Co-Diagnostics, Inc. Common Stock Investor update

Thank you very much. Thank you, Rob, and thank you everyone for your interest in Co-Diagnostics.

I would like to begin with the problem we are working to address because it explains why we are pursuing this opportunity. The figures in this slide illustrate the urgency. As of the World Health Organization's most recent situation report, the Democratic Republic of the Congo has reported 6,757 confirmed cases and 3,267 deaths. A case fatality rate of roughly 48% across 61 health zones in six provinces. The World Health Organization has described this as the second largest Ebola outbreak on record, and one that is spreading substantially faster than previous outbreaks. This is not a problem that stays in Central Africa. Imported cases have already been reported in Germany and in France this year. Outbreaks that begin where diagnostic infrastructure is thinnest do not stay there.

For us, the central question is how to make molecular testing more accessible in the places where response is needed. A test has greater practical value when it can fit the setting where patients seek care. That view is reinforced by the organizations that fund outbreak response. In our conversations with global health foundations, the message has been consistent. The world does not need another centralized laboratory test. There are plenty of those. What is missing is a molecular test that can reach the remote settings where patients actually present and return a result on site. That has been the objective behind our investment in decentralized PCR. We are developing a platform to bring molecular testing closer to patients, including communities with limited access to centralized laboratories.

As we discussed on our second quarter call, we completed an extraction-free proof of concept study for Bundibugyo virus detection using diluted plasma on the Kodiak PCR Pro. That was an important early demonstration of the platform's potential beyond swab-based testing. There is more development work to do, but I want to be direct about why we are pursuing this, because the significance is considerably larger than Ebola. Until now, the Kodiak PCR platform has been designed around swab-based samples, nasal swabs, tongue swabs. Establishing blood as a validated sample type would open the platform to an entire category of blood-borne pathogens that a swab simply cannot reach, HIV, hepatitis B, hepatitis C, and others. Each of those applications would require its own development, its own validation, and its own regulatory authorization.

But the size of the opportunity in front of this platform changes materially with the introduction of blood-borne pathogen detection. Put another way, Ebola is where we are proving this out. However, the larger opportunity is the ability to run blood-based molecular testing into a doctor's office or a rural clinic at the price point of our instrument, rather than sending the sample to a centralized laboratory. The next step is to determine how sample preparation and our platform can work together in a practical workflow, and that is where ReadyGo comes in. We are collaborating with ReadyGo Diagnostics, a U.K.-based company, to evaluate a new approach to blood-based testing on the Kodiak PCR platform, initially focused on the Ebola detection. ReadyGo developed a field-capable sample preparation technology, and they concluded that they needed a molecular platform that could actually operate where their product is used.

They identified the Co-Dx PCR platform as a viable platform. To give you a sense of the setting we are both building for, India alone has roughly 650,000 villages with no practical access to molecular diagnostics of any kind. ReadyGo brings its GoCollect sample preparation technology. We bring the PCR platform, the test cartridge, and the connected infrastructure that can support reporting and outbreak response. We recently entered into a material transfer agreement to support this work, which we disclosed in the Form 8-K filed yesterday afternoon. Over the past several days, we have taken delivery of ReadyGo's materials and devices, and that hands-on evaluation work is now underway. This is a non-exclusive development collaboration, deliberately so. Both companies remain free to pursue their own grant funding and their own commercial paths, which we consider an advantage rather than a limitation.

We rely on the inherent strength of our accessible and affordable platform. The work builds on our earlier plasma proof of concept that gives us a starting point, while the combined GoCollect and PCR Pro workflow still needs to be demonstrated and validated. What makes this strategically interesting is the potential to expand the application supported by the platform. If we can establish a suitable blood-based workflow, we believe that could create opportunities well beyond the initial Ebola program. Let me walk through the sample preparation component first so you can see how the pieces are intended to fit together. This slide shows the GoCollect capillary collector and GoCollect plasma. Together, they address the preparation of a blood sample for downstream molecular testing. The collector combines capillary blood collection with sample conditioning chemistry. The plasma device then separates plasma from whole blood to provide a prepared sample for testing.

One feature worth calling out specifically, the collector's chemistry is designed to inactivate the virus at the moment of collection. In a field setting, handling live Ebola samples is itself a serious constraint on who can perform tests and where. A sample that is rendered safe at the point of collection changes what is operationally possible. We are evaluating two possible workflows. In the simpler case, a modified capillary collector could feed our test cartridge directly. The more likely near-term path uses GoCollect plasma to separate plasma from whole blood, which then goes into the cartridge. Both require real R&D work, and determining which one prevails is precisely what this collaboration is meant to do. We need to establish compatibility across the complete process, including the prepared sample, our chemistry, and the test cartridge. Successful work on an individual component doesn't automatically establish the performance of the combined workflow.

The development objective is a workflow that can be practical at the point of need. Reducing the infrastructure required for sample preparation could help us reach settings that are difficult to serve today. That's why we view sample preparation as an important part of the commercialization strategy. The customer needs a simple, safe, and effective process from collection through to result. Once the sample is prepared, the next component is molecular detection on PCR Pro. The Co-Dx PCR platform brings together the instrument, a consumable test cartridge, and connectivity. Our objective is to make PCR more accessible while connecting the result to the people who need it. In this proposed cloud-based reporting and visualization application, blood-derived samples would be tested using the Ebola assay under development. The results are uploaded immediately if a Wi-Fi or cellular data connection is available.

If no internet connection is available, the results are temporarily stored on the connected phone or tablet, then uploaded later, as soon as a connection can be established. The instrument and cloud illustration here shows how that data could then be visualized, thus immediately connecting local testing in support of a broader response. The dashboard on this slide is illustrative and uses simulated data. It is not a display of actual Ebola testing performed by our platform in the DRC. The concept is straightforward. Each individual test result can inform a local decision, while connected reporting can help authorized officials to understand and respond to testing activity across multiple locations. This digital architecture has been part of our strategy from the beginning. Our investment in the mobile application and secure cloud infrastructure supports reporting, remote system management, and access to diagnostic information.

As adoption develops, we also see potential for analytics and artificial intelligence to help make that information more useful. Those opportunities depend on validated capabilities and responsible use of the data. Commercially, our aim is to build an installed base that supports ongoing test use. A broader menu could give customers more reasons to use the platform and create recurring demand for consumables over time. The next slide brings sample preparation testing and connected reporting into one view. This is the complete approach we're working toward. Prepare a blood-derived sample, perform molecular testing at the point of need, and connect the information to support a well-targeted and scaled response. ReadyGo's technology addresses the sample preparation step. Co-Dx PCR Pro is the detection platform. The mobile application and Kodiak's cloud are intended to make results available beyond the instrument itself. Ebola is our initial focus for the collaboration.