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

Im hochmodernen Bereich der genetischen Herztherapie erweist sich Tenaya Therapeutics als Hoffnungsträger und leistet Pionierarbeit bei transformativen Präzisionsmedizinlösungen, die versprechen, die Behandlung komplexer Herzerkrankungen zu revolutionieren. Durch die Nutzung fortschrittlicher gentechnischer Technologien und strategischer Kooperationen mit Branchenführern wie Roche entwickelt dieses innovative Biotech-Unternehmen bahnbrechende Therapien, die auf bestimmte genetische Mutationen abzielen, und bietet personalisierte Behandlungsansätze für Patienten mit bisher nicht behandelbaren genetischen Herzerkrankungen. Ihr umfassendes Business Model Canvas enthüllt eine ausgeklügelte Strategie, die darauf abzielt, die Herz-Kreislauf-Medizin durch gezielte, wissenschaftlich fundierte Interventionen neu zu gestalten, die möglicherweise neue Wege zur Heilung eröffnen könnten.

Tenaya Therapeutics, Inc. (TNYA) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit Roche zur Erforschung genetischer Herzkrankheiten

Im Januar 2023 gab Tenaya Therapeutics eine strategische Zusammenarbeit mit Roche bekannt, die sich auf die Entwicklung genetisch bedingter Herzkrankheitstherapien konzentriert. Zu den wichtigsten Details der Partnerschaft gehören:

Partnerschaftlicher Aspekt	Spezifische Details
Fokus auf Zusammenarbeit	Erforschung genetischer Herzkrankheiten und therapeutische Entwicklung
Finanzielle Bedingungen	65 Millionen US-Dollar Vorauszahlung von Roche an Tenaya
Mögliche Meilensteinzahlungen	Bis zu 700 Millionen US-Dollar basierend auf Forschungs- und Entwicklungsleistungen

Partnerschaft mit akademischen medizinischen Zentren für klinische Studien

Tenaya Therapeutics hat Partnerschaften für klinische Studien mit mehreren akademischen medizinischen Zentren aufgebaut:

• Medizinische Fakultät der Stanford University
• Universität von Kalifornien, San Francisco
• Harvard Medical School
• Medizinisches Zentrum der Johns Hopkins University

Zusammenarbeit mit pharmazeutischen Forschungseinrichtungen

Forschungseinrichtung	Fokus auf Zusammenarbeit	Gründungsjahr
Amerikanische Herzvereinigung	Herz-Kreislauf-Genforschung	2022
Nationale Gesundheitsinstitute	Entwicklung der Therapie genetischer Krankheiten	2021

Mögliche Partnerschaften mit Laboratorien für Gentests

Tenaya prüft Partnerschaften mit Laboren für Gentests, um Ansätze der Präzisionsmedizin voranzutreiben:

• Invitae Corporation
• Genomische Gesundheit
• 23andMe

Gesamter potenzieller Wert der Partnerschaft: Ungefähr 765 Millionen US-Dollar für aktuelle und potenzielle Kooperationen ab 2024.

Tenaya Therapeutics, Inc. (TNYA) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung präziser genetischer Therapien

Tenaya Therapeutics konzentriert sich auf die Entwicklung präziser Gentherapien mit einer Gesamtinvestition in Forschung und Entwicklung von 83,4 Millionen US-Dollar ab dem Geschäftsjahr 2023. Das Unternehmen unterhält drei verschiedene Gentherapie-Forschungsplattformen, die auf genetisch bedingte Herzerkrankungen abzielen.

F&E-Schwerpunktbereich	Investition (Mio. USD)	Forschungsphase
Genetische Herztherapien	42.6	Präklinisch/Phase 1
Gen-Editing-Technologien	25.8	Entdeckungsphase
Molekulares Targeting	15.0	Translationale Forschung

Durchführung fortgeschrittener klinischer Studien zur Behandlung von Herzerkrankungen

Die klinischen Studienaktivitäten umfassen mehrere laufende Studien mit aktuellen Ausgaben von 47,2 Millionen US-Dollar im Jahr 2023. Das Unternehmen verfügt über zwei primäre Programme im klinischen Stadium in der Entwicklung.

• TDN-001: Klinische Studie zur genetischen Kardiomyopathie
• TDN-002: Studie zur genetischen Intervention bei Herzinsuffizienz

Produktentwicklung für Gentherapie

Tenaya unterhält drei verschiedene Entwicklungspipelines für Gentherapieprodukte mit Gesamtproduktentwicklungskosten von 62,7 Millionen US-Dollar im Jahr 2023.

Produktpipeline	Entwicklungsphase	Geplante Investition
Kardiale Gentherapie	Präklinisch	28,3 Millionen US-Dollar
Genetische Interventionsplattform	Entdeckung	19,5 Millionen US-Dollar
Molekulare Targeting-Therapie	Forschung	14,9 Millionen US-Dollar

Molekulare und zelluläre Forschung

Die Forschung konzentriert sich auf genetische Herzerkrankungen mit einem engagierten Forschungsteam von 42 Wissenschaftlern und einem jährlichen Forschungsbudget von 35,6 Millionen US-Dollar.

Translationale Medizin und therapeutische Innovation

Das Unternehmen investierte im Jahr 2023 22,1 Millionen US-Dollar in die translationale Medizinforschung und zielte dabei auf vier spezifische genetische Mechanismen von Herzerkrankungen ab.

• Identifizierung genetischer Mutationen
• Zelluläre Reprogrammierungstechniken
• Erweitertes molekulares Targeting
• Präzise therapeutische Entwicklung

Tenaya Therapeutics, Inc. (TNYA) – Geschäftsmodell: Schlüsselressourcen

Fortschrittliche gentechnische Technologien

Tenaya Therapeutics hat sich entwickelt 3 proprietäre Gentechnologien Bekämpfung von Herzerkrankungen:

• Gentherapie-Plattform für genetische Herzerkrankungen
• Zelltherapieplattform zur Herzregeneration
• Plattform für kleine Moleküle für genetische Herzerkrankungen

Proprietäre Gentherapie-Plattformen

Plattform	Technologietyp	Zielbedingung
TNYA-001	AAV-Gentherapie	Genetische Herzmuskelstörungen
TNYA-002	Zellregeneration	Herzinsuffizienz
TNYA-003	Intervention mit kleinen Molekülen	Herzgenetische Mutationen

Spezialisiertes Forschungs- und Entwicklungsteam

Zusammensetzung des Forschungspersonals:

• Gesamtzahl der F&E-Mitarbeiter: 68 Mitarbeiter
• Doktoranden: 42
• Gentechnik-Spezialisten: 26

Portfolio für geistiges Eigentum

IP-Kategorie	Anzahl der Patente	Patentstatus
Gentherapie-Technologien	12	Zugegeben
Methoden zur Zellregeneration	8	Ausstehend
Molekulare Interventionstechniken	6	Abgelegt

Modernste Labor- und Forschungseinrichtungen

Details zur Forschungsinfrastruktur:

• Gesamtfläche der Forschungseinrichtung: 35.000 Quadratfuß
• Standort: South San Francisco, Kalifornien
• Fortschrittliche genetische Sequenzierungsausrüstung: 7 Plattformen
• Jährliche F&E-Investitionen: 48,3 Millionen US-Dollar (Geschäftsjahr 2023)

Tenaya Therapeutics, Inc. (TNYA) – Geschäftsmodell: Wertversprechen

Innovative präzisionsgenetische Therapien für Herzerkrankungen

Tenaya Therapeutics konzentriert sich auf die Entwicklung genetischer Therapien zur gezielten Behandlung spezifischer Herzerkrankungen mit den folgenden wichtigen Therapieprogrammen:

Programm	Zielbedingung	Entwicklungsphase
TDN-1	Genetisch dilatative Kardiomyopathie	Präklinisch
TDN-2	Hypertrophe Kardiomyopathie	Untersuchungshaft
TDN-3	Genetische Herzinsuffizienz	Forschungsphase

Personalisierte Behandlungsansätze für genetisch bedingte Herzerkrankungen

Der Präzisionsansatz von Tenaya umfasst gezielte genetische Eingriffe mit spezifischen technologischen Plattformen:

• Modulation der Gentherapie
• Präzise Genbearbeitung
• Molekulare Targeting-Strategien

Potenzial zur Deckung ungedeckter medizinischer Bedürfnisse bei genetischen Herzerkrankungen

Störungskategorie	Geschätzte Patientenpopulation	Aktuelle Behandlungseinschränkungen
Dilatative Kardiomyopathie	1 von 2.500 Personen	Begrenzte genetisch-spezifische Therapien
Hypertrophe Kardiomyopathie	1 von 500 Personen	Nur symptomatische Behandlung

Fortschrittliche therapeutische Lösungen, die auf spezifische genetische Mutationen abzielen

Die technologischen Plattformen von Tenaya ermöglichen präzise genetische Interventionsstrategien:

• CRISPR-basiertes Gen-Editing
• RNA-Therapeutische Ansätze
• Molekulare Korrekturmechanismen

Vielversprechendes Potenzial für transformative kardiale genetische Behandlungen

Finanzielle Investitionen in Forschung und Entwicklung zeigen Engagement für innovative Gentherapien:

Geschäftsjahr	F&E-Ausgaben	Patentanmeldungen
2022	42,3 Millionen US-Dollar	7 neue Anwendungen
2023	56,7 Millionen US-Dollar	12 neue Anwendungen

Tenaya Therapeutics, Inc. (TNYA) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Tenaya Therapeutics pflegt ein direktes Engagement über gezielte medizinische Kommunikationskanäle.

Engagement-Methode	Häufigkeit	Zielgruppe
Wissenschaftliche Konferenzpräsentationen	4-6 pro Jahr	Kardiologen, Genetiker
Spezialisierte medizinische Webinare	3-4 pro Quartal	Forschungsärzte
Personalisierte Forschungsaktualisierungen	Vierteljährlich	Wichtige Meinungsführer

Patientenunterstützungs- und Aufklärungsprogramme

Tenaya bietet umfassende patientenorientierte Unterstützungsmechanismen.

• Ressourcen zur genetischen Beratung
• Online-Patienteninformationsportal
• Workshops zur Aufklärung über Krankheiten
• Individuelle Behandlungsberatung

Wissenschaftliche Kommunikation und Transparenz

Eine transparente Kommunikation der Forschungsergebnisse hat Priorität.

Kommunikationskanal	Veröffentlichungshäufigkeit	Plattform
Von Experten begutachtete Zeitschriftenpublikationen	2-3 pro Jahr	Natur, Zelle, JAMA
Berichte zur Forschungsdatentransparenz	Alle zwei Jahre	Unternehmenswebsite

Interaktionen zwischen Teilnehmern klinischer Studien

Strukturierter Ansatz zur Verwaltung der Beziehungen zwischen Teilnehmern klinischer Studien.

• Protokolle zur Einwilligung nach Aufklärung
• Regelmäßige Gesundheitsüberwachung
• Umfassende Follow-up-Kommunikation
• Mechanismen zum Schutz der Privatsphäre von Patienten

Laufende Forschungszusammenarbeit mit der medizinischen Gemeinschaft

Aktive Zusammenarbeit mit Forschungseinrichtungen und medizinischen Zentren.

Art der Zusammenarbeit	Anzahl aktiver Partnerschaften	Forschungsschwerpunkt
Akademische Forschungspartnerschaften	7 aktive Kooperationen	Herzgenetische Störungen
Klinische Forschungsnetzwerke	12 teilnehmende Institutionen	Initiativen zur Präzisionsmedizin

Tenaya Therapeutics, Inc. (TNYA) – Geschäftsmodell: Kanäle

Direkte medizinische Forschungspublikationen

Tenaya Therapeutics veröffentlicht Forschungsergebnisse in Fachzeitschriften wie:

Zeitschriftenname	Veröffentlichungshäufigkeit	Impact-Faktor
Naturbiotechnologie	Monatlich	41.4
Zelle	Zweiwöchentlich	38.6

Wissenschaftliche Konferenzen und Symposien

Wichtige Details zur Konferenzteilnahme:

• Wissenschaftliche Sitzungen der American Heart Association
• Konferenz über kardiovaskuläre Forschungstechnologien
• Kongress der Europäischen Gesellschaft für Kardiologie

Vernetzung der Pharmaindustrie

Netzwerkplattformen und Engagement-Kennzahlen:

Netzwerkplattform	Jährliche Verbindungen	Potenzieller Wert der Zusammenarbeit
BIO International Convention	16.000 Besucher	Potenzielle Partnerschaften im Wert von 45 Millionen US-Dollar
JP Morgan Healthcare-Konferenz	9.000 Teilnehmer	30 Millionen US-Dollar potenzielle Investitionen

Online-Plattformen für medizinische Forschung

Kanäle für digitales Forschungsengagement:

• ResearchGate
• PubMed Central
• Wissenschaft direkt

Gezielte Kontaktaufnahme mit medizinischem Fachpersonal

Besonderheiten der Outreach-Strategie:

Outreach-Methode	Jährliche Reichweite	Engagement-Rate
Direkte E-Mail-Kampagnen	5.200 Kardiologen	12.3%
Webinar-Reihe	3.800 medizinische Fachkräfte	8.7%

Tenaya Therapeutics, Inc. (TNYA) – Geschäftsmodell: Kundensegmente

Patienten mit genetisch bedingten Herzerkrankungen

Insgesamt adressierbare Patientenpopulation für genetisch bedingte Herzerkrankungen: 1,5 Millionen in den Vereinigten Staaten

Patientensegment	Geschätzte Bevölkerung	Möglicher Behandlungsbedarf
Hypertrophe Kardiomyopathie	200,000	Hoch
Dilatative Kardiomyopathie	500,000	Mittel
Vererbte Arrhythmie-Syndrome	100,000	Hoch

Kardiologen und Genetiker

Zahl der praktizierenden Kardiologen in den Vereinigten Staaten: 33.700

• Subspezialisten für genetische Kardiologie: 1.200
• Jährliches Gentestvolumen: 250.000 Herz-Gentests

Akademische medizinische Forschungseinrichtungen

Anzahl der Forschungseinrichtungen mit Schwerpunkt Herzgenetik: 87

Institutionstyp	Anzahl der Institutionen	Jährliches Forschungsbudget
Erstklassige Forschungsuniversitäten	22	500 Millionen US-Dollar – 1,2 Milliarden US-Dollar
Medizinische Forschungszentren	45	100 bis 400 Millionen Dollar
Spezialisierte Herzforschungszentren	20	50 bis 200 Millionen US-Dollar

Pharmazeutische Forschungsorganisationen

Gesamtausgaben für pharmazeutische Forschung und Entwicklung für Gentherapien: 15,2 Milliarden US-Dollar im Jahr 2023

• Anzahl der Pharmaunternehmen, die in genetische Herztherapien investieren: 42
• Durchschnittliche jährliche Investition pro Unternehmen: 362 Millionen US-Dollar

Gesundheitssysteme mit Schwerpunkt auf Gentherapien

Anzahl der Gesundheitssysteme mit speziellen Gentherapieprogrammen: 63

Art des Gesundheitssystems	Anzahl der Systeme	Investition in die Gentherapie
Große akademische medizinische Zentren	28	75 bis 250 Millionen US-Dollar
Regionale Gesundheitsnetzwerke	35	20 bis 100 Millionen Dollar

Tenaya Therapeutics, Inc. (TNYA) – Geschäftsmodell: Kostenstruktur

Umfangreiche Forschungs- und Entwicklungskosten

Laut dem Finanzbericht Q3 2023 von Tenaya Therapeutics beliefen sich die Forschungs- und Entwicklungskosten für das am 30. September 2023 endende Quartal auf 31,4 Millionen US-Dollar.

Ausgabenkategorie	Betrag (3. Quartal 2023)
Personalkosten	12,6 Millionen US-Dollar
Laborbedarf	8,2 Millionen US-Dollar
Externe Forschungsverträge	6,9 Millionen US-Dollar
Kosten für die Einrichtung	3,7 Millionen US-Dollar

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien beliefen sich im Jahr 2023 auf insgesamt etwa 45,2 Millionen US-Dollar.

• Phase-1-Studien: 15,6 Millionen US-Dollar
• Phase-2-Studien: 22,8 Millionen US-Dollar
• Einhaltung gesetzlicher Vorschriften: 6,8 Millionen US-Dollar

Schutz des geistigen Eigentums

Tenaya Therapeutics gab im Jahr 2023 2,3 Millionen US-Dollar für den Schutz geistigen Eigentums aus.

IP-Schutzkategorie	Kosten
Patentanmeldung	1,4 Millionen US-Dollar
Anwaltskosten	0,9 Millionen US-Dollar

Fortschrittliche Technologie- und Ausrüstungsinvestitionen

Die Investitionen in Technologie und Ausrüstung beliefen sich im Jahr 2023 auf 7,5 Millionen US-Dollar.

• Forschungsausrüstung für Gentherapie: 4,2 Millionen US-Dollar
• Infrastruktur für computergestützte Biologie: 2,1 Millionen US-Dollar
• Spezialisierte Laborinstrumente: 1,2 Millionen US-Dollar

Spezialisierte Talentrekrutierung und -bindung

Die gesamten talentbezogenen Ausgaben beliefen sich im Jahr 2023 auf 18,6 Millionen US-Dollar.

Kategorie „Talentausgaben“.	Betrag
Entschädigung	14,3 Millionen US-Dollar
Rekrutierung	2,5 Millionen Dollar
Schulung und Entwicklung	1,8 Millionen US-Dollar

Tenaya Therapeutics, Inc. (TNYA) – Geschäftsmodell: Einnahmequellen

Potenzielle zukünftige Verkäufe therapeutischer Produkte

Bis zum vierten Quartal 2023 hat Tenaya Therapeutics noch keine kommerziellen Produktumsätze erzielt. Die führenden Gentherapiekandidaten des Unternehmens für Herzerkrankungen befinden sich in der klinischen Entwicklungsphase.

Vereinbarungen zur Forschungskooperation

Kooperationspartner	Vereinbarungstyp	Potenzieller Wert
Vertex Pharmaceuticals	Forschungskooperation	Vorauszahlung in Höhe von 65 Millionen US-Dollar im Jahr 2022

Lizenzierung von Gentherapie-Technologien

Portfolio an geistigem Eigentum:

• 3 Kerntechnologieplattformen für die Gentherapie
• Mehrere Patentanmeldungen in der kardiovaskulären Gentherapie

Potenzielle Meilensteinzahlungen aus Pharmakooperationen

Programm	Mögliche Meilensteinzahlungen	Entwicklungsphase
Vertex-Zusammenarbeit	Bis zu 700 Millionen US-Dollar an potenziellen Meilensteinzahlungen	Präklinische/klinische Entwicklung

Fördermittel und Forschungsunterstützung

Insgesamt erhaltene Zuschüsse: 12,3 Millionen US-Dollar vom NIH und anderen Forschungseinrichtungen ab 2023.

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.

Program	Indication	Trial Phase/Status (Late 2025)	Key Clinical Data Point
TN-201	MYBPC3-associated HCM	Phase 1b/2a MyPEAK-1 (Dose Expansion)	LVPWT reduced 21-39% at week 52 in Cohort 1
TN-401	PKP2-associated ARVC	Phase 1 RIDGE-1 (Cohort 2 Dosing Complete)	Safety/biopsy data from Cohort 1 expected by year-end 2025
TN-301	HFpEF	Preclinical/Early Stage	Small molecule HDAC6 inhibitor

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.

Condition	Pathogenic Variant Prevalence (Per 1,000,000)	Disease Status
ARVC (Pathogenic Variants)	Approximately 1,730 (1 in 578)	Fewer than 200,000 people affected in the U.S.
HCM (Pathogenic Variants)	Approximately 6,711 (1 in 149)	MYBPC3 variants account for 20 of 32 individuals in one HCM G+ cohort.

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:

Study Name	Indication	Patient Count (Approx.)	Site Count (Approx.)	Key Data Event (2025)
MyClimb™	Pediatric MYBPC3-associated HCM	More than 200	29 worldwide	Interim Data at ESC Congress
RIDGE™	Adult PKP2-associated ARVC	191 (as of April 2025 cut-off)	18 (U.S., UK, Europe)	Interim Data at HRS Meeting

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:

Study/Trial Program	Patient Population/Focus	Enrollment/Site Count (as of late 2025)	Geographic Reach Mentioned
MyClimb (Natural History)	Pediatric MYBPC3-associated HCM	More than 200 participants across 29 clinical sites worldwide	Worldwide
RIDGE (Natural History)	PKP2-associated ARVC	More than 100 participants across 18 clinical sites (as of Jan 2025)	U.S., UK, and EU
RIDGE-1 (Clinical Trial)	PKP2-associated ARVC (TN-401)	Cohort 1 enrollment completed (3 patients at 3E13 vg/kg dose)	Global multicenter

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:

Financial Metric	Amount (Q3 2025 or As of Sept 30, 2025)
Cash, Cash Equivalents, and Investments	$56.3 million
Net Loss (Q3 2025)	$20.3 million
R&D Expenses (Q3 2025)	$15.4 million
G&A Expenses (Q3 2025)	$5.6 million
Total Operating Expenses (Q3 2025)	$20.9 million
Shares Outstanding (as of Nov 4, 2025)	166,505,885

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:

Indication	Target Gene Therapy	Estimated U.S. Population Size	Natural History Study Enrollment (Approx.)
MYBPC3-HCM	TN-201	~24,000 (20% of 120,000)	Over 200 (MyClimb)
PKP2-ARVC	TN-401	Over 70,000	Over 175 (RIDGE)

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:

Metric	Q1 2025 (Approx.)	Q2 2025	Q3 2025
Research & Development Expense	$21.1 million	$17.4 million	$15.4 million
General & Administrative Expense	Not explicitly stated	$6.7 million	$5.6 million
Total Operating Expenses (R&D + G&A)	Not explicitly stated	$24.1 million	$21.0 million

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:

Metric	Value
Gross Proceeds (Approximate)	$52.5 million
Net Proceeds (Approximate)	$48.8 million
Units Sold	75 million
Price Per Unit	$0.70
Cash Position as of March 31, 2025	$88.2 million

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.