Annuncio • Jul 16
Co-Diagnostics Appoints Wes Lindsey as Chief Scientific Officer Co-Diagnostics, Inc. announced the appointment of Wes Lindsey, PhD, MBA as the Company's new Chief Scientific Officer ("CSO"). Dr. Lindsey brings more than 20 years' experience in molecular diagnostics. He holds a PhD in Genetics & Molecular Biology from Emory University and an MBA from Georgia State University. Over his career, Dr. Lindsey has led assay development and R&D teams that produced more than a dozen FDA 510(k) submissions and CE-marked assays for sample-to-result in vitro diagnostic ("IVD") products. Annuncio • Jul 13
Co-Diagnostics, Inc., Annual General Meeting, Sep 03, 2026 Co-Diagnostics, Inc., Annual General Meeting, Sep 03, 2026. Location: 2401 s. foothill, dr, ste. d, slc, utah 84109, United States Annuncio • Jul 02
Co-Diagnostics, Inc. Completes Clinical and Analytical Studies for Co-Dx Pcr Flu A/B & Rsv Upper Respiratory Multiplex Test in Preparation for Fda 510(K) Submission Co-Diagnostics, Inc. announced the completion of clinical and analytical performance studies for the Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro instrument that the Company currently expects to include in its planned submission package. Completion of these studies represents a significant milestone in preparation of a Dual 510(k) and CLIA Waiver by Application submission to the U.S. Food and Drug Administration, targeted for Third Quarter 2026. More than 1,400 patients enrolled across 9 clinical sites; analytical performance testing included 27 individual studies and over 10,000 PCR test cup runs. Analytical data to support concurrent 510(k) submission with CLIA Waiver by Application for point-of-care settings, with submission targeted for Third Quarter 2026. Prior to IVD test submission to the FDA for review, medical device manufacturers are required to complete extensive analytical and clinical validation studies to demonstrate that the test performs reliably under both controlled laboratory conditions and its intended real-world use. Analytical validation of the Co-Dx PCR test included over 10,000 PCR test cup runs across 27 individual studies, including studies supporting the CLIA Waiver by Application to allow the test to be used in waived point-of-care settings. This also included a rigorous external multicenter reproducibility study demonstrating consistent performance when operated by untrained operators across multiple sites and instruments. The reproducibility study was designed to evaluate whether performance observed in clinical settings could be replicated across different operators, sites and instruments, and the results support inclusion of those data in the planned FDA submission. That consistency is central to what a CLIA Waiver requires. 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. Annuncio • Jun 02
Co-Diagnostics and Cosara Advance Ebola Pcr Test Development and Co-Dx Pcr Point-Of-Care Platform Capabilities Co-Diagnostics, Inc. announced continued progress in its Ebola PCR development program with joint venture CoSara Diagnostics Pvt. Ltd. The program includes development of both a pan-Ebola assay designed to rapidly detect multiple ebolavirus species and a multiplex assay capable of differentiating among Sudan, Taï Forest, Zaire, and Bundibugyo ebolaviruses currently associated with outbreaks in Central Africa. This dual-assay strategy is intended to provide flexibility in supporting outbreak response efforts, including those of potential NGO partners, subject to future development, validation, regulatory review, and deployment requirements. The Ebola PCR assay workflow configurations also being developed to support point-of-care environments for the Co-Dx PCR point-of-care platform would represent the first blood-based pathogen assay designed for use on the Co-Dx PCR Pro. This would significantly expand the platform's capabilities beyond swab-based infectious disease testing and increase the range of potential applications that may be addressed through future menu expansion. Many of the world's most serious infectious diseases are identified using blood samples, and expanding the platform to support those applications would represent an important step forward for Co-Diagnostics. The ability to bring rapid, high-quality PCR testing closer to patients, whether through respiratory, tuberculosis, HPV, or blood-borne disease applications, supports the broader goal of making molecular diagnostics more accessible in both developed and emerging markets. 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. Annuncio • May 26
Co-Diagnostics Advances Ebola Pcr Assay Development Strategy with Joint Venture Cosara Co-Diagnostics, Inc. has advanced the PCR assay development strategy for the Bundibugyo virus ("BDBV") currently causing an outbreak of Ebola disease in the Democratic Republic of the Congo ("DRC") and Uganda, with the support of CoSara Diagnostics Pvt. Ltd. ("CoSara" or the "JV"), the Indian joint venture between Co-Dx and Ambalal Sarabhai Enterprises Limited ("ASE Group"). The joint assay development strategy is expected to more rapidly address the needs of the international community if the current outbreak expands globally, or if localized governmental or non-governmental support is needed in the areas of DRC and Uganda. CoSara's regional manufacturing and operational capabilities may support rapid deployment initiatives in certain international markets, subject to applicable regulatory requirements. The proposed development program includes evaluation of both BDBV-specific and pan-Ebola assay configurations designed to detect multiple ebolavirus species. The Company is also evaluating workflow configurations intended to support point-of-care and decentralized testing environments for the Co-Dx PCR point-of-care platform. 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. On May 25, the World Health Organization ("WHO") reported that the outbreak of Ebola disease caused by BDBV, which the WHO Director-General declared a public health emergency of international concern ("PHEIC") on May 17, 2026, has resulted in more than 900 suspected cases and 220 suspected deaths, and that the epidemic is currently outpacing response operations. Annuncio • May 21
Co-Diagnostics Inc Develops Ebola Assay Strategy Co-Diagnostics, Inc. has completed the assay development strategy for the Bundibugyo virus ("BDBV") currently causing an outbreak of Ebola disease in the Democratic Republic of the Congo and Uganda. On May 17, WHO declared an outbreak of Ebola disease caused by BDBV as a public health emergency of international concern ("PHEIC"). As of May 17, eight laboratory-confirmed cases, 246 suspected cases, and 80 suspected deaths have been reported in the Democratic Republic of the Congo, along with two laboratory-confirmed cases and one reported death in Uganda. The announcement also follows recent guidance from the U.S. Centers for Disease Control and Prevention ("CDC") regarding enhanced screening and monitoring measures for travelers arriving from regions impacted by Ebola outbreaks. According to the CDC, these measures include increased traveler monitoring, contact tracing coordination, and enhanced hospital preparedness efforts, underscoring the importance of rapid testing and real-time outbreak visibility in responding to emerging infectious disease threats. 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. Annuncio • May 20
Co-Diagnostics, Inc. announced that it expects to receive $3 million in funding Co-Diagnostics, Inc. announced that it has entered into a securities purchase agreement with certain institutional investors to sell an aggregate of 1,647,447 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate 3,294,894 shares of common stock, in a private placement priced at-the-market under Nasdaq rules for gross proceeds of $3,000,000 on May 19, 2026. The combined effective offering price for each share of common stock (or pre-funded warrant in-lieu thereof) and accompanying warrants to be issued is $1.821. The warrants will have an exercise price of $1.571 per share, will be exercisable immediately upon issuance, and will expire five years from the date of issuance. The Offering is expected to close on or about May 21, 2026, subject to the satisfaction of customary closing conditions. The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities purchased in the private placement. Annuncio • Apr 30
Co-Diagnostics, Inc. to Report Q1, 2026 Results on May 14, 2026 Co-Diagnostics, Inc. announced that they will report Q1, 2026 results After-Market on May 14, 2026 Annuncio • Apr 15
Co-Diagnostics, Inc. Showcases Co-Dx Pcr Platform and Ce-Ivd Solutions At Escmid Global 2026 in Munich, Germany Co-Diagnostics, Inc. announced it will participate in the Congress of the European Society of Clinical Microbiology and Infectious Disease ESCMID Global 2026, taking place April 17-21 in Munich, Germany. ESCMID Global 2026 features academic and industry programming that brings together clinical microbiology and infectious diseases leaders dedicated to advancing scientific, education, research and technologies. Prior ESCMID Global events have historically attracted more than 16,000 registrants, nearly a third of which originated from outside of Europe, underscoring its role as the premier global forum for the infectious disease community. Company representatives look forward to establishing and strengthening relationships with new and existing customers and distributors from around the world while also showcasing the Company's suite of CE-IVD testing solutions for clinical laboratories, as well as the upcoming Co-Dx PCR platform. Registrants interested in learning more about Co-Diagnostics are invited to visit Booth #G55. 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. Annuncio • Mar 17
Co-Diagnostics, Inc. to Report Q4, 2025 Results on Mar 31, 2026 Co-Diagnostics, Inc. announced that they will report Q4, 2025 results After-Market on Mar 31, 2026 Annuncio • Jan 16
Co-Diagnostics, Inc.(OTCPK:CODX) dropped from S&P TMI Index Co-Diagnostics, Inc.(OTCPK:CODX) dropped from S&P TMI Index Annuncio • Dec 18
Co-Diagnostics Performs Analysis of Influenza Co-Primers®? to Confirm Reactivity Against Flu A H3n2 Mutation Co-Diagnostics, Inc. announced that it has performed an in silico analysis of the Co-Primers®? used in its Logix Smart®? ABC test for the detection of influenza A, influenza B and COVID-19. The analysis showed a high homology against 3,900 influenza sequences, confirming comparable reactivity of the primer sets against the influenza A H3N2 subclade K. According to the World Health Organization, seasonal influenza causes approximately 3-5 million cases of severe illness annually, resulting in 290,000-650,000 respiratory fatalities. This year's flu vaccine is observed with subclade K (or "J.2.4.1"), which has limited natural immunity within communities. influenza A subtype H3N2 has historically been associated with higher rates of hospitalization and death, and preliminary data has already linked subclade K to countries like Japan and the United Kingdom experiencing earlier than usual flu seasons in 2025, following Australia reporting a record flu season. In November 2020, the Logix Smart ABC test received CE-marking for the simultaneous detection of and differentiation of influenza A, influenza B, and SARS-CoV-2, the virus that causes COVID-19. The in silico analysis concluded that there is no concern that any emerging H3N2 strains would affect the test kit's sensitivity. The Logix Smart ABC test is intended for use by qualified and trained clinical laboratory personnel. In November 2025, the Company announced that it had initiated clinical performance testing for the Co-Dx PCR Flu A/B, COVID-19, RSV point-of-care upper-respiratory multiplex test, which is intended to support a submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. Similar to the Logix Smart test, the flu A targets in this test are not expected to be affected by H3N2 subclades K. This test is not approved or cleared by the U.S. Food & Drug Administration (FDA). It is for export only and is not for sale in the United States. The Co-Dx PCR platform (including the Co-Dx PCR Home™?, Co-Dx PCR Pro™?, mobile app, and all associated tests and software) is subject to review by the FDA and/or other regulatory bodies and is not available for sale. Annuncio • Nov 19
Co-Diagnostics Initiates Clinical Evaluations for Upper Respiratory Multiplex Point-of-Care Test on Co-Dx™? PCR Platform to Support Submission to the U.S. FDA Co-Diagnostics, Inc. announced that it has begun clinical evaluations for its Co-Dx™? PCR Flu A/B, COVID-19, RSV Test Kit. The clinical performance testing is expected to support a submission to the United States Food and Drug Administration ("FDA") for 510(k) clearance of the upper respiratory multiplex point-of-care test, and the Co-Dx PCR Pro™? instrument. Annuncio • Oct 31
Co-Diagnostics, Inc. to Report Q3, 2025 Results on Nov 13, 2025 Co-Diagnostics, Inc. announced that they will report Q3, 2025 results After-Market on Nov 13, 2025 Annuncio • Oct 30
Co-Diagnostics, Inc. has completed a Follow-on Equity Offering in the amount of $6.999927 million. Co-Diagnostics, Inc. has completed a Follow-on Equity Offering in the amount of $6.999927 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 12,002,272
Price\Range: $0.55
Discount Per Security: $0.0385
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 725,000
Price\Range: $0.5499
Discount Per Security: $0.0385
Transaction Features: Registered Direct Offering Annuncio • Oct 28
Co-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $7 million. Co-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $7 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Transaction Features: Registered Direct Offering Annuncio • Oct 21
Co-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $4.086645 million. Co-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $4.086645 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 4,086,645
Price\Range: $1
Transaction Features: At the Market Offering Annuncio • Oct 16
Co-Diagnostics, Inc. Announces Development of Proprietary Sample Prep Instrument for PoC Testing Co-Diagnostics, Inc. announced the development of a proprietary sample preparation instrument designed to streamline and simplify the workflow for its point-of-care (PoC) Co-Dx PCR Mycobacterium Tuberculosis (MTB) Test. The new instrument has been engineered to deliver a low-cost, user-friendly solution for sample processing in resource-limited PoC and near-PoC settings, supporting both sputum and the novel tongue swab sample collection used in the Company's upcoming MTB test, which is expected to begin clinical evaluations in India before year-end. The single-button operation and no need for measurement or dispensing tools enable rapid sample prep with minimal training, while incorporating a built-in safety feature to inactivate live organisms in the sample and help protect test operators. Annuncio • Sep 19
Co-Diagnostics, Inc. has completed a Follow-on Equity Offering in the amount of $3.8476 million. Co-Diagnostics, Inc. has completed a Follow-on Equity Offering in the amount of $3.8476 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 9,619,000
Price\Range: $0.4
Discount Per Security: $0.028
Transaction Features: Registered Direct Offering Annuncio • Sep 11
Co-Diagnostics, Inc. Performs Analysis of Chikungunya Co-Primers to Confirm Reactivity Against Known Virus Strains Co-Diagnostics, Inc. announced that it has performed an in silico analysis of the primers sets used in its Co-Primers-based PCR tests for the detection of chikungunya virus (or "CHIKV"), showing a high homology against over 1,200 CHIKV sequences and confirming reactivity of the CHIKV primers against known recent strains of the virus. As of July, there have been nearly 250,000 cases and 90 deaths from CHIKV worldwide, primarily concentrated in South America, but also found in countries across Africa, Asia and Europe. An estimated 5.6 billion people currently live in at-risk areas across 119 countries as warming trends contribute to expanded regions for the mosquitoes that can carry CHIKV. Chikungunya imposes a significant economic burden, especially in low- and middle-income countries. Long-term consequences for the patient are also common, particularly joint pain that can be debilitating, with 40% of people contracting chronic chikungunya arthritis, leading to the pain lasting months or even years according to the Mayo Clinic. Less common complications include auto-immune disorders and chronic fatigue. The Co-Diagnostics Logix Smart®? ZDC Test received CE-marking regulatory clearance in 2019 to be sold as an in vitro diagnostic ("IVD") for the viruses that cause Zika, dengue and chikungunya. The test functions via the Company's patented Co-Primers technology and a single-step reverse transcriptase real-time PCR process to detect and differentiate between the viral RNA of Zika, dengue (all 4 serotypes), and chikungunya in blood drawn from patients. It is available for markets that accept CE-marking as valid regulatory clearance, pending local product registration requirements. Differentiating CHIKV cases from other infections with similar symptoms, such as dengue, helps physicians avoid administering certain pain and fever medications that can increase risk of bleeding and be life-threatening in patients with severe dengue infections. As an arbovirus spread by mosquitoes, accurate diagnosis is also vital to indicate to an infected patient that they should take additional precautions to limit contact with mosquitoes, to prevent further spread of the virus. Co-Dx also offers its Co-Primers-based environmental use only Vector Smart VZDC Test to mosquito abatement districts ("MADs"), as part of its suite of vector control tests used by around 30 MADs across approximately 20 U.S. states to identify pathogens such as Zika, dengue, chikungunya, West Nile virus, St. Louis encephalitis, and Eastern and Western equine encephalitis in mosquito pools. The Vector Smart VZDC Test CHIKV primer sets are the same as those used in the Logix Smart ZDC test. Co-Diagnostics Indian joint venture CoSara Diagnostics Pvt Ltd. received clearance in October 2021 by Indian authorities to manufacture and sell its SaraGene Dengue and Chikungunya Multiplex RT-PCR test as an IVD, which is also built on the Company's Co-Primers platform technology. This product is for export only and is not for sale in the United States. Annuncio • Jul 31
Co-Diagnostics, Inc. to Report Q2, 2025 Results on Aug 14, 2025 Co-Diagnostics, Inc. announced that they will report Q2, 2025 results After-Market on Aug 14, 2025 Annuncio • Apr 29
Co-Diagnostics, Inc. to Report Q1, 2025 Results on May 08, 2025 Co-Diagnostics, Inc. announced that they will report Q1, 2025 results After-Market on May 08, 2025 Annuncio • Apr 16
Co-Diagnostics, Inc., Annual General Meeting, May 28, 2025 Co-Diagnostics, Inc., Annual General Meeting, May 28, 2025. Location: company s offices located at 2401 s. foothilldr, ste. d, slc, utah 84109, United States Annuncio • Mar 13
Co-Diagnostics, Inc. to Report Q4, 2024 Results on Mar 27, 2025 Co-Diagnostics, Inc. announced that they will report Q4, 2024 results After-Market on Mar 27, 2025 Annuncio • Mar 07
Co-Diagnostics, Inc. Wins Dismissal of Class Action Lawsuit Co-Diagnostics, Inc. announced that on March 4, 2025, the Securities & Governance Litigation Team at BakerHostetler, the legal firm retained to represent the Company, won complete dismissal on summary judgment of a Section 10(b) securities class action that had been pending against the Company in the United States District Court for the District of Utah. On June 15, 2020, Plaintiff Gelt Trading Ltd. filed a securities class action against Co-Diagnostics, Inc. and certain of the Company's current and former directors and officers alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.At issue was the Company's May 1, 2020, press release, which disclosed, among other things, that the Company's Logix Smart® COVID-19 test demonstrated "100% sensitivity and 100% specificity"—well-defined scientific metrics—across independent evaluations. Plaintiff alleged that the May 1 press release was false and/or misleading because it conveyed to investors that the Logix Smart test was "100% accurate" (i.e., perfect), allegedly causing the Company's stock price to be artificially inflated. Plaintiff alleged that this artificial inflation was removed, and investors suffered losses, when the Company's stock price dropped on May 15 following three disclosures that allegedly revealed the May 1 press release to be false ("Alleged Corrective Disclosures"). BakerHostetler was retained to replace prior counsel after the motion to dismiss was denied and the case was in the early phases of discovery. On summary judgment, BakerHostetler argued that Plaintiff could not establish any genuine issue of material fact supporting liability as to any element of its Section 10(b) claim—falsity, scienter, reliance, loss causation, or damages. BakerHostetler also argued that Plaintiff's experts' testimony—which related to clinical testing and loss causation—should be excluded on summary judgment under Daubert. On March 4, 2025, after oral argument, the Court granted Defendants' Daubert motion to exclude the testimony of Plaintiff's loss causation expert and granted summary judgment for Defendants, concluding that Plaintiff could not demonstrate loss causation. The Court held that none of the three Alleged Corrective Disclosures actually "corrected" the May 1 press release, either because they did not discuss the Company's Logix Smart test, or because the allegedly contradictory information was long known to the market and already baked into the Company's stock price. Accordingly, Plaintiff could not establish that the May 1 press release was the cause of Plaintiff's or the class's losses. Having reached this conclusion, the Court declined to address the other summary judgment arguments or Daubert motions. The Company regards this dismissal as a tremendous victory and is optimistic about its chances of prevailing in any appeal Plaintiff might file. The Company looks forward to putting the matter behind it, as it moves ahead with its mission of increasing the availability of high-quality molecular diagnostics on a global scale. Annuncio • Feb 22
Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance Co-Diagnostics, Inc. announced that, following a collaborative and informative dialogue with the Food and Drug Administration (FDA), the Company has withdrawn its 510(k) application to the FDA for its Co-Dx™ PCR COVID-19 Test on the PCR Pro™*, in favor of submitting an enhanced version of the test for 510(k) clearance. Co-Dx is pleased with the productive engagement with the FDA related to the initial regulatory submission and with the performance of the test in clinical evaluations, including performance data and functionality of the instrument. The decision by the Company to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related to shelf-life stability. Following dialogue with the FDA and exploring the various courses of action available, Co-Dx has determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review process. The Company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, following the collection of clinical evaluation data to support the new test's performance. A new submission also allows the Company to incorporate more recent Co-Dx PCR platform developments into the COVID-19 test, which Co-Dx believes will also help to create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize the next generation of test kits and instruments across all tests on the at-home and point-of-care platform. The Company's primary objective is to execute a robust development and commercialization plan for the Co-Dx PCR platform, including ongoing innovations to the PCR Pro instrument. The Co-Dx PCR COVID-19 test is expected to be followed by additional tests for tuberculosis, upper-respiratory multiplex, and a multiplex HPV test, among others. Annuncio • Jan 11
Co-Diagnostics Receives a Notice from Nasdaq Listing Qualifications Department of the Nasdaq Stock Market On January 10, 2025, Co-Diagnostics, Inc. received a notice from Nasdaq Listing Qualifications department of the Nasdaq Stock Market LLC (“Nasdaq”) stating that the closing bid price of the Company’s common stock for the last 30 consecutive business days had closed below the minimum $1.00 per share required for continued listing under Listing Rule 5550(a)(2). The Company has a period of 180 calendar days, or until July 9, 2025 (the “Compliance Date”), to regain compliance with Listing Rule 5550(a)(2). To regain compliance, the bid price of the Company’s common stock must close at $1 or more for a minimum of ten consecutive business days before the Compliance Date. The Nasdaq notification letter does not result in the immediate delisting of the Company’s common stock, and the stock will continue to trade uninterrupted on the The Nasdaq Capital Market under the symbol “CODX”. If the Company does not regain compliance with Rule 5550(a)(2) by the Compliance Date, the Company may be eligible for additional time. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company meets these requirements, the Staff will inform the Company that it has been granted an additional 180 calendar days. However, if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, the Staff will provide notice that its securities will be subject to delisting. Reported Earnings • Nov 10
Third quarter 2024 earnings released: US$0.32 loss per share (vs US$0.20 loss in 3Q 2023) Third quarter 2024 results: US$0.32 loss per share (further deteriorated from US$0.20 loss in 3Q 2023). Net loss: US$9.70m (loss widened 62% from 3Q 2023). Revenue is expected to decline by 95% p.a. on average during the next 2 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.0%. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 49 percentage points per year, which is a significant difference in performance. Annuncio • Oct 26
Co-Diagnostics, Inc. to Report Q3, 2024 Results on Nov 07, 2024 Co-Diagnostics, Inc. announced that they will report Q3, 2024 results After-Market on Nov 07, 2024 Reported Earnings • Aug 11
Second quarter 2024 earnings released: US$0.25 loss per share (vs US$0.31 loss in 2Q 2023) Second quarter 2024 results: US$0.25 loss per share (improved from US$0.31 loss in 2Q 2023). Net loss: US$7.60m (loss narrowed 15% from 2Q 2023). Revenue is expected to decline by 107% p.a. on average during the next 2 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.5%. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 52 percentage points per year, which is a significant difference in performance. Annuncio • Jul 25
Co-Diagnostics, Inc. to Report Q2, 2024 Results on Aug 08, 2024 Co-Diagnostics, Inc. announced that they will report Q2, 2024 results After-Market on Aug 08, 2024 Annuncio • Jul 17
Co-Diagnostics, Inc., Annual General Meeting, Aug 29, 2024 Co-Diagnostics, Inc., Annual General Meeting, Aug 29, 2024. Annuncio • Jun 15
Co-Diagnostics, Inc. Submits First FDA 510(k) Application for Co-Dx PCR Pro Platform Co-Diagnostics, Inc. announced that the Company has completed its first U.S. Food and Drug Administration (FDA) application for 510(k) clearance for the Co-Dx PCR Pro instrument, and the Co-Dx PCR COVID-19 Test for over-the-counter (OTC) use. Co-Diagnostics completed the submission via the FDA's electronic Submissions Template And Resource (eSTAR) system, and have received the acknowledgement from the FDA that the 510(k) application was received. eSTAR serves as a comprehensive resource for medical device manufacturers to standardize and consolidate the necessary information and links needed for 510(k) submission preparation. The Co-Dx PCR platform has been designed to help close the access gap for infectious disease diagnosis by facilitating the widespread decentralization of gold-standard PCR diagnostics, which have historically only been found in high-complexity clinical laboratories. It consists of a compact and robust real-time PCR instrument operated at point-of-care or in at-home settings via an intuitive smartphone interface, with test cups powered by patented Co-Primers technology. The Company is also preparing to shortly pursue clearance for the Co-D x PCR COVID-19 test on the new instrument, to be used for point-of-care testing (POCT). Other diagnostics for the platform in varying stages of development or preparation for clinical evaluations include tests for tuberculosis, human papillomavirus, strep A, and a respiratory multiplex that detects influenza A and B, COVID-19 and RSV in a single test. 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. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA. Reported Earnings • May 13
First quarter 2024 earnings released: US$0.31 loss per share (vs US$0.20 loss in 1Q 2023) First quarter 2024 results: US$0.31 loss per share (further deteriorated from US$0.20 loss in 1Q 2023). Net loss: US$9.31m (loss widened 62% from 1Q 2023). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 62 percentage points per year, which is a significant difference in performance. New Risk • May 12
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 3.3% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 18% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (3.3% increase in shares outstanding). Market cap is less than US$100m (€32.2m market cap, or US$34.7m). Annuncio • Apr 27
Co-Diagnostics, Inc. to Report Q1, 2024 Results on May 09, 2024 Co-Diagnostics, Inc. announced that they will report Q1, 2024 results After-Market on May 09, 2024 Annuncio • Apr 04
Co-Diagnostics, Inc. Appoints Executive Appointments Co-Diagnostics, Inc. appointed David Nielsen to be its Chief Operations Officer (COO), Christopher Thurston as its Chief Technology Officer (CTO), and Seth Egan as Chief Commercialization Officer (CCO). David Nielsen (COO) previously held the role of COO for Idaho Molecular, also acquired by Co-Dx in 2021, and has worked in concert with Advanced Conceptions and Co-Dx to help guide the development of the Company's new platform since that time. Including his time at Idaho Molecular, Mr. Nielsen has over 25 years of R&D technical and leadership experience, primarily at BioFire and BioFire Defense, filling various key roles which also included managing and coordinating the FilmArray diagnostic system throughout development and launch as the VP of Product Development. David earned both a Master of Science and M.B.A. from the University of Utah. As COO, David will leverage his experience to help lead Co-Dx's product development and manufacturing processes. Christopher Thurston's (CTO) distinguished career has included decades of experience serving as senior developer and architect of software platforms for companies including Ernst and Young, BioFire Defense, and BioMerieux, demonstrating his expertise in big-data solutions. Following his experience in executive positions at several startups, Christopher co-invented the Co-Dx PCR platform at Idaho Molecular, pursuing his passion for democratizing access to PCR diagnostics though technological innovation. Mr. Thurston's technology expertise will be significant in the advancement of Co-Dx's platform and tests. Seth Egan (CCO) has been with Co-Dx since its inception, leading the Company's sales, marketing and product commercialization efforts from the beginning, including managing the sales team as it sold approximately 35M Logix Smart® tests to centralized laboratories in more than 50 countries since the beginning of the pandemic. Mr. Egan has operated in many key capacities for the Company and continues to play an important role helping to oversee the relationship with CoSara Diagnostics, the Co-Dx joint venture in India. He holds a Bachelor of Science in Business Communications from Utah Valley University. Mr. Egan will play a crucial role as CCO in driving the Co-Dx PCR platform's commercialization efforts. Reported Earnings • Mar 15
Full year 2023 earnings released: US$1.20 loss per share (vs US$0.45 loss in FY 2022) Full year 2023 results: US$1.20 loss per share (further deteriorated from US$0.45 loss in FY 2022). Net loss: US$35.3m (loss widened 148% from FY 2022). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 47 percentage points per year, which is a significant difference in performance. Annuncio • Mar 01
Co-Diagnostics, Inc. to Report Q4, 2023 Results on Mar 14, 2024 Co-Diagnostics, Inc. announced that they will report Q4, 2023 results at 4:00 PM, US Eastern Standard Time on Mar 14, 2024 Annuncio • Dec 27
Co-Diagnostics, Inc. Completes Submission to FDA for Co-Dx PCR Pro Co-Diagnostics, Inc. announced that it has submitted its Co-Dx™? PCR COVID-19 test with Co-Dx PCR Pro™? instrument for review by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). The submission includes the PCR Pro instrument, COVID-19 detection test, and mobile app, all designed for use in point-of-care and at-home settings. Tests run on the new platform use the Company's patented real-time polymerase chain reaction (PCR) Co-Primers™? technology. The Co-Dx COVID-19 test kit for the PCR Pro instrument included in the Company's FDA submission has been shown in clinical evaluations to detect the presence of COVID-19 in anterior nasal swab samples, with results displayed on the user's smartphone or mobile device in approximately 30 minutes. The menu of future tests that are currently in development for the new platform includes tuberculosis (TB) and human papillomavirus (HPV), as well as an upper respiratory multiplex panel that will detect influenza A/B, COVID-19, and respiratory syncytial virus (RSV) within a single sample. All three tests have also been the subject of grant support by notable funding bodies over the last half of this year. Reported Earnings • Nov 11
Third quarter 2023 earnings released: US$0.20 loss per share (vs US$0.043 loss in 3Q 2022) Third quarter 2023 results: US$0.20 loss per share (further deteriorated from US$0.043 loss in 3Q 2022). Net loss: US$5.98m (loss widened 340% from 3Q 2022). Revenue is expected to decline by 104% p.a. on average during the next 2 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.0%. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 34 percentage points per year, which is a significant difference in performance. Annuncio • Oct 27
Co-Diagnostics, Inc. to Report Q3, 2023 Results on Nov 09, 2023 Co-Diagnostics, Inc. announced that they will report Q3, 2023 results After-Market on Nov 09, 2023 Annuncio • Aug 30
Co-Diagnostics, Inc. Appoints Ivory Chang as Chief Regulatory Affairs Officer Co-Diagnostics, Inc. announced the appointment of Ivory Chang as the Company's Chief Regulatory Affairs Officer. Ms. Chang's in-depth regulatory affairs experience has included time spent with several notable names in the diagnostics industry, including Roche, Boston Scientific, BD Biosciences, Cepheid, Thermo Fisher Scientific, and more. Her background has involved regulatory and registration submissions to major regulatory bodies around the world for infectious disease, oncology, point-of-care, in vitro diagnostics (IVD), and software diagnostic products. Reported Earnings • Aug 13
Second quarter 2023 earnings released: US$0.31 loss per share (vs US$0.083 loss in 2Q 2022) Second quarter 2023 results: US$0.31 loss per share (further deteriorated from US$0.083 loss in 2Q 2022). Net loss: US$8.92m (loss widened 232% from 2Q 2022). Revenue is expected to decline by 80% p.a. on average during the next 2 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.3%. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 11 percentage points per year, which is a significant difference in performance. Annuncio • Jul 29
Co-Diagnostics, Inc. to Report Q2, 2023 Results on Aug 10, 2023 Co-Diagnostics, Inc. announced that they will report Q2, 2023 results After-Market on Aug 10, 2023 New Risk • Jul 25
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 10% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (10% average weekly change). Minor Risk Market cap is less than US$100m (€40.1m market cap, or US$44.3m). Annuncio • Jul 23
Co-Diagnostics, Inc., Annual General Meeting, Aug 30, 2023 Co-Diagnostics, Inc., Annual General Meeting, Aug 30, 2023, at 10:00 Mountain Standard Time. Agenda: To elect the two (2) Class II director nominees, each of whom are currently serving on company's board of directors, each to serve until the 2026 annual meeting of shareholders or until their successors are duly elected and qualified, or until his or her earlier death, resignation, or removal; to approve, on an advisory basis, the compensation of the Company’s named executive officers; to ratify the appointment of Tanner LLC as our independent registered public accounting firm for the fiscal year ending December 31, 2023; and to consider other business matters. Annuncio • Jul 14
Co-Diagnostics, Inc. Receives Funding for Co-Dx PCR Home Platform from NIH RADx Tech Program Co-Diagnostics, Inc. announced that it has been awarded $1.2 million in funding from the National Institutes of Health (NIH) as part of the Rapid Acceleration of Diagnostics (RADx®) Tech program for completion of its upcoming upper respiratory panel on the Company's Co-Dx PCR Home™ testing platform. Co-Diagnostics will utilize the funds from the RADx Tech award to complete development of its flu A/B, COVID-19, and RSV multiplex test, preparatory for that test to begin clinical trials on the Co-Dx PCR Home. The Co-Dx PCR Home is currently undergoing clinical evaluations in anticipation of its submission to the FDA and an initial product launch for a COVID-19 test. This project has been funded in part with federal funds from the National Institute of Biomedical Imaging (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92023D00001. The Co-Dx PCR Home testing platform and its associated tests are subject to FDA review and are not available for sale. Reported Earnings • May 14
First quarter 2023 earnings released: US$0.20 loss per share (vs US$0.34 profit in 1Q 2022) First quarter 2023 results: US$0.20 loss per share (down from US$0.34 profit in 1Q 2022). Revenue: US$602.0k (down 97% from 1Q 2022). Net loss: US$5.76m (down 149% from profit in 1Q 2022). Over the last 3 years on average, earnings per share has fallen by 31% per year but the company’s share price has fallen by 59% per year, which means it is performing significantly worse than earnings. Annuncio • May 06
Co-Diagnostics, Inc. to Report Q1, 2023 Results on May 11, 2023 Co-Diagnostics, Inc. announced that they will report Q1, 2023 results at 4:00 PM, US Eastern Standard Time on May 11, 2023 Reported Earnings • Mar 17
Full year 2022 earnings released: US$0.45 loss per share (vs US$1.27 profit in FY 2021) Full year 2022 results: US$0.45 loss per share (down from US$1.27 profit in FY 2021). Revenue: US$34.2m (down 65% from FY 2021). Net loss: US$14.2m (down 139% from profit in FY 2021). Over the last 3 years on average, earnings per share has increased by 10% per year but the company’s share price has fallen by 36% per year, which means it is significantly lagging earnings. Reported Earnings • Nov 16
Third quarter 2022 earnings released: US$0.043 loss per share (vs US$0.40 profit in 3Q 2021) Third quarter 2022 results: US$0.043 loss per share (down from US$0.40 profit in 3Q 2021). Revenue: US$5.09m (down 83% from 3Q 2021). Net loss: US$1.36m (down 112% from profit in 3Q 2021). Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 6.2% growth forecast for the Medical Equipment industry in Germany. Over the last 3 years on average, earnings per share has increased by 46% per year but the company’s share price has increased by 63% per year, which means it is tracking significantly ahead of earnings growth. Board Change • Nov 16
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 4 experienced directors. 1 highly experienced director. Chairman, CEO & President Dwight Egan is the most experienced director on the board, commencing their role in 2013. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Reported Earnings • Nov 12
Third quarter 2022 earnings released: US$0.043 loss per share (vs US$0.40 profit in 3Q 2021) Third quarter 2022 results: US$0.043 loss per share (down from US$0.40 profit in 3Q 2021). Revenue: US$5.09m (down 83% from 3Q 2021). Net loss: US$1.36m (down 112% from profit in 3Q 2021). Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 6.2% growth forecast for the Medical Equipment industry in Germany. Over the last 3 years on average, earnings per share has increased by 46% per year but the company’s share price has increased by 63% per year, which means it is tracking significantly ahead of earnings growth. Annuncio • Nov 02
Co-Diagnostics, Inc. Appoints Dr. Mark Poritz as New Chief Scientific Officer Co-Diagnostics, Inc. announced that it is pleased to welcome Mark Poritz, PhD as the Company's new Chief Scientific Officer ("CSO"). Dr. Poritz is a Harvard University and UC San Francisco educated molecular biologist with more than 30 years of experience in the application of PCR and related methods to gene cloning, drug discovery, infectious disease diagnostics and aptamer selection, who has also served as a reviewer for more than 30 different NIH/NIAID study sections focusing on infectious disease diagnostics. Notably, Dr. Poritz played a key role in the growth of BioFire® Diagnostics from 2002-2018, including in the development of the FilmArray® platform, an in vitro diagnostic system that uses a syndromic approach to accurately detect and identify infectious pathogens. He also has numerous patents issued and pending in his name. Dr. Poritz has most recently served as the CSO of Idaho Molecular, the subsidiary acquired by Co-Dx at the end of 2021 and has been actively involved with the development of the Company's upcoming Co-Dx PCR Home testing platform. Annuncio • Oct 28
Co-Diagnostics, Inc. to Report Q3, 2022 Results on Nov 10, 2022 Co-Diagnostics, Inc. announced that they will report Q3, 2022 results at 4:00 PM, US Eastern Standard Time on Nov 10, 2022 Annuncio • Sep 20
Pomerantz Law Firm Announces the Filing of a Class Action Against Co-Diagnostics, Inc. and Certain Officers Pomerantz LLP announced that a class action lawsuit has been filed against Co-Diagnostics, Inc. and certain of its officers. The class action, filed in the United States District Court for the Southern District of New York, and docketed under 22-cv-07988, is on behalf of a class of all persons and entities who purchased the publicly traded securities of Co-Dx during the period May 12, 2022 through the close of the market on August 11, 2022 (4:00 p.m. ET), inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials. If one is a shareholder who purchased Co-Dx securities during the Class Period, he has until October 17, 2022 to ask the Court to appoint him as Lead Plaintiff for the class. On April 6, 2020, Co-Dx announced that it had received an Emergency Use Authorization for its Logix Smart™ COVID-19 detection test from the Food and Drug Administration, allowing it to commence sales of the test to laboratories certified by the Center for Medicare and Medicaid Services under the Clinical Laboratories Improvements Act (“CLIA”) to accept human samples for diagnostics testing throughout the United States. Co-Dx has sold its Logix Smart™ COVID-19 test to such CLIA labs since that time. Co-Dx services over 500 centralized lab customers, including about 200 U.S. CLIA labs, 130 foreign labs, and approximately 200 labs in India certified by the National Accreditation Board for Testing and Calibration Laboratories. The complaint alleges that, during the Class Period, Defendants repeatedly touted the Logix Smart™ COVID-19 Test, reassuring investors about the demand for the product. At the same time, Defendants failed to disclose that: (1) demand for the Logix Smart™ COVID19 Test had plummeted throughout the quarter ended June 30, 2022, and (2) as a result, Defendants’ positive statements about the demand for the Logix Smart™ COVID-19 Test lacked a reasonable basis. On August 11, 2022, Co-Dx shocked investors when, after the market closed, the Company issued a press release and filed a report with the U.S. Securities and Exchange Commission on Form 8-K that disclosed its financial results for the quarter ended June 30, 2022, in which the Company disclosed revenue of $5.0 million for the quarter ended June 30, 2022, down from $27.4 million during the prior year period, a decline of almost 82%. The Company primarily attributed the decrease to lower demand of the Logix Smart™ COVID-19 Test. Valuation Update With 7 Day Price Move • Aug 18
Investor sentiment deteriorated over the past week After last week's 37% share price decline to €3.97, the stock trades at a forward P/E ratio of 54x. Average forward P/E is 36x in the Medical Equipment industry in Germany. Total returns to shareholders of 303% over the past three years. Annuncio • Aug 17
Kaplan Fox & Kilsheimer LLP Files Class Action Suit in the United States District Court for the Southern District of New York Against Co-Diagnostics, Inc Kaplan Fox & Kilsheimer LLP has filed a class action suit in the United States District Court for the Southern District of New York against Co-Diagnostics, Inc. (‘Co-Dx’ or the ‘Company’); Dwight H. Egan, the Company’s Chief Executive Officer, President and Chairman of the Board; and Brian L. Brown, the Company’s Chief Financial Officer and Secretary (‘Defendants’). The Complaint alleges that Defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the SEC, and is brought by plaintiff on behalf of all persons and entities who purchased the publicly traded securities of Co-Dx during the period May 12, 2022 through the close of the market on August 11, 2022 (4:00 p.m. ET), inclusive (the ‘Class Period’). The Complaint alleges that on April 6, 2020, Co-Dx announced that it had received an Emergency Use Authorization for its Logix Smart™ COVID-19 detection test from the Food and Drug Administration, allowing it to commence sales of the test to laboratories certified by the Center for Medicare and Medicaid Services under the Clinical Laboratories Improvements Act (‘CLIA’) to accept human samples for diagnostics testing throughout the United States. The Complaint further alleges that during the Class Period, Defendants repeatedly touted its Logix Smart™ COVID-19 Test, reassuring investors about the demand for the product. At the same time, Defendants failed to disclose that: (1) demand for its Logix Smart™ COVID-19 Test had plummeted throughout the quarter ended June 30, 2022, and (2) as a result, Defendants’ positive statements about the demand for its Logix Smart™ COVID-19 Test lacked a reasonable basis. On August 11, 2022, Co-Dx shocked investors when, after the market closed, the Company issued a release and filed a report with the SEC on Form 8-K that disclosed its financial results for the quarter and June 30, 2022, in which the Company disclosed revenue of $5.0 million for the quarter ended June 30, 2022, down from $27.4 million during the prior year period, a decline of almost 82%. The Company primarily attributed the decrease to lower demand of the Logix Smart™ COVID-19 Test. Plaintiff seeks to recover damages on behalf of the proposed Class and is represented by Kaplan Fox & Kilsheimer LLP. Reported Earnings • Aug 13
Second quarter 2022 earnings released: US$0.083 loss per share (vs US$0.34 profit in 2Q 2021) Second quarter 2022 results: US$0.083 loss per share (down from US$0.34 profit in 2Q 2021). Revenue: US$5.02m (down 82% from 2Q 2021). Net loss: US$2.69m (down 127% from profit in 2Q 2021). Over the next year, revenue is expected to shrink by 30% compared to a 7.5% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 68% per year but the company’s share price has only increased by 60% per year, which means it is significantly lagging earnings growth. Annuncio • Aug 03
Co-Diagnostics, Inc. to Report Q2, 2022 Results on Aug 11, 2022 Co-Diagnostics, Inc. announced that they will report Q2, 2022 results After-Market on Aug 11, 2022 Annuncio • Jul 21
Co-Diagnostics, Inc., Annual General Meeting, Aug 31, 2022 Co-Diagnostics, Inc., Annual General Meeting, Aug 31, 2022, at 10:00 US Mountain Standard Time. Agenda: To elect the two (2) Class I director nominees, each of whom are currently serving on board of directors, each to serve until the 2025 annual meeting of stockholders or until their successors are duly elected and qualified, or until his or her earlier death, resignation, or removal; to approve an amendment to the Co-Diagnostics, Inc. 2015 Long Term Incentive Plan, as amended and restated (the “Plan”), increasing the number of common shares authorized for awards under the Plan by 6,000,000; to approve, on an advisory basis, the compensation of the Company’s named executive officers; and to consider other matters. Buying Opportunity • Jun 25
Now 23% undervalued after recent price drop Over the last 90 days, the stock is down 2.4%. The fair value is estimated to be €6.65, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 90% over the last 3 years. Meanwhile, the company has become profitable. Revenue is forecast to decline by 18% in a year. Earnings is forecast to decline by 45% in the next year. Valuation Update With 7 Day Price Move • Jun 24
Investor sentiment improved over the past week After last week's 16% share price gain to €5.61, the stock trades at a forward P/E ratio of 9x. Average forward P/E is 24x in the Medical Equipment industry in Germany. Total returns to shareholders of 732% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €7.17 per share. Buying Opportunity • May 28
Now 21% undervalued after recent price drop Over the last 90 days, the stock is down 12%. The fair value is estimated to be €5.77, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 90% over the last 3 years. Meanwhile, the company has become profitable. Revenue is forecast to decline by 18% in a year. Earnings is forecast to decline by 45% in the next year. Annuncio • May 27
Co-Diagnostics, Inc. Completes Principal Design of Test for Monkeypox Virus Co-Diagnostics, Inc. announced that it has completed the principal design work of a PCR test for the monkeypox virus currently exhibiting a multi-country outbreak. According to the World Health Organization, monkeypox is a virus originally transmitted to humans from animals, and then transmitted from one person to another by close contact with lesions, body fluids, respiratory droplets and contaminated materials such as bedding. Since 13 May 2022, cases of monkeypox have been reported to WHO from 18 Member States that are not endemic for the virus. When complete, the new test will feature the Company's patented CoPrimer™ technology and was designed using its proprietary software system. Valuation Update With 7 Day Price Move • May 19
Investor sentiment improved over the past week After last week's 34% share price gain to €4.69, the stock trades at a forward P/E ratio of 8x. Average forward P/E is 29x in the Medical Equipment industry in Germany. Total returns to shareholders of 520% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €6.71 per share. Reported Earnings • May 14
First quarter 2022 earnings released: EPS: US$0.34 (vs US$0.28 in 1Q 2021) First quarter 2022 results: EPS: US$0.34 (up from US$0.28 in 1Q 2021). Revenue: US$22.7m (up 13% from 1Q 2021). Net income: US$11.7m (up 48% from 1Q 2021). Profit margin: 52% (up from 39% in 1Q 2021). The increase in margin was primarily driven by higher revenue. Over the next year, revenue is expected to shrink by 19% compared to a 7.1% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 86% per year but the company’s share price has only increased by 74% per year, which means it is significantly lagging earnings growth. Board Change • Apr 27
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 1 experienced director. 1 highly experienced director. Chairman, CEO & President Dwight Egan is the most experienced director on the board, commencing their role in 2013. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Valuation Update With 7 Day Price Move • Apr 23
Investor sentiment deteriorated over the past week After last week's 16% share price decline to €4.35, the stock trades at a forward P/E ratio of 8x. Average forward P/E is 34x in the Medical Equipment industry in Germany. Total returns to shareholders of 397% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €7.89 per share. Board Change • Apr 02
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 1 experienced director. 1 highly experienced director. Chairman, CEO & President Dwight Egan is the most experienced director on the board, commencing their role in 2013. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Valuation Update With 7 Day Price Move • Mar 19
Investor sentiment improved over the past week After last week's 18% share price gain to €5.88, the stock trades at a forward P/E ratio of 11x. Average forward P/E is 35x in the Medical Equipment industry in Germany. Total returns to shareholders of 465% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €3.32 per share. Valuation Update With 7 Day Price Move • Jan 25
Investor sentiment deteriorated over the past week After last week's 23% share price decline to €5.92, the stock trades at a forward P/E ratio of 12x. Average forward P/E is 33x in the Medical Equipment industry in Germany. Total loss to shareholders of 41% over the past year. Simply Wall St's valuation model estimates the intrinsic value at €2.90 per share. Annuncio • Dec 24
Co-Diagnostics, Inc. (NasdaqCM:CODX) entered into an Agreement and Plan of Merger to acquire Idaho Molecular Inc. Co-Diagnostics, Inc. (NasdaqCM:CODX) entered into an Agreement and Plan of Merger to acquire Idaho Molecular Inc. on December 21, 2021. At the effective time of the merger, all the outstanding shares of capital stock of Idaho Molecular shall be cancelled and converted into the right to receive, in the aggregate: 1,650,000 shares of CODX common Stock, par value $0.001 per share, which number may be adjusted upward or downward at closing based on Idaho Molecular’s net cash at the time of closing; an additional 708,500 shares of CODX Common Stock that is subject to a right of forfeiture in favor of CODX if certain milestones have not been satisfied on or before January 1, 2027 and the right of forfeiture has not been released due to the occurrence of certain events; and warrants to purchase 232,500 shares of CODX Common Stock, at an exercise price of $9.125 per Warrant that are also subject to a right of forfeiture if certain milestones have not been satisfied on or before January 1, 2027 and the right of forfeiture has not been released due to the occurrence of certain events. In a related transaction, Co-Diagnostics, Inc. also entered into an agreement to acquire Advanced Conceptions, Inc. Each of these companies will become wholly owned subsidiaries of Co-Diagnostics. The transactions will provide Co-Diagnostics with all existing and future assets and intellectual property related to the platform. Per the terms of the agreements, Kirk Ririe and Carl Wittwer will respectively become president of the wholly owned subsidiary and Chairman of Co-Diagnostics' Scientific Advisory Board.
Completion of the IM merger is subject to the simultaneous closing of the merger of ACI and customary closing conditions, including, regulatory approvals, Idaho Molecular obtaining the requisite stockholder approval of the IM Merger, Net Closing Cash shall be in an amount equal to or exceed zero, and the execution of support and non solicitation agreements. The boards of directors of CODX and Idaho Molecular have unanimously approved the transaction. The transaction is expected to close prior to end of the year 2021. Mark Morris of Snell & Wilmer L.L.P. acted as legal advisor to Co-Diagnostics, Inc. while Mary Piciocchi of Piciocchi Legal PLLC acted as legal advisor to Idaho Molecular Inc. Reported Earnings • Nov 12
Third quarter 2021 earnings released: EPS US$0.40 (vs US$0.56 in 3Q 2020) The company reported a mediocre third quarter result with weaker earnings and profit margins, although revenues improved. Third quarter 2021 results: Revenue: US$30.1m (up 38% from 3Q 2020). Net income: US$11.5m (down 27% from 3Q 2020). Profit margin: 38% (down from 72% in 3Q 2020). The decrease in margin was driven by higher expenses. Annuncio • Sep 29
Co-Diagnostics, Inc. to Introduce at Home/Point of Care Device at AACC on Sept 28 Co-Diagnostics, Inc. announced that it will be introducing its upcoming at-home and point-of-care PCR device in a press conference at the 2021 AACC Annual Scientific Meeting & Clinical Lab Expo, held September 26-30 in Atlanta, GA, as well as hosting a booth to promote its existing suite of diagnostics products and technology applications. Annuncio • Sep 09
Co-Diagnostics, Inc. SARS-CoV-2 Test Used in New Community Surveillance Method in Italy Co-Diagnostics, Inc. announced that its Logix Smart™ COVID-19 Test Kit was used by Italian researchers to confirm the presence of SARS-CoV-2, including mutated strains of the virus, in a community surveillance method of testing single-use waste, with the peer-reviewed results published in the journal Science of the Total Environment. The innovative approach for surveilling communities involved testing the saliva left on single-use glasses and bottles for the presence of SARS-CoV-2 in 20 different sites in Northern Italy during the second peak of COVID-19 in January and February 2021. The objects tested, including plastic coffee cups, plastic glasses, beverage cans, and plastic bottles discarded in snack bars, cafes, schools, and businesses, were swabbed, pooled, and then analyzed at the Istituto Superiore di Sanità using commercially available PCR reagents. Researchers then used Co-Diagnostics' Logix Smart COVID-19 Test to corroborate the results with complete concordance. The positive samples were later sequenced, and some were found to contain the presence of mutated variants of the virus. Valuation Update With 7 Day Price Move • Aug 19
Investor sentiment improved over the past week After last week's 16% share price gain to US$9.28, the stock trades at a forward P/E ratio of 13x. Average forward P/E is 48x in the Medical Equipment industry in Germany. Total loss to shareholders of 28% over the past year. Reported Earnings • Aug 13
Second quarter 2021 earnings released: EPS US$0.34 (vs US$0.54 in 2Q 2020) The company reported a soft second quarter result with weaker earnings and profit margins, although revenues improved. Second quarter 2021 results: Revenue: US$27.4m (up 14% from 2Q 2020). Net income: US$9.79m (down 35% from 2Q 2020). Profit margin: 36% (down from 62% in 2Q 2020). The decrease in margin was driven by higher expenses. Annuncio • Aug 13
Co-Diagnostics, Inc. Provides Earnings Guidance for the Third Quarter 2021 Co-Diagnostics, Inc. provided earnings guidance for the third quarter 2021. The company expects revenue to be in the range of $23.0 million to $25.0 million. Diluted earnings per share forecasted to be in the $0.19 to $0.22 range, with shares outstanding expected to be approximately 30 million and a corporate effective tax rate of approximately 19.0%. Valuation Update With 7 Day Price Move • Jul 24
Investor sentiment improved over the past week After last week's 34% share price gain to US$8.46, the stock trades at a forward P/E ratio of 12x. Average forward P/E is 44x in the Medical Equipment industry in Germany. Total loss to shareholders of 56% over the past year. Annuncio • Jun 19
Co-Diagnostics, Inc Receives CE Marking for Direct Saliva SARS-CoV-2 Test Co-Diagnostics, Inc. announced that its Logix Smart™ SARS-CoV-2 DS (Direct Saliva) has obtained regulatory authorization to be sold as an in vitro diagnostic ("IVD") for the diagnosis of COVID-19 in markets that accept CE markings, and is now available for purchase from the Company's Utah-based ISO-13485:2016 certified facility. Co-Diagnostics' Logix Smart DS test kit is designed to detect the presence of the RdRp and E genes of SARS-CoV-2 directly from minimally processed human saliva samples while eliminating RNA extraction of the samples, a costly and time-consuming process required by most PCR tests. Co-Diagnostics believes that eliminating the extraction process has the potential to increase throughput and lower costs of not only COVID-19 testing, but also any other pathogen for which the Company develops a direct saliva test. Valuation Update With 7 Day Price Move • May 20
Investor sentiment improved over the past week After last week's 18% share price gain to US$7.04, the stock trades at a forward P/E ratio of 8x. Average forward P/E is 48x in the Medical Equipment industry in Germany. Total loss to shareholders of 59% over the past year. Reported Earnings • May 15
First quarter 2021 earnings released: EPS US$0.28 (vs US$0.047 loss in 1Q 2020) The company reported a strong first quarter result with improved earnings, revenues and profit margins. First quarter 2021 results: Revenue: US$20.0m (up US$18.5m from 1Q 2020). Net income: US$7.90m (up US$8.96m from 1Q 2020). Profit margin: 39% (up from net loss in 1Q 2020). The move to profitability was driven by higher revenue. Annuncio • May 14
Co-Diagnostics, Inc. Provides Earnings Guidance for the Second Quarter of Fiscal 2021 Co-Diagnostics, Inc. provided earnings guidance for the second quarter of fiscal 2021. For the quarter, the company expects revenue to be in the range of $20.0 million to $22.0 million and diluted earnings per share forecasted to be in the $0.19 to $0.23 range. Valuation Update With 7 Day Price Move • Apr 01
Investor sentiment deteriorated over the past week After last week's 38% share price decline to US$7.05, the stock trades at a forward P/E ratio of 12x. Average forward P/E is 48x in the Medical Equipment industry in Germany. Total returns to shareholders of 3.7% over the past year. 
