Co-Diagnostics' Q3 2025 Earnings Call: Contradictions Emerge on CoMira/CoSara Performance, MTB/HPV Programs, Clinical Trials, PCR Pro Pricing, and FDA Resubmission Timelines

Date of Call: October 30, 2025

Financials Results

• Revenue: $0.1M in Q3 2025, down from $0.6M in Q3 2024 (prior year included ~$0.4M in grants); Q3 2025 revenue comprised entirely of product sales
• EPS: Net loss $5.9M, -$0.16 per diluted share in Q3 2025 versus a $9.7M loss, -$0.32 per diluted share in Q3 2024

Guidance:

• Multiple commercial launches expected in 2026, company is optimistic about near-term commercialization.
• Initiating and completing clinical evaluations (upper respiratory multiplex, MTB, HPV) to support future regulatory submissions in the U.S. and SFDA.
• Planning to meet capital needs via equity and debt financing, additional grant funding, and strategic transactions (e.g., CoSara SPAC).
• Continue operating efficiencies and cost optimization; Q3 cash and equivalents and marketable securities totaled $11.4M.

Business Commentary:

* Financial Performance and Operational Efficiency: - Co-Diagnostics reported $0.1 million in revenue for Q3 2025, compared to $0.6 million in the same period last year, with all revenue recognized from product sales. - The decline in revenue was due to a decrease in grant-funded revenue and a focus on operational efficiency, as research and development expenses also decreased to $4.5 million compared to $4.9 million in the prior year.

• SPAC Transaction and Indian Joint Venture:
• Co-Diagnostics engaged Maxim Group to explore strategic alternatives for its Indian joint venture, CoSara Diagnostics, which may include a merger with a SPAC.

• The transaction aims to unlock value from the joint venture and support Co-Diagnostics' long-term funding strategy, with the expectation that it will provide financial stability as they Commercialize new platforms.

• Global Expansion and Partnerships:

• The company established a joint venture with Arabian Eagle Manufacturing, forming CoMira Diagnostics in the Middle East and North Africa.
  

• This partnership aims to localize the Co-Dx PCR platform and expand Co-Diagnostics' global presence, aligning with Saudi Vision 2030 and supporting technology localization and regional healthcare innovation.

• Clinical Evaluations and Product Pipeline:

• Co-Diagnostics plans to initiate clinical evaluations for its upper respiratory multiplex test, designed to detect flu A, B, COVID-19, and RSV.
• The clinical evaluations are supported by a RADx Tech grant from the National Institutes of Health and represent a key milestone for the company in expanding its clinical pipeline and enhancing its product offerings.
  

  Sentiment Analysis:

  Overall Tone: Positive

  • Management emphasized momentum and value-creating initiatives: called the period a "key inflection point," highlighted CoSara SPAC preparation, CoMira JV expansion, AI unit launch, imminent clinical evaluations, and noted improved operating efficiency and a smaller net loss versus prior year alongside $11.4M in cash and securities.

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 newly formed CoMira are performing to management's expectations; CoMira will leverage longstanding Saudi market relationships while CoSara is a mature, India-based manufacturing and commercial operation aligned with Make in India and expected to drive mutual value.

• Question from Michael Okunewitch (Maxim Group): Could you talk a little bit about how a potential spinout of CoSara might interact with the MTB and HPV point-of-care programs? Is this something where they might be licensed over or you get some sort of distribution agreement signed? I'm just curious since it seems like there's quite a significant market in India for these programs.
  Response: CoSara is intended to commercialize MTB and HPV programs in India to expand access to molecular diagnostics and replace smear microscopy; specific transaction/structural details (licenses, distribution, spinout mechanics) are under consideration and not finalized.

• Question from Michael Okunewitch (Maxim Group): I want to see if you could give a little bit more color on how you're actually able to reach a price point that is so much more affordable than your competitors. Does this have something to do with Co-Primers allowing you to use a more -- less complex device?
  Response: Device cost targets ($300–$500 at scale) were engineered from the outset via focused R&D and design choices; Co-Primers enable class-leading multiplexing (reducing primer-dimers) but the affordability stems from the overall device engineering and manufacturing approach.

• Question from Michael Okunewitch (Maxim Group): When looking at the CoMira JV in Saudi Arabia and the Middle East, are there any particular products, particularly from the PCR Pro that you believe are most relevant for that market?
  Response: Management indicated the entire pipeline is relevant for CoMira, highlighting the upper respiratory multiplex (flu A/B, COVID-19, RSV) as a particularly important market-fit for the region.

Contradiction Point 1

CoMira and CoSara Performance Expectations

It involves differing statements regarding the performance expectations and financial outlook for CoMira and CoSara, which are critical for understanding the company's international growth strategy.

Are CoSara and CoMira meeting expectations, and how will CoMira perform compared to CoSara? - Katherine Degen (H.C. Wainwright)

20251114-2025 Q3: We're pleased with the performance of both CoSara and CoMira. CoMira is newly formed and led by partners with extensive knowledge of the Saudi market... CoSara, with which we've been involved for 8 years, has established a strong presence in India. - Dwight Egan(CEO)

Is CoSara meeting your performance expectations? - Unknown Analyst (H.C. Wainwright)

2025Q3: With respect to the performance of both CoSara and CoMira, we're very pleased with the performance of both of those entities... We expect them to be a wonderful partner to this joint venture in moving our agenda forward. - Dwight Egan(CEO)

Contradiction Point 2

MTB and HPV Point-of-Care Programs and CoSara Spinout

It involves differing statements regarding the interaction of a potential CoSara spinout with the MTB and HPV point-of-care programs, which are crucial for understanding the company's strategic direction in India and Africa.

How would a potential CoSara spinout interact with MTB and HPV POC programs? - Michael Okunewitch (Maxim Group)

20251114-2025 Q3: Tuberculosis is the #1 killer in terms of infectious diseases in the world, with about 25% of deaths coming from India... We think we can be that solution to fill that gap, and we will continue to address other health issues in India and Africa. - Dwight Egan(CEO)

How would a potential spinout of CoSara interact with the MTB and HPV point-of-care programs? - Michael Okunewitch (Maxim Group LLC, Research Division)

2025Q3: CoSara capitalizing on being able to fill the gap between where they currently have access to PCR tests and where they need to have access... We think we can be that solution to fill that gap. - Dwight Egan(CEO)

Contradiction Point 3

Clinical Trials and Product Launch Timeline

It involves changes in the expected timeline for clinical trials and product launches, which are critical for product commercialization and revenue generation.

How could a CoSara spinout affect MTB and HPV point-of-care programs, and how does PCR Pro achieve affordability? - Michael Okunewitch (Maxim Group)

20251114-2025 Q3: The clinical trials for COVID-19, multiplex flu A/B, COVID-19 and RSV, MTB (tuberculosis), and HPV tests are expected to commence during the remainder of this calendar year. - Dwight H. Egan(CEO)

Can you provide the timeline for clinical trials and 510(k) applications for the tests, as well as your marketing strategy for the commercial launch? - Antonio Eduardo Arce (Unidentified Company)

2025Q2: The clinical trials for COVID-19, multiplex flu A/B, COVID-19 and RSV, MTB (tuberculosis), and HPV tests are expected to commence during the remainder of this calendar year. - Dwight H. Egan(CEO)

Contradiction Point 4

Affordability and Pricing Strategy for PCR Pro

It involves changes in the pricing strategy for the PCR Pro, which impacts the affordability and potential market penetration of the product, especially in low- and middle-income regions.

How would the spinout of CoSara affect the MTB and HPV point-of-care programs, and how is PCR Pro's affordability achieved? - Michael Okunewitch (Maxim Group)

20251114-2025 Q3: The affordability of PCR Pro comes from our initial goal of a $300-$500 scale price point. Co-Primers enable multiplexing without primer-dimers, contributing to affordability. - Brian Brown(CFO)

Could you clarify the timeline for clinical trials and 510(k) applications for the tests, and how you plan the marketing strategy for the commercial launch? - Antonio Eduardo Arce (Unidentified Company)

2025Q2: Our large point-of-care test, PCR Pro, is expected to enhance the rapid test market by offering a lower per-run cost with the ability to also test for multiple diseases, as well as easy-to-use functionality. - Dwight H. Egan(CEO)

Contradiction Point 5

COVID Test Resubmission Timeline

It involves changes in the timeline for resubmitting the COVID test to the FDA, which impacts the company's regulatory progress and potential revenue from the COVID-19 market.

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20251114-2025 Q3: We are currently preparing and expect to submit the 510(k) application to the FDA for our COVID-19 test in the fourth quarter of 2025. - Dwight Egan(CEO)

What is the resubmission timeline for the COVID test? What additional requirements are needed for the 510(k) application? - Unidentified Analyst (H.C. Wainwright)

2025Q1: We expect the revised 510 application to increase the probability of successful clearance. - Dwight Egan(CEO)