Co-Diagnostics Inc【CODX】株式ニュース

Co-Diagnostics Joint Venture CoMira Finalizes Lease Agreement for Manufacturing Facility in Saudi Arabia's Sudair Industrial CityMay 8, 2026 9:00 AM
PR Newswire (US) Lease execution highlights transition from approval to development and advances localized manufacturing strategy in the Kingdom of Saudi Arabia in accordance with Vision 2030SALT LAKE CITY, May 8, 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 that its joint venture, CoMira Diagnostics LLC ("CoMira"), has finalized a lease agreement for its planned manufacturing facility in Sudair Industrial City in the Kingdom of Saudi Arabia ("KSA"). The lease execution represents a key milestone as CoMira advances domestic manufacturing capabilities within the KSA and follows the Company's previously announced approval for an industrial land allocation in Sudair Industrial City by the Saudi Authority for Industrial Cities and Technology Zones ("MODON")."Co-Dx continues to advance our CoMira joint venture, with today's lease finalization marking an important milestone in expanding our presence in the KSA," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "Executing the lease moves us from planning into the execution phase of development and reflects ongoing progress in localizing our platform within Saudi Arabia. We believe this initiative supports the Kingdom's Vision 2030 goals related to healthcare infrastructure, domestic manufacturing, and supply-chain resilience."The lease covers an industrial facility of approximately 14,400 square feet in Sudair Industrial City, one of Saudi Arabia's leading industrial hubs. The facility is designated for approved manufacturing activities, including diagnostic instruments, laboratory testing equipment, and medical consumables, and is intended to support CoMira's planned manufacturing activities related to the Co-Dx PCR platform* and other Co-Dx technology, subject to applicable regulatory approvals and operational requirements.The turnkey nature of the facility is expected to support a more efficient transition to operational readiness compared to traditional ground-up development, aligning with the Company's focus on capital-efficient expansion.Ihssan Rjoob, CEO of CoMira Diagnostics, remarked "Sudair Industrial City is intended to play a central role in Saudi Arabia's Vision 2030 initiative to diversify the economy and expand local manufacturing capabilities. We believe that establishing a presence within this industrial ecosystem aligns CoMira with national priorities around healthcare localization and industrial development."CoMira is focused on establishing localized manufacturing and distribution capabilities across Saudi Arabia and the broader Middle East and North Africa (MENA) region. The Company believes that domestic production of molecular diagnostics within the Kingdom may offer strategic advantages, particularly in government procurement processes that prioritize locally manufactured healthcare solutions.In addition, the Company believes that as relevant regulatory clearances are obtained by the U.S. FDA, the Co-Dx PCR platform may be introduced into the Saudi market through a more streamlined regulatory pathway compared to other international jurisdictions, potentially supporting earlier commercial activity as the facility is developed.This announcement represents the latest step in Co-Diagnostics' broader strategy to deploy its platform globally through localized partnerships, including its CoSara joint venture in India, and reflects the Company's continued focus on scalable, capital-efficient international expansion.*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 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.Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will," "seeks," "anticipates," and similar expressions, or the negative of these terms. Forward-looking statements in this press release include, but are not limited to, statements regarding: (i) the planned development, timing, scope, and operationalization of a manufacturing facility by CoMira Diagnostics; (ii) the ability of such facility to support manufacturing of molecular diagnostic instruments and assays; (iii) expectations regarding CoMira's positioning as an early domestic manufacturer within the Kingdom of Saudi Arabia; (iv) the potential benefits of local manufacturing, including participation in government procurement programs and contribution to Saudi Arabia's Vision 2030 objectives; and (v) the Company's broader international expansion strategy across the Middle East and North Africa. These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management as of the date of this release. Such statements are subject to a number of risks and uncertainties, including, without limitation: risks associated with satisfying infrastructure requirements and other conditions precedent; risks related to the design, financing, construction, and timely completion of the contemplated manufacturing facility; risks associated with operating through a joint venture, including governance, funding, and partner-related risks; risks related to obtaining and maintaining required regulatory approvals in the Kingdom of Saudi Arabia and other jurisdictions; risks that anticipated benefits of localization and participation in government procurement programs are not realized; uncertainties associated with market acceptance and adoption of the Company's products; competitive dynamics in the global molecular diagnostics market; execution risks associated with international expansion; and general economic, geopolitical, and public health conditions in the regions in which the Company operates or intends to operate. Actual results may differ materially from those expressed or implied in these forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements. A further description of risks and uncertainties can be found in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2026, and in its other filings with the SEC. The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law. View original content to download multimedia:https://www.prnewswire.com/news-releases/co-diagnostics-joint-venture-comira-finalizes-lease-agreement-for-manufacturing-facility-in-saudi-arabias-sudair-industrial-city-302766568.htmlSOURCE Co-Diagnostics Original: Co-Diagnostics Joint Venture CoMira Finalizes Lease Agreement for Manufacturing Facility in Saudi Arabia's Sudair Industrial City

Co-Diagnostics Reports Full Year 2025 Financial ResultsMarch 31, 2026 4:01 PM
PR Newswire (US)

Advancing Global Commercialization Strategy Through CoSara and CoMira Joint VenturesProgressing Clinical Pipeline and Regulatory Pathways for PCR PlatformStrengthening Technology Leadership with AI Integration and Expanding IP PortfolioSALT LAKE CITY, March 31, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (NASDAQ: CODX) ("Co-Diagnostics," "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 full year ended December 31, 2025.

Full Year 2025 Financial Results:Revenue of $0.6 million, compared to $3.9 million in 2024, primarily due to lower grant revenueOperating expenses of $50.6 million, compared to $43.0 million in 2024, driven by a non-cash impairment charge of $18.9 million from revaluation of intangible assetsOperating loss of $50.2 million, compared to $40.1 million in 2024Net loss of $46.9 million, or $35.25 per share, compared to net loss of $37.6 million, or $37.22 per share in 2024, primarily due to intangible asset impairment charges and lower grant revenue, partially offset by decreases in operating expenses and a benefit from income taxesAdjusted EBITDA loss of $28.0 million, compared to a loss of $33.5 million in 2024Cash, cash equivalents, and marketable investment securities totaled $11.9 million as of December 31, 2025, compared to $29.7 million as of December 31, 2024Full Year 2025 Business Highlights:Closed $3.8 million offering of 9.62 million shares of common stock at an offering price of $0.40 per share on a pre-reverse split basisClosed $7.0 million offering of 12.7 million shares of common stock at an offering price of $0.55 per share on a pre-reverse split basisContinued advancement of CoSara Diagnostics joint venture in India, including regulatory progress and manufacturing readiness for PCR Pro® instrument*Signed definitive agreement with Arabian Eagle to establish CoMira Diagnostics joint venture in Saudi Arabia; currently progressing on execution and finalizing lease for manufacturing facilityInitiated and advanced clinical evaluations of upper respiratory multiplex testFurther progressed development across pipeline programs, including tuberculosis (TB) and HPV testsExpanded the AI business unit, integrating machine learning capabilities into the Co-Dx™ Primer Ai™ platformStrengthened the intellectual property portfolio with a new international patent granted in AustraliaEngaged Maxim Group to pursue SPAC transaction for CoSara DiagnosticsReceived recognition from Utah Governor's Office and BioUtah for the formation of CoMira DiagnosticsRecent Developments:Received CDSCO license to manufacture and sell the CoSara PCR Pro® instrument in India, representing a key regulatory milestone and enabling commercialization readinessSigned an agreement to expand CoSara Diagnostics' commercial and distribution territory across South Asia to include Bangladesh, Pakistan, Nepal, and Sri Lanka, increasing the regional addressable market to approximately $13 billionInitiated shipments of PCR Pro® instruments and tuberculosis (TB) test* materials to India to support upcoming clinical performance studies, with the instrument and test kits being aligned with new WHO guidance on TB testingStrengthened the intellectual property portfolio with a new international patent granted in Japan"Over the past year, we made meaningful progress across multiple initiatives that have positioned the Company for its next phase of growth, including advancing our clinical pipeline, expanding our global footprint, and preparing for commercialization of the platform in 2026," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "Importantly, we have remained focused on execution and continued to build momentum across the business. Our strategy is centered on four key pillars: advancing CoSara and our broader opportunity in India, executing on our CoMira joint venture in the Middle East and Northern Africa, progressing our clinical programs toward key regulatory milestones, and expanding our AI-driven capabilities. Together, these initiatives support our scalable, globally deployable diagnostics platform and reinforce our focus on long-term value creation."Mr. Egan continued, "Based on dramatically reduced rates of COVID prevalence in our clinical study locations, we are currently planning on an initial FDA 510(k) submission for our upper respiratory test focused on flu A, flu B, and RSV. As we move forward, we remain committed to disciplined performance as we advance toward commercialization, and we anticipate that this modified approach will allow us to accelerate regulatory and commercialization timelines while retaining the flexibility to incorporate COVID into the test at a later stage if conditions change."We believe the progress we've made in our clinical studies and on all other initiatives are creating a clear path to unlock the full potential of our platform as we enter the next phase of execution in 2026."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 hereConference 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 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 to detect and/or analyze 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, which is a non-GAAP measure defined as net loss excluding depreciation, amortization, (gain) loss on disposition of assets, income tax (benefit) expense, net interest (income) expense, stock-based compensation, change in fair value of contingent consideration, impairment charges 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 statements regarding (i) advancement into clinical evaluations and continued development and regulatory submissions for the Co-Dx PCR platform and (ii) our belief that the platform will play a key role in transforming the global accessibility of diagnostic testing solutions. 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 of the anticipated results will occur on a timely basis 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

December 31,
2025

December 31,
2024
Assets

Current assets

Cash and cash equivalents
$11,884,607

$2,936,544
Marketable investment securities

-

26,811,098
Accounts receivable, net

190,375

132,570
Inventory, net

992,397

1,072,724
Income taxes receivable

44,559

-
Prepaid expenses and other current assets

581,527

1,338,762
Total current assets

13,693,465

32,291,698
Property and equipment, net

2,272,098

2,761,280
Operating lease right-of-use asset

1,207,453

2,114,876
Intangible assets, net

7,219,000

26,101,000
Investment in joint ventures

350,569

294,304
Total assets
$24,742,585

$63,563,158
Liabilities and stockholders' equity

Current liabilities

Accounts payable
$1,878,225

$3,294,254
Accrued expenses

865,301

2,562,169
Operating lease liability, current

662,258

915,619
Contingent consideration liabilities, current

119,036

502,819
Deferred revenue

14,800

40,857
Total current liabilities

3,539,620

7,315,718
Long-term liabilities

Income taxes payable

-

713,643
Operating lease liability

574,301

1,236,560
Contingent consideration liabilities

-

422,080
Total long-term liabilities

574,301

2,372,283
Total liabilities

4,113,921

9,688,001
Commitments and contingencies (Note 13)

Stockholders' equity

Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively

-

-
Common stock, $0.001 par value; 100,000,000 shares authorized; 2,256,654 shares issued and 2,095,031 shares outstanding as of December 31, 2025 and 1,263,408 shares issued and 1,101,785 shares outstanding as of December 31, 2024

67,700

37,902
Treasury stock, at cost; 161,623 shares held as of December 31, 2025 and December 31, 2024, respectively

(15,575,795)

(15,575,795)
Additional paid-in capital

116,510,298

102,472,210
Accumulated other comprehensive income

-

418,443
Accumulated deficit

(80,373,539)

(33,477,603)
Total stockholders' equity

20,628,664

53,875,157
Total liabilities and stockholders' equity
$24,742,585

$63,563,158
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

Years Ended December 31,

2025

2024
Product revenue
$418,205

$770,048
Grant revenue

204,284

3,145,112
Total revenue

622,489

3,915,160
Cost of revenue

222,377

999,124
Gross profit

400,112

2,916,036
Operating expenses

Sales and marketing

2,381,131

4,483,339
General and administrative

9,058,283

16,157,152
Research and development

19,137,242

20,979,589
Depreciation and amortization

1,106,808

1,377,266
Impairment charges

18,882,000

-
Total operating expenses

50,565,464

42,997,346
Loss from operations

(50,165,352)

(40,081,310)
Other income, net

Interest income, net

292,932

1,091,825
Realized gain on investments

683,365

870,745
Gain (loss) on disposition of assets

(82,421)

8,291
Gain on remeasurement of acquisition contingencies

805,863

714,876
Loss on equity method investment in joint ventures

(46,301)

(186,067)
Total other income, net

1,653,438

2,499,670
Loss before income taxes

(48,511,914)

(37,581,640)
Income tax provision (benefit)

(1,615,978)

57,368
Net loss
$(46,895,936)

$(37,639,008)
Other comprehensive income (loss)

Change in net unrealized gains (losses) on marketable securities, net of tax

(418,443)

271,743
Total other comprehensive income (loss)
$(418,443)

$271,743
Comprehensive loss
$(47,314,379)

$(37,367,265)

Loss per common share:

Basic and Diluted
$(35.25)

$(37.22)
Weighted average shares outstanding:

Basic and Diluted

1,330,200

1,011,179
CO-DIAGNOSTICS, INC. AND SUBSIDIARIESGAAP AND NON-GAAP MEASURES Reconciliation of net loss to adjusted EBITDA:

Years Ended December 31,

2025

2024
Net loss
$(46,895,936)

$(37,639,008)
Interest income, net

(292,932)

(1,091,825)
Realized gain on investments

(683,365)

(870,745)
Depreciation and amortization

1,106,808

1,377,266
(Gain) loss on disposition of assets

82,421

(8,291)
Change in fair value of contingent consideration

(805,863)

(714,876)
Stock-based compensation expense

2,248,053

5,434,904
Income tax provision

(1,615,978)

57,368
Impairment charges

18,882,000

-
Adjusted EBITDA
$(27,974,792)

$(33,455,207)

Reconciliation of net loss to adjusted net loss:

Net loss
$(46,895,936)

$(37,639,008)
Impairment charges

18,882,000

-
Adjusted net loss
$(28,013,936)

$(37,639,008)

View original content to download multimedia:https://www.prnewswire.com/news-releases/co-diagnostics-reports-full-year-2025-financial-results-302730537.htmlSOURCE Co-Diagnostics

Original: Co-Diagnostics Reports Full Year 2025 Financial Results