Co-Diagnostics' Q3 2025: Contradictions Emerge on CoMira/CoSara Financials, Market Priorities, India-Africa Markets, PCR Pro Pricing, and CoSara's Strategic Outlook

Date of Call: November 13, 2025

Financials Results

• Revenue: $0.1M in Q3 2025, down from $0.6M in Q3 2024 (prior period included ~$0.4M in grants); Q3 2025 revenue all from product sales
• EPS: Net loss $5.9M, or $0.16 loss per fully diluted share, improved from a $9.7M loss or $0.32 loss per fully diluted share in Q3 2024

Guidance:

• Multiple commercial launches expected in 2026.
• Initiating clinical evaluations now (upper respiratory multiplex; MTB and HPV on track to start before year-end) to support regulatory submissions (U.S. FDA and SFDA).
• Pursuing a CoSara SPAC transaction to raise growth capital; updates expected in coming weeks/months.
• Managing capital via equity/debt, grant funding and operational efficiencies; cash position $11.4M.

Business Commentary:

* Strategic Growth Initiatives: - Co-Diagnostics announced several strategic initiatives, including a potential SPAC transaction for CoSara Diagnostics and the formation of CoMira Diagnostics with Arabian Eagle. - These initiatives aim to unlock value from international joint ventures, expand market reach, and drive innovation through AI integration.

• Financial Performance and Cash Position:
• Total revenue for Q3 2025 was $0.1 million, down from $0.6 million in the same period last year.

• Despite the decrease in revenue, the company ended the quarter with $11.4 million in cash, cash equivalents, and marketable securities, indicating a focus on maintaining financial stability.

• Operational Efficiency and Cost Management:

• Total operating expenses decreased to $7.1 million in Q3 2025, down from $10.6 million in Q3 2024.

• This reduction reflects a focus on operational efficiency and cost savings, with a continued emphasis on managing spending to maintain a healthy balance sheet.

• Upper Respiratory Multiplex Test and Clinical Evaluations:

• Co-Diagnostics is initiating clinical evaluations for its upper respiratory multiplex test, which is designed to simultaneously detect flu A, flu B, COVID-19, and RSV.
• This test has the potential to address a critical need in the domestic market and support future regulatory submissions and commercial readiness.

Sentiment Analysis:

Overall Tone: Positive

• CEO: "one of the most active and important times for our business"; "key inflection point...execution is on track". CFO: reduced operating expenses ($7.1M vs $10.6M prior), improved adjusted EBITDA loss ($6.3M vs $8.8M) and cash $11.4M, supporting a constructive outlook.

Q&A:

• Question from Katherine Degen (H.C. Wainwright): For CoSara, are they meeting your performance expectations? And if not, what's causing that discrepancy? And how do you kind of expect CoMira to perform financially in comparison?
  Response: Both CoSara and CoMira are meeting expectations: CoSara is a mature, 8-year operation with local manufacturing and broad market coverage in India; CoMira is newly formed with strong Saudi partners and is expected to perform well given Saudi Arabia's status as the largest international customer.

• Question from Michael Okunewitch (Maxim Group LLC): How might a potential spinout of CoSara interact with the MTB and HPV point-of-care programs—would they be licensed or distributed by CoSara given the large market in India?
  Response: CoSara is expected to play a central role in deploying MTB and HPV solutions in India to replace smear microscopy with accessible molecular diagnostics; structural details (licensing/distribution) are being evaluated and no definitive arrangements have been announced.

• Question from Michael Okunewitch (Maxim Group LLC): How are you able to reach a much more affordable price point for the PCR Pro—does Co-Primers or device complexity drive that advantage?
  Response: Affordability stems from purpose-built engineering and design to achieve a $300–$500 target at scale; Co-Primers enable superior multiplexing and reduce primer-dimers, but the primary cost advantage is the device's engineered low-cost architecture.

• Question from Michael Okunewitch (Maxim Group LLC): For the CoMira JV in Saudi Arabia and the Middle East, which products from the PCR Pro pipeline are most relevant to that market?
  Response: Multiple pipeline products are relevant—especially the upper respiratory multiplex (flu A/B, COVID-19, RSV)—and also TB and HPV; the full pipeline is expected to address regional infectious-disease needs.

Contradiction Point 1

CoMira and CoSara Financial Performance Expectations

It involves differing expectations regarding the financial performance of CoMira and CoSara, which are critical for understanding the company's strategic direction and financial outlook.

Is CoSara meeting performance expectations, and if not, what's causing the discrepancy? How do you expect CoMira to perform compared to CoSara? - [Katherine Degen](H.C. Wainwright)

2025Q3: CoMira, as a new entity, is expected to perform well due to its strategic partnerships and alignment with global market demands. - [Dwight Egan](CEO)

Can you repeat your expected timeline for the specific tests and provide an update on the cadence of progress? - [Antonio Eduardo Arce](H.C. Wainwright)

2025Q2: With the CoMira joint venture in Saudi Arabia, we would like to leverage that distribution to go into the Middle East and that Agreement is still under negotiation. - [Dwight H. Egan](CEO)

Contradiction Point 2

Market Focus and Priority of Diagnostic Tests

It highlights a shift in market focus and the priority of diagnostic tests, which could impact resource allocation and strategic direction.

Which PCR Pro products are most relevant for the CoMira JV in Saudi Arabia and the Middle East? - [Michael Okunewitch](Maxim Group LLC)

2025Q3: All of the current pipeline is relevant to the CoMira market, including upper respiratory and other tests, aligning with market needs and demand. - [Dwight Egan](CEO)

Will you prioritize TB and multiplex due to their urgent global and domestic demand? - [Antonio Eduardo Arce](H.C. Wainwright)

2025Q2: There is a solid need for all 4 panels. COVID is still a vibrant market, including in the U.S. The COVID-19 test and the multiplex ABCR test will be prioritized for FDA 510(k) applications. - [Dwight H. Egan](CEO)

Contradiction Point 3

India and Africa as Major Markets

It involves differing expectations about the potential significance of India and Africa as markets for Co-Diagnostics' products, which are crucial for strategic planning and revenue expectations.

How would a CoSara spinout affect the MTB and HPV point-of-care programs? Could India and Africa be significant markets? - [Michael Okunewitch](Maxim Group LLC)

2025Q3: Tuberculosis and human papillomavirus are significant problems in India and Africa, and Co-Diagnostics' solution can address these issues effectively. - [Dwight Egan](CEO)

What is the timeline for launching the multiplex ABCR, HPV, and TB tests in India and South Africa, and what is the regulatory process? - [Unidentified Analyst](H.C. Wainwright)

2025Q1: The effort to take our products into those markets is ongoing, and we're going to take our time to do it right. We'll be kind of more aggressive in India in the short-term to get the right partners. - [Dwight Egan](CEO)

Contradiction Point 4

PCR Pro Pricing Strategy and Pricing Target

It involves the pricing strategy and target for the PCR Pro, which directly impacts the company's revenue and competitive positioning.

How does the PCR Pro achieve a lower price point than competitors, and is it because Co-Primers enable a simpler design? - [Michael Okunewitch](Maxim Group LLC)

2025Q3: The pricing strategy for the PCR Pro was set at the outset to produce a product at a scale of about $300 to $500. - [Dwight Egan](CEO)

Can you provide details on pricing and gross margins for the device and test cups? - [Unidentified Analyst](H.C. Wainwright)

2025Q1: The target price for the instrument is in the range of $300 to $500. Pricing for test cartridges varies by geography, with a range of $15 to $20 in developed countries and lower in low and middle-income countries for certain diseases like tuberculosis. - [Dwight Egan](CEO)

Contradiction Point 5

CoSara's Performance and Market Strategy

This contradiction involves differing perspectives on CoSara's performance and its strategic relevance, which could impact investor expectations and market positioning.

Is CoSara meeting performance expectations? If not, what's causing the discrepancy? How does CoMira's financial performance compare? - [Katherine Degen](H.C. Wainwright)

2025Q3: CoSara has a solid footprint in India with significant manufacturing operations and is well-respected in the country. Co-Diagnostics is pleased with CoSara's development and expects mutual benefit from the upcoming transaction. - [Dwight Egan](CEO)

Are you interested in or open to developing an avian flu test for birds or humans? - [Unidentified Analyst](H.C. Wainwright)

2024Q4: We have developed a H5N1 test, and we are very prepared to make additions to that type of test, should the need arise. Our ambition would be that it would have use both for humans, and for livestock and birds. - [Dwight Egan](CEO)