Eiger BioPharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Business Update

On August 6, 2020 Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported financial results for second quarter 2020 and provided a business update (Press release, Eiger Biopharmaceuticals, AUG 6, 2020, View Source [SID1234563203]).

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"Eiger is executing toward multiple important milestones across our pipeline, including anticipated FDA approval of Zokinvy in Progeria and Progeroid Laminopathies," said David Cory, President and CEO. "Our Phase 3 HDV D-LIVR trial continues to enroll and dose patients with full enrollment expected in 2021, and we plan for end-of-treatment and end-of-study data from our Phase 2 HDV LIFT study of peginterferon lambda in combination with lonafarnib this year. In addition, we look forward to results from multiple ongoing investigator sponsored studies of peginterferon lambda in COVID-19 patients."

Recent Highlights and Upcoming Milestones

Zokinvy (lonafarnib) in Progeria and Progeroid Laminopathies

New Drug Application (NDA) accepted for filing by FDA with priority review and Prescription Drug User Fee Act (PDUFA) target action date of November 20, 2020
Marketing Authorization Application (MAA) under review by EMA will follow a standard review timeline. EMA request for inspections, in addition to travel restrictions due to COVID-19, will delay EMA from completing its review within the framework of previously granted accelerated assessment.
Lonafarnib in Hepatitis Delta Virus (HDV)

Phase 3 D-LIVR study (N=400) continues to enroll and dose patients
Full enrollment expected in 2021
Peginterferon Lambda in HDV

Phase 2 LIFT (combo with lonafarnib) end-of-treatment data planned for EASL 2020; end-of-study data planned for AASLD 2020
Single, Phase 3 study design agreement with FDA and EMA
Peginterferon Lambda in COVID-19

Six International Investigator Sponsored Studies in progress
Second Quarter 2020 Financial Results

Cash, cash equivalents, and short-term investments as of June 30, 2020 totaled $90.8 million.

The Company reported net loss of $15.3 million, or $0.60 per share, for second quarter 2020, as compared to $17.5 million, or $0.75 per share, for second quarter 2019.

Research and Development expenses were $9.8 million for second quarter 2020, as compared to $12.9 million for second quarter 2019. The decrease was primarily due to a decrease in regulatory expenses and lower clinical trial related expenses, including clinical material costs.

General and Administrative expenses were $4.9 million for second quarter 2020, as compared to $4.2 million for second quarter 2019. The increase was primarily due to an increase in outside legal, consulting, advisory and accounting services.

Total operating expenses include total non-cash expenses of $1.8 million for second quarter 2020, as compared to $1.8 million for the same period in 2019.

As of June 30, 2020, the Company had 27,241,640 of common shares outstanding.

Synthetic Biologics Reports 2020 Second Quarter Operational Highlights and Financial Results

On August 6, 2020 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, reported financial results for the quarter ended June 30, 2020 (Press release, Synthetic Biologics, AUG 6, 2020, View Source [SID1234563198]).

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"During the second quarter, we remained diligently focused on advancing our portfolio of GI and microbiome-focused clinical development programs while continuing to navigate the unprecedented global health and economic crisis sparked by the COVID-19 global pandemic," said Steven A. Shallcross, Chief Executive and Financial Officer of Synthetic Biologics. "We made significant progress positioning SYN-020, our orally delivered recombinant version of bovine intestinal alkaline phosphatase (IAP), for its first clinical trial. We were pleased to report the FDA responded to our Investigational New Drug application (IND) with a study-may-proceed letter to conduct a Phase 1 single ascending dose study of SYN-020 in healthy volunteers. Additionally, we expanded our collaboration with Massachusetts General Hospital (MGH) in the form of an exclusive option agreement to license intellectual property and technology to commercially develop SYN-020 for the treatment and prevention of metabolic and inflammatory diseases associated with aging. The Phase 1 clinical trial is intended to support the clinical development of SYN-020 in multiple indications, including an initial indication for the treatment of radiation enteropathy secondary to pelvic cancer therapy and indications that may be developed under the MGH license agreement."

Mr. Shallcross continued, "Enrollment in the Phase 2b investigator-sponsored clinical trial of SYN-010, intended to treat irritable bowel syndrome-constipation (IBS-C) and being conducted out of Cedars-Sinai Medical Center (CSMC), has recommenced following a temporary postponement during the first and second quarter due to the impact of the COVID-19 global pandemic. A data readout in the form of an interim futility analysis is expected during the third quarter and topline data is anticipated during the first quarter of 2021, subject to potential COVID-19 complications." Mr. Shallcross concluded, "We remain in close contact with Washington University as we continue to evaluate opportunities to initiate the planned Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients in the face of the ongoing COVID-19 pandemic. We continue to closely monitor the crisis caused by the spread of the COVID-19 and look forward to sharing important updates and progress for this and all our GI and microbiome-focused clinical programs."

Clinical Development and Operational Update

Submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for SYN-020, the Company’s recombinant version of bovine intestinal alkaline phosphatase (IAP) supporting an initial indication to mitigate the intestinal damage caused by radiation therapy routinely used to treat pelvic cancers (Q2 2020)
Received study-may-proceed letter from FDA to conduct a Phase 1 single ascending dose study in healthy volunteers, designed to evaluate SYN-020 for safety, tolerability, and pharmacokinetic parameters (Q3 2020),
The Phase 1 clinical program is intended to support the clinical development of SYN-020 in multiple indications, including an initial indication for the treatment and prevention of radiation enteropathy secondary to cancer therapy;
Entered into an agreement with Massachusetts General Hospital (MGH) granting the Company an option for an exclusive license to intellectual property and technology related to the use of IAP to maintain GI and microbiome health, diminish systemic inflammation, and treat age-related diseases (Q2 2020)
Under the terms of the agreement, Synthetic Biologics is granted exclusive rights to negotiate a worldwide license with MGH to commercially develop SYN-020 to treat and prevent metabolic and inflammatory diseases associated with aging,
If executed, the Company plans to use this license in the advancement of an expanded clinical development program for SYN-020;
Enrollment in the investigator-sponsored Phase 2b clinical trial of SYN-010, intended to treat IBS-C, has recommenced following a temporary halt in Q1 and Q2 2020 due to the COVID-19 global pandemic; however, the ability to continue to recruit new patients into this clinical trial remains at the discretion of CSMC and contingent upon the impact of the COVID-19 global pandemic
A data readout in the form of an interim futility analysis is expected during the third quarter of 2020 and topline data is anticipated during the first quarter of 2021, subject to the impact of COVID-19,
CSMC and Synthetic Biologics are co-funding the study. The patent rights covering the use of SYN-010 are owned by CSMC and are exclusively licensed by CSMC to Synthetic Biologics;
Received written notification from the FDA informing the Company that the FDA determined the Phase 1b/2a clinical program in adult allogeneic hematopoietic cell transplant (HCT) recipients may proceed per the submitted clinical program protocol (Q3 2020)
Due to the unique challenges posed by the global COVID-19 pandemic, Washington University continues to evaluate non-essential activities, which may have a direct impact on planned and ongoing clinical trials, including the SYN-004 (ribaxamase) Phase 1b/2a clinical program in allogeneic HCT recipients,
At this time, the Company has determined that postponing the initiation of the planned Phase 1b/2a clinical trial in allogeneic HCT recipients until at least the first quarter of 2021 remains the appropriate course of action due to continued uncertainty surrounding the ongoing global COVID-19 pandemic;
On July 30, 2020, the Company received written communication from NYSE American LLC (the "Exchange"), the Company’s current listing exchange, stating that in addition to Section 1003(iii), it is now also not in compliance with both Section 1003(i) and Section 1003(ii) of the NYSE American Company Guide since it reported a stockholders’ deficit of ($4.0) million as of March 31, 2020 and losses from continuing operations and/or net losses in its five most recent fiscal years ended December 31, 2019
The Company has previously submitted a plan of compliance which was accepted by the Exchange addressing how it intends to regain compliance with the Exchange continued listing standards by November 25, 2020, the end of the current compliance plan period,
The NYSE American notification does not affect the Company’s business operations or the listing of the Company’s shares on the Exchange, and does not represent any change or amendment to the Company’s consolidated financial statements or to its quarterly reports for the quarter ended March 30, 2020 or to its annual report on Form 10-K for the year ended December 31, 2019.
Quarter Ended June 30, 2020 Financial Results

General and administrative expenses increased by 23% to $1.3 million for the three months ended June 30, 2020, from $1.0 million for the three months ended June 30, 2019. This increase is primarily due to increased legal costs related to business development, patent execution and employee contract matters, vacation expense, and insurance costs. The charge related to stock-based compensation expense was $67,000 for the three months ended June 30, 2020, compared to $59,000 the three months ended June 30, 2019.

Research and development expenses decreased by 38% to $1.6 million for the three months ended June 30, 2020, from $2.6 million for the three months ended June 30, 2019. This decrease is primarily the result of the response to the global COVID-19 pandemic by our clinical development partners which led to the postponement of the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients and a temporary halt during the second quarter in new enrollment in the Phase 2b investigator sponsored clinical trial of SYN-010. The charge related to stock-based compensation expense was $19,000 for the three months ended June 30, 2020, compared to $31,000 for the three months ended June 30, 2019.

Other income was $6,000 for the three months ended June 30, 2020, compared to other income of $80,000 for the three months ended June 30, 2019. Other income for the three months ended June 30, 2020 and 2019 is primarily comprised of interest income.

Cash and cash equivalents as of June 30, 2020 totaled $8.1 million, a decrease of $7.0 million from December 31, 2019.

Conference Call

Synthetic Biologics will hold a conference call today, Thursday, August 6, 2020, at 4:30 p.m. (EST). The dial-in information for the call is as follows, U.S. toll free: 1-888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source, for 90 days after the call.

10-Q – Quarterly report [Sections 13 or 15(d)]

Clovis Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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AMN Healthcare Announces Second Quarter 2020 Results

On August 6, 2020 AMN Healthcare Services, Inc. (NYSE: AMN), the leader and innovator in total talent solutions for healthcare organizations across the United States, reported its second quarter 2020 financial results (Press release, AMN Healthcare Services, AUG 6, 2020, View Source [SID1234563197]). Financial highlights are as follows:

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Business Highlights

AMN team members and our healthcare professionals have been instrumental in responding to our country’s needs to care for COVID-19 patients.
We have increased diversity, inclusion, equity and equality actions and education to support our team members and communities in fighting social injustice and racism.
Second quarter financial results were ahead of guidance, led by strength in travel nurse staffing and the quick recovery of our language interpretation business, Stratus Video.
Revenue of $608 million was 14% above prior year, with organic revenue higher by 2%, and adjusted EBITDA was $81 million.
While many of our businesses saw demand disrupted by the COVID-19 pandemic, most business lines performed in line with or better than our expectations in the second quarter.
Operating cash flow in the quarter was $77 million, helping us to pay down $127 million of debt and reach a leverage ratio of 2.7 to 1.
With improving healthcare utilization and the continued impact of COVID-19, current travel nurse demand is significantly higher than prior-year levels.
"Our healthcare professionals and the entire AMN team are doing an exceptional job of pivoting and leaning in to help patients receive the compassionate care needed as our country navigates through this crisis, and we are prioritizing their health and well-being," said Susan R. Salka, Chief Executive Officer of AMN Healthcare. "AMN’s long-standing commitment to diversity, equality, equity and inclusion has been a critical part of our culture and collaboration with stakeholders. Our dedication in fighting for social justice and against racism has been fortified over these last few months, and AMN is taking greater action to support our team members, healthcare professionals, clients and communities.

"In this unprecedented business environment, we have adapted our operations and cost structure to be more agile and responsive to the fast-changing needs of our healthcare professionals and clients. We are also continuing to make important investments in our people, processes and technology to further differentiate AMN and enable future growth opportunities," Ms. Salka said. "We believe these past few months have strengthened our relationship with our strategic clients and improved our competitive positioning as we have launched expanded and new solutions, demonstrating the value of having a total talent solutions partner."

Second Quarter 2020 Results

Consolidated revenue for the quarter was $608 million, a 14% increase over prior year and 1% higher than prior quarter. On an organic basis, consolidated revenue was up 2% over prior year.

Revenue for the Nurse and Allied Solutions segment was $444 million up 21% year over year, up 13% organic excluding the June 2019 acquisition of Advanced Medical, and up 5% sequentially. Travel Nurse revenue led the way with 41% year-over-year growth, including 35% organic. Allied division revenue increased 10% year over year due to the acquisition of Advanced Medical, with organic revenue down 13%.

The Physician and Leadership Solutions segment reported revenue of $109 million, down 24% year over year and down 21% sequentially. All business lines in the segment were negatively affected by the reductions in non-emergency care. Locum tenens revenue was $62 million, down 25% year over year and down sequentially by 22%. Interim leadership revenue fell 17% year over year, and our physician and leadership search businesses saw revenue decline 34% compared with a year ago.

Technology and Workforce Solutions segment revenue was $55 million for an increase of 123% year over year (3% organic), driven in large part by our acquisitions of Stratus Video and b4health. Stratus Video contributed $28 million revenue in the quarter, significantly better than expected as this business quickly rebounded from a COVID-19-driven slowdown in March and April. Our vendor management systems, open marketplace and scheduling and predictive analytics businesses also performed better than expected.

Gross margin was 32.5%, lower by 100 basis points year over year and sequentially. The variance was driven primarily by a segment mix shift toward lower-margin Nurse and Allied staffing and a lower gross margin in the Nurse and Allied Solutions segment from a lower bill-pay spread.

SG&A expenses were $137 million, or 22.5% of revenue, compared with $122 million, or 22.7% of revenue, in the same quarter last year. SG&A was $146 million, or 24.3% of revenue, in the previous quarter. The year-over-year increase in SG&A costs included $10 million of additional SG&A from acquired companies. SG&A in the quarter also included $4 million of restructuring expenses associated with our cost reduction actions, $4 million of acquisition integration expenses, and a $5 million increase in the earn-out obligation associated with the b4health acquisition.

Income from operations was $38 million with an operating margin of 6.3%, compared with $45 million and 8.4%, respectively, in the same quarter last year. Adjusted EBITDA was $81 million, a year-over-year increase of 21%. Adjusted EBITDA margin was 13.2%, representing an increase of 70 basis points year over year.

Net income was $22 million, or $0.47 per diluted share, compared with $29 million, or $0.61 per diluted share, in the same quarter last year. Adjusted diluted EPS in the second quarter was $0.83. As noted in the tables of this press release, the difference between GAAP and adjusted net income and EPS is driven by higher amortization related to recent acquisitions, integration-related expenses, and an increase in the earn-out obligation for the b4health acquisition, offset in part by adjustments to normalize our tax rate.

At June 30, 2020, cash and cash equivalents totaled $43 million. Cash flow from operations was $77 million for the quarter, and capital expenditures were $6 million. The Company ended the quarter with total debt outstanding of $973 million and a leverage ratio of 2.7 to 1.

Third Quarter 2020 Outlook

The COVID-19 pandemic has been highly disruptive to economic activity and to healthcare infrastructure in the United States, making healthcare labor demand volatile, differing widely among client segments. COVID-19 patient volumes have been highly variable, with surges continuing across the country driving significantly higher demand for nurses; however, elective procedures and routine care are still below pre-crisis levels. The trajectory of healthcare and economic recovery is uncertain, and we are anticipating continued surges in COVID-19 care coupled with a modest recovery of non-COVID-19 healthcare services.

In our Nurse and Allied Solutions segment, we expect third quarter revenue to be down approximately 10% from prior year. For our largest business of travel nurse staffing, we expect revenue to be up 3-5% to prior year, with lower volumes offset by higher rates and hours worked. Allied revenue is expected to be lower than prior year by 27-29% as a result of reduced healthcare utilization, particularly impacting our physical therapy discipline.

Our Physician and Leadership Solutions segment saw a sharp sequential drop in April revenue as the national response to the pandemic resulted in an abrupt falloff of contingent and permanent labor demand. The revenue trend stabilized in June, and we expect the segment will remain at this level in the third quarter with revenue estimated at nearly 30% below prior year.

We project revenue for our Technology and Workforce Solutions segment to rise approximately 140% compared with prior year, including the recent acquisitions of Stratus Video and b4health. Segment revenue dropped in April, but May and June rebounded. Our language interpretation business has experienced steady growth in billable minutes since May, which we expect will continue through the third quarter.

Based on the above trends, we are projecting consolidated third quarter revenue to be in a range of $510 million to $525 million. Third quarter gross margin is expected to be 33.0-33.5%, operating margin is expected to be above 7%, and adjusted EBITDA margin is expected to be greater than 13%.

Third quarter estimates for certain financial items include depreciation of $7 million, non-cash amortization expense of $15 million, stock-based compensation expense of $4 million, interest expense of $10 million, integration expenses of $6 million, and an adjusted tax rate of 30%.

Conference Call on August 6, 2020

AMN Healthcare Services, Inc. (NYSE: AMN), the leader and innovator in total talent solutions for healthcare, will host a conference call to discuss its second quarter 2020 financial results and outlook on Thursday, August 6, 2020, at 5:00 p.m. Eastern Time. A live webcast of the call can be accessed through AMN Healthcare’s website at View Source Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Interested parties may participate live via telephone by dialing (833) 968-2219 in the U.S. or +1 778-560-2894 internationally and using passcode 5756627. Following the conclusion of the call, a replay of the webcast will be available at the Company’s website. Alternatively, a telephonic replay of the call will be available starting at 8:00 p.m. Eastern Time on August 6, 2020, and can be accessed until 11:59 p.m. Eastern Time on August 20, 2020, by calling (800) 585-8367 in the U.S. or +1 416-621-4642 internationally, with access code 5756627.

Accelerate Diagnostics Reports Second Quarter 2020 Financial Results & Announces New Product Offering

On August 6, 2020 Accelerate Diagnostics, Inc. (Nasdaq: AXDX) reported financial results for the second quarter ended June 30, 2020 (Press release, ACCELERATED MEDICAL DIAGNOSTICS, AUG 6, 2020, View Source;announces-new-product-offering-301107931.html [SID1234563196]).

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"While the progress of new contracts and go-lives continued to be slowed by the effects of the pandemic, utilization within our existing base of live Pheno instruments continued to prove durable during the second quarter," commented Jack Phillips, President and CEO of Accelerate Diagnostics, Inc. "Despite these external disruptions, our internal R&D teams have made considerable progress, enabling today’s announcement of several new products as part of our enhanced portfolio strategy. These include the immediate launch of an AST-only test kit and the imminent launch of a new workflow instrument, the PhenoPrep, the first application of which is enabling automated rapid MALDI identification results. We also entered into an exclusive supply and collaboration arrangement with Ascend Diagnostics to commercialize a complementary desktop MALDI instrument. We are excited about these new additions to our product portfolio and believe they will help position Accelerate for sustained success and more rapid adoption of our technology as the market continues to recover from the unprecedented impacts of COVID-19."

Second Quarter 2020 Highlights

Added 6 new contracted instruments in the quarter and brought 6 instruments live, including 4 in the U.S.
Ended the second quarter with 201 U.S. live revenue-generating instruments, with another 213 U.S. contracted Pheno instruments not yet live.
Net sales of $2.1 million, compared to $1.8 million in the second quarter of 2019, or 17% growth.
Gross margin was 45.0% for the quarter, compared to 50% in the second quarter of 2019. This decrease was the result of lower absorption of labor and overhead costs in the current quarter.
Selling, general, and administrative expenses for the quarter were $11.3 million, compared to $12.8 million in the second quarter of 2019. This decrease was driven by pandemic-related reductions in sales and marketing spend related to travel and trade shows.
Research and development (R&D) costs for the quarter were $5.3 million, compared to $6.1 million in the second quarter of 2019. This decrease was the result of increased efficiencies and lower external study spend.
Net loss was $19.2 million in the second quarter, or $0.35 per share, which included $3.4 million in non-cash stock-based compensation expense.
Net cash used in the quarter was $8.1 million, and the company ended the quarter with total cash, investments, and cash equivalents of $88.7 million.
Launched PhenoAST Test, an AST-only test kit, and announced the upcoming launch of PhenoPrep instrument in Q1 2021
Entered into exclusive supply and collaboration agreement with Ascend Diagnostics to commercialize a desktop MALDI system.
Recently submitted final FDA Emergency Use Authorization review items and data for the MS Fast fully-automated chemiluminescence immunoassay analyzer and SARS-CoV-2 tests for the detection of IgG and IgM.
Year to Date 2020 Highlights

Net sales were $4.4 million year-to-date as compared to $3.6 million from the same period in the prior year, or 22% growth.
Gross margin was 45.0% year-to-date, compared to 49% from the same period in the prior year. This decrease was the result of lower absorption of labor and overhead costs in the first half of 2020.
Selling, general, and administrative expenses were $24.3 million year-to-date, compared to $25.6 million from the same period in the prior year. This decrease was driven by pandemic-related reductions in sales and marketing spend related to travel and trade shows.
Research and development (R&D) costs were $11.2 million year-to-date, compared to $13.1 million from the same period in the prior year. This decrease was the result of increased efficiencies and lower external study spend.
Net loss was $40.5 million year-to-date, or $0.74 per share, which included $7.6 million in non-cash stock-based compensation expense.
Net cash used was $24.5 million year-to-date, and the company ended the quarter with total cash, investments, and cash equivalents of $88.7 million.
Full financial results for the quarter ending June 30, 2020 will be filed on Form 10-Q through the Securities and Exchange Commission’s (SEC) website at View Source

Audio Webcast and Conference Call

The company will host a conference call at 4:30PM ET today to review its second quarter results. To participate in the conference call, dial +1.877.883.0383 and enter the conference ID: 6487727. International participants may dial +1.412.902.6506. Please dial in 10 to 15 minutes prior to the start of the conference call. A replay of the call will be available by telephone at +1.877.344.7529 (U.S.) or +1.412.317.0088 (international) using replay code 10145894 until August 27, 2020.

This conference call will also be webcast and can be accessed from the "Investors" section of the company’s website at axdx.com/investors. A replay of the audio webcast will be available until November 7, 2020.