Co-Diagnostics, Inc. (NASDAQ:CODX) Q3 2023 Earnings Call Transcript

The commercialization strategy for the TB test includes plans to accelerate development while also increasing our manufacturing capacity, both domestically and in India through our joint venture CoSara. We are confident that CoSara has the capacity to effectively manufacture and support the commercialization of our TB test. In addition to providing manufacturing support, CoSara will distribute the Co-Dx PCR point-of-care platform throughout India, where TB currently takes the lives of two people every three minutes, and which Prime Minister Modi is committed to eradicating. We expect that demand for our platform in India will be robust, and we plan to utilize our most recent grant to offset additional costs. Since 2019, CoSara has received approval from the Indian CDSCO for 14 in vitro diagnostic tests that utilize our Co-Primers technology, which gives us additional confidence in our regulatory and commercialization approach in that country.

In response to broader international efforts to eradicate TB, an important element of our TB strategy includes receiving a recommendation from the World Health Organization. A WHO recommendation is a requirement for sales in many regions across the world, including countries in Africa, which bear a disproportionately high TB burden, and where we anticipate introducing the platform with our TB test. We plan to initially pursue a regulatory pathway for this test to the Australian Regulatory Authority, the TGA, which will be followed by a submission to the CDSCO in India, as authorizations for both the TGA and CDSCO are recognized by the WHO when it makes recommendations for diagnostics. We will look forward to providing further updates as we continue to make progress on these fronts.

While we plan to initially target point-of-care settings with the tests that are under development, we believe that our platform also has the potential to serve as the cornerstone of a local, regional or national healthcare monitoring infrastructure. One of the most exciting features of the Co-Dx PCR platform will be direct real time HIPAA compliant integration into the EMR, creating additional use cases for our platform, including outbreak monitoring. In the wake of the COVID pandemic disease monitoring has become a focal point for government health officials around the world. Officials are actively looking at solutions to ensure epidemiological data can be collected and sorted efficiently to identify and monitor disease clusters and outbreaks.

Ultimately, in part due to cloud based analytics, the device is expected to include the capability to automatically report de-identified test results, whether from an assisted living facility, physician’s office, or the home directly to regional public health officials. Over the past few months, we have also had initial conversations with government entities in the United States about how this technology could be used to help slow or even prevent large outbreaks of infectious disease in the United States and abroad. We are particularly encouraged by the Pandemic and All-Hazards Preparedness Act, PAHPA in which the federal government is contemplating a significant set of initiatives in the context of outbreak and monitoring capabilities. The proposed act further supports the use and need for real time PCR testing and a device with technology that can support outbreak and disease monitoring.

Over time, we believe the new platforms ability to support these initiatives will become another competitive differentiator for our end users. To close, we remain confident that the quality, ease of use, affordability and quick turnaround time of our platform will deliver an impact to patients and communities around the world. We are excited about the future of Co-Diagnostics and the value that our disruptive technology can provide to a global healthcare infrastructure. In the near term, we look forward to the potential FDA authorization for our COVID-19 test on the Co-Dx PCR platform. Our company is well funded with $63.4 million in cash and equivalents on the balance sheet, grant support from notable international leaders in health care. And with more funding potentially available via additional grants.

We look forward to providing future updates on our development, regulatory and commercial progress in the coming quarters. With that, I will turn the call over to Brian to discuss our third quarter financials in greater detail. Brian?