Co-Diagnostics Reports Third Quarter 2026 Financial Results
Two Regulatory Submissions Under Review in India and the U.S.
Third Quarter Operating Expenses Down 12% Year Over Year
Platform Capabilities Expanding with ReadyGo Collaboration, India Connectivity and Vector Smart Growth
SALT LAKE CITY, Nov. 10, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced its financial results for the third quarter ended September 30, 2026.
Third Quarter 2026 Business Highlights:
"The third quarter was a period of significant regulatory and operational progress for Co-Diagnostics," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "CoSara completed its clinical performance study for our point-of-care tuberculosis test and submitted it to India's Central Drugs Standard Control Organization (CDSCO), and together with our August FDA 510(k) submission for the Flu A/B & RSV test, we now have two regulatory submissions under review in two important markets for our platform. We also launched our cloud and mobile infrastructure in India, began evaluating blood-based testing with ReadyGo, and completed the first international deployment of Vector Smart. With our submissions in India and the U.S. under review, our focus is on supporting those reviews, advancing our feasibility work with ReadyGo and continuing to grow Vector Smart."
Recent Developments:
Third Quarter 2026 Financial Results:
Conference Call and Webcast:
Co-Diagnostics will host a conference call and webcast at 4:30 p.m. ET today to review its third quarter 2026 results. 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 or authorization by applicable regulatory authorities in the jurisdictions in which clearance or approval is sought, including the US FDA, and is not yet available for sale.
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform (subject to regulatory review and not currently for sale) and to identify genetic markers for use in applications other than infectious disease.
Non-GAAP Financial Measures:
This press release contains adjusted EBITDA, a non-GAAP measure defined as net income (loss) adjusted for 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 within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. 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, regulatory submissions and regulatory reviews, including the anticipated timing of CDSCO clearance and the commencement of commercial sales in India; (iii) the Company's ability to develop, scale, and commercialize its manufacturing capabilities, including through CoSara and CoMira and other third parties; (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. These risks and uncertainties include, among others, risks relating to the timing and outcome of FDA and other regulatory review processes; the possibility that clinical or analytical data may not support regulatory clearance, authorization or commercialization; the Company's ability to successfully complete product development, manufacturing scale-up and commercialization activities; market acceptance and adoption of the Company's products and technologies; the Company's dependence on joint ventures, distributors, manufacturers and other third parties; risks associated with conducting business and obtaining regulatory approvals in international markets; the Company's ability to obtain additional capital when needed, maintain sufficient liquidity to execute its business plans and continue as a going concern; and competitive and technological developments. 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. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statement as a result of new information, future events or otherwise, except as required by applicable law.
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
September 30, 2026
December 31, 2025
Assets
Current assets
Cash and cash equivalents
$
714,803
$
11,884,607
Accounts receivable, net
51,828
190,375
Inventory, net
672,950
992,397
Income taxes receivable
-
44,559
Prepaid expenses and other current assets
498,517
581,527
Total current assets
1,938,098
13,693,465
Property and equipment, net
1,767,749
2,272,098
Operating lease right-of-use asset
1,531,986
1,207,453
Intangible assets, net
7,219,000
7,219,000
Investment in joint ventures
335,015
350,569
Total assets
$
12,791,848
$
24,742,585
Liabilities and stockholders' equity
Current liabilities
Accounts payable
$
937,294
$
1,878,225
Accrued expenses
850,200
865,301
Operating lease liability, current
709,754
662,258
Contingent consideration liabilities, current
12,572
119,036
Deferred revenue
2,000
14,800
Total current liabilities
2,511,820
3,539,620
Long-term liabilities
Operating lease liability
854,749
574,301
Total long-term liabilities
854,749
574,301
Total liabilities
3,366,569
4,113,921
Commitments and contingencies (Note 11)
Stockholders' equity
Convertible preferred stock, $0.001 par value; 5,000,000 shares
authorized; 0 shares issued and outstanding as of September 30, 2026
and December 31, 2025, respectively
-
-
Common stock, $0.001 par value; 100,000,000 shares authorized;
7,450,224 shares issued and 7,288,601 shares outstanding as of
September 30, 2026 and 2,256,654 shares issued and 2,095,031 shares
outstanding as of December 31, 2025
72,893
67,700
Treasury stock, at cost; 161,623 shares held as of September 30, 2026
and December 31, 2025, respectively
(15,575,795)
(15,575,795)
Additional paid-in capital
127,031,952
116,510,298
Accumulated deficit
(102,103,771)
(80,373,539)
Total stockholders' equity
9,425,279
20,628,664
Total liabilities and stockholders' equity
$
12,791,848
$
24,742,585
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
Three Months Ended September 30,
2026
2025
Product revenue
$
282,881
$
145,380
Total revenue
282,881
145,380
Cost of revenue
303,344
26,285
Gross profit
(20,463)
119,095
Operating expenses
Sales and marketing
579,902
568,937
General and administrative
1,871,838
1,815,945
Research and development
3,574,784
4,480,678
Depreciation and amortization
222,363
267,383
Total operating expenses
6,248,887
7,132,943
Loss from operations
(6,269,350)
(7,013,848)
Other income (expense), net
Interest income, net
3,123
13,194
Realized gain on investments
-
41,542
Gain (loss) on disposition of assets
-
4,000
Gain (loss) on remeasurement of acquisition contingencies
60,355
(42,345)
Loss on equity method investment in joint ventures
(100,036)
(55,959)
Total other income (expense), net
(36,558)
(39,568)
Loss before income taxes
(6,305,908)
(7,053,416)
Income tax provision (benefit)
500
(1,166,593)
Net loss
$
(6,306,408)
$
(5,886,823)
Other comprehensive loss
Change in net unrealized gains on marketable securities, net of tax
-
(39,180)
Total other comprehensive loss
$
-
$
(39,180)
Comprehensive loss
$
(6,306,408)
$
(5,926,003)
Loss per common share:
Basic and Diluted
$
(1.01)
$
(4.66)
Weighted average shares outstanding:
Basic and Diluted
6,272,635
1,263,031
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
GAAP AND NON-GAAP MEASURES
(Unaudited)
Reconciliation of net loss to adjusted EBITDA:
Three Months Ended September 30,
2026
2025
Net loss
$
(6,306,408)
$
(5,886,823)
Interest income, net
(3,123)
(13,194)
Realized gain on investments
-
(41,542)
Depreciation and amortization
222,363
267,383
Gain (loss) on disposition of assets
-
(4,000)
Change in fair value of contingent consideration
(60,355)
42,345
Stock-based compensation expense
255,184
500,585
Income tax provision (benefit)
500
(1,166,593)
Adjusted EBITDA
$
(5,891,839)
$
(6,301,839)
SOURCE Co-Diagnostics