for a single, global Phase 3 trial for nebokitug, defintely de-risking the clinical path for Primary Sclerosing Cholangitis (PSC). But here's the rub-while R&D expenses dropped, the company's cash, equivalents, and short-term deposits stood at only $10.2 million as of September 30, 2025, meaning the entire financial future hinges on securing a strategic partnership to fund that expensive Phase 3 launch. Let's break down the political tailwinds, the economic headwind, and the technological edge that defines this moment.

Chemomab Therapeutics Ltd. (CMMB) - PESTLE Analysis: Political factors

The political and regulatory landscape for Chemomab Therapeutics Ltd. (CMMB) is defintely a significant driver of its near-term valuation. The most critical factor is the strong regulatory alignment in major markets, which creates a streamlined, lower-risk path to market for its lead candidate, nebokitug (CM-101). But, you also have to be a realist: the company's base in Israel introduces a material, unquantifiable geopolitical risk that is explicitly called out in their filings.

Favorable US regulatory alignment on a single Phase 3 trial for nebokitug

The political risk tied to the US Food and Drug Administration (FDA) is largely mitigated by the clarity Chemomab Therapeutics Ltd. has established for nebokitug's Phase 3 program in Primary Sclerosing Cholangitis (PSC). Following the successful End-of-Phase 2 (EOP2) meeting in February 2025, the company secured FDA agreement on a crucial point: a single pivotal Phase 3 registration study will be sufficient to support a future Biologics Licensing Application (BLA) for approval. This is a huge win because it cuts down on the time and capital typically required for two separate pivotal trials.

In June 2025, the FDA provided further flexibility. They agreed that the additional, mandatory animal toxicology testing (non-clinical fetal and embryo developmental studies) can be conducted in parallel with the Phase 3 clinical trial, which supports the timely advancement of the program. This regulatory efficiency is a direct positive political factor, speeding up the development timeline and reducing the overall cost to market.

Nebokitug holds FDA Fast Track and Orphan Drug designations for Primary Sclerosing Cholangitis (PSC)

The regulatory system has already signaled its support for nebokitug through two key designations. The FDA granted nebokitug both Fast Track and Orphan Drug status for the treatment of PSC in adults.

• Fast Track: This designation is for drugs that treat serious conditions and fill an unmet medical need, providing the benefit of more frequent FDA communication and potential for Accelerated Approval or Priority Review.
• Orphan Drug: This is for drugs targeting rare diseases, which in the U.S. means a condition affecting fewer than 200,000 people. PSC affects an estimated 30,000 patients in the U.S. and about 80,000 worldwide. This status grants Chemomab Therapeutics Ltd. seven years of market exclusivity in the U.S. post-approval, a major commercial advantage.

Alignment with the European Medicines Agency (EMA) supports a single global Phase 3 study

Regulatory alignment extends beyond the U.S., which is essential for a global biotech. In their November 20, 2025, Q3 financial update, Chemomab Therapeutics Ltd. confirmed they have received guidance from the European Medicines Agency (EMA) supporting the use of a single Phase 3 registration trial with a composite clinical event endpoint. This alignment with both the FDA and EMA means the company can run one global pivotal trial, which is highly cost-effective and accelerates the path to potential approval in both the U.S. and Europe.

Here's the quick math on the regulatory pathway:

This streamlined approach means less spending on trial duplication. For context, Chemomab Therapeutics Ltd.'s cash, cash equivalents, and short-term deposits were $10.2 million as of September 30, 2025, which is expected to fund operations through the end of the fourth quarter of 2026.

Operational risk from the current war in Israel, where the company is based, is a stated risk factor

The primary political risk for Chemomab Therapeutics Ltd. is geopolitical, stemming from its headquarters in Tel Aviv, Israel. The company is a clinical-stage biotechnology firm, and its financial filings, including the Q3 2025 report, explicitly list the intensity and duration of the current war in Israel, and its impact on our operations in Israel as a material risk factor. While the company has not reported a direct halt to operations, the ongoing conflict creates uncertainty for investors and partners.

This risk is mostly operational and strategic, not regulatory. The risk is that business or economic disruptions due to the conflict could affect personnel, supply chains, or the ability to conduct necessary administrative functions. While the net loss for Q3 2025 was reduced to $1.7 million from $3.5 million in Q3 2024, the geopolitical instability remains an external factor that is beyond management's control and could impact their ability to secure the strategic partner they are seeking to launch the Phase 3 trial.

Chemomab Therapeutics Ltd. (CMMB) - PESTLE Analysis: Economic factors

Cash, equivalents, and short-term deposits totaled $10.2 million as of September 30, 2025.

You're looking at Chemomab Therapeutics Ltd. (CMMB) and trying to gauge its financial staying power in a tough biotech market. The core economic reality for CMMB right now is a tight cash position coupled with a crucial need for external funding to advance its lead drug candidate. As of September 30, 2025, Chemomab Therapeutics Ltd. held $10.2 million in cash, equivalents, and short-term deposits. This is the defintely critical number you need to anchor your near-term valuation on. For a clinical-stage biotech, that cash balance is the lifeline, and it directly dictates the company's negotiating leverage for partnerships or future financing rounds.

Existing liquidity is projected to fund operations through the end of Q4 2026.

Based on their current burn rate, the company projects its existing liquidity will fund operations through the end of the fourth quarter of 2026. That gives Chemomab Therapeutics Ltd. approximately a 15-month runway from the Q3 2025 reporting date. This is a decent projection for a pre-revenue company, but it means the clock is ticking to secure a major partnership or additional capital before that deadline. The market will start pricing in dilution risk as that Q4 2026 date approaches.

Q3 2025 Research and Development (R&D) expenses dropped to approximately $1 million from $2.8 million in Q3 2024.

The company has shown a clear focus on cost control, which is smart. Research and Development (R&D) expenses for Q3 2025 dropped significantly to approximately $1 million, down from $2.8 million in Q3 2024. Here's the quick math: that's a reduction of roughly 64% year-over-year. This sharp reduction is the primary driver behind the extended cash runway, but it also signals a pause or slowdown in certain clinical activities, pending external financing for the larger trials.

Wall Street analysts forecast $0 in revenue for the full fiscal year 2025.

As a pre-commercial entity, Chemomab Therapeutics Ltd. has no product revenue. Wall Street analysts forecast $0 in revenue for the full fiscal year 2025, which is standard for a company focused solely on clinical development. This zero-revenue reality emphasizes the binary nature of the company's economic outlook: success hinges entirely on clinical trial results and subsequent partnership deals, not on commercial sales in the near term.

The company is actively pursuing multiple strategic partnerships to finance the expensive Phase 3 program.

The biggest economic hurdle is financing the expensive Phase 3 program-the final stage of clinical testing before regulatory submission. Management is actively pursuing multiple strategic partnerships, which is the most capital-efficient path. A successful partnership, likely with a large pharmaceutical company, would not only provide a significant upfront cash payment but also validate the science and share the enormous cost of a pivotal trial. This is their primary path to avoid a highly dilutive equity raise.

The company's financial health is best summarized by the following operational metrics:

The immediate economic action items for Chemomab Therapeutics Ltd. are clear:

• Secure a strategic partner: Offload Phase 3 costs.
• Maintain R&D discipline: Keep the cash runway beyond 2026.
• Manage investor expectations: Communicate progress on clinical milestones.

Chemomab Therapeutics Ltd. (CMMB) - PESTLE Analysis: Social factors

Focus on Primary Sclerosing Cholangitis (PSC), a disease with a high unmet medical need and no approved treatments

The core social factor driving Chemomab Therapeutics Ltd.'s value proposition is the profound, unaddressed need in Primary Sclerosing Cholangitis (PSC). This is a rare, chronic, and progressive liver disease that causes inflammation and scarring (fibrosis) of the bile ducts, ultimately leading to liver failure. Crucially, as of 2025, there is no medical therapy approved by the FDA or EMA that has been shown to improve transplant-free survival for PSC patients. The current standard of care is managing symptoms and complications, with the definitive treatment being liver transplantation, a procedure that costs over $577,000 in the U.S. and carries a recurrence risk of up to 38%. This high cost and lack of a disease-modifying drug creates enormous social pressure for a breakthrough therapy.

Positive Phase 2 data presented at major conferences like AASLD 2025 increases awareness among key opinion leaders (KOLs) and patient advocacy groups

Recent clinical milestones have significantly amplified the social awareness and credibility of nebokitug (the company's lead candidate). At the American Association for the Study of Liver Disease (AASLD) The Liver Meeting® in November 2025, Chemomab Therapeutics presented new clinical data from the nebokitug Phase 2 SPRING trial's Open Label Extension (OLE). These presentations, all designated as 'posters of distinction,' highlighted favorable safety and consistent improvements in key inflammatory and fibrotic biomarkers for up to 48 weeks of treatment. The CEO noted that the PSC community, including Key Opinion Leaders (KOLs), global clinical centers, and patient advocates, voiced support for the nebokitug Phase 3 design at the conference. This public endorsement from the medical and patient community is defintely a powerful social tailwind.

Potential for nebokitug to be a first-in-class therapy drives high social and patient interest

The prospect of nebokitug being a first-in-class therapy-a monoclonal antibody that neutralizes the soluble protein CCL24-is the main driver of patient and advocacy interest. This dual anti-inflammatory and anti-fibrotic mechanism positions it as a potential disease-modifying agent, which is a massive step beyond the current symptom-management approach. The global Primary Sclerosing Cholangitis market is estimated to be valued at $174.9 million in 2025 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 7.6% through 2035, underscoring the commercial opportunity tied directly to this high social need. The company estimates the commercial opportunity for nebokitug in PSC alone to be over $1 billion, a figure that reflects the high value placed on solving this critical unmet need.

Here's the quick math on the market size and the severity of the disease:

PSC and Systemic Sclerosis are severe, life-threatening fibro-inflammatory diseases, underscoring the social value of a successful treatment

The social value of Chemomab Therapeutics' work extends beyond PSC to Systemic Sclerosis (SSc), another severe and life-threatening fibro-inflammatory disease with no approved disease-modifying therapies. SSc is considered the most lethal of the systemic connective tissue diseases. Nebokitug has received FDA and EMA Orphan Drug designations for both PSC and SSc, plus FDA Fast Track status for PSC, indicating a high regulatory recognition of the diseases' severity and the urgent need for new treatments. This focus on rare, debilitating, and lethal diseases with a large commercial opportunity (SSc is estimated at over $1.5 billion potential) aligns the company's financial success directly with a major positive social outcome. The company's Research and Development (R&D) expenses were approximately $1 million in the third quarter of 2025, a focused investment aimed at addressing these critical public health issues.

Key social and patient interest factors include:

• Nebokitug is a first-in-class monoclonal antibody.
• It targets the dual mechanisms of inflammation and fibrosis.
• The drug has Orphan Drug and Fast Track status for PSC.
• PSC is a leading cause of liver transplantation in the U.S.

Chemomab Therapeutics Ltd. (CMMB) - PESTLE Analysis: Technological factors

You are looking at Chemomab Therapeutics Ltd. (CMMB) at a pivotal moment, where its core technology is moving from clinical proof-of-concept (POC) to a streamlined, de-risked Phase 3. The strength of the company's technological platform-its first-in-class drug-is the single biggest driver of its valuation right now. Simply put, the data from 2025 shows a clear, actionable path to market for a drug addressing a disease with zero approved therapies, which is a massive technological advantage.

Lead candidate, nebokitug, is a first-in-class monoclonal antibody targeting the soluble protein CCL24.

The entire technological thesis for Chemomab rests on nebokitug (CM-101), a first-in-class monoclonal antibody (mAb) that neutralizes the soluble protein CCL24 (also known as eotaxin-2). This is a smart, targeted approach because CCL24 is a key chemokine that drives both inflammation and fibrosis, which are the dual engines of progressive diseases like Primary Sclerosing Cholangitis (PSC). Targeting this specific protein is what gives the drug its 'dual activity' potential-it's not just an anti-inflammatory, but a potential anti-fibrotic as well. This is a crucial distinction in the biotech space.

Phase 2 data (up to 48 weeks) showed consistent improvements in inflammatory and fibrotic biomarkers.

The Phase 2 SPRING trial's Open Label Extension (OLE) data, reported in March 2025, provided the necessary technological validation to move forward. Patients with moderate/advanced PSC treated with nebokitug for up to 48 weeks showed sustained and consistent improvements across multiple key biomarkers. The fact that over 90% of eligible patients chose to continue into the OLE portion of the study also speaks volumes about the drug's tolerability and perceived benefit.

Here's the quick math on the key technical metrics:

• ELF Score: Continued reduction in the Enhanced Liver Fibrosis (ELF) score, a composite marker of liver stiffness and fibrosis.
• PRO-C3: Improvement in the fibrosis biomarker PRO-C3, which is directly related to the formation of new scar tissue.
• Liver Stiffness: Substantially lower liver stiffness scores (measured by FibroScan®) in treated patients with moderate/advanced disease compared to matching historical controls.

Regulatory agreement on using a composite clinical event endpoint simplifies the Phase 3 trial design.

This is a major technological and regulatory de-risking event that happened in early 2025. Chemomab successfully completed its End-of-Phase 2 meeting with the FDA and received alignment from both the FDA and the European Medicines Agency (EMA) that a single pivotal Phase 3 registration trial will be sufficient for potential approval. This is a huge win for speed and capital efficiency. The key technological decision here was agreeing to use a composite clinical event endpoint-a combination of clinically relevant outcomes-as the primary measure, rather than requiring invasive liver biopsies. This streamlined design is expected to enroll around 350 PSC patients.

Mechanistic data presented at AASLD 2025 confirms the drug's direct macrophage-mediated action.

The most recent technological validation came on November 10, 2025, at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting®, where new mechanistic data was presented. This data wasn't just about patient outcomes; it was about proving how the drug works, which is critical for long-term commercial credibility and further research. The analysis showed nebokitug's direct macrophage-mediated action.

The data confirmed two things about the drug's mechanism of action (MOA):

• Dose-dependent reductions in serum macrophage-related proteins were observed, particularly in patients receiving the 20 mg/kg dose.
• Changes in these biomarkers were directly correlated with improvements in the ELF score and liver stiffness measurements, definitively linking the drug's MOA to clinical benefit.

This is defintely the kind of data that attracts a strategic partner, as it solidifies the drug's unique position as a disease-modifying therapy for PSC. The company is actively pursuing these partnerships to fund the Phase 3 trial, with existing cash of $10.2 million as of September 30, 2025, expected to fund operations through the end of the fourth quarter of 2026.

Chemomab Therapeutics Ltd. (CMMB) - PESTLE Analysis: Legal factors

For a biotech firm like Chemomab Therapeutics Ltd., the legal landscape is not just about compliance; it is the primary engine of value, driven by intellectual property (IP) and regulatory clarity. You need to see these legal milestones-patents and FDA alignment-as tangible assets that de-risk the company's future cash flows.

The key legal developments in 2025 have significantly strengthened the commercial foundation for nebokitug, their lead candidate for primary sclerosing cholangitis (PSC). Still, as a foreign private issuer, the dual compliance burden of Israeli and U.S. Securities and Exchange Commission (SEC) regulations remains a constant operational cost.

New patents for nebokitug were issued in China and Russia in June 2025, extending intellectual property protection through 2041.

The expansion of nebokitug's patent portfolio into key international markets is a critical move to protect future commercialization potential, especially as the company seeks strategic partnerships. On June 3, 2025, Chemomab announced the issuance of two new patents covering the use of nebokitug for liver diseases, including PSC, in China and Russia. This IP extension is vital for maximizing the drug's market exclusivity.

Here is the quick math on IP longevity in these major territories:

This protection through 2041 in Russia, and 2038 in China, significantly reinforces the composition of matter and methods of use patents already in place in the U.S., Europe, and Japan. That is a clear, long-term moat against generic competition.

FDA alignment on the Chemistry, Manufacturing, and Controls (CMC) strategy streamlines the Biologics Licensing Application (BLA) process.

Regulatory clarity from the U.S. Food and Drug Administration (FDA) is arguably the biggest legal de-risker for a clinical-stage biotech. Following the End-of-Phase 2 review process, Chemomab obtained confirmation from the FDA on June 11, 2025, regarding two major development milestones for the nebokitug Phase 3 program. The FDA agreed with the proposed Chemistry, Manufacturing, and Controls (CMC) strategy, which focuses on the quality and consistency of the drug supply, essentially smoothing the path for the BLA (Biologics Licensing Application) submission.

Plus, the FDA agreed that additional animal toxicology testing, which is routinely required, can be conducted in parallel with the Phase 3 clinical trial. This parallel approach is a huge win because it eliminates a potential sequential delay, accelerating the overall time-to-market and shortening the regulatory timeline before the BLA filing.

Completed a one-for-four reverse ADS split (1:80 ratio) effective August 26, 2025, to manage share structure.

To manage its American Depositary Share (ADS) structure and maintain compliance with NASDAQ listing requirements, Chemomab executed a ratio change that functioned as a reverse split for ADS holders. Effective August 26, 2025, the ADS ratio changed from one ADS representing 20 ordinary shares to one ADS representing 80 ordinary shares. This was a mandatory one-for-four reverse ADS split.

This action reduced the number of publicly traded ADSs without affecting the underlying ordinary shares, aiming to boost the per-share price and improve the company's appeal to institutional investors. Here's the quick math on the resulting share structure, based on the latest 2025 fiscal data:

• Ordinary shares outstanding as of September 30, 2025: 492,409,320
• ADSs outstanding (post-split, 1:80 ratio) as of September 30, 2025: 6,155,117

The weighted average number of ordinary shares outstanding for the third quarter of 2025 was 494,338,497, which translates to approximately 6,179,231 ADSs at the new ratio. This ratio adjustment was a necessary structural cleanup.

The company must comply with SEC filing requirements as a foreign issuer on NASDAQ.

As an Israeli company listed on the Nasdaq Capital Market under the ticker CMMB, Chemomab is classified as a foreign private issuer (FPI) by the SEC. This status provides certain exemptions but still requires rigorous and timely disclosure to the U.S. market. The company files its quarterly updates using Form 6-K (Report of foreign issuer) and its annual reports on Form 20-F (Annual and transition report of foreign private issuers).

This compliance is defintely a high-cost administrative function, but it is non-negotiable for maintaining the NASDAQ listing. For example, the company filed a Form 6-K on November 21, 2025, to furnish its Third Quarter 2025 financial results. The key risk here is maintaining compliance with listing standards, particularly the minimum bid price requirement, which the August reverse ADS split was designed to address.

Finance: Monitor new SEC guidance on FPI disclosure requirements for 2026 by year-end.

Chemomab Therapeutics Ltd. (CMMB) - PESTLE Analysis: Environmental factors

As a clinical-stage biotech, direct environmental footprint is low, relying on contract manufacturers.

As a clinical-stage biotechnology company, Chemomab Therapeutics Ltd. (CMMB) has a minimal direct environmental footprint. Its core operations are research, development, and clinical trials, not large-scale manufacturing. This means the company's primary environmental exposure is indirect, residing in its supply chain, specifically with its Contract Development and Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs).

The company's focus is on advancing its lead product, nebokitug, into a single Phase 3 registration trial for primary sclerosing cholangitis (PSC). This capital-light model defintely lowers Scope 1 and Scope 2 emissions (direct and energy-related) compared to a fully integrated pharmaceutical company. The real risk is in Scope 3 emissions (supply chain), which account for an estimated 75% to 90% of the pharmaceutical sector's total environmental footprint.

Biotech industry increasingly faces pressure for supply chain and manufacturing sustainability.

The pressure on the biotech industry for supply chain sustainability has intensified significantly in 2025, driven by investors, regulators, and patients. Major pharmaceutical companies are now spending an estimated $5.2 billion yearly on environmental programs, a 300% increase from 2020, setting a new market standard. This pressure flows directly down to smaller, clinical-stage companies like Chemomab Therapeutics, even if they outsource production.

Investors are increasingly scrutinizing ESG (Environmental, Social, and Governance) performance, and CDMOs are now being examined on how they handle waste streams and ensure responsible disposal of pharmaceutical byproducts. The European Union's Corporate Sustainability Reporting Directive (CSRD), which began mandating extensive ESG impact reporting for large companies in 2025, is setting a global precedent that impacts the entire supply chain.

Here's a snapshot of the environmental risk transfer:

• Direct Footprint (Low): Limited to office space, labs, and travel.
• Indirect Footprint (High Risk): Entirely dependent on CDMO/CRO partners.
• Investor Focus: Shifting from pure R&D to R&D plus ESG-conscious operations.

Compliance with global regulations regarding biological waste disposal from clinical trials is mandatory.

Compliance with global regulations for the disposal of biological and hazardous waste is mandatory for all clinical trials, including Chemomab Therapeutics' nebokitug Phase 3 trial. These regulations cover everything from sharps and contaminated materials to unused drug product and patient samples. Failure to comply, even by a contracted CRO, can lead to costly delays, fines, and reputational damage.

The complexity rises because the Phase 3 trial is a global effort, with regulatory alignment secured from both the FDA and the EMA. This means the company must ensure its partners adhere to the specific, stringent biomedical waste management rules of every country where the trial is conducted. The risk here is one of oversight: Chemomab Therapeutics is ultimately responsible for the compliance of its third-party partners.

No specific public sustainability initiatives were disclosed in 2025 financial reports.

As of the third quarter 2025 financial results announced on November 20, 2025, Chemomab Therapeutics did not disclose any specific public sustainability initiatives, ESG reports, or measurable environmental targets. While common for a small clinical-stage company, this absence is a growing gap against industry best practices and investor expectations.

The company's immediate focus is securing funding and a partner to launch the Phase 3 trial, which is understandable given the cash position. Cash, cash equivalents, and short-term deposits were $10.2 million as of September 30, 2025. The net loss for Q3 2025 was $1.7 million, with R&D expenses at approximately $1 million. While the cash runway is projected through the end of the fourth quarter of 2026, the upcoming Phase 3 trial will significantly increase cash burn, making a strategic partnership critical.

Here's the quick math: with only $10.2 million in cash and a Phase 3 launch imminent, securing a strategic partner is the single most important action. Finance: provide an updated cash burn projection incorporating Phase 3 start-up costs by end of next week.