Co-Diagnostics' CoSara Maturity, CoMira Formation, and Covid Trial Timelines Clash in 2025 Q4 Earnings Call

Date of Call: Mar 31, 2026

Financials Results

• Revenue: $0.6 million for full year 2025, compared to $3.9 million in 2024 (year-over-year decrease primarily driven by lower grant revenue)
• EPS: Net loss of $35.25 per share for full year 2025, compared to a net loss of $37.22 per share in 2024

Guidance:

• Expect to continue generating operating losses in the near term.
• Focus on advancing clinical pipeline, achieving regulatory milestones, and positioning for future revenue growth.
• Continue evaluating financing alternatives (equity, debt, strategic partnerships) and securing non-dilutive funding.
• Disciplined capital allocation as company advances toward key inflection points like clinical submissions and commercialization milestones.

Business Commentary:

Financial Performance and Strategic Focus:

• Co-Diagnostics reported a significant year-over-year decrease in total revenue, from $3.9 million in 2024 to $0.6 million in 2025.
• The decline was primarily driven by lower grant revenue, as most of the previously awarded grant funding was recognized in the prior year.

Clinical Pipeline and Regulatory Strategy:

• Clinical evaluations for the upper respiratory multiplex test are progressing, with plans to pursue an initial regulatory submission focusing on Flu A, Flu B, and RSV.
• The decision to exclude COVID-19 from the initial submission was due to limited availability of COVID-positive samples during the clinical trial period.

International Expansion and Manufacturing:

• CoSara has expanded its commercial and distribution territory across South Asia, increasing the addressable market to approximately 13 billion.
• The expansion aligns with the strategic goal of leveraging the mature CoSara joint venture to cover the broader South Asian market, enhancing long-term growth opportunities.

Intellectual Property and Platform Advancement:

• Co-Diagnostics has received international patents covering key components of the Kodiak PCR platform, including recent grants in Australia and Japan.
• These patents are crucial for securing the company's competitive positioning and supporting the long-term strategy of building a globally deployable diagnostics platform.

Sentiment Analysis:

Overall Tone: Positive

• CEO states: 'This continues to be one of the most active and strategically important periods in our company’s history... These efforts are not isolated. They represent cumulative progress with each initiative contributing to a broader integrated strategy designed to create long-term shareholder value.' CFO notes: 'We are entering the next phase of growth with a strong foundation, expanding opportunities, and a clear path toward commercialization.'

Q&A:

• Question from Katie Chen (H.C. Wainwright): Looking at your now three target tests, dropping COVID seems like a great idea. Where does the sample accrual stand for the three target panel? Is first half of 2026 still the target? How quickly could you add COVID back if for some reason conditions change and it makes sense to add it back?
  Response: The decision to exclude COVID was due to its limited availability in the powered clinical trial across eight U.S. locations; the company plans a submission for flu A, B, and RSV. Adding COVID back later would not require redesign or re-engineering; it would involve FDA negotiation on sample requirements and is not viewed as onerous.

• Question from Michael Okunewitch (Maxim Group): I wanted to see if you could talk a little bit about the South Asia distribution expansion to the other countries like Nepal, Pakistan and Bangladesh. Is this more for supporting the existing commercial tests, or would this be to expand the opportunity for PCR Pro, particularly on TB?
  Response: The expansion increases the total addressable market from $11B to $13B by adding countries with similar disease burdens; it is a strategic geographical move managed through the mature CoSara joint venture.

• Question from Michael Okunewitch (Maxim Group): For the U.S. FDA study in particular, can you just comment on how many samples you’re expecting to need to support that study?
  Response: The clinical trial involves more than 1,200 enrolled patients. The company is waiting to add COVID to the submission until sufficient positive samples are available, as they did not show up during the initial trial period.

• Question from Michael Okunewitch (Maxim Group): I saw that you’ve gained the clearance to sell the PCR Pro device now in India. You started shipping devices over there. Could you talk about what are the immediate next steps and timelines for getting that study up and running and then moving on to commercialization?
  Response: Technology transfer and training are underway in India while manufacturing continues in Utah. The company expects to begin clinical trials quickly and anticipates commercialization of TB tests in India by the third quarter of 2026.

Contradiction Point 1

CoSara Joint Venture's Strategic Role and Maturity

Contradiction on whether CoSara is a mature, established entity or a new venture being discussed for potential transaction.

Michael Okunewitch (Maxim Group) - Michael Okunewitch (Maxim Group)

2025Q4: The expansion is a **geographic and economic strategy** to increase the total addressable market from ~$11 billion to ~$13 billion by leveraging the **mature CoSara joint venture's existing infrastructure**. - Dwight Egan(CEO)

How does CoSara's expansion into Nepal, Pakistan, and Bangladesh aim to support existing tests versus expanding the PCR Pro opportunity (e.g., for TB), and how does the disease burden in these countries compare to India? - Katherine Degen (H.C. Wainwright)

20251114-2025 Q3: CoSara has been operating for about 8 years with a solid footprint... The company is enthusiastic about the prospects of both and believes a transaction could mutually benefit both entities. - Dwight Egan(CEO)

Contradiction Point 2

CoMira Joint Venture's Formation Status

Contradiction on whether CoMira is a newly formed entity or has an established, long-term partnership.

Michael Okunewitch (Maxim Group) - Michael Okunewitch (Maxim Group)

2025Q4: The entire pipeline is relevant... which addresses a major infectious disease problem, in addition to TB and HPV. - Dwight Egan(CEO)

How many samples are expected to support the U.S. FDA study? - Katherine Degen (H.C. Wainwright)

20251114-2025 Q3: CoMira is newly formed and built on a strong existing partnership with the primary distributor in Saudi Arabia... - Dwight Egan(CEO)

Contradiction Point 3

Clinical Trial Timeline for COVID-19 Test

Timing for COVID-19 clinical trial completion and FDA submission appears inconsistent.

Michael Okunewitch (Maxim Group) - Michael Okunewitch (Maxim Group)

2025Q4: The company is nearing the conclusion of this study and is preparing for the analytical studies and FDA submission. - Dwight Egan(CEO)

How many samples are expected to support the U.S. FDA study? - Antonio Eduardo Arce (H.C. Wainwright)

2025Q2: Clinical trials for all four tests... are expected to begin in the remainder of 2025. The anticipated order is: 1) COVID-19 test (clinical trial imminent)... - Dwight Egan(CEO)

Contradiction Point 4

Timeline for COVID Test Resubmission and Clinical Trial

Contradictory statements on when clinical trials for the COVID test can begin.

Katie Chen (H.C. Wainwright) - Katie Chen (H.C. Wainwright)

2025Q4: The decision to exclude COVID from the initial submission was due to an unexpected lack of COVID-positive samples during the multi-month clinical trial... Adding COVID back would involve a negotiation with the FDA to determine required sample numbers and demographics. - Dwight Egan(CEO)

What is the current sample accrual status for the three-target panel (Flu A, Flu B, RSV), is the first half of 2026 still the target, and how quickly could COVID be added back if conditions change? - Eduardo (H.C. Wainwright)

2025Q1: The timing of clinical trial commencement depends on the prevalence of COVID-19, as the company needs sufficient cases for an effective trial. - Dwight Egan(CEO)

Contradiction Point 5

Status of Clinical Trial Planning for Upper Respiratory Panel

Contradictory descriptions of the status of clinical trial preparations for the Flu A, Flu B, RSV panel.

Michael Okunewitch (Maxim Group) - Michael Okunewitch (Maxim Group)

2025Q4: The company chose to proceed with the available data... The company is nearing the conclusion of this study and is preparing for the analytical studies and FDA submission. - Dwight Egan(CEO)

For the U.S. FDA study, how many samples are expected to support it? - Eduardo (H.C. Wainwright)

2025Q1: Plans are to initiate clinical trials for the 4-plex respiratory panel (ABCR test) during the remainder of 2025. The timing of trials for these tests is not constrained by the availability of clinical samples... - Dwight Egan(CEO)