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In Brief This Week: Alere, Fulgent Diagnostics, Volition, and More

NEW YORK (360Dx) – Alere said on Thursday in a filing with the US Securities and Exchange Commission that it is unable to file its quarterly report on Form 10-Q for the quarter ended March 31, 2017 within the prescribed period "without unreasonable effort or expense."

Alere had previously disclosed that the audit committee of its board of directors, acting on recommendations from management, concluded that several of its financial statements filed with the SEC from Dec. 31, 2013 through Q3 2016 "should not be relied upon because of certain misstatements."

The firm noted in its filing on Thursday that the misstatements were principally due to the failure to correctly apply US GAAP regarding the timing of revenue recognition, and the "principal cause" had to do with "inappropriate conduct at Standard Diagnostics," Alere's South Korean subsidiary.

Danaher said that its board of directors has approved a quarterly dividend of $.14 per share payable on July 28, 2017 to holders of record on June 30, 2017.

Fulgent Diagnostics said that its first quarter revenues increased 54 percent year over year to $5.3 million, while it posted a net income of $232,000, or $.01 per share. Non-GAAP EPS was $.03. Its R&D costs rose 52 percent year over year to $851,000, while its SG&A costs increased 9 percent to $2.4 million. The company finished the quarter with $6.7 million in cash and cash equivalents and $40.2 million in investments in marketable securities.

Volition Diagnostics reported that its net loss in Q1 2017 widened to $3.35 million, or $.13 per share, from $2.49 million, or $.13 per share, in Q1 2016.

The company said that it had cash and cash equivalents of $18.5 million at the end of the quarter. It noted that it is targeting "several important clinical and commercial milestones,” for the rest of 2017, including "significantly increased capacity" in its new facility in Walloon, Belgium, which would enable it to run large-scale clinical trials and extend its efforts into cancers other than colorectal cancer, including pancreatic, lung, and prostate cancers.

Volition said that during Q1, it completed two large validation studies of its CE-marked Nu.Q Colorectal Cancer Triage Test. With a combined dataset of about 8,000 subjects, the test identified a reduced need for colonoscopies by 24.5 percent over current standard fecal immunochemical screening test, with a sensitivity for CRC detection of about 95 percent.

Interleukin Genetics on Friday reported a steep drop in its first quarter revenues to $196,000 from $961,000 year over year. The firm said the drop was the result of revenues tied to contracted research recognized in Q1 2016 but not 2017. It also cited a decline in its genetic testing revenue. Its net loss for the quarter was $2.5 million, or $.01 per share, compared to a loss of $1.5 million, or $.01 per share, for the first quarter of 2016. Interleukin finished the quarter with $791,000 in cash, which it said was sufficient to fund its operations through the second quarter of 2017.

SQI Diagnostics reported its first quarter revenues fell 10 percent to C$251,000 ($183,000) from C$280,000 ($204,000). The firm's net loss for the quarter was C$1.3 million, or C$.01 per share, compared to a net loss of C$987,000, or C$.01 per share, a year ago. SQI spent C$633,000 on R&D in Q1 2017, up from C$452,000 a year ago. Its SG&A costs were trimmed to C$563,000 in the recently completed quarter from C$566,000 a year ago.

Great Basin Scientific said in a regulatory document that it has entered into a definitive loan agreement with the Utah Autism Foundation and issued a promissory note with an effective date of April 13, 2017 for a $1.2 million advance that the foundation gave to the firm at that time.

The principal and all accrued and unpaid interest, thereon, will be repaid by Great Basin in 23 consecutive monthly installments of $45,000 each, starting May 13.

On April 13, 2019, a final payment of $300,401 will be paid by Great Basin, representing all remaining unpaid principal and accrued interest. The $1.2 million loan was used to repurchase analyzers from Onset Financial that were leased from Onset pursuant to a sale-leaseback deal, Great Basin said.

Trovagene this week reported that its first quarter revenues dropped to $95,000 from $120,000. It posted a net loss of $10 million, or $.32 per share, compared to a loss of $10.5 million, or $.36 per share, in Q1 2016. The San Diego-based firm retains a CLIA lab that conducts liquid biopsy testing for pharma partners and for its own internal purposes. In recent months, Trovagene shifted its focus to therapeutics development.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on the 360Dx site.