Terns Pharmaceuticals, Inc. (TERN): PESTLE Analysis [Nov-2025 Updated]

You're trying to figure out if Terns Pharmaceuticals is a calculated bet or a high-wire act right now. The simple truth is Terns is sitting on a robust cash pile of $295.6 million-enough to fund operations into 2028-but its $2.45 billion market cap is riding almost entirely on TERN-701, an oncology asset that just showed a compelling 75% Major Molecular Response (MMR) rate in Phase 1. That's a powerful technological signal, but it's constantly battling political headwinds from FDA uncertainty and an economic burn rate that hit a $24.6 million net loss in Q3 2025. We'll map out the exact Political, Economic, Sociological, Technological, Legal, and Environmental forces-the PESTLE-that will defintely determine if Terns can translate that promising clinical data into a commercial win.

Terns Pharmaceuticals, Inc. (TERN) - PESTLE Analysis: Political factors

US administration's shifting regulatory oversight creates FDA uncertainty.

The regulatory landscape for biopharma is defintely in motion, driven by the current US administration's push for both faster drug approvals and greater transparency. The Food and Drug Administration (FDA) has rolled out a series of new guidance documents in 2025 aimed at streamlining the development process, particularly for novel drugs and biologics. This focus on efficiency is a double-edged sword for a clinical-stage company like Terns Pharmaceuticals, Inc.

On one hand, initiatives like the proposed 'plausible mechanism' pathway, hinted at in April 2025, and the clearer guidance on the Rare Disease Evidence Principles (RDEP) process (issued in September 2025) could expedite the path for TERN-701, its Chronic Myeloid Leukemia (CML) candidate. CML is a rare cancer, so a more flexible regulatory environment for rare disease therapies is a clear opportunity.

On the other hand, the FDA is also increasing scrutiny. In July 2025, the agency published over 200 'complete response letters' (CRLs) from the 2020-2024 period, signaling a move toward greater transparency in its decision-making. This means the bar for a New Drug Application (NDA) remains high, and any regulatory misstep will be visible to the market.

Drug pricing reform pressure, like the 340B program, impacts future market access.

Drug pricing reform is one of the most significant political risks for any biopharma company, even a clinical-stage one. While Terns Pharmaceuticals, Inc. is not yet generating revenue (with losses expected through at least 2026), the future market for its pipeline, especially TERN-701, will be shaped by these reforms.

The 340B Drug Pricing Program, which mandates substantial discounts (typically 25% to 50% off the average manufacturer price) for eligible healthcare providers, is under intense political pressure. The administration's Executive Order 14297, signed in May 2025, signals a potential revival of Medicare reimbursement cuts and a push for increased transparency to prevent 'profiteering.' Honestly, the sheer size of the program is the issue; it has grown by 50% over the last two years and is expected to surpass Medicare Part D in size by 2028.

Another major political push is for 'most favored nation' pricing, which aims to align US drug prices with those in other developed countries. If TERN-701 or a partnered metabolic asset like TERN-601 reaches the market, its pricing strategy will be immediately constrained by this political environment. You need to model a lower peak revenue scenario right now.

America First trade policies could disrupt global biopharma supply chains and manufacturing.

The 'America First' trade agenda, characterized by a renewed focus on domestic manufacturing, is creating immediate cost and supply chain headaches for the entire biopharma sector. This is a crucial area for a small molecule company like Terns Pharmaceuticals, Inc., which relies on global sourcing for Active Pharmaceutical Ingredients (APIs) and other raw materials.

The US government has imposed new tariffs in 2025, including a June 2025 announcement of a 25% duty on APIs from China and a 20% duty on those from India. Considering that up to 82% of API 'building blocks' for vital US drugs come from these two countries, this translates directly into higher input costs.

Plus, the administration announced a massive 100% tariff on imported branded and patented drugs, effective October 1, 2025, with exemptions only for companies building US manufacturing plants. While Terns Pharmaceuticals, Inc. is US-based (Foster City, CA), its contract manufacturing and supply chain partners are likely exposed, forcing a costly and complex reshoring or diversification effort.

• Tariff on China-sourced APIs: 25% duty.
• Tariff on India-sourced APIs: 20% duty.
• US pharmaceutical imports: Over $200 billion annually.
• Near-term action: Map TERN's entire API and excipient supply chain to quantify tariff exposure and identify alternative, tariff-free sourcing options.

Geopolitical tensions increase scrutiny on supply chain and data handling practices.

Geopolitical instability, particularly in the Asia-Pacific region, is no longer just a macro-risk; it's a direct operational threat in 2025. This tension is driving legislation that increases scrutiny on foreign entities in the biopharma supply chain, which is particularly relevant given Terns Pharmaceuticals, Inc.'s likely global clinical trial footprint and manufacturing needs.

A key legislative action is the Senate's passage of the 2026 NDAA, which includes the BIOSECURE Act Amendment (October 2025). This amendment aims to restrict federal contracts with foreign biopharma companies deemed a national security risk. This political climate necessitates a greater focus on supply chain resilience and data security.

For Terns Pharmaceuticals, Inc., the action is clear: you must ensure your data handling practices and clinical trial data storage meet the highest US government standards, and that your contract research and manufacturing organizations (CROs/CMOs) are not flagged under new security-focused legislation. The industry is responding by investing in technologies like blockchain and IoT for enhanced supply chain transparency, which is a necessary expense now.

Terns Pharmaceuticals, Inc. (TERN) - PESTLE Analysis: Economic factors

You're looking at Terns Pharmaceuticals, Inc. (TERN) and trying to gauge the financial staying power of a clinical-stage biotech. The economic picture is typical for this sector: high valuation driven by pipeline potential, but also a significant cash burn. The key takeaway is that their current cash position buys them critical time, pushing the next major financing event well into the future, which is a defintely positive signal for investors.

Strong cash position of $295.6 million (as of Q3 2025) provides runway into 2028.

The company's most important economic buffer is its cash and marketable securities. As of September 30, 2025, Terns Pharmaceuticals held a strong balance of $295.6 million in cash, cash equivalents, and marketable securities. This isn't just a number; it's a strategic asset. Management explicitly guided that this funding is expected to sustain operations into 2028, which gives them a long runway to hit critical clinical milestones for their lead oncology program, TERN-701, before needing to raise more capital.

Here's the quick math: a three-year runway reduces the near-term risk of dilutive equity financing (selling new shares, which lowers the value of existing ones), which is a constant worry for biotech investors.

High burn rate with a Q3 2025 net loss of $24.6 million, typical for clinical-stage biotech.

Still, Terns Pharmaceuticals is a clinical-stage company, so it operates at a net loss-that's the cost of innovation. For the third quarter ended September 30, 2025, the company reported a net loss of $24.6 million. This is a slight increase from the $21.9 million net loss reported in the same quarter of 2024, reflecting their accelerated investment in the pipeline. This burn rate is a necessary cost of doing business when you're developing high-impact medicines like TERN-701, but it's the primary factor that will deplete the cash reserves over time.

R&D expenses were $19.9 million in Q3 2025, reflecting heavy pipeline investment.

The biggest driver of that net loss is the investment in Research and Development (R&D). R&D expenses for Q3 2025 were $19.9 million, up from $15.2 million in Q3 2024. This jump shows a clear strategic focus, particularly on the oncology pipeline, following the decision to discontinue internal development of metabolic programs like TERN-601 for obesity and shift to an oncology-exclusive focus. This strategic pivot is meant to concentrate capital on the highest-potential assets.

To be fair, the R&D spend is what creates the value. It's a capital expenditure on future revenue.

High market valuation (Market Cap of $2.53 billion) is driven almost entirely by pipeline success.

The market capitalization (Market Cap) of Terns Pharmaceuticals is currently about $2.53 billion as of November 24, 2025. This is a substantial valuation for a company with no commercial product. What this estimate hides is that the value is almost entirely based on the perceived success of their clinical pipeline, particularly TERN-701 for Chronic Myeloid Leukemia (CML). The market is pricing in a high probability of success for their lead drug, which showed an overall cumulative Major Molecular Response (MMR) rate of 75% by 24 weeks in its Phase 1 CARDINAL trial.

This high valuation means the stock price is extremely sensitive to clinical trial data readouts. Any positive data, like the expanded Phase 1 CARDINAL data presented at ASH 2025, can cause a massive spike, but a negative result would trigger a sharp decline. The economic opportunity, and the risk, are both concentrated in these upcoming milestones.

The economic factors boil down to a simple equation:

• Cash Runway: $295.6 million is the buffer.
• Burn Rate: $24.6 million per quarter is the drain.
• Valuation: $2.53 billion is the market's bet on the pipeline.

Terns Pharmaceuticals, Inc. (TERN) - PESTLE Analysis: Social factors

High unmet medical need in relapsed/refractory Chronic Myeloid Leukemia (CML) drives TERN-701 focus

The core of Terns Pharmaceuticals' strategy is now anchored in addressing the significant social need in oncology, specifically for patients with relapsed/refractory Chronic Myeloid Leukemia (CML) who have failed prior treatments. This patient population has a high unmet medical need, which is a powerful social driver for new drug development.

The global CML market is valued at approximately $8.86 billion in 2025, and it is projected to grow to $12.07 billion by 2030, underscoring the demand for more effective, next-generation treatments. Terns' lead asset, TERN-701, an oral allosteric BCR-ABL inhibitor, is positioned to capture this need, especially for those resistant to established therapies like asciminib.

The latest clinical data from the Phase 1 CARDINAL trial, with a cutoff date of June 30, 2025, highlights this potential. For efficacy-evaluable patients, the overall (cumulative) Major Molecular Response (MMR) rate was a remarkable 75% by 24 weeks, with 100% of patients maintaining MMR at the data cutoff. This level of efficacy in heavily pre-treated patients directly addresses the social burden of treatment failure.

Public demand for weight loss drugs is massive, but Terns is exiting this highly competitive metabolic space

While public demand for weight loss drugs has created a massive market, Terns Pharmaceuticals is making the hard, realistic decision to exit this highly competitive metabolic space, a move announced after disappointing Phase 2 results in October 2025. This strategic pivot reflects a social factor-the intense public and market demand for highly efficacious therapies-that Terns could not meet with its current asset.

The oral GLP-1 receptor agonist, TERN-601, showed a maximum placebo-adjusted weight loss of only 4.6% at 12 weeks in its Phase 2 trial. Honestly, that result fell short of the company's internal target of 6% to 7%, making it uncompetitive against front-runners like Eli Lilly's orforglipron. The company will discontinue internal development of TERN-601 and other metabolic assets beyond year-end 2025, focusing its cash, which was $295.6 million as of September 30, 2025, entirely on oncology. That's a clear action based on a competitive social reality.

Patient-centric data and real-world evidence are increasingly important for regulatory approval

The social expectation for pharmaceutical companies is shifting; patients and regulators now demand that drug development incorporates the patient voice and real-world outcomes. This is the rise of patient-centric data and Real-World Evidence (RWE).

Regulatory bodies are increasingly accepting RWE to support drug approvals, a trend that is dominant in 2025. For oncology, a new Patient-Centered Real-World Evidence (PCRWE) Framework was proposed in November 2025 to guide the integration of patient perspectives into RWE research. Terns demonstrates alignment with this social trend by emphasizing its commitment to patient safety and thoughtful clinical trial design for the CARDINAL study, actively seeking to develop therapies that have fewer side effects and are more convenient.

• Patient-centric RWE is generated through wearables, mobile apps, and patient registries.
• The goal is to provide insights into patient-relevant questions and unmet needs.
• This social shift accelerates drug development and improves patient outcomes.

Increased investor focus on Environmental, Social, and Governance (ESG) standards globally

Investors are scrutinizing biotech companies not just for pipeline success, but also for their social impact, captured under Environmental, Social, and Governance (ESG) metrics. This is a non-negotiable social factor for attracting capital in 2025.

Terns Pharmaceuticals has a measurable social footprint. According to The Upright Project, the company has a net impact ratio of 58.8%, indicating an overall positive sustainability impact. This positive contribution is driven by core social value creation:

The positive impact on 'Physical diseases' is a strong social selling point, directly linked to the CML program, but the negative impact in areas like 'Scarce human capital' shows a limit to their current social contribution that needs to be defintely managed.

Terns Pharmaceuticals, Inc. (TERN) - PESTLE Analysis: Technological factors

You're looking at Terns Pharmaceuticals, Inc. (TERN) at a critical technological inflection point, a moment where the success of a single, small-molecule innovation dictates the company's entire future. The core technological factor here is the power of a highly-targeted, small-molecule drug to deliver best-in-class efficacy, but also the brutal reality that a similar small-molecule approach can fail against a rapidly advancing class of competitors, forcing a complete strategic pivot.

TERN-701 is a next-generation, allosteric BCR-ABL inhibitor, a key small-molecule innovation.

The company's technology bet is now entirely focused on TERN-701, an oral, allosteric BCR-ABL inhibitor for Chronic Myeloid Leukemia (CML). This is a precise, small-molecule innovation designed to overcome resistance to older tyrosine kinase inhibitors (TKIs), which is a huge technological hurdle in oncology. The Phase 1 CARDINAL trial data, released in late 2025, shows this technology is defintely competitive.

Here's the quick math on the potential: In heavily pre-treated CML patients, the overall (cumulative) Major Molecular Response (MMR) rate by 24 weeks reached an impressive 75% (24 out of 32 efficacy-evaluable patients). This level of response in a difficult-to-treat population suggests the drug has a best-in-class profile, which is the technological edge Terns Pharmaceuticals needs to compete with established TKI therapies.

Phase 1 data showed a 75% cumulative Major Molecular Response (MMR) rate by 24 weeks, suggesting best-in-class potential.

The technological sophistication of TERN-701 is evident in its ability to maintain efficacy in patients who failed prior treatments, including the next-generation TKI asciminib. The data is strong, and it's the primary driver of the company's valuation and strategic focus as of the end of 2025.

Discontinuation of TERN-601 (GLP-1 RA) after 4.6% weight loss data highlights high bar for new obesity tech.

The flip side of technological innovation is the high bar for market entry, especially in a crowded space like metabolic disease. Terns Pharmaceuticals made the strategic decision in October 2025 to discontinue internal clinical development of its oral GLP-1 receptor agonist (GLP-1 RA), TERN-601. The Phase 2 topline 12-week data showed a maximum placebo-adjusted weight loss of only 4.6%. This result was simply uncompetitive when compared to the 15%+ weight loss seen with leading injectable GLP-1s, and even fell short of the 5% to 7% internal expectations. The technology was not differentiated enough to justify the substantial R&D spend, which reached $19.9 million in the third quarter of 2025 alone.

Biopharma is increasingly adopting AI for clinical trial design and advanced diagnostics.

The broader technological landscape is being reshaped by Artificial Intelligence (AI) and advanced data analytics, an external factor Terns Pharmaceuticals must use to accelerate its TERN-701 program. The global market for AI in clinical trials is estimated to be valued at $1.77 billion in 2025, reflecting a major industry shift toward optimizing drug development. This technology is crucial for Terns as it moves TERN-701 into later-stage trials, where efficiency is paramount.

Terns Pharmaceuticals is essentially a small-molecule technology house, so it must embrace these digital advancements to stay competitive. The goal is to reduce trial costs by up to 70% and shorten timelines by as much as 80%, which is the kind of operational efficiency a focused oncology company needs. This is not just a trend; it's a necessity for survival.

• AI in biopharma is projected to generate $350 billion to $410 billion in annual value by 2025.
• AI spending in the pharmaceutical industry is expected to hit $3 billion in 2025.
• AI is primarily used to optimize trial design, improve patient recruitment, and monitor real-time data.

The next concrete step is for the Oncology R&D team to start a formal review of three AI-driven clinical trial optimization platforms by the end of the current quarter.

Terns Pharmaceuticals, Inc. (TERN) - PESTLE Analysis: Legal factors

FDA's rigorous regulatory review process requires TERN-701 to meet the 6-month MMR endpoint for pivotal trial design.

The core legal and regulatory hurdle for Terns Pharmaceuticals' lead oncology asset, TERN-701 (for Chronic Myeloid Leukemia or CML), is meeting the U.S. Food and Drug Administration (FDA) standard for a pivotal trial. For CML, this standard is the achievement of a Major Molecular Response (MMR) at six months (24 weeks), which is the critical surrogate endpoint for accelerated approval.

The company's Phase 1 CARDINAL trial data, updated in November 2025, shows they are on track, which is defintely a risk mitigator. Specifically, the data presented at the ASH 2025 abstract showed an overall (cumulative) MMR rate of 75% by 24 weeks in heavily pre-treated patients. This is the number that will drive the design and cost of the subsequent, more expensive Phase 3 trial. The FDA's consistent requirement for this 6-month MMR benchmark means Terns must maintain this high efficacy signal in a larger patient population to move TERN-701 toward a New Drug Application (NDA).

Here's the quick math on their current financial position versus their R&D burn, which is directly tied to regulatory progression:

What this estimate hides is the step-up in R&D costs when a pivotal trial starts, so the current quarterly R&D expense of $19.9 million will rise significantly as TERN-701 advances into a larger, global study.

Intellectual property (IP) protection is crucial for small-molecule drugs like TERN-701 against generics and competitors.

As a small-molecule drug, TERN-701 faces an elevated IP risk compared to biologics, as small molecules are generally easier to reverse-engineer and manufacture as generics once the primary patent expires. Terns Pharmaceuticals' strategy is to build a robust patent portfolio around the molecule itself, its formulation, and its use.

The company has secured and is pursuing multiple layers of protection to extend its market exclusivity, which is essential for maximizing return on its R&D investment. The goal is to secure a patent life that extends well beyond the typical 20-year term from filing.

• Issued patents and pending applications cover the drug's polymorphs (different crystalline forms), methods of treatment/dosing, and combination treatment approaches.
• The company can potentially extend its patent exclusivity for up to an additional 5 years through a Patent Term Extension (PTE) under the Hatch-Waxman Act, which compensates for time lost during the FDA review process.
• Current IP timelines for TERN-701 are projected to extend past 2040 in the U.S. and other key territories, providing a long commercial runway against generic competition.

This long IP runway is a major asset, but still, any challenge from a competitor or generic manufacturer (an Abbreviated New Drug Application or ANDA filing) would trigger costly, time-consuming litigation. That's a significant, albeit necessary, legal expense for a company with a quarterly General and Administrative (G&A) expense of $7.8 million as of Q3 2025.

Biosecure Act implications could force supply chain changes if Terns uses specified foreign contractors.

The legislative environment in late 2025, particularly the potential enactment of the Biosecure Act (as part of the National Defense Authorization Act for Fiscal Year 2026), creates a major legal risk for Terns' supply chain. This Act is designed to prohibit U.S. federal agencies from contracting with, or providing loans/grants to, entities that use biotechnology equipment or services from a 'biotechnology company of concern'-which often means companies linked to foreign adversaries.

If Terns Pharmaceuticals uses a Contract Development and Manufacturing Organization (CDMO) or a Contract Research Organization (CRO) that is later designated as a company of concern, the implications are immediate and severe, especially since Terns is a clinical-stage company that relies heavily on third parties for manufacturing and trials. If the Act is passed, its reach extends to subcontractors, CROs, and data-management vendors.

The key action for Terns is supply chain due diligence right now. They need to:

• Identify all third-party vendors (CDMOs, CROs, data platforms) with ties to the specified foreign entities.
• Develop a substitution plan for any at-risk contractors, because a sudden transition can cause drug development delays and increase manufacturing costs.
• Be aware that there is no grace period for contracts with entities already on the Department of Defense's 1260H List, meaning an abrupt termination of those relationships would be required upon enactment.

Increased scrutiny on data security and privacy for clinical trial data.

The legal landscape governing clinical trial data security and privacy has tightened significantly in 2025, increasing compliance costs and risk for Terns. This scrutiny comes from multiple directions: U.S. national security, public transparency, and general data privacy regulations like the European Union's General Data Protection Regulation (GDPR).

First, a Department of Justice (DOJ) rule, effective April 8, 2025, prohibits or restricts access to bulk sensitive personal data of U.S. persons by entities tied to countries of concern, though there are exemptions for FDA-regulated clinical investigations. Terns must ensure its data-sharing practices with global partners fall within these exemptions.

Second, the 2025 amendments to the FDAAA 801 Final Rule, effective in September 2025, significantly increase public transparency requirements and penalties for non-compliance.

• The rule imposes tighter deadlines for submitting clinical trial results to ClinicalTrials.gov.
• It mandates the public posting of informed consent documents.
• Non-compliance can result in daily civil monetary penalties and public notices of violation, which is a major reputational risk.

Terns' internal compliance and IT systems must be up-to-date to handle these faster reporting deadlines and new data fields. The company's privacy policy already states it generally receives de-identified patient data from Investigative Sites and CROs, but the increasing regulatory focus means their compliance framework needs constant auditing.

Terns Pharmaceuticals, Inc. (TERN) - PESTLE Analysis: Environmental factors

As a clinical-stage company, Terns' direct environmental impact from manufacturing is currently low.

You need to see Terns Pharmaceuticals, Inc. (TERN) for what it is: a clinical-stage biotech, not a major manufacturer. That means its direct environmental footprint from operations (Scope 1 and 2 emissions) is minimal compared to a company with commercial-scale production facilities. Still, this low impact is temporary. The company's focus is now heavily on advancing its Chronic Myeloid Leukemia (CML) candidate, TERN-701, toward a pivotal trial, which means a future pivot to commercial-scale manufacturing is the goal. When that happens, the environmental profile changes completely, bringing in significant risks related to energy consumption, water use, and air emissions that must be planned for now.

Here's the quick math on their current scale: Terns' Research and Development (R&D) expenses were $19.9 million for the quarter ended September 30, 2025. This R&D spend is primarily on clinical trials, contract research, and lab work, not large-scale, energy-intensive Active Pharmaceutical Ingredient (API) production. The real environmental risk is currently hidden in the supply chain (Scope 3), which is where 70% to 90% of the pharmaceutical industry's greenhouse gas (GHG) emissions originate.

Global regulatory bodies like the EMA are applying stricter guidelines on sustainability in manufacturing.

Even as a clinical-stage company, Terns cannot ignore global regulatory pressure, especially if it plans to commercialize TERN-701 in Europe. The European Medicines Agency (EMA) is embedding stricter sustainability requirements into its Good Manufacturing Practices (GMP) framework. For any future drug approval, Terns must conduct thorough environmental risk assessments (ERAs) for its pharmaceutical products. This means assessing the persistence, bioaccumulation, and toxicity of active ingredients in water and soil. This is a critical, up-front R&D cost that impacts the drug development timeline.

Also, the European Union's Corporate Sustainability Reporting Directive (CSRD), which took effect in 2025, mandates detailed sustainability reports for large companies operating in the EU. While Terns may not be immediately in the first wave of reporting, its future partners or acquirers will be, and they will demand this data. This isn't a future problem; it's a defintely a current due diligence requirement for any partnership. The EMA also recently updated guidance in August 2025 on transitioning to low global warming potential (GWP) propellants, a sign of the increasing granularity of environmental regulation.

US regulatory emphasis on ESG reporting may ease, but global investors still prioritize it.

Honestly, the US federal regulatory picture on Environmental, Social, and Governance (ESG) is fragmented right now; the Securities and Exchange Commission (SEC) climate disclosure rules are stalled due to legal challenges. But don't mistake federal inaction for a lack of risk. State-level regulations, particularly in California, are stepping in to fill the void. California's Senate Bills (SB) 253 and 261 mandate extensive greenhouse gas emissions and climate-related financial risk disclosures for large businesses operating in the state. Terns, being a California-based company, will face these requirements as its revenue grows past the $1 billion threshold defined in the proposed state bills.

The real driver is the capital market. Global investors are still prioritizing ESG. Major pharmaceutical companies are spending an estimated $5.2 billion yearly on environmental programs, a 300% increase from 2020. This is the market signal, not the SEC. Terns' ability to secure future funding and partnerships, especially for its metabolic assets, hinges on demonstrating a credible ESG strategy, even if the US federal government eases its reporting emphasis.

Waste management and disposal of chemical compounds from R&D remain a compliance requirement.

Even at the R&D scale, Terns is generating hazardous waste. The disposal of chemical compounds, solvents, and biological materials from its lab work is a non-negotiable compliance requirement under US Environmental Protection Agency (EPA) regulations. This is a cost center, not a variable expense.

The company must maintain strict protocols for waste segregation, labeling, and disposal, which adds to the General and Administrative (G&A) overhead, which was $7.8 million in Q3 2025. The industry is shifting toward Green Chemistry (GC) principles to proactively minimize waste and reduce the use of toxic solvents, which is the smart way to cut future compliance costs. Terns' R&D teams need to embed GC into their process design now to avoid costly retrofits later when TERN-701 moves to commercial production.

Here is a summary of the key environmental compliance pressures for Terns:

Next step: Operations: Integrate Green Chemistry principles into all TERN-701 process development contracts by Q1 2026 to de-risk future commercial manufacturing.