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In Brief This Week: MiRxes, Oncocyte, OpGen, Biodesix, Element Biosciences, More

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, the 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.

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.

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.

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.

Element Biosciences said this week that it has expanded its comarketing partnership with Agilent Technologies. The firms will promote, market, and provide training on each other’s products. Financial and other details were not disclosed.

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. Earlier this week the firm reported a 67 percent year-over-year drop in second quarter revenues.

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.

ERS Genomics said this week that it has signed a nonexclusive licensing agreement with Santa Cruz Biotechnology (SCBT), granting the firm access to its ERS CRISPR-Cas9 patent portfolio. SCBT, based in Dallas, has been developing products for biomedical research, including monoclonal antibodies, biochemicals, labware, and CRISPR products.

BioFlyte announced this week that it raised $5.4 million in Series B financing. The Albuquerque, New Mexico-based maker of biothreat surveillance systems will use the funds to continue scaling its manufacturing and sales operations for an instrument that uses MALDI-TOF to identify toxins, viruses, and bacteria.

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 GenomeWeb.