Co-Diagnostics Reports First Quarter 2026 Financial Results
Rhea-AI Summary
Co-Diagnostics (Nasdaq: CODX) reported Q1 2026 revenue of $0.15 million, up from $0.05 million in Q1 2025. Operating expenses were $9.2 million and net loss was $9.1 million, or $4.06 per share. Cash was $8.2 million on March 31, 2026.
Key updates include an Indian CDSCO license and ISO 13485 certification for the CoSara PCR Pro® instrument, South Asia territory expansion lifting TAM to about $13 billion, completion of upper respiratory clinical enrollment, TB study preparations in India, and advancement of a CoMira manufacturing facility in Saudi Arabia.
AI-generated analysis. Not financial advice.
Positive
- Q1 2026 revenue increased to $0.15 million from $0.05 million year over year
- CDSCO license obtained to manufacture and sell PCR Pro in India
- ISO 13485 certification achieved for CoSara’s manufacturing facility in India
- South Asia territory expansion raises estimated TAM to approximately $13 billion
- Upper respiratory clinical studies fully enrolled with more than 1,400 patients
- CoMira manufacturing facility in Saudi Arabia advanced with regulatory approval and lease execution
- Cash and cash equivalents of $8.2 million as of March 31, 2026
Negative
- Q1 2026 operating loss widened to $9.2 million from $8.6 million
- Q1 2026 net loss increased to $9.1 million from $7.5 million
- Adjusted EBITDA loss rose to $8.7 million from $7.4 million year over year
- Cash and cash equivalents declined to $8.2 million from $11.9 million at December 31, 2025
Key Figures
Market Reality Check
Peers on Argus
CODX fell 6.98% while peers were mixed: INBS up 14%, AIMD up 2.4%, SINT up 0.63%, XAIR down 1.88%, NXL down 0.56%, indicating a stock-specific move rather than a sector trend.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 31 | Full-year 2025 results | Negative | -12.9% | Full-year 2025 revenue drop, large losses, limited cash balance. |
| Nov 13 | Q3 2025 earnings | Negative | -10.9% | Q3 2025 revenue decline with ongoing losses despite lower expenses. |
| Aug 14 | Q2 2025 earnings | Neutral | +10.8% | Q2 2025 small revenue, net loss, and reduced operating expenses. |
| May 08 | Q1 2025 earnings | Negative | -4.3% | Q1 2025 revenue drop and continued net loss despite cost cuts. |
| Mar 27 | Full-year 2024 results | Negative | -18.3% | Full-year 2024 revenue decline and sizable operating and net losses. |
Earnings releases have typically coincided with negative price reactions, with only one recent quarter showing a positive move.
Over the past year, Co-Diagnostics’ earnings reports have highlighted declining revenue, persistent net losses, and ongoing investment in its Co-Dx PCR platform and global partnerships. Prior earnings on Mar 31, 2026 and throughout 2025 showed revenue contraction, high operating expenses, and repeated negative price reactions, including moves of -12.9% and -18.26%. Against this backdrop, the current Q1 2026 results—with small revenue, larger losses, and reduced cash—fit a pattern of financially weak, R&D-heavy updates tied to long-term commercialization efforts.
Historical Comparison
Past earnings-related releases for CODX averaged a -7.11% move. The current -6.98% pre-news decline sits in line with this pattern of weak reactions to financial updates.
Earnings releases depict shrinking revenue, recurring net losses, and declining cash while management advances the Co-Dx PCR platform and international manufacturing and distribution initiatives.
Regulatory & Risk Context
On May 12, 2026, Co-Diagnostics filed an S-3 shelf to offer up to $150,000,000 of various securities over time for working capital and general corporate purposes, including product development, sales and marketing, acquisitions, or debt repayment.
Market Pulse Summary
This announcement combines Q1 2026 financials with operational updates, including revenue of $0.15M, an operating loss of $9.2M, and cash of $8.2M as the company advances clinical studies and international commercialization. Historically, earnings releases have coincided with weak price moves and highlight recurring losses. Investors may watch upcoming 510(k) progress, clinical data from the MTB and upper respiratory programs, cash usage trends, and any offerings under the new $150M shelf registration.
Key Terms
CDSCO regulatory
ISO 13485 regulatory
tuberculosis (TB) medical
WHO guidance medical
510(k) regulatory
PCR technical
AI-generated analysis. Not financial advice.
Advancing Global Commercialization Through CoSara Regulatory Progress and Regional Expansion
Executing Clinical Strategy with Upper Respiratory Submission Preparation and TB Study Initiation
Expanding International Presence and Reinforcing Platform Differentiation Through Partnerships and IP
First Quarter 2026 Business Highlights:
- Received CDSCO license to manufacture and sell the CoSara PCR Pro® instrument in
India , marking a key regulatory milestone and supporting commercialization readiness - Received ISO 13485 certification for CoSara's manufacturing facility in
India , supporting regulatory submissions and meeting international quality standards - Entered into an agreement to expand CoSara Diagnostics' commercial and distribution territory across
South Asia to includeBangladesh ,Pakistan ,Nepal , andSri Lanka , increasing the regional total addressable market to approximately$13 billion - Initiated shipments of PCR Pro* instruments and tuberculosis (TB) test materials to
India to support upcoming clinical performance studies, with the instrument and test kits designed to support testing approaches reflected in recent WHO guidance on TB testing - Strengthened distributor relationships and expanded market presence through CoSara Diagnostics' participation in regional conferences in
India - Showcased the Co-Dx PCR platform at industry events including Medical Korea 2026 in
Seoul, South Korea and World Health Expo LabsDubai inDubai ,UAE , highlighting the Company's point-of-care testing platform and engaging with global stakeholders - Expanded the intellectual property portfolio with the issuance of a new international patent in
Japan
First Quarter 2026 Financial Results:
- Revenue of
$0.15 million $0.05 million - Operating expenses of
$9.2 million $8.6 million - Operating loss of
$9.2 million $8.6 million - Net loss of
$9.1 million $4.06 $7.5 million $7.05 - Adjusted EBITDA loss of
$8.7 million $7.4 million - Cash and cash equivalents totaled
$8.2 million $11.9 million
"The progress we've made across the business is translating into tangible milestones and expanded opportunities," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "During the quarter, we advanced key initiatives across our clinical pipeline, strengthened our presence in strategic global markets through CoSara and CoMira, and continued to build the foundation for a scalable, globally deployable diagnostics platform. These efforts reflect a focused strategy centered on execution, innovation, and expanding our reach into high-need markets."
Mr. Egan continued, "We believe we have generated the data needed to support a regulatory submission for our upper respiratory multiplex test and are advancing toward a 510(k) filing with the FDA. We are also preparing to initiate clinical performance studies for our MTB program in
Recent Developments:
- Completed enrollment in the upper respiratory Co-Dx test clinical studies, with more than 1,400 patients enrolled
- Advanced CoMira Diagnostics' manufacturing facility in Sudair Industrial City in the
Kingdom of Saudi Arabia ("KSA") through regulatory approval and lease execution, supporting localized manufacturing and expansion across theMiddle East andNorth Africa ("MENA") - Participated in a European trade mission across
Switzerland andGermany with theUtah Governor's Office and World Trade Center Utah, engaging with prospective customers and distributors, including at ESCMID Global 2026 - Presented at the Stop TB Partnership Summit in
Washington, D.C. , showcasing the Company's Co-Dx PCR tuberculosis (TB) test during a roundtable withU.S. government agencies and global health stakeholders
Conference Call and Webcast:
Co-Diagnostics will host a conference call and webcast at 4:30 p.m. EDT today to discuss its financial results with analysts and institutional investors. The conference call and webcast will be available via:
Webcast: ir.co-dx.com on the Events & Webcasts page, or accessible directly here
Conference Call: 1-888-880-3330 (Toll Free) or 1-646-357-8766 (Toll)
The call will be recorded and later made available on the Company's website.
*The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.
About Co-Diagnostics, Inc.
Co-Diagnostics, Inc., a
Non-GAAP Financial Measures:
This press release contains adjusted EBITDA, which is a non-GAAP measure defined as net income excluding depreciation, amortization, income tax (benefit) expense, net interest (income) expense, stock-based compensation, change in fair value of contingent consideration, and realized gain (loss) on investments. The Company believes that adjusted EBITDA provides useful information to management and investors relating to its results of operations. The Company's management uses this non-GAAP measure to compare the Company's performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The Company believes that the use of adjusted EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company's financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making.
Management does not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recorded in the Company's financial statements. In order to compensate for these limitations, management presents the non-GAAP financial measure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A reconciliation table of the net income, the most comparable GAAP financial measure to adjusted EBITDA, is included at the end of this release. The Company urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company's business.
Forward-Looking Statements:
This press release contains forward-looking statements. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release include, but are not limited to, statements regarding: (i) the continued development, clinical evaluation, regulatory submission, clearance, authorization, and commercialization of the Co-Dx PCR platform and related tests; (ii) anticipated timing and progress of clinical studies and regulatory submissions; (iii) commercialization and manufacturing activities involving CoSara and CoMira; (iv) anticipated market opportunities and international expansion initiatives; (v) the expected capabilities, differentiation, and adoption of the Company's platform technologies; and (vi) the Company's strategic, operational, and growth initiatives generally. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any regulatory submission, authorization, commercialization milestone, manufacturing initiative, strategic collaboration, or market opportunity will occur on the timelines anticipated by the Company, or at all, due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 31, 2026, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (Unaudited)
| ||||||||
March 31, 2026 | December 31, 2025 | |||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 8,230,984 | $ | 11,884,607 | ||||
Accounts receivable, net | 82,339 | 190,375 | ||||||
Inventory, net | 846,119 | 992,397 | ||||||
Income taxes receivable | 49 | 44,559 | ||||||
Prepaid expenses and other current assets | 622,760 | 581,527 | ||||||
Total current assets | 9,782,251 | 13,693,465 | ||||||
Property and equipment, net | 2,158,670 | 2,272,098 | ||||||
Operating lease right-of-use asset | 2,002,597 | 1,207,453 | ||||||
Intangible assets, net | 7,219,000 | 7,219,000 | ||||||
Investment in joint ventures | 337,208 | 350,569 | ||||||
Total assets | $ | 21,499,726 | $ | 24,742,585 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 2,017,852 | $ | 1,878,225 | ||||
Accrued expenses | 1,364,754 | 865,301 | ||||||
Operating lease liability, current | 857,638 | 662,258 | ||||||
Contingent consideration liabilities, current | 43,756 | 119,036 | ||||||
Deferred revenue | 600 | 14,800 | ||||||
Total current liabilities | 4,284,600 | 3,539,620 | ||||||
Long-term liabilities | ||||||||
Operating lease liability | 1,172,716 | 574,301 | ||||||
Total long-term liabilities | 1,172,716 | 574,301 | ||||||
Total liabilities | 5,457,316 | 4,113,921 | ||||||
Commitments and contingencies (Note 10) | ||||||||
Stockholders' equity | ||||||||
Convertible preferred stock, | - | - | ||||||
Common stock, | 69,207 | 67,700 | ||||||
Treasury stock, at cost; 161,623 shares held as of March 31, 2026 and December 31, 2025, respectively | (15,575,795) | (15,575,795) | ||||||
Additional paid-in capital | 121,062,575 | 116,510,298 | ||||||
Accumulated deficit | (89,513,577) | (80,373,539) | ||||||
Total stockholders' equity | 16,042,410 | 20,628,664 | ||||||
Total liabilities and stockholders' equity | $ | 21,499,726 | $ | 24,742,585 | ||||
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited)
| ||||||||
Three Months Ended March 31, | ||||||||
2026 | 2025 | |||||||
Product revenue | $ | 145,954 | $ | 50,277 | ||||
Total revenue | 145,954 | 50,277 | ||||||
Cost of revenue | 193,768 | 21,590 | ||||||
Gross profit (loss) | (47,814) | 28,687 | ||||||
Operating expenses | ||||||||
Sales and marketing | 467,955 | 657,030 | ||||||
General and administrative | 2,503,126 | 2,773,149 | ||||||
Research and development | 5,934,071 | 4,870,019 | ||||||
Depreciation and amortization | 255,445 | 280,445 | ||||||
Impairment charges | - | - | ||||||
Total operating expenses | 9,160,597 | 8,580,643 | ||||||
Loss from operations | (9,208,411) | (8,551,956) | ||||||
Other income, net | ||||||||
Interest income, net | 6,974 | 13,601 | ||||||
Realized gain on investments | - | 301,465 | ||||||
Gain on remeasurement of acquisition contingencies | 75,280 | 717,067 | ||||||
Loss on equity method investment in joint ventures | (13,361) | (1,444) | ||||||
Total other income, net | 68,893 | 1,030,689 | ||||||
Loss before income taxes | (9,139,518) | (7,521,267) | ||||||
Income tax provision | 520 | 12,004 | ||||||
Net loss | $ | (9,140,038) | $ | (7,533,271) | ||||
Other comprehensive income (loss) | ||||||||
Change in net unrealized gains (losses) on marketable securities, net of tax | - | (87,790) | ||||||
Total other comprehensive income (loss) | $ | - | $ | (87,790) | ||||
Comprehensive loss | $ | (9,140,038) | $ | (7,621,061) | ||||
Loss per common share: | ||||||||
Basic and Diluted | $ | (4.06) | $ | (7.05) | ||||
Weighted average shares outstanding: | ||||||||
Basic and Diluted | 2,253,474 | 1,068,299 | ||||||
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES GAAP AND NON-GAAP MEASURES (Unaudited)
| ||||||||
Reconciliation of net loss to adjusted EBITDA: | ||||||||
Three Months Ended March 31, | ||||||||
2026 | 2025 | |||||||
Net loss | $ | (9,140,038) | $ | (7,533,271) | ||||
Interest income, net | (6,974) | (13,601) | ||||||
Realized gain on investments | - | (301,465) | ||||||
Depreciation and amortization | 255,445 | 280,445 | ||||||
Change in fair value of contingent consideration | (75,280) | (717,067) | ||||||
Stock-based compensation expense | 219,114 | 875,228 | ||||||
Income tax provision | 520 | 12,004 | ||||||
Adjusted EBITDA | $ | (8,747,213) | $ | (7,397,727) | ||||
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SOURCE Co-Diagnostics