Co-Diagnostics outlines clinical trial timeline and targets mid-2026 commercialization for PCR platform

Earnings Call Insights: Co-Diagnostics, Inc. (CODX) Q2 2025

Management View

• CEO Dwight H. Egan reported continued progress on the Co-DX PCR point-of-care platform, stating, “We remain on track to initiate clinical evaluations for all tests in our pipeline during 2025.” Egan highlighted imminent clinical evaluations for the COVID-19 test and noted additional pipeline tests including a 4-plex respiratory panel, tuberculosis (TB), and an HPV 8-type multiplex panel. According to Egan, “Our focus remains on bringing the Co-DX PCR platform to the point-of-care market which has included incorporating ongoing advancements developed by our scientific engineering and software development teams as we prepare for our upcoming regulatory submissions in the appropriate jurisdictions for each indication.”
• Egan emphasized TB as a major opportunity, mentioning, “The company remains on track to begin clinical evaluations for our TB test in both India and South Africa before the end of 2025, which will gather data to support regulatory submissions to the South Africa Health Products Regulatory Agency, or SAHPRA, and the Central Drugs Standard Control Organization, or CDSCO in India.”
• Expansion plans include scaling manufacturing domestically and in India. Egan stated, “Principal manufacturing for tests and instruments will take place in our domestic manufacturing facility in South Salt Lake, inaugurated a little over a year ago, before being completed in the upgraded CoSara manufacturing campus prior to distribution and commercialization in India.”
• CFO Brian L. Brown said, “For the second quarter of 2025, total revenue decreased to $0.2 million as compared to $2.7 million in the prior year same period. In the prior year same period, revenue from grants represented $2.5 million, while all revenue recognized during the second quarter of 2025 came from product sales.”
• Brown added, “Total operating expenses for the second quarter of 2025 decreased to $8.2 million from $10.1 million in the second quarter of 2024. Net loss for the second quarter of 2025 was $7.7 million or a loss of $0.23 per fully diluted share compared to a net loss of $7.6 million or a loss of $0.25 per fully diluted share in the prior year comparable period.”

Outlook

• Egan indicated all four indications—COVID-19, multiplex flu A/B, COVID-19 and RSV test, TB, and HPV—are expected to enter clinical trials during the remainder of 2025. “We anticipate to begin with the COVID-19 test which has already begun its site visits and training prior to putting customers through the trial or applicants through the trial. We believe that the next test up will be our ABCR or multiplex flu A/B over, COVID and RSV test. And probably the next one after that will be our tuberculosis test followed by HPV.”
• Regarding commercialization, Egan said, “We plan to do that as soon as we have a clearance from the FDA in the case of COVID-19… I would think that we’ll be wrapping that up because we’re imminently beginning the clinical trial in COVID. I believe we’ll be wrapping that up near year-end and that sometime in that—by the end of the second quarter, we have a reasonable possibility of having it cleared through the FDA.”
• The company targets commercialization in the U.S. through physician offices, clinics, skilled nursing facilities, and pharmacies, and in India through primary health care centers.

Financial Results

• Brown reported, “Total revenue decreased to $0.2 million as compared to $2.7 million in the prior year same period.” The company recognized all revenue for the quarter from product sales. Operating expenses fell to $8.2 million. Research and development expenses were $4.7 million. Net loss for the quarter was $7.7 million, or ($0.23) per share. EBITDA loss was $7.2 million. Cash, equivalents, and marketable investment securities at quarter end totaled $13.4 million.
• Brown said, “We plan to provide for the company’s capital requirements through equity and/or debt financing, additional grant funding and operational efficiencies. More specifically, we are using our ATM to generate capital when appropriate.”

Q&A

• Antonio Eduardo Arce, H.C. Wainwright: “I was hoping if you could just kind of repeat your expected time line… which one you expect to have earlier completion of those trials and then the consequent 510(k) applications.” Egan responded, “We expect all of those indications to be into clinical trials during the remainder of this calendar year. We anticipate to begin with the COVID-19 test… the next test up will be our ABCR… probably the next one after that will be our tuberculosis test followed by HPV.”
• Arce: “Are you going to prioritize them in that order as they finish as well?” Egan noted, “We believe that there is a solid need for all 4 of those panels… COVID still is a vibrant market, including in the U.S., and we’re seeking FDA approval for a 510(k) application for both the COVID-19 test and for the multiplex ABCR test.”
• Arce: “Do you have some visibility towards commercial launch… how you plan your marketing strategy…?” Egan outlined U.S. target markets as physician offices, clinics, skilled nursing facilities, pharmacies, and home use, and in India, primary health care centers.
• Arce: “Would this be commercial launch potentially end of 2026, early 2027?” Egan replied, “I hope we have the commercialization before the end of 2026… by the end of the second quarter, we have a reasonable possibility of having it cleared through the FDA.”

Sentiment Analysis

• Analysts asked detailed and forward-focused questions regarding product timelines, regulatory strategy, and commercialization, indicating a neutral to slightly positive tone, with a focus on clarifying sequencing and market strategy.
• Management maintained a confident and optimistic tone, with Egan stating, “We believe the Co-DX PCR platform can revolutionize and set a new bar for the affordability, accessibility, decentralization, accurate gold standard PCR infectious disease testing.”
• Compared to the previous quarter, management’s tone remained steady and forward-looking, reaffirming timelines and progress, while analysts continued to probe for specifics on timing and market entry.

Quarter-over-Quarter Comparison

• Management reiterated and clarified clinical trial sequencing, with more specific projections for clinical trial start dates and commercialization timelines this quarter. The previous quarter focused on platform development and regulatory preparation, while the current quarter provided greater detail on planned trial initiation and expected regulatory submissions.
• Financial results showed an increase in revenue compared to the previous quarter ($0.2 million vs. $0.1 million) and a reduction in operating expenses. Cash reserves decreased from $21.5 million to $13.4 million.
• Analysts’ focus shifted slightly from technical and regulatory details to specific timing and prioritization for clinical trials and market entry.
• Management’s confidence in achieving regulatory and commercial milestones remained consistent, but with a stronger emphasis on imminent trial activity and a more defined commercialization timeline.

Risks and Concerns

• Management acknowledged dependency on regulatory clearance for commercialization, particularly FDA 510(k) submission and approval timelines for the COVID-19 and multiplex respiratory tests.
• Egan cited the need for sufficient clinical trial participants with active disease as a gating factor for trial completion, especially for COVID-19.
• Brown outlined plans to secure additional capital via debt, equity, and grants to support ongoing operations and commercialization.
• Analyst questions highlighted potential variability in trial timelines and the impact of disease prevalence on enrollment speed.

Final Takeaway

Co-Diagnostics management underscored steady progress toward key clinical evaluations for its PCR platform, projecting the start of all four major trials in 2025 and targeting commercialization as early as mid-2026, contingent on regulatory approvals. The company remains focused on operational efficiency and capital management while preparing for an expansion into both U.S. and international markets through strategic manufacturing and distribution plans. The call detailed a clear sequencing of clinical milestones and reinforced confidence in the platform’s disruptive potential for infectious disease diagnostics.

Read the full Earnings Call Transcript

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