Co-Diagnostics, Inc. (CODX): Business Model Canvas [Dec-2025 Updated]

You're looking at Co-Diagnostics, Inc. (CODX) right now, trying to map out how they transition from those big pandemic-era sales to their next chapter, and honestly, it's a critical pivot point; as someone who's spent two decades dissecting these models, I can tell you the defintely is in the details of their new platform strategy, especially when you see Q3 2025 results showing operating expenses of $7.1 million against product revenue of just $0.1 million, though they bolstered liquidity with $11.4 million in cash and equivalents. This Business Model Canvas cuts through the noise, showing exactly how their patented Co-Primers® technology and new AI unit are meant to generate revenue through international joint ventures and direct sales, so dive in below to see the full structure that will define their success moving forward.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Key Partnerships

You're looking at the core relationships Co-Diagnostics, Inc. (CODX) relies on to scale its patented molecular diagnostic technology globally. These aren't just vendor agreements; they are strategic anchors for manufacturing, market access, and critical development funding. Honestly, for a micro-cap company with a market capitalization around $18.25 million as of early November 2025, these partnerships are everything.

Here's the quick math on the two primary geographic joint ventures that form the backbone of their international strategy:

The CoMira Diagnostics venture, established with Arabian Eagle Manufacturing in the Kingdom of Saudi Arabia (KSA), is a massive step. This JV is set to cover KSA and 18 other nations throughout the Middle East and North Africa (MENA) region, creating a commercial footprint across 19 countries. Arabian Eagle is taking the lead on the manufacturing facility set-up and managing the regulatory clearance process, starting with the SFDA, which they believe will help entry into other Territory nations.

For CoSara Diagnostics in India, which was established back in 2017, the focus has shifted to unlocking shareholder value. Co-Diagnostics engaged Maxim Group LLC in November 2025 to act as its exclusive financial advisor to investigate options, specifically a merger with a Special Purpose Acquisition Company (SPAC) or a similar listing on a U.S. national securities exchange.

Development of the next-generation platform isn't purely self-funded, which is important given the Q3 2025 net loss was $5.9 million. The development of the Co-Dx PCR Home platform received a significant external boost from the National Institutes of Health (NIH). Specifically, the company was awarded $1.2 million in funding from the NIH's Rapid Acceleration of Diagnostics (RADx) Tech program back in July 2023.

This NIH support was earmarked for completing the development of their upper respiratory panel, designed to simultaneously detect influenza A and B, COVID-19, and RSV. This development work directly feeds into the next critical partnership requirement:

• Clinical evaluation sites for regulatory submission trials.
• Infectious disease tests on the new Co-Dx PCR platform, including the upper respiratory multiplex, were in preparation to begin clinical evaluations before the end of 2025 in various jurisdictions.
• The company noted in its Q1 2025 update that it remained on track for the initiation of clinical evaluations for 4 tests in the product pipeline by year-end 2025.

To be fair, the NIH RADx Tech program, managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), validates the public health relevance of the Co-Dx PCR Home platform, which is still subject to regulatory review and not currently for sale as of late 2025.

Finance: draft 13-week cash view by Friday, incorporating the $11.4 million cash position as of September 30, 2025.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Key Activities

You're looking at the core engine of Co-Diagnostics, Inc. (CODX) right now, which is heavily weighted toward development and regulatory navigation as they pivot from pandemic-era revenue to platform commercialization. Honestly, the Key Activities reflect a company betting big on its proprietary technology translating into new, cleared products.

Research and development (R&D) of new diagnostic assays

The R&D focus centers on leveraging the patented Co-Primers® technology across the Co-Dx PCR platform. While specific Q3 2025 R&D spend isn't isolated from the total operating expenses of $7.1 million for that quarter, the activity is clearly directed at pipeline advancement. The company is also integrating next-generation tools to increase operational efficiency and minimize human error in development.

Key R&D outputs and activities include:

• Developing proprietary AI-powered diagnostics via the new AI business unit.
• Performing in-silico analysis of primer sets, such as showing high homology against over 1,200 CHIKV sequences for the chikungunya virus test.
• Developing a proprietary sample preparation instrument for the point-of-care (PoC) Co-Dx PCR Mycobacterium Tuberculosis (MTB) Test.

Initiating clinical evaluations for four key test panels

A major activity in late 2025 is the initiation of clinical evaluations for the core pipeline tests. Management projected the start of all four major trials in 2025. The company is training sites and preparing for enrollment, which is critical for subsequent regulatory submissions.

Here's the quick math on the pipeline progression as of late 2025:

Manufacturing and assembly of the Co-Dx PCR platform

The activity here involves preparing the infrastructure to support future commercial launches of the Co-Dx PCR platform and its associated test cups. The company has expanded its manufacturing capabilities, including an oligonucleotide synthesis facility, to enhance operational efficiencies.

Furthermore, Co-Diagnostics, Inc. is executing on international manufacturing and distribution through joint ventures:

• Signed a definitive agreement in late 2025 with Arabian Eagle Manufacturing to establish CoMira Diagnostics for commercialization across KSA and 18 MENA nations.
• Actively pursuing a strategic transaction, potentially a SPAC merger, for CoSara Diagnostics, the joint venture in India, which also supports manufacturing infrastructure.

Advancing the new AI business unit (Primer Ai™ platform)

Co-Diagnostics, Inc. announced the formation of a newly organized artificial intelligence (AI) business unit in November 2025, led by Chief Technology & AI Officer Christopher Thurston. This is a core strategic activity to reduce time-to-market for new tests.

The unit's mandate is to integrate AI applications into the Co-Dx™ Primer Ai™ platform. This platform is designed to:

• Support internal data orchestration and Co-Primers design and optimization.
• Eventually enhance automated test interpretation.
• Create predictive epidemiological awareness by leveraging analytics from widespread deployment of the Co-Dx PCR Pro.

Securing regulatory clearances (e.g., FDA 510(k), SFDA)

This is the critical gatekeeping activity that unlocks revenue from the developed pipeline. The company is preparing for submissions based on the clinical trial data it is currently gathering.

Key regulatory targets and timelines include:

• Targeting a 510(k) submission to the U.S. FDA for the enhanced COVID-19 test after clinical data collection.
• Gathering data from Indian and South African trials to support regulatory submissions to the CDSCO in India and the SAHPRA in South Africa for the TB and HPV tests.
• Management is targeting commercialization for the COVID-19 test as early as mid-2026, contingent on regulatory approvals.

To be fair, the company's current financial standing, with Q3 2025 revenue at only $0.14538 million and a net loss of $5.89 million, shows the capital intensity of these pre-commercial activities. Finance: draft 13-week cash view by Friday.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Key Resources

You're looking at the core assets Co-Diagnostics, Inc. (CODX) relies on to execute its strategy as of late 2025. These aren't just line items; they are the proprietary engines and established networks driving their molecular diagnostics play.

The foundation is definitely the patented Co-Primers® technology, which is central to designing high-specificity PCR tests. This technology underpins the entire Co-Dx PCR platform, which includes the planned compact Point-of-Care (PoC) and Home instruments like the PCR Pro™ and PCR Home™, alongside its mobile app. To be fair, this platform, along with its associated tests, is still subject to review by the FDA and other regulatory bodies, meaning it isn't commercially available for sale yet as of the Q3 2025 reporting period. Still, the company is advancing clinical evaluations for multiple assays, like the upper respiratory multiplex test, to support future regulatory submissions.

The company's global reach is anchored by its joint venture infrastructure. You have CoSara Diagnostics in India, for which the company is actively pursuing strategic alternatives, including a potential SPAC transaction. Then there's the newer CoMira Diagnostics in the Middle East, established via a definitive agreement with Arabian Eagle Manufacturing. This JV is set up to localize the technology across the Kingdom of Saudi Arabia (KSA) and 18 additional nations in the MENA territory.

Also critical is the investment in future capabilities, specifically the newly organized artificial intelligence (AI) business unit. This unit is tasked with integrating the company's planned AI applications into the proprietary Co-Dx™ Primer Ai™ platform, which is intended to streamline test design and potentially aid in outbreak prediction.

Here's a quick look at the hard numbers and structural scale as of the end of Q3 2025:

The company's pipeline tests, which are designed for the Co-Dx PCR platform, include specific assays supported by external funding sources, which are also a key, albeit less tangible, resource.

• Tests in preparation for clinical evaluations include:
• Tuberculosis (MTB) Test.
• Upper Respiratory Multiplex Test (Flu A/B, COVID-19, RSV).
• 8-type Human Papillomavirus (HPV) Multiplex Panel.

Finance: draft 13-week cash view by Friday.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Value Propositions

Accessible and affordable real-time PCR testing at PoC/Home

The commercial targeting for the Co-Diagnostics, Inc. (CODX) instrument pricing is aimed at $300-$500 based on scale, with test cups priced at $15-$20 in developed markets, and lower pricing planned for LMICs (Least Developed Countries). As of September 30, 2025, the Company held $11.4 million in cash, cash equivalents, and marketable securities, following recent fundraising efforts that brought in approximately $10.8 million gross proceeds across two Registered Direct Offerings in the last two months before that date.

Gold standard PCR accuracy via proprietary Co-Primers® technology

The proprietary Co-Primers® technology has been supported by scientific analysis, such as the in-silico confirmation of high homology for chikungunya virus (CHIKV) primers against over 1,200 CHIKV sequences. The Co-Dx PCR platform remains subject to review by the U.S. Food and Drug Administration (FDA) and other regulatory bodies and was not yet available for sale as of the third quarter of 2025 report.

Rapid results in approximately 30 minutes for timely treatment decisions

While the specific turnaround time is not explicitly quantified in recent reports, the development focus is on point-of-care (PoC) testing using the compact Co-Dx PCR Pro™ instrument, with clinical evaluations for the upper respiratory multiplex test initiated on November 18, 2025, to support a U.S. FDA 510(k) submission.

Multiplex testing for simultaneous detection (e.g., Flu A/B, COVID-19, RSV)

Co-Diagnostics, Inc. (CODX) has begun clinical evaluations for its upper respiratory multiplex point-of-care test kit, which simultaneously detects four pathogens. The Company is also advancing other pipeline tests.

• The enhanced COVID-19 test is planned as the first of four infectious disease PCR test panels for regulatory submission.
• The multiplex RT-PCR test detects Influenza A, Influenza B, COVID-19, and RSV.
• Clinical studies for the Tuberculosis (TB) test are scheduled in India and South Africa in H2 2025 for CDSCO and SAHPRA submissions.

Simplified, video-guided workflow via a smartphone application

The Company announced the formation of a new artificial intelligence (AI) business unit to integrate existing and planned AI applications into the Co-Dx™ Primer Ai™ platform. Furthermore, a proprietary sample preparation instrument was developed to streamline and simplify the workflow for the PoC Co-Dx PCR Mycobacterium Tuberculosis (MTB) Test.

Key Financial and Operational Metrics as of Late 2025:

The focus on operational efficiency is evident in the expense reduction: Operating expenses for Q3 2025 were 32.6% lower year-over-year, decreasing from approximately $10.6 million in Q3 2024 to $7.1 million in Q3 2025. The net loss per fully diluted share for Q3 2025 was $0.16, an improvement from $0.32 in Q3 2024.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Customer Relationships

You're looking at Co-Diagnostics, Inc. (CODX) in late 2025, and the customer relationship structure is heavily weighted toward building future commercial channels rather than servicing a large installed base of paying customers for the core platform right now. The entire thesis rests on the successful, timely launch of the Co-Dx PCR Home platform, which is still pending regulatory review by the FDA and/or other regulatory bodies and is not currently for sale.

Dedicated B2B sales and support for institutional/clinic users is currently focused on pre-commercial engagement, which means building the pipeline for when the platform launches, expected in 2026. The company is actively engaging with potential customers and training clinical evaluation sites for its pipeline tests, such as the Upper Respiratory Multiplex Test, which is designed to detect flu A, flu B, COVID-19, and RSV simultaneously.

Strategic partnership management is a major focus, as the company leans on joint ventures for international market entry. You see this clearly in the structure:

• CoMira Diagnostics: New JV with Arabian Eagle Manufacturing covering KSA and 18 MENA nations.
• CoSara Diagnostics: The Indian JV, for which the company is engaging Maxim Group LLC to explore strategic alternatives, potentially a SPAC transaction, to unlock value.

Management stated they are 'very pleased with the performance of both entities'.

The app-driven, self-service model for the Co-Dx PCR Home platform is in the development and regulatory queue. Since the platform is not yet available for sale, there are no established self-service customer metrics to report; the relationship is currently one of anticipation and regulatory progress tracking, not transactional support. The company did receive recognition at the Utah Business 2025 Innovation Awards Summit for this platform in the Healthcare and Life Sciences category.

Regulatory and clinical support for partner-led market entry is intrinsically linked to the JV strategy. The company is advancing clinical evaluations for its pipeline tests, which is the tangible output of this support structure. For example, the company is advancing clinical evaluations for the upper respiratory multiplex test to support submission to the U.S. FDA.

Investor relations is focused on communicating the long-term platform commercialization strategy while managing the current capital-intensive phase. The financial reality of this investment phase is stark, as the company reported Q3 2025 revenue of only $0.1 million, with all revenue coming from product sales, as grant revenue was absent in that quarter (compared to $0.4 million in grant revenue in Q3 2024). The net loss for Q3 2025 was $5.9 million, an improvement from the $9.7 million loss in the prior year period. The cash position reflects the ongoing need for capital to fund this development; cash, cash equivalents, and marketable securities stood at $11.4 million as of September 30, 2025, following a subsequent Registered Direct Offering that raised gross proceeds of approximately $7.0 million.

Here's a quick look at the financial context surrounding these customer-facing development efforts for the first three quarters of 2025, showing the heavy investment required to build these future relationships:

The company is defintely managing spend carefully to bridge the gap to commercialization next year.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Channels

Direct sales force targeting U.S. physician offices and urgent care activity showed Sales and Marketing expenditures at approximately $0.6 million for the second quarter of 2025.

The Co-Dx PCR Pro instrument has a listed device cost of $500, with a price per test cited at $82.99 for the Co-Dx platform, compared to an antigen price per test of $20.

The platform's potential U.S. reach is mapped against the fact that 88.9% of the U.S. population lives within 5 miles of a point-of-care location.

The Co-Dx PCR platform, including the PCR Pro instrument, is noted as currently used in 19 US states.

The Co-Dx PCR Pro instrument is 6½" x 4½" x 6" and weighs 2 lbs.

Deployment numbers indicate over 200+ Co-Dx boxes have been deployed.

International distribution is anchored by two joint ventures, CoSara in India and CoMira in the Middle East/North Africa (MENA) region.

The CoMira Diagnostics joint venture, formed with Arabian Eagle Manufacturing, establishes a commercial presence in the Kingdom of Saudi Arabia (KSA) and 18 additional MENA markets, covering 19 total countries.

The CoSara Diagnostics joint venture is the subject of an engagement with Maxim Group LLC to pursue a strategic transaction, which may include a SPAC transaction.

The company reported Q3 2025 revenue of $0.1 million, with all revenue recognized from product sales, down from $0.6 million in Q3 2024.

The overall financial position as of September 30, 2025, included cash, cash equivalents, and marketable securities totaling $11.4 million.

The Co-Dx PCR at-home and point-of-care platform, which includes the mobile application, is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.

The mobile application, Co-Dx PCR Pro App, delivers results via cloud reporting in approximately 30 minutes from sample to result.

Direct regulatory submissions are in progress, with clinical evaluations initiated in November 2025 for the upper respiratory multiplex test to support a submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of the Co-Dx PCR Pro instrument.

Results from these clinical evaluations are also expected to support submissions to other regulators, including the Saudi Food and Drug Authority (SFDA).

The company withdrew its initial COVID-19 Test 510(k) application to the FDA in February 2025 to submit an enhanced version.

Here's a snapshot of the Q3 2025 financial context surrounding these channels:

The platform pipeline includes tests for:

• Upper respiratory multiplex test (Flu A/B, COVID-19, RSV)
• Mycobacterium Tuberculosis (MTB) Test
• Multiplex HPV test

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Customer Segments

You're looking at the customer base for Co-Diagnostics, Inc. (CODX) as of late 2025. The financial reality right now shows that product revenue for the quarter ending September 30, 2025, was $0.15 million, which missed analyst projections of $153,000 for that quarter. Total revenue for the last twelve months was $507.89K, a significant drop of -93.06% year-over-year. This context shows the current reliance on pre-commercial activities and existing revenue streams while the new platform ramps up.

Healthcare providers (physician offices, clinics, skilled nursing facilities)

In the United States, Co-Diagnostics, Inc. is specifically targeting physician offices and clinics as a point-of-care application for the Co-Dx PCR platform. Skilled nursing facilities and residential homes, which house vulnerable populations needing extensive testing, are also key targets. The company is pricing its instrument in a range of $300-$500, depending on the scale of the order. The associated test cups are priced between $15-$20 in developed markets.

International governments and public health organizations (India, MENA)

International markets are a major focus, particularly for regulatory pathways and adoption of tests like those for HPV and Tuberculosis (TB). The company has established operations in India through its joint venture, CoSara Diagnostics Pvt Ltd. Furthermore, in September 2025, Co-Diagnostics, Inc. signed a strategic Memorandum of Understanding (MOU) to explore a joint venture in the Kingdom of Saudi Arabia (KSA). This KSA venture aims to manufacture and distribute the Co-Dx™ PCR platform across the Middle East and North Africa (MENA) region. KSA has historically been one of the largest international markets for the company's Logix Smart® tests. Clinical evaluations to support submissions to the CDSCO (India) and SAHPRA (Africa) were anticipated to begin in 2025.

Here's a look at the key international market focus areas:

National pharmacy and retail chains for PoC/at-home sales

Co-Diagnostics, Inc. anticipates developing a presence in the US pharmacy market, noting that there are tens of thousands of pharmacies equipped to conduct testing. The company is working toward commercialization of its platform, which is designed for point-of-care use.

Diagnostic laboratories and reference labs

While not explicitly detailed with specific 2025 financial breakdowns, the company's core technology is based on a PCR platform designed for molecular diagnostics. The cloud-based analysis feature of the Co-Dx PCR Pro platform allows for de-identified epidemiological data to be made available to health departments at local, regional, national, or international levels.

Individual consumers for future at-home testing (PCR Home)

The company is actively seeking clearance for home use testing in the United States. The Co-Dx PCR Home™ is a component of the Co-Dx PCR platform that received recognition at the Utah Business 2025 Innovation Awards Summit in September 2025. Commercialization for the platform, which includes the home testing component, is currently expected in 2026, pending regulatory review by the FDA and other bodies.

The planned customer base for at-home sales includes:

• Individual consumers seeking accessible PCR testing.
• The platform is expected to be commercialized in 2026.
• Test cups for developed markets are priced between $15-$20.
• The platform includes the Co-Dx PCR Home™ and a mobile app.

Finance: review Q4 2025 cash burn projections against the $13.4 million cash position as of June 30, 2025.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Cost Structure

You're looking at the core spending that keeps Co-Diagnostics, Inc. running as it pushes its platform toward broader commercialization. The cost structure is heavily weighted toward getting the technology validated and approved.

Heavy investment in Research and Development (R&D) represents a significant portion of the cash burn. This spending fuels the development of the Co-Dx PCR platform and the various assays in the pipeline. For the third quarter of fiscal 2025, Research and development expense was reported at $4.5 million. That compares to $4.9 million in the same quarter of fiscal 2024, showing a slight reduction in R&D spend year-over-year, though it still consumes the majority of the operating budget.

Here's a quick look at how the major expense categories stacked up in Q3 2025 compared to the prior year:

Operating expenses of approximately $7.1 million in Q3 2025 reflects a conscious effort toward operational efficiency, coming down from $10.6 million in Q3 2024. Honestly, managing this burn rate is key while the company is still pre-commercial for its core tests.

Costs associated with clinical trials and regulatory submissions are an immediate, forward-looking cost driver. Management indicated they anticipate beginning clinical evaluations for all four main tests-COVID-19, ABCR, tuberculosis, and HPV-during the remainder of the 2025 calendar year. Preparing for and executing these trials, plus the subsequent 510(k) applications for the COVID-19 and multiplex ABCR tests, demands significant financial outlay for site management, patient enrollment, and data processing.

For manufacturing and assembly costs for instruments and test kits, the structure is evolving through strategic partnerships. The formation of the CoMira Diagnostics joint venture with Arabian Eagle Manufacturing is intended to localize manufacturing, assembly, distribution, and commercialization across the KSA and 18 MENA nations. Principal manufacturing for tests and instruments is planned to occur at the domestic facility before completion at the upgraded CoSara manufacturing campus in India for that region's distribution.

General and administrative expenses for corporate overhead and legal make up the remainder of the total operating expenses after R&D is accounted for. If total OpEx was $7.1 million and R&D was $4.5 million in Q3 2025, the G&A and other operating costs were approximately $2.6 million for that quarter. This covers everything from executive salaries to legal fees associated with corporate structuring and intellectual property defense.

• R&D expense in Q3 2025 was $4.5 million.
• Total Operating Expenses in Q3 2025 were $7.1 million.
• Cash, cash equivalents, and marketable securities stood at $11.4 million as of September 30, 2025.
• Subsequent to the quarter end, gross proceeds of approximately $7.0 million were raised from a Registered Direct Offering.

Finance: draft 13-week cash view by Friday.

Co-Diagnostics, Inc. (CODX) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for Co-Diagnostics, Inc. (CODX) as of late 2025, and it's clear the company is navigating a transition away from grant dependency toward product sales and capital raises to fund growth. Honestly, the numbers reflect a pivot point.

Product sales of diagnostic test kits and reagents formed the entirety of the recognized revenue for the third quarter of 2025. For the three months ending September 30, 2025, total revenue was reported at \$0.1 million. This compares to the prior year's Q3 2024 revenue of \$0.6 million, which included approximately \$0.4 million from grant revenue. So, in Q3 2025, all recognized revenue, that \$0.1 million, came directly from product sales.

Here's a quick look at the key financial data points relevant to revenue and capital generation around that time:

Sales of the Co-Dx PCR Pro and Co-Dx Home instruments are a key part of the product sales stream, though specific instrument sales revenue isn't broken out from the total \$0.1 million. The company is focused on market access through affordability for the PCR Pro device, aiming for a price point potentially as low as about \$300 to \$500. This pricing strategy is defintely important for driving adoption of the platform.

Potential grant funding was negligible in the third quarter. The company recognized \$0 in grant revenue for Q3 2025, a notable drop from the prior year period which included approximately \$0.4 million in grant revenue. Management indicated plans for seeking additional grant funding to support future capital requirements.

Licensing fees and royalties from international joint ventures, specifically CoSara Diagnostics in India and CoMira Diagnostics in the MENA region, are strategic, long-term revenue drivers. While the company is actively pursuing a SPAC transaction for CoSara and expanding commercial footprint with CoMira, the search results do not provide a specific revenue figure for licensing fees or royalties recognized from these ventures during Q3 2025.

The balance sheet was bolstered by proceeds from strategic direct offerings. Co-Diagnostics raised a total of \$10.8 million across two strategic direct offerings in the last two months leading up to the Q3 2025 report. This total is comprised of a registered direct offering that closed on September 18, 2025, for gross proceeds of approximately \$3.8 million at \$0.40 per share, and a subsequent offering announced around late October 2025 for approximately \$7 million at \$0.55 per share. These proceeds are earmarked for working capital and general corporate purposes.

The strategic focus areas tied to these revenue streams include:

• Advancing clinical evaluations for the upper respiratory multiplex test.
• Pursuing a SPAC transaction for the CoSara joint venture in India.
• Expanding commercial presence via the CoMira joint venture in 19 MENA nations.
• Integrating AI applications into the Co-Dx Primer Ai platform.
• Positioning the Co-Dx PCR Pro device for scale with target pricing of \$300-\$500.

Finance: draft 13-week cash view by Friday.