🧾 What This Document Is

This is an 8-K filing, which is a report for major events that shareholders should know about. Attached as Exhibit 99.1 is the company's official press release announcing its financial results for the full year of 2025 and providing a business update. It's a comprehensive look at where the company stands financially and strategically.

🏢 What The Company Does

In simple terms, Co-Diagnostics develops and makes DNA/RNA-based tests. Think of them as creating the instructions (like a recipe) to find specific genetic markers for diseases. Their patented platform is designed to be flexible for making various tests, including ones for at-home use. They are currently focused on commercializing this platform globally through joint ventures. 👉 Why it matters: They are a molecular diagnostics company transitioning from a focus on COVID-19 tests to a broader, multi-disease platform. Their success now hinges on executing this global commercialization strategy.

💰 Financial Highlights: A Tough Year

The numbers show a company in a significant investment and transition phase, with revenues down sharply and losses widening.

Revenue: Plunged to $0.6 million in 2025 from $3.9 million in 2024. The drop was almost entirely due to a $2.9 million decrease in grant revenue, which is non-recurring funding.
Operating Loss: Came in at $50.2 million, worse than the 2024 loss of $40.1 million. A major reason was a one-time, non-cash impairment charge of $18.9 million. This means they wrote down the value of intangible assets (like patents or rights) they previously owned.
Net Loss: The bottom-line loss was $46.9 million, or $35.25 per share. While still large, the loss per share is slightly better than last year's $37.22, partly due to issuing more shares (which dilutes ownership).
Cash Position: A critical metric. They ended the year with $11.9 million in cash and investments, down from $29.7 million at the end of 2024. This burn rate is key to watch. 👉 The Big Picture: The financials are dominated by heavy R&D spending ($19.1 million) and the one-time impairment charge. The core business is not yet generating significant revenue to cover these costs.

🚀 Key Strategic Moves

Beyond the financials, the company is actively laying the groundwork for future growth through partnerships and clinical progress.

Global Joint Ventures (JVs): This is their core commercialization strategy.
- CoSara (India): They hit a major milestone by getting a license to manufacture and sell their PCR Pro® instrument in India. They've also expanded the territory for this JV to include Bangladesh, Pakistan, Nepal, and Sri Lanka, targeting a ~$13 billion market.
- CoMira (Saudi Arabia): A new JV with Arabian Eagle is in the works to serve the Middle East and North Africa.
Pipeline & Regulatory Shift: They are advancing tests for tuberculosis (TB) and HPV. Notably, due to low COVID-19 rates in their study locations, they are changing their FDA submission strategy. Instead of a full respiratory panel, they will first seek approval for a test focusing on Flu A, Flu B, and RSV, keeping COVID-19 as a potential add-on later.
Funding: They raised capital twice through stock offerings, totaling $10.8 million. However, this came at the cost of significantly increasing the number of shares outstanding.

📦 Financial Position: What Changed

The balance sheet tells the story of a company deploying its cash reserves to fund its losses and operations.

Assets Shrank: Total assets dropped from $63.6 million to $24.7 million, mainly due to the impairment charge and using up cash.
Cash Usage: Cash and investments fell by $17.8 million year-over-year. This is the net result of losses and spending, partially offset by the new stock offerings.
Liabilities Decreased: Total liabilities also fell, from $9.7 million to $4.1 million, as some obligations were paid down or reclassified. 👉 Why it matters: The company is burning through cash to fund its growth initiatives. The upcoming "next phase of execution in 2026" is crucial to start generating more meaningful revenue from its JVs and platform.

🔮 What's Next: The Path Forward

Management has outlined a clear four-pillar strategy for 2026:

Launch Commercialization: The big goal for 2026 is to begin selling the CoSara platform in India and advance the CoMira JV in the Middle East.
Advance Clinical Programs: Move the TB and HPV tests toward regulatory approval. The modified FDA strategy for the respiratory test aims to "accelerate regulatory and commercialization timelines."
Expand AI Capabilities: Continue integrating machine learning into their test design platform (Primer Ai™).
Pursue SPAC for CoSara: They've engaged an investment bank to explore a SPAC transaction for their Indian joint venture, which could be a path to greater funding or valuation.

⚖️ Big Picture: Strengths & Risks

👍 Strengths & Opportunities:

Strategic JVs: Partnerships in India and Saudi Arabia provide local manufacturing and distribution, lowering barriers to entry in huge, growing markets.
Platform Flexibility: The technology is designed for multiple tests (respiratory, TB, HPV), reducing reliance on a single product.
IP Portfolio: Regularly filing and receiving patents (recently in Australia and Japan) strengthens their competitive moat.
Clear Strategy: Management has a focused plan with specific geographic and product goals.

⚠️ Key Risks & Challenges:

Cash Burn & Going Concern: With only $11.9 million in cash and ongoing losses, the company will likely need to raise more capital soon, which could dilute shareholders further.
Execution Risk: Their entire growth thesis depends on successfully launching commercial operations in new countries and getting regulatory approvals.
Revenue Concentration Risk: The prior year had higher revenue from COVID-related grants, which have now dried up. New revenue from JVs and products must ramp up quickly.
Competitive Field: The molecular diagnostics space is crowded with established players.

🧠 The Analogy

Imagine Co-Diagnostics is a talented chef who has invented a revolutionary new oven (their patented PCR platform) that can cook many different types of dishes (diseases tests). Right now, they are spending heavily to build restaurant franchises in India and Saudi Arabia (the JVs) and perfect new recipes (TB, HPV tests) before the ovens are officially certified for home use (FDA approval). Their bank account is dwindling because they are building everything before the customers start pouring in. The next year is about finally opening those restaurants and proving the oven's value to the world.

📇 Key Contacts & People

Dwight Egan, Chief Executive Officer
Andrew Benson, Head of Investor Relations | [email protected] | +1 801-438-1036
Valter Pinto, Managing Director, KCSA Strategic Communications (Investor Contact) | [email protected] | +1 212.896.1254
Jennifer Webb, Media Contact, ColtrinMethod PR | [email protected]

🧩 Final Takeaway

Co-Diagnostics is in a high-stakes transition year, pouring resources into global partnerships and clinical development for its diagnostic platform. The 2025 financials reflect this heavy investment phase, resulting in a significant loss and a shrinking cash reserve. All eyes are on 2026 to see if they can successfully launch commercialization in key markets and start turning their technology into substantial revenue before they need to raise more money.

Co-Diagnostics, Inc. — 8-K Filing