Category: Bioscience

Troubled Louisville biopharma GlobeImmune to delist its stock from Nasdaq exchange

LOUISVILLE — Having failed in a yearlong quest to find a buyer or other “strategic transaction” for the company, officials for GlobeImmune Inc. disclosed in a regulatory filing on Tuesday that they plan to delist the firm’s common stock from the Nasdaq Capital Market exchange.

The move continues the downward spiral for the Louisville biopharmaceutical company, which suffered a crippling blow last year when clinical trial results for its hepatitis B drug candidate revealed that the drug did not show a reduction of the disease at the end of a 24-week study.

Down to 2.5 full-time employees, GlobeImmune (Nasdaq: GBIM) in May of this year received a delisting warning from Nasdaq for falling out of compliance with a rule requiring minimum stockholders equity of $2.5 million, as well as alternative benchmarks for market cap and net income from continuing operations. At that time, GlobeImmune had a 45-day grace period to submit a plan for regaining compliance but has instead opted to voluntarily delist.

GlobeImmune’s share price plunged 36 percent Wednesday on the news of the delisting plans. Shares were trading at $1.15 apiece by late afternoon.

The company will making a formal filing with the U.S. Securities and Exchange Commission on July 15 officially notifying the regulatory body of its plans to delist and deregister its common stock. GlobeImmune expects the filing to become effective July 25, at which time the company will request the suspension of its financial reporting obligations as well.

Following the effectiveness of the delisting, GlobeImmune officials expect the company’s stock to begin trading on the OTC Market’s Pink market tier under the company’s current ticker symbol of GBIM.

“The Board made the decision to allow the Common Stock to be delisted from NASDAQ and to seek deregistration under the Exchange Act following the Company’s review and careful consideration of several factors including the inability to find a suitable strategic transaction despite a comprehensive year-long process, the ongoing listing, legal, administrative and additional accounting costs associated with being a publicly listed company, the non-compliance letter received from NASDAQ for the continued listing requirements, the inordinate amount of executive time and Company resources consumed in regulatory compliance obligations and the lack of investor interest as shown in the low daily trading volumes of the Common Stock on NASDAQ,” company officials wrote in the Form 8-K filed Tuesday. “The Board determined that delisting and deregistration are in the overall best interests of the Company and its stockholders.”

In the company’s first-quarter earnings report in May, GlobeImmune officials disclosed that they could be forced to shut down the company if a strategic alternative, such as a buyer, is not found “in the near future.” They added that the company has enough cash to operate as a going concern through the middle of next year, but that a decision to wind down the company would burn through its cash more quickly.

GlobeImmune laid off all but six of its 22 employees last summer following the negative trial results. As of the company’s most recent quarterly report, only vice president Jeffrey Dekker and a scientist remained onboard full-time, while chief executive Timothy Rodell is a half-time employee at this point.

GlobeImmune is focused on developing products for the treatment of cancer and infectious diseases. The company has three ongoing clinical trials being conducted by Gilead Sciences Inc. and Celgene Corp.

GlobeImmune was founded in 1995 as a spinoff of University of Colorado technology. The company raised a Series A funding round in 2003 and pulled in a total of $119 million in private equity before going public in 2014 with a $17.25 million initial public offering.

Array BioPharma submits melanoma drug for FDA approval

BOULDER — Array BioPharma (Nasdaq: ARRY) this week submitted a New Drug Application with the U.S. Food and Drug Administration for the use of drug candidate binimetinib in the treatment of NRAS-mutant melanoma.

The submission is the first for Boulder-based Array, which has several drugs in the development stage. It comes on the heels of positive Phase 3 trial results for binimetinib that were released earlier this month.

Array shares spiked as high as $3.82 Friday morning from Thursday’s close of $3.56 before gradually settling back to $3.62 by mid-afternoon trading.

If granted, FDA approval of the first NDA could mark just the beginning for binimetinib. The drug is being examined in a pair of other Phase 3 trials. One is looking at the use of binimetinib in combination with Array drug encorafenib in the treatment of BRAF-mutant melanoma. Another is looking at the combination of both of those drugs, along with Merck drug Erbitux, in the treatment of colorectal cancer.

Another Array drug, selumetinib, is licensed by AstraZeneca, which is conducting Phase 3 trials looking at the drug in the treatment of lung cancer and thyroid cancer.

Hickenlooper dubs Aug. 1-5 Tech Week in Colorado

DENVER – Gov. John Hickenlooper has proclaimed the week of Aug. 1-5 as Tech Week in Colorado to highlight the entrepreneurs and companies that are helping transform the state into a major tech hub.

Tech and “tech-enabled” businesses around the state are being encouraged to host events during the week – ranging from happy hours to demonstrations to pitch contests to tours.

Those events can be submitted for promotion through www.coloradotechweek.org. Businesses can also submit stories on the site of how Colorado has helped grow their companies.

In addition, the Colorado Technology Association will host its second annual Colorado Tech Tour, stopping in five regions over five days for events and stops at local businesses.

“We know technology underpins much of Colorado’s economic progress today, and will increasingly do so in the future,” Hickenlooper said in a news release. “Tech week is a catalyst for showcasing the real impact of technology in our lives, and in helping make Colorado one of the nation’s premier technology-inspired hubs.”

More information on Tech Week and the Tech Tour can be attained by contacting the CTA at 303-592-4070 or colotech@coloradotechnology.org.

Clovis Oncology shares surge on competitor’s positive trial results

BOULDER — Shares of Boulder biopharmaceutical firm Clovis Oncology Inc., which has seen its stock price take a beating over the past seven months, climbed in value by 22 percent Wednesday thanks to some positive trial results of a competitor.

Clovis shares (Nasdaq: CLVS) closed at $15.06 Wednesday, up from $12.36 on Tuesday, though that’s still well below the stock’s 52-week high of $116.75.

Tesaro Inc. (Nasdaq: TSRO) saw its own shares more than double Wednesday after posting positive results from a Phase 3 trial for its ovarian cancer drug niraparib.

Kennen MacKay, a biotech analyst for Credit-Suisse, said the results were significant for Clovis because its own ovarian cancer drug, rucaparib, uses the same mechanism of action in attacking cancer as niraparib. Both drugs are poly polymerase (PARP) inhibitors.

MacKay said that, initially, people in the industry thought that PARP inhibitors would work mainly for a narrow percentage of cancer patients with BRCA gene mutations. But the niraparib phase 3 trial showed strong results not only for BRCA patients but also in patients without the BRCA mutation, a development that potentially expands the market for PARP inhibitor drugs.

“The data from Tesaro today showed that it can actually work in a much broader population of patients,” MacKay said.

Rather than good results for a competitor having a negative impact on Clovis’ stock, which can often be the case in the biotech world, the potential broadening of the PARP inhibitor market from the Tesaro results had the opposite effect Wednesday.

Clovis officials could not comment on Wednesday’s developments because the company is in a quiet period related to its New Drug Application with the U.S. Food and Drug Administration for rucaparib.

One distinction between Niraparib and rucaparib, MacKay said, is that the Phase 3 results Tesaro reported were for the maintenance phase of treatment for ovarian cancer. That’s an earlier line of treatment than is being examined in Clovis’ Ariel II phase 3 trial, on which the current NDA submittal is based. But Clovis also has an Ariel III phase 3 trial looking at the maintenance phase of treatment that should report results next year.

While being first to market is key in the oncology market, MacKay said, Clovis would still have the opportunity with its Ariel III trial to post better maintenance data than Tesaro and compete with the company in the space.

“Tesaro has set a pretty high bar for this data,” MacKay said.

Successfully going to market with rucaparib would be a major boost for Clovis, which earlier this year pulled the plug on lung-cancer drug candidate rociletinib after receiving notice that it was unlikely to receive approval from the FDA. Clovis’ stock plunged last November from nearly $100 per share to $30 per share after the FDA indicated that data submitted with an NDA for rociletinib was insufficient.

JustRight Surgical gains additional FDA approval

LOUISVILLE — JustRight Surgical LLC in Louisville said Tuesday it has received additional clearance from the FDA for one of its electrosurgical devices, making it the first instrument cleared for use specifically for surgeries involving pediatric patients.

The JustRight Surgical Vessel Sealing System already had FDA approval and is being used in surgeries on adults and children. But questions have been posed on the safety of bulkier tools using high power to create the heat to cauterize tissue in children.

Company spokeswoman Patti Hoag explained that doctors have the choice to use whatever device they want to seal vessels in adults and children, and the FDA approved electrosurgical devices 15 years ago.

This clearance, she said, says Just Right’s vessel-sealing device is safe to use in extremely tight or small spaces found in teens, children, infants and neonates.  The new, low-power vessel-sealing technology was found to permanently fuse vessels while using significantly less energy.

“This additional clearance will allow us to market the device as being safe for pediatric surgery,” Hoag said.

Russ Lindemann, president and chief executive of JustRight Surgical, said pediatric surgeons have been requesting “right-sized” surgical instruments and technologies for years.

“This validates the truly unique technical advancements made by our development team. … We are the only surgical-device manufacturer to focus solely on pediatrics. Now, surgeons and hospitals are recognizing the value we bring to caring for the smallest of patients.”

JustRight Surgical’s instruments are being used for general and thoracic procedures in more than 100 children’s hospitals in the United States and Europe. JustRight Surgical has the only 5-millimeter stapler using the classic titanium wire staple in a clinically accepted “B” shape along with the 3- millimeter vessel sealer.

Treehouse Health launches in Boulder, offering new way to treat myopia

BOULDER — Matt Oerding and Dr. Gary Gerber have launched their startup Treehouse Health LLC in Boulder to take advantage of the area’s startup scene.

The company, formed in 2015, plans to open Treehouse Eyes eye-care centers that will offer a patent-pending method of treating myopia, or nearsightedness, which causes blurry distance vision.

“Boulder has an amazing startup scene with best-in-breed professional services for entrepreneurs,” said Oerding, the company’s chief executive and co-founder. “Our legal counsel, CFO, accountant, business banker and CPA are all here and specialize in working with startups. We’re excited to play a role in the growing health-care arena happening in Boulder.”

Right now, Oerding is running the company out of the Impact Hub Boulder at 1877 Broadway. The company has six employees, including Oerding and Gerber, who works from New Jersey.

The company raised $2 million in seed funding in less than six months. The company’s advisory board includes experts in myopia control and Lenscrafters’ founder Dean Butler.

Oerding said the Treehouse treatments can slow or stop the progression of near-sightedness, but does not reverse it.

“There are more than 10 million children with myopia in the United States, and that number is expected to increase to 30 million by 2025,” Oerding said.

Myopia generally is caused by genetics, but among the reasons for the increased number of children with myopia is that they are spending more time looking at a screen on a digital device and less time outdoors where they would use their distance vision, he said.

Erin Stahl, pediatric ophthalmologist and investor in Treehouse Eyes, said the types of treatments Treehouse Eyes offers are noninvasive and supported by strong evidence of their effectiveness and safety.

“Most eye doctors have busy practices, which makes it difficult to recommend and provide the types of customized treatments Treehouse Eyes will offer,” Stahl said. “I’m excited there is finally a place dedicated to providing this type of needed service for children with myopia.”

The first two Treehouse Eyes centers will open in the Washington, D.C. suburbs — Bethesda, Md., at the end of July, and Tysons Corner, Va., in August, areas that have a high prevalence of myopia, Oerding said.

Current plans include expansion in major markets across the United States with a goal of opening more than 20 centers in the next two years. Oerding couldn’t say when a center would be opened in the Boulder Valley.

The centers are designed to be engaging and inviting and will offer appointments designed to accommodate the schedules of parents and children, including before and after school and on the weekends.

“We want our centers to be a uniquely nurturing and positive space offering families diagnosed with myopia a new pathway to better vision for life,” said Oerding. “We’re challenging the status quo around vision care and have the opportunity to help kids see a brighter, and clearer, future.”

Medtronic scoops up Massachusetts-based HeartWare

Medtronic Plc on Monday said it has agreed to acquire ailing HeartWare International Inc. for $1.1 billion, adding more products to treat heart failure to the medical-device maker’s portfolio.

Ireland-based Medtronic has a neurosurgery division based in Louisville, operating as Medtronic Navigation Inc. in the Colorado Technology Center. Medtronic’s subsidiary Covidien Ltd. operates a research and development division in Gunbarrel, northeast of Boulder, and it has a hearing-aid division, Medtronic-Sophono, in Boulder.
It is unclear how the acquisition might affect workers in Boulder, Gunbarrel and Louisville. Medtronic spokeswoman Tracy McNulty said, “Operations details will be worked out once the acquisition is completed.” The companies said they expect the deal to close during Medtronic’s second fiscal quarter, ending in late October.

The acquisition of HeartWave gives Medtronic more diagnostic tools and treatments for heart failure, a condition where the heart isn’t pumping enough blood to meet the body’s needs. HeartWare makes surgical implants that mimic the heart’s blood-pumping function, known as ventricular assist devices.

Medtronic (NYSE: MDT) will pay $58 a share in cash for Framingham, Mass.-based HeartWare (Nasdaq: HTWR), a 93 percent premium over HeartWare’s Friday closing price of $29.98. Before Monday, HeartWare’s stock had fallen 60 percent over the past year amid declining sales, problems with product studies and an acquisition that fell through.

In 2014, Minneapolis-based Medtronic Inc. paid $42.9 billion to acquire Dublin, Ireland-based medical-device maker Covidien Plc, including operations in Gunbarrel. In 2015, Medtronic acquired Boulder-based Sophono Inc., which makes hearing aids that work by using bone conduction.

Davis picked to head NREL’s Biosciences Center

GOLDEN — Mark Davis has been named director of the Biosciences Center at the Energy Department’s National Renewable Energy Laboratory in Golden.

The Biosciences Center develops the underlying science and processes to produce cost-effective fuels and products from biomass.

Mark Davis

Mark Davis

“I am excited to be able to lead a team of world-class researchers focused on creating novel solutions to the important energy problems facing the nation,” Davis said in a prepared statement. He said the center “continues to publish multiple keynote scientific findings in high-impact journals, such as Science and Nature Biotechnology, and was recently recognized with an R&D 100 Award. It’s really an honor to work with this group of high-caliber individuals.”

“Mark has been serving in this capacity for almost a year, and we are very excited to now have him in this position formally,” said Adam Bratis, NREL’s associate lab director for BioEnergy Science and Technology, which oversees the Biosciences Center.

Davis earned his bachelor’s degree in chemistry from the University of Cincinnati, a master’s degree in physical chemistry from Colorado State University, and a doctorate in wood sciences, also from CSU.

He joined NREL in 1993 as a post-doctoral research associate and, since 2010, has served as the platform program manager for thermochemical processes. Davis also is directing the Enabling Technologies Focus Area for the BioEnergy Science Center, an Energy Department-sponsored effort led by Oak Ridge National Laboratory.

Since joining NREL, Davis has also served as the group manager for Chemical and Catalyst Sciences in NREL’s National Bioenergy Center. He has authored or co-authored more than 90 peer-reviewed publications and three book chapters.

Pfizer plans shutdown of Boulder plant by 2019

BOULDER — Officials for pharmaceutical giant Pfizer Inc. (NYSE: PFE) on Wednesday told Boulder employees that the company would be closing down its local manufacturing facility by 2019 and eliminating the 100-plus jobs there.

The 50,000-square-foot facility at 4876 Sterling Drive came under Pfizer control following the company’s $16 billion acquisition of Hospira last year.

Pfizer spokeswoman Joan Campion said no layoffs have occurred at the site, yet. She said that the exact timing of the layoffs isn’t yet clear, but noted that they will occur in phases over the next three years. She said Boulder employees would be considered for manufacturing jobs elsewhere within Pfizer. The company operates 63 plants globally, though the Boulder site is Pfizer’s only facility in Colorado.

Campion said the decision to cease Boulder operations follows an analysis of Pfizer’s and Hospira’s combined manufacturing capabilities that determined there is “underutilized capacity” within the company’s network.

The Boulder facility makes various active pharmaceutical ingredients, including paclitaxel, tromethamine and irenotecan. The APIs are then shipped to other production sites to be used in high-potency sterile injectable products treating a range of conditions. Campion said production of the drugs made in Boulder will be transferred to other sites.

“The recommendation to exit the site is not a reflection of the work performed at Boulder, but rather is based on a number of factors, including the existing capacity within Pfizer’s manufacturing network and the efficiency of consolidating manufacturing to fewer locations,” Campion said.

The closure is a blow for Boulder’s bioscience sector, which last month saw Clovis Oncology announce that it would eliminate 35 percent of its jobs by the end of the year.

But Clif Harald, executive director of the Boulder Economic Council, said he’s hopeful that many of the affected Pfizer employees will be able to land locally. He noted that some 125 bioscience companies account for roughly 4,700 jobs in Boulder County, and that the Boulder-Denver region as a whole is seen as a bioscience hub thanks largely to the University of Colorado campuses. While there have been layoffs and exits from the sector locally, AstraZeneca is in the process of ramping up operations at a former Amgen site in east Boulder.

“It’s always painful to know people are losing their jobs,” Harald said. “But we’re pretty confident that with the growth in other companies those people will be able to find other opportunities, if not in Boulder, then nearby.”

13 local firms named to Colorado OEDIT’s ‘Companies to Watch’ list

DENVER — Nine companies based in the Boulder Valley and four in Northern Colorado are among the 50 Colorado Companies to Watch for 2016 that were announced Friday evening.

Seven of the companies are based in Boulder: Agribotix Inc., Astra LLC, Avid4 Adventure Inc., Purely Elizabeth, Quinn Snacks, SnapEngage and Kindara Inc.

Sustainable Supply in Broomfield and Liqid Inc. in Lafayette made the list.

Companies in Northern Colorado include Canyon Bakehouse and Good Day Pharmacy in Loveland, CPP Inc. in Fort Collins and All Phase Restoration in Windsor.

The 50 winning firms are second-stage companies. They were honored for innovation and economic impact. Chosen from more than 1,000 nominations, the winners represent a range of industries and are recognized for their success and potential for growth, community involvement, philanthropy and corporate culture.

In 2015, this year’s winners employed 1,913 full-time employees and are expecting to create 380 new jobs in 2016. They combined for $503 million in revenue in 2015 and are expected to earn $679.9 million in 2016.

The awards program was launched in 2009 by the Colorado Office of Economic Development and International Trade in conjunction with the Edward Lowe Foundation and community partners from across Colorado.