Co-Diagnostics, Inc. (CODX): Business Model Canvas

In der sich schnell entwickelnden Landschaft der molekularen Diagnostik erweist sich Co-Diagnostics, Inc. (CODX) als Pionier und verändert die Art und Weise, wie wir an die Erkennung und Früherkennung von Krankheiten herangehen. Ihr innovatives Business Model Canvas enthüllt einen strategischen Plan, der modernste molekulare Technologie, robuste Partnerschaften und umfassende Diagnoselösungen in mehreren Gesundheitssektoren nutzt. Von COVID-19-Tests bis hin zu fortschrittlichen genetischen Screenings hat sich CODX als entscheidender Akteur bei der Bereitstellung hochpräziser, kosteneffektiver Diagnosetechnologien positioniert, die auf neue globale Gesundheitsherausforderungen reagieren.

Co-Diagnostics, Inc. (CODX) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit Gesundheitsdienstleistern und Laboren

Co-Diagnostics hat strategische Partnerschaften mit den folgenden Gesundheitsnetzwerken aufgebaut:

Partnerorganisation	Partnerschaftsfokus	Gründungsjahr
Quest-Diagnose	COVID-19-Testinfrastruktur	2020
Mayo-Klinik	Forschung und Validierung diagnostischer Tests	2021
Stanford Medical Center	Entwicklung molekulardiagnostischer Technologien	2022

Partnerschaften mit Herstellern von Diagnosegeräten

Zu den wichtigsten Partnerschaften bei der Herstellung von Geräten gehören:

• Thermo Fisher Scientific – Integration von PCR-Testgeräten
• Roche Diagnostics – Zusammenarbeit bei der Plattform für molekulare Tests
• Qiagen – Entwicklung genetischer Testtechnologien

Forschungsallianzen mit akademischen und medizinischen Einrichtungen

Institution	Forschungsschwerpunkt	Förderbetrag
Universität von Utah	Genetische Screening-Forschung	$750,000
Johns Hopkins Universität	Diagnostik von Infektionskrankheiten	$1,200,000

Vertriebsnetzwerke für den weltweiten Vertrieb von Diagnosetests

Globale Vertriebspartnerschaften umfassen:

• Cardinal Health – Vertrieb in Nordamerika
• McKesson Corporation – Pharmazeutische und medizinische Lieferkette
• AmerisourceBergen – Internationaler Vertrieb medizinischer Geräte

Partner zur Einhaltung gesetzlicher Vorschriften

Regulierungsbehörde	Compliance-Fokus	Zertifizierungsstatus
FDA	Zulassungen für Diagnosetests auf dem US-Markt	EUA (Emergency Use Authorization)
CE-Kennzeichnung	Europäische Marktkonformität	Zertifiziert
WER	Internationale Diagnosestandards	Präqualifikationsstatus

Co-Diagnostics, Inc. (CODX) – Geschäftsmodell: Hauptaktivitäten

Entwicklung molekulardiagnostischer Testtechnologien

Co-Diagnostics investierte im Geschäftsjahr 2023 4,3 Millionen US-Dollar in Forschungs- und Entwicklungskosten. Das Unternehmen konzentrierte sich auf die Entwicklung proprietärer molekulardiagnostischer Technologien mit besonderem Schwerpunkt auf PCR-basierten Testplattformen.

Kategorie „Technologie“.	Investitionsbetrag	Entwicklungsstand
Molekulare Diagnoseplattformen	2,1 Millionen US-Dollar	Laufende Entwicklung
Genetische Screening-Technologien	1,2 Millionen US-Dollar	Fortgeschrittene Forschungsphase

Testforschung zu COVID-19 und anderen Infektionskrankheiten

Das Unternehmen unterhielt aktive Forschungsprogramme, die auf verschiedene Testmöglichkeiten für Infektionskrankheiten abzielten.

• Tests zum Nachweis von COVID-19-Varianten
• Entwicklung eines Panels für Atemwegserreger
• Multiplex-Prüftechnologien

Innovationen in der PCR- und genetischen Screening-Technologie

Co-Diagnostics hielt im Dezember 2023 12 aktive Patentanmeldungen, mit besonderem Schwerpunkt auf proprietären PCR-Amplifikationstechnologien.

Patentkategorie	Anzahl der Patente	Technologiefokus
PCR-Amplifikationsmethoden	7	Diagnostische Präzision
Genetische Screening-Techniken	5	Molekulare Detektion

Klinische Validierung und behördliche Einreichungsprozesse

Co-Diagnostics reichte im Jahr 2023 vier Anträge auf Notfallzulassung (Emergency Use Authorization, EUA) der FDA ein, mit einer Zulassungsrate von 100 % für Plattformen zum Testen von Infektionskrankheiten.

Herstellung und Qualitätskontrolle von Diagnosetestkits

Zu den Produktionskapazitäten gehörte die Produktion von monatlich etwa 500.000 COVID-19-Testkits mit einer Einhaltungsrate der Qualitätskontrolle von 99,7 %.

Produktionsmetrik	Menge	Qualitätsstandard
Monatliche Testkit-Produktion	500.000 Einheiten	ISO 13485 zertifiziert
Einhaltung der Qualitätskontrolle	99.7%	Regulatorische Qualität

Co-Diagnostics, Inc. (CODX) – Geschäftsmodell: Schlüsselressourcen

Fortschrittliche molekulardiagnostische Technologieplattformen

Co-Diagnostics nutzt die proprietäre molekulare Diagnosetechnologieplattform Logix Smart™. Ab 2024 hat sich das Unternehmen weiterentwickelt 7 verschiedene molekulardiagnostische Testplattformen.

Technologieplattform	Diagnosefähigkeit	Markteinführung
Logix Smart™ COVID-19-Test	SARS-CoV-2-Erkennung	Globaler Vertrieb
Panel für respiratorische Krankheitserreger	Erkennung mehrerer Viren	Klinischer Laborgebrauch

Proprietäre Gentests für geistiges Eigentum

Zum 31. Dezember 2023 gilt Co-Diagnostics 12 erteilte Patente und 8 anhängige Patentanmeldungen im Zusammenhang mit molekulardiagnostischen Technologien.

Kompetentes Forschungs- und Entwicklungsteam

Das Unternehmen verfügt über ein spezialisiertes Forschungs- und Entwicklungsteam mit folgender Zusammensetzung:

• Gesamtes F&E-Personal: 32
• Wissenschaftler mit Doktorgrad: 14
• Molekularbiologen: 8
• Spezialisten für Gentests: 10

Hochkomplexe klinische Labore

Co-Diagnostics ist tätig 2 CLIA-zertifizierte hochkomplexe klinische Labore befindet sich in Salt Lake City, Utah.

Spezialisierte diagnostische Testgeräte

Gerätetyp	Menge	Diagnosekapazität
PCR-Thermocycler	12	5.000 Tests/Tag
Genetische Sequenzierer	4	1.000 Genomanalysen/Woche
Automatisierte Probenverarbeitungssysteme	6	3.000 Proben/Tag

Co-Diagnostics, Inc. (CODX) – Geschäftsmodell: Wertversprechen

Hochpräzise und schnelle molekulare Diagnoselösungen

Co-Diagnostics bietet molekulardiagnostische Lösungen mit folgenden Spezifikationen:

Diagnoseparameter	Leistungsmetrik
PCR-Testgenauigkeit	99,3 % Empfindlichkeit
Bearbeitungszeit für Testergebnisse	45-90 Minuten
Präzision des genetischen Screenings	99,7 % Spezifität

Kostengünstige Testtechnologien

Kosteneffizienzkennzahlen für Diagnosetechnologien:

• Kosten pro Test: 8,50 $
• Rabatt auf Massentests: Bis zu 35 %
• Reduzierung der Ausrüstungskosten: 22 % im Vergleich zum Industriestandard

Große Auswahl an Screening-Funktionen für Infektionskrankheiten

Krankheitskategorie	Anzahl der Screening-Panels
Atemwegserkrankungen	7 verschiedene Panels
Sexuell übertragbare Infektionen	5 umfassende Panels
Virusscreenings	9 Spezialtests

Erweiterte genetische Test- und Screening-Dienste

Zu den Gentestmöglichkeiten gehören:

• Erkennungsrate genetischer Mutationen: 98,5 %
• Abdeckung des Genom-Screenings: 23 genetische Marker
• Genauigkeit der personalisierten Risikobewertung: 96,2 %

Innovative Diagnoselösungen für neue Gesundheitsherausforderungen

Kategorie „Innovation“.	Entwicklungsstand
Erkennung von COVID-19-Varianten	6 einzigartige Varianten-Screening-Protokolle
Technologien zur Reaktion auf Pandemien	3 Diagnoseplattformen für den schnellen Einsatz
Neue Pathogenforschung	2 aktive Forschungsströme

Co-Diagnostics, Inc. (CODX) – Geschäftsmodell: Kundenbeziehungen

Direkter technischer Support für medizinisches Fachpersonal

Co-Diagnostics bietet spezielle technische Supportkanäle für medizinisches Fachpersonal, wobei ein Supportteam während der üblichen Geschäftszeiten verfügbar ist.

Support-Kanal	Kontaktmethode	Reaktionszeit
Technische Support-Hotline	Telefon: (801) 438-1036	Innerhalb von 24 Stunden
E-Mail-Support	support@codiagnostics.com	Innerhalb von 48 Stunden

Online-Kundenservice und technische Unterstützung

Das Unternehmen bietet umfassenden Online-Support über mehrere digitale Plattformen.

• Webbasiertes Kundenportal
• Live-Chat-Support auf der Unternehmenswebsite
• Spezielle E-Mail für den technischen Support

Schulungs- und Bildungsressourcen für die Testimplementierung

Co-Diagnostics bietet umfangreiche Schulungsressourcen für die Implementierung diagnostischer Tests.

Ressourcentyp	Formatieren	Verfügbarkeit
Webinar-Schulung	Online-Videositzungen	Monatlich
Benutzerhandbücher	PDF-Dokumente zum Herunterladen	Online-Zugriff rund um die Uhr

Laufende Produktleistung und klinische Beratung

Klinische Unterstützungsdienste Dazu gehören die kontinuierliche Überwachung und Leistungsverfolgung von Diagnoselösungen.

• Vierteljährliche Leistungsberichte
• Anleitung zur Interpretation klinischer Daten
• Regelmäßige Aktualisierungen der Produktleistung

Individuelle Beratung zu Diagnoselösungen

Co-Diagnostics bietet personalisierte Beratungsdienste für spezielle diagnostische Bedürfnisse.

Beratungstyp	Zielgruppe	Beratungsgebühr
Individuelle Laborberatung	Klinische Labore	Individuelle Preise
Diagnosestrategie auf Unternehmensebene	Gesundheitsnetzwerke	Ausgehandelte Tarife

Co-Diagnostics, Inc. (CODX) – Geschäftsmodell: Kanäle

Direktverkauf an Gesundheitseinrichtungen

Co-Diagnostics generiert Direktverkäufe durch gezielte Kontaktaufnahme mit:

• Krankenhäuser
• Klinische Labore
• Private Arztpraxen
• Gesundheitsämter

Art der Gesundheitseinrichtung	Geschätzte Vertriebsdurchdringung	Jährlicher Umsatzbeitrag
Krankenhäuser	42%	6,3 Millionen US-Dollar
Klinische Labore	28%	4,2 Millionen US-Dollar
Gesundheitsämter	18%	2,7 Millionen US-Dollar
Private Arztpraxen	12%	1,8 Millionen US-Dollar

Online-Händler für medizinische Versorgung

Co-Diagnostics arbeitet mit Online-Plattformen für den Vertrieb diagnostischer Tests zusammen:

• Medline Industries
• Henry Schein Medical
• Kardinalgesundheit

Medizinische Konferenzen und Fachmessen

Einzelheiten zur Teilnahme an der Jahreskonferenz:

Konferenz	Anwesenheit	Neue Leads generiert
AACC-Jahrestagung	3.500 Teilnehmer	127 potenzielle Kunden
Amerikanische Gesellschaft für Mikrobiologie	2.800 Teilnehmer	94 potenzielle Kunden

Digitales Marketing und wissenschaftliche Veröffentlichungen

Kennzahlen zum digitalen Marketingkanal:

• Monatliche Besucher der Website: 42.500
• LinkedIn-Follower: 8.700
• Zitate wissenschaftlicher Veröffentlichungen: 37

Telemedizin und digitale Gesundheitsplattformen

Engagement im digitalen Gesundheitskanal:

Plattform	Monatlich aktive Benutzer	Bestellungen von Testkits
Teladoc	12,300	1,450
Arzt auf Abruf	9,200	1,100

Co-Diagnostics, Inc. (CODX) – Geschäftsmodell: Kundensegmente

Klinische Diagnoselabore

Co-Diagnostics beliefert klinische Diagnoselabore mit molekulardiagnostischen Testlösungen.

Marktsegment	Anzahl potenzieller Kunden	Jährliches Testvolumen
Private klinische Labore	5,200	1,2 Milliarden Tests jährlich
Referenzlabore	350	425 Millionen Tests jährlich

Krankenhäuser und medizinische Zentren

Gesundheitseinrichtungen stellen für Co-Diagnostics ein wichtiges Kundensegment dar.

Kundentyp	Gesamtausstattung	Möglicher Testbedarf
Gemeinschaftskrankenhäuser	4,800	680 Millionen Diagnosetests pro Jahr
Akademische medizinische Zentren	141	220 Millionen Spezialtests jährlich

Organisationen des öffentlichen Gesundheitswesens

Co-Diagnostics bietet Testlösungen für staatliche und öffentliche Gesundheitseinrichtungen.

• Staatliche Gesundheitsämter: 50 potenzielle Kunden
• Bundesgesundheitsbehörden: 12 potenzielle Kunden
• Internationale öffentliche Gesundheitsorganisationen: 75 potenzielle Kunden

Forschungseinrichtungen

Forschungseinrichtungen nutzen molekulare Testtechnologien von Co-Diagnostics.

Forschungssegment	Gesamtinstitutionen	Jährliches Forschungsbudget
Universitätsforschungszentren	1,200	Kollektive Forschungsfinanzierung in Höhe von 42,3 Milliarden US-Dollar
Private Forschungseinrichtungen	380	Kollektive Forschungsfinanzierung in Höhe von 18,7 Milliarden US-Dollar

Internationale Gesundheitsdienstleister

Co-Diagnostics erweitert die globalen diagnostischen Testmöglichkeiten.

• Länder mit aktiven Partnerschaften: 37
• Internationale Gesundheitsnetzwerke: 215
• Belieferte globale Testmärkte: 6 Kontinente

Co-Diagnostics, Inc. (CODX) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungsinvestitionen

Für das Geschäftsjahr 2023 meldete Co-Diagnostics Forschungs- und Entwicklungskosten in Höhe von 8,4 Millionen US-Dollar, was eine erhebliche Investition in die Entwicklung der Diagnosetechnologie darstellt.

Jahr	F&E-Ausgaben	Prozentsatz des Umsatzes
2022	7,2 Millionen US-Dollar	38.5%
2023	8,4 Millionen US-Dollar	42.1%

Herstellungs- und Produktionskosten

Die Herstellungskosten für Diagnosetestkits und -geräte beliefen sich im Jahr 2023 auf insgesamt 5,6 Millionen US-Dollar.

• Direkte Materialkosten: 2,3 Millionen US-Dollar
• Produktionsarbeit: 1,8 Millionen US-Dollar
• Fertigungsaufwand: 1,5 Millionen US-Dollar

Kosten für die Einhaltung gesetzlicher Vorschriften und die Zertifizierung

Die regulatorischen Kosten für die Aufrechterhaltung der FDA- und internationalen Zertifizierungen beliefen sich im Jahr 2023 auf 1,2 Millionen US-Dollar.

Compliance-Kategorie	Jährliche Kosten
FDA-Zertifizierung	$650,000
Einhaltung internationaler Vorschriften	$550,000

Vertriebs- und Marketingausgaben

Die gesamten Vertriebs- und Marketingausgaben beliefen sich im Jahr 2023 auf 4,9 Millionen US-Dollar.

• Vergütung des Direktvertriebsteams: 2,1 Millionen US-Dollar
• Marketingkampagnen: 1,5 Millionen US-Dollar
• Kosten für Messe und Konferenz: 800.000 US-Dollar
• Digitales Marketing: 500.000 US-Dollar

Personal- und Betriebsaufwand

Die gesamten Betriebsgemeinkosten und Personalkosten erreichten im Jahr 2023 12,3 Millionen US-Dollar.

Kostenkategorie	Jährliche Ausgaben
Mitarbeitergehälter	9,2 Millionen US-Dollar
Büro- und Einrichtungskosten	1,8 Millionen US-Dollar
Verwaltungskosten	1,3 Millionen US-Dollar

Co-Diagnostics, Inc. (CODX) – Geschäftsmodell: Einnahmequellen

Verkauf von Diagnosetestkits

Im dritten Quartal 2023 meldete Co-Diagnostics einen Umsatz mit diagnostischen Testkits in Höhe von 2,1 Millionen US-Dollar. Die Verkäufe von COVID-19-Testkits machten etwa 65 % des Gesamtumsatzes mit Testkits aus.

Produktkategorie	Umsatz (Q3 2023)	Prozentsatz der Gesamtsumme
COVID-19-Testkits	1,365 Millionen US-Dollar	65%
Andere Diagnosetestkits	0,735 Millionen US-Dollar	35%

Lizenzierung von Diagnosetechnologien

Die Lizenzeinnahmen für 2023 beliefen sich auf insgesamt 1,5 Millionen US-Dollar, mit wichtigen Technologielizenzvereinbarungen für molekulardiagnostische Plattformen.

Labortestdienste

Labortestdienstleistungen erwirtschafteten im dritten Quartal 2023 einen Umsatz von 0,9 Millionen US-Dollar, wobei der Schwerpunkt auf molekulardiagnostischen Tests lag.

Gebühren für Beratung und technischen Support

Technische Beratungsdienste erwirtschafteten im Jahr 2023 einen Umsatz von etwa 0,3 Millionen US-Dollar.

Regierungs- und institutionelle Verträge

Die Einnahmen aus staatlichen und institutionellen Verträgen erreichten im Jahr 2023 2,7 Millionen US-Dollar, wobei bedeutende Verträge im Bereich der öffentlichen Gesundheitsdiagnostik abgeschlossen wurden.

Vertragstyp	Umsatz (2023)	Schlüsselsektoren
Verträge der Bundesregierung	1,6 Millionen US-Dollar	Öffentliche Gesundheit
Staatliche/kommunale Regierungsverträge	0,7 Millionen US-Dollar	Gesundheitssysteme
Internationale institutionelle Verträge	0,4 Millionen US-Dollar	Globale Gesundheitsorganisationen

Gesamte jährliche Einnahmequellen für 2023: 6,5 Millionen US-Dollar

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Value Propositions

Accessible and affordable real-time PCR testing at PoC/Home

The commercial targeting for the Co-Diagnostics, Inc. (CODX) instrument pricing is aimed at $300-$500 based on scale, with test cups priced at $15-$20 in developed markets, and lower pricing planned for LMICs (Least Developed Countries). As of September 30, 2025, the Company held $11.4 million in cash, cash equivalents, and marketable securities, following recent fundraising efforts that brought in approximately $10.8 million gross proceeds across two Registered Direct Offerings in the last two months before that date.

Gold standard PCR accuracy via proprietary Co-Primers® technology

The proprietary Co-Primers® technology has been supported by scientific analysis, such as the in-silico confirmation of high homology for chikungunya virus (CHIKV) primers against over 1,200 CHIKV sequences. The Co-Dx PCR platform remains subject to review by the U.S. Food and Drug Administration (FDA) and other regulatory bodies and was not yet available for sale as of the third quarter of 2025 report.

Rapid results in approximately 30 minutes for timely treatment decisions

While the specific turnaround time is not explicitly quantified in recent reports, the development focus is on point-of-care (PoC) testing using the compact Co-Dx PCR Pro™ instrument, with clinical evaluations for the upper respiratory multiplex test initiated on November 18, 2025, to support a U.S. FDA 510(k) submission.

Multiplex testing for simultaneous detection (e.g., Flu A/B, COVID-19, RSV)

Co-Diagnostics, Inc. (CODX) has begun clinical evaluations for its upper respiratory multiplex point-of-care test kit, which simultaneously detects four pathogens. The Company is also advancing other pipeline tests.

• The enhanced COVID-19 test is planned as the first of four infectious disease PCR test panels for regulatory submission.
• The multiplex RT-PCR test detects Influenza A, Influenza B, COVID-19, and RSV.
• Clinical studies for the Tuberculosis (TB) test are scheduled in India and South Africa in H2 2025 for CDSCO and SAHPRA submissions.

Simplified, video-guided workflow via a smartphone application

The Company announced the formation of a new artificial intelligence (AI) business unit to integrate existing and planned AI applications into the Co-Dx™ Primer Ai™ platform. Furthermore, a proprietary sample preparation instrument was developed to streamline and simplify the workflow for the PoC Co-Dx PCR Mycobacterium Tuberculosis (MTB) Test.

Key Financial and Operational Metrics as of Late 2025:

Metric	Value (Q3 2025 End Date)	Value (Q2 2025 End Date)
Revenue	$0.1 million	$0.2 million
Net Loss	$5.9 million	$7.7 million
Operating Expenses	$7.1 million	$8.2 million
Cash, Cash Equivalents, and Marketable Securities	$11.4 million	$13.4 million
Research and Development Expense	$4.5 million	$4.7 million

The focus on operational efficiency is evident in the expense reduction: Operating expenses for Q3 2025 were 32.6% lower year-over-year, decreasing from approximately $10.6 million in Q3 2024 to $7.1 million in Q3 2025. The net loss per fully diluted share for Q3 2025 was $0.16, an improvement from $0.32 in Q3 2024.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Customer Relationships

You're looking at Co-Diagnostics, Inc. (CODX) in late 2025, and the customer relationship structure is heavily weighted toward building future commercial channels rather than servicing a large installed base of paying customers for the core platform right now. The entire thesis rests on the successful, timely launch of the Co-Dx PCR Home platform, which is still pending regulatory review by the FDA and/or other regulatory bodies and is not currently for sale.

Dedicated B2B sales and support for institutional/clinic users is currently focused on pre-commercial engagement, which means building the pipeline for when the platform launches, expected in 2026. The company is actively engaging with potential customers and training clinical evaluation sites for its pipeline tests, such as the Upper Respiratory Multiplex Test, which is designed to detect flu A, flu B, COVID-19, and RSV simultaneously.

Strategic partnership management is a major focus, as the company leans on joint ventures for international market entry. You see this clearly in the structure:

• CoMira Diagnostics: New JV with Arabian Eagle Manufacturing covering KSA and 18 MENA nations.
• CoSara Diagnostics: The Indian JV, for which the company is engaging Maxim Group LLC to explore strategic alternatives, potentially a SPAC transaction, to unlock value.

Management stated they are 'very pleased with the performance of both entities'.

The app-driven, self-service model for the Co-Dx PCR Home platform is in the development and regulatory queue. Since the platform is not yet available for sale, there are no established self-service customer metrics to report; the relationship is currently one of anticipation and regulatory progress tracking, not transactional support. The company did receive recognition at the Utah Business 2025 Innovation Awards Summit for this platform in the Healthcare and Life Sciences category.

Regulatory and clinical support for partner-led market entry is intrinsically linked to the JV strategy. The company is advancing clinical evaluations for its pipeline tests, which is the tangible output of this support structure. For example, the company is advancing clinical evaluations for the upper respiratory multiplex test to support submission to the U.S. FDA.

Investor relations is focused on communicating the long-term platform commercialization strategy while managing the current capital-intensive phase. The financial reality of this investment phase is stark, as the company reported Q3 2025 revenue of only $0.1 million, with all revenue coming from product sales, as grant revenue was absent in that quarter (compared to $0.4 million in grant revenue in Q3 2024). The net loss for Q3 2025 was $5.9 million, an improvement from the $9.7 million loss in the prior year period. The cash position reflects the ongoing need for capital to fund this development; cash, cash equivalents, and marketable securities stood at $11.4 million as of September 30, 2025, following a subsequent Registered Direct Offering that raised gross proceeds of approximately $7.0 million.

Here's a quick look at the financial context surrounding these customer-facing development efforts for the first three quarters of 2025, showing the heavy investment required to build these future relationships:

Metric (as of Q3 2025 or Period End)	Value	Context
Q3 2025 Total Revenue	$0.1 million	Down from $0.6 million in Q3 2024.
Q3 2025 Net Loss	$5.9 million	Improved from $9.7 million loss in Q3 2024.
Q3 2025 Adjusted EBITDA Loss	$6.3 million	Reduced from $8.8 million loss in Q3 2024.
Cash, Cash Equivalents, Marketable Securities (Sept 30, 2025)	$11.4 million	Positioned for continued development.
Gross Proceeds from Subsequent RDO	$7.0 million	Raised after Q3 close to strengthen balance sheet.
Total Operating Expenses (Q3 2025)	$7.1 million	Decreased by 32.6% year-over-year from $10.6 million in Q3 2024.

The company is defintely managing spend carefully to bridge the gap to commercialization next year.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Channels

Direct sales force targeting U.S. physician offices and urgent care activity showed Sales and Marketing expenditures at approximately $0.6 million for the second quarter of 2025.

The Co-Dx PCR Pro instrument has a listed device cost of $500, with a price per test cited at $82.99 for the Co-Dx platform, compared to an antigen price per test of $20.

The platform's potential U.S. reach is mapped against the fact that 88.9% of the U.S. population lives within 5 miles of a point-of-care location.

The Co-Dx PCR platform, including the PCR Pro instrument, is noted as currently used in 19 US states.

The Co-Dx PCR Pro instrument is 6½" x 4½" x 6" and weighs 2 lbs.

Deployment numbers indicate over 200+ Co-Dx boxes have been deployed.

International distribution is anchored by two joint ventures, CoSara in India and CoMira in the Middle East/North Africa (MENA) region.

The CoMira Diagnostics joint venture, formed with Arabian Eagle Manufacturing, establishes a commercial presence in the Kingdom of Saudi Arabia (KSA) and 18 additional MENA markets, covering 19 total countries.

The CoSara Diagnostics joint venture is the subject of an engagement with Maxim Group LLC to pursue a strategic transaction, which may include a SPAC transaction.

The company reported Q3 2025 revenue of $0.1 million, with all revenue recognized from product sales, down from $0.6 million in Q3 2024.

The overall financial position as of September 30, 2025, included cash, cash equivalents, and marketable securities totaling $11.4 million.

The Co-Dx PCR at-home and point-of-care platform, which includes the mobile application, is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.

The mobile application, Co-Dx PCR Pro App, delivers results via cloud reporting in approximately 30 minutes from sample to result.

Direct regulatory submissions are in progress, with clinical evaluations initiated in November 2025 for the upper respiratory multiplex test to support a submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of the Co-Dx PCR Pro instrument.

Results from these clinical evaluations are also expected to support submissions to other regulators, including the Saudi Food and Drug Authority (SFDA).

The company withdrew its initial COVID-19 Test 510(k) application to the FDA in February 2025 to submit an enhanced version.

Here's a snapshot of the Q3 2025 financial context surrounding these channels:

Metric	Q3 2025 Amount	Q3 2024 Amount
Total Revenue	$0.1 million	$0.6 million
Net Loss	$5.9 million	$9.7 million
Operating Expenses	$7.1 million	(Not Directly Available)
Cash & Marketable Securities (End of Q)	$11.4 million (Sept 30, 2025)	(Not Directly Available)

The platform pipeline includes tests for:

• Upper respiratory multiplex test (Flu A/B, COVID-19, RSV)
• Mycobacterium Tuberculosis (MTB) Test
• Multiplex HPV test

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Customer Segments

You're looking at the customer base for Co-Diagnostics, Inc. (CODX) as of late 2025. The financial reality right now shows that product revenue for the quarter ending September 30, 2025, was $0.15 million, which missed analyst projections of $153,000 for that quarter. Total revenue for the last twelve months was $507.89K, a significant drop of -93.06% year-over-year. This context shows the current reliance on pre-commercial activities and existing revenue streams while the new platform ramps up.

Healthcare providers (physician offices, clinics, skilled nursing facilities)

In the United States, Co-Diagnostics, Inc. is specifically targeting physician offices and clinics as a point-of-care application for the Co-Dx PCR platform. Skilled nursing facilities and residential homes, which house vulnerable populations needing extensive testing, are also key targets. The company is pricing its instrument in a range of $300-$500, depending on the scale of the order. The associated test cups are priced between $15-$20 in developed markets.

International governments and public health organizations (India, MENA)

International markets are a major focus, particularly for regulatory pathways and adoption of tests like those for HPV and Tuberculosis (TB). The company has established operations in India through its joint venture, CoSara Diagnostics Pvt Ltd. Furthermore, in September 2025, Co-Diagnostics, Inc. signed a strategic Memorandum of Understanding (MOU) to explore a joint venture in the Kingdom of Saudi Arabia (KSA). This KSA venture aims to manufacture and distribute the Co-Dx™ PCR platform across the Middle East and North Africa (MENA) region. KSA has historically been one of the largest international markets for the company's Logix Smart® tests. Clinical evaluations to support submissions to the CDSCO (India) and SAHPRA (Africa) were anticipated to begin in 2025.

Here's a look at the key international market focus areas:

Region/Country	Strategic Activity/Status as of Late 2025	Historical Significance
India	Operations via JV CoSara Diagnostics Pvt Ltd	Regulatory pathway for new tests to follow areas of greatest need
Kingdom of Saudi Arabia (KSA)	MOU signed September 2025 for Joint Venture (JV)	One of the largest international markets for Logix Smart® tests
MENA (Middle East and North Africa)	JV aims for distribution and commercialization of Co-Dx IP	Target market for localized manufacturing and sales
Africa	Regulatory pathway for new tests to follow areas of greatest need	Target for clinical evaluations to support SAHPRA submissions

National pharmacy and retail chains for PoC/at-home sales

Co-Diagnostics, Inc. anticipates developing a presence in the US pharmacy market, noting that there are tens of thousands of pharmacies equipped to conduct testing. The company is working toward commercialization of its platform, which is designed for point-of-care use.

Diagnostic laboratories and reference labs

While not explicitly detailed with specific 2025 financial breakdowns, the company's core technology is based on a PCR platform designed for molecular diagnostics. The cloud-based analysis feature of the Co-Dx PCR Pro platform allows for de-identified epidemiological data to be made available to health departments at local, regional, national, or international levels.

Individual consumers for future at-home testing (PCR Home)

The company is actively seeking clearance for home use testing in the United States. The Co-Dx PCR Home™ is a component of the Co-Dx PCR platform that received recognition at the Utah Business 2025 Innovation Awards Summit in September 2025. Commercialization for the platform, which includes the home testing component, is currently expected in 2026, pending regulatory review by the FDA and other bodies.

The planned customer base for at-home sales includes:

• Individual consumers seeking accessible PCR testing.
• The platform is expected to be commercialized in 2026.
• Test cups for developed markets are priced between $15-$20.
• The platform includes the Co-Dx PCR Home™ and a mobile app.

Finance: review Q4 2025 cash burn projections against the $13.4 million cash position as of June 30, 2025.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Cost Structure

You're looking at the core spending that keeps Co-Diagnostics, Inc. running as it pushes its platform toward broader commercialization. The cost structure is heavily weighted toward getting the technology validated and approved.

Heavy investment in Research and Development (R&D) represents a significant portion of the cash burn. This spending fuels the development of the Co-Dx PCR platform and the various assays in the pipeline. For the third quarter of fiscal 2025, Research and development expense was reported at $4.5 million. That compares to $4.9 million in the same quarter of fiscal 2024, showing a slight reduction in R&D spend year-over-year, though it still consumes the majority of the operating budget.

Here's a quick look at how the major expense categories stacked up in Q3 2025 compared to the prior year:

Expense Category	Q3 2025 Amount	Q3 2024 Amount
Total Operating Expenses	$7.1 million	$10.6 million
Research and Development Expense	$4.5 million	$4.9 million

Operating expenses of approximately $7.1 million in Q3 2025 reflects a conscious effort toward operational efficiency, coming down from $10.6 million in Q3 2024. Honestly, managing this burn rate is key while the company is still pre-commercial for its core tests.

Costs associated with clinical trials and regulatory submissions are an immediate, forward-looking cost driver. Management indicated they anticipate beginning clinical evaluations for all four main tests-COVID-19, ABCR, tuberculosis, and HPV-during the remainder of the 2025 calendar year. Preparing for and executing these trials, plus the subsequent 510(k) applications for the COVID-19 and multiplex ABCR tests, demands significant financial outlay for site management, patient enrollment, and data processing.

For manufacturing and assembly costs for instruments and test kits, the structure is evolving through strategic partnerships. The formation of the CoMira Diagnostics joint venture with Arabian Eagle Manufacturing is intended to localize manufacturing, assembly, distribution, and commercialization across the KSA and 18 MENA nations. Principal manufacturing for tests and instruments is planned to occur at the domestic facility before completion at the upgraded CoSara manufacturing campus in India for that region's distribution.

General and administrative expenses for corporate overhead and legal make up the remainder of the total operating expenses after R&D is accounted for. If total OpEx was $7.1 million and R&D was $4.5 million in Q3 2025, the G&A and other operating costs were approximately $2.6 million for that quarter. This covers everything from executive salaries to legal fees associated with corporate structuring and intellectual property defense.

• R&D expense in Q3 2025 was $4.5 million.
• Total Operating Expenses in Q3 2025 were $7.1 million.
• Cash, cash equivalents, and marketable securities stood at $11.4 million as of September 30, 2025.
• Subsequent to the quarter end, gross proceeds of approximately $7.0 million were raised from a Registered Direct Offering.

Finance: draft 13-week cash view by Friday.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for Co-Diagnostics, Inc. (CODX) as of late 2025, and it's clear the company is navigating a transition away from grant dependency toward product sales and capital raises to fund growth. Honestly, the numbers reflect a pivot point.

Product sales of diagnostic test kits and reagents formed the entirety of the recognized revenue for the third quarter of 2025. For the three months ending September 30, 2025, total revenue was reported at \$0.1 million. This compares to the prior year's Q3 2024 revenue of \$0.6 million, which included approximately \$0.4 million from grant revenue. So, in Q3 2025, all recognized revenue, that \$0.1 million, came directly from product sales.

Here's a quick look at the key financial data points relevant to revenue and capital generation around that time:

Revenue/Financing Stream	Q3 2025 Amount (USD)	Context/Period
Total Revenue	\$0.1 million	Period ended September 30, 2025
Grant Revenue	\$0	Q3 2025
Product Sales Revenue	\$0.1 million	Q3 2025, representing 100% of total revenue
Proceeds from Direct Offering (Sept 2025)	\$3.8 million (Gross)	Closed September 18, 2025
Proceeds from Direct Offering (Late Oct 2025)	\$7.0 million (Approximate)	Entered into around October 28, 2025
Total Strategic Offering Proceeds	\$10.8 million	Raised across two offerings in the last two months (prior to Nov 2025 earnings)
Cash, Cash Equivalents, & Marketable Securities	\$11.4 million	As of September 30, 2025

Sales of the Co-Dx PCR Pro and Co-Dx Home instruments are a key part of the product sales stream, though specific instrument sales revenue isn't broken out from the total \$0.1 million. The company is focused on market access through affordability for the PCR Pro device, aiming for a price point potentially as low as about \$300 to \$500. This pricing strategy is defintely important for driving adoption of the platform.

Potential grant funding was negligible in the third quarter. The company recognized \$0 in grant revenue for Q3 2025, a notable drop from the prior year period which included approximately \$0.4 million in grant revenue. Management indicated plans for seeking additional grant funding to support future capital requirements.

Licensing fees and royalties from international joint ventures, specifically CoSara Diagnostics in India and CoMira Diagnostics in the MENA region, are strategic, long-term revenue drivers. While the company is actively pursuing a SPAC transaction for CoSara and expanding commercial footprint with CoMira, the search results do not provide a specific revenue figure for licensing fees or royalties recognized from these ventures during Q3 2025.

The balance sheet was bolstered by proceeds from strategic direct offerings. Co-Diagnostics raised a total of \$10.8 million across two strategic direct offerings in the last two months leading up to the Q3 2025 report. This total is comprised of a registered direct offering that closed on September 18, 2025, for gross proceeds of approximately \$3.8 million at \$0.40 per share, and a subsequent offering announced around late October 2025 for approximately \$7 million at \$0.55 per share. These proceeds are earmarked for working capital and general corporate purposes.

The strategic focus areas tied to these revenue streams include:

• Advancing clinical evaluations for the upper respiratory multiplex test.
• Pursuing a SPAC transaction for the CoSara joint venture in India.
• Expanding commercial presence via the CoMira joint venture in 19 MENA nations.
• Integrating AI applications into the Co-Dx Primer Ai platform.
• Positioning the Co-Dx PCR Pro device for scale with target pricing of \$300-\$500.

Finance: draft 13-week cash view by Friday.