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

You're looking to understand the engine room of a company like Tenaya Therapeutics, Inc. (TNYA) as they push their gene therapies for rare heart conditions through the clinic. Honestly, their business model is pure biotech runway: it's all about converting proprietary AAV technology and clinical data into future revenue, because right now, their $71.7 million cash pile (as of June 30, 2025) is funding high R&D costs-we're talking $38.5 million spent in just the first half of 2025. This canvas distills exactly how they are keeping the lights on through non-dilutive grants, like the $8.0 million from CIRM, and strategic financing, mapping out the key partnerships and activities needed before they see a single dollar from a product sale. Dive in below to see the precise structure supporting their high-stakes race to market.

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Key Partnerships

You're mapping out the external relationships Tenaya Therapeutics, Inc. relies on to push its gene therapy pipeline, especially as they approach key data readouts in late 2025. These partnerships are critical for funding, execution, and future commercialization.

Clinical Trial Sites across the U.S., U.K., and E.U.

Executing global clinical trials for rare diseases requires a broad network of specialized clinical sites. Tenaya Therapeutics, Inc. has established a significant footprint to support its ongoing studies, particularly for TN-401 in PKP2-associated ARVC (Arrhythmogenic Right Ventricular Cardiomyopathy) via the RIDGE-1 trial.

The RIDGE study, which includes the natural history component and the interventional RIDGE-1 trial, spans multiple geographies. As of the February 2025 data cut-off, the RIDGE study had enrolled participants at more than 20 clinical sites across the U.S., UK, and EU. The RIDGE-1 Phase 1b trial itself is specifically noted as being conducted at clinical sites across the U.S. and in the UK, with an enrollment target of up to 15 adults with PKP2-associated ARVC.

For its pediatric natural history study, MyClimb, the network is even wider. Tenaya Therapeutics reported that MyClimb had enrolled more than 200 patients across 29 sites worldwide as of the update in the first half of 2025. This scale suggests heavy reliance on established site networks and potentially Contract Research Organizations (CROs) to manage the logistics.

Here's a quick look at the scale of site activation for the MyClimb study:

• Total MyClimb Patients Enrolled: >200
• Total MyClimb Sites Worldwide: 29
• RIDGE Study Sites (Total): >20
• RIDGE-1 Trial Enrollment Cap (ARVC): Up to 15 adults

California Institute for Regenerative Medicine (CIRM) for the $8.0 million grant

Securing non-dilutive funding is a major partnership win, and Tenaya Therapeutics, Inc. successfully landed a significant award from the California Institute for Regenerative Medicine (CIRM). This partnership directly supports the clinical advancement of TN-401.

In February 2025, CIRM awarded Tenaya Therapeutics a $8.0 million CLIN2 grant. The proceeds from this substantial grant are specifically earmarked to help fund the clinical trial costs for the ongoing Phase 1b RIDGE-1 clinical trial of the TN-401 gene therapy for PKP2-associated ARVC. This funding mechanism, established by Californians to accelerate regenerative medicine research, validates the science behind TN-401 from a key state agency.

The financial impact of this non-dilutive capital is important, especially when viewed alongside the March 2025 public offering which brought in net proceeds of approximately $48.8 million.

Advocacy partners for patient enrollment and natural history studies

While Tenaya Therapeutics, Inc. has not publicly detailed specific advocacy partners by name in recent financial updates, the success of their natural history studies implies strong collaboration with patient advocacy groups. These groups are essential for reaching the specific, often small, patient populations required for genetic cardiomyopathy trials.

The RIDGE study, which collected natural history and AAV9 antibody (seroprevalence) data among ARVC patients carrying PKP2 gene mutations, is described as the largest natural history study to date in this population. Similarly, the MyClimb study for pediatric MYBPC3-associated HCM is designed to characterize disease burden in patients under age 18 for whom no approved agents exist.

The enrollment numbers speak to the effectiveness of these outreach efforts:

Contract Research Organizations (CROs) for clinical trial execution

For a company running multi-center, international trials like RIDGE-1 (U.S. and UK) and MyPEAK-1, the use of Contract Research Organizations (CROs) is standard practice for clinical trial execution, site management, and data collection. Tenaya Therapeutics, Inc. leverages an internal suite of capabilities, including capsid engineering and manufacturing, but external CRO support is necessary to manage the logistics across 20+ sites for RIDGE alone. Specific financial amounts or names of contracted CROs are not detailed in the latest public financial reports, but their function is embedded in the reported R&D expenses.

Potential strategic partner for late-stage development of TN-301

Tenaya Therapeutics, Inc. has clearly articulated its view on the future of its small molecule inhibitor, TN-301, which targets HDAC6 for potential treatment of HFpEF (Heart Failure with preserved Ejection Fraction) and related cardio/muscular disease. The company has completed a Phase 1 clinical study for TN-301, demonstrating safety, tolerability, and robust target engagement.

The strategy for this asset is partnership-focused. Tenaya Therapeutics, Inc. explicitly states its belief that late-stage development and commercialization of TN-301 would best be led by a strategic partner. This partner would need the global resources necessary to explore the molecule's full potential across cardiometabolic conditions beyond cardiology. As of late 2025, no specific partner has been announced for TN-301, indicating this remains a key business development objective for the company.

Finance: draft 13-week cash view by Friday.

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Key Activities

You're running a clinical-stage biotech, so your key activities are all about moving those complex, high-stakes programs through the clinic while keeping the lights on. Here's the breakdown of what Tenaya Therapeutics, Inc. (TNYA) is actively driving as we close out 2025.

Advancing Clinical Trials for Lead Gene Therapies (TN-201, TN-401)

The core activity is pushing the two lead gene therapies forward, which means managing dose escalation and data collection across multiple sites. For TN-201, targeting MYBPC3-associated Hypertrophic Cardiomyopathy (HCM) in the MyPEAK-1 Phase 1b/2a trial, dosing has progressed through two cohorts. You completed dosing in Cohort 2 at the 6E13 vg/kg dose level, following initial data presentation from Cohort 1 at 3E13 vg/kg (Source 11). In total, seven patients have been dosed with TN-201 as of the Q3 update (Source 6). For TN-401, treating PKP2-associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) in the RIDGE-1 Phase 1b trial, enrollment in Cohort 1, dosed at 3E13 vg/kg, is complete, and dosing for Cohort 2 at 6E13 vg/kg is also complete (Source 6). Initial data readouts for both programs were anticipated in the fourth quarter of 2025 (Source 11).

The clinical trial progress involves specific data generation milestones:

• TN-201 Cohort 1 patients had follow-up data presented out to 52-78 weeks (Source 2).
• The RIDGE-1 trial is designed to test doses of 3E13 vg/kg and 6E13 vg/kg (Source 16).
• TN-301, the small molecule HDAC6 inhibitor, is also advancing through a Phase 1b dose-escalation trial (Source 1).

Proprietary AAV Vector and Capsid Engineering/Manufacturing

Tenaya Therapeutics, Inc. is focused on maintaining its platform advantage through internal capabilities. This activity is about ensuring a reliable, scalable supply chain for their AAV9-based therapies and developing next-generation tools. They tout a modality-agnostic cardiac genetic-medicine platform, which is a fancy way of saying their delivery system is reusable for different targets (Source 1).

Key metrics supporting this capability include:

Research and Development (R&D) for Preclinical Pipeline

Beyond the clinical leads, a significant activity is advancing the earlier-stage pipeline, which includes exploring gene editing. This R&D work is what feeds the future of the company. For example, they presented preclinical data at the ASGCT 2025 Annual Meeting on TN-501, which is a Cas9 gene editing therapy aimed at PLN-R14del-associated Dilated Cardiomyopathy (DCM) (Source 17). Furthermore, the foundational science for the clinical candidates continues to be published, such as the March 2025 publication in Nature Communications detailing preclinical studies for TN-201 (Source 15).

The company's R&D spending reflects this focus. For the third quarter of 2025, Research & Development (R&D) Expenses totaled $15.4 million (Source 6).

Securing Non-Dilutive Funding and Equity Financing

You can't run trials without cash, so securing capital is a constant, critical activity. In the first half of 2025, Tenaya Therapeutics, Inc. executed a significant equity raise in March 2025, pricing an offering of 75,000,000 units at $0.70 per unit for gross proceeds of approximately $52.5 million (Source 10, 19). This was a dilutive move, but it was necessary to fund the clinical development of TN-201 and TN-401 (Source 19). On the non-dilutive side, the company secured an $8.0 million clinical grant from the California Institute for Regenerative Medicine (CIRM) in February 2025 (Source 8, 13). As of September 30, 2025, the cash position stood at $56.3 million, with guidance suggesting this is sufficient to support operations into the second half of 2026 (Source 6).

Regulatory Engagement with the FDA and European Commission

Navigating the regulatory pathway is paramount, especially with novel gene therapies. Tenaya Therapeutics, Inc. has secured key designations for its lead candidates, which streamlines development for these rare diseases. Specifically, TN-201 has Fast Track, Orphan Drug, and Rare Pediatric Drug Designations from the FDA (Source 16). TN-401 also has Orphan Drug and Fast Track Designations from the FDA (Source 16). Both candidates have also secured orphan medicinal product designation from the European Commission (Source 16). However, a major activity in late 2025 involved engaging with the FDA after they placed a clinical hold on the TN-201 trial in November 2025 (Source 4). The company is actively working on protocol amendments focused on standardizing patient monitoring and immunosuppression management across trial sites to resolve this hold (Source 4, 6).

Regulatory designations secured include:

• TN-201: FDA Fast Track, Orphan Drug, Rare Pediatric Drug (Source 16).
• TN-401: FDA Fast Track, Orphan Drug (Source 16).
• Both: European Commission Orphan Medicinal Product Designation (Source 16).

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Key Resources

You're looking at the core assets Tenaya Therapeutics, Inc. (TNYA) relies on to execute its mission of delivering potentially curative therapies for heart disease. These aren't just ideas; they are tangible, quantifiable assets as of late 2025.

Proprietary AAV Gene Therapy Platform and IP Portfolio

Tenaya Therapeutics, Inc. has built an integrated system centered on its modality-agnostic cardiac genetic-medicine platform. This platform is designed to generate a portfolio of novel medicines based on genetic insights, utilizing a large library of heart-tropic Adeno-Associated Viruses (AAVs). The intellectual property strength is evidenced by recent patents issued by the U.S. Patent and Trademark Office covering its HDAC6 inhibitors, such as TN-301. The platform's breadth is a key resource, encompassing:

• Proprietary capabilities in capsid engineering and manufacturing.
• A library supporting over 50 clinical disease models.
• Over 140 genetically validated targets.

Financial Position

The financial runway is critical for a clinical-stage company. The cash position as of the second quarter close was a key indicator of near-term operational stability, though it saw a sequential decline as clinical activities ramped up.

The company has not drawn on the credit facility established with Silicon Valley Bank. Still, the sequential cash draw from $88.2 million at March 31, 2025, to $71.7 million at June 30, 2025, shows ongoing operating spend ahead of data readouts.

Key Scientific Personnel and Internal Manufacturing

The expertise of the scientific team is embedded within the company's internal capabilities, which include modality agnostic target validation, capsid engineering, and manufacturing. This internal capacity is designed to be a reusable engine for multiple heart-focused genetic medicines. The manufacturing component is significant:

• Internal cGMP AAV manufacturing capacity at 1,000L scale.
• Internal cGMP and non-GMP AAV manufacturing capabilities located in the San Francisco Bay Area.

Clinical Data from MyPEAK-1 and RIDGE-1 Trials

The ongoing clinical trials represent the most immediate value drivers, with crucial data expected in late 2025. Both programs have received positive endorsements from their Data Safety Monitoring Boards (DSMBs), allowing for advancement.

For TN-201 in the MyPEAK-1 trial (MYBPC3-associated HCM):

• Enrollment completed in Cohorts 1 (3E13 vg/kg dose) and 2 (6E13 vg/kg dose).
• Positive safety review enabled enrollment of expansion cohorts.
• New data presented at the American Heart Association Scientific Sessions in November 2025.

For TN-401 in the RIDGE-1 trial (PKP2-associated ARVC):

• Cohort 1 (3E13 vg/kg dose) data on track for company presentation before year-end 2025.
• Dosing completed in Cohort 2 at the 6E13 vg/kg dose level.
• DSMB endorsed dose escalation and expansion following Cohort 1 review in July 2025.

The company anticipates sharing meaningful new data readouts for both TN-201 and TN-401 in the fourth quarter of 2025. Also, the MyClimb pediatric natural history study has enrolled more than 200 participants.

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Value Propositions

Potentially curative, one-time treatment for genetic heart diseases.

Tenaya Therapeutics, Inc. is advancing gene therapies designed to offer a single-administration solution for inherited cardiomyopathies, aiming to halt or reverse disease progression. As of the third quarter of 2025, the company reported a net loss of $20.3 million, with Research & Development Expenses at $15.4 million for the quarter, reflecting investment in these pipeline assets. The cash, cash equivalents, and investments stood at $56.3 million as of September 30, 2025, which management believes, along with potential loan availability, funds operations into the second half of 2026.

The core value proposition is rooted in the potential for durable, disease-modifying effects from a single dose, contrasting with chronic management strategies. The company's market capitalization was reported at $221.5 million in early December 2025.

Addressing the underlying cause of MYBPC3-HCM and PKP2-ARVC.

For MYBPC3-HCM, the value proposition is correcting the genetic defect causing the disease. The MyPEAK-1 trial has dosed a total of seven patients to date, with the study designed to recruit up to 30 patients. Data presented in November 2025 showed that all Cohort 1 patients achieved NYHA Class I by one year post-treatment.

For PKP2-ARVC, the therapy aims to restore the structural integrity of heart muscle cells by delivering a functional PKP2 gene. The RIDGE-1 trial is assessing a one-time intravenous infusion of TN-401.

• The MyClimb natural history study for pediatric MYBPC3-associated HCM enrolled over 200 individuals across 29 clinical sites worldwide.
• In a study of MYBPC3-associated HCM patients, nearly 95% would be below the 1:80 neutralizing antibody (NAb) titer threshold for the AAV9 vector used in TN-201.
• For TN-401, a seroprevalence study in PKP2-associated ARVC indicated 84% of volunteers had NAb titers of less than 1:20 against AAV9.
• The PKP2 mutation is found in about 45% of people diagnosed with genetic ARVC in the U.S.

Therapies targeting rare diseases with high unmet medical need.

The gene therapies target rare, progressive, and life-threatening conditions where current treatment options are largely supportive rather than curative. The scale of the need is defined by the prevalence of the underlying genetic variants.

Small molecule (TN-301) for more prevalent heart failure (HFpEF).

TN-301 is a small molecule HDAC6 inhibitor being developed for Heart Failure with preserved Ejection Fraction (HFpEF), a more prevalent condition than the rare cardiomyopathies in the pipeline. This program diversifies the value proposition toward a larger patient population, though it is in earlier development stages as of late 2025. The company's Q3 2025 operating expenses totaled $20.9 million, demonstrating cost control while advancing this and other pipeline assets.

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Customer Relationships

You're hiring before product-market fit, so the relationship with the scientific and investment communities is everything right now. Tenaya Therapeutics, Inc. (TNYA) focuses its customer relationship strategy on deep engagement with the specialized groups that validate its science and fund its pipeline.

High-touch, direct engagement with clinical investigators and key opinion leaders

Direct scientific exchange is paramount for a clinical-stage company. Tenaya Therapeutics, Inc. actively engages investigators through trial execution and scientific presentations. For instance, interim clinical data from the MYPEAK™-1 Phase 1b/2a trial of TN-201 for MYBPC3-associated Hypertrophic Cardiomyopathy (HCM) was presented at the American Heart Association Scientific Sessions in November 2025. This trial, a multi-center, open-label, dose-escalation study, had dosed a total of seven patients with TN-201 across two dose levels as of November 10, 2025. Also, the company hosted a Virtual Key Opinion Leader event on August 19, 2025, focused on 'Measuring Protein Expression in Cardiac Gene Therapy,' featuring experts like Michael Previs, Ph. That kind of focused event helps shape the perception of the science among the most influential clinicians.

The RIDGE™-1 trial for TN-401 also required close investigator management, with Cohort 2 dosing completed as of the Q3 2025 update. The company's visibility is amplified by presenting at major medical meetings; for example, late-breaker data on MyPEAK-1 was featured at the ACC Annual Scientific Session in March 2025.

Patient advocacy groups for support and natural history studies (MyClimb, RIDGE)

Tenaya Therapeutics, Inc. treats patients with rare genetic cardiomyopathies, making advocacy groups crucial partners for understanding disease burden and trial recruitment. The company runs two significant non-interventional natural history studies to characterize the patient populations they aim to treat. These studies provide the real-world context needed to design better trials and manage expectations with regulators and investors alike.

Here's a quick look at the scale of engagement in these patient-centric studies as of mid-to-late 2025:

The MyClimb study, initiated in 2021, characterized disease burden in patients under eighteen, where 93% of participants had the nonobstructive HCM phenotype, an area with no approved treatments. For the RIDGE study, data showed a high burden of disease, with more than 80% of participants experiencing $\ge \mathbf{500}$ premature ventricular contractions (PVCs) per day.

Investor relations and conference presentations to manage market expectations

Managing market expectations is a constant relationship Tenaya Therapeutics, Inc. maintains with its shareholders. The company provided a business update alongside its Third Quarter 2025 Financial Results on November 10, 2025. Financially, the Q3 2025 Net Loss narrowed to $20.3 million, an improvement from $25.6 million a year prior. Cash and cash equivalents stood at $56.3 million as of September 30, 2025, supported by net proceeds of approximately $48.8 million from a March 2025 follow-on offering. The management team held a conference call that day at 8:00 a.m. ET/5:00 a.m. PT to discuss the latest clinical data and financial standing.

Investor engagement is structured around key milestones. Beyond the earnings call, Tenaya Therapeutics, Inc. participated in several investor conferences:

• H.C. Wainwright Genetic Medicines Virtual Conference on October 14, 2025.
• Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025.

These events are used to communicate progress, such as the positive Data Safety Monitoring Board (DSMB) recommendations for both TN-201 and TN-401 programs, which allowed for dose escalation and expansion cohorts.

Regulatory body interactions (FDA, EMA) for expedited pathways (Fast Track, Orphan Drug)

Regulatory interactions define the path to market for orphan and rare disease therapies. Tenaya Therapeutics, Inc. has secured significant designations for its lead candidates, which streamlines development and provides market exclusivity incentives. The relationship with the FDA and EMA is characterized by these positive regulatory acknowledgments.

Key regulatory statuses as of late 2025 include:

• TN-401 (for PKP2-associated ARVC): Received Orphan Drug and Fast Track Designations from the FDA, plus orphan medicinal product designation from the European Commission.
• TN-201 (for MYBPC3-associated HCM): Received Fast Track, Orphan Drug and Rare Pediatric Drug Designations from the FDA, and orphan medicinal product designation from the European Commission.

However, these relationships also involve managing challenges; for example, the FDA placed the MyPEAK-1 trial for TN-201 on a clinical hold to standardize monitoring and immunosuppression protocol activities, a situation the company is actively working to resolve.

Finance: draft 13-week cash view by Friday.

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Channels

You're looking at how Tenaya Therapeutics, Inc. gets its investigational therapies and corporate story out to the world-from clinical sites to the capital markets. This isn't about selling widgets; it's about reaching highly specialized physicians, researchers, and investors, so the channels are very targeted.

Specialized cardiac and genetic disease clinical centers worldwide

The core channel for clinical validation is the network of specialized centers running the trials. Tenaya Therapeutics, Inc. uses a global footprint to enroll patients in its gene therapy programs for genetic cardiomyopathies. This is how they generate the safety and efficacy data needed for regulatory approval.

For the MyPEAK-1 trial of TN-201 (for MYBPC3-associated HCM), the trial is multi-center, and the company has been advancing through dose cohorts. For the RIDGE-1 trial of TN-401 (for PKP2-associated ARVC), the structure is also global multicenter.

Here's a look at the scale of their natural history studies, which feed into trial design and site identification:

The company was planning to activate its first ex-U.S. RIDGE-1 clinical site in the first half of 2025.

Scientific and medical conferences (ACC, ASGCT) for data dissemination

Disseminating clinical and preclinical data is crucial for establishing scientific credibility. Tenaya Therapeutics, Inc. prioritizes high-impact medical meetings to present their findings directly to key opinion leaders and the broader scientific community. This is where they showcase the results from trials like MyPEAK-1 and RIDGE-1.

Key conference engagements in 2025 included:

• Presenting new TN-201 clinical data at the American Heart Association (AHA) 2025 Scientific Sessions in New Orleans, Louisiana (November 7-10, 2025).
• Presenting data at the American College of Cardiology's (ACC) Annual Scientific Session in Chicago, IL (March 29-31, 2025).
• Presenting a poster detailing the RIDGE-1 trial design at the European Society of Gene and Cell Therapy (ESGCT 2025) Annual Congress in October 2025.
• Presenting interim data from the MyClimb study at the European Society of Cardiology Congress in August 2025.

For investor awareness, the CEO participated in the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, and the H.C. Wainwright Genetic Medicines Virtual Conference on October 14, 2025.

Direct communication with patient advocacy organizations

Direct engagement with patient advocacy groups is a primary channel for gathering insights into the patient journey and driving awareness for genetic testing and precision medicines. Tenaya Therapeutics, Inc. states they partner with leading heart disease patient organizations to better understand community needs and inform drug development efforts.

The company's patient advocacy team connects with patients, caregivers, and advocates to drive awareness of the unmet needs in conditions like MYBPC3-associated HCM and PKP2-associated ARVC. However, for their investigational products, clinical trial participation remains the main pathway for access; for instance, the Expanded Access Policy for TN-201 is specifically limited to pediatric patients with confirmed MYBPC3-associated HCM.

Investor presentations and press releases for capital markets

Keeping the capital markets informed is vital for a clinical-stage company funding its pipeline. This channel relies heavily on formal financial reporting and strategic presentations to analysts and investors. You need to know the cash position to gauge operational runway.

Key financial metrics reported as of the end of Q3 2025 (September 30, 2025) include:

Capital raising efforts are also part of this channel; Tenaya Therapeutics, Inc. completed a March 2025 follow-on offering that brought in net proceeds of approximately $48.8 million. Furthermore, an SVB loan agreement offers the right to draw $10.0 million through December 31, 2025. As of November 10, 2025, the Market Cap stood at $226.45 million, with Institutional Ownership at 22.21%. The company stated that existing resources, potential loan availability, and warrant exercises will fund operations for at least twelve months following the filing.

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Customer Segments

You're looking at the core groups Tenaya Therapeutics, Inc. (TNYA) targets with its gene therapy pipeline, which is still pre-revenue as of late 2025. These segments are defined by the specific, rare genetic heart conditions they are trying to address, and the financial ecosystem that supports their development.

Patients with rare, monogenic cardiomyopathies (MYBPC3-HCM, PKP2-ARVC)

This is the primary, most critical segment for Tenaya Therapeutics, Inc. (TNYA) right now, as their lead candidates, TN-201 and TN-401, target specific genetic mutations. For MYBPC3-associated hypertrophic cardiomyopathy (HCM), the target population is estimated to be roughly 20% of the entire U.S. HCM patient base, which itself is estimated at 120,000 patients in the United States. The company's natural history study, MyClimb^TM, enrolled more than 200 pediatric patients diagnosed before age 18 across 29 clinical sites worldwide. Furthermore, a September 2025 seroprevalence study found that nearly 95% of these MYBPC3-associated HCM patients would be below the Nab titers of 1:80 threshold required for the TN-201 gene therapy trial. For PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), the prevalence is estimated at more than 70,000 people in the U.S. alone, with PKP2 mutations accounting for approximately 40 percent of the overall ARVC population. The RIDGE natural history study for this indication enrolled more than 175 patients across about 20 clinical sites in the U.S., UK, France, Germany, Italy and Sweden.

Here's a quick look at the patient pool sizes and study scopes:

Cardiologists and specialized heart failure treatment centers

These are the key prescribers and gatekeepers for clinical trial participation and future product adoption. They are the ones who manage the patients with these rare conditions. The clinical trial infrastructure itself shows the reach into these centers. For instance, the MyClimb study for TN-201 utilized 29 clinical sites worldwide, and the RIDGE study for TN-401 involved approximately 20 clinical sites across multiple countries. These centers are where the data on TN-201's improvements-like reductions in left ventricular posterior wall thickness (LVPWT) by 21-39% at week 52 in Cohort 1 patients-are generated and validated. It's all about building trust with the specialists who see the unmet need daily.

Payers and government health systems (future commercialization)

While Tenaya Therapeutics, Inc. (TNYA) is pre-revenue, payers-both private insurers and government systems like Medicare/Medicaid-become a critical segment upon regulatory approval. Their focus will be on the cost-effectiveness of a one-time curative therapy versus decades of standard-of-care management for chronic, progressive diseases. The company's Q3 2025 net loss was $20.3 million, reflecting the high cost of development that payers will eventually need to justify. The CIRM grant recognized the public health importance, providing $1.5 million of an $8.0 million award for the TN-401 program, which signals early validation from a public health funding body.

Investors and institutional funds focused on biotech and gene therapy

This segment provides the necessary capital to fund the expensive clinical development. As of September 30, 2025, Tenaya Therapeutics, Inc. (TNYA) held $56.3 million in cash and cash equivalents, with total assets at $105.0 million. The company completed a March 2025 follow-on offering that brought in net proceeds of approximately $48.8 million. Management stated that current resources, plus an available $10.0 million tranche from an SVB loan agreement (with an additional $20.0 million discretionary option), should fund operations for at least twelve months following the Q3 2025 filing. The stock trades on NASDAQ GS: TNYA, and the consensus target price as of late 2025 was $10.14 based on 7 estimates. The book value P/B ratio stood at 2.7, slightly below the peer average of 2.9. You've got to keep these folks happy with clinical milestones.

• Shares outstanding were 166,505,885 as of November 4, 2025.
• The nine-month net loss through Q3 2025 was $70.4 million.
• R&D expenses for Q3 2025 were $15.4 million.

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Cost Structure

You're looking at the major cash outlays for Tenaya Therapeutics, Inc. as they push their gene therapies through critical clinical stages. For a company at this stage, the cost structure is almost entirely driven by research, development, and keeping the lights on while waiting for data readouts.

The Research & Development (R&D) expenses are the single largest component, reflecting the cost of advancing the TN-201 and TN-401 programs. For the first half of 2025 (H1 2025), the total R&D spend hit $38.5 million. This total is derived from the reported quarterly figures: $21.1 million in the first quarter (Q1 2025) and $17.4 million in the second quarter (Q2 2025).

These R&D costs inherently cover the heavy lifting of the clinical programs. Specifically, the costs associated with the clinical trial costs for TN-201 (for MYBPC3-associated HCM) and TN-401 (for PKP2-associated ARVC) are embedded here. The progression itself is a cost driver; for instance, the Data Safety Monitoring Boards (DSMBs) endorsed dose escalation and expansion for both programs following safety reviews.

General and administrative (G&A) expenses represent the overhead required to run the business. For Q2 2025, the G&A expense was $6.7 million. This figure was down from $8.2 million in the same period of 2024, partly due to a decrease in stock-based compensation.

The structure of these operating expenses is detailed below, showing the quarterly trend for the first half of 2025 and the subsequent third quarter (Q3 2025) data, which shows continued cost containment efforts:

The personnel costs for specialized scientific and clinical teams are a major component within the R&D spend. While a specific dollar amount for personnel alone isn't broken out separately from R&D, we know that non-cash stock-based compensation within R&D for Q2 2025 was $1.9 million. This gives you a sense of the non-cash element of compensation for those specialized teams.

The costs related to manufacturing and process development for AAV vectors are also captured within R&D. The advancement of the trials, such as dosing patients at 6E13 vg/kg for TN-201 and dosing the second cohort for TN-401, necessitates ongoing vector production and quality control, which are significant fixed and variable costs for a gene therapy company.

You can see the operating spend is high, but management is actively managing it. Here's the quick math: the sequential drop in operating expenses from Q2 2025 ($24.1 million) to Q3 2025 ($21.0 million) helped extend the cash runway. The cash position at the end of Q2 2025 was $71.7 million, projected to last into the second half of 2026.

Key cost drivers embedded within the R&D line item include:

• Costs for AAV vector production and characterization.
• Site initiation and patient enrollment fees for clinical sites.
• Biomarker analysis, such as biopsy sample processing for TN-401 DNA/mRNA.
• Salaries and benefits for research scientists and clinical operations staff.

Finance: draft 13-week cash view by Friday.

Tenaya Therapeutics, Inc. (TNYA) - Canvas Business Model: Revenue Streams

As of late 2025, Tenaya Therapeutics, Inc. is firmly in the clinical-stage, meaning its revenue streams are entirely composed of non-operating, financing-related inflows, as the company has not yet reached commercialization for any of its product candidates.

Non-Dilutive Grant Funding

A key non-dilutive source of capital supporting clinical development is grant funding. Tenaya Therapeutics, Inc. secured a significant award from the California Institute for Regenerative Medicine (CIRM) in early 2025. This was an $8.0 million CLIN2 grant announced on February 3, 2025.

• The $8.0 million grant proceeds are earmarked to help fund clinical trial costs for the ongoing Phase 1b RIDGE-1 clinical trial of TN-401 gene therapy.
• One record indicates a CIRM award value of $9,017,000 to Tenaya Therapeutics, Inc..

Equity Financing Proceeds

The most substantial recent inflow has been from equity financing, which provides the necessary runway to advance the lead gene therapy candidates, TN-201 and TN-401. In March 2025, Tenaya Therapeutics, Inc. executed an underwritten public offering.

Here's a look at the key figures from that financing event:

The net proceeds of approximately $48.8 million from the March 2025 public offering, combined with existing cash, were expected to support planned company operations into the second half of 2026. The offering structure included warrants, which represent potential future equity dilution but are not current revenue.

Future Potential Revenue from Strategic Licensing or Collaboration Agreements

Tenaya Therapeutics, Inc. is pursuing a strategy that involves developing its portfolio of genetic medicines internally. While the current financial statements reflect no realized revenue from this area, the development of clinical candidates like TN-201 and TN-401 creates the potential for future revenue streams through strategic out-licensing or collaboration agreements with larger pharmaceutical partners upon achieving key clinical milestones.

No Product Revenue

Tenaya Therapeutics, Inc. is explicitly a pre-commercial stage company. Consequently, there is no revenue generated from the sale of products. Analyst expectations for the quarter ending September 30, 2025, reflect this reality, projecting no change in quarterly revenue.

• The company is focused on advancing its lead candidates through clinical trials, such as TN-201 in the MyPEAK-1 trial and TN-401 in the RIDGE-1 trial.
• The cash runway extension into the second half of 2026 is based on current cash levels and the assumption of continued operational expenditure without product sales.