Category: Research & Development

BizWest 500 highlights largest, fastest-growing companies

Purchase this new publication by clicking BizWest 500. For a preview of the content, here’s the first page.

Welcome to the BizWest 500, an ambitious undertaking that highlights the largest or fastest-growing companies throughout the Boulder Valley and Northern Colorado (and the highest-paid executives).

This special edition of BizWest aggregates content that previously had been published over a span of many months, but it also represents a dramatic increase in the data that we publish on the region’s largest private- and public-sector employers.

In these pages, you’ll find:

• The Mercury 100 list of the fastest-growing private companies in the Boulder Valley, along with five profiles of interesting companies on the list.

• The Mercury 100 list of the fastest-growing private companies in Northern Colorado, along with five profiles of interesting companies on the list.

• A list of the Top 25 highest-paid executives of public companies.

• A list of the 50 largest public-sector employers, including municipalities, counties, universities, federal laboratories, etc.

• A vastly expanded list of the region’s largest employers — 200 companies listed, compared with 50 published last year.

• A list of the largest publicly traded companies based in our region. (We’ve stretched this a bit, opting to include a handful of companies that have shifted their headquarters to the Denver area or other nearby cities, but which retain a significant presence in our region.)

All told, these lists represent the largest number of ranked lists we’ve ever published in one issue, outside of our annual Book of Lists publication.

Most companies cited in these lists responded to our surveys. Others are included based on BizWest estimates, reports by economic-development agencies, news accounts or other sources. Data for the public companies and highest-paid executives lists came entirely from the U.S. Securities and Exchange Commission.

This endeavor represents many months of work by our staff, especially our chief researcher, Chad Collins. As with any undertaking of this magnitude, errors and omissions are likely. In particular, our lists of the largest private-sector and public-sector employers will continue to be refined and expanded. If you’d like to see your company included — or if you spot a mistake or other omission — please contact Chad at ccollins@bizwestmedia.com.

It should be noted that we’ve opted to include aggregated numbers for some employers, such as major health systems, as well as numbers for some of their constituent institutions, i.e., a hospital within the system.

If you have a suggestion for the BizWest 500 next year, please feel free to contact me at the number below.

Christopher Wood can be reached at 303-630-1942, 970-232-3133 or cwood@bizwestmedia.com.

Clovis posts net loss, plans new-drug application

BOULDER — Officials for Boulder pharmaceutical company Clovis Oncology on Thursday reported a 2015 net loss of $352.9 million, and also said the company is planning to submit a new-drug application for cancer drug rucaparib to the U.S. Food and Drug Administration sometime during the second quarter of this year.

Clovis’ loss amounted to $9.79 per share as the company works toward gaining FDA approval for a pair of its cancer drugs this year.

The FDA is expected to make a decision on lung cancer drug rociletinib by the end of June. In addition to the upcoming NDA for the use of rucaparib in the treatment of ovarian cancer, the company also is planning to initiate a study of that drug in the second half of this year looking at its use in the treatment of prostate cancer.

If approved, rociletinib would be the first drug to market for Clovis.

“2016 has the potential to be a very transformational year for Clovis,” chief executive Patrick Mahaffy said in the company’s earnings report. “Our U.S. commercial and medical affairs organizations are in place as we work toward the potential launch of two oncology drugs in the U.S. within the next 12 months.”

Clovis, which had no revenue for 2015, reported a fourth-quarter net loss of $119.5 million, or $3.12 per share. The company finished the year with $528.6 million in cash, cash equivalents and available-for-sale securities. Research and development expenses for the fourth quarter totaled $76 million, and $269.3 million for the year. That’s compared with $50.1 million and $137.7 million, respectively, for the fourth quarter and full year 2014.

Thursday’s earnings report came after markets closed.

Despite the company’s optimism surrounding the New Drug Applications, Clovis has seen its share price languish since November when the firm announced the FDA had requested more clinical data on rociletinib. That request caused the goal date for a decision on the drug to be pushed back from March to June, and caused Clovis’ stock price to plunge from a closing price of $99.43 on Nov. 13 to a close of $30.24 the following Monday.

Clovis shares sank 79 cents on Thursday to close at $17.29, not far off their 52-week low.

Clovis shares dive as FDA delays drug OK

BOULDER — Shares of Boulder-based Clovis Oncology Inc. lost nearly 70 percent of their value by midafternoon Monday on news that the U.S. Food and Drug Administration’s review and decision whether to approve a drug designed to fight lung cancer probably will be delayed.

The FDA has requested more clinical data on both the 500-milligram and 625-milligram doses of rociletinib, which Clovis has developed as an oral treatment for lung cancer. The FDA review team told Clovis last week that it wanted to focus exclusively on confirmed responses from the drug’s clinical trials, but that the data set it received so far included mostly unconfirmed responses.

A statement from Clovis said it would submit more data by the end of the day, but that it probably would mean the FDA’s scheduled March 30 decision date on approval of the drug would be set back.

That’s a competitive blow to Clovis because London-based AstraZeneca PLC on Friday won FDA approval for Tagrisso, its own lung-cancer drug. Like rociletinib, Tagrisso focuses on a genetic mutation that blocks the current crop of lung-cancer medications from reaching tumors.

Near the closing bell on Wall Street, Clovis’ stock (NYSE: CLVS) was trading at $31.31, down more than 68 percent from Monday’s opening price but a slight recovery from a 72 percent decline just after noon. AstraZeneca shares (NYSE: AZN) were up more than 4.7 percent at $32.79.

AstraZeneca is collaborating with Boulder-based Array BioPharma (Nasdaq: ARRY), which invented the drug selumetinib and licensed it in 2003 to AstraZeneca for development and commercialization. In September, AstraZeneca bought Amgen’s LakeCentre manufacturing facility at 5550 Airport Road in Boulder for $14.8 million, and company officials said the cite eventually could employ up to 400 people. Amgen (Nasdaq: AMGN) announced last year it was closing its facilities in Boulder and Longmont.

The FDA said that in Clovis’ clinical trials, the number of patients with an unconfirmed response to rociletinib who converted to a confirmed response has been lower than expected, with progression of tumors or failure to show tumor shrinkage greater than 30 percent.

Patrick J. Mahaffy, Clovis’ president and chief executive, said in a prepared statement last month that Clovis was ready to launch rociletinib in Europe late next year and already was building its sales force there.

On Monday, Mahaffy said the company remains “confident in rociletinib and its potential to treat patients with mutant EGFR T790M-positive lung cancer. We will continue to work diligently with the FDA on our (new-drug application) submission.”

Clovis had been upbeat in late September when it announced that the FDA accepted its new-drug application under priority review and the European Medicines Agency accepted its marketing authorization application under accelerated assessment, which shortened that review clock to 150 days from 210 days.

Clovis recently reported a loss of $98.6 million for its third quarter that ended Sept. 30, driving its loss for the first nine months of the fiscal year to $233 million as it raced toward the launch of

rociletinib and another cancer-fighting drug, rucaparib. In July, the company raised net proceeds of $298.5 million through an offering of 4.1 million shares of common stock.

Founded in 2009, Clovis leased 5,844 square feet of space at 2525 28th St. for its headquarters. The building was familiar to Mahaffy because it’s the same space where he operated his former company, Pharmion Corp., before selling it to Celgene Corp. in 2008 for $2.9 billion.

PanTheryx adds nearly $3 million to funding round

BOULDER – Biotechnology company PanTheryx Inc. is nearing the three-quarter mark in its effort to raise $10 million, according to a recent regulatory filing with the Securities and Exchange Commission.

Boulder-based PanTheryx has raised $7.3 million of the round that began in April 2013 through equity investments and issuing warrants and options. PanTheryx reported it had raised $4.4 million of its goal in March of last year.

PanTheryx, headed by president and chief executive Mark Braman, is working on medical nutrition products, including a treatment for children with infectious diarrhea that has shown in clinical trials to be safe and effective in replenishing nutrients lost during a bout with the disease.

The company also is working on foods as dietary supplements to help healthy people maintain intestinal health, and medical foods for dietary management that would be used under medical supervision.

Diarrhea, the company said, is a life-threatening global health concern, representing 11 percent of child deaths worldwide, second only to pneumonia. The World Health Organization estimates that worldwide there are 1.7 billion infectious diarrhea cases annually among children younger than age 5. Nearly 1 million children die each year from diarrhea complications, killing more children than AIDS, malaria and measles combined.

In addition to Braman, Scott Hyman and George Stagnitti are listed as executive officers of the company. Tom Washing and David Cook are listed as company directors. Washing is a partner at Sequel Venture Partners LLC, a venture capital firm in Boulder. Cook is a retired lawyer from the local office of Faegre Baker Daniels LLP. He received the Esprit Entrepreneur Lifetime Achievement Award from the Boulder Chamber in 2005.

Boulder biopharma luring array of investment

BOULDER — The renewed investor interest seen in Array Biopharma Inc. over the last seven weeks might be just the beginning if analyst projections prove correct.

A month and a half after announcing a deal to regain full worldwide rights from Novartis to the late-stage cancer drug candidate binimetinib – a deal one analyst termed “transformative” for Array – the Boulder-based company’s shares continue to trade nearly 15 percent ahead of where they closed on Dec. 3.

Shares of Array (Nasdaq: ARRY) rose from $3.91 at the end of trading Dec. 3 to $4.93 in the days after the announcement. They’ve cooled a bit since, closing at $4.49 on Jan. 16. But analysts’ price targets range from $5 to $9, with multiple analysts upgrading the stock in the wake of the deal.

Piper Jaffray biotech analyst Ted Tenthoff rates the stock overweight, with a price target of $9. Binimetinib has the potential to treat multiple types of cancer. But in just one type of melanoma – for which binimetinib could gain Food and Drug Administration approval by sometime in 2016 – Tenthoff believes the market potential could be $200 million.

“It’s just a fantastic deal in my view for Array,” Tenthoff said.

In addition to regaining full rights to binimetinib, the deal generating the buzz will see Array receiving payment of up to $85 million from Novartis, not to mention an extinguishment of $15 million in payments Array owed Novartis for development costs. Novartis also will continue to reimburse Array for the clinical trials necessary to get binimetinib to market.

Under the previous deal, signed in 2010, Array had received $40 million up front from Novartis plus milestones of $20 million. Total milestones were to top $400 million, with royalties on top of that. But Array officials believe they’ll be able to market the drug on their own once approved, meaning large potential for additional annual revenue.

The new deal comes in the wake of Novartis’ acquisition of GlaxoSmithKline oncology products that included a binimetinib competitor, Mekinist. Novartis had to sell off some of its assets that could have prevented the deal with GSK from gaining regulatory approval. Array’s deal for binimetinib will become official upon closing of the Novartis/GSK deal, which is slated for the first half of this year.

“It’s an excellent deal for Array, no doubt,” Array chief executive Ron Squarer said.

Binimetinib is a MEK inhibitor, targeting a key enzyme on a critical pathway that drives several types of cancer.

The drug is undergoing Phase 3 trials for the treatment of NRAS melanoma, BRAF melanoma and low-grade serous ovarian cancer. BRAF melanoma, for which Mekinist already is on the market, accounts for about 40 percent of all melanoma cases. But NRAS melanoma – the potential $200 million market noted by Tenthoff – accounts for about 20 percent of melanoma cases, and binimetinib would likely be the first MEK inhibitor to market for treatment of the disease, helping drive much of the excitement around Array’s new deal.

Array shares, trading at $5.23 on March 18 last year, slid steeply to $3.74 by April 14. Tenthoff said much of that drop had to do with market conditions and the decline of a key Nasdaq biotech index. The Novartis/GSK deal was announced on April 22, leading to some uncertainty over the next few months about what would happen to binimetinib and Array’s stake in it. The company’s stock closed at $3.03 per share as recently as Oct. 3 before the rebound.

“We think that as we move forward, especially in clarity, we think there’s potential for more appreciation of the company,” Squarer said.

Founded in 1998, Array has received most of its revenue from a number of collaborations with other pharmaceutical and biotech companies.

The company has two wholly owned drugs in clinical development, including one for multiple myeloma and another for a rare cardiovascular disease. Including binimetinib, Array has partnerships involving 11 more clinical-stage programs, mostly cancer drugs. Selumetinib, another MEK inhibitor being developed with AstraZeneca (NYSE: AZN), is also in stage 3 clinical trials, looking at treatment of non-small-cell lung cancer, melanoma of the eye and thyroid cancer. The lung cancer application, Tenthoff said, could be the largest market opportunity of all of the MEK inhibitors.

Array employs about 200 people, mostly at offices in Boulder and Longmont. Tricia Haugeto, Array’s director of corporate communications and investor relations, said it won’t be clear how many employees might be added in the wake of the binimetinib deal until after the deal is closed. She also stopped short of making any revenue projections for the drug, although Tenthoff’s view of the market for NRAS melanoma suggests such a number could be quite large.

“We’ll just have to see where it comes out,” Tenthoff said. “But for a small company like Array, it’s a pretty nice revenue potential.”

In addition to the $85 million coming Array’s way in the binimetinib deal, the company also recently announced a licensing deal with Seattle-based Oncothyreon Inc. (Nasdaq: ONTY) to develop and commercialize breast cancer drug ONT-380. That deal brings with it an upfront payment of $20 million.

A $105 million cash infusion is significant for a company such as Array, which finished the fiscal quarter ending Sept. 30 with $47 million in cash and cash equivalents. The company reported $42 million in revenue and an $85.3 million net loss for fiscal year 2014, which ended June 30. That followed $69.6 million in revenue and a $61.9 million net loss in 2013.

CU’s pane eases pain of energy loss

BOULDER — A research group from the physics department at the University of Colorado Boulder has invented a new type of smart-window technology designed to dramatically reduce energy loss.

The technology, still in early-stage development, reduces energy waste by allowing users to hit a button and modify the kinds of light allowed into the window, depending on outside temperature. The switch controls an electric current that shoots through nanoparticles held in a liquid-crystal composite within the window glass.

Smart window technologies have been around for years. But the CU team believes its window marks a major advancement because it can be easily controlled and doesn’t require high voltage to trigger, as other technologies do.

Dr. Qingkun Liu, a postdoctoral research associate at CU Boulder’s physics department who leads the smart-window research team, said that many people don’t notice that windows are a major source of energy loss.

“Traditional windows waste about 30 percent of the energy used on heating and cooling,” Liu said, “and that’s equivalent to about $300 to $500 for each house every year.”

The team has registered the patent for the technology and has won a $180,000 grant from the state’s Advanced Industries Accelerator Program. The team plans to use the grant to build a prototype.

Robert Renent, senior scientist at the National Renewable Energy Laboratory in Golden, said that the CU team’s technical approach is intriguing and comes at a time when major players, such as Corning, are developing their own products.

According to a report by Dallas-based MarketsandMarkets, a research and consulting firm, the smart-window market was worth $1.58 billion in 2013 and is expected to reach $5.81 billion by 2020 with an estimated annual growth rate of 20 percent from 2014 to 2020.

Currently, the industry has five types of smart windows that rely on several different technologies such as photochromics, which are materials that change color in response to radiant light, and thermochromics, which are compounds that change color when exposed to heat.

None of them is flexible enough to control the heat gain, and some require use of high voltages in their control mechanisms, Liu said.

Liu’s technology, on the other hand, is flexible and uses low voltages in the control mechanism.

“Our technology allows you to switch within 100 milliseconds,” Liu said. “It’s very tunable. You could choose how much infrared light or visible light you want to block.”

Renent said Liu’s technology is “absolutely novel.”

“I think people will believe there’s a market for it,” he said. “The only concern I have is that the technology is still expensive compared to traditional windows.”

According to Liu’s research, the traditional window on average costs $5 per square foot. His smart window is estimated to cost $15 per square foot.

Liu also found that the existing smart windows cost more than his, ranging from $20 to $100 per square foot.

“If people can save $300 to $500 every year on heating and cooling by using our smart window, they will recover the investment in about a year,” Liu said.

Plus, the materials they use – liquid crystal and a type of nanoparticle — may become cheaper in the future.

The technology already has attracted some potential investors.

Douglas Henston, a clean-technology entrepreneur, heard about Liu’s smart-window project from CU Boulder’s technology transfer office.

“I’m interested in their technology and wish to do some collaboration or formation of the company to commercialize it,” Henston said.

Henston said this technology seems to have a great value proposition.

“The most important element is to figure out what the value proposition is – in other words, what it does for the consumers,” he said. “I think this project has a good value proposition for the building market.

“However, it still remains to be seen whether the technology is cost-effective.”

CSU to host vet med, bio med student forum

The 15th annual Colorado State University College of Veterinary Medicine and Biomedical Sciences Research Day will be held at noon at the Hilton Fort Collins, Saturday, Jan. 25.
The research symposium spotlights student research and scientific approaches of clinical or basic science studies from all CVMBS departments. A keynote address by Dr. Greg Amberg, associate professor in the Department of Biomedical Sciences and winner of the Pfizer Research Award, will kickoff the symposium, followed by poster and oral presentations submitted by graduate students, veterinary students, veterinary residents, postdoctoral fellows and interns.
Students were required to submit abstract presentations by Dec. 12, 2013.
Throughout the day, 145 students will present their research, followed by an awards ceremony at 6 p.m. to honor outstanding presentations. Last year, seven students were honored for their research presentation in clinical or basic studies.
The symposium is free to the public, and the detailed presentation schedule can be found here.

Deadline for early stage tech grants Jan. 2

The Colorado Office of Economic Development and International Trade is accepting applications for a second round of grants under its new Advanced Industries Accelerator Program.

Grant applications are due Jan. 2.

Earlier this month, $2.9 million in first-round funding was awarded under the new program. Four out of the eight grant winners are from Northern Colorado.

The companies include Loveland-based Lightning Hybrids, which was awarded $500,000 for its work developing a hydraulic launch assist that converts traditional fuel vehicles to hybrids.

Fort Collins-based VetDC Inc. was awarded $250,000 to continue developing a drug for canine lymphoma. The drug, VDC-1101, is scheduled for regulatory review by the U.S. Food and Drug Administration in early 2014, according to the OEDIT.

Prieto Battery Inc., a Fort Collins-based spin-off from Colorado State University, was awarded $150,000 for work on a prototypical electrode to be used to improve the effectiveness of lithium batteries.

And Membrane Protective Technologies Inc., also of Fort Collins, was awarded $125,000 for its work on a protective technology inserted in semen to improve the rates of artificial insemination.

The early stage capital and retention grants are designed to help start-ups with viable products that can be created and or manufactured in Colorado. For more information on the accelerator grants program, visit www.advancecolorado.com.

Monfort College entrepreneurial challenge offering $50,000 in prizes

Colorado-based start-up ventures or businesses can apply to win part of $50,000 in prize money in the fifth annual Monfort College of Business Entrepreneurial Challenge at the University of Northern Colorado.

Entrepreneurs can submit entries online at www.mcb-echallenge.com. The deadline for applications is Friday, Nov. 8.

Entries will be scrutinized by a panel of experts and semi-finalists will be notified by Nov. 22. Following a second presentation, five finalists will be selected and explain their business plan in a “Shark Tank” format to three judges at Monfort College of Business Entrepreneurial Challenge on Tuesday, March 25.

The first place winner will receive $25,000, second-place $15,000, and the third-place prize is $10,000. Winners will also receive business incubator services from UNC BizHub, the new business incubator at the university.

Past prize winners have included Vertikle Enterprises LLC/5280 Prosthetics, a prosthetic company that took first place in 2013, Branch Out Cider, a Northern Colorado craft cider company which placed second in 2012, and Panda Bicycles, a Fort Collins manufacturer of bamboo bicycles that placed second in 2011.