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November 19, 2019 Bioscience Notebook

Sema4 names biotech veteran CFO; Achillion drug wins priority status in Europe; Trevi, BioXcel report 3Q earnings

PHOTO | Contributed Joel Sendek
By Natalie Missakian

Genomic-testing company Sema4, which has a lab in Branford, has tapped a biotech veteran with experience bringing companies through initial public offerings to be its chief financial officer. 

Newly appointed CFO Joel Sendek most recently held the top financial post at Cambridge, Mass.-based Spero Therapeutics. Before that he was CFO at Danish biopharmaceutical firm Forward Pharma. 

Sendek oversaw successful initial public offerings at both companies, Stamford-based Sema4 said in announcing his appointment.

“As Sema4’s growth continues to accelerate, building relationships with patients and providers to provide more actionable clinical guidance, Joe’s experience with fundraising and running the finances of publicly traded companies will be invaluable,”  said founder and CEO Eric Schadt in announcing the appointment.

Schadt told Hearst Connecticut Media in September that the privately held company, spun out of New York’s Mount Sinai Health System, had no current plans to go public but wasn’t ruling it out for the future.

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Achillion Pharmaceuticals Inc. said Tuesday morning its new drug for a life-threatening rare blood disease has been awarded a special designation from European regulators that could speed its approval.

The European Medicines Agency has granted its PRIME (Priority Medicines) designation to Achillion’s danicopan for the treatment of paroxysmal nocturnal hemoglobinuria in patients who have not responded to treatment.

The program aims to accelerate regulatory approval for promising medicines that may provide a therapeutic advantage over existing drugs.  The designation makes Achillion eligible for earlier and more frequent interactions with regulators. 

The agency based its decision on promising data from a phase 2 clinical trial that tested danicopan combined with Alexion Pharmaceuticals’ Soliris, the standard treatment for the disease. (Alexion announced a plan to acquire Achillion for $930 million last month. The deal is expected to close in 2020.)

The EMA’s decision comes on the heels of the U.S. Food and & Drug Administration decision in September to designate danicopan a “breakthrough therapy,” which offers similar benefits. 

Achillion plans to launch a phase 3 trial on the drug in early 2020. 

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New Haven diagnostics company Ikonisys Inc. said it has partnered with an Israeli hospital to develop highly sensitive tests to detect specific cancers by analyzing rare tumor cells in patients’ blood. 

The circulating tumor cells (CTC) tests will be aimed at a variety of clinical purposes, including detecting cancer recurrence, the company announced last week.

Ikonisys said its partner in developing the new technology, the Sheba Medical Center based in metro Tel Aviv, is the largest hospital in the Middle East. 

“We are proud to cooperate with one of the world’s leading medical centers in developing innovative tests for the diagnosis and monitoring of cancers,” Ikonisys Chief Scientific Officer Michael Kilpatrick said in a statement. 

Ikonisys said CTC tests have the ability to detect cancer and its progression as well as the likely efficacy of treatment, but they have been limited so far by difficulties in finding extremely rare cells, which can be as few as 10 out of millions in a typical blood sample.

The company said its platform would allow the efficient screening of a much larger number of cells than possible by manual analysis. 

Ikonisys has offices in New Haven’s Science Park and Milan, Italy. 

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New Haven-based Trevi Therapeutics Inc. posted higher third-quarter losses than it did a year ago as it continued to invest in clinical trials of its non-addictive opioid drug to treat chronic itching, chronic cough and liver disease.

For the quarter ended Sept. 30, Trevi reported a net loss of $7.4 million, up from $5.7 million during the same period in 2018. 

The loss of 41 cents a share beat Wall Street analysts’ forecasted 48-cents-a- share loss, according to Zacks Investment Research.

Trevi said it spent $5.6 million on research and development, up from $3.7 million a year ago, mostly due to increased clinical trial activity. 

General and administrative expenses rose to $2 million, from $1.2 million a year ago, due to increased personnel expenses and costs related to being a public company, the biotech said. 

Trevi, which went public in May, is testing a new formulation of an older opioid, nalbuphine ER, in a phase 2b/3 clinical trial for chronic itching, a phase 2 trial for chronic cough and a phase 1b trial for chronic liver disease.

The company ended the quarter with $63.5 million in cash and cash equivalents, which it said will be sufficient to keep operating through early 2021. 

Trevi’s stock was trading at $4.20 as of Monday afternoon, up 15 percent from $3.64 a week ago, but down from its IPO price of $10 a share in May.

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Branford-based big data biotech BioXcel Therapeutics Inc. reported a third-quarter 2019 loss of $9 million, up from $4.9 million a year ago, but said it has enough cash to operate through the middle of next year.

The company said the higher losses came as it expanded R&D and continued clinical trials on its immuno-oncology drug BXCL-701 and its acute agitation drug BXCL-501.

For the quarter ended Sept. 30, BioXcel said its R&D spending rose to $7.1 million, from $3.8 million in the year-ago period. It attributed the increase to higher personnel costs, clinical trial expenses and professional fees associated with its two lead drug candidates. 

G&A expenses rose to $2 million, up from $1.3 million a year ago. The increase was due to additional payroll and other expenses associated with operating as a public company, BioXcel said. 

The company, which uses artificial intelligence to repurpose older drugs and discover new ones, said it raised $19 million during the quarter, ending with $40.2 million in cash and cash equivalents. 

BioXcel said that was enough to fund its operations through key data readouts on its agitation drug, which are expected in the first half of 2020.

BioXcel’s stock was trading at $6.34 as of mid-morning Tuesday, up 45 percent from $4.36 last Thursday, when it released the earnings report. 

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The Japanese Patent Office has issued Guilford-based Bioasis Inc. a patent on its xB³ platform, which it says can deliver drugs past the brain’s filtering mechanism, known as the blood-brain barrier.

Bioasis’ lead drug, which targets HER2+ breast cancer that has spread to the brain, combines the technology with the chemotherapy drug trastuzumab.

The patent adds to one already granted in Europe, CEO Deborah Rathjen said. 

Contact Natalie Missakian at news@newhavenbiz.com

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