Aankondiging • Aug 19
Accelerate Diagnostics, Inc. announced delayed 10-Q filing On 08/18/2025, Accelerate Diagnostics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Aankondiging • May 17
Accelerate Diagnostics, Inc. announced delayed 10-Q filing On 05/16/2025, Accelerate Diagnostics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Aankondiging • May 16
Accelerate Diagnostics, Inc.(OTCPK:AXDX.Q) dropped from NASDAQ Composite Index Accelerate Diagnostics, Inc has been dropped from the NASDAQ Composite Index Aankondiging • May 13
Accelerate Diagnostics Receives Delisting Determination and Minimum Bid Price Non-Compliance Letter from Nasdaq As previously disclosed, on May 8, 2025, Accelerate Diagnostics, Inc. (the “ Company”) and certain of its subsidiaries (together, the “ Debtors”) filed voluntary petitions (the “ Bankruptcy Petitions”) under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware (such court, the “ Court” and such cases, the “ Cases”). On May 8, 2025, the Company received written notice (the “ Delisting Notice”) from the Listing Qualifications Staff (the “ Staff”) of The Nasdaq Stock Market LLC (“ Nasdaq”) notifying the Company that, as a result of the Bankruptcy Petitions and in accordance with Nasdaq Listing Rules 5101, 5110(b) and IM-5101-1, the Staff has determined that the Company’s common stock (the “ Securities”) will be delisted from Nasdaq. In addition, on May 6, 2025, the Company received written notice from the Staff notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company’s common stock had closed below the minimum $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “ Minimum Bid Price Requirement”). In the Delisting Notice, the Staff stated that its determination was based on (i) public interest concerns related to the Bankruptcy Petitions, (ii) concerns regarding the residual equity interest of the existing holders of listed Securities and (iii) concerns about the Company’s ability to sustain compliance with all requirements for continued listing on Nasdaq. Specifically, the Staff noted that the Company was not in compliance with the Minimum Bid Price Requirement, nor in compliance with Nasdaq’s Market Value of Listed Securities (as defined under Nasdaq rules) requirement pursuant to Nasdaq Listing Rule 5550(b)(2) (the “ MVLS Requirement”), as previously disclosed in the Company’s Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission (the “ SEC”) on January 30, 2025. As a result, the Staff determined that the Company’s Minimum Bid Price Requirement and MVLS Requirement deficiencies served as an additional and separate basis for delisting. The Delisting Notice also indicates that the Company may appeal Nasdaq’s determination pursuant to procedures set in the Nasdaq Listing Rule 5800 Series. The Company does not intend to appeal the determination and, therefore, it is expected that the Securities will be delisted. Trading of the Securities will be suspended at the opening of business on May 15, 2025 and a Form 25-NSE will be filed by Nasdaq with the SEC, which will remove the Securities from listing and registration on Nasdaq. The Company expects the Securities will begin trading on the over-the-counter (the “ OTC”) market under the symbol “AXDXQ” on May 15, 2025, but no assurance can be made that trading in the Securities on the OTC market will commence or be maintained. Aankondiging • Apr 16
Accelerate Diagnostics, Inc. Announces Director Appointments, Effective from April 10, 2025 On April 10, 2025, the Board of Directors of Accelerate Diagnostics, Inc, unanimously elected Paul Shalhoub and Gilbert Nathan to serve as new directors, effective immediately. Messrs. Shalhoub and Nathan will serve as members of the Board until their successors are elected and qualified or until their earlier death, resignation, disqualification or removal. Mr. Nathan was proposed for election to the Board by certain holders pursuant to their director nomination rights under that certain note purchase agreement, dated August 8, 2024, relating to the Company’s 16.00% Super-Priority Senior Secured PIK Notes due 2025. The Board reviewed Mr. Nathan’s qualifications and unanimously agreed to his appointment. There are no transactions between the Company and either Messrs. Shalhoub or Nathan that would require disclosure under Item 404(a) of Regulation S-K. The Board has determined that Messrs. Shalhoub and Nathan are independent directors under the applicable rules of the Nasdaq Stock Market LLC. Aankondiging • Mar 22
Accelerate Diagnostics Submits WAVE System and Gram-Negative Positive Blood Culture Menu to the FDA for 510(k) Clearance Accelerate Diagnostics, Inc. announced the submission of its Accelerate WAVE system and positive blood culture gram-negative test kit to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. The Accelerate WAVE system is designed to provide rapid antimicrobial susceptibility testing (AST) directly from positive blood culture bottles and bacterial isolate colonies. The WAVE system is designed to deliver accurate results in an average of 4.5 hours, enabling same shift targeted antimicrobial therapy for patients with serious infections. With a user-friendly workflow, high throughput capacity, and scalable design, once approved by the FDA, the WAVE system will offer microbiology laboratories a comprehensive AST solution to meet a wide range of testing demands and hospital formulary needs. According to the World Health Organization, sepsis affects an estimated 49 million people globally each year, resulting in approximately 11 million deaths. Of those, around 1.32 million deaths are attributed to bacterial antimicrobial resistance. Sepsis also represents the most significant cost burden to the U.S. healthcare system, with an estimated annual expense of $62 billion. By delivering rapid AST results, the WAVE system is designed to support earlier, targeted antimicrobial therapy-- improving patient outcomes, reducing hospital costs, and helping combat antimicrobial resistance. Aankondiging • Jan 30
Accelerate Diagnostics Receives Non-Compliance Letter Regarding Nasdaq MVLS Requirement On January 28, 2025, Accelerate Diagnostics, Inc. (the Company") received written notice (the Notice") from the Listing Qualifications Staff (the Staff") of the Nasdaq Stock Market, LLC (Nasdaq") notifying the Company that, for the last 30 consecutive business days prior to the date of the Notice, the Company's Market Value of Listed Securities (as defined under Nasdaq rules) was below the minimum of $35 million required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2) (the MVLS Requirement"). In accordance with Nasdaq Listing Rule 5810(c)(3)(C), Nasdaq has provided the Company with 180 calendar days, or until July 28, 2025 (the Compliance Date"), to regain compliance with the MVLS Requirement. If, at any time before the Compliance Date, the Market Value of the Company's common stock (calculated in accordance with Nasdaq rules) closes at $35 million or more for a minimum of ten consecutive business days, Nasdaq will provide written confirmation to the Company and close the matter. The Notice does not result in the delisting of the Company's common stock from the Nasdaq Capital Market. However, in the event the Company does not regain compliance with the MVLS Requirement prior to the Compliance Date, the Company will receive written notification that its common stock will be subject to delisting. At that time, the Company may appeal the Staff's delisting determination to a Nasdaq Hearing Panel. The Company is evaluating potential actions to regain compliance with the MVLS Requirement and intends to actively monitor the market value of its common stock. There can be no assurance that the Company will regain compliance with the MVLS Requirement or otherwise maintain compliance with any of the other Nasdaq listing requirements. Aankondiging • Oct 01
Accelerate Diagnostics, Inc. Announces FDA Clearance of its Accelerate Arc™? System Accelerate Diagnostics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the Accelerate Arc system and BC kit, an innovative, automated positive blood culture sample preparation platform, for use with Bruker's MALDI Biotyper®? CA System (MBT-CA System) and MBT-CA Sepsityper®? software extension. Designed for clinical laboratories, the Accelerate Arc system has a simple workflow that automates positive blood culture sample preparation for direct downstream microbial identification (ID) using Bruker's MBT-CA system. This eliminates the need for overnight culture methods, reducing the wait time for microbial ID results, which is critical in the fight against sepsis. The Accelerate Arc system is designed to leverage the breadth of the Bruker MBT-CA reference library to provide rapid ID. This, in conjunction with its future rapid phenotypic antibiotic susceptibility testing (AST) innovation, the Accelerate WAVE™ system1, can enable same shift reporting to Antimicrobial Stewardship teams and clinicians alike. By providing clinicians with rapid ID and AST results, clinicians can get the patient on the optimal antibiotic therapy many hours sooner, which has been shown to improve patient outcomes with Sepsis, reduce antimicrobial resistance rates and hospital costs. The Accelerate Arc system is also designed to supplant both overnight subculture as well as laborious Laboratory Developed Test (LDT) sample preparation methods. Clinical laboratories are under pressure to run FDA-cleared devices due to increased legislation and enforcement associated with the use of LDTs. Accordingly, such laboratories can now utilize the Accelerate Arc system as an automated, FDA-cleared system. Aankondiging • Aug 09
Accelerate Diagnostics, Inc. Announces Successful Completion of Its Wave Pre-Clinical Trial Accelerate Diagnostics, Inc. announced the successful completion of its WAVE pre-clinical trial. The Accelerate WAVE system is designed to deliver rapid antimicrobial susceptibility testing ("AST") directly from positive blood culture ("PBC") bottles and bacterial isolated colonies ("Isolates") to report accurate results within 4.5 hours, on average. By delivering rapid AST results, patients with serious infections can be put on targeted antimicrobial therapy to improve patient outcomes, cut hospital costs, and reduce antimicrobial resistance. The pre-clinical trial included 1,570 WAVE results compared to Broth Microdilution ("BMD"), the reference method. The trial included an equal number of prospective patient samples and site selected challenge samples which resulted in excellent concordance between sample types. About the Accelerate WAVE System: The Accelerate WAVE system are intended to deliver same-shift antibiotic susceptibility test results enabling antimicrobial stewardship teams and clinicians alike to tailor therapy for patients with serious infections in a timely manner. Getting the patient on optimal therapy, as shown with numerous peer-reviewed publications, not only reduces morbidity associated with bacteremia but also reduces healthcare costs. The WAVE system will offer a comprehensive test menu and incorporates essential features to optimize workflow across laboratories. With full random access for continuous sample loading, the scalability of the Wave system addresses the needs of various health care settings from small community hospitals to large academic centers and reference labs. The WAVE System employs novel holographic imaging technology to determine bacterial growth and morphology changes in real time, enabling same-shift, quantitative usceptibility test results. Aankondiging • May 03
Accelerate Diagnostics, Inc. to Report Q1, 2024 Results on May 08, 2024 Accelerate Diagnostics, Inc. announced that they will report Q1, 2024 results on May 08, 2024 Aankondiging • May 01
Accelerate Diagnostics, Inc. Receives Written Notice from the Listing Qualifications Staff of Nasdaq On April 26, 2024, Accelerate Diagnostics, Inc. (the Company") received written notice from the Listing Qualifications Staff (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company's common stock had closed below the minimum $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the Minimum Bid Price Requirement"). In accordance with Nasdaq rules, the Company has been provided an initial period of 180 calendar days, or until October 23, 2024 (the Compliance Date"), to regain compliance with the Minimum Bid Price Requirement. If, at any time before the Compliance Date, the closing bid price for the Company's common stock is at least $1.00 for a minimum of ten consecutive business days, the Staff will provide the Company written confirmation of compliance with the Minimum Bid Price Requirement and close the matter. If the Company does not regain compliance with the Minimum Bid Price Requirement by the Compliance Date, the Company may be eligible for an additional 180 calendar day compliance period, provided that it meets the continued listing requirement for the market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and notifies the Staff in writing of its intention to cure the deficiency during the additional compliance period. If the Company does not regain compliance with the Minimum Bid Price Requirement by the Compliance Date and is not eligible for an additional compliance period at that time, the Staff will provide written notification to the Company that its common stock will be subject to delisting. At that time, the Company may appeal the Staff's delisting determination to a Nasdaq Hearing Panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement or otherwise maintain compliance with any of the other Nasdaq listing requirements. The Company intends to monitor the closing bid price of its common stock and will consider various options available to it if its common stock does not trade at a level to regain compliance with the Minimum Bid Price Requirement. These options include effecting a reverse stock split designed to increase the bid price of the Company's common stock in an amount sufficient to regain compliance with the Minimum Bid Price Requirement. There can be no assurances that a reverse stock split will be consummated or that it will achieve its intended effects. Aankondiging • Apr 13
Accelerate Diagnostics, Inc., Annual General Meeting, May 07, 2024 Accelerate Diagnostics, Inc., Annual General Meeting, May 07, 2024, at 10:30 Pacific Daylight. Agenda: To elect the following 9 persons to serve as directors of the Company (“Directors”) until the 2025 Annual Meeting of Shareholders or until their successors have been duly elected and qualified: Mark Black, Wayne C. Burris, Louise L. Francesconi, Hany Massarany, Marran H. Ogilvie, John Patience, Jack Phillips, Jennifer Regan, and Jack W. Schuler; to ratify the selection of Ernst & Young LLP as the independent registered public accounting firm of the Company for the year ending December 31, 2024; to approve an amendment to the Accelerate Diagnostics, Inc. 2022 Omnibus Equity Incentive Plan (the “2022 Incentive Plan”) to increase the total number of authorized shares of the Company’s common stock (“Shares”) available for grant thereunder by 4,000,000 Shares; and to transact such other business as may properly come before the meeting or any continuation, postponement or adjournment thereof. Aankondiging • Mar 06
Accelerate Diagnostics, Inc. Receives Written Notice from the Listing Qualifications Staff of the Nasdaq Stock Market, LLC On March 4, 2024, Accelerate Diagnostics, Inc. (the Company") received written notice (the Notice") from the Listing Qualifications Staff (the Staff") of the Nasdaq Stock Market, LLC (Nasdaq") notifying the Company that for the last 31 consecutive business days prior to the date of the Notice, the Company's Market Value of Listed Securities (as defined under Nasdaq rules) was below the minimum of $35 million required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2) (the MVLS Requirement"). In accordance with Nasdaq Listing Rule 5810(c)(3)(C), Nasdaq has provided the Company with 180 calendar days, or until September 3, 2024 (the Compliance Date"), to regain compliance with the MVLS Requirement. If, at any time before the Compliance Date, the market value of the Company's common stock (calculated in accordance with Nasdaq rules) closes at $35 million or more for a minimum of ten consecutive business days, Nasdaq will provide written confirmation to the Company and close the matter. The Notice does not result in the delisting of the Company's common stock from the Nasdaq Capital Market. However, in the event the Company does not regain compliance with the MVLS Requirement prior to the Compliance Date, the Company will receive written notification that its common stock will be subject to delisting. At that time, the Company may appeal the Staff's delisting determination to a Nasdaq Hearing Panel. The Company is evaluating potential actions to regain compliance with the MVLS Requirement and intends to actively monitor the market value of its common stock. The Company may also, if appropriate, consider other options to regain compliance with Nasdaq's continued listing standards, such as by increasing its stockholders' equity to at least $2.5 million. There can be no assurance that the Company will regain compliance with the MVLS Requirement or otherwise maintain compliance with any of the other Nasdaq listing requirements. Aankondiging • Jan 25
Accelerate Diagnostics, Inc. announced that it expects to receive $4.749996 million in funding from Jack W. Schuler Living Trust Accelerate Diagnostics, Inc. announced that it has entered into a securities purchase agreement to issue 33,332 units at a price of $1.5 per unit for the gross proceeds of $49,998 and 2,716,762 units at a price of $1.73 per unit for the gross proceeds of $4,699,998.26 for the total gross proceeds of $4,749,996 on January 25, 2024. The transaction will include participation from individual investors, Chief Executive Officer and Chief Financial Officer for $49,998 and returning investor, Jack W. Schuler Living Trust for $4,749,996. The transaction became effective as of May 20, 2024. Aankondiging • Jan 21
Accelerate Diagnostics, Inc. has completed a Composite Units Offering. Accelerate Diagnostics, Inc. has completed a Composite Units Offering.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 6,860,659
Price\Range: $1.5
Security Name: Pre-Funded Units
Security Type: Equity/Derivative Unit
Securities Offered: 6,860,659
Price\Range: $1.49 Aankondiging • Jul 11
Accelerate Diagnostics Announces 1-For-10 Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement of $1.00 Per Share Required to Maintain Continued Listing on the Nasdaq Capital Market Accelerate Diagnostics, Inc. (the "Company") announced that it will conduct a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-10. The reverse stock split will become effective at 5:00 p.m. Eastern Time, on July 11, 2023. The Company's common stock will begin trading on a post-split basis at the market open on July 12, 2023, under the Company's existing trading symbol "AXDX". The reverse stock split is part of the Company's plan to regain compliance with the Minimum Bid Price Requirement of $1.00 per share required to maintain continued listing on The Nasdaq Capital Market, among other benefits. The reverse stock split was approved by the Company's stockholders at the Company's Annual Meeting of Stockholders held on May 19, 2023 to be effected in the Board's discretion within approved parameters. The final ratio was approved by the Company's Board on July 7, 2023. The reverse stock split reduces the number of shares of the Company's outstanding common stock from approximately 144 million shares to approximately 14 million shares, subject to adjustment due to the payment of cash in lieu of fractional shares. As a result of the Reverse Stock Split, proportionate adjustments will be made to the number of shares of the Company's common stock underlying the Company's outstanding equity awards, warrants and convertible notes and the number of shares issuable under the Company's equity incentive plans and other existing agreements, as well as the exercise or conversion price, as applicable. There will be no change to the number of authorized shares or the par value per share. Reported Earnings • May 12
First quarter 2023 earnings released: US$0.17 loss per share (vs US$0.21 loss in 1Q 2022) First quarter 2023 results: US$0.17 loss per share. Revenue: US$2.81m (down 4.9% from 1Q 2022). Net loss: US$16.8m (loss widened 18% from 1Q 2022). Revenue is forecast to grow 27% p.a. on average during the next 3 years, compared to a 9.0% growth forecast for the Global Medical Equipment industry. Reported Earnings • Mar 07
Third quarter 2022 earnings released: US$0.18 loss per share (vs US$0.15 loss in 3Q 2021) Third quarter 2022 results: US$0.18 loss per share (further deteriorated from US$0.15 loss in 3Q 2021). Revenue: US$2.96m (down 5.2% from 3Q 2021). Net loss: US$15.9m (loss widened 77% from 3Q 2021). Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 8.6% growth forecast for the Global Medical Equipment industry. Board Change • Mar 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 7 experienced directors. 5 highly experienced directors. CEO, President & Director Jack Phillips was the last director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Aankondiging • Jan 12
Accelerate Diagnostics Receives A Deficiency Letter from Nasdaq Regarding Minimum Bid Price Requirement On January 5, 2023, Accelerate Diagnostics, Inc. ("the Company") received a deficiency letter from the Listing Qualifications Department (the Staff") of The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company's common stock had closed below the minimum $1.00 per share requirement for continued inclusion on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the Minimum Bid Price Requirement"). In accordance with Nasdaq rules, the Company has been provided an initial period of 180 calendar days, or until July 5, 2023 (the Compliance Date"), to regain compliance with the Minimum Bid Price Requirement. If, at any time before the Compliance Date, the closing bid price for the Company's common stock is at least $1.00 for a minimum of ten consecutive business days, the Staff will provide the Company written confirmation of compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance with the Minimum Bid Price Requirement by the Compliance Date, the Company may be eligible for an additional 180 calendar day compliance period, provided that it meets the continued listing requirement for the market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and notifies the Staff of its intention to cure the deficiency during the additional compliance period. If the Company does not regain compliance with the Minimum Bid Price Requirement by the Compliance Date and is not eligible for an additional compliance period at that time, the Staff will provide written notification to the Company that its common stock will be subject to delisting. At that time, the Company may appeal the Staff's delisting determination to a Nasdaq Hearing Panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement or otherwise maintain compliance with any of the other Nasdaq listing requirements. The Company intends to monitor the closing bid price of its common stock and will consider various options available to it if its common stock does not trade at a level to regain compliance with the Minimum Bid Price Requirement. These options include effecting a reverse stock split designed to increase the bid price of the Company's common stock in an amount sufficient to regain compliance with the Minimum Bid Price Requirement. There can be no assurances that a reverse stock split will be consummated or that it will achieve its intended effects. Reported Earnings • Nov 16
Third quarter 2022 earnings released: US$0.18 loss per share (vs US$0.15 loss in 3Q 2021) Third quarter 2022 results: US$0.18 loss per share (further deteriorated from US$0.15 loss in 3Q 2021). Revenue: US$2.96m (down 5.2% from 3Q 2021). Net loss: US$15.7m (loss widened 75% from 3Q 2021). Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 9.2% growth forecast for the Global Medical Equipment industry. Recent Insider Transactions • Aug 31
Insider recently bought Mex$1.6m worth of stock On the 30th of August, Larry Mertz bought around 50k shares on-market at roughly Mex$32.16 per share. This transaction amounted to 13% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought Mex$225m more in shares than they have sold in the last 12 months. Reported Earnings • Aug 16
Second quarter 2022 earnings released: US$0.23 loss per share (vs US$0.35 loss in 2Q 2021) Second quarter 2022 results: US$0.23 loss per share (up from US$0.35 loss in 2Q 2021). Revenue: US$3.86m (up 38% from 2Q 2021). Net loss: US$17.8m (loss narrowed 18% from 2Q 2021). Over the next year, revenue is forecast to grow 11%, compared to a 19% growth forecast for the Medical Equipment industry in Mexico. Over the last 3 years on average, earnings per share has increased by 14% per year but the company’s share price has fallen by 44% per year, which means it is significantly lagging earnings. Reported Earnings • May 17
First quarter 2022 earnings released: US$0.21 loss per share (vs US$0.41 loss in 1Q 2021) First quarter 2022 results: US$0.21 loss per share (up from US$0.41 loss in 1Q 2021). Revenue: US$2.96m (up 18% from 1Q 2021). Net loss: US$14.2m (loss narrowed 42% from 1Q 2021). Over the next year, revenue is forecast to grow 19%, compared to a 17% growth forecast for the industry in Mexico.