Faced with a looming deadline to lift its stock price or be delisted from the Nasdaq, New Haven’s Precipio Inc. is asking shareholders to approve a reverse stock split as one of several worst-case scenario rescue plans for the company.
Precipio’s stock has traded below the Nasdaq’s required $1 minimum since last March. The specialty diagnostics company, whose products are designed to reduce disease misdiagnosis, has until March 25, 2019, to regain compliance after being granted a six-month extension by the stock exchange in September.
“My team and I are committed to doing everything we can to build shareholder value, to avoid a reverse split, as well as to avoid any unnecessary dilution,” CEO Ilan Danieli said in a recent letter to shareholders.
Companies often implement a reverse stock split, reducing the total number of shares, as a way to boost their share price artificially, but the move is typically viewed negatively by the stock market.
Precipio shares were trading at 26 cents as of Tuesday morning.
Danieli said he believed the company’s stock price still could climb above $1 in the next few months as positive developments are publicized, citing as an example a previously announced partnership with life sciences giant Perkin Elmer to market Precipio’s liquid biopsy technology.
But he added that in a volatile stock market, it would be “irresponsible to rely solely on what we hope will happen” and said the company needs the flexibility to act quickly on a “Plan B” if necessary.
“We cannot ignore the possibility that things may not turn out as we hoped for them. We must be prepared, by establishing these tools as options,” he said.
Shareholders will be asked to vote on the measure during a special shareholders meeting Dec. 20.
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Antibiotics maker Melinta Therapeutics Inc. said Tuesday that its antibiotic Vabomere has been approved in Europe for treating several types of serious infections.
The European Commission has approved Vabomere for adult patients with complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia (including ventilator-associated pneumonia), bacteraemia in association with any of these infections, and gram-negative infections with limited treatment options.
Marketing authorization was granted in all 28 European Union member states, as well as Norway, Iceland and Liechtenstein, Melinta said.
“Few effective treatment options and increasing resistance have made KPC-producing Enterobacteriaceae a significant challenge to patients worldwide,” said Interim CEO John H. Johnson. “With the EC authorization of Vabomere, we believe Melinta. . .will be able to make a significant impact on the European effort to address this life-threatening pathogen.”
The dose of good news follows the company’s confirmation last week that it would lay off 22 of 25 employees in its flagship New Haven office and outsource research and development in a cost-cutting move. The company cited challenging times for the antibiotics industry as a reason for the decision.
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Biohaven Pharmaceuticals Holding Co. Ltd.’s new version of an older Amyotrophic Lateral Sclerosis (ALS) drug just got one step closer to FDA approval.
The New Haven biotech said the U.S. Food and Drug Administration has accepted its new drug application for BHB-0223, a lower dose, orally-dissolving version of the FDA-approved ALS treatment riluzole.
Biohaven said the drug would be the only formulation of riluzole (marketed under the brand name Rilutek) that does not require swallowing of tablets or liquids, since it is designed to quickly dissolve and be absorbed under the tongue.
More than 80 percent of people with ALS, a progressive, neurodegenerative disease characterized by muscle weakness and eventual paralysis, experience difficulty swallowing, Biohaven said.
“If approved, we believe BHV-0223 would provide an important advancement in treatment for people living with ALS, including the large number of patients who have difficulty swallowing tablets,” Biohaven Chief Medical Officer Dr. Robert Berman said in a statement.
The submission represents Biohaven’s first new drug application (NDA) before the FDA.
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Guilford’s Bioasis Technologies Inc. said a study in animals shows its technology to deliver medicines across the brain’s filtering mechanism can also penetrate the lymphatic system, opening new possibilities for its application in breast cancer and other diseases.
The findings were the result of a recent peripheral whole-body PET/CT scan study of its XB³-001 platform in non-human primates, which Bioasis conducted with New Haven medical imaging firm Invicro LLC.
The study looked at XB³-001, developed to deliver drugs across the blood-brain barrier, in combination with trastuzumab (brand name: Herceptin), a common treatment for certain types of breast cancer.
It found a more selective peripheral distribution pattern for animals treated with the combination, and also showed accumulation of XB³-001 in cervical lymph nodes (near the collarbone), which was not seen with trastuzumab alone.
Bioasis, a pre-clinical, research-stage biopharma, said it has filed a patent application based on the data.
“These findings… are truly exciting and we look forward to conducting additional research as it potentially opens significant opportunities for Bioasis,” CEO Mark Day said.
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NanoViricides Inc., a Shelton-based biotech working on drugs to fight shingles and other viral diseases, said Monday it narrowed its third-quarter losses compared to a year ago.
For the period ended Sept. 30, the company reported a net loss of $1.84 million, or 3 cents a share, compared to $2 million during the third quarter of 2017, a drop it attributed to a decrease in operating expenses.
R&D expenses fell slightly to $1.41 million, down from $1.45 million in the year-ago period, while general and administrative expenses dipped to $627,615, compared to $778,540 a year ago.
The company said it produced no revenue during the quarter. It reported $6.1 million in cash and cash equivalents on hand and liabilities of $1.39 million.
NanoViricides is developing a new class of drugs that use tiny particles, called nanoviricides, to attack and dismantle the virus. Its program is especially targeting diseases caused by the herpes simplex virus.
Contact Natalie Missakian at news@newhavenbiz.com
