Category: Bioscience

Heska touts strong first-quarter results

LOVELAND — Heska Corp., a provider of veterinary diagnostic and specialty products, on Tuesday reported increased revenue, gross profit, operating income and net income for the first quarter.

Loveland-based Heska (Nasdaq: HSKA) reported $27.1 million in revenue for the quarter that ended March 31, a 19 percent increase from the same quarter last year. Its revenue from blood-testing instruments and consumables was up 25.8 percent to $11.4 million, and revenue from  digital imaging increased 44.5 percent to $6.1 million.

Heska reported that it saw a 13 percent increase in gross profit to $11.4 million, a 93 percent gain in operating income to $2 million and net income attributable to Heska up 98 percent to $1.2 million, or 17 cents per diluted share.

“Heska finished 2015 with record results and momentum,” said Kevin Wilson, Heska’s president and chief executive, in a prepared statement. “The first quarter of 2016 affirms the trends with record first quarter results and positive signs for the rest of the year. The overall veterinary market is healthy, our end-user analyzer consumables continue to track to expectations, we are gaining market share, profits are scaling nicely, and work to register our full line of next generation lateral flow single-use tests is on schedule.”

On March 31, according to the report, Heska had $6.2 million in cash and $22.7 million in working capital. It said stockholders’ equity increased to $65.5 million, up from $63.5 million as of Dec. 31.

The value of Heska shares surged Tuesday after the report was released. After opening at $29.79 a share, the stock price soared more than 20 percent to close at $35.86 a share. The stock had been trading for as little as $28 a share less than a week ago.

Array BioPharma posts $22.7M quarterly loss

BOULDER — Array BioPharma Inc. (Nasdaq: ARRY) on Tuesday reported a net loss of $22.7 million for its third fiscal quarter as the company continues the push toward commercialization with a pair of its cancer drugs.

The Boulder-based firm’s share price was up 1.5 percent in mid-afternoon trading to $3.36.

Array’s loss for the period ending March 31 equated to 16 cents per share.

Revenue climbed to $43 million, up from $6.6 million for the same period last year, thanks primarily to $36.9 million in reimbursement revenue from Novartis.

The company finished the quarter, meanwhile, with $118 million in cash, cash equivalents and marketable securities.

Array plans to submit a new-drug application to the U.S. Food and Drug Administration this year for approval of binimetinib in the treatment of NRAS-mutant melanoma. Binimetinib is also in a Phase 3 trial, along with encorafenib that is looking at the combination of the drugs in the treatment of BRAF mutant melanoma.

Array officials announced last month that they were discontinuing a Phase 3 trial looking at the use of binimetinib to treat low-grade serous ovarian cancer due to disappointing results.

Nivalis cites increased losses in first quarter

BOULDER — Clinical-stage pharmaceutical company Nivalis Therapeutics Inc. on Tuesday reported a first-quarter loss of $7.8 million, or 51 cents a share.

The Boulder-based company (Nasdaq: NVLS), which went public last June and remains pre-revenue, is developing drug candidates for the treatment of cystic fibrosis, including lead candidate N91115.

The loss for the quarter ending March 31 was a substantial increase from the net loss of $4.3 million in the first quarter of 2015, before the company went public. Nivalis said the loss primarily was the result of increased research and development expenses associated with the Phase 2 clinical program, as well as other related development costs for N91115. It also cited increased general and administrative costs related to becoming and operating as a publicly traded company.

“We are making progress toward our goal of improving clinical outcomes for patients with cystic fibrosis with encouraging recruitment in our ongoing Phase 2 study” of the drug, said Jon Congleton, president and chief executive of Nivalis, in a statement that accompanied the earnings report.

Near the close of trading Tuesday, Heska shares were up 31 cents or 7.4 percent at $4.50.

SiVEC Biotechnologies wins top prize at CSU Collegiate Challenge

FORT COLLINS – SiVEC Biotechnologies, a startup founded by Colorado State University graduate student Lyndsey Linke, took home the $20,000 top prize from the CSU Collegiate Challenge business pitch competition on Wednesday night.

Linke out-pitched outpitched 13 other startups from five states that were competing in the challenge.

In addition to the cash prize, SiVEC also earns an entry into a preliminary round of the $250,000 Capital Championship, which was formerly known as the CSU Blue Ocean Enterprises Challenge. The startup also earned an automatic interview for the Boulder-based Boomtown startup accelerator, a year of services from AllProWebTools and public relations firm Meld Strategy + Communications and various in-kind legal services.

SiVEC formed out of Link’s work as a doctoral student at CSU and her post-doctoral research in clinical sciences. The company is developing aerosol-based antiviral products for the rapid prevention of respiratory diseases in commercial poultry.

“The validation that you’re working toward something that can have an impact is really meaningful,” Linke said in a release from CSU. “To take it a step further and receive a prize and money, and people who believe in the technology and want to see it move forward, is even more exciting.”

Another CSU startup, IgnoreU, took home second place and $5,000. The company, founded by CSU MBA grad Carmelo Mannino and computer science grad Brandon Dewey, makes a mobile app that acts as a spam filter for people’s social media feeds.

Judges for the challenge included Cliintel Capital Group CEO Rich Batenberg, Zayo Group chief operations officer Matt Erickson, Innosphere CEO Mike Freeman, Thrive on Group CEO Sue Kunz, and angel investor and Epicentral Coworking cofounder Lisa Tessarowicz.

But it wasn’t just the judges whom SiVEC won over. The company also took home the People’s Choice Award voted on by audience members.

Broomfield biotech firm Accera moves to Boulder

BOULDER — Clinical-stage biotech firm Accera, which is developing a therapy to treat Alzheimer’s Disease, has moved from Broomfield to Boulder to become part of the latter’s bustling life-sciences scene and cash in Boulder’s international reputation as a startup haven.

Accera CEO Charles Stacey said Wednesday that the company officially made the move April 11 to 3005 Center Green Drive. Accera has about 8,000 square feet at its new digs, slightly less than it had at 380 Interlocken Crescent in Broomfield. But Stacey said the new space is more usable and will allow Accera to grow.

“We’re a little bit more in the thick of the life-sciences community,” Stacey said in a phone interview. “I think one of the other things that was key for us is Boulder definitely has more international cachet. It’s more recognizable internationally.”

Accera employs 20 people, a number Stacey expects to grow to 30 by the end of this year or early next, though some of that growth will come through remote hires as the company adopts the practice of trying to attract top life-science talent no matter where those people might be located.

Once as large as 140 employees, Accera has undergone a major transformation over the past two years.

The company is currently in the midst of a phase 3 clinical trial for its drug candidate AC 1204, which is aimed at addressing a metabolic defect in the brains of Alzheimer’s patients. That trial, which is being run entirely in the United States, is to be completed this fall, with an international Phase 3 trial to begin early next year.

Assuming those trials go as planned, Accera is aiming to apply approval from the U.S. Food and Drug Administration sometime in 2019 and have AC 1204 to market in 2020.

The company just made the shift toward new drug approval in 2014.

Founded in the early 2000s, Accera began marketing a product based on the same premise as AC 1204 in 2010. Dubbed Axona, the product was marketed as a medical food rather than a drug. Medical foods are those designated for use in the dietary management of medical conditions or diseases under supervision of a doctor. While medical foods don’t require FDA approval, the FDA does have oversight of them.

Stacey said Axona had tens of thousands of users but never gained the market traction or adoption in the medical community the firm had expected. On top of that, the FDA had sent Accera a warning letter in late 2013, contending that Axona did not meet the requirements of a medical food. Accera issued a response arguing its case and never got an official response from the FDA, Stacey said. But he said the challenging marketing and regulatory environments around medical foods led the firm to pivot toward the more-expensive route of going through phase 3 trials and gaining approval for Accera’s technology as a drug. Accera stopped marketing Axona, though it is still available to those who use it.

Accera laid off its entire commercial and sales teams in 2014 and got down to 12 people at one point. Much of last year was spent transitioning and building out the drug-development team to fulfill Accera’s current strategy.

“We feel we’ve got a really great team now,” said Stacey, who joined Accera as interim CEO in early 2014 and was named to the role in a permanent capacity last summer.

Stacey said the company will likely open an office in London next year to help oversee the international trial. An Asian office is possible as well.

Accera has raised more than $200 million since its founding. Global life-sciences investment firm Inventages, which is backed by food giant Nestle, has been an investor since 2004. Nestle itself came onboard with a large investment in Accera in 2012.

The demand for Alzheimer’s drugs is high, as there is still no cure for the disease and even the root cause has been elusive. No new drugs have gained FDA approval since 2003. Two companies working on Alzheimer’s treatments, Axovant and vTv Therapeutics, had initial public offerings last year, and Stacey said an IPO is one route Accera could go, though he declined to disclose specific fundraising plans as the company works to advance its trials.

While Accera’s current trials are aimed at treating Alzheimer’s symptoms, Stacey said Accera officials believe their technology could ultimately also be used as a mechanism for preventing the onset of the disease in patients deemed at high risk earlier in life. To gain approval for use in prevention would take further, lengthier trials in younger patients.

“We want to be able to prevent the onset of this disease, eventually,” Stacey said.

Bioscience roundtable: Attracting development capital, talent top of mind in Colorado

BOULDER — Venture-capital investment in life-science and biotechnology companies nationwide, according to MoneyTree data dating back to 1995, hit its highest level ever during that period in 2015.

What concerns David Traylor — senior managing director for investment banking firm Golden Eagle Partners active in those sectors — is that from a Colorado standpoint, the amount of investment in those spaces accounts for only a small proportion of the overall VC flowing into the state.

  • Participants in Wednesday’s CEO Roundtable on bioscience:
  • Tom Cech, distinguished professor/director of BioFrontiers Institute, University of Colorado Boulder
  • Robin Cowie, vice president of finance, Biodesix Inc.
  • Byron Hewett, CEO, SomaLogic Inc.
  • Hans Hinrichs, managing director, Silicon Valley Bank
  • Kyle Lefkoff, founder & general partner, Boulder Ventures Ltd.
  • Misha Plam, CEO, AmideBio LLC
  • Brynmor Rees, interim director of technology transfer, CU Boulder
  • Charles Stacey, president & CEO, Accera Inc.
  • David Traylor, senior managing director, Golden Eagle Partners
  • Moderator: Christopher Wood, editor/co-publisher, BizWest
  • Sponsors: Hy Harris, EKS&H; Brent Peterson, EKS&H; Patrick Haines, Berg Hill Greenleaf Ruscitti

“Nationally, you have this number going up but here in Colorado, it seems like it’s going the wrong direction,” Traylor said Wednesday.

Traylor was one of several executives gathered for BizWest’s CEO Roundtable event on the bioscience industry held at the University of Colorado Boulder’s Jenny Smoly Caruthers Biotechnology Building. One common theme was how to attract more venture capital to Colorado’s bioscience companies.

But Kyle Lefkoff — partner of VC firm Boulder Ventures Ltd. and chairman of Boulder-based Array BioPharma Inc. — said that the dollar value invested in Colorado bioscience companies isn’t necessarily a knock on the state’s sector. Boulder in particular, he said, has traditionally been much more of a drug-discovery town than a development town, where companies are ramping toward commercialization like local players Array and Clovis Oncology Inc. are now with some of their cancer drugs. Development costs exponentially more than discovery, and most of the companies doing it are on the coasts, meaning the investments going to those places are comparatively larger than those in Colorado companies.

“Just because there is one-tenth the money going into Colorado doesn’t mean there’s not a lot of stuff going on,” Lefkoff said.

Lefkoff said one way to attract those development dollars to the state — and maybe even get other development companies to relocate here — is for a company like Array or Clovis to go to market and plant a flag as an “indigenous anchor tenant” for Colorado’s bioscience industry. Most companies that could have done that in the past, he said, have been bought or acquired and lost their identity as Colorado firms.

Hans Hinrichs, a managing director at Silicon Valley Bank, said raising capital is always tricky in bioscience. For investors, he said there is massive potential for growth returns as the industry tackles pressing problems for society. Biotech is at the “top of the heap for opportunities in capital deployment,” he said.

“But it also sits at the top of the risk stack for capital deployment,” Hinrichs said, noting the often longer and unsure road to returns.

Other topics covered at Wednesday’s roundtable included:

ATTRACTING TALENT: Just like VC, bioscience talent is concentrated heavily on the coasts. Charles Stacey, president and CEO at Boulder-based Accera Inc., said he was skeptical when he joined the company 18 months ago about whether the firm could do development here as it advances its therapies for Alzheimer’s disease. But he said he believes it’s doable and that Colorado companies simply must work harder at things like attracting talent from the coasts, where workers have more job opportunities available if a company’s technology doesn’t pan out.

Stacey said he’s employed a combination of strategies in recruiting, including hiring employees from the East Coast who have stayed there while working remotely for Accera. That includes the company’s chief financial officer.

“If you want to succeed in Colorado, you need to accept these things,” Stacey said.

TALENT PART 2 (CU): Asked how much of a challenge CU faces in having its own talent poached from larger or more prestigious universities due to drops in state funding for higher education, Tom Cech — distinguished professor and director of CU’s BioFrontiers Institute — said that from a bioscience standpoint, CU is largely unfazed.

“We are always competing with the top places in the country for talent,” said Cech, a Nobel Prize-winning chemist. “We steal from them, and they steal from us. That’s part of being successful,” he added, noting that CU is among the top 15 schools in the country for biology and biochemistry.

In some respects, Cech said, the fact that state funding for higher ed in Colorado has nearly bottomed has made CU more resilient in figuring out how to deal with that reality. That’s a learning curve many of CU’s peers, he said, will have to play catch-up on as their own state funds dwindle.

“Sure, we lose some (top faculty and students to other schools),” Cech said. “But look at the building around campus. We’ve got world-class facilities, world-class faculty, world-class students. So I’m not depressed about that.”

Boulder’s entrepreneurial ecosystem is one thing CU officials are finding is helping to attract top talent in the bioscience arena, added Brynmor Rees, interim director of CU’s Technology Transfer Office.

“I think what Boulder can offer is our ability to turn out startup companies and to have an entrepreneurial student body,” Rees said. “So there are some things that Boulder and Colorado offer that are unique here and position us well with other schools.”

DOING BUSINESS IN CHINA: Boulder-based SomaLogic Inc., which makes tests for analyzing biological samples for use in both research and development as well as diagnostics, is planning to open a lab in China where some of the world’s major pharmaceutical brands operating in the country can send samples for testing. SomaLogic is also forming a joint venture in China to begin gaining regulatory approval in the country for the use of its tests in diagnostics by clinics and hospitals.

Many around the table Wednesday said there has been less worry in recent years from bioscience firms about doing business in China due to the threat of small companies there stealing their intellectual property.

SomaLogic CEO Byron Hewett said because of some of the fraud that’s gone on in the country, there has been a movement toward more trusted brands in China. And companies that have patents filed in China can count on the country to protect their IP.

“As a result, trusted brands are coveted there more than you think,” he said. “They’re really trying to stop the fly-by-night ripoff companies.”

Colorado Therapeutics closes $4.3M round of angel funding

BROOMFIELD — Medical-device startup Colorado Therapeutics LLC closed recently on a $4.3 million round of angel funding as the company works toward FDA approval of its first product.

The company disclosed the amount in a filing with the U.S. Securities and Exchange Commission this week.

Eric Schauble, vice president of corporate development, said the Broomfield-based company’s hope is that it will have FDA clearance to sell its Xenograft biologic implant for use in hernia repairs by the end of the year. He said the company, which is hiring for manufacturing and production support now, would likely begin building its sales and marketing teams in the third quarter, with five to 10 new hires projected this year.

Colorado Therapeutics’ first product is made from porcine pericardium, a membrane that surrounds the hearts of pigs. The company’s proprietary process allows the membrane to be dried and used in a ready-to-use state.

Schauble said the product is geared toward providing the durability and permanence of the synthetic mesh often used to repair hernias while also having the compatibility of a biologic material that becomes incorporated with a patient’s own tissue.

“We view it as it combines the best of both worlds,” Schauble said.

Colorado Therapeutics was spun off into a separate operating entity by Colibri Heart Valve last year to allow Colibri to monetize some of its technology in applications outside the heart. Colorado Therapeutics filed its FDA application in January.

The two companies share the same executive leadership and headquarters, though Schauble said the new company — which aims to raise a Series A round of funding late this year or early next — has about five to eight employees of its own.

“If everything goes as planned we would easily double to triple that,” Schauble said.

While the initial focus of the company is on hernia repair, Schauble said Colorado Therapeutics has many products in the pipeline. Other possible applications include tendon and ligament repair and replacement, as well as dental and vascular applications.

“We believe we can apply our proprietary processing to other types of biologic materials,” Schauble said.

Clovis lung-cancer drug suffers major setback before FDA advisory committee

BOULDER — Clovis Oncology Inc.’s share price continued its freefall on Tuesday after an advisory committee for the U.S. Food and Drug Administration recommended against accelerated approval of Clovis lung cancer drug rociletinib.

Boulder-based Clovis had been hoping to receive regulatory approval for the drug by this summer. If the FDA, which is scheduled to rule on rociletinib in June, goes along with the committee’s decision, the move could push back approval of rociletinib to 2019, if approval comes at all.

The FDA’s Oncologic Drugs Advisory Committee voted 12-1 to recommend the FDA wait for final results from an ongoing Phase 3 clinical trial of rociletinib in the treatment of non-small cell lung cancer. The trial, dubbed TIGER-3, isn’t expected to complete patient enrollment until late 2018.

The FDA in May 2014 had granted rociletinib Breakthrough Therapy designation, a status intended to help expedite development and review of certain drugs. But in November, the FDA requested more clinical data on the drug in part because the number of study patients with unconfirmed responses to rociletinib who had converted to confirmed responses was lower than had been expected. That led to an extension of the FDA’s decision date on the drug from March 30 to June 28.

Then on Friday, the FDA posted briefing materials in advance of Tuesday’s ODAC meeting that raised questions about side effects and dosing of rociletinib, as well as whether the drug’s efficacy was better than treatments already available on the market.

“We are disappointed with today’s outcome, as we believe in the strength of the data we presented for rociletinib,” Clovis president and CEO Patrick Mahaffy said in a prepared statement. “We will work with the FDA to evaluate the best path forward as it continues to review our application.”

The Nasdaq stock exchange temporarily halted trading of Clovis stock (Nasdaq: CLVS) on Tuesday while the ODAC met to discuss the company’s New Drug Application. When trading resumed, shares opened at $12.91 and sank to a new 52-week low of $12.25 before closing at $14.24, down more than 5 percent from Monday’s close.

Clovis’ stock price hit a 52-week high of $116.75 on Sept. 17 before plunging nearly 70 percent on Nov. 16 after the FDA’s request for more information. The company’s share price has continued a steady decline since.

Rociletinib is not the only Clovis drug to have been granted Breakthrough Therapy status. Early last year, the company received the same designation for rucaparib, which is currently in advanced clinical trials for the treatment of ovarian cancer.

CU-built hardware hitching ride to space station

BOULDER — Hardware designed and built at the University of Colorado Boulder is headed to the International Space Station and will be used in four bioscience experiments that could lead to advances in medical care.

Developed by BioServe Space Technologies in CU-Boulder’s Department of Aerospace Engineering Sciences, the hardware is aboard the commercial SpaceX Dragon capsule that was launched Friday from Cape Canaveral, Fla.

BioServe hardware includes several shoebox-sized devices known as “plate habitats” to support a range of life-science experiments. Each habitat is used to culture biological organisms, according to BioServe’s director Louis Stodieck.

One experiment is designed to better understand cell biology by charting the behavior of yeast cell cultures in microgravity. Since multicellular yeast colonies are similar to mammalian cell tumors, researchers hope to identify biological factors that may contribute to the health and disease of humans in space and on Earth, Stodieck said.

A second experiment is designed to help researchers better understand the mechanisms of molecular transport across tiny membrane channels, with implications for future human implants that could release drugs to treat various diseases, he said.

The third experiment will involve culturing fungi, which could lead to the production of new pharmaceuticals.

The fourth experiment will look at developing treatments for bone and muscle loss by both space travelers and people on Earth, Stodieck said. The experiment could help lead to new treatments of muscle and bone diseases in humans like muscular dystrophy, osteoporosis and cancer cachexia, a syndrome of progressive weight loss in cancer victims due to loss of skeletal muscle and body fat.

The experiments were created by researchers at University of Southern California, the Durham VA Medical Hospital in Durham, North Carolina, Lilly Research Laboratories in Indianapolis, Indiana and the Houston Methodist Research Institute in Texas.

Since its inception in 1987, BioServe has partnered with more than 100 companies and performed dozens of NASA-sponsored investigations, Stodieck said.

“We believe these experiments in the microgravity of space are extremely valuable for both research and education,” Stodieck said. “By conducting experiments in microgravity, scientists can learn more about biochemical changes in cells and organisms that the force of gravity on Earth may be masking.”

BioServe researchers and students have flown hardware and experiments on more than 50 missions aboard NASA space shuttles, the ISS and on Russian and Japanese government cargo rockets.

Array discontinues trial on ovarian-cancer drug

BOULDER — Array BioPharma Inc. has pulled the plug on one of three trials it is conducting for its cancer drug binimetinib, the Boulder-based company announced Friday.

Array (Nasdaq: ARRY) is stopping its MILO study, a phase 3 trial of binimetinib for the treatment of patients with -ovarian cancer, after a planned interim analysis showed that the treatment was not meeting predefined goals.

Array, in a prepared statement, said it will work with investigators to conclude the MILO study in a manner consistent with the best interest of each patient, while more-detailed results will be shared with the scientific community in the future.

Dr. Victor Sandor, Array’s chief medical officer, said other ongoing studies of binimetinib to treat two different forms of skin cancer are unaffected.

Array BioPharma has five studies related to three cancer drugs, including binimetinib, encorafenib to treat colorectal cancer, and selemetinib to treat lung and thyroid cancers.

Array’s stock fell about 4 percent to $2.82 per share in early trading on Friday.