Dyne Therapeutics, Inc. (DYN): Business Model Canvas [Dec-2025 Updated]

You're digging into Dyne Therapeutics, Inc. (DYN) right now, and honestly, what you're looking at is a classic high-risk, high-reward biotech play, especially with registrational trials pushing for potential Accelerated Approval in 2026. This business model is all about fueling that proprietary FORCE™ platform-their targeted muscle delivery tech-through massive Research and Development spend, which hit $97.2 million in Q3 2025 alone, even while holding a war chest of $791.9 million in cash and equivalents. We need to see how their key activities, like executing the ACHIEVE and DELIVER trials and managing that $275 million Hercules Capital debt, translate into the value proposition of functional improvement for Myotonic Dystrophy Type 1 (DM1) and Duchenne Muscular Dystrophy (DMD) patients; check out the full canvas breakdown below to see the precise structure supporting this make-or-break near-term push.

Dyne Therapeutics, Inc. (DYN) - Canvas Business Model: Key Partnerships

You're looking at how Dyne Therapeutics, Inc. (DYN) structures its external relationships to fund its pipeline and execute its clinical strategy as of late 2025. Honestly, for a clinical-stage company, these partnerships-especially the financing ones-are the lifeblood keeping the lights on and the trials moving forward.

The company has clearly been active in shoring up its balance sheet through both debt and equity offerings in mid-2025, which directly impacts its operational runway. As of September 30, 2025, Dyne Therapeutics reported cash, cash equivalents and marketable securities totaling $791.9 million. Management stated this cash position is expected to be sufficient to fund operations into the third quarter of 2027.

Financing and Capital Market Partnerships

The debt facility with Hercules Capital and the recent public stock offering highlight key financial partners Dyne Therapeutics relies on to advance its programs, like DYNE-101 for myotonic dystrophy type 1 (DM1) and DYNE-251 for Duchenne muscular dystrophy (DMD).

Here's a quick look at the structure of the major financing events from mid-2025:

• Hercules Capital debt facility size: up to $275 million non-dilutive senior secured term loan.
• Initial Hercules Capital funding at closing: $100 million.
• Contingent Hercules Capital funding tied to milestones: up to $175 million.
• Public offering gross proceeds (July 2025): approximately $230.0 million.
• Public offering share price: $8.25 per share.
• Total shares sold in the closing offering: 27,878,788 shares.

These financial relationships are critical, as they are timed to support potential U.S. Accelerated Approval submissions planned for 2026 and a targeted U.S. launch of the DMD treatment by 2027.

The investment banks that managed these capital market activities are crucial for executing equity raises. The structure of the July 2025 offering involved a syndicate of major financial players:

The initial proposed offering was for $200.0 million, with an option for underwriters to purchase an additional $30,000,000 of shares, which was fully exercised for the final $230.0 million gross proceeds.

Operational and Research Partnerships

While specific financial terms for operational partners aren't always public, Dyne Therapeutics, Inc. relies on a network to execute its global clinical strategy. The outline suggests partnerships in three key operational areas:

• Clinical research organizations (CROs) for global trial execution.
• Academic and medical institutions for clinical trial sites and expertise.
• Specialized suppliers for oligonucleotide and Fab component manufacturing.

For instance, the company reported in May 2025 that it had initiated a global placebo-controlled Registrational Expansion Cohort in the ACHIEVE trial, which will include up to 48 participants, with full enrollment planned for mid-2025. Data from this cohort is planned for the first half of 2026. For the DELIVER trial in DMD, the Registrational Expansion Cohort of 32 patients was fully enrolled, with data planned for late 2025. These trial activities necessitate strong relationships with CROs and site investigators.

Finance: review debt covenant triggers for the remaining $175 million Hercules tranche by next Tuesday.

Dyne Therapeutics, Inc. (DYN) - Canvas Business Model: Key Activities

You're looking at the core engine of Dyne Therapeutics, Inc. (DYN) right now, which is heavily weighted toward clinical execution and platform validation. The key activities center on pushing their two lead candidates through registrational trials while maintaining a tight grip on capital.

Research and development (R&D) of the FORCE™ platform

The primary R&D activity is advancing the proprietary FORCE™ platform, which is designed to deliver targeted therapeutics broadly and deeply into muscle and the central nervous system (CNS) for genetically driven neuromuscular diseases. This work is reflected directly in the operating expenses.

Here's the quick math on R&D spend:

The company is focused on using this platform to develop zeleciment rostudirsen (for DMD) and zeleciment basivarsen (for DM1). What this estimate hides is the allocation between the two lead programs and platform maintenance.

Conducting registrational clinical trials (ACHIEVE for DM1, DELIVER for DMD)

Dyne Therapeutics is executing on two critical registrational expansion cohorts (REC) to support potential U.S. Accelerated Approval submissions. The activity here is intense enrollment and data generation.

• DELIVER Trial (z-rostudirsen/DYNE-251 for DMD): Enrollment of the REC, which included 32 patients, was completed in March 2025. Topline data from this cohort is expected in December 2025.
• ACHIEVE Trial (z-basivarsen/DYNE-101 for DM1): This cohort is planned to enroll 60 participants, randomized 3:1 to the 6.8 mg/kg Q8W dose or placebo. Full enrollment is now anticipated in early Q2 2026, a change from previous guidance of Q4 2025, following an expansion of clinical trial sites in the U.S. starting in September 2025.

Additional one-year clinical data from the ACHIEVE trial, demonstrating functional improvement across multiple measures at the 6.8 mg/kg Q8W dose, was presented in October 2025 at the World Muscle Society (WMS) congress.

Manufacturing and supply chain development (CMC infrastructure)

A key activity is building out the Chemistry, Manufacturing, and Controls (CMC) infrastructure necessary for commercial readiness. This is being done concurrently with late-stage clinical work.

The Chief Financial Officer stated in November 2025 that Dyne Therapeutics is on track with the buildout of its CMC infrastructure. This activity is supported by the company's current cash position, which is expected to fund operations, debt service, and capital expenditure requirements into Q3 2027.

Regulatory submissions (BLA) and securing expedited designations (Breakthrough Therapy)

Securing regulatory momentum and preparing for Biologics License Application (BLA) submissions are high-priority activities.

Expedited designations secured include:

• Breakthrough Therapy Designation (BTD) from the FDA for z-rostudirsen in DMD (August 2025).
• Breakthrough Therapy Designation (BTD) from the FDA for z-basivarsen in DM1 (June 2025).
• Orphan Drug Designation from the European Commission for z-rostudirsen in April 2025.

Anticipated BLA submission timelines for U.S. Accelerated Approval are:

The company believes it has sufficient funds to submit two BLAs for U.S. Accelerated Approval. For z-basivarsen, an intermediate efficacy endpoint of video hand opening time (vHOT) was agreed upon with the FDA to support Accelerated Approval.

Building a capital-efficient rare disease commercial organization

Dyne Therapeutics is actively engaged in building out its commercial capabilities, aiming for efficiency given the rare disease focus. This is a forward-looking activity supported by recent financing.

The CFO confirmed in November 2025 that the company is on track with the buildout of a capital-efficient rare disease commercial organization. This is supported by a strong balance sheet, with cash, cash equivalents, and marketable securities totaling $791.9 million as of September 30, 2025. Furthermore, a $275 million non-dilutive senior secured term loan facility was entered into in June 2025, with an initial term loan tranche of $100 million funded at closing, providing strategic flexibility through key inflection points toward a potential first U.S. launch in Q1 2027.

Dyne Therapeutics, Inc. (DYN) - Canvas Business Model: Key Resources

You're looking at the core assets Dyne Therapeutics, Inc. (DYN) is relying on to execute its strategy in late 2025. These aren't just line items; they are the engine for their entire value proposition.

The most tangible resource right now is the balance sheet strength. As of September 30, 2025, Dyne Therapeutics, Inc. reported cash, cash equivalents, and marketable securities of $791.9 million. This capital position is expected to fund operations into the third quarter of 2027, which is a critical runway given the near-term data readouts planned.

This financial backing directly supports the heavy investment in R&D. For the three months ended September 30, 2025, Research and development (R&D) expenses were $97.2 million. This is up from $92.8 million for the same period in 2024. Also, General and administrative (G&A) expenses for the quarter were $16.7 million, compared to $12.9 million the prior year.

The intellectual capital is centered around the proprietary FORCE™ platform. This is their technology for targeted muscle delivery, designed to overcome existing limitations in gene therapy delivery. This platform underpins their pipeline candidates, which are Fab-oligonucleotide conjugates, and the associated Intellectual Property (IP) is a major barrier to entry for competitors. Honestly, without that platform, the cash is just cash.

The specialized scientific and clinical development personnel are the team that brings this IP to life. As of October 2025, Dyne Therapeutics, Inc. has approximately 241 employees across 3 continents. These are the folks driving the clinical execution.

Key clinical data from the lead programs are perhaps the most time-sensitive resources. Here's a quick look at the status of the two lead assets as of late 2025:

• The registrational expansion cohort of the DELIVER trial for DYNE-251 in Duchenne Muscular Dystrophy (DMD) completed enrollment of 32 patients in March 2025.
• Data from this DELIVER cohort is expected in December 2025, which could support a potential U.S. Accelerated Approval submission.
• For DYNE-101 in Myotonic Dystrophy Type 1 (DM1), Dyne Therapeutics, Inc. presented additional one-year clinical data from the ACHIEVE trial in October 2025, specifically showing improvement at the 6.8 mg/kg Q8W dose.

To give you a clearer picture of the financial scale supporting these human and technological resources, look at this snapshot:

The ability to generate and interpret this clinical data-especially functional improvement across multiple measures in DM1 and DMD-is a core, non-fungible resource. The European Commission granted Orphan Drug Designation to DYNE-251 in April 2025, which is another form of regulatory IP protection that adds value to that asset.

Dyne Therapeutics, Inc. (DYN) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Dyne Therapeutics, Inc. (DYN) is positioned to create value in the neuromuscular space as of late 2025. It all comes down to their delivery technology and the clinical progress of their lead assets.

Targeted delivery to muscle and CNS via the FORCE™ platform

The FORCE™ platform is the engine here, designed to deliver therapeutics specifically to muscle tissue and the central nervous system (CNS). This is key because many neuromuscular diseases involve both areas. For instance, zeleciment basivarsen (DYNE-101) uses an antisense oligonucleotide (ASO) linked to a fragment antibody (Fab) that binds to the transferrin receptor 1 (TfR1) to achieve this targeted delivery. The platform's modularity supports a broad pipeline across several indications.

The platform supports a pipeline targeting:

• Myotonic Dystrophy Type 1 (DM1)
• Duchenne Muscular Dystrophy (DMD)
• Facioscapulohumeral Muscular Dystrophy (FSHD) (preclinical)
• Pompe disease (preclinical)

Potential to address the root cause of genetically driven neuromuscular diseases

Dyne Therapeutics, Inc. is focused on creating therapeutics that go after the underlying genetic cause of these diseases, rather than just managing symptoms. This approach is what drives the potential for life-transforming results. For DM1, DYNE-101 is designed to reduce toxic nuclear DMPK RNA, which then releases splicing proteins to allow normal mRNA processing.

Functional improvement for patients with Myotonic Dystrophy Type 1 (DM1) and Duchenne Muscular Dystrophy (DMD)

The value proposition is being validated by clinical data showing functional gains in the two lead programs. The market is watching these milestones closely, as reflected by the company's market capitalization of $3.21B as of October 31, 2025.

For DM1, Dyne Therapeutics, Inc. is targeting an estimated patient population of approximately 40,000 in the U.S. and 55,000 in the EU. For DMD, the company is pursuing patients amenable to exon 51 skipping.

Expedited regulatory pathway potential (Breakthrough Therapy Designation)

The potential for faster regulatory review is a significant value driver, especially given the lack of approved disease-modifying therapies for DM1. Dyne Therapeutics, Inc. has secured key designations:

• DYNE-101 (DM1): Granted Breakthrough Therapy Designation by the FDA in June 2025.
• DYNE-251 (DMD): Granted Breakthrough Therapy Designation by the FDA in August 2025.
• DYNE-251 (DMD): Received Orphan Drug Designation from the European Commission in April 2025.

These designations support the company's plans for potential U.S. Accelerated Approval submissions in 2026 for both lead programs. The company's financial position, with cash, cash equivalents, and marketable securities at $791.9 million as of September 30, 2025, is intended to fund operations into the third quarter of 2027, covering these critical milestones.

Non-viral, modular platform for multiple neuromuscular indications

The platform's design allows for the development of multiple candidates by swapping out the payload component while keeping the delivery system consistent. This modularity suggests efficiency in expanding the pipeline beyond the two clinical-stage assets. The company is advancing preclinical programs for FSHD and Pompe disease, indicating a strategy to address several genetically driven neuromuscular conditions with a common technological base.

Dyne Therapeutics, Inc. (DYN) - Canvas Business Model: Customer Relationships

You're looking at how Dyne Therapeutics, Inc. manages its critical external relationships-the people and bodies that directly influence its path to market and its valuation. For a company focused on rare, genetically driven diseases, these aren't just transactional contacts; they are deep, necessary partnerships. Honestly, the success of a platform like FORCE™ hinges on earning trust with these specific groups.

High-touch engagement with patient advocacy groups for rare diseases

Dyne Therapeutics maintains a commitment to listening to and learning from the communities it aims to serve, specifically those living with myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD), and facioscapulohumeral muscular dystrophy (FSHD). The company views community members as experts who guide the development of targeted therapies focused on functional improvement. This engagement is formalized through dedicated roles, such as the Vice President of Global Patient Advocacy, who implements engagement strategies to integrate patient expertise into clinical development. For instance, to commemorate Rare Disease Day in 2025, Dyne Therapeutics hosted members of the neuromuscular disease community, including the Dynamos and their families, to hear firsthand accounts emphasizing the need for societal change in how people with rare diseases are seen and treated.

The functional data shared with these groups is concrete, reflecting the patient-centric focus:

• Mean absolute dystrophin level of 3.7% of normal at 6 months for DYNE-251 (20 mg/kg Q4W).
• Adjusted mean absolute dystrophin level of 8.2% when accounting for muscle content.
• Improvements observed in multiple functional endpoints, including the NorthStar Assessment for Duchenne Muscular Dystrophy (NSAA).

Direct communication with regulatory bodies (FDA, EMA) for expedited pathways

Direct, frequent communication with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) is central to Dyne Therapeutics' strategy to accelerate development for serious conditions. The company actively pursues expedited pathways, which is evident in the designations granted to its lead candidates. This close dialogue is designed to secure senior-level involvement and early feedback on trial design to streamline development and review timelines.

Here's a snapshot of the regulatory interactions and achievements as of late 2025:

The goal of these expedited pathways is clear: Dyne Therapeutics anticipates a potential Biologics License Application (BLA) submission for U.S. Accelerated Approval for DYNE-251 in early 2026.

Close collaboration with clinical investigators and key opinion leaders

The company relies on a network of clinical investigators and Key Opinion Leaders (KOLs) to execute its global trials and validate its approach. This collaboration spans multiple specialties relevant to neuromuscular diseases. Dyne Therapeutics engages KOLs across various disciplines, including neurology, cardiology, physical medicine and rehabilitation, pulmonology, and physical therapy, gathering feedback globally to ensure patient-centric trial design. For example, the DELIVER trial for DYNE-251 has fully enrolled its Registrational Expansion Cohort (REC) of 32 patients.

The structure of these collaborations is adaptive. The ACHIEVE trial for DYNE-101 included an adaptive design to optimize dose and regimen, and the company submitted a revised protocol to the FDA for its REC, incorporating video hand opening time (vHOT) as a primary endpoint for U.S. Accelerated Approval.

Investor relations and public updates on clinical milestones

Investor relations activity is tightly coupled with clinical data readouts, which are the primary value drivers for a clinical-stage biotech. Dyne Therapeutics schedules major announcements around key data points to manage market expectations and provide transparency on financial runway.

Key dates and financial context for late 2025 include:

• Planned announcement of topline clinical results from the DELIVER REC (DYNE-251) on December 8, 2025, with a webcast at 8:00 a.m. ET.
• The primary endpoint for this REC data is the change from baseline in dystrophin protein by Western blot at 6 months.
• As of September 30, 2025, Dyne Therapeutics reported cash, cash equivalents, and marketable securities of $791.9 million.
• The company estimates these funds are sufficient to fund operations into the third quarter of 2027.
• For the three months ended September 30, 2025, the net loss was $108.0 million, or $0.76 per basic and diluted share.
• General and administrative (G&A) expenses for the three months ended September 30, 2025, totaled $16.7 million.

The stock price was $20.28 at the last close before the December 8, 2025, data event, trading above the 200-day moving average of $13.11. Finance: draft 13-week cash view by Friday.

Dyne Therapeutics, Inc. (DYN) - Canvas Business Model: Channels

You're looking at the pathways Dyne Therapeutics, Inc. uses-and plans to use-to get their specialized treatments from the lab bench to the patient's bedside. For a company focused on rare neuromuscular diseases, these channels are highly specialized, relying heavily on clinical sites and regulatory bodies before a commercial sales force is even built out.

Global clinical trial network for patient enrollment and drug administration

The clinical trial network is the primary channel for drug administration right now. Dyne Therapeutics, Inc. is running global trials, like the DELIVER trial for DYNE-251 in Duchenne muscular dystrophy (DMD) and the ACHIEVE trial for DYNE-101 in myotonic dystrophy type 1 (DM1). These sites are where the data-and the drug-are actually delivered to the patient population.

For the DELIVER trial, Dyne Therapeutics, Inc. has completed enrollment of 32 patients in the Registrational Expansion Cohort. As of March 16, 2025, a total of 970 doses of DYNE-251 had been administered across the trial, representing over 77.1 patient-years of follow-up, with some participants followed for up to ~2.5 years. Data from this DMD cohort are planned for late 2025.

The ACHIEVE trial for DM1 is also a key channel. Dyne plans to complete enrollment of the Registrational Expansion Cohort, which is planned for up to 48 patients (with 60 patients planned in total for this cohort), in Q4 2025. Data from this DM1 cohort are expected in mid-2026. The MAD (Multiple Ascending Dose) portion of ACHIEVE had 56 patients enrolled through the 6.8 mg/kg Q8W cohort as of June 2025, with over 72-patient years of follow-up reported.

Here's a quick look at the patient engagement scale:

• DELIVER Trial (DYNE-251/DMD) Registrational Cohort Size: 32 patients.
• ACHIEVE Trial (DYNE-101/DM1) Registrational Cohort Target: Up to 48 patients.
• Total Doses Administered in DELIVER (as of March 2025): 970 doses.
• Patient Follow-up in DELIVER (as of March 2025): Up to ~2.5 years.

Regulatory agencies (FDA, EMA) as the initial channel for product approval

Before you can sell anything, you need the green light, and for Dyne Therapeutics, Inc., the FDA and EMA are the gatekeepers. These agencies act as a critical channel by granting designations that streamline development and, ultimately, provide market authorization. The path to approval is being aggressively pursued for both lead candidates.

For DYNE-251 in DMD, the FDA granted Breakthrough Therapy Designation on August 4, 2025. It also holds Fast Track, Orphan Drug, and Rare Pediatric disease designations from the FDA, plus Orphan Drug designation from the EMA. A potential U.S. Biologics License Application (BLA) submission for Accelerated Approval is anticipated in early 2026.

For DYNE-101 in DM1, the FDA granted Fast Track designation in January 2025 and Breakthrough Therapy Designation in June 2025. The company plans a potential U.S. Accelerated Approval BLA submission in late 2026, supported by data from the ACHIEVE Registrational Expansion Cohort.

The regulatory status and key dates define the near-term channel milestones:

Scientific publications and presentations at medical congresses (e.g., WMS)

Before a commercial channel exists, scientific communication is the channel for establishing credibility and educating key opinion leaders (KOLs). Dyne Therapeutics, Inc. actively uses medical congresses to present data from its FORCE platform and clinical trials.

In 2025, the company presented at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in March, with oral presentations covering both the DELIVER and ACHIEVE trials. They also presented at the 21st Annual WORLDSymposium™ in February 2025. Preclinical data for DYNE-302 in FSHD were presented in June 2025 at the 32nd Annual FSHD Society's International Research Congress. The World Muscle Society (WMS) Congress in October 2024 also featured presentations on the FORCE platform.

These presentations disseminate data on functional improvement metrics, such as Stride Velocity 95th Centile (SV95C) for DMD and the composite alternative splicing index (CASI-22) for DM1.

Direct sales force for specialized rare disease commercial launch (planned)

The direct sales force channel is still in the planning stages, as the focus remains on achieving regulatory milestones. Dyne Therapeutics, Inc. is positioning itself for a launch, with a potential U.S. launch in DMD targeted for 2027. This commercial build-out will be funded by recent capital raises designed to bridge the gap through 2025 and 2026 milestones.

To support this future channel, the company raised significant capital in mid-2025. They entered a $275 million non-dilutive senior secured term loan facility with Hercules Capital, Inc. in June 2025, with $100 million funded upfront. Additionally, in July 2025, Dyne Therapeutics, Inc. raised $200 million through a public offering of common stock. This financing is intended to support advancement through clinical and regulatory milestones towards that potential 2027 launch.

Finance: draft 13-week cash view by Friday.

Dyne Therapeutics, Inc. (DYN) - Canvas Business Model: Customer Segments

You're looking at the core of Dyne Therapeutics, Inc.'s strategy right now: the patient populations they are targeting with their FORCE platform therapeutics. This is where the near-term value is being built, centered on rare, genetically driven neuromuscular diseases.

Patients with Myotonic Dystrophy Type 1 (DM1) amenable to DYNE-101

The primary focus here is on adults with DM1 receiving zeleciment basivarsen (DYNE-101). This segment is defined by the specific genetic target, DMPK, and the amenability to exon skipping via the ASO-Fab conjugate. The potential market size is substantial for a rare disease, especially given the lack of approved disease-modifying therapies.

Dyne Therapeutics plans to complete enrollment of the Registrational Expansion Cohort for the ACHIEVE trial in early Q2 2026, aiming for a potential U.S. Accelerated Approval Biologics License Application (BLA) submission in late 2026. This timeline dictates the near-term commercial readiness focus for this customer group.

Patients with Duchenne Muscular Dystrophy (DMD) amenable to exon 51 skipping (DYNE-251)

This segment involves males with DMD who have mutations that allow for exon 51 skipping, making them candidates for zeleciment rostudirsen (DYNE-251). The FDA granted this candidate Breakthrough Therapy Designation in August 2025, signaling a high level of regulatory interest. The Registrational Expansion Cohort of 32 patients in the DELIVER trial has completed enrollment, and topline data are expected in December 2025 to support a potential U.S. Accelerated Approval BLA submission in Q2 2026.

To be fair, the company is reaffirming its expected cash runway into Q3 2027, which is positioned to cover the first planned commercial launch of z-rostudirsen in DMD. Here's the quick math: with a Q3 2025 net loss of $108.0 million, that runway provides a significant buffer past the anticipated early 2026 submission.

Future segments: Patients with Facioscapulohumeral Muscular Dystrophy (FSHD) and Pompe disease

Dyne Therapeutics maintains a broader view, with preclinical programs targeting FSHD (DYNE-302) and Pompe disease (DYNE-401). These represent the next wave of customer segments, though they are not yet in the clinic for Dyne Therapeutics. The company's current cash position as of June 30, 2025, was $683.9 million, which supports advancing these preclinical assets alongside the late-stage clinical work.

The estimated patient populations for these future segments are:

Neuromuscular disease specialists and treating physicians

This group is the essential intermediary. They are the gatekeepers who diagnose, manage, and ultimately prescribe the therapeutics to the patient segments above. Their adoption hinges entirely on the clinical data presented, particularly functional improvement metrics.

For DYNE-101 in DM1, data presented at the World Muscle Society (WMS) in October 2025 showed sustained functional improvement across multiple measures at the selected registrational dose of 6.8 mg/kg Q8W. For DYNE-251 in DMD, data showed sustained functional improvement through eighteen months at the 20 mg/kg Q4W dose.

The key characteristics that influence this segment's decision-making include:

• Favorable safety profile observed across both lead programs.
• Demonstrated functional improvement on key endpoints like vHOT for DM1.
• Targeted muscle tissue delivery via the FORCE platform.
• Orphan Drug and Breakthrough Therapy Designations from the FDA.

As of October 31, 2025, Dyne Therapeutics' market capitalization stood at $3.21B, reflecting the market's current valuation of the potential success in reaching these specialized physician segments with their pipeline.

Dyne Therapeutics, Inc. (DYN) - Canvas Business Model: Cost Structure

You're looking at where Dyne Therapeutics, Inc. is putting its capital to work to push its pipeline forward. Honestly, the biggest drain on the P&L is definitely the science itself.

The dominant cost for Dyne Therapeutics, Inc. is Research and Development (R&D) at $97.2 million for the third quarter of 2025. This figure shows where the bulk of the operational spend is directed, supporting the advancement of their novel RNA chemistry platform.

Here's a quick look at the operating expense breakdown for that quarter:

That R&D spend is directly funding the clinical trial expenses for the two registrational programs you mentioned. Specifically, this covers costs associated with the DELIVER trial for z-rostudirsen (DYNE-251) in Duchenne Muscular Dystrophy (DMD), which completed enrollment for its registrational expansion cohort in Q2 2025, and the ACHIEVE trial for zeleciment basivarsen (DYNE-101) in Myotonic Dystrophy Type 1 (DM1), which was enrolling its registrational expansion cohort through Q3 2025.

General and Administrative (G&A) expenses were $16.7 million for the three months ended September 30, 2025. This covers the necessary corporate infrastructure, legal, finance, and executive functions required to run a clinical-stage company.

Dyne Therapeutics, Inc. is also incurring manufacturing and commercial readiness costs, often called Chemistry, Manufacturing, and Controls (CMC) buildout. Subsequent to the quarter end, Dyne Therapeutics, Inc. committed at least $25.5 million through March 2027 under a CMO manufacturing agreement, showing forward-looking investment toward potential commercial supply.

Finally, you have to account for debt service obligations on the Hercules Capital term loan. Dyne Therapeutics, Inc. drew an initial tranche of $100.0 million under this facility in July 2025, which matures on July 1, 2030. The company reported that its cash runway, bolstered by equity raises and this debt, was sufficient to fund operating expenses and debt service obligations into the third quarter of 2027. The net long-term debt stood at $99.1 million as of September 30, 2025.

Finance: draft the full 2026 operating budget forecast by end of month.

Dyne Therapeutics, Inc. (DYN) - Canvas Business Model: Revenue Streams

You're looking at the current state of Dyne Therapeutics, Inc.'s money-making potential as of late 2025. Honestly, right now, the story is about funding the pipeline, not product sales.

As a clinical-stage company, Dyne Therapeutics, Inc. currently generates $0 in product revenue. For the third quarter ending September 30, 2025, Dyne Therapeutics reported quarterly revenue of $0.00. This is the reality when you're deep in development; the focus is on hitting clinical milestones to unlock future value, not shipping product today.

The most significant, concrete revenue streams to date have come from capital markets activity, which is how you fund those expensive trials. You definitely saw the big equity raise back in July 2025.

Here's a quick look at the recent financing proceeds that bolster the cash position, which the company stated extends its runway into the third quarter of 2027.

Future revenue is entirely dependent on the success of the pipeline. The near-term value drivers are the potential product sales from their lead candidates, assuming they clear regulatory hurdles. Dyne Therapeutics anticipates a potential U.S. launch for DYNE-251 in the first quarter of 2027 and for both DYNE-101 and DYNE-251 to have potential commercial launches in 2027.

The revenue streams for Dyne Therapeutics, Inc. can be categorized like this:

• Currently, product revenue is $0, as the company is clinical-stage.
• Future revenue from sales of approved therapeutics, specifically DYNE-251 for Duchenne Muscular Dystrophy (DMD) and DYNE-101 for Myotonic Dystrophy Type 1 (DM1).
• Potential milestone payments or royalties derived from future strategic partnerships or licensing deals, which the Chief Business Officer is actively pursuing.
• Non-operating proceeds from equity offerings, such as the $230.0 million gross proceeds from the July 2025 offering.

Data readouts in late 2025 for DYNE-251 and mid-2026 for DYNE-101 are the next major value-creating inflection points that could lead to partnership discussions or future royalty streams. Finance: draft 13-week cash view by Friday.