NEW YORK – This week Laboratory Corporation of American said in a Form 8-K filed with the US Securities and Exchange Commission that it had entered accelerated share repurchase agreements with Goldman Sachs and Morgan Stanley to repurchase roughly $1.0 billion of its common stock. Under the agreements, Labcorp will make an aggregate payment of $1.0 billion to the two banks and will receive from them an aggregate initial number of 3,740,590 shares. The specific number of shares purchased will depend on the average of the daily volume-weighted average price per share of Labcorp’s common stock during the repurchase period. The transactions are expected to be completed by the end of 2023.
T2 Biosystems reported a 67 percent year-over-year drop in second quarter revenues this week attributed to a $3.4 million reduction in research contribution revenues from the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA). The Lexington, Mass.-based firm reported Q2 revenues of $2.0 million, compared to $5.9 million in the year-ago period. Product revenues were down 23 percent to $2.0 million from $2.6 million, which T2 attributed to the decline in COVID-19 test sales partially offset by increased sepsis test sales. The firm recognized sepsis test panel revenues of $1.3 million, which it said represented an increase of 7 percent compared to the prior-year period despite ending the quarter with a $350,000 sepsis test backorder. In the quarter, T2 also executed 11 contracts for its T2Dx instrument and secured a multiyear contract with a distributor in Europe to supply seven T2Dx Instruments and sepsis test panels to customers in Poland. T2 received breakthrough device designation from the US Food and Drug Administration in the quarter for its a direct-from-blood assay to detect Candida auris. It also received an extension to comply with Nasdaq listing requirements through Nov. 20. The company ended the quarter with $16.1 million in cash and cash equivalents.
In a separate announcement this week, T2 Biosystems said that it has regained compliance with the Nasdaq’s market value of listed securities (MVLS) requirement. The firm was notified in November 2022 that it was not in compliance with the requirement because it failed to maintain an MVLS of at least $35 million for 30 consecutive business days. The company regained compliance on Aug. 7, after it maintained an MVLS of $35 million for 10 consecutive trading days. T2 has until Nov. 20 to regain compliance with the Nasdaq’s minimum bid price requirement.
Accelerate Diagnostics said this week that its second quarter revenues fell 26 percent year over year to $2.9 million from $3.9 million. During the recently completed quarter, the Tucson, Arizona-based developer of antibiotic resistance and sepsis tests and instruments added 13 contracted instruments for a total of 339 revenue-generating instruments in the US. Another 70 US contracted instruments are being implemented but are not yet generating revenues, it noted. Accelerate ended the quarter with a net loss of $26.0 million, or $2.36 per share, compared to a net loss of $18.5 million, or $2.43 per share, a year ago. The firm used 11,009 shares to calculate its loss per share figure in Q2 2023 compared to 7,623 shares a year ago. Subsequent to the end of the quarter, the company executed a 1-for-10 reverse stock split in order to regain compliance with a Nasdaq listing requirement. A month earlier, it announced it closed transactions related to its restructuring support agreement.
Accelerate reduced its R&D spending in Q2 2023 24 percent to $5.8 million from $7.6 million a year ago and cut its SG&A spending 34 percent to $7.6 million from $11.5 million. It ended the recently completed quarter with $29.3 million in cash and cash equivalents.
MiRxes said this week that its flagship GastroClear PCR-based in vitro diagnostic test for the early detection of gastric cancer has been granted breakthrough device designation by the US Food and Drug Administration. MiRxes developed GastroClear in Singapore through a seven-year public-private partnership involving researchers and physicians at A*STAR's Bioprocessing Technology Institute, Diagnostics Development Hub, the Singapore Gastric Cancer Consortium, the National University of Singapore, the National University Hospital, and Tan Tock Seng Hospital. The test was approved by the Singapore Health Science Authority in 2019, and MiRxes recently conducted a large prospective clinical trial involving more than 9,000 patients to support the test's registration with China's National Medical Product Administration. The company said it is evaluating partnerships to launch the test in the US.
Last month the company said it completed a Series D financing round totaling $50 million primarily to support the commercialization of GastroClear in the Asia-Pacific region.
Biodesix this week reported an 8 percent increase in its second quarter revenues. The Boulder, Colorado-based firm saw $11.9 million in total revenues compared to $11.0 million in the same period of 2022. Discounting COVID-19 testing, which the company no longer performs, total revenues were up 48 percent year over year. Revenues from Biodesix's core lung nodule diagnostic business were $11.4 million, up 58 percent year over year from $7.3 million, while its biopharma services revenue dropped 43 percent to $423,000 from $744,000. The firm's net loss for the quarter was $13.4 million, or $.17 per share, compared to a loss of $15.8 million, or $.40 per share, in Q2 2022. The company ended the quarter with cash and cash equivalents totaling $17.4 million and reaffirmed its full-year 2023 outlook of between $52 million and $55 million in total revenue.
Sera Prognostics said this week that its second quarter revenues grew 58 percent year over year to $123,000 from $78,000. For the three months ended June 30, the firm recorded a net loss of $10.5 million, or $.34 per share, compared to a net loss of $11.5 million, or $.37 per share, a year ago. Its R&D costs rose 12 percent to $3.7 million from $3.3 million a year ago, while its SG&A spending was trimmed 8 percent to $7.8 million from $8.5 million. The Salt Lake City-based developer of maternity and neonatal health tests ended Q2 2023 with $32.3 million in cash and cash equivalents and $31.5 million in marketable securities. Sera also said that Austin Aerts was recently appointed interim CFO.
Oncocyte said this week that its second quarter revenues were $463,000, up nearly 100 percent from $237,000 in the same period last year. The firm's R&D expenses were down 56 percent year over year at $2.4 million, compared to $5.6 million in the same period of 2022. Its SG&A costs were $4.3 million, down 23 percent from $5.6 million in the year-ago quarter. Oncocyte's net loss attributable to common stockholders for the quarter was $8.6 million, or $1.07 per share, compared to $8.4 million, or $1.48 per share, in Q2 2022. The company ended the quarter with $17.9 million in cash, cash equivalents, and marketable securities.
Co-Diagnostics announced this week that its second quarter revenues fell to $197,806 from $5.0 million in Q2 2022 due to a global decline in demand for COVID-19 testing. The Salt Lake City, Utah-based firm posted a net loss of $8.9 million, or $.31 per share, compared to a net loss of $2.7 million, or $.08 per share in the year-ago period. It ended the quarter with $13.8 million in cash and cash equivalents and $55.3 million in marketable investment securities. In the quarter, Co-Diagnostics was awarded $1.2 million from the National Institute of Health's RADx Tech program to support development of an at-home PCR test system and upper respiratory panel. It was also awarded $2.3 million from the Bill and Melinda Gates Foundation to develop assays for the detection of human papillomavirus and tuberculosis.
Epigenomics this week announced its financial results for the first half of 2023, reporting that revenues fell 16 percent to €203,000 ($223,640) from €241,000 in the same period last year. The decline was due to the discontinuation of sales of the firm’s Epi proColon test as part of its restructuring program announced in February. The company posted a net loss of €8.2 million, or €1.93 per share, compared to a loss of €4.0 million, or €.98 per share, in the first half of 2022. As of June 30, the firm had cash and cash equivalents of €3.6 million.
Last month, the company announced that it would sell its patents and biobank to New Day Diagnostics for about $12.1 million in cash and milestone payments and a small stake in New Day Diagnostics. The deal is still subject to approval by Epigenomics shareholders.
OpGen this week reported that its Q2 2023 revenues were about $736,137 down from $967,205 in the year-ago quarter. The company posted a net loss of $5.8 million, or $.93 per share, compared to $5.8 million, or $2.51 per share, in Q2 2022. OpGen used more than 6.2 million shares to calculate its loss per share figure in Q2 2023 compared to more than 2.3 million shares to calculate its year-ago loss per share number. The firm ended the quarter with $3.2 million in cash and cash equivalents.
The company said that it does not expect that its current cash will be enough to fund its operations beyond September and has pursued options to improve its cash position or mitigate a liquidity shortfall. OpGen also said that it is considering all alternatives, including restructuring or refinancing its debt, seeking additional debt or equity capital, reducing or delaying its business activities, selling assets, and other strategic transactions or other measures, including obtaining relief under US as well as applicable foreign bankruptcy laws.
Autoimmune testing firm Exagen said this week that its second quarter revenues nearly doubled year over year to $14.1 million from $7.6 million. The San Diego-based company said the increase was primarily driven by an increase in the average sales price for its Avise CTD test, as well as Medicare revenue that was constrained in the year-ago period that was recognized in Q3 2022. During Q2 2023, a record 37,749 CTD tests were delivered, an 8 percent rise year over year. Exagen had a net loss of $5 million, or $.28 per share, compared to a net loss of $14.7 million, or $.86 per share, a year ago. It finished the quarter with $31.5 million in cash and cash equivalents. For the third quarter, it expects between $10 million and $10.5 million in revenues.
MyHealthChecked this week reported a sharp drop in revenues for the first half of 2023, to £2.5 million ($3.2 million) from £9.8 million in H1 2022, due to a reduction in demand for COVID-19 tests. Revenues were mainly driven by sales of COVID-19 lateral flow tests for at-home use through pharmacy retailers. In May, the company signed an agreement with pharmacy chain Boots to offer MyHealthChecked's full range of at-home testing products. As of June 30, the company had £5 million in cash left.
Talis Biomedical this week said its second quarter revenues inched up to $581,000 from $572,000 a year ago. Grant revenues shot up to $533,000 from $70,000, while product revenues dropped to $48,000 from $502,000. For the three months ended June 30, the Redwood City, California-based developer of point-of-care tests had a net loss of $15.0 million, or $8.27 per share, compared to a net loss of $27.0 million, or $15.01 per share, in Q2 2022. It cut its R&D costs to $10.6 million in the recently completed quarter from $17.4 million a year ago and lowered its SG&A spending to $6.4 million from $9.2 million. Talis ended Q2 2023 with $98.2 million in cash and cash equivalents and $1.0 million in restricted cash. In a statement, the company noted it has started a clinical study to support a 510(k) submission to the US Food and Drug Admission for its Talis One system for COVID-19 testing. Last month, the firm said it had regained compliance with a Nasdaq listing requirement calling for a minimum bid price of $1.00 per share for the firm's stock.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.