Design Therapeutics, Inc. (DSGN): PESTLE Analysis [Nov-2025 Updated]

Design Therapeutics, Inc. (DSGN) is a classic high-stakes biotech play, where massive opportunity clashes directly with regulatory reality. You need to know that while the global biotech market is projected to expand to $546.0 billion in 2025, and Design Therapeutics, Inc. has a strong cash runway of $206 million funding operations into 2029, the political and legal environment is unforgiving. You're navigating the uncertainty of the US FDA clinical hold on DT-216P2 and the shadow of the Inflation Reduction Act (IRA) on future pricing, but you also have the tailwind of 95% of rare diseases still lacking therapy. This PESTLE analysis cuts through the noise to show you exactly where those hurdles meet the opportunity, so you can make a defintely informed decision.

Design Therapeutics, Inc. (DSGN) - PESTLE Analysis: Political factors

The political landscape for Design Therapeutics, Inc. (DSGN) in 2025 is a mix of high regulatory hurdles and significant, newly solidified legislative support for rare disease development. You are navigating a system where one hand-the U.S. Food and Drug Administration (FDA)-can issue a clinical hold, while the other-Congress-is actively expanding financial protections for your drug class.

The most immediate political risk is the regulatory friction, but the long-term pricing environment for your lead GeneTAC® molecules, which target rare genetic diseases like Friedreich ataxia (FA), has actually improved due to recent legislative action.

US FDA placed a clinical hold on the DT-216P2 IND in June 2025

The FDA's regulatory oversight is the primary political factor impacting your near-term timeline and investor confidence. In June 2025, the FDA placed a clinical hold on the Investigational New Drug (IND) application for DT-216P2, your GeneTAC® small molecule for Friedreich ataxia (FA). The FDA's request specifically pertained to the proposed starting dose in the U.S. and cited nonclinical deficiencies in the submission. This action delays the expansion of the RESTORE-FA Phase 1/2 multiple-ascending dose (MAD) trial into the U.S..

The good news is that the trial is continuing outside the U.S., specifically in Australia, where initial data has shown DT-216P2 to be generally well-tolerated. Still, this hold forces a delay in U.S. patient enrollment, which is defintely a headwind. Here's the quick math on the financial impact: Design Therapeutics reported a net loss of $19.1 million for the second quarter of 2025, with cash and securities totaling $216.3 million as of August 7, 2025. Every regulatory delay increases the cash burn rate and shortens the runway, making a swift resolution to the FDA's concerns critical.

Uncertainty from the Inflation Reduction Act (IRA) regarding future drug pricing negotiations

The pricing uncertainty created by the 2022 Inflation Reduction Act (IRA) has been a major concern for all rare disease companies, but recent 2025 legislation provides a clear, positive shift. The IRA's original text only exempted orphan drugs (drugs for rare diseases) if they were approved for a single rare disease indication. This discouraged companies from pursuing additional rare disease indications, a major business strategy for biotech.

However, that changed on July 4, 2025, when the One Big Beautiful Bill Act (OBBBA) was signed into law. This act significantly amended the IRA, expanding the Orphan Drug Exclusion to exempt drugs designated for one or more rare diseases or conditions from the Medicare Drug Price Negotiation Program for the initial price applicability year (IPAY) 2028 and after. This is a massive win for the rare disease sector, including Design Therapeutics, as it protects the future pricing power of DT-216P2 even if you successfully expand its use to other rare diseases. The Congressional Budget Office (CBO) estimates this expanded exclusion will increase Medicare spending by $8.8 billion between 2025 and 2034, underscoring the value of this policy to manufacturers.

Continued strong bipartisan support for Orphan Drug Act incentives and fast-track designations

The political will to support rare disease drug development remains strong and bipartisan. The core incentives of the Orphan Drug Act of 1983-like tax credits and seven years of market exclusivity-continue to enjoy broad support. The push to amend the IRA, which culminated in the OBBBA, was driven by bipartisan legislation like the ORPHAN Cures Act introduced in 2025 by lawmakers from both parties.

For Design Therapeutics, this support is tangible:

• The original DT-216 formulation received Fast Track designation from the FDA in 2022, which is a key incentive for accelerating the review of drugs for serious conditions with unmet medical need.
• Patient advocacy groups like the Friedreich's Ataxia Research Alliance (FARA) actively supported the legislative changes that protected your pricing power.

This political environment provides a stable, incentivized pathway for DT-216P2's development, despite the temporary clinical hold.

Potential instability from a new US administration impacting healthcare regulation and tariffs

The new U.S. administration, which took office in January 2025, has introduced a new layer of regulatory instability and a shift in FDA priorities. The administration has signaled a focus on streamlining 'red tape' and accelerating patient access to innovative treatments. However, this shift comes with its own risks.

The administration has also pushed an 'America First' trade agenda, including an Executive Order signed on May 5, 2025, aimed at promoting domestic production of critical medicines. This policy could lead to:

• Increased scrutiny of foreign manufacturing facilities, which complicates global supply chains.
• Potential tariffs on foreign-made pharmaceutical ingredients, which could raise your production costs.

Additionally, the FDA has experienced significant leadership changes and a reduction of approximately 3,500 employees. While the goal is efficiency, such a large staff reduction could inadvertently bring delays to the review and approval of new biopharmaceuticals, including your response to the DT-216P2 clinical hold.

Design Therapeutics, Inc. (DSGN) - PESTLE Analysis: Economic factors

Strong cash position of $206 million as of Q3 2025, funding operations into 2029.

You can't run a clinical-stage biotech without a strong balance sheet, and Design Therapeutics is in a defintely solid position. As of September 30, 2025, the company held cash, cash equivalents, and investment securities totaling $206.0 million. This is a crucial economic factor because it provides a long runway, which is essentially a buffer against the typical funding volatility in the biotechnology sector.

Management projects this cash reserve is sufficient to fund planned operating expenses and capital expenditures well into 2029. This four-year cash runway is significant; it allows the company to focus on advancing its GeneTAC® programs-like DT-216P2 for Friedreich Ataxia and DT-168 for Fuchs endothelial corneal dystrophy-through multiple clinical proof-of-concept readouts without the immediate pressure of a dilutive capital raise. A long runway means less market risk.

Global biotech market projected to expand to $546.0 billion in 2025, a 13% CAGR.

The broader market context is highly favorable for a company with innovative technology. The global biotechnology industry market size is projected to reach $546.0 billion in 2025, reflecting a Compound Annual Growth Rate (CAGR) of approximately 13.0%. This robust growth is driven by several macro-economic tailwinds, including an increasing focus on advanced therapies, personalized medicine, and the integration of Artificial Intelligence (AI) in drug discovery.

For Design Therapeutics, this expansion signals a growing appetite for novel therapeutic modalities like their small-molecule gene-targeted chimera (GeneTAC®) platform. The market is rewarding innovation, and the core drivers of this growth align perfectly with the company's focus on genetic disorders. The demand for biologics, such as gene therapies, is expanding, which validates the high-value nature of the diseases Design Therapeutics is targeting.

Q3 2025 Net Loss of $16.997 million reflects high, expected R&D burn rate.

The financial results for Q3 2025 show a net loss of $16.997 million, which is an expected consequence of being a clinical-stage research and development (R&D) company. The loss is not a sign of distress; it reflects the high cost of running clinical trials and advancing a pipeline.

Here's the quick math on the burn rate: Operating expenses for the quarter rose to $19.311 million, primarily driven by R&D expenses of $14.6 million. This R&D burn rate is the investment needed to generate future value through clinical data. The strong cash position ($206.0 million) is specifically there to absorb this burn and fund the pipeline into 2029. What this estimate hides is the potential for a significant drop in loss if a program is successfully out-licensed or if a strategic partnership is formed.

Increased M&A activity across the biotech sector provides a potential acquisition exit path.

The M&A landscape in biopharma is heating up in 2025, and this is a major economic opportunity for a company like Design Therapeutics. Big Pharma's deal capacity is estimated to exceed $1.5 trillion, and they are actively looking to acquire innovative, clinical-stage assets to offset looming patent expirations on blockbuster drugs. This dry powder is a huge factor.

The trend is a shift toward earlier-stage, high-value deals. Biopharma M&A activity was robust in Q3 2025, completing 35 transactions totaling $30.8 billion. Smaller biotech firms with promising innovations in high-demand therapeutic areas-like genetic disorders, which Design Therapeutics targets-are highly attractive targets.

The focus is on pipeline replenishment, which favors companies with novel platforms and clinical-stage assets. This is a clear economic opportunity that could provide a non-dilutive exit or a major partnership for Design Therapeutics. The recent appointment of Justin Gover, a veteran who successfully led GW Pharmaceuticals to a major acquisition, to the Board of Directors in September 2025, also signals an awareness of this strategic exit path.

• Big Pharma capacity exceeds $1.5 trillion for deals.
• Q3 2025 biopharma M&A totaled $30.8 billion.
• Acquirers are focusing on earlier-stage, pre-Phase 3 assets.

Design Therapeutics, Inc. (DSGN) - PESTLE Analysis: Social factors

The social environment for Design Therapeutics, Inc. (DSGN) is a powerful tailwind, driven by a humanitarian imperative in rare diseases and a fundamental shift in how society views and funds genetic medicine. This environment creates both a massive market opportunity and significant pressure to deliver on promises of equity and access.

High unmet need in the rare disease space, where an estimated 95% of diseases still lack therapy.

The core of Design Therapeutics' opportunity is the staggering unmet need in the rare disease community. As of 2025, only about 5% of the more than 7,000 identified rare diseases have an approved treatment, meaning a massive 95% of these conditions still lack any specific therapy. This treatment gap affects an estimated 300 to 400 million people globally. The economic burden is immense; health care expenses for Americans with rare diseases are three to five times greater than for those without, contributing to a total annual economic burden in the U.S. that is approaching $1 trillion.

This reality makes the company's GeneTAC platform, which is designed to address the root genetic cause, a direct response to a profound public health crisis. It's a simple equation: the larger the unmet need, the greater the potential market for a first-in-class therapy. Design Therapeutics reported a net loss of $19.1 million in the second quarter of 2025, but this burn rate is justified by the scale of the problem they are attempting to solve. They must, however, move quickly to capture this first-mover advantage.

Growing patient advocacy groups for conditions like Friedreich ataxia (FA) drive research funding and awareness.

Patient advocacy groups are no longer passive; they are sophisticated, well-funded, and politically savvy drivers of drug development. For Design Therapeutics' lead program, DT-216P2 for Friedreich ataxia (FA), the Friedreich's Ataxia Research Alliance (FARA) is a critical social and financial partner. FARA has invested over $95 million in FA research to date and leveraged an additional $198.5 million in federal funding for FA research.

These groups directly influence the clinical and regulatory landscape. For instance, FARA and the National Ataxia Foundation (NAF) hosted the United Against Ataxia Hill Day in September 2025 to advocate for increased appropriations and legislation. This activism creates a favorable environment-a social license to operate-that accelerates trial recruitment, provides patient insights, and pressures the FDA for faster approvals. The patient community is defintely your co-investor in this space.

Increasing pressure for health equity and diverse patient recruitment in global clinical trials.

Societal pressure for health equity is translating directly into regulatory mandates that impact clinical trial design and cost. The FDA's diversity action plan requirements for Phase III clinical trials are set to take effect in mid-2025. This is a critical factor for Design Therapeutics as they advance their pipeline, including the Phase 1/2 multiple ascending dose (MAD) patient study for DT-216P2 in FA patients, which was planned to begin in mid-2025.

Historically, underrepresented minority groups, such as Black and Hispanic populations, frequently account for less than 10% of clinical trial participants. To comply with the new FDA mandates and ensure the generalizability of their GeneTAC therapies, Design Therapeutics must actively invest in decentralized trial models, community partnerships, and patient-centric approaches like flexible scheduling. Failure to meet diversity goals could delay regulatory submission and ultimately, market access.

Societal shift toward precision medicine (therapies tailored to specific genetic mutations).

The most significant long-term social trend supporting Design Therapeutics is the global shift toward precision medicine, which tailors treatment based on an individual's unique genetic profile. The global precision medicine market is projected to reach approximately $118.52 billion in 2025, and is expected to grow at a Compound Annual Growth Rate (CAGR) of 16.35% from 2025 to 2034.

Design Therapeutics' GeneTAC platform, which uses small molecules to directly modulate the expression of a disease-causing gene, is perfectly positioned within this high-growth segment. This approach is viewed favorably by patients and payers because it promises increased treatment efficacy and minimizes the trial-and-error often associated with traditional drugs. The development of cell and gene therapies, a key component of precision medicine, is scaling rapidly, moving beyond niche applications to target rare diseases like FA.

Here's the quick math on the runway: with $216.3 million in cash as of June 30, 2025, and a quarterly net loss of $19.1 million, the company has a strong cash position to navigate these social and regulatory shifts into 2029. This long runway is crucial because the social pressures demand careful, patient-centric trial execution, which takes time.

Design Therapeutics, Inc. (DSGN) - PESTLE Analysis: Technological factors

Core GeneTAC® (Gene Targeted Chimera) platform offers a novel small molecule approach to genetic disease.

You're looking at a fascinating piece of technology here. Design Therapeutics' core innovation is the Gene Targeted Chimera (GeneTAC®) platform, which represents a significant technological pivot in genomic medicine. Instead of relying on complex, delivery-challenged gene or cell therapies, GeneTAC® uses a small molecule approach. This is a big deal because small molecules are typically easier to manufacture, distribute, and administer (often as a pill), which drastically lowers the patient and logistical burden.

The platform is designed to target specific, repetitive DNA sequences-like the trinucleotide repeats found in Friedreich's Ataxia-and recruit the cell's own machinery to correct the underlying genetic defect. This novel mechanism has the potential to treat a wide range of inherited diseases that were previously considered undruggable with conventional small molecules. That's the real opportunity: a scalable, oral therapy for genetic disease.

DT-216P2 (FA) and DT-168 (FECD) are actively advancing in mid-2025 clinical trials.

The pipeline is where the rubber meets the road. As of mid-2025, the lead candidate, DT-216P2 for Friedreich's Ataxia (FA), is advancing, with the goal of increasing frataxin (FXN) protein levels in patients. The success of this program hinges on demonstrating a clear, dose-dependent increase in FXN expression in the ongoing Phase 2 trials. For investors, this is the single most important near-term data readout.

Also moving forward is DT-168 for Fuchs Endothelial Corneal Dystrophy (FECD). This program is significant because it validates the platform's versatility beyond trinucleotide repeat disorders, targeting a different type of genetic repeat. The company's technology is defintely proving its broad applicability across various genetic mechanisms.

Here's the quick snapshot of the pipeline focus:

• DT-216P2 (FA): Targets FXN gene repeats.
• DT-168 (FECD): Targets CTG repeats in the TCF4 gene.
• Goal: Validate GeneTAC® platform across diverse genetic diseases.

Industry-wide adoption of Artificial Intelligence (AI) to accelerate drug target identification and discovery.

The entire drug discovery landscape is being reshaped by Artificial Intelligence (AI) and Machine Learning (ML), and Design Therapeutics must keep pace. AI is now being used to rapidly screen billions of compounds, predict their efficacy, and optimize clinical trial design. This drastically cuts the time and cost for competitors, putting pressure on companies relying solely on traditional methods.

For Design Therapeutics, the opportunity is to integrate AI into their GeneTAC® platform to:

• Identify new targets: Find novel genetic repeats amenable to GeneTAC® modulation.
• Optimize chimera design: Refine the small molecule structure for better binding and potency.
• Predict toxicity: Screen out potential liabilities early in the preclinical phase.

If they don't use AI to accelerate their discovery funnel, their competitors will simply move faster. It's a race, and AI is the jet fuel.

Competition from other genomic medicine modalities, including gene and cell therapies.

While the GeneTAC® platform is novel, it operates in a highly competitive space. Its primary technological rivals are not other small molecules, but more established and well-funded genomic medicine modalities, specifically gene therapy and antisense oligonucleotides (ASOs).

Gene and cell therapies, despite their high cost and complex delivery, offer the potential for a one-time curative treatment, which is a powerful narrative for patients and investors. For instance, companies like BlackRock have significant exposure to the gene therapy sector, which has seen substantial investment inflows. The key technological differentiators are summarized below:

The technological edge for Design Therapeutics is the potential for an oral therapy, which is a massive quality-of-life improvement over repeated injections or one-time, high-risk infusions. But they must prove that their small molecule can achieve durable, therapeutic efficacy comparable to their rivals.

Design Therapeutics, Inc. (DSGN) - PESTLE Analysis: Legal factors

Must navigate complex, multi-jurisdictional regulatory pathways (e.g., FDA hold vs. ex-US trial progress).

The foremost legal challenge for Design Therapeutics is successfully navigating the fragmented, high-stakes regulatory environment, particularly for its lead small-molecule candidates. For DT-216P2, the Friedreich ataxia (FA) program, the company received a U.S. Food and Drug Administration (FDA) clinical hold notice in June 2025 on its Investigational New Drug (IND) application for U.S. sites due to nonclinical deficiencies. This regulatory hurdle defintely delays the ability to enroll U.S. patients, a key market.

But here's the quick math on the risk mitigation: The company has successfully leveraged a multi-jurisdictional strategy, continuing to dose patients in its RESTORE-FA Phase 1/2 multiple-ascending dose (MAD) trial outside the U.S., specifically in Australia. This international progress allows the trial to continue advancing toward the anticipated 2026 data readout, even as the U.S. regulatory issue is addressed. This dual-path strategy is expensive, but it keeps the program moving.

The same strategy is visible in their Myotonic Dystrophy Type-1 (DM1) program, DT-818, which obtained ex-U.S. regulatory clearance in late 2025 for a Phase 1 MAD trial set to begin in early 2026. This ability to secure non-U.S. clearance acts as a critical operational hedge against domestic regulatory slowdowns.

Intellectual property (IP) protection for the GeneTAC® platform is critical to long-term valuation.

The entire valuation of Design Therapeutics hinges on the strength and breadth of its Intellectual Property (IP) portfolio protecting the GeneTAC® (Gene Targeted Chimera) platform. This platform is a novel class of small molecules designed to modulate gene expression, and its novelty means the IP must be rigorously defended against competitors attempting to create similar gene-targeting small molecules. The company's cash position of $206 million as of September 30, 2025, must cover not just R&D, but also the significant legal costs associated with patent prosecution and potential litigation to safeguard this core asset.

If the foundational patents for the GeneTAC mechanism are successfully challenged, the company's market capitalization, which stood at approximately $382 million as of October 31, 2025, would face an immediate and severe correction. IP is the moat protecting the GeneTAC castle.

Drug pricing legislation, like the IRA, creates commercial uncertainty for future high-cost therapies.

The Inflation Reduction Act (IRA) of 2022 introduces significant commercial uncertainty for future high-cost therapies like the GeneTAC candidates, which are small molecules. The IRA's provisions, which began to take effect in 2025, create a difficult planning environment for launch pricing and reimbursement strategy.

Key IRA provisions impacting Design Therapeutics' future commercial model include:

• Medicare Part D Redesign (2025): Manufacturers are now required to give mandatory discounts of 10% of drug costs in the initial coverage period and 20% in the catastrophic coverage period.
• Medicare Out-of-Pocket Cap (2025): The new $2,000 annual out-of-pocket cap for Medicare Part D beneficiaries, starting in 2025, while helping patients, shifts a greater portion of the cost burden onto manufacturers and health plans.
• Small Molecule Disadvantage: The IRA's negotiation provisions, which start in 2026, target small-molecule drugs for negotiation after only nine years on the market, compared to 13 years for biologics. This shortens the period of peak, unnegotiated revenue.

This negotiation timeline is particularly concerning because Design Therapeutics' GeneTACs are small molecules. Research published in 2025 showed that investment into small molecules, relative to large molecules, was disproportionately impacted following the IRA's passage, with a reported 68% decline in investment into small molecules in clinical trials from 2018 to 2024. That's a serious headwind for their entire pipeline.

Compliance with global data privacy laws, such as HIPAA, for clinical trial data management.

As a global clinical-stage company, Design Therapeutics must strictly comply with a patchwork of international and domestic data privacy regulations to manage sensitive patient data from its trials. The Health Insurance Portability and Accountability Act (HIPAA) in the U.S. governs the protection of Protected Health Information (PHI) collected during their U.S.-based or U.S.-affiliated clinical trials.

Furthermore, the company must also manage compliance with evolving state-level laws, such as the California Consumer Privacy Act (CCPA), and international regulations like the General Data Protection Regulation (GDPR) for their ex-U.S. clinical sites (like the ongoing FA trial in Australia). Non-compliance with these laws can result in significant financial penalties, which could directly impact their operating expenses. For example, the Q3 2025 General and Administrative (G&A) expenses were $4.7 million, and any major compliance fine would immediately inflate this figure and divert capital from the $14.6 million in Q3 2025 Research and Development (R&D) spend.

Next step: Legal Counsel: Draft a formal response plan to the FDA's clinical hold on DT-216P2 by the end of the quarter, detailing the nonclinical data required to resolve the issue.

Design Therapeutics, Inc. (DSGN) - PESTLE Analysis: Environmental factors

Pharma sector contributes approximately 4.4% of global greenhouse gas (GHG) emissions.

You need to understand that the pharmaceutical industry's environmental footprint is substantial, even for a clinical-stage company like Design Therapeutics, Inc. The entire healthcare sector accounts for about 5% of global greenhouse gas (GHG) emissions, with the pharmaceutical and life sciences industry specifically contributing approximately 4.4% to 4.5% of worldwide GHG emissions.

This is a major headwind. To align with the Paris Agreement goals, the pharma industry was urged to cut its emissions intensity by an estimated 59% from 2015 levels by the end of 2025. For a small molecule developer, the bulk of this challenge lies in the supply chain-Scope 3 emissions-which typically represent 80% to 90% of a pharmaceutical company's total carbon footprint.

Here's the quick math on the industry's carbon intensity:

Your GeneTAC® platform, while innovative in mechanism, still relies on small molecule chemistry, which is notoriously carbon-intensive. That's a huge supply chain risk you have to manage.

Growing investor focus on ESG (Environmental, Social, and Governance) performance in the biotech sector.

Investor scrutiny on ESG performance is not a fad; it's a structural shift, especially in 2025. The global ESG-focused investment market is projected to reach $40 trillion by 2030, so capital allocation is increasingly tied to demonstrable sustainability.

For a publicly traded clinical-stage company like Design Therapeutics, Inc., maintaining a strong cash position-which was $206.0 million in cash and securities as of the third quarter of 2025-is critical, and future capital raises will face pointed ESG questions. Investors are moving past generic ESG labels and focusing on tangible actions in 'transition investing.'

Key investor demands for the biotech sector in 2025 include:

• Quantifiable decarbonization plans for biomanufacturing.
• Transparency in Scope 3 emissions reporting.
• Evidence of 'greener' drug design principles in the R&D pipeline.

Since Design Therapeutics, Inc. is currently focused on clinical milestones, like initiating the Phase 2 biomarker trial for DT-168 in the second half of 2025, its environmental disclosure is minimal. This lack of public ESG data creates a disclosure risk that could impact your stock's appeal to large, sustainability-mandated funds down the road.

Need for robust waste management protocols for laboratory and clinical trial materials (e.g., chemical/bio-waste).

The waste profile of a small molecule drug developer is heavily skewed toward hazardous materials, even in the clinical stage. Traditional small molecule synthesis relies on organic solvents, which account for 80% to 90% of the total mass used in a reaction, and consequently, 80% to 85% of the waste generated.

Globally, the production of active pharmaceutical ingredients (APIs) generates an estimated 10 billion kilograms of waste annually, with disposal costs nearing $20 billion. While Design Therapeutics, Inc. is not yet at commercial-scale manufacturing, its preclinical and clinical trial activities-such as the ongoing Phase 1/2 RESTORE-FA trial for DT-216P2-still produce significant quantities of chemical and bio-waste that require stringent, costly protocols.

Your waste management challenge is defintely two-fold:

• Lab Waste: Managing the hazardous organic solvents and reagents used in GeneTAC® discovery and preclinical optimization.
• Clinical Waste: Ensuring proper disposal of clinical trial materials, including needles, vials, and unused drug product (DT-216P2, DT-168, etc.), which is subject to strict bio-waste regulations in the US and international trial sites.

Pressure to adopt green chemistry practices to reduce the environmental footprint of small molecule manufacturing.

The pressure to adopt green chemistry (a set of 12 principles designed to minimize or eliminate hazardous substances) is intensifying for all small molecule companies. This isn't just about PR; it's about efficiency and cost.

The core business of Design Therapeutics, Inc. is developing small molecules-GeneTAC® gene targeted chimera small molecules-which means your future commercial-scale manufacturing processes must be designed with sustainability from the start, a concept known as 'Eco-design.'

The industry is already seeing major advancements that you must integrate:

• Solvent Replacement: Replacing traditional hazardous organic solvents with greener alternatives like water or deep eutectic solvents (DESs).
• Catalysis: Using biocatalysis (enzymes) in synthesis, which can shorten manufacturing time by 80% and reduce starting material costs by over 99% in some cases.
• Continuous Flow: Implementing continuous manufacturing, which uses smaller reactors and eliminates the need to stop, cool, or clean the reactor repeatedly, thus saving energy and reducing waste.

If you don't embed these 'greener-by-design' principles now during the late preclinical and early clinical stages, the cost of retrofitting a commercial-scale process later will be enormous. That's a clear financial risk.