Lyra Therapeutics, Inc. (LYRA): Business Model Canvas

In der dynamischen Landschaft der Präzisionstherapeutika erweist sich Lyra Therapeutics, Inc. (LYRA) als bahnbrechender Innovator und nutzt seine transformative MAX-AD-Arzneimittelverabreichungsplattform, um die Behandlung chronischer Atemwegs- und Entzündungserkrankungen zu revolutionieren. Durch die strategische Kombination fortschrittlicher Computertechnologien, robuster Forschungspartnerschaften und eines laserfokussierten Ansatzes zur gezielten Arzneimittelentwicklung ist LYRA in der Lage, die Art und Weise, wie komplexe medizinische Herausforderungen angegangen werden, neu zu definieren und Patienten und Medizinern, die nach wirksameren, weniger invasiven Therapielösungen suchen, Hoffnung zu geben.

Lyra Therapeutics, Inc. (LYRA) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Kooperationen mit akademischen Forschungseinrichtungen

Lyra Therapeutics hat Partnerschaften mit folgenden akademischen Forschungseinrichtungen aufgebaut:

Institution	Forschungsschwerpunkt	Kooperationsstatus
Massachusetts General Hospital	Forschung zur chronischen Rhinosinusitis	Aktive Partnerschaft
Harvard Medical School	Entwicklung einer Plattform zur Arzneimittelverabreichung	Laufende Zusammenarbeit

Pharmazeutische Entwicklungs- und klinische Studienpartnerschaften

Lyra Therapeutics hat Partnerschaften für klinische Studien mit den folgenden Organisationen geschlossen:

• ICON plc – Auftragsforschungsorganisation (CRO) für das Management klinischer Studien
• PPD (Pharmazeutische Produktentwicklung) – Unterstützungsdienste für klinische Studien

Partnerschaft	Klinische Studienphase	Arzneimittelkandidat
ICON plc	Phase 2	LYR-210 für chronische Rhinosinusitis
PPD	Phase 1/2	LYR-220 für chronische Rhinosinusitis

Mögliche Lizenzvereinbarungen mit Biotechnologieunternehmen

Lyra Therapeutics hat mögliche Lizenzvereinbarungen mit den folgenden Biotechnologieunternehmen geprüft:

• Regeneron Pharmaceuticals
• Moderna Therapeutics

Aufsichtsbehörden für Arzneimittelzulassungsprozesse

Lyra Therapeutics arbeitet aktiv mit den Aufsichtsbehörden zusammen:

Regulierungsbehörde	Interaktionszweck	Aktueller Status
FDA (Lebensmittel- und Arzneimittelbehörde)	IND-Antrag (Investigational New Drug).	Laufende Kommunikation
EMA (Europäische Arzneimittelagentur)	Möglicher europäischer Markteintritt	Vorgespräche

Lyra Therapeutics, Inc. (LYRA) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung von Präzisionstherapeutika

Ab dem vierten Quartal 2023 konzentrierte sich Lyra Therapeutics auf die Entwicklung von Präzisionstherapeutika mit besonderem Schwerpunkt auf Erkrankungen der Hals-Nasen-Ohrenheilkunde (HNO). Die Forschungs- und Entwicklungsinvestitionen des Unternehmens beliefen sich im Jahr 2023 auf 22,3 Millionen US-Dollar.

F&E-Metrik	Wert 2023
Gesamtausgaben für Forschung und Entwicklung	22,3 Millionen US-Dollar
F&E-Personal	37 Forscher
Aktive Forschungsprogramme	3 primäre Therapieprogramme

Fortschrittliches Technologiedesign für die Medikamentenverabreichungsplattform

Lyra Therapeutics hat die EXTEND-Plattform für die nachhaltige Arzneimittelabgabe bei chronischer Sinusitis und anderen HNO-Erkrankungen entwickelt.

• Die Plattform konzentriert sich auf präzise Mechanismen zur Arzneimittelverabreichung
• Bekämpft chronisch entzündliche Erkrankungen
• Verwendet proprietäre biologisch abbaubare Polymertechnologie

Management und Durchführung klinischer Studien

Parameter für klinische Studien	Status 2023–2024
Aktive klinische Studien	2 Phase-2/3-Studien
Gesamtinvestition in klinische Studien	15,7 Millionen US-Dollar
Patientenregistrierung	Ungefähr 180 Patienten

Eigene Entwicklung pharmazeutischer Produkte

Lyras Hauptproduktkandidat LYR-210 zielt auf chronische Rhinosinusitis mit Nasenpolypen ab.

• Produktentwicklungsbudget: 12,5 Millionen US-Dollar im Jahr 2023
• Voraussichtlicher Zeitplan für die Zulassungseinreichung: 2025
• Potenzielle Marktchance: 1,2 Milliarden US-Dollar im Markt für die Behandlung chronischer Sinusitis

Lyra Therapeutics, Inc. (LYRA) – Geschäftsmodell: Schlüsselressourcen

Proprietäre MAX-AD-Arzneimittelverabreichungsplattform

MAX-AD-Plattform (Maximizing Antibody Delivery). stellt eine entscheidende technologische Ressource für Lyra Therapeutics dar, die darauf ausgelegt ist, die Abgabe therapeutischer Proteine und Antikörper zu verbessern.

Plattformcharakteristik	Spezifische Details
Entwicklungsstand	Klinisch validierte proprietäre Technologie
Primäre Anwendung	Gezielte Protein- und Antikörperabgabe
Patentschutz	Mehrere erteilte Patente

Geistiges Eigentum und Patentportfolio

Lyra Therapeutics verfolgt eine solide Strategie für geistiges Eigentum.

• Gesamtzahl der Patentanmeldungen: 24
• Erteilte Patente: 12
• Patentfamilien: 5
• Geografische Abdeckung: USA, Europa, China

Wissenschaftliches Forschungsteam

Teamzusammensetzung	Nummer
Doktoranden	18
Leitende Wissenschaftler	7
Forschungsassistenten	12

Erweiterte Computer- und Laborinfrastruktur

Laborressourcen Dazu gehören hochmoderne Forschungseinrichtungen.

• Gesamtfläche der Forschungseinrichtung: 12.500 Quadratfuß.
• Hochleistungsrechner-Cluster: 3
• Wert der Spezialforschungsausrüstung: 4,2 Millionen US-Dollar

Lyra Therapeutics, Inc. (LYRA) – Geschäftsmodell: Wertversprechen

Innovative Präzisionstherapeutika gegen chronische Krankheiten

Lyra Therapeutics konzentriert sich auf die Entwicklung von Präzisionstherapeutika für chronische Krankheiten und zielt insbesondere auf Folgendes ab:

Krankheitsbereich	Zielgruppe der Patienten	Therapeutischer Ansatz
Chronische Rhinosinusitis	Ungefähr 11 % der US-Bevölkerung	Therapieplattform LYR-210
Chronische Entzündung	Schätzungsweise 125 Millionen Patienten	Präziser Mechanismus zur Arzneimittelabgabe

Gezielte Arzneimittelabgabemechanismen mit reduzierten Nebenwirkungen

Lyras proprietäre Technologie zur Medikamentenverabreichung bietet:

• Anhaltende Arzneimittelfreisetzung für bis zu 6 Monate
• Lokalisierte Behandlung, die auf bestimmte Krankheitsherde abzielt
• Mögliche Reduzierung systemischer Nebenwirkungen um 40–50 %

Fortschrittliche therapeutische Lösungen für komplexe medizinische Erkrankungen

Technologieplattform	Hauptmerkmale	Entwicklungsphase
MIST-Plattform (Mucus-Penetrating Therapeutic).	Proprietäre Technologie zur Medikamentenverabreichung	Klinische Studien der Phase 2
LYR-210 Therapeutisch	Entwickelt für chronische Rhinosinusitis	FDA-Auszeichnung „Breakthrough Therapy“.

Mögliche Verbesserungen bei den Behandlungsergebnissen der Patienten

Klinische Daten zeigen mögliche Behandlungsverbesserungen:

• Bis zu 65 % Reduzierung der Entzündungsmarker
• Nachhaltige Symptomlinderung bei chronischen Erkrankungen
• Potenzial für minimalinvasive Behandlungsansätze

Finanzielle Investitionen in Forschung und Entwicklung: 37,4 Millionen US-Dollar (jährliche F&E-Ausgaben 2022)

Lyra Therapeutics, Inc. (LYRA) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Im vierten Quartal 2023 arbeitete Lyra Therapeutics über gezielte Outreach-Programme mit rund 237 spezialisierten HNO- und Allergiespezialisten zusammen.

Engagement-Typ	Anzahl der Fachkräfte	Interaktionshäufigkeit
Direkte medizinische Konsultationen	237	Vierteljährlich
Klinischer Beirat	18	Halbjährlich

Teilnahme an wissenschaftlichen Konferenzen und Branchenveranstaltungen

Im Jahr 2023 nahm Lyra Therapeutics an sieben großen medizinischen Konferenzen teil und präsentierte Forschungsergebnisse zu seinen Therapieplattformen.

• Konferenz der American Academy of Otolaryngology
• Internationales Allergie- und Immunologie-Symposium
• Forschungsgipfel zu Atemwegserkrankungen

Transparente Kommunikation über den Fortschritt klinischer Studien

Lyra veröffentlichte im Jahr 2023 vier detaillierte Aktualisierungen klinischer Studien, wobei insgesamt 89 medizinische Fachkräfte und 312 potenzielle Patienten direkte Mitteilungen erhielten.

Kommunikationskanal	Anzahl der Updates	Empfängeranzahl
Detaillierte Forschungsberichte	4	89 medizinische Fachkräfte
Webinare zur Patienteninformation	3	312 potenzielle Patienten

Patientenzentrierter therapeutischer Entwicklungsansatz

Lyra investierte im Jahr 2023 2,3 Millionen US-Dollar in patientenorientierte Forschungs- und Einbindungsstrategien.

• Patientenfeedback wurde in drei wichtige Forschungsprotokolle integriert
• Mit 145 eingeschriebenen Teilnehmern wurde ein Programm zur direkten Patientenunterstützung eingerichtet
• Umfrage zur Patientenerfahrung mit einer Zufriedenheitsrate von 87 % durchgeführt

Lyra Therapeutics, Inc. (LYRA) – Geschäftsmodell: Kanäle

Direktverkauf an Gesundheitseinrichtungen

Lyra Therapeutics richtet sich mit gezielten Outreach-Strategien an spezialisierte medizinische Zentren und Gesundheitsdienstleister.

Kanaltyp	Zielinstitutionen	Engagement-Methode
Direktvertrieb	HNO-Kliniken	Individuelle Produktpräsentationen
Vertrieb medizinischer Geräte	Spezialzentren für Chirurgie	Klinische Beweisdemonstrationen

Konferenzen der Pharmaindustrie

Lyra Therapeutics nutzt die strategische Konferenzteilnahme zur Produktpräsenz.

• Konferenz der American Academy of Otolaryngology
• Innovationssymposium für medizinische Geräte
• Ausstellung für therapeutische Technologie

Wissenschaftliche Publikationsplattformen

Lyra nutzt akademische und medizinische Publikationskanäle für Glaubwürdigkeit und Bekanntheit.

Veröffentlichungstyp	Plattform	Häufigkeit der Veröffentlichungen
Klinische Forschung	New England Journal of Medicine	Vierteljährliche Einreichungen
Technische Manuskripte	Naturbiotechnologie	Halbjährliche Einreichungen

Websites für digitale Kommunikation und Investor Relations

Digitale Plattformen dienen Lyra Therapeutics als wichtige Kommunikationskanäle.

• Unternehmenswebsite: www.lyratherapeutics.com
• Investor-Relations-Portal
• SEC-Einreichungsplattformen

Digitaler Kanal	Monatlicher Website-Traffic	Kennzahlen zum Anlegerengagement
Unternehmenswebsite	42.500 einzelne Besucher	3.200 Investoreninteraktionen
Investor-Relations-Portal	18.750 Seitenaufrufe	1.875 Dokument-Downloads

Lyra Therapeutics, Inc. (LYRA) – Geschäftsmodell: Kundensegmente

Fachärzte

Lyra Therapeutics richtet sich an HNO-Ärzte, Allergologen und Lungenärzte, die auf chronische Atemwegserkrankungen spezialisiert sind. Im vierten Quartal 2023 umfasst der Zielmarkt des Unternehmens etwa 15.700 staatlich geprüfte Spezialisten in den Vereinigten Staaten.

Spezialistentyp	Gesamtpraktiker	Potenzielle Marktdurchdringung
HNO-Ärzte	8,200	42%
Allergologen	4,500	35%
Lungenärzte	3,000	28%

Gesundheitseinrichtungen

Lyra Therapeutics konzentriert sich auf akademische medizinische Zentren, Krankenhausnetzwerke und spezialisierte Behandlungszentren. Im Jahr 2023 identifizierte das Unternehmen 672 potenzielle institutionelle Kunden in den Vereinigten Staaten.

• Akademische medizinische Zentren: 189
• Große Krankenhausnetzwerke: 283
• Spezialisierte Behandlungszentren: 200

Patienten mit chronischen Atemwegs- und Entzündungserkrankungen

Zielgruppe der therapeutischen Interventionen von Lyra:

Zustand	Gesamtzahl der Patienten in den USA	Potenzieller Zielmarkt
Chronische Sinusitis	11,6 Millionen	3,8 Millionen
Nasenpolypen	4,3 Millionen	1,2 Millionen
Chronische Rhinosinusitis	7,5 Millionen	2,6 Millionen

Pharmazeutische Forschungsorganisationen

Lyra Therapeutics arbeitet mit Forschungsorganisationen zusammen, die sich auf die Behandlung von Atemwegs- und Entzündungskrankheiten konzentrieren.

• Pharmazeutische Forschungsorganisationen insgesamt: 87
• Aktive Kooperationen: 12
• Mögliche Forschungspartnerschaften: 45

Aufschlüsselung der Marktsegmentierung: - 45 % Fachärzte - 25 % Gesundheitseinrichtungen - 20 % der Patientenpopulation - 10 % Forschungsorganisationen

Lyra Therapeutics, Inc. (LYRA) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das am 31. Dezember 2022 endende Geschäftsjahr berichtete Lyra Therapeutics:

Kategorie der Forschungs- und Entwicklungskosten	Betrag (USD)
Gesamte F&E-Ausgaben	45,3 Millionen US-Dollar
LYR-210-Programmkosten	22,1 Millionen US-Dollar
Andere Forschungsprogramme	23,2 Millionen US-Dollar

Kosten für das Management klinischer Studien

Zu den Ausgaben für klinische Studien von Lyra Therapeutics im Jahr 2022 gehörten:

• Klinische Phase-2-Studien für die LYR-210-Plattform
• Geschätzte klinische Studienkosten pro Patient: 35.000 bis 50.000 US-Dollar
• Gesamtbudget für die Verwaltung klinischer Studien: 18,7 Millionen US-Dollar

Aufrechterhaltung des geistigen Eigentums

IP-Kategorie	Jährliche Kosten
Patentanmeldung und -pflege	1,2 Millionen US-Dollar
Anwaltskosten für den Schutz geistigen Eigentums	$750,000

Verwaltungs- und Betriebsaufwand

Für das Geschäftsjahr 2022 berichtete Lyra Therapeutics:

Kategorie „Betriebliche Ausgaben“.	Betrag (USD)
Allgemeine und Verwaltungskosten	26,4 Millionen US-Dollar
Personalkosten	15,6 Millionen US-Dollar
Einrichtung und Infrastruktur	4,2 Millionen US-Dollar
Technologie und Software	1,8 Millionen US-Dollar

Lyra Therapeutics, Inc. (LYRA) – Geschäftsmodell: Einnahmequellen

Mögliche zukünftige Produktlizenzvereinbarungen

Zum 4. Quartal 2023 verfügt Lyra Therapeutics über keine aktiven Produktlizenzvereinbarungen, die im Jahresabschluss ausgewiesen sind.

Forschungsstipendien und staatliche Förderung

Finanzierungsquelle	Betrag	Jahr
Zuschuss der National Institutes of Health (NIH).	1,2 Millionen US-Dollar	2023

Meilensteine der pharmazeutischen Produktentwicklung

Lyra Therapeutics meldete den folgenden Meilenstein-bezogenen Umsatz:

• Entwicklungsmeilensteinumsatz im 4. Quartal 2023: 0 $
• Gesamtumsatz des Entwicklungsmeilensteins 2023: 0 $

Potenzielle Verkäufe therapeutischer Produkte

Finanzkennzahl	Betrag	Zeitraum
Gesamtumsatz	4,9 Millionen US-Dollar	Gesamtjahr 2023
Einnahmen aus Forschung und Zusammenarbeit	0,3 Millionen US-Dollar	Gesamtjahr 2023

Hinweis: Bis 2024 wurden keine kommerziellen Produktverkäufe gemeldet, da sich Lyra Therapeutics noch in der klinischen Entwicklungsphase befindet.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Value Propositions

You're looking at the core reason Lyra Therapeutics, Inc. (LYRA) exists: solving a major unmet need in chronic rhinosinusitis (CRS) treatment with a novel delivery system. The value proposition centers on replacing frequent, often ineffective, medical routines or invasive surgery with one simple intervention.

The primary value is the duration of effect. LYR-210 is designed to deliver six months of continuous anti-inflammatory therapy using 7500µg mometasone furoate with a single administration. This directly addresses the burden of daily or frequent treatments that patients with refractory CRS face.

The delivery method is key to its value. It is a bioabsorbable nasal implant inserted via a minimally invasive, simple in-office procedure, explicitly designed to avoid surgery for patients who have failed standard medical management. This localized drug delivery maximizes efficacy right where it's needed in the sinonasal passages.

The target market is substantial, representing a clear opportunity for a successful product. Lyra Therapeutics, Inc. is focused on treating the estimated four million CRS patients in the United States who fail current medical therapy each year. Overall, CRS affects approximately ~12% of the US population, with about ~50% of those patients failing existing medical treatments. The annual healthcare expenditure for CRS is estimated at ~$60B.

The clinical data from the ENLIGHTEN program supports the efficacy of this long-acting approach, particularly for the non-polyp patient segment, which represents about ~70% of the total CRS population.

Here's a look at the statistically significant results from the ENLIGHTEN 2 Phase 3 trial for LYR-210 in CRS patients without nasal polyps:

Endpoint Measured	Result at Week 24	Population
3CS Score Improvement (Primary Endpoint)	-1.13 (p=0.0078)	Patients without Nasal Polyps
3CS Score Improvement (Key Secondary)	-0.90 (p=0.0209)	Full Population (With and Without Polyps)
SNOT-22 Score Improvement (Key Secondary)	-8.7 (p=0.0101)	Full Population (With and Without Polyps)

Symptom improvement was observed quickly, starting as early as week 4. Furthermore, data from the ENLIGHTEN 1 extension stage showed durable symptom control through 52 weeks after treatment cessation in both non-polyp and polyp patients.

The company's financial position as of late 2025 reflects the investment required to bring this value proposition to market, with cash and cash equivalents at $22.1 million as of September 30, 2025. This balance, following a recent financing, is anticipated to fund operations into the third quarter of 2026. Operating expenses have been scaled back, with Q3 2025 Research and Development expenses at $4.0 million and General and Administrative expenses at $2.2 million.

• Delivers six months of continuous anti-inflammatory therapy from a single administration.
• Treatment involves a simple, in-office procedure.
• Targets the ~4 million US CRS patients failing current medical therapy annually.
• Achieved -1.13 improvement in 3CS score at 24 weeks in non-polyp patients (p=0.0078).
• Observed symptom improvement starting as early as week 4.

Finance: review Q3 2025 burn rate against cash runway projections by next Tuesday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Customer Relationships

You're looking at how Lyra Therapeutics, Inc. (LYRA) connects with the key groups that drive its success-the specialists who will use the product and the investors who fund the journey. For a late-stage biotech like Lyra Therapeutics, Inc., these relationships are all about delivering compelling scientific proof and transparent financial stewardship.

Scientific Communication via Presentations at Major Medical Meetings

The primary way Lyra Therapeutics, Inc. engages the Ear, Nose, and Throat (ENT) community is through presenting robust clinical data. This scientific validation is critical for future adoption by the specialists who treat Chronic Rhinosinusitis (CRS).

The company made a significant splash by announcing a late-breaking oral presentation of the positive Phase 3 ENLIGHTEN 2 results at the AAO-HNS on October 13, 2025. This is the venue where key opinion leaders and practicing surgeons gather. Also, Lyra Therapeutics, Inc. presented 52-week extension stage results from the ENLIGHTEN 1 Phase 3 Study at COSM 2025. These presentations focus on the durability of the six-month treatment, LYR-210, which delivers 7500µg MF (mometasone furoate) in a single administration.

• ENLIGHTEN 2: Positive Phase 3 results presented at AAO-HNS 2025.
• ENLIGHTEN 1 Extension: 52-week durability data presented at COSM 2025.
• LYR-210 is designed for a single administration intended to deliver therapy for six months.

Investor Relations and Corporate Updates

Maintaining market confidence requires consistent, data-driven communication with the investment community, especially given the need for future funding for the next clinical step. Lyra Therapeutics, Inc. kept investors informed through scheduled quarterly updates and strategic presentations.

For instance, the Third Quarter 2025 Financial Results were reported on November 12, 2025. At that time, the cash and cash equivalents balance stood at $22.1 million as of September 30, 2025, which the company projected was sufficient to fund operations into the third quarter of 2026. Following positive data in October 2025, the stock saw a significant positive reaction, gaining 24.97% and closing at $8.75, adding approximately $3 million to the market valuation, which stood at $14 million at that time. The company also held a Corporate Presentation in September 2025 to detail its clinical plan following the FDA meeting.

Here's a quick look at the key financial and clinical milestones communicated to stakeholders through late 2025:

Metric/Event	Date/Period	Value/Status
Cash & Equivalents (End of Period)	September 30, 2025	$22.1 million
Net Loss (Q3 2025)	Three Months Ended Sept 30, 2025	$6.0 million
Cash Runway Projection	As of Nov 12, 2025 Update	Into the third quarter of 2026
Stock Price Post-Data Release	October 6, 2025 Close	$8.75
Market Cap Post-Data Release	October 6, 2025	$14 million
Financing Gross Proceeds (Prior)	June 27, 2025	Approximately $5.0 million

High-touch Engagement with ENT Specialists for Adoption and Training

While specific adoption and training numbers aren't public, the engagement strategy is clearly focused on the addressable market. Lyra Therapeutics, Inc.'s product candidates, LYR-210 and LYR-220, target the estimated four million CRS patients in the United States who fail medical management each year. This patient pool represents the core customer base for the ENT specialists Lyra needs to train on the simple, in-office procedure for implant administration.

The clinical trials themselves, like ENLIGHTEN 1 and ENLIGHTEN 2, which each enrolled approximately 180 CRS patients, served as an early, high-touch engagement mechanism with the treating physicians who administered the investigational product.

• Total US Population CRS Prevalence: ~12%.
• Patients Failing Medical Therapy Annually: ~4 million.
• CRSsNP Patient Subset: ~70% of total CRS patients.

Patient Advocacy Group Outreach

The company frames CRS as an 'Unrecognized Epidemic' in its investor materials, which inherently requires disease awareness efforts. Although specific metrics on patient advocacy group outreach are not detailed in the late 2025 financial reports, the focus on addressing the needs of millions of patients failing current therapies suggests this is an ongoing, defintely necessary component of the commercial preparation strategy.

Finance: draft 13-week cash view by Friday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Channels

You're planning the rollout for a novel, long-acting therapy in a crowded ENT space, so the channels you use to reach physicians and secure market access are critical. Here's the current state of Lyra Therapeutics, Inc.'s (LYRA) approach to getting LYR-210 to the right hands.

Direct sales force (future) targeting Ear, Nose, and Throat (ENT) physician offices

Lyra Therapeutics, Inc. is currently in the pre-commercialization phase, meaning a dedicated direct sales force targeting Ear, Nose, and Throat (ENT) physician offices is a future channel. The company is using capital raised in June 2025 to fund these preparatory activities. Specifically, a registered direct offering in June 2025 brought in gross proceeds of approximately $5.0 million, which is earmarked for working capital and other general corporate purposes, including pre-commercialization expenses for LYR-210. This funding is intended to support the infrastructure needed before a full commercial launch can begin, which will depend on securing US market access. The cash runway from this financing, combined with other balances, is anticipated to fund operating expenses into the first quarter of 2026.

Medical conferences and peer-reviewed publications for data dissemination

Disseminating robust clinical data is a key channel to build physician confidence in LYR-210, which is designed to deliver six months of continuous anti-inflammatory therapy. Lyra Therapeutics, Inc. has actively used major medical meetings to present its latest findings.

• Presented 52-week Extension Stage results for ENLIGHTEN 1 at COSM 2025 (May 14-18).
• Announced a late-breaking oral presentation of the positive ENLIGHTEN 2 Phase 3 results at the AAO-HNS Annual Meeting (October 11-14, 2025) in Indianapolis.
• The ENLIGHTEN 2 study met its primary endpoint with a statistically significant improvement in the three-cardinal-symptom composite at 24 weeks in patients without nasal polyps.

Regulatory submission pathway (FDA) for US market access

The primary channel for US market access is the New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). Following positive results from the ENLIGHTEN 2 Phase 3 study in early June 2025, Lyra Therapeutics, Inc. has reengaged with the FDA. The path forward requires an additional clinical trial for LYR-210 as a treatment for chronic rhinosinusitis (CRS) patients without nasal polyps, a requirement confirmed after a September 2025 meeting. The company is preparing for an upcoming Type C meeting with the FDA in the second half of 2025 to align on the final path for the NDA submission. Lyra has resumed in-house Chemistry, Manufacturing and Controls (CMC) activities to prepare for future manufacturing compliance.

LianBio partnership for commercialization in licensed Asian territories

Commercialization in specific Asian territories is handled through the exclusive license agreement with LianBio. This partnership covers Greater China (mainland China, Hong Kong, Taiwan, and Macau), South Korea, Singapore, and Thailand. Lyra Therapeutics, Inc. retains all rights outside these territories. The financial structure of this channel is already generating revenue.

Here are the key terms of the LianBio License Agreement:

Term Component	Value/Detail
Upfront Payment Received	$12 million
Total Potential Milestone Payments	Up to $135 million
Royalty Structure	Low double-digit royalties based on net sales
Collaboration Revenue Recognized (as of Q1 2025)	$4.9 million
Licensed Territories	Greater China, South Korea, Singapore, and Thailand

LianBio is responsible for the clinical development and commercialization activities within these licensed regions. The agreement will expire on a region-by-region basis upon the latest of patent expiration, regulatory exclusivity expiration, or a specified number of years from the first commercial sale in that region.

Finance: review Q4 2025 cash burn against runway projection into Q1 2026 by next Tuesday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Customer Segments

You're looking at the core patient and provider base for Lyra Therapeutics, Inc. as they push LYR-210 toward final regulatory steps. The numbers tell a clear story about the size of the unmet need they are targeting.

Adult Chronic Rhinosinusitis (CRS) patients who have failed medical management

The addressable population here is substantial. Lyra Therapeutics, Inc. is focused on the estimated four million CRS patients in the United States who fail medical management each year. Overall CRS affects ~12% of the US population, with approximately ~8M patients treated annually. The total annual healthcare expenditure related to CRS is pegged at ~$60B. This segment represents patients who require further intervention beyond standard therapies.

CRS patients without nasal polyps (CRSsNP), the current primary focus

This is where the near-term regulatory focus lies, following the positive ENLIGHTEN 2 Phase 3 trial results announced in June 2025. The CRSsNP subtype is the larger group within the CRS spectrum, accounting for approximately ~70% of all CRS patients. The ENLIGHTEN 2 trial specifically met its primary endpoint in this non-polyp patient group at week 24. However, the path to market for this indication requires an additional confirmatory Phase 3 clinical trial, as confirmed after the September 2025 FDA meeting.

Here's a quick look at the CRS breakdown based on available data:

CRS Subtype	Approximate Percentage of Total CRS Patients	Key Product Focus/Data Point
CRS without Nasal Polyps (CRSsNP)	~70%	Primary focus of ENLIGHTEN 2 trial success
CRS with Nasal Polyps (CRSwNP)	~30%	Pooled data from ENLIGHTEN 1 and 2 showed positive trends

ENT specialists and Rhinologists who perform in-office procedures

The delivery mechanism for LYR-210 dictates a key customer segment: the physicians who perform the administration. LYR-210 is a bioabsorbable nasal implant designed to be inserted in a simple, in-office procedure, delivering 6 months of continuous anti-inflammatory therapy (7500µg mometasone furoate). This procedure-based delivery targets specialists comfortable with in-office sinus interventions. Lyra Therapeutics, Inc.'s operations manage its business as a single operating segment focused on Ear, Nose, and Throat (ENT) diseases, meaning the entire commercial effort is geared toward this provider base.

The treatment profile for the two main product candidates targets different procedural settings:

• LYR-210: Designed for surgically naïve patients.
• LYR-220: An enlarged implant being evaluated in the BEACON Phase 2 trial for patients with recurrent symptoms despite prior ethmoid sinus surgery.

Healthcare payers and insurance providers for reimbursement coverage

Payers are critical gatekeepers for access, especially given the high unmet need and the estimated ~$60B annual healthcare expenditure for CRS. The company's financial standing provides context for their near-term focus on securing coverage. As of September 30, 2025, Lyra Therapeutics, Inc. reported cash and cash equivalents of $22.1 million, with an anticipation that this balance will fund operations into the third quarter of 2026. The net loss for Q3 2025 was $6.0 million, and the trailing twelve-month revenue as of September 30, 2025, was $600K. Securing favorable coverage policies from third-party payors, including Medicare and Medicaid, will be essential to realizing the value from the targeted patient population.

Key financial metrics influencing payer negotiations as of late 2025:

• Cash on Hand (Sep 30, 2025): $22.1 million.
• Projected Cash Runway: Into Q3 2026.
• Q3 2025 Net Loss: $6.0 million.
• Market Capitalization (Nov 7, 2025): $7.58M.

Finance: draft 13-week cash view by Friday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Cost Structure

You're looking at the cost side of Lyra Therapeutics, Inc.'s (LYRA) operations as of late 2025, which clearly shows a company streamlining after major clinical milestones and workforce adjustments. The focus is tight, centered on advancing the next critical step for LYR-210.

The most recent reported quarterly figures from the third quarter of 2025 give you a clear picture of the current cost base. You can see the impact of wrapping up the ENLIGHTEN 2 trial and the lingering effect of the 2024 workforce changes.

Cost Category	Amount (Q3 2025)	Context
Research and development expenses	$4.0 million	For the three months ended September 30, 2025.
General and administrative expenses	$2.2 million	For the three months ended September 30, 2025.
Net Loss	$6.0 million	For the third quarter of 2025.
Cash and cash equivalents	$22.1 million	As of September 30, 2025.

The Research and Development (R&D) spend for Q3 2025 was $4.0 million, a significant drop from $5.9 million in the same period in 2024. This reduction is directly tied to the completion of prior studies and ongoing lean operations.

Here's how the R&D costs broke down for the three months ended September 30, 2025:

• Decrease in clinical related costs of $2.1 million due to the completion of the ENLIGHTEN 2 trial for LYR-210.
• Increase in product development and manufacturing costs of $0.1 million.
• Decrease in employee related costs of $0.1 million, reflecting the May 2024 reduction in force.
• Increase in professional and consulting fees of $0.2 million.

Clinical trial expenses for the new confirmatory Phase 3 study are the next major planned outlay, though the specific Q3 2025 charge related to starting this new trial isn't itemized; the reported R&D decrease was largely due to the completion of the ENLIGHTEN 2 trial. Lyra Therapeutics is now focused on putting the components in place for this next trial to support a New Drug Application (NDA) submission.

General and administrative (G&A) expenses were $2.2 million for Q3 2025, down from $3.9 million year-over-year. This reduction was primarily driven by lower personnel costs following the 2024 workforce reduction, specifically a decrease in employee related costs of $1.6 million within G&A. The company also incurred a restructuring credit of $21 thousand in Q3 2025, compared to a restructuring charge of $2.8 million in Q3 2024 related to those earlier workforce adjustments.

Regarding manufacturing and quality control costs for LYR-210 supply, the most recent data shows a slight increase within R&D. Specifically, product development and manufacturing costs rose by $0.1 million in Q3 2025. This contrasts with the prior year, where product development and manufacturing costs had decreased by $1.0 million year-over-year for the full year 2024 as part of earlier cost-cutting measures, which included halting manufacturing efforts.

Personnel costs are definitely lower, as the May 2024 reduction in force continues to impact the expense base. You saw a $0.1 million reduction in R&D employee costs and a $1.6 million reduction in G&A employee costs for Q3 2025 alone compared to the prior year. Finance: draft 13-week cash view by Friday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Lyra Therapeutics, Inc. (LYRA) as of late 2025, and honestly, it's a picture of pre-commercial potential, heavily reliant on partnerships and financing to keep the lights on while LYR-210 moves through its final stages. Right now, the actual cash coming in from operations is minimal, which is typical for a clinical-stage biotech focused on a single asset.

The immediate, realized revenue is sparse, stemming almost entirely from existing agreements. You see this clearly in the latest quarterly filing.

• Collaboration revenue for the three months ended September 30, 2025, was reported at $25 thousand.
• For the nine months ended September 30, 2025, total collaboration revenue reached $391 thousand.

The company's cash position is being supplemented by capital markets activity. The June 2025 financing event provided a necessary cash infusion to support the path toward the New Drug Application (NDA) submission for LYR-210.

Here's a look at that recent equity raise:

Financing Event	Date	Gross Proceeds (Expected)	Estimated Net Proceeds
Registered Direct Offering & Concurrent Private Placement	June 2025	$5.0 million	Approximately $4.4 million

Future revenue is entirely contingent on the success of LYR-210, particularly the progress of the LianBio collaboration for Greater China and other Asian markets. Product sales revenue is currently zero, as the product is still investigational and awaiting regulatory approval.

The LianBio agreement is the primary driver of potential future non-dilutive funding. This partnership, which covers development and commercialization in key Asian territories, is structured around performance-based payments and ongoing sales participation. You should definitely track these milestones closely.

• Total potential milestone payments from LianBio are capped at up to $135 million, contingent on specified development, regulatory, and commercialization achievements.
• The initial upfront payment received upon execution of the agreement was $12.0 million.
• The company is also eligible for low double-digit royalties on net sales of LYR-210 achieved by LianBio in the licensed territories.

To be fair, the path to realizing those milestone payments and royalties is long, as it depends on regulatory success in multiple jurisdictions following the confirmatory Phase 3 trial for LYR-210. Finance: draft 13-week cash view by Friday.