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[10-Q] Co-Diagnostics, Inc. Quarterly Earnings Report

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
10-Q
Rhea-AI Filing Summary

Co-Diagnostics, Inc. (CODX) reported continued operating losses and heavy customer concentration alongside notable cash inflows in the first half of 2025. The company recorded a loss per share of $(0.23) and $(0.25) for the comparable three-month periods and $(0.47) and $(0.56) for the six-month comparatives, with weighted average basic shares around 33.1 million for the most recent quarter. Grant funding dropped to $0 for both the three- and six-month periods ended June 30, 2025, versus $2.5 million and $2.7 million in the prior-year periods. Accounts receivable net balances were $210,968 at June 30, 2025 and $132,570 at December 31, 2024, with two large customers representing a majority of receivables and three customers accounting for roughly 53% of product revenue in the quarter. Cash and liquidity improved: the company reported a $8.18 million net increase in cash and cash equivalents and received net proceeds of $1.02 million from an at-the-market equity program after selling 2,209,131 shares; maturities of marketable securities generated $31.51 million. Inventory totaled $1,084,627 with reserves recorded; the company recognized inventory reserve changes of $59,591 and $101,065 for the three- and six-month periods ended June 30, 2025. Lease obligations include operating lease long-term portion of $879,258 and present value of operating lease liabilities of $1,703,716. Nasdaq notified the company of a bid-price deficiency but CODX is eligible for an additional compliance period and may cure via a reverse split if needed.

Co-Diagnostics, Inc. (CODX) ha registrato perdite operative continue e una forte concentrazione dei clienti, ma anche significativi flussi di cassa nel primo semestre 2025. La società ha riportato una perdita per azione di $(0.23) e $(0.25) per i rispettivi trimestri comparabili e di $(0.47) e $(0.56) per i confronti semestrali, con una media ponderata delle azioni ordinarie in circolazione intorno a 33,1 milioni nell’ultimo trimestre. I finanziamenti a fondo perduto sono scesi a $0 sia per i periodi di tre che di sei mesi conclusi il 30 giugno 2025, rispetto a $2,5 milioni e $2,7 milioni nei periodi dell’anno precedente. I crediti netti verso clienti ammontavano a $210.968 al 30 giugno 2025 e a $132.570 al 31 dicembre 2024; due grandi clienti rappresentano la maggior parte dei crediti e tre clienti costituiscono circa il 53% dei ricavi da prodotti nel trimestre. Liquidità e disponibilità liquide sono migliorate: la società ha riportato un aumento netto di cassa e disponibilità liquide di $8,18 milioni e ha ricevuto proventi netti di $1,02 milioni da un programma di emissione azioni at-the-market dopo la vendita di 2.209.131 azioni; le scadenze dei titoli negoziabili hanno generato $31,51 milioni. Le scorte ammontavano a $1.084.627 con accantonamenti registrati; la società ha riconosciuto variazioni delle riserve di inventario per $59.591 e $101.065 per i periodi di tre e sei mesi conclusi il 30 giugno 2025. Gli impegni di locazione comprendono la porzione a lungo termine dei lease operativi di $879.258 e il valore attuale delle passività da lease operativo di $1.703.716. Nasdaq ha notificato alla società una non conformità relativa al prezzo di offerta, ma CODX è idonea a un periodo aggiuntivo per la conformità e potrebbe risolvere la situazione con uno split inverso se necessario.

Co-Diagnostics, Inc. (CODX) informó pérdidas operativas continuas y una alta concentración de clientes, junto con entradas de efectivo relevantes en el primer semestre de 2025. La compañía registró una pérdida por acción de $(0.23) y $(0.25) para los periodos trimestrales comparables y de $(0.47) y $(0.56) para los comparativos semestrales, con un promedio ponderado de acciones básicas alrededor de 33,1 millones en el trimestre más reciente. La financiación por subvenciones se redujo a $0 tanto en los periodos de tres como de seis meses terminados el 30 de junio de 2025, frente a $2,5 millones y $2,7 millones en los periodos del año anterior. Los saldos netos de cuentas por cobrar fueron $210,968 al 30 de junio de 2025 y $132,570 al 31 de diciembre de 2024; dos grandes clientes representan la mayor parte de las cuentas por cobrar y tres clientes explican aproximadamente el 53% de los ingresos por productos en el trimestre. El efectivo y la liquidez mejoraron: la empresa informó un aumento neto en efectivo y equivalentes de $8,18 millones y recibió ingresos netos de $1,02 millones por un programa de acciones at-the-market tras vender 2.209.131 acciones; los vencimientos de valores negociables generaron $31,51 millones. El inventario totalizó $1,084,627 con reservas registradas; la compañía reconoció cambios en las provisiones de inventario de $59,591 y $101,065 para los periodos de tres y seis meses terminados el 30 de junio de 2025. Las obligaciones de arrendamiento incluyen la porción a largo plazo de arrendamientos operativos de $879,258 y el valor presente de las obligaciones por arrendamiento operativo de $1,703,716. Nasdaq notificó a la compañía una deficiencia en el precio de oferta, pero CODX es elegible para un periodo adicional de cumplimiento y podría subsanarlo mediante una consolidación inversa de acciones si fuera necesario.

Co-Diagnostics, Inc. (CODX)ëŠ� 2025ë…� ìƒë°˜ê¸°ì— ì§€ì†ì ì� ì˜ì—…ì†ì‹¤ê³� ë†’ì€ ê³ ê° ì§‘ì¤‘ë„를 보고했으ë‚� 현금 유입ë� ëˆˆì— ë„게 ì¦ê°€í–ˆìŠµë‹ˆë‹¤. 회사ëŠ� ë¹„êµ ëŒ€ìƒ� 분기별로 주당 ì†ì‹¤ì� ê°ê° $(0.23)와 $(0.25), 반기 비êµì—서ëŠ� $(0.47)와 $(0.56)ë¥� 기ë¡í–ˆìœ¼ë©�, 최근 분기 가중í‰ê·� 보통ì£� 수는 ì•� 3,310ë§� 주였습니ë‹�. ë³´ì¡°ê¸� ìˆ˜ìž…ì€ 2025ë…� 6ì›� 30ì� 종료ë� 3개월 ë°� 6개월 기간 ëª¨ë‘ $0ë¡� ê°ì†Œí–ˆìœ¼ë©�, ì „ë…„ ë™ê¸°ì—는 ê°ê° $250만과 $270ë§Œì´ì—ˆìŠµë‹ˆë‹¤. 매출채권 ìˆœìž”ì•¡ì€ 2025ë…� 6ì›� 30ì� 기준 $210,968, 2024ë…� 12ì›� 31ì� 기준 $132,570였으며, ë‘� ê°œì˜ ëŒ€í˜� ê³ ê°ì� 채권ì� ëŒ€ë¶€ë¶„ì„ ì°¨ì§€í•˜ê³  ì„� ê³ ê°ì� 분기 제품 매출ì� ì•� 53%ë¥� 차지했습니다. 현금 ë°� 유ë™ì„±ì€ 개선ë˜ì–´ 회사ëŠ� 현금 ë°� 현금성ìžì‚°ì—ì„� $8.18백만 순ì¦ì� 보고했고, 2,209,131주를 매ê°í•� ë’� 시장íŒë§¤(ATM) 프로그램으로부í„� $1.02백만ì� 순수ìµì„ 받았으며, 유가ì¦ê¶Œ 만기ë¡� $31.51백만ì� 창출했습니다. 재고ëŠ� $1,084,627였ê³� ì¶©ë‹¹ê¸ˆì´ ì„¤ì •ë˜ì—ˆìœ¼ë©°, 2025ë…� 6ì›� 30ì� 종료ë� 3개월 ë°� 6개월 기간ì—� 대í•� 재고충당ê¸� ë³€ë™ì•¡ì€ ê°ê° $59,591 ë°� $101,065였습니ë‹�. 리스 부채는 ìš´ì˜ë¦¬ìФ 장기분부ê¸� $879,258ê³� ìš´ì˜ë¦¬ìФ ë¶€ì±„ì˜ í˜„ìž¬ê°€ì¹� $1,703,716ë¥� í¬í•¨í•©ë‹ˆë‹�. ë‚˜ìŠ¤ë‹¥ì€ ìž…ì°°ê°€ ë¶€ì¡±ì„ í†µì§€í–ˆìœ¼ë‚� CODXëŠ� 추가 준ìˆ� 기간ì� ë°›ì„ ìžê²©ì� 있으ë©� í•„ìš”í•� 경우 역병합으ë¡� ì´ë¥¼ 해소í•� ìˆ� 있습니다.

Co-Diagnostics, Inc. (CODX) a déclaré des pertes d’exploitation continues et une forte concentration de sa clientèle, tout en affichant des entrées de trésorerie notables au premier semestre 2025. La société a enregistré une perte par action de $(0.23) et $(0.25) pour les périodes trimestrielles comparables et de $(0.47) et $(0.56) pour les comparaisons semestrielles, avec un nombre moyen pondéré d’actions ordinaires d’environ 33,1 millions au trimestre le plus récent. Le financement par subventions est tombé à $0 pour les périodes de trois et six mois clôturées le 30 juin 2025, contre $2,5 millions et $2,7 millions lors des périodes de l’exercice précédent. Les soldes nets des comptes clients étaient de $210,968 au 30 juin 2025 et de $132,570 au 31 décembre 2024 ; deux gros clients représentent la majeure partie des créances et trois clients représentent environ 53% des revenus produits du trimestre. La trésorerie et la liquidité se sont améliorées : la société a déclaré une augmentation nette des liquidités de $8,18 millions et a reçu des produits nets de $1,02 million d’un programme d’actions at‑the‑market après la vente de 2 209 131 actions ; les échéances de titres négociables ont généré $31,51 millions. Les stocks s’élevaient à $1,084,627 avec des provisions enregistrées ; la société a comptabilisé des variations de provisions pour stocks de $59,591 et $101,065 pour les périodes de trois et six mois clôturées le 30 juin 2025. Les engagements locatifs incluent la partie long terme des baux opérationnels de $879,258 et la valeur actuelle des passifs liés aux baux opérationnels de $1,703,716. Le Nasdaq a informé la société d’une insuffisance du cours des offres, mais CODX est éligible à une période de conformité supplémentaire et peut remédier à la situation par une fusion inversée d’actions si nécessaire.

Co-Diagnostics, Inc. (CODX) meldete im ersten Halbjahr 2025 weiterhin operative Verluste und eine starke Kundenkonzentration, zeigte aber zugleich nennenswerte Cashzuflüsse. Das Unternehmen verzeichnete einen Verlust je Aktie von $(0.23) und $(0.25) für die jeweiligen Vergleichsquartale sowie $(0.47) und $(0.56) für die Halbjahresvergleiche, bei einem gewichteten durchschnittlichen Stammaktienbestand von rund 33,1 Millionen im jüngsten Quartal. Fördermittel fielen in den für den 30. Juni 2025 beendeten drei- und sechsmonatigen Perioden auf $0, gegenüber $2,5 Mio. bzw. $2,7 Mio. im Vorjahr. Die Nettobestände der Forderungen beliefen sich auf $210.968 zum 30. Juni 2025 und $132.570 zum 31. Dezember 2024; zwei Großkunden machten den Großteil der Forderungen aus, und drei Kunden waren für rund 53% des Produktumsatzes im Quartal verantwortlich. Kasse und Liquidität verbesserten sich: Das Unternehmen meldete einen Nettozufluss an Zahlungsmitteln und Zahlungsmitteläquivalenten von $8,18 Mio. und erhielt Nettoerlöse von $1,02 Mio. aus einem At‑the‑Market‑Aktienprogramm nach dem Verkauf von 2.209.131 Aktien; Fälligkeiten von marktfähigen Wertpapieren generierten $31,51 Mio.. Der Lagerbestand belief sich auf $1.084.627 mit gebildeten Rückstellungen; das Unternehmen erkannte Lagerwertberichtigungsänderungen in Höhe von $59.591 bzw. $101.065 für die drei- und sechsmonatigen Perioden zum 30. Juni 2025 an. Leasingverpflichtungen umfassen den langfristigen Anteil operativer Leasingverträge von $879.258 und den Barwert der Verbindlichkeiten aus operativen Leasingverhältnissen von $1.703.716. Die Nasdaq hat das Unternehmen wegen eines zu niedrigen Geldkurses benachrichtigt, CODX ist jedoch für einen zusätzlichen Compliance‑Zeitraum berechtigt und kann dies gegebenenfalls durch einen Reverse Split beheben.

Positive
  • $31.51 million of proceeds from maturities of marketable investment securities increased liquidity
  • Net increase in cash and cash equivalents of $8.18 million during the period
  • Raised net proceeds of $1.02 million by selling 2,209,131 shares under the ATM program
Negative
  • Continued operating losses with loss per share of $(0.23) and $(0.47) for the three- and six-month periods shown
  • No grant funding recognized in the three- and six-month periods ended June 30, 2025 versus $2.50M and $2.71M in prior-year periods
  • High revenue and receivable concentration: three customers ~53% of product revenue and two customers ~82% of accounts receivable at June 30, 2025
  • NASDAQ bid-price deficiency noted; company may need a reverse stock split to regain compliance

Insights

TL;DR: Losses persist but cash inflows from marketable securities and an ATM program materially bolster near-term liquidity.

Co-Diagnostics shows operating losses but generated significant cash from maturities of marketable securities ($31.51M) and a smaller ATM equity raise ($1.02M net). The company reported a quarter-over-quarter net cash increase of $8.18M, which provides runway despite negative operating results. However, the absence of grant funding in 2025 removes a previously material revenue source. Revenue concentration is high—three customers represented ~53% of product revenue in the quarter—creating receivables and cash collection risk. Balance-sheet lease liabilities and inventory reserves are noted but not outsized relative to the cash inflows disclosed.

TL;DR: Material governance and market-risk concerns include revenue concentration and Nasdaq bid-price noncompliance risk.

The filing highlights significant customer concentration with a small number of customers and granting agencies accounting for the bulk of revenue and receivables, which elevates counterparty risk. The company disclosed a Nasdaq bid-price deficiency and intends to seek cure options, including a potential reverse stock split, which is a governance and shareholder-value consideration. Stock-based compensation and outstanding contingent securities (warrants tied to milestones) could dilute shareholders if triggered. Lease obligations and operating losses underscore the need to monitor liquidity despite recent cash receipts.

Co-Diagnostics, Inc. (CODX) ha registrato perdite operative continue e una forte concentrazione dei clienti, ma anche significativi flussi di cassa nel primo semestre 2025. La società ha riportato una perdita per azione di $(0.23) e $(0.25) per i rispettivi trimestri comparabili e di $(0.47) e $(0.56) per i confronti semestrali, con una media ponderata delle azioni ordinarie in circolazione intorno a 33,1 milioni nell’ultimo trimestre. I finanziamenti a fondo perduto sono scesi a $0 sia per i periodi di tre che di sei mesi conclusi il 30 giugno 2025, rispetto a $2,5 milioni e $2,7 milioni nei periodi dell’anno precedente. I crediti netti verso clienti ammontavano a $210.968 al 30 giugno 2025 e a $132.570 al 31 dicembre 2024; due grandi clienti rappresentano la maggior parte dei crediti e tre clienti costituiscono circa il 53% dei ricavi da prodotti nel trimestre. Liquidità e disponibilità liquide sono migliorate: la società ha riportato un aumento netto di cassa e disponibilità liquide di $8,18 milioni e ha ricevuto proventi netti di $1,02 milioni da un programma di emissione azioni at-the-market dopo la vendita di 2.209.131 azioni; le scadenze dei titoli negoziabili hanno generato $31,51 milioni. Le scorte ammontavano a $1.084.627 con accantonamenti registrati; la società ha riconosciuto variazioni delle riserve di inventario per $59.591 e $101.065 per i periodi di tre e sei mesi conclusi il 30 giugno 2025. Gli impegni di locazione comprendono la porzione a lungo termine dei lease operativi di $879.258 e il valore attuale delle passività da lease operativo di $1.703.716. Nasdaq ha notificato alla società una non conformità relativa al prezzo di offerta, ma CODX è idonea a un periodo aggiuntivo per la conformità e potrebbe risolvere la situazione con uno split inverso se necessario.

Co-Diagnostics, Inc. (CODX) informó pérdidas operativas continuas y una alta concentración de clientes, junto con entradas de efectivo relevantes en el primer semestre de 2025. La compañía registró una pérdida por acción de $(0.23) y $(0.25) para los periodos trimestrales comparables y de $(0.47) y $(0.56) para los comparativos semestrales, con un promedio ponderado de acciones básicas alrededor de 33,1 millones en el trimestre más reciente. La financiación por subvenciones se redujo a $0 tanto en los periodos de tres como de seis meses terminados el 30 de junio de 2025, frente a $2,5 millones y $2,7 millones en los periodos del año anterior. Los saldos netos de cuentas por cobrar fueron $210,968 al 30 de junio de 2025 y $132,570 al 31 de diciembre de 2024; dos grandes clientes representan la mayor parte de las cuentas por cobrar y tres clientes explican aproximadamente el 53% de los ingresos por productos en el trimestre. El efectivo y la liquidez mejoraron: la empresa informó un aumento neto en efectivo y equivalentes de $8,18 millones y recibió ingresos netos de $1,02 millones por un programa de acciones at-the-market tras vender 2.209.131 acciones; los vencimientos de valores negociables generaron $31,51 millones. El inventario totalizó $1,084,627 con reservas registradas; la compañía reconoció cambios en las provisiones de inventario de $59,591 y $101,065 para los periodos de tres y seis meses terminados el 30 de junio de 2025. Las obligaciones de arrendamiento incluyen la porción a largo plazo de arrendamientos operativos de $879,258 y el valor presente de las obligaciones por arrendamiento operativo de $1,703,716. Nasdaq notificó a la compañía una deficiencia en el precio de oferta, pero CODX es elegible para un periodo adicional de cumplimiento y podría subsanarlo mediante una consolidación inversa de acciones si fuera necesario.

Co-Diagnostics, Inc. (CODX)ëŠ� 2025ë…� ìƒë°˜ê¸°ì— ì§€ì†ì ì� ì˜ì—…ì†ì‹¤ê³� ë†’ì€ ê³ ê° ì§‘ì¤‘ë„를 보고했으ë‚� 현금 유입ë� ëˆˆì— ë„게 ì¦ê°€í–ˆìŠµë‹ˆë‹¤. 회사ëŠ� ë¹„êµ ëŒ€ìƒ� 분기별로 주당 ì†ì‹¤ì� ê°ê° $(0.23)와 $(0.25), 반기 비êµì—서ëŠ� $(0.47)와 $(0.56)ë¥� 기ë¡í–ˆìœ¼ë©�, 최근 분기 가중í‰ê·� 보통ì£� 수는 ì•� 3,310ë§� 주였습니ë‹�. ë³´ì¡°ê¸� ìˆ˜ìž…ì€ 2025ë…� 6ì›� 30ì� 종료ë� 3개월 ë°� 6개월 기간 ëª¨ë‘ $0ë¡� ê°ì†Œí–ˆìœ¼ë©�, ì „ë…„ ë™ê¸°ì—는 ê°ê° $250만과 $270ë§Œì´ì—ˆìŠµë‹ˆë‹¤. 매출채권 ìˆœìž”ì•¡ì€ 2025ë…� 6ì›� 30ì� 기준 $210,968, 2024ë…� 12ì›� 31ì� 기준 $132,570였으며, ë‘� ê°œì˜ ëŒ€í˜� ê³ ê°ì� 채권ì� ëŒ€ë¶€ë¶„ì„ ì°¨ì§€í•˜ê³  ì„� ê³ ê°ì� 분기 제품 매출ì� ì•� 53%ë¥� 차지했습니다. 현금 ë°� 유ë™ì„±ì€ 개선ë˜ì–´ 회사ëŠ� 현금 ë°� 현금성ìžì‚°ì—ì„� $8.18백만 순ì¦ì� 보고했고, 2,209,131주를 매ê°í•� ë’� 시장íŒë§¤(ATM) 프로그램으로부í„� $1.02백만ì� 순수ìµì„ 받았으며, 유가ì¦ê¶Œ 만기ë¡� $31.51백만ì� 창출했습니다. 재고ëŠ� $1,084,627였ê³� ì¶©ë‹¹ê¸ˆì´ ì„¤ì •ë˜ì—ˆìœ¼ë©°, 2025ë…� 6ì›� 30ì� 종료ë� 3개월 ë°� 6개월 기간ì—� 대í•� 재고충당ê¸� ë³€ë™ì•¡ì€ ê°ê° $59,591 ë°� $101,065였습니ë‹�. 리스 부채는 ìš´ì˜ë¦¬ìФ 장기분부ê¸� $879,258ê³� ìš´ì˜ë¦¬ìФ ë¶€ì±„ì˜ í˜„ìž¬ê°€ì¹� $1,703,716ë¥� í¬í•¨í•©ë‹ˆë‹�. ë‚˜ìŠ¤ë‹¥ì€ ìž…ì°°ê°€ ë¶€ì¡±ì„ í†µì§€í–ˆìœ¼ë‚� CODXëŠ� 추가 준ìˆ� 기간ì� ë°›ì„ ìžê²©ì� 있으ë©� í•„ìš”í•� 경우 역병합으ë¡� ì´ë¥¼ 해소í•� ìˆ� 있습니다.

Co-Diagnostics, Inc. (CODX) a déclaré des pertes d’exploitation continues et une forte concentration de sa clientèle, tout en affichant des entrées de trésorerie notables au premier semestre 2025. La société a enregistré une perte par action de $(0.23) et $(0.25) pour les périodes trimestrielles comparables et de $(0.47) et $(0.56) pour les comparaisons semestrielles, avec un nombre moyen pondéré d’actions ordinaires d’environ 33,1 millions au trimestre le plus récent. Le financement par subventions est tombé à $0 pour les périodes de trois et six mois clôturées le 30 juin 2025, contre $2,5 millions et $2,7 millions lors des périodes de l’exercice précédent. Les soldes nets des comptes clients étaient de $210,968 au 30 juin 2025 et de $132,570 au 31 décembre 2024 ; deux gros clients représentent la majeure partie des créances et trois clients représentent environ 53% des revenus produits du trimestre. La trésorerie et la liquidité se sont améliorées : la société a déclaré une augmentation nette des liquidités de $8,18 millions et a reçu des produits nets de $1,02 million d’un programme d’actions at‑the‑market après la vente de 2 209 131 actions ; les échéances de titres négociables ont généré $31,51 millions. Les stocks s’élevaient à $1,084,627 avec des provisions enregistrées ; la société a comptabilisé des variations de provisions pour stocks de $59,591 et $101,065 pour les périodes de trois et six mois clôturées le 30 juin 2025. Les engagements locatifs incluent la partie long terme des baux opérationnels de $879,258 et la valeur actuelle des passifs liés aux baux opérationnels de $1,703,716. Le Nasdaq a informé la société d’une insuffisance du cours des offres, mais CODX est éligible à une période de conformité supplémentaire et peut remédier à la situation par une fusion inversée d’actions si nécessaire.

Co-Diagnostics, Inc. (CODX) meldete im ersten Halbjahr 2025 weiterhin operative Verluste und eine starke Kundenkonzentration, zeigte aber zugleich nennenswerte Cashzuflüsse. Das Unternehmen verzeichnete einen Verlust je Aktie von $(0.23) und $(0.25) für die jeweiligen Vergleichsquartale sowie $(0.47) und $(0.56) für die Halbjahresvergleiche, bei einem gewichteten durchschnittlichen Stammaktienbestand von rund 33,1 Millionen im jüngsten Quartal. Fördermittel fielen in den für den 30. Juni 2025 beendeten drei- und sechsmonatigen Perioden auf $0, gegenüber $2,5 Mio. bzw. $2,7 Mio. im Vorjahr. Die Nettobestände der Forderungen beliefen sich auf $210.968 zum 30. Juni 2025 und $132.570 zum 31. Dezember 2024; zwei Großkunden machten den Großteil der Forderungen aus, und drei Kunden waren für rund 53% des Produktumsatzes im Quartal verantwortlich. Kasse und Liquidität verbesserten sich: Das Unternehmen meldete einen Nettozufluss an Zahlungsmitteln und Zahlungsmitteläquivalenten von $8,18 Mio. und erhielt Nettoerlöse von $1,02 Mio. aus einem At‑the‑Market‑Aktienprogramm nach dem Verkauf von 2.209.131 Aktien; Fälligkeiten von marktfähigen Wertpapieren generierten $31,51 Mio.. Der Lagerbestand belief sich auf $1.084.627 mit gebildeten Rückstellungen; das Unternehmen erkannte Lagerwertberichtigungsänderungen in Höhe von $59.591 bzw. $101.065 für die drei- und sechsmonatigen Perioden zum 30. Juni 2025 an. Leasingverpflichtungen umfassen den langfristigen Anteil operativer Leasingverträge von $879.258 und den Barwert der Verbindlichkeiten aus operativen Leasingverhältnissen von $1.703.716. Die Nasdaq hat das Unternehmen wegen eines zu niedrigen Geldkurses benachrichtigt, CODX ist jedoch für einen zusätzlichen Compliance‑Zeitraum berechtigt und kann dies gegebenenfalls durch einen Reverse Split beheben.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2025

 

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from __________ to __________

 

Commission File No. 001-38148

 

CO-DIAGNOSTICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Utah   46-2609396

(State or other jurisdiction

of incorporation or organization)

 

(I.R.S. Employer

Identification Number)

 

2401 S. Foothill Drive, Suite D, Salt Lake City, Utah 84109

(Address of principal executive offices and zip code)

 

(801) 438-1036

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock   CODX   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer Accelerated filer
Non-accelerated filer Smaller reporting company
    Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No

 

As of August 12, 2025, there were 38,523,582 shares of common stock, par value $0.001 per share, outstanding.

 

 

 

 

 

 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

 

TABLE OF CONTENTS

 

PART I FINANCIAL INFORMATION:  
     
Item 1. Financial Statements (unaudited): 3
     
  Condensed Consolidated Balance Sheets 3
     
  Condensed Consolidated Statements of Operations 4
     
  Condensed Consolidated Statements of Cash Flows 5
     
  Condensed Consolidated Statements of Stockholders’ Equity 6
     
  Notes to Condensed Consolidated Financial Statements 7
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 19
     
Item 3. Quantitative and Qualitative Disclosures About Market Risk 22
     
Item 4. Controls and Procedures 22
     
PART II OTHER INFORMATION:  
     
Item 1. Legal Proceedings 23
     
Item 1A. Risk Factors 23
     
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 23
     
Item 3. Defaults Upon Senior Securities 23
     
Item 4. Mine Safety Disclosures 23
     
Item 5. Other Information 23
     
Item 6. Exhibits 24
     
  Signatures 25

 

2

 

 

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

CO – DIAGNOSTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

   June 30, 2025   December 31, 2024 
Assets          
Current assets          
Cash and cash equivalents  $11,115,181   $2,936,544 
Marketable investment securities   2,247,638    26,811,098 
Accounts receivable, net   210,968    132,570 
Inventory, net   1,084,627    1,072,724 
Prepaid expenses and other current assets   648,752    1,338,762 
Total current assets   15,307,166    32,291,698 
Property and equipment, net   2,673,390    2,761,280 
Operating lease right-of-use asset   1,668,416    2,114,876 
Intangible assets, net   26,101,000    26,101,000 
Investment in joint venture   715,861    731,065 
Total assets  $46,465,833   $63,999,919 
Liabilities and stockholders’ equity          
Current liabilities          
Accounts payable  $1,635,196   $3,294,254 
Accrued expenses   1,008,127    2,562,169 
Operating lease liability, current   824,458    915,619 
Contingent consideration liabilities, current   197,610    502,819 
Deferred revenue   45,857    40,857 
Total current liabilities   3,711,248    7,315,718 
Long-term liabilities          
Income taxes payable   736,933    713,643 
Operating lease liability   879,258    1,236,560 
Contingent consideration liabilities   -    422,080 
Total long-term liabilities   1,616,191    2,372,283 
Total liabilities   5,327,439    9,688,001 
Commitments and contingencies (Note 10)   -    - 
Stockholders’ equity          
Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively   -    - 
Common stock, $0.001 par value; 100,000,000 shares authorized; 41,031,146 shares issued and 36,182,468 shares outstanding as of June 30, 2025 and 37,902,222 shares issued and 33,053,544 shares outstanding as of December 31, 2024   41,031    37,902 
Treasury stock, at cost; 4,848,678 shares held as of June 30, 2025 and December 31, 2024, respectively   (15,575,795)   (15,575,795)
Additional paid-in capital   104,843,320    102,472,210 
Accumulated other comprehensive income   134,068    418,443 
Accumulated deficit   (48,304,230)   (33,040,842)
Total stockholders’ equity   41,138,394    54,311,918 
Total liabilities and stockholders’ equity  $46,465,833   $63,999,919 

 

See accompanying notes to unaudited condensed consolidated financial statements

 

3

 

 

CO – DIAGNOSTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

 

   2025   2024   2025   2024 
   Three Months Ended June 30,   Six Months Ended June 30, 
   2025   2024   2025   2024 
Product revenue  $162,910   $161,102   $213,187   $413,847 
Grant revenue   -    2,495,738    -    2,710,847 
Total revenue   162,910    2,656,840    213,187    3,124,694 
Cost of revenue   32,106    212,148    53,696    446,653 
Gross profit   130,804    2,444,692    159,491    2,678,041 
Operating expenses                    
Sales and marketing   609,713    1,041,243    1,266,743    2,604,925 
General and administrative   2,599,982    3,132,385    5,373,131    6,051,188 
Research and development   4,687,459    5,612,691    9,557,478    11,292,369 
Depreciation and amortization   291,414    338,335    571,859    668,908 
Total operating expenses   8,188,568    10,124,654    16,769,211    20,617,390 
Loss from operations   (8,057,764)   (7,679,962)   (16,609,720)   (17,939,349)
Other income, net                    
Interest income, net   12,158    342,188    25,759    704,921 
AGÕæÈ˹ٷ½ized gain on investments   340,358    74,165    641,823    302,235 
Gain (loss) on disposition of assets   (9,004)   3,500    (9,004)   3,500 
Gain (loss) on remeasurement of acquisition contingencies   10,222    (244,116)   727,289    206,144 
Loss on equity method investment in joint venture   (13,760)   (74,503)   (15,204)   (145,458)
Total other income, net   339,974    101,234    1,370,663    1,071,342 
Loss before income taxes   (7,717,790)   (7,578,728)   (15,239,057)   (16,868,007)
Income tax provision   12,327    20,590    24,331    43,354 
Net loss  $(7,730,117)  $(7,599,318)  $(15,263,388)  $(16,911,361)
Other comprehensive income (loss)                    
Change in net unrealized gains (losses) on marketable securities, net of tax   (196,585)   144,653    (284,375)   224,508 
Total other comprehensive income (loss)  $(196,585)  $144,653   $(284,375)  $224,508 
Comprehensive loss  $(7,926,702)  $(7,454,665)  $(15,547,763)  $(16,686,853)
                     
Loss per common share:                    
Basic and Diluted  $(0.23)  $(0.25)  $(0.47)  $(0.56)
Weighted average shares outstanding:                    
Basic and Diluted   33,108,399    30,124,696    32,581,603    29,983,785 

 

See accompanying notes to unaudited condensed consolidated financial statements

 

4

 

 

CO – DIAGNOSTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   2025   2024 
   Six Months Ended June 30, 
   2025   2024 
Cash flows from operating activities          
Net loss  $(15,263,388)  $(16,911,361)
Adjustments to reconcile net loss to cash used in operating activities:          
Depreciation and amortization   571,859    668,908 
Stock-based compensation expense   1,455,493    3,070,892 
Common stock issued for financial advisory services   135,000    - 
Change in fair value of acquisition contingencies   (727,289)   (206,144)
Non-cash lease expense   (2,003)   10,613 
AGÕæÈ˹ٷ½ized gain on investments   (641,823)   (302,235)
Loss from equity method investment   15,204    145,458 
(Gain) loss on disposition of assets   9,004    (3,500)
Provision for (recoveries of) credit losses   (13,248)   (40,944)
Inventory obsolescence expense (recovery)   (95,302)   84,430 
Changes in assets and liabilities:          
Accounts receivable   (65,150)   (206,634)
Prepaid expenses and other assets   690,010    299,970 
Inventory   83,399    116,335 
Deferred revenue   5,000    (141,519)
Income taxes payable   23,290    39,927 
Accounts payable, accrued expenses and other liabilities   (3,213,100)   (318,728)
Net cash used in operating activities   (17,033,044)   (13,694,532)
Cash flows from investing activities          
Purchases of property and equipment   (492,973)   (500,922)
Proceeds from maturities of marketable investment securities   31,509,485    26,836,743 
Purchases of marketable securities   (6,588,577)   (13,699,301)
Net cash provided by investing activities   24,427,935    12,636,520 
Cash flows from financing activities          
Issuance of common stock related to at-the-market offering, net of offering costs   783,746    - 
Net cash provided by financing activities   783,746    - 
Net increase (decrease) in cash and cash equivalents   8,178,637    (1,058,012)
Cash and cash equivalents at beginning of period   2,936,544    14,916,878 
Cash and cash equivalents at end of period  $11,115,181   $13,858,866 
Supplemental disclosure of cash flow information          
Income taxes paid  $-   $800 

 

See accompanying notes to unaudited condensed consolidated financial statements

 

5

 

 

CO – DIAGNOSTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

 

   Shares   Amount   Shares   Amount   Stock   Capital   Income   (Deficit)   Equity 
   Convertible Preferred Stock   Common Stock   Treasury   Additional Paid-in   Accumulated Other Comprehensive   Accumulated Earnings   Total Stockholders’ 
   Shares   Amount   Shares   Amount   Stock   Capital   Income   (Deficit)   Equity 
Balance as of December 31, 2024   -   $-    37,902,222   $37,902   $(15,575,795)  $102,472,210   $418,443   $(33,040,842)  $54,311,918 
Issuance of common stock related to at-the-market offering, net of offering costs   -    -    519,099    519    -    354,227    -    -    354,746 
Stock-based compensation   -    -    -    -    -    875,228    -    -    875,228 
Other comprehensive loss, net of tax   -    -    -    -    -    -    (87,790)   -    (87,790)
Net loss   -    -    -    -    -    -    -    (7,533,271)   (7,533,271)
Balance as of March 31, 2025   -    -    38,421,321    38,421    (15,575,795)   103,701,665    330,653    (40,574,113)   47,920,831 
Issuance of common stock related to at-the-market offering, net of offering costs   -    -    1,375,325    1,375    -    427,625    -    -    429,000 
Stock-based compensation   -    -    734,500    735    -    579,530    -    -    580,265 
Issuance of common stock related to financial advisory services   -    -    500,000    500    -    134,500    -    -    135,000 
Other comprehensive loss, net of tax   -    -    -    -    -    -    (196,585)   -    (196,585)
Net loss   -    -    -    -    -    -    -    (7,730,117)   (7,730,117)
Balance as of June 30, 2025   -   $-    41,031,146   $41,031   $(15,575,795)  $104,843,320   $134,068   $(48,304,230)  $41,138,394 

 

   Convertible Preferred Stock   Common Stock   Treasury   Additional Paid-in   Accumulated Other Comprehensive   Accumulated Earnings   Total Stockholders’ 
   Shares   Amount   Shares   Amount   Stock   Capital   Income   (Deficit)   Equity 
Balance as of December 31, 2023   -   $-    36,108,346   $36,108   $(15,575,795)  $96,808,436   $146,700   $4,598,166   $86,013,615 
Stock-based compensation   -    -    18,750    19    -    1,571,215    -    -    1,571,234 
Other comprehensive income, net of tax   -    -    -    -    -    -    79,855    -    79,855 
Net loss   -    -    -    -    -    -    -    (9,312,043)   (9,312,043)
Balance as of March 31, 2024   -    -    36,127,096    36,127    (15,575,795)   98,379,651    226,555    (4,713,877)   78,352,661 
Stock-based compensation   -    -    632,584    633    -    1,499,025    -    -    1,499,658 
Other comprehensive income, net of tax   -    -    -    -    -    -    144,653    -    144,653 
Net loss   -    -    -    -    -    -    -    (7,599,318)   (7,599,318)
Balance as of June 30, 2024   -   $-    36,759,680   $36,760   $(15,575,795)  $99,878,676   $371,208   $(12,313,195)  $72,397,654 

 

See accompanying notes to unaudited condensed consolidated financial statements

 

6

 

 

CO – DIAGNOSTICS, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

Note 1 – Overview and Basis of Presentation

 

Description of Business

 

Co-Diagnostics, Inc., a Utah corporation (the “Company” or “CODX”), is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company’s technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx™ PCR platform and to locate genetic markers for use in applications other than infectious disease. In connection with the sale of our tests we may sell diagnostic equipment from other manufacturers as self-contained lab systems.

 

Unaudited Condensed Consolidated Financial Statements

 

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information as they are prescribed for smaller reporting companies. As permitted under those rules and regulations, certain notes or other financial information normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. Accordingly, the accompanying unaudited condensed consolidated financial statements do not include all the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary to make the financial statements not misleading have been included. Operating results for the three and six months ended June 30, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025. These statements should be read in conjunction with the Company’s audited financial statements and related notes for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 27, 2025. A summary of the Company’s significant accounting policies is set forth in Note 2 to the consolidated financial statements in its Annual Report on Form 10-K for the year ended December 31, 2024.

 

Use of Estimates

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. Such estimates include receivables and other long-lived assets, legal contingencies, income taxes, share based arrangements, and others. These estimates and assumptions are based on management’s best estimates and judgments. Actual amounts and results could differ from those estimates.

 

Liquidity and Going Concern

 

In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, (“ASC 205-40”) the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date on which this Quarterly Report on Form 10-Q is filed. Based on the Company’s cash, cash equivalents, and short-term investments as of June 30, 2025, the Company’s current and forecasted level of operations, and its forecasted cash flows, the Company’s ability to continue as a going concern is dependent upon its ability to obtain the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they come due, and to generate profitable operations in the future. Management plans to provide for the Company’s capital requirements through equity financing, including through selling shares under the Company’s ATM Agreement, seeking additional grant funding, and through operational efficiencies. Our ability to obtain additional financing in equity capital markets is subject to several factors, including market and economic conditions, our performance and investor sentiment with respect to us and our industry. Accordingly, there can be no assurance that the Company will be able to raise a sufficient amount of additional capital to fund operations with terms acceptable to the Company, or at all. Because certain elements of management’s plans to mitigate the conditions that raised substantial doubt about the Company’s ability to continue as a going concern are outside of the Company’s control, including the ability to raise capital through equity or other financings, those elements cannot be considered probable according to ASC 205-40, and therefore cannot be considered in the evaluation of mitigating factors. As a result, management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for 12 months from the date these condensed consolidated financial statements are issued.

 

7

 

 

The condensed consolidated financial statements as of June 30, 2025 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months after these financial statements are issued, and that contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company’s ability to continue as a going concern is dependent upon its uncertain ability to obtain additional capital, reduce expenditures, and execute on its business plans. These consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Note 2 – Summary of Significant Accounting Policies

 

Reclassifications

 

Certain prior year amounts have been reclassified to conform with the current year’s presentation. These reclassifications have no impact on the previously reported results.

 

Operating Segments

 

The Company operates as one operating segment. Operating segments are defined as components of an entity for which separate financial information is regularly evaluated by the chief operating decision maker (“CODM”), which is the Company’s Chief Executive Officer, in deciding how to allocate resources and assess performance. The Company’s CODM evaluates financial information and resources and assesses the performance of these resources on a consolidated basis. There is no expense or asset information that is supplemental to information disclosed within the condensed consolidated financial statements, that is regularly provided to the CODM. The allocation of resources and assessment of performance of the operating segment is based on consolidated net loss and functional expenses as reported on our condensed consolidated statements of operations and comprehensive loss. Because the Company operates as one operating segment, financial segment information, including expense and asset information, can be found in the condensed consolidated financial statements. All material long-lived assets are located in the United States and India.

 

Accounts Receivable

 

Trade accounts receivable are recorded at the invoiced amount (net of allowance) and do not bear interest. The Company maintains an allowance for doubtful accounts for amounts the Company does not expect to collect. In establishing the required allowance, management considers historical losses, current market condition, customers’ financial condition, the age of receivables, and current payment patterns. Account balances are written off against the allowance once the receivable is deemed uncollectible. Recoveries of trade receivables previously written off are recorded when collected. At June 30, 2025 total accounts receivable was $297,991 with an allowance for uncollectable accounts of $87,023 resulting in a net amount of $210,968. At December 31, 2024 total accounts receivable was $242,625 with an allowance for uncollectable accounts of $110,055 resulting in a net amount of $132,570. At December 31, 2023 total accounts receivable was $504,264 with an allowance for uncollectable accounts of $200,338 resulting in a net amount of $303,926.

 

Inventory

 

Inventory is stated at the lower of cost or net-realizable value. Inventory cost is determined on a first-in first-out basis that approximates average cost in accordance with ASC 330-10-30-12. At June 30, 2025, the Company had $1,084,627 in net inventory, of which $601,756 was finished goods and $482,871 was raw materials. At December 31, 2024, the Company had $1,072,724 in net inventory, of which $567,281 was finished goods and $505,443 was raw materials. The Company establishes reserves to reduce low-moving, obsolete, or unusable inventories to their estimated useful or scrap values. The Company recognized $59,591 and $101,065 related to the change in inventory reserves during the three and six months ended June 30, 2025, respectively, compared to $24,333 and $287,006 during the three and six months ended June 30, 2024, respectively.

 

8

 

 

Revenue Recognition

 

The Company generates revenue from customers from product and license sales. The Company recognizes revenue from customers when all of the following criteria are satisfied: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when, or as the Company satisfies each performance obligation.

 

The Company constrains revenue by giving consideration to factors that could otherwise lead to a probable reversal of revenue. The Company records any payments received from customers prior to the Company fulfilling its performance obligation(s) as deferred revenue.

 

Grant Revenue

 

The Company may submit applications to receive grant funding from governmental and non-governmental entities. The Company accounts for grants by analogizing to the contribution accounting model under ASC 958-605, Not-for-Profit Entities (“ASC 958”). Revenues from grants, contracts, and awards provided by governmental and non-governmental agencies are recorded based upon the terms of the specific agreements. The Company recognizes grant funding without conditions or continuing performance obligations as revenue in the consolidated statements of operations and comprehensive income (loss). The Company recognizes grant funding with conditions or continuing performance obligations as deferred revenue in the consolidated balance sheets if the conditions or performance obligations have not yet been met. The Company recognized no grant funding revenue during the three and six months ended June 30, 2025, respectively, compared to $2,495,738 and $2,710,847 during the three and six months ended June 30, 2024, respectively. At June 30, 2025, and December 31, 2024, the Company has recorded $40,857 of deferred revenue related to grant funding for which the cash was received, but the underlying conditions or performance obligations have not yet been met. Cash received from federal grants, contracts, and awards can be subject to audit by the grantor and, if the examination results in a disallowance of any expenditure, repayment could be required.

 

Income Taxes

 

The Company accounts for income taxes in accordance with the liability method of accounting for income taxes. Under this method, deferred income tax assets and deferred income tax liabilities represent the tax effect of temporary differences between financial reporting and tax reporting measured at enacted tax rates in effect for the year in which the differences are expected to reverse. The Company recognizes only the impact of tax positions that, based on their technical merits, are more likely than not to be sustained upon an audit by the taxing authority.

 

Valuation allowances are provided when it is more-likely-than-not that some or all of the deferred income tax assets may not be realized. In assessing the need for a valuation allowance, the Company has considered its historical levels of income, expectations of future taxable income and ongoing tax planning strategies.

 

Developing the provision for income taxes, including the effective tax rate and analysis of potential tax exposure items, if any, requires significant judgment and expertise in federal and state income tax laws, regulations and strategies, including the determination of deferred income tax assets and liabilities and any estimated valuation allowances deemed necessary to value deferred income tax assets. Judgments and tax strategies are subject to audit by various taxing authorities. The Company has uncertain income tax positions in the condensed consolidated financial statements, and adverse determinations by these taxing authorities could have a material adverse effect on the condensed consolidated financial positions, result of operations, or cash flows.

 

Concentrations Risk and Significant Customers

 

The Company had certain customers which were each responsible for generating 10% or more of the total revenue for the three and six months ended June 30, 2025 and 2024. Three customers accounted for approximately 53% of product revenue recognized during the three months ended June 30, 2025. Three customers accounted for approximately 41% of product revenue recognized during the six months ended June 30, 2025. Two customers accounted for approximately 37% of product revenue, and two granting agencies accounted for approximately 94% of grant revenue recognized during the three months ended June 30, 2024. One customer accounted for approximately 29% of product revenue, and two granting agencies accounted for approximately 95% of grant revenue recognized during the six months ended June 30, 2024.

 

9

 

 

Three customers individually accounted for more than 10% of accounts receivable at June 30, 2025 and two customers individually accounted for more than 10% of accounts receivable at December 31, 2024. These customers together accounted for approximately 82% and 94% of accounts receivable at June 30, 2025 and December 31, 2024, respectively.

 

Recently Issued Accounting Standards

 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) that are adopted by the Company as of the specified effective date. If not discussed, management believes that the impact of recently issued standards, which are not yet effective, will not have a material impact on the Company’s financial statements upon adoption.

 

In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The standard is effective for full year 2024 reporting, and for interim reporting beginning in 2025. The adoption of this ASU did not change the way the Company evaluates its reportable segments and, as a result, did not have a material impact on the Company’s segment-related disclosures.

 

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires an entity to disclose annually additional information related to the company’s income tax rate reconciliation and income taxes paid during the period. The guidance should be applied prospectively with the option to apply the standard retrospectively. The standard becomes effective for the Company for full year 2025 reporting. The Company is currently evaluating the impact of this new standard on its consolidated financial statements.

 

In November 2024, the FASB issued ASU 2024-03, Income Statement (Subtopic 220-40): Reporting Comprehensive Income - Expense Disaggregation Disclosures, which requires an entity to disclose on an annual and interim basis, disaggregated information about specific income statement expense categories. The guidance should be applied prospectively with the option to apply the standard retrospectively. The standard becomes effective for the Company for full year 2027 reporting. The Company is currently evaluating the impact of this new standard on its consolidated financial statements.

 

Note 3 – Cash, Cash Equivalents, and Financial Instruments

 

The following table shows the Company’s cash, cash equivalents, and marketable investment securities by significant investment category:

 

   June 30, 2025 
   Adjusted Cost   Total Unrealized Gains / (Losses)   Fair Value   Cash and Cash Equivalents   Marketable Investment Securities 
Cash  $11,115,181   $-   $11,115,181   $11,115,181   $- 
Level 2:                         
U.S. treasury securities   2,113,570    134,068    2,247,638    -    2,247,638 
Subtotal   2,113,570    134,068    2,247,638    -    2,247,638 
Total  $13,228,751   $134,068   $13,362,819   $11,115,181   $2,247,638 

 

10

 

 

   December 31, 2024 
   Adjusted Cost   Total Unrealized Gains / (Losses)   Fair Value   Cash and Cash Equivalents   Marketable Investment Securities 
Cash  $2,936,544   $-   $2,936,544   $2,936,544   $- 
Level 2:                         
U.S. treasury securities   26,392,655    418,443    26,811,098    -    26,811,098 
Subtotal   26,392,655    418,443    26,811,098    -    26,811,098 
Total  $29,329,199   $418,443   $29,747,642   $2,936,544   $26,811,098 

 

Marketable investment securities held as of June 30, 2025 mature over the next 12 months.

 

Note 4 – Fair Value Measurements

 

The Company measures and records certain financial assets and liabilities at fair value on a recurring basis. Fair value is based on the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.

 

The following three levels of inputs are used to measure the fair value of financial assets and liabilities:

 

Level 1: Quoted market prices in active markets for identical assets or liabilities.

 

Level 2: Observable market-based inputs or unobservable inputs that are corroborated by market data.

 

Level 3: Unobservable inputs that are not corroborated by market data.

 

The following table summarizes the assets and liabilities measured at fair value on a recurring basis as of June 30, 2025 and December 31, 2024, by level within the fair value hierarchy:

 

   (Level 1)   (Level 2)   (Level 3)   Total 
   June 30, 2025 
   (Level 1)   (Level 2)   (Level 3)   Total 
Assets:                    
Cash equivalents  $10,301,832   $-   $-   $10,301,832 
Marketable securities (U.S. treasury bills and notes)   -    2,247,638    -    2,247,638 
Total assets measured at fair value  $10,301,832   $2,247,638   $-   $12,549,470 
Liabilities:                    
Contingent consideration - common stock  $-   $-   $197,610   $197,610 
Contingent consideration - warrants   -    -    -    - 
Total liabilities measured at fair value  $-   $-   $197,610   $197,610 

 

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   (Level 1)   (Level 2)   (Level 3)   Total 
   December 31, 2024 
   (Level 1)   (Level 2)   (Level 3)   Total 
Assets:                    
Cash equivalents  $441,000   $-   $-   $441,000 
Marketable securities (U.S. treasury bills and notes)   -    26,811,098    -    26,811,098 
Total assets measured at fair value  $441,000   $26,811,098   $-   $27,252,098 
Liabilities:                    
Contingent consideration - common stock  $-   $-   $743,794   $743,794 
Contingent consideration - warrants   -    -    181,105    181,105 
Total liabilities measured at fair value  $-   $-   $924,899   $924,899 

 

The Company’s financial instruments that are measured at fair value on a recurring basis consist of U.S. treasury bills and notes as of June 30, 2025 and December 31, 2024.

 

The fair value of contingent consideration is calculated using a discounted probability weighted valuation model. Discount rates used in such calculations are a significant assumption that are not observed in the market, and therefore, the resulting fair value represents a Level 3 measurement.

 

The changes for Level 3 items measured at fair value on a recurring basis are as follows:

 

      
Fair value as of December 31, 2024  $924,899 
Change in fair value of contingent consideration issued for business acquisitions   (727,289)
Fair value as of June 30, 2025  $197,610 

 

The fair value of the contingent consideration is based on the fair value of the contingent consideration-common stock and contingent consideration-warrants. The fair value of the contingent consideration-common stock is equal to the probability-adjusted value of the Company’s common stock as of the valuation date. The fair value of the contingent consideration-warrants is equal to the probability adjusted value of a call option with terms consistent with the terms of the warrants as of the valuation date. Prior to the probability adjustments, the warrants were valued based on the following inputs:

 

   June 30, 2025   December 31, 2024 
Stock price  $0.28   $0.75 
Strike price  $9.13   $9.13 
Volatility   332.5%   246.4%
Risk-free rate   3.8%   4.3%
Expected term (years)   1.5    2.0 

 

Fair Value of Other Financial Instruments

 

The carrying amounts of certain financial instruments, including cash held in banks, accounts receivable, notes receivable, accounts payable, accrued liabilities, and other liabilities approximate fair value due to their short-term maturities and are excluded from the fair value tables above.

 

Note 5 – Intangible Assets, Net

 

Intangible assets, net consisted of the following:

 

   June 30, 2025
   Weighted-Average  Gross       Net 
   Useful Life (1)  Carrying   Accumulated   Carrying 
   (in Years)  Amount   Amortization   Amount 
In-process research and development  Indefinite  $26,101,000   $-   $26,101,000 
Non-competition agreements      1,094,000    (1,094,000)   - 
Total intangible assets     $27,195,000   $(1,094,000)  $26,101,000 

 

   December 31, 2024
   Weighted-Average  Gross       Net 
   Useful Life (1)  Carrying   Accumulated   Carrying 
   (in Years)  Amount   Amortization   Amount 
In-process research and development  Indefinite  $26,101,000   $-   $26,101,000 
Non-competition agreements      1,094,000    (1,094,000)   - 
Total intangible assets     $27,195,000   $(1,094,000)  $26,101,000 

 

  (1) Based on weighted-average useful life established as of the acquisition date.

 

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Note 6 – Revenue

 

The following table sets forth revenue by geographic area:

 

   2025   2024   2025   2024 
   Three Months Ended June 30,   Six Months Ended June 30, 
   2025   2024   2025   2024 
United States                    
Product revenue  $162,910   $137,411   $203,087   $223,706 
Grant revenue   -    2,495,738    -    2,710,847 
Total United States   162,910    2,633,149    203,087    2,934,553 
Rest of World                    
Product revenue   -    23,691    10,100    190,141 
Grant revenue   -    -    -    - 
Total Rest of World   -    23,691    10,100    190,141 
Total  $162,910   $2,656,840   $213,187   $3,124,694 
Percentage of revenue by area:                    
United States   100%   99%   95%   94%
Rest of World   0%   1%   5%   6%

 

Changes in the Company’s deferred revenue balance for the six months ended June 30, 2025 were as follows:

 

Balance as of December 31, 2024  $40,857 
Revenue recognized included in deferred revenue balance at the beginning of the period   - 
Increase due to prepayments from customers   5,000 
 Balance as of June 30, 2025  $45,857 

 

Note 7 – Loss Per Share

 

The following table reconciles the numerator and the denominator used to calculate basic and diluted loss per share for three and six months ended June 30, 2025 and 2024, respectively:

 

   2025   2024   2025   2024 
   Three Months Ended June 30,   Six Months Ended June 30, 
   2025   2024   2025   2024 
Numerator                    
Net loss, as reported  $(7,730,117)  $(7,599,318)  $(15,263,388)  $(16,911,361)
                     
Denominator                    
Weighted average shares, basic   33,108,399    30,124,696    32,581,603    29,983,785 
Dilutive effect of stock options, warrants and RSUs   -    -    -    - 
Shares used to compute diluted earnings per share   33,108,399    30,124,696    32,581,603    29,983,785 
                     
Loss per share, basic and diluted  $(0.23)  $(0.25)  $(0.47)  $(0.56)

 

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The computation of diluted loss per share for the three and six months ended June 30, 2025 and 2024, respectively, also excludes approximately 1.4 million shares of common stock and approximately 465,000 warrants to purchase shares of common stock that are contingent upon the achievement of certain milestones.

 

As a result of incurring a net loss for the three and six months ended June 30, 2025 and 2024, respectively, no potentially dilutive securities are included in the calculation of diluted loss per share because such effect would be anti-dilutive. The Company had potentially dilutive securities as of June 30, 2025, consisting of: (i) 2,535,184 restricted stock units and (ii) 982,918 options and warrants. The Company had potentially dilutive securities as of June 30, 2024, consisting of: (i) 1,758,323 restricted stock units and (ii) 532,112 options and warrants.

 

Note 8 – Stock-Based Compensation

 

Stock Incentive Plans

 

The Company’s board of directors adopted, and shareholders approved, the Co-Diagnostics, Inc. Amended and Restated 2015 Long Term Incentive Plan (the “Incentive Plan”) providing for the issuance of stock-based incentive awards to employees, officers, consultants, directors and independent contractors. On August 31, 2022, the shareholders approved an increase in the number of awards available for issuance under the Incentive Plan to an aggregate of 12,000,000 shares of common stock. The number of awards available for issuance under the Incentive Plan was 3,237,236 at June 30, 2025.

 

The Incentive Plan will expire on December 31, 2025. The Company’s board of directors adopted in March 2025, and in May 2025 our shareholders approved, the Co-Diagnostics, Inc. 2025 Equity Incentive Plan (the “2025 Plan”) providing for the issuance of stock-based incentive awards to employees, officers, consultants, directors and independent contractors. The number of awards available for issuance under the 2025 Plan was 6,700,000 at June 30, 2025. No awards have been made under the 2025 Plan.

 

Stock Options

 

The following table summarizes option activity during the six months ended June 30, 2025:

 

   Number of Options   Weighted Average Exercise Price   Weighted Average Fair Value   Weighted Average Remaining Contractual Life (Years) 
Outstanding at December 31, 2024   1,040,572   $2.19   $1.37    3.88 
Granted   -    -    -      
Expired   (70,002)  $1.29   $0.76      
Forfeited/Cancelled   -    -    -      
Exercised   -    -    -      
Outstanding at June 30, 2025   970,570   $2.26   $1.41    3.57 
                     
Exercisable at June 30, 2025   970,570   $2.26   $1.41    3.57 

 

The aggregate intrinsic value of outstanding options at June 30, 2025 and 2024 was approximately $0 and $152,521, respectively.

 

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Stock-based compensation cost is measured at the grant date based on the fair value of the award granted and recognized as expense over the vesting period using the straight-line method. The Company uses the Black-Scholes model to value options granted. As of June 30, 2025, there were no unvested options and no unrecognized stock-based compensation expense related to options.

 

Restricted Stock Units

 

The grant date fair value of RSUs granted is determined using the closing market price of the Company’s common stock on the grant date with the associated compensation expense amortized over the vesting period of the awards. The following table sets forth the outstanding RSUs and related activity for the six months ended June 30, 2025:

 

   Number of RSUs   Weighted Average Grant Date Fair Value 
Unvested at December 31, 2024   2,742,316   $2.50 
Granted   -    - 
Vested   (734,500)   2.59 
Forfeited/Cancelled   (105,285)   5.32 
Unvested at June 30, 2025   1,902,531   $2.30 

 

As of June 30, 2025, there was approximately $3,000,770 of unrecognized stock-based compensation expense related to outstanding RSUs which is expected to be recognized over a weighted-average period of 1.5 years.

 

Warrants

 

The Company has issued warrants related to financings, acquisitions and as compensation to third parties for services provided. The Company estimates the fair value of issued warrants on the date of issuance as determined using a Black-Scholes pricing model. The Company amortizes the fair value of issued warrants using a vesting schedule based on the terms and conditions of each warrant if granted for services.

 

The following table summarizes warrant activity during the six months ended June 30, 2025:

 

   Number of Warrants   Weighted Average Exercise Price   Weighted Average Fair Value   Weighted Average Remaining Contractual Life (Years) 
Outstanding at December 31, 2024   485,000   $8.81   $1.00    2.0 
Granted   -    -    -      
Expired   (20,000)   1.40    15.19      
Forfeited/Cancelled   -    -    -      
Exercised   -    -    -      
Outstanding at June 30, 2025   465,000   $9.13   $-    1.5 

 

The aggregate intrinsic value of outstanding warrants at June 30, 2025 was $0.

 

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There are no warrants exercisable at June 30, 2025. The ability to exercise the 465,000 warrants issued in connection with acquisitions in prior years is contingent upon the achievement of certain development and revenue milestones on or before January 1, 2027. There was no unrecognized stock-based compensation expense related to warrants.

 

Stock-Based Compensation Expense

 

The Company recognized stock-based compensation expense as follows:

 

   2025   2024   2025   2024 
   Three Months Ended June 30,   Six Months Ended June 30, 
   2025   2024   2025   2024 
Cost of revenue  $-   $6,054   $-   $14,195 
Sales and marketing   105,342    292,983    241,539    663,363 
General and administrative   531,707    1,046,148    1,267,622    2,132,644 
Research and development   (56,784)   154,473    (53,668)   260,690 
Total stock-based compensation expense  $580,265   $1,499,658   $1,455,493   $3,070,892 

 

Note 9 – Income Taxes

 

For the three months ended June 30, 2025, the Company recognized expense from income taxes of $12,327, representing an effective tax rate of 0.2%. For the six months ended June 30, 2025, the Company recognized expense from income taxes of $24,331, representing an effective tax rate of 0.2%. The Company’s effective tax rate will generally differ from the U.S. Federal statutory rate of 21.0%, primarily due to the full valuation allowance as well as state taxes, permanent items, and discrete items. For the three and six months ended June 30, 2024, the Company recognized expense from income taxes of $20,590 and $43,354, respectively.

 

Note 10 – Commitments and Contingencies

 

Lease Obligations

 

The Company leases administrative, R&D, sales and marketing and manufacturing facilities under non-cancellable operating leases and leases cancellable with one month notice. The Company expenses the cancellable leases in the period incurred in accordance with the practical expedient elected.

 

The components of lease expense are summarized as follows:

 

   2025   2024   2025   2024 
   Three Months Ended June 30,   Six Months Ended June 30, 
   2025   2024   2025   2024 
Operating lease costs  $258,122   $252,646   $516,188   $503,841 
Short-term lease costs   -    12,250    -    37,789 
Total lease costs  $258,122   $264,896   $516,188   $541,630 

 

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As of June 30, 2025, the maturities of the Company’s lease liabilities are as follows:

 

   Years Ending December 31, 
2025 (remainder)  $511,287 
2026   714,630 
2027   300,591 
2028   308,462 
Total lease payments   1,834,970 
Less: imputed interest   131,254 
Present value of operating lease liabilities   1,703,716 
Less: current portion   824,458 
Long-term portion  $879,258 

 

Other information related to operating leases was as follows:

 

   Six Months Ended June 30, 2025 
Cash paid for operating leases included in operating cash flows  $518,191 
Remaining lease term of operating leases   2.5 
Discount rate of operating leases   6.2%

 

Litigation

 

Liabilities for loss contingencies arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. Legal costs incurred in connection with loss contingencies are expensed as incurred.

 

The Company is a defendant in one class action claim and four derivative actions claiming that the Company promulgated false and misleading press releases to increase the price of our stock to improperly benefit the officers and directors of the Company. The plaintiffs demand compensatory damages sustained as a result of the Company’s alleged wrongdoing in an amount to be proven at trial. The Company is also a party to three civil actions, two in the US and the other in the United Kingdom. Each of the civil actions is based on breach of contract claims against the Company. The Company believes these lawsuits are without merit and intends to defend the cases vigorously. The Company is unable to estimate a range of loss, if any, that could result were there to be an adverse final decision in these cases. As of the date of this report, the Company does not believe it is probable that these cases will result in an unfavorable outcome; however, if an unfavorable outcome were to occur in these cases, it is possible that the impact could be material to the Company’s results of operations in the period(s) in which any such outcome becomes probable and estimable.

 

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Note 11 – Share Repurchase Program

 

In March 2022, the Company’s Board of Directors authorized a share repurchase program that would allow the Company to repurchase up to $30.0 million of CODX common stock. The repurchase program does not obligate the Company to acquire any particular number of common shares, and the repurchase program may be suspended or discontinued at any time at the Company’s discretion. The timing and amount of any share repurchases under the share repurchase program will be determined by Co-Diagnostics’ management at its discretion based on ongoing assessments of the capital needs of the business, the market price of the Company’s common stock, corporate and regulatory requirements, and general market conditions.

 

For accounting purposes, common stock repurchased under the stock repurchase program is recorded based upon the transaction date of the applicable trade. Such repurchased shares are held in treasury and are presented using the cost method. These shares are not retired and are considered issued but not outstanding. No shares were repurchased during the three and six months ended June 30, 2025.

 

Note 12 – At-the-Market Agreement

 

The Company has entered into an Amended and Restated Equity Distribution Agreement (the “ATM Agreement”) with Piper Sandler & Co. (“Piper Sandler”) and Clear Street, LLC (“Clear Street”), pursuant to which it may offer and sell shares of its common stock having an aggregate offering price of up to $17,111,650 from time to time through Piper Sandler and Clear Street acting as agents, under the prospectus supplement dated October 18, 2024. As of June 30, 2025, the Company has sold 2,209,131 shares of common stock under the ATM Agreement resulting in net proceeds to the Company of $1,016,988. As of June 30, 2025, the Company has up to $16,063,209 remaining in aggregate gross proceeds that can be issued through the ATM Agreement.

 

Note 13 – Related Party Transactions

 

The Company has a services agreement with CoSara Diagnostics Pvt Ltd (“CoSara”), our joint venture for manufacturing in India, under which CoSara provides certain research and development consulting and support services. The Company recognized $182,364 and $422,467 of expense related to this agreement during the three and six months ended June 30, 2025, respectively, compared to $74,040 and $179,965 of expense during the three and six months ended June 30, 2024, respectively.

 

Note 14 – Subsequent Events

 

New United States tax legislation was signed into law on July 4, 2025. Income tax effects of changes in tax law or rates on deferred tax assets or liabilities are recognized at the date of enactment. The Company is still evaluating the impact of the changes included in this new legislation but does expect to realize material future benefits from certain aspects of the new law.

 

On July 10, 2025, the Company received notification from the NASDAQ Stock Market indicating that the Company will have an additional 180-day grace period, until January 5, 2026, to regain compliance with NASDAQ’s $1.00 minimum bid requirement. The notification indicated that the Company did not regain compliance during the initial 180-day grace period provided under the rule. In accordance with NASDAQ Marketplace Rule 5810(c)(3)(A), the Company is eligible for the additional grace period because it meets the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on the Nasdaq Capital Market with the exception of the bid price requirement, and provided written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Cautionary Note Regarding Forward-Looking Statements

 

This Quarterly Report on Form 10-Q contains “forward-looking statements” that involve risks and uncertainties. All statements other than statements of historical fact contained in this Quarterly Report and the documents incorporated by reference herein, including statements regarding future events, our future financial performance, business strategy, and plans and objectives of management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. These statements are only predictions and involve known and unknown risks, uncertainties and other factors and the documents incorporated by reference herein, which may affect our or our industry’s actual results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Moreover, we operate in a highly regulated, very competitive, and rapidly changing environment. New risks emerge from time to time, and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements.

 

These forward-looking statements are subject to certain risks and uncertainties that could cause our actual results to differ materially from those reflected in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in other documents we file with the SEC, including our Annual Report on form 10-K for the year ended December 31, 2024. The following discussion should be read in conjunction with the Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 27, 2025, and the audited financial statements and notes included therein.

 

As used in this Quarterly Report, the terms “we”, “us”, “our”, and “Co-Diagnostics” means Co-Diagnostics, Inc., a Utah corporation and its consolidated subsidiaries (the “Company”), unless otherwise indicated.

 

Executive Overview

 

The following management’s discussion and analysis of financial condition and results of operations describes the principal factors affecting the results of our operations, financial condition, and changes in financial condition. This discussion should be read in conjunction with the accompanying unaudited financial statements and notes thereto included elsewhere in this report. The information contained in this discussion is subject to a number of risks and uncertainties. We urge you to review carefully the section of this report entitled “Cautionary Note Regarding Forward-Looking Statements.

 

Business Overview

 

Co-Diagnostics, Inc., a Utah corporation (the “Company” or “CODX”), develops, manufactures and sells reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), including robust and innovative molecular tools for detection of infectious diseases. Our diagnostics systems enable dependable, low-cost, molecular testing for organisms and genetic diseases by automating or simplifying historically complex procedures in both the development and administration of tests. CODX’s technical advance involves a novel, proprietary approach to PCR test design of primer and probe structure (“Co-Primers®”) that dramatically reduces one of the key vexing issues of PCR amplification: the exponential growth of primer-dimer amplification (false positives) which adversely interferes with identification of the target DNA/RNA. Using our proprietary test design system and reagents, we have designed and obtained regulatory approval to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. These initial diagnostic tests are cleared for use in clinical labs only and not for point-of-care or at-home use.

 

We are currently developing a unique, groundbreaking portable diagnostic device and test system designed for point-of-care and at-home use. The system is comprised of our PCR instrument that we refer to as the Co-Dx™ PCR Pro™ instrument, our patent-pending diagnostic test cup system and a mobile application to be installed on the user’s mobile device. We refer to the system as the “Co-Dx™ PCR platform which has been designed to bring affordable, reliable polymerase chain reaction (“PCR”) testing to patients in point-of-care and at-home settings. The Co-Dx PCR platform is subject to U.S. Food and Drug Administration (“FDA”) review and is not available for sale at the time of this filing. In June 2024, we completed our first U.S. Food and Drug Administration (FDA) application for 510(k) clearance for the Co-Dx™ PCR Pro™ instrument, the Co-Dx PCR COVID-19 Test, and the Co-Dx PCR mobile app for over-the-counter (OTC) use. Following productive engagement with the FDA related to the regulatory submission, the Company withdrew its 510(k) application. The decision to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related to shelf-life stability. Following dialogue with the FDA and exploring the various courses of action available, we determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review process. The Company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, following the collection of clinical evaluation data to support the new test’s performance. A new submission also allows the Company to incorporate more recent Co-Dx PCR platform developments into the COVID-19 test, which Co-Dx believes will also help create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize the next generation of test kits and instruments across all tests on the at-home and point-of-care Co-Dx PCR platform. There is no guarantee that our Co-Dx PCR platform will receive the necessary regulatory approvals for commercialization, or that, if regulatory approval is received, we will be able to successfully commercialize this platform.

 

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Technology

 

We believe our proprietary and patented molecular diagnostics technology is paving the way for innovation in disease detection and life sciences research through our enhanced detection of genetic material. For various reasons, including owning our own platform, we believe we will be able to accomplish this faster and more economically than some competitors, allowing for significant margins while still positioning ourselves as a low-cost provider of molecular diagnostics and screening services. For example, we were the first US-based company to receive a CE-marking for a COVID-19 test in early 2020, as we worked to help slow the spread of the pandemic through our global network of distributors covering clinical labs in more than 50 countries. Our Logix Smart® COVID-19 test was designed, developed, submitted for regulatory approval and ready to be used as an in vitro diagnostic or IVD in countries that accept CE marking for regulatory clearance in a period of just over 30 days. This is a real-world example of how CODX technology can be used in an evolving epidemic or pandemic to get diagnostic tools in the hands of medical professionals in a timely manner. It can be similarly used to design a test for mutated strains of SARS-CoV-2 or other viruses should they not be detectable using currently available tests.

 

In addition, continued development has demonstrated the unique properties of our Co-Primers technology that we believe makes it ideally suited for a variety of applications where specificity is key to optimal results, including multiplexing several targets, enhanced Single Nucleotide Polymorphism (“SNP”) detection and enrichment for next generation sequencing.

 

Our scientists use the complex mathematics of DNA/RNA PCR test design to engineer and optimize PCR tests and to automate algorithms that rapidly screen millions of possible options to pinpoint the optimum design. The intellectual property we use in our business consists of the predictive mathematical algorithms and patented molecular structure used in the testing process, which together represent a major advance in PCR testing systems. CODX technologies are now protected by more than 20 granted or pending US and foreign patents, as well as certain trade secrets and copyrights. Ownership of our proprietary platform permits us the advantage of avoiding payment of patent royalties required by other PCR test systems, which may allow the sale of diagnostic PCR tests at a lower price than competitors, while enabling us to maintain profit margins.

 

Our proprietary test design process involves identifying the optimal locations on the target genes for amplification and pairing the locations with the optimized primer and probe structure to achieve outputs that meet the design input requirements identified from market research. This is done by following planned and documented processes, procedures and testing. In other words, we use the data resulting from our tests to verify whether we succeeded in designing what we intended. Verification involves a series of testing that concludes that the product is ready to proceed to validation in an evaluation either in our laboratory or in an independent laboratory setting using initial production tests to confirm that the product as designed meets the user needs.

 

Using our proprietary test design system and reagents, we have designed and obtained regulatory approval in the European Community and in India to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. In the United States, we obtained Emergency Use Authorization (“EUA”) for our Logix Smart® COVID-19 detection test from the FDA, and we sell that test to qualified labs. In addition, our COVID-19 detection test and certain of our other suite of COVID-19 products have been cleared for sale in countries such as the United Kingdom, Australia, India, and Mexico by the regulatory bodies in those countries and have been registered for sale in many more countries. In connection with the sale of our tests we may sell diagnostic equipment from other manufacturers, including an OEM’s PCR instrument which we refer to here as the “Co-Dx Box”.

 

In addition to testing for infectious disease, Co-Primers technology lends itself to identifying any section of a DNA or RNA strand that describes any type of genetic trait, which creates several significant applications. We, in conjunction with our customers, have designed and licensed tests that identify genetic traits in plant and animal genomes. We also have commercialized three multiplexed tests to test mosquitos for the presence of diseases they carry, which enables municipalities to concentrate their efforts in managing mosquito populations in specific areas where mosquitos carrying deadly viruses are known to breed.

 

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RESULTS OF OPERATIONS

 

The Three Months Ended June 30, 2025 Compared to the Three Months ended June 30, 2024

 

Revenues

 

For the three months ended June 30, 2025, we generated revenues of $0.2 million, compared to revenues of $2.7 million for the three months ended June 30, 2024. The decrease in revenue was due to lower grant revenues recognized in the current period.

 

Cost of Revenues

 

We recorded cost of revenues of approximately $.03 million for the three months ended June 30, 2025, compared to $0.2 million for the three months ended June 30, 2024. Included within cost of revenues is a decrease of approximately $0.1 million for the three months ended June 30, 2025, and an increase of approximately $.02 million for the three months ended June 30, 2024, related to reserves against certain raw materials and finished goods inventories.

 

Expenses

 

Total operating expenses were $8.2 million for the three months ended June 30, 2025 compared to total operating expenses of $10.1 million for the three months ended June 30, 2024. The decrease in operating expenses was primarily due to decreased stock-based compensation expense, personnel related expenses, and expense related to development of the Co-Dx PCR platform.

 

Sales and marketing expenses for the three months ended June 30, 2025 were $0.6 million compared to $1.0 million for the three months ended June 30, 2024. The decrease was primarily a result of decreased stock-based compensation expense, consulting and professional services expenses, and personnel related expenses.

 

General and administrative expenses for the three months ended June 30, 2025 were $2.6 million compared to $3.1 million for the three months ended June 30, 2024. The decrease resulted primarily from lower stock-based compensation expense.

 

Research and development expenses for the three months ended June 30, 2025 were $4.7 million compared to $5.6 million for the three months ended June 30, 2024. The decrease was primarily a result of decreased expenses related to development of the Co-Dx PCR platform, personnel related expenses, and stock-based compensation expense, partially offset by increases in professional services expense.

 

Other Income

 

Other income was $0.3 million for the three months ended June 30, 2025, compared to other income of $0.1 million for the three months ended June 30, 2024. Decreases in interest income were offset by increases in realized gains from investments in marketable securities and the change in the fair value of contingent consideration liabilities.

 

Net Loss

 

We realized a net loss for the three months ended June 30, 2025 of $7.7 million, compared to $7.6 million for the three months ended June 30, 2024. The larger net loss was primarily the result of decreased grant revenues, partially offset by lower operating expenses.

 

The Six Months Ended June 30, 2025 Compared to the Six Months ended June 30, 2024

 

Revenues

 

For the six months ended June 30, 2025, we generated revenues of $0.2 million, compared to revenues of $3.1 million for the six months ended June 30, 2024. The decrease in revenue was due to lower product and grant revenues recognized in the current period.

 

Cost of Revenues

 

We recorded cost of revenues of approximately $0.1 million for the six months ended June 30, 2025, compared to $0.4 million for the six months ended June 30, 2024. Included within cost of revenues is a decrease of approximately $0.1 million for the six months ended June 30, 2025, and a decrease of approximately $0.3 million for the six months ended June 30, 2024, related to reserves against certain raw materials and finished goods inventories.

 

Expenses

 

Total operating expenses were $16.8 million for the six months ended June 30, 2025 compared to total operating expenses of $20.6 million for the six months ended June 30, 2024. The decrease in operating expenses was primarily due to decreased stock-based compensation expense, personnel related expenses, tradeshow and travel expense, and expense related to development of the Co-Dx PCR platform. These decreases were partially offset by increased legal expenses.

 

Sales and marketing expenses for the six months ended June 30, 2025 were $1.3 million compared to $2.6 million for the six months ended June 30, 2024. The decrease was primarily a result of decreased stock-based compensation expense, tradeshow and travel expenses, consulting and professional services expenses, and personnel related expenses.

 

General and administrative expenses for the six months ended June 30, 2025 were $5.4 million compared to $6.1 million for the six months ended June 30, 2024. Decreases in stock-based compensation expense and consulting and professional services expense were partially offset by increased legal expenses.

 

Research and development expenses for the six months ended June 30, 2025 were $9.6 million compared to $11.3 million for the six months ended June 30, 2024. The decrease was primarily a result of decreased expenses related to development of the Co-Dx PCR platform, personnel related expenses, and stock-based compensation expense, partially offset by increases in professional services expense.

 

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Other Income

 

Other income was $1.4 million for the six months ended June 30, 2025, compared to other income of $1.1 million for the six months ended June 30, 2024. Decreases in interest income were offset by increases in realized gains from investments in marketable securities and increases in the change in the fair value of contingent consideration liabilities.

 

Net Loss

 

We realized a net loss for the six months ended June 30, 2025 of $15.3 million, compared to $16.9 million for the six months ended June 30, 2024. The smaller net loss was primarily the result of decreases in operating expenses.

 

Liquidity and Capital Resources

 

At June 30, 2025, we had cash and cash equivalents of $11.1 million and marketable investment securities of $2.2 million. We consider our marketable investment securities an important part of our liquidity and focus such investments in securities that can readily be converted into cash if needed. Additionally, our total current assets at June 30, 2025, were $15.3 million compared to total current liabilities of $3.7 million.

 

Net cash used in operating activities during the six months ended June 30, 2025 was $17.0 million, compared to $13.7 million for the six months ended June 30, 2024. The increase in cash used in operating activities was primarily due to a higher usage of cash to pay accounts payable and accrued liabilities related to higher legal expenses, along with decreases in revenue, grant funding, net interest income, and realized gains on investments.

 

Net cash provided by investing activities was $24.4 million for the six months ended June 30, 2025, compared to $12.6 million during the six months ended June 30, 2024. The increase in cash provided by investing activities is primarily due to the timing of the redemption of certain investments as they matured.

 

Net cash provided by financing activities was $0.8 million for the six months ended June 30, 2025, compared to $0 for the six months ended June 30, 2024. The cash provided by financing activities during 2025 relates to issuances of common stock under the ATM.

 

Since commencing sales of our Logix Smart COVID-19 test in March 2020, we have used our cash generated from those sales to fund the purchase of inventories and the development of our Co-Dx PCR Platform, and to pay our operating expenses.

 

Our available capital resources may be consumed more rapidly than currently expected and we may need or want to raise additional financing for strategic opportunities. It is anticipated that the Company will continue to generate operating losses and use cash in operations in the near term. If needed, we expect additional investment capital to come from additional issuances of our common stock or other equity-based securities with existing and new investors similar to those that have provided funding in the past or debt financing. We have entered into an Amended and Restated Equity Distribution Agreement (the “ATM Agreement”) with Piper Sandler & Co. (“Piper Sandler”) and Clear Street, LLC (“Clear Street”), pursuant to which we may offer and sell shares of our common stock having an aggregate offering price of up to $17,111,650 from time to time through Piper Sandler and Clear Street acting as our agents, under our prospectus supplement dated October 18, 2024. As of June 30, 2025, we have sold 2,209,131 shares of common stock under the ATM Agreement resulting in net proceeds to the Company of $1.0 million.

 

Although we are seeking to obtain additional equity and/or debt financing, such funding is not assured and may not be available to us on favorable or acceptable terms and may involve significant restrictive covenants. Any additional equity financing, if available to us at all, will most likely be dilutive to our current stockholders. If we are not able to obtain additional debt or equity financing on a timely basis, the impact on us will be material and adverse. These uncertainties create substantial doubt about our ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.

 

Off-Balance Sheet Arrangements

 

We have no off-balance sheet arrangements.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

Not required under Regulation S-K for “smaller reporting companies.”

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

We maintain “disclosure controls and procedures,” as defined in Rules 13a-15I and 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2025. Based on the evaluation of our disclosure controls and procedures as of June 30, 2025, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective.

 

Changes in Internal Control over Financial Reporting

 

There have been no changes in our internal control over financial reporting during the three months ended June 30, 2025, that have materially affected or, are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings

 

There have been no material developments to the legal proceedings previously disclosed under Part I. Item 3 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

 

Item 1A. Risk Factors.

 

Not required under Regulation S-K for “smaller reporting companies.”

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

Effective June 16, 2025, the Company entered into an Advisory Services Agreement pursuant to which the Company agreed to issue 500,000 shares of its common stock to the advisor who will provide general financial advisory and investment banking services to the Company. The shares were offered and sold in a private placement pursuant to exemptions from registration available under Section 4(a)(2) of the Securities Act of 1933, as amended.

 

Dividends

 

We have never declared or paid any cash dividends on our capital stock. The payment of dividends on our common stock in the future will depend on our earnings, capital requirements, operating and financial condition and such other factors as our board of directors may consider appropriate. We currently expect to use all available funds to finance the future development and expansion of our business and do not anticipate paying dividends on our common stock in the foreseeable future.

 

Pursuant to Section 16-10a-640 of the Utah Revised Business Corporation Act, no distribution may be made if, after giving it effect:

 

  (a) the corporation would not be able to pay its debts as they become due in the usual course of business; or
     
  (b) the corporation’s total assets would be less than the sum of its total liabilities plus, unless the articles of incorporation permit otherwise, the amount that would be needed, if the corporation were to be dissolved at the time of the distribution, to satisfy the preferential rights upon dissolution of shareholders whose preferential rights are superior to those receiving the distribution.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

None.

 

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Item 6. Exhibits

 

Exhibit Index

 

(a) Exhibits

 

Exhibit   Number Description
10.1**   Amended and Restated Equity Distribution Agreement, dated as of April 25, 2025, by and among Co-Diagnostics, Inc., Piper Sandler & Co., and Clear Street LLC.
31.1*   Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*   Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1*   Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2*   Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS   Inline XBRL Instance Document
101.SCH   Inline XBRL Taxonomy Extension Schema Document
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document
104   Cover Page Interactive Data File

 

* Filed herewith.

**Incorporated herein by reference to Exhibit 10.1 of Form 8-K, filed April 28, 2025, File No. 001-38148.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  CO-DIAGNOSTICS, INC.
     
Date: August 14, 2025 By: /s/ Dwight H. Egan
  Name: Dwight H. Egan
  Title: Chief Executive Officer and Principal Executive Officer
     
Date: August 14, 2025 By: /s/ Brian Brown
  Name: Brian Brown
  Title: Chief Financial Officer and Principal Financial and Accounting Officer

 

25

 

FAQ

What was Co-Diagnostics (CODX) cash flow change in the quarter?

The company reported a $8,178,637 net increase in cash and cash equivalents for the period presented.

Did CODX receive grant funding in 2025?

No. The company reported no grant funding during the three- and six-month periods ended June 30, 2025, compared with $2,495,738 and $2,710,847 in the prior-year periods.

How concentrated is CODX revenue and receivables?

Three customers accounted for approximately 53% of product revenue in the three months ended June 30, 2025; two customers represented ~82% of accounts receivable at June 30, 2025.

What equity financing did CODX complete in the period?

Under its ATM agreement, CODX sold 2,209,131 shares and received net proceeds of $1,016,988 as of June 30, 2025.

What is CODX's reported loss per share?

Reported basic and diluted loss per share were $(0.23) and $(0.25) for the comparable three-month periods, and $(0.47) and $(0.56) for the six-month comparatives.
Co-Diagnostics Inc

NASDAQ:CODX

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CODX Stock Data

8.55M
30.68M
9%
17.49%
2.5%
Medical Devices
Surgical & Medical Instruments & Apparatus
United States
SALT LAKE CITY