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May 12, 2020 Bioscience Notebook

Branford firm wins contract to develop speedy COVID-19 test

PHOTO | Contributed Tangen's GeneSpark instrument.
By Natalie Missakian

A Branford company that received federal funding to develop a rapid, portable test for anthrax has won a government contract to develop a similar diagnostic test for the virus that causes COVID-19.

The test for SARS-CoV-2 would be conducted using Tangen Biosciences Inc.’s  Tangen DX and GeneSpark molecular diagnostic system, a hand-held device that can be used outside of a lab setting. The company has touted the device as faster, cheaper and more sensitive than existing testing technology.

Results would be available in an hour and could be reported to public health agencies through a cloud-based mobile platform, officials said. 

Tangen developed the hand-held system to detect anthrax under a 2017 contract with the U.S. Department of Health & Human Services’ Biomedical Advanced Research & Development Authority (BARDA).

The company has already received $7 million under that contract and has just begun a second optional phase valued at an additional $3.3 million. 

The COVID-19 contract, also awarded by BARDA, would build on that earlier work. Financial terms of the latest contract were not disclosed.

“The BARDA funding has contributed to the creation of a small, portable, yet very powerful molecular diagnostic point-of-care platform,” said John Davidson, Tangen’s co-founder and chief scientific officer. “We hope to bring our instrument and COVID-19 test to nursing homes, quarantine facilities, retail clinics, urgent care, doctor’s offices — wherever it is needed.”

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Biohaven Pharmaceuticals’ new migraine drug, launched in the middle of the coronavirus pandemic, brought in $1.2 million during the first quarter of 2020, according to the company’s quarterly earnings report.

The New Haven drugmaker said in a business update last week that more than 1,000 health care providers wrote more than 6,000 prescriptions for the Nurtec ODT, which won federal approval in February and hit the market on March 12. Biohaven attributed much of the sales revenue to channel-building by distributors. 

“Our early prescription metrics show that Nurtec ODT has the potential to be a market leader in the class of new treatments for migraine and we believe it will be a key driver for revenue growth for Biohaven in the years to come,” said CEO Vlad Coric, MD in a statement. 

Still, Biohaven continued to widen its losses compared to a year ago, primarily due to increased R&D costs and spending on the Nurtec launch.

For the period ended March 31, Biohaven reported a net loss of $172.9 million, or $3.07 per share, compared to $62.3 million, or $1.41 per share, during the first quarter of 2019. 

Net loss, adjusted for non-recurring costs, was $134.9 million, or $2.39 a share, compared to $47.3 million ($1.07 a share) for the year-ago period. The results fell slightly short of the Zacks Investment Research consensus estimate of $2.28 a share. 

Biohaven ended the quarter with $429.2 million in cash, compared to $317.7 million at the end of 2019. Biohaven said it raised $283.3 million in a January public offering, which was partially offset by costs associated with the Nurtec launch.  

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Trevi Therapeutics Inc. reported a net loss of $8.5 million, or 48 cents a share, during the first quarter of 2020 as it spent more on clinical trials for its drug to treat chronic itching and chronic cough. 

But the company said it has enough cash to fund its operations into the fourth quarter of 2021. 

The New Haven biotech lost $3.7 million more in the January-to-March period than the $4.8 million it lost during the first quarter of 2019, according to a quarterly earnings report released last week. It does not yet have a revenue-producing product. 

The loss was slightly higher than Wall Street analysts’ projected 44 cents-a-share loss, according to a consensus estimate from Zacks Investment Research. 

R&D spending reached $6 million, up from $3.3 million a year ago, primarily due to increased clinical trial activity, the company said. 

General and administrative costs were $2.6 million, up from $1.5 million a year ago, which the company attributed to an increase in stock-based compensation expenses and expenses related to becoming a publicly traded corporation. Trevi went public in May 2019.

Trevi ended the quarter with $52.6 million in cash, compared to $57.3 million at the end of 2019.

The company is conducting human testing on its non-addictive opioid, nalbuphine ER, in two clinical trials, which have faced delays caused by the COVID-19 pandemic.

A trial testing the drug for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) has been postponed due to the high-risk nature of the patients, the company said in a corporate update. Enrollment is expected to resume during the second half of the calendar year.

Meanwhile, screening and enrollment of new patients has been temporarily delayed in a second trial evaluating the drug for severe itching in patients with the skin condition prurigo nodularis. Trevi expects screening and enrollment to resume throughout May and June.

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New Haven’s BioXcel Therapeutics Inc. doubled its first-quarter losses in 2020 compared to a year ago as it spent twice as much on R&D for its two drugs in clinical trials. 

BioXcel said Tuesday morning it lost $14.9 million for the period ended March 31, up from $7.2 million during the first quarter of 2019. The figure includes about $800,000 in non-cash stock-based compensation, BioXcel said. The company has no revenue-producing products. 

The 79 cents-a-share quarterly loss missed Wall Street expectations. Analysts predicted a loss of 55 cents a share, according to a consensus estimate by Zacks Investment Research.  

The company said R&D spending was $12.4 million for the quarter, up from $5.7 million a year ago. BioXcel attributed the increase to higher clinical trial expenses, salaries and bonuses and other costs related to its drug candidates BXCL501 and BXCL701. The drugs are in human testing for agitation and prostate cancer, respectively. 

General and administrative expenses were $2.6 million, up from $1.7 million a year ago, due primarily to additional legal and patent services fees, the company said. 

BioXcel said it ended the quarter with roughly $80 million in cash, giving it enough of a runway to fund key clinical, regulatory and operational milestones into 2021. The company raised $60 million in a follow-on offering in February. 

BioXcel said so far there have been no “significant delays” in clinical trials from the COVID-19 pandemic. 

Contact Natalie Missakian at news@newhavenbiz.com

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