CohBar, Inc. (CWBR): PESTLE Analysis [Nov-2025 Updated]

You're holding a highly speculative asset, CohBar, Inc. (CWBR), a micro-cap biotech now trading over-the-counter (OTC) following its Nasdaq delisting, and the core question isn't about incremental growth; it's about survival and the massive binary bet on its merged pipeline. With a market capitalization of just $1.19 million as of November 2025, and a trailing 12-month operating cash flow of -$7.94 million, the company is a tiny boat in a choppy sea. We'll cut through the noise with a PESTLE analysis that maps the extreme political, economic, and legal risks-like the January 2025 liquidation action-against the technological promise of its new immuno-oncology focus, giving you a defintely clear view of the external forces at play.

CohBar, Inc. (CWBR) - PESTLE Analysis: Political factors

US Food and Drug Administration (FDA) approval pathways remain long and costly for novel therapeutics.

The regulatory path for novel therapeutics, especially for a clinical-stage biotech like CohBar, Inc., remains the single largest near-term political risk. The US Food and Drug Administration (FDA) process is not just scientifically demanding; it carries a massive, non-negotiable financial burden before a drug ever generates revenue. For Fiscal Year 2025, the fee to file a New Drug Application (NDA) requiring clinical data is a staggering $4,310,002. That's just the application fee, not the billions spent on research and trials leading up to it.

This high cost is compounded by the annual Prescription Drug Program Fee, which is $403,889 for FY2025. CohBar must maintain a substantial cash runway to cover these and other operational costs, especially now that its pipeline is focused on the high-cost immuno-oncology space following the Morphogenesis merger. The simple truth is, a single clinical delay can burn through cash and necessitate dilutive financing, regardless of scientific merit.

Government funding for mitochondrial disease and immuno-oncology research creates indirect opportunities.

While CohBar is primarily a private-sector enterprise, the massive US government investment in its core therapeutic areas creates a powerful, indirect tailwind. The company's post-merger focus on immuno-oncology aligns with the National Cancer Institute (NCI) budget, which was allocated $7.22 billion for Fiscal Year 2025. This funding supports the entire cancer research ecosystem, from basic science to clinical trial infrastructure, which CohBar's lead immuno-oncology asset, IFx-Hu2.0, can potentially benefit from through collaboration or by leveraging publicly funded research data.

Furthermore, the Biden Cancer Moonshot initiative, which aims for a 50% reduction in cancer death rates by 2047, has proposed an additional $1.448 billion in new mandatory funding for FY2025. This clearly signals a sustained national priority. For its legacy mitochondrial disease pipeline, the company can also tap into smaller, but critical, non-governmental funding streams, such as the United Mitochondrial Disease Foundation and The Mito Foundation's 2025 grant program, which offered up to $500,000 for research and clinical work.

Potential US political shifts could impact drug pricing and reimbursement policies, affecting future revenue.

The political climate in 2025 is defined by an aggressive push to lower drug prices, posing a significant risk to future revenue for any successful biotech. The Trump Administration has advanced several initiatives, including the threat of a 100% tariff on imported branded drugs, aimed at forcing domestic manufacturing and price concessions. This creates supply chain uncertainty, even for a US-based company.

More critically, the ongoing debate around the Inflation Reduction Act (IRA) and its Medicare Drug Price Negotiation Program (MDPNP) introduces volatility. While CohBar's novel, early-stage therapies are likely years away from negotiation eligibility, political maneuvering is already attempting to weaken the law. For example, proposals to extend the small molecule exemption period would have barred negotiation for drugs that accounted for an estimated $32.4 billion in Part D spending in the first round alone. This is the quick math on the potential revenue at risk for the entire industry, and it defintely impacts investor sentiment and future valuation models.

Debates on 'march-in rights' for federally funded research could threaten core intellectual property (IP) assets.

The political debate over 'march-in rights' under the Bayh-Dole Act of 1980 is a direct threat to the core intellectual property (IP) assets of any biotech that has used federal funding for its foundational research. This authority allows the government to grant a compulsory license to a third party if the patent owner fails to make the invention available to the public on reasonable terms.

The current political environment, driven by drug pricing concerns, has revived the push to use this power. Although the right has never been invoked in the law's 45-year history, the threat alone chills investment. If CohBar's novel mitochondrially-derived peptides (MDPs) or its immuno-oncology platform were found to have originated from federally funded research, a successful drug could have its patent stripped away and relicensed over a pricing dispute. This risk is a major factor for venture capital and institutional investors who fund the high-risk, high-reward model of drug development.

• Risk: Government sets a precedent using price as the trigger for IP seizure.

• Reality: March-in rights have never been exercised by a federal agency.

CohBar, Inc. (CWBR) - PESTLE Analysis: Economic factors

You're looking at CohBar, Inc.'s economic reality, and the immediate takeaway is a classic biotech funding paradox: the science is capital-intensive, but the company's valuation makes new money extremely hard to find. The economic environment is a mixed bag-high-interest rates have squeezed the sector, but a potential shift in Federal Reserve policy offers a glimmer of hope for venture capital (VC) funding later in 2025.

$1.19 million market capitalization makes capital raising extremely difficult in 2025.

The company's minuscule market capitalization (market cap) of only $1.19 million as of late 2025 is the single biggest economic constraint. This micro-cap valuation signals extreme investor skepticism and effectively shuts the door on traditional equity financing, like a secondary public offering, without massive shareholder dilution. Honestly, a valuation this low means the company is valued less than a single Series A funding round for a typical biotech startup.

To put the financial pressure into perspective, here's a quick snapshot of CohBar, Inc.'s near-term funding challenge:

Anticipated lower interest rates in late 2025 could slightly improve venture capital appetite for biotech.

The broader macroeconomic environment offers a slight tailwind. Biotech is highly sensitive to interest rates because its value is based on distant future cash flows (discounted cash flow, or DCF, valuation). The Federal Reserve's anticipated rate cuts in the latter half of 2025, which some forecasts see bringing the year-end rate down to around 4.5%, are a positive signal. Lower borrowing costs, even marginally, can increase the risk appetite of venture capital and private equity firms for early-stage, cash-burning companies like CohBar, Inc.

This shift is already visible in the sector's funding data:

• Biotech venture financing deal value grew by 70.9% from Q2 2025 to Q3 2025.
• Lower cost of capital makes long-duration R&D projects more financially viable.
• Improved investor optimism facilitates greater venture capital investment.

Still, this is a sector-wide trend, not a company-specific solution. CohBar, Inc. still needs to secure a deal, and its low market cap makes it a very difficult sell, even in a recovering market.

The company faces a high cash burn rate, with a trailing 12-month operating cash flow of -$7.94 million.

For a clinical-stage company, a negative operating cash flow is normal, but the magnitude here is critical. CohBar, Inc.'s trailing 12-month operating cash flow is -$7.94 million. This means the company is burning through cash at a rate that is over six times its current market capitalization of $1.19 million. This high cash burn rate, which is essentially the cost of keeping the lights on and running clinical trials, creates an urgent need for capital, which must be addressed through a partnership, asset sale, or highly dilutive financing. What this estimate hides is the runway-this cash burn rate suggests the company has a very short time before it must raise funds or cease operations.

Dominance of GLP-1 drugs (for obesity/NASH) creates intense competition for CohBar's original pipeline assets.

The economic landscape for CohBar, Inc.'s lead pipeline asset, CB4211 for nonalcoholic steatohepatitis (NASH) and obesity, is dominated by the massive success of Glucagon-like Peptide-1 (GLP-1) receptor agonists. This class of drugs, led by Eli Lilly and Novo Nordisk, is a pharmaceutical juggernaut. The global obesity drug market, heavily driven by GLP-1s, is projected to reach billions of dollars by 2025, with a Compound Annual Growth Rate (CAGR) exceeding 20% in some projections. Forecasts even estimate the GLP-1 therapy market could reach $180 billion by 2034.

This dominance creates an incredibly high bar for any new entrant, including CohBar, Inc.'s mitochondria-based therapeutics. The competition is fierce, with over 100 investigational obesity drugs in development, many aiming to improve upon GLP-1 pathways. CohBar, Inc. must demonstrate a truly differentiated mechanism of action or superior efficacy and tolerability to capture any meaningful share of this market, and it must do so with a fraction of the capital its competitors command.

CohBar, Inc. (CWBR) - PESTLE Analysis: Social factors

Growing demand for therapies targeting age-related diseases like NASH and idiopathic pulmonary fibrosis (IPF).

You're looking at a massive, undeniable demographic tailwind that makes the market for age-related therapeutics a long-term winner. The core business CohBar, Inc. (CWBR) was built on-mitochondria-based treatments for age-related diseases-still addresses a huge, unmet need, even with the strategic pivot to oncology.

The sheer size and growth of the US geriatric population drive this demand. The US population aged 65 and older reached 61.2 million in 2024, accounting for 18.0% of the total population. This group grew by 3.1% from 2023 to 2024, significantly outpacing the growth of the under-65 population. This means more patients are entering the high-risk pool for diseases like Idiopathic Pulmonary Fibrosis (IPF) and Metabolic Dysfunction-Associated Steatohepatitis (MASH), formerly known as NASH.

Here's the quick math on the market opportunity for these two key age-related diseases, based on 2025 data, which CohBar, Inc. (CWBR) still has a legacy interest in:

To be fair, the IPF market alone is estimated at $3,252.8 million globally in 2025, and the North American MASH market is projected at $3,640.80 million in 2025. That's a huge addressable market, and it's defintely a social pressure point for new treatments.

Increased public awareness and funding focus on cancer immunotherapy following the Morphogenesis merger.

The merger with Morphogenesis, which created TuHURA Biosciences, Inc., completely shifted the social and market focus to immuno-oncology. This is a smart move because public awareness and funding for cancer research are at an all-time high, especially for next-generation therapies that overcome resistance to existing treatments.

The social drive is visible in advocacy efforts that directly influence federal funding. For instance, the American Society of Clinical Oncology (ASCO) Advocacy Summit in April 2025 focused on urging Congress to increase and stabilize funding for the NIH, NCI, and ARPA-H for the FY2026 budget. This sustained, high-profile lobbying ensures a favorable funding environment for the combined company's lead asset, IFx-Hu2.0, which is a personalized cancer vaccine platform. The public and political will is there to fund a cure, so the capital is more accessible.

The new focus is on a critical, socially visible problem: resistance to checkpoint inhibitors. When you're tackling a problem this visible, you get a significant boost in public profile and, more importantly, a better chance at securing non-dilutive government and grant funding.

Demographic tailwinds from the aging US population drive the long-term market for chronic disease treatments.

The aging population isn't just a short-term trend; it's a fundamental shift that underpins the entire biotech industry's long-term value. The US median age reached a new record high of 39.1 in 2024. The number of people aged 65 or older is projected to grow at an average annual rate of 1.1% between 2025 and 2055, much faster than the working-age population.

This demographic pressure creates a permanent demand for chronic disease treatments, including both the legacy CohBar, Inc. (CWBR) pipeline (anti-fibrotics for IPF, metabolic regulators for MASH) and the new immuno-oncology focus, since cancer incidence rises sharply with age. The social necessity for better, more effective treatments for the elderly population is only going to intensify.

This means that even if the new company, TuHURA Biosciences, Inc., were to divest its older assets, the buyer would be stepping into a market with guaranteed, growing demand. The social structure of the US is becoming older, and that translates directly into a larger patient pool for every age-related chronic condition.

Patient advocacy groups can accelerate clinical trial recruitment or pressure for faster drug approval.

Patient advocacy groups are a crucial, often underestimated, social factor in the clinical development process. They are not just for awareness; they are accelerators for trial recruitment and regulatory pressure.

• Accelerate Recruitment: Groups like the Pulmonary Fibrosis Foundation (PFF) actively promote clinical trials, offering resources like a Clinical Trial Finder and sharing updates from major conferences like the American Thoracic Society (ATS) 2025 Conference. This direct patient engagement significantly reduces the time and cost associated with finding eligible participants for trials like the former CohBar, Inc. (CWBR) IPF program.
• Boost Visibility and Funding: The American Society of Clinical Oncology (ASCO) supports patient advocates through the Conquer Cancer Patient Advocate Scholarship Program and a dedicated booth at the 2025 ASCO Annual Meeting. This integration of the patient voice into the scientific community helps shape the research agenda and creates a social mandate for faster drug development in oncology, which directly benefits the new company's lead asset.

When you have a strong patient community, you don't just get volunteers; you get powerful, informed allies who can lobby the FDA for accelerated approval pathways, especially in high-unmet-need areas like advanced Merkel cell carcinoma, the target of the new company's lead asset.

CohBar, Inc. (CWBR) - PESTLE Analysis: Technological factors

The technological landscape for CohBar, Inc., which now operates as TuHURA Biosciences, Inc. following its merger with Morphogenesis, Inc., is defined by a sharp pivot from niche geroscience to the hyper-competitive field of immuno-oncology, all while being pressured by the accelerating pace of AI and gene-editing platforms. You are essentially operating at the intersection of three of the most complex areas in biotech: mitochondrial biology, personalized cancer vaccines, and computational drug discovery. This environment creates immense opportunity but also a high technological barrier to entry.

Focus on Mitochondria-Based Therapeutics (MBTs) is a highly specialized, cutting-edge area of geroscience

CohBar's original core technology-Mitochondria-Based Therapeutics (MBTs) or mitochondrially-derived peptides-is a defintely specialized area of geroscience. While the company has shifted focus, the underlying technology remains a potential value driver, evidenced by the contingent value right (CVR) granted to pre-merger shareholders for proceeds from the legacy mitochondrial assets. The market for MBTs is still nascent but growing steadily, reflecting a deeper scientific understanding of mitochondrial dysfunction in age-related diseases.

Here's the quick math on that niche market:

The challenge is that this field requires significant, sustained capital, and the company's immediate cash runway, supported by a $15 million PIPE financing from the merger, was anticipated to last only through 2024. That means any remaining MBT assets are a long-term, high-risk, high-reward technological bet that needs a partner to move forward.

The merger introduced a Phase 2/3 immuno-oncology pipeline, leveraging personalized cancer vaccine technology

The merger with Morphogenesis, Inc. fundamentally changed the technological profile, introducing a late-stage immuno-oncology pipeline. The new company, TuHURA Biosciences, Inc., is now focused on two key technologies: Immune Fx (IFx) personalized cancer vaccines and Tumor Microenvironment (TME) modulators. This is a massive technological step up in terms of clinical stage and market opportunity.

The lead personalized cancer vaccine candidate, IFx-Hu2.0, was expected to enter a Phase 2/3 registration trial as a first-line treatment for advanced Merkel cell carcinoma in early 2024. This technology is designed to activate a patient's immune system to target tumor cells by making them appear like bacteria, aiming to overcome resistance to existing immunotherapies like checkpoint inhibitors. The advantage here is the near-term clinical data readout, which is a much faster technological validation path than the original MBT pipeline.

Advances in artificial intelligence (AI) and machine learning are speeding up drug discovery and target identification

The entire biotechnology sector is being redefined by artificial intelligence (AI) and machine learning (ML), and this is a critical pressure point for a smaller, merged entity like TuHURA Biosciences, Inc. AI is not a luxury anymore; it's a competitive necessity for any company with a discovery-stage pipeline, whether in MBTs or TME modulators.

Look at the impact AI is having on the industry right now:

• AI investments in the pharma sector are projected to exceed $13 billion globally in 2025.
• The AI-native drug discovery market is expected to reach $1.7 billion this year.
• AI-driven approaches can cut R&D costs by an estimated 40-60% and reduce development timelines from over 10 years to potentially 3-6 years.
• AI-designed drugs are showing an impressive 80-90% success rate in Phase I trials, compared to the traditional 40-65% rate.

The company must either partner with an AI-native platform or rapidly integrate these tools to make its preclinical TME modulator pipeline competitive. Sticking to traditional discovery methods is a recipe for being outpaced.

Competitors are rapidly leveraging CRISPR and mRNA platforms, setting a high bar for innovation

The competitive technology landscape is dominated by platforms that offer speed, precision, and scalability, namely CRISPR and mRNA. These technologies are not just for infectious diseases; they are rapidly moving into oncology and geroscience.

The broader Gene, Cell, + RNA Therapy Landscape Report noted 4,099 therapies in development, with gene therapies making up 49% of the total. Companies like CRISPR Therapeutics, Intellia Therapeutics, and Editas Medicine are already major players in gene editing. The first FDA-approved CRISPR therapy, Casgevy, was a landmark approval in late 2023, validating the entire field. The mRNA platform, while facing some political headwinds, is also showing strong potential in personalized cancer care by activating immunity against tumor-specific antigens.

The challenge for TuHURA Biosciences, Inc. is that its personalized cancer vaccine platform, while late-stage, is competing against these highly flexible and rapidly evolving gene-editing and gene-delivery platforms. The market for CRISPR technology alone is a multi-billion dollar industry, having been valued at $5.72 billion in 2024. The company's technology must demonstrate superior efficacy or a significantly better safety profile to justify its position against these powerful, well-funded platform technologies.

CohBar, Inc. (CWBR) - PESTLE Analysis: Legal factors

Nasdaq Delisting (late 2023) and Subsequent Trading on the Over-the-Counter (OTC) Market Reduces Liquidity and Investor Trust

You're looking at CohBar, Inc. as a case study in how quickly a legal-regulatory event can fundamentally shift a company's risk profile. The single biggest legal factor affecting the legacy CohBar entity is its Nasdaq delisting. Trading of the common stock was suspended on November 29, 2023, after Nasdaq determined the company was a 'public shell' and non-compliant with certain listing rules.

This move from a major exchange to the Over-the-Counter (OTC) market immediately reduced liquidity and investor confidence. Honesty, for a biotech, losing that Nasdaq visibility can be fatal to fundraising. The legal and regulatory oversight on the OTC market is less stringent, but that's a double-edged sword; it reduces administrative burden but also scares away institutional capital that has strict mandates for exchange-listed securities.

Here's the quick market view of the shift:

The January 2025 Liquidation Action at $1.7710 per Share Signals a Significant Corporate Restructuring Event

The final chapter for the legacy CohBar entity was the corporate restructuring that followed the merger with Morphogenesis, Inc., which created the new entity, TuHURA Biosciences, Inc. This action, which was essentially a final wind-down of the original company's remaining assets, signaled a definitive end to the original business model.

The reported liquidation action in January 2025, with a value of $1.7710 per share, is a crucial legal marker. This is not a typical stock price; it represents the final, tangible value distributed to shareholders of the legacy entity as part of the corporate dissolution process. It's a clean one-liner: the legal structure was dissolved, and this was the final cash-out value.

Strict Phase 1, 2, and 3 Clinical Trial Regulations Require Immense Financial and Operational Compliance

For any clinical-stage biotech, the Food and Drug Administration (FDA) regulatory pathway is the paramount legal and operational risk. The stringent requirements for Phase 1, 2, and 3 trials demand massive capital and meticulous compliance, especially with the 2025 focus on enhanced data integrity and the use of Real-World Data (RWD) in submissions.

To be fair, CohBar's pivot to a 'public shell' status was largely driven by the inability to sustain these costs. For context, the mean R&D cost to develop a new drug, including failures, is estimated to be around $1.31 billion in the current environment. Contrast that with CohBar's R&D expenses, which fell to just $0.2 million in the second quarter of 2023 as development activities were suspended. This stark difference highlights the immense regulatory compliance burden that ultimately forced the company's strategic pivot and merger.

Patent Protection for Novel Mitochondrial Peptides and the IFx-Hu2.0 Cancer Vaccine is Absolutely Crucial

Intellectual Property (IP) is the lifeblood of a biotech. The legal protection of novel mitochondrial peptides (MDPs) and the IFx-Hu2.0 cancer vaccine is the only thing that justifies the multi-billion-dollar regulatory expense of drug development.

The value of the legacy CohBar entity is tied to its IP portfolio, which included key patents for its MDPs. For example, a core U.S. Patent (U.S. No. 11,111,271) covering the lead candidate CB4211 extends to at least 2037. This long-term protection is what makes the asset valuable for the new combined entity.

The legal status of the IFx-Hu2.0 cancer vaccine is now primarily a concern for TuHURA Biosciences, Inc., the new company formed from the merger. This product is now in a Phase 3 accelerated approval trial in 2025, which means the IP is actively being leveraged under the new corporate structure.

Key IP and Regulatory Status:

• CB4211 Patent Protection: Extends to at least 2037 (U.S. No. 11,111,271).
• IFx-Hu2.0 Status: Advanced by TuHURA Biosciences, Inc. into a Phase 3 trial in 2025.
• Legacy Filings: Over 65 patent applications filed for novel MDPs as of late 2021.

The legal team's next step is defintely to ensure the seamless transfer and defense of this core IP under the TuHURA Biosciences, Inc. banner, as that is the primary source of future organizational performance.

Next Step: Legal Counsel: Audit all legacy CohBar IP transfer agreements to TuHURA Biosciences, Inc. by the end of Q1 2026.

CohBar, Inc. (CWBR) - PESTLE Analysis: Environmental factors

Minimal direct environmental impact; primary concern is the safe handling and disposal of lab chemicals and biological waste.

For a clinical-stage biotech like CohBar, with a small operational footprint-just 14 total employees as of late 2023-the direct environmental impact is defintely minimal compared to a large-scale manufacturer. The primary environmental risk isn't carbon emissions from a factory; it's the strict, regulated management of laboratory output. This means handling and disposal of chemical and biological waste is the core environmental concern, and frankly, a major operational cost.

The company's focus on Mitochondria-Based Therapeutics (MBTs) requires specialized research and development (R&D) lab work. In 2025, compliance is getting tighter. For instance, new EPA regulations on Per- and Polyfluoroalkyl Substances (PFAS) reporting, effective July 11, 2025, will require even small entities to track and report data on their use, disposal, and production volumes since 2011. This means CohBar must invest in rigorous chemical inventory management, or risk steep fines.

Here's the quick math on waste compliance:

• RCRA e-Manifests: The EPA's shift to electronic manifests for hazardous waste, effective December 1, 2025, requires registration for all generators, including small ones like CohBar.
• OSHA Risk Assessments: New 2025 updates require individualized risk assessments for each experimental protocol, moving beyond general lab-wide hazard plans.
• Biohazardous Waste: Proper segregation into color-coded containers (e.g., red for biohazardous, white for sharps) is non-negotiable for compliance with OSHA and EPA standards.

Increasing investor and public pressure for Environmental, Social, and Governance (ESG) reporting, even for small biotechs.

You might think a small, delisted company like CohBar-with a market cap of only $7.85 million as of August 2023-can ignore ESG. Honestly, you can't, not anymore. While the consensus for penalizing a company for lacking a formal ESG report is generally for those over $1 billion in revenue or 1,000 employees, the pressure is flowing down.

Financial analysts are already incorporating ESG scores. Firms like TD Cowen now give every biotech an ESG score on a 0-100 scale using FactSet technology, right next to the analyst recommendation. A low score, even without a formal report, can spook the few institutional investors CohBar might be targeting for future funding rounds. The reality is, a first-time, outsourced ESG report for a smaller company can cost between $75,000 and $125,000 for outside consultants, which is a significant, but potentially necessary, capital expenditure for a firm with limited cash.

Supply chain stability for specialized reagents and raw materials remains a risk in the global biotech sector.

The global supply chain for life science reagents is a massive, but volatile, market. It was valued at $62.3 billion in 2024 and is projected to surpass $113.4 billion by 2035, growing at a Compound Annual Growth Rate (CAGR) of 5.7% from 2025. CohBar's work on novel peptides requires highly specialized, high-purity reagents and raw materials, and this is where the risk lies.

Geopolitical instability and regulatory pressure are the biggest threats in 2025, leading to potential shortages and high costs. If a critical, specialized reagent for their lead compound, CB4211 (in Phase 1b for NASH and obesity), sees a supply disruption, the entire clinical trial timeline and budget are at risk. The complexity of cold chain logistics for sensitive biologics further pushes costs up, demanding real-time monitoring and a resilient, multi-tiered network.

This is a critical operational risk for a small company.

Clinical trials require ethical oversight and adherence to bio-safety standards for novel biological agents.

The core of CohBar's business is developing novel biological agents-mitochondria-derived peptides. This means their clinical trials and lab work are under intense scrutiny for bio-safety. The principle of 'containment and inactivation' is the cornerstone of BSL-3/4 waste disposal regulations, and while CohBar may not be at that level, the ethos of protecting public health and the environment is paramount.

The environmental factor here merges with the 'Social' and 'Legal' aspects of PESTLE, as ethical oversight is a key component of ESG. Diversity in clinical trials, for example, is now a must-have for regulatory approvals, which is a social factor with environmental implications in terms of responsible research. The company must ensure its clinical trial materials and processes adhere to the highest standards, especially when dealing with novel peptide sequences, which are, by definition, less understood than traditional small molecules.

• Bio-Safety Standards: Must adhere to strict protocols for containment and decontamination of all biological waste generated during the Phase 1b trial.
• Ethical R&D: Transparency and ethical R&D are crucial for long-term growth and attracting funding.
• Novel Agent Risk: Handling novel peptide sequences (over 100 discovered by CohBar) requires stringent, protocol-specific bio-safety measures to prevent environmental contamination.

Finance: Budget a minimum of $75,000 for a preliminary ESG risk assessment by Q2 2026 to mitigate investor concern.