Category: Bioscience

Array BioPharma shares spike following 2Q earnings report

BOULDER — Shares of Array BioPharma Inc. (Nasdaq: ARRY) had surged nearly 12 percent by mid-afternoon trading Thursday after the release of the company’s fiscal year-end earnings report.

The gains came despite a net loss for the year ending June 30 of $92.8 million as the Boulder-based firm continues with Phase 3 trials for multiple cancer drugs and prepares for commercialization.

Array’s net loss equated to 65 cents per share and compared with a net income of $9.4 million, or 7 cents per share, for the previous fiscal year, which was bolstered by a one-time $80 million payment from Novartis related to Array’s binimetinib and encorafenib programs.

Revenue for the 2016 fiscal year climbed to $137.9 million, up from $51.9 million the previous year, also due largely to reimbursement revenue from Novartis.

Array in June submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the use of binimetinib in the treatment of NRAS-mutant melanoma. The drug is also being examined in a pair of other Phase 3 trials in combination with other drugs to treat BRAF melanoma and colorectal cancer.

Array’s share price has climbed steadily since February, and was at $4.58 by mid-afternoon Thursday, up 48 cents from Wednesday’s close.

Heska shares soar on 2Q earnings gains

LOVELAND – Shares of Heska Corp. (Nasdaq: HSKA), which makes veterinary diagnostic and specialty products, were up more than 11 percent in Wednesday afternoon trading after the company posted major year-over-year gains in net income and revenue for the second quarter.

The Loveland-based company reported net income for the period ending June 30 of $2.5 million, or 35 cents per diluted share, more than double the marks of $1.2 million and 17 cents per share for the same period a year earlier.

Revenue for the second quarter, meanwhile, came in at $30 million, up 25 percent over a year ago.

Heska’s Core Companion Animal Health segment saw sales rise 18 percent to $24.5 million on strong performance from blood testing instruments, consumables and digital imaging, company officials said. The company’s Other Vaccines, Pharmaceuticals and Products segment, meanwhile, climbed 74 percent to $5.5 million.

The company finished the second quarter with $6.7 million in cash. Stockholder’s equity increased from $63.5 million as of Dec. 31 to $75.7 million as of June 30.

As the trading day neared its close Wednesday, Heska shares were trading at $48.50 apiece, up $4.89 from Tuesday’s close.

$1 million gift to BioFrontiers Institute to aid CU grad students

BOULDER — A couple in California has given a $1 million gift to the University of Colorado’s BioFrontiers Institute in Boulder to establish a fund for graduate students participating in an interdisciplinary bioscience program.

John F. Milligan and Kathryn Bradford-Milligan’s gift will start the Olke C. Uhlenbeck Endowed Graduate Fund that will support first-year grad students pursuing doctorates in one of nine academic departments and includes additional coursework in interdisciplinary bioscience.

The fellowship is intended to fund each recipient for a two-year period for roughly $55,000 and is expected to be awarded every other year beginning in fall 2016.

The funding will support tuition and stipend costs for first-year graduate students pursuing doctoral degrees as part of the BioFrontiers IQ Biology PhD Certificate program.

Milligan is president and chief of California-based Gilead Sciences Inc. that has operations in North America, Europe, Asia and Australia. The biopharma company is focused on discovering, developing and commercializing therapeutics and advancing the care of patients suffering from life-threatening diseases worldwide.

Milligan spent two years of his doctoral studies in Uhlenbeck’s lab at CU Boulder after it was moved from the University of Illinois in 1986. Milligan subsequently joined Gilead Sciences as a research scientist.

Uhlenbeck, an internationally known biochemist, spent 16 years at CU Boulder at a time when the university was becoming a leader in RNA research. He was elected into the National Academy of Sciences in 1993 and is a founding member of the RNA Society, which publishes the scientific journal RNA.

“I really value the time I spent at CU Boulder with Olke,” Milligan said in a prepared statement. “I appreciate the conversations we had as I developed into a scientist. He also taught me to be a leader by showing me what it meant to be engaged in research and intellectually curious.”

Distinguished professor Tom Cech, director of the BioFrontiers Institute, will participate in selecting the first Uhlenbeck Fellow from the incoming class of IQ Biology students this fall. Cech shared the 1989 Nobel Prize in chemistry for his discovery that RNA in living cells is not only a molecule of heredity but also can function as a catalyst.

Biodesix raises additional $7M from sale of preferred shares

BOULDER — Biodesix Inc. has raised $7 million on a follow-on sale of its offering of series F preferred shares, bringing the total amount raised for the round to $24.8 million.

The Boulder-based diagnostic test-maker had raised nearly $17.8 million in February through the Series F funding round. A preferred stock is a class of ownership in a corporation that has a higher claim on its assets and earnings than common stock.

The additional capital was provided by existing Biodesix investors and will be used for the development of new diagnostic tests for clinical use with immunotherapies — treatments that use certain parts of a person’s immune system to fight diseases such as cancer. Biodesix’s blood tests identify which cancer patients could best benefit from various cancer drugs, because most cancer drugs work only on specific sets of the population. In essence, the tests help get the right drugs to the right patients.

The money also will be used to expand the company’s offering of its commercialized tests, Veristrat and GeneStrat.

 

Array BioPharma appoints Haddock as CFO

BOULDER — Array BioPharma Inc, a biopharmaceutical company based in Boulder, said Thursday it has hired a former executive at Bristol-Myers Squibb as chief financial officer.

 Jason Haddock

Jason Haddock

Jason Haddock will take over for David Horin, who had been acting as Array’s interim CFO. Horin will provide consulting services to Array (Nasdaq: ARRY), which is developing drugs to treat cancer.

Haddock has more than 15 years of financial and operational experience in the biopharma industry. He held leadership positions of increasing responsibility at Bristol-Myers Squibb, a global pharmaceutical company with a strong focus on immuno-oncology therapies, in a variety of accounting, planning, commercial, analytical and business-development capacities for more than 13 years through 2015.

Haddock most recently served as CFO and chief operating officer of BERG Health, an oncology-focused research, diagnostics and development company.

“We are pleased to welcome Jason to Array’s executive team during a pivotal time for our company,” said Ron Squarer, Array’s chief executive. “He brings strong financial and operational expertise across many therapeutic areas and in commercial, medical and operational functions, and is well-versed on the nuances and challenges in the pharmaceutical landscape.”

Array is working toward commercializing two wholly owned drugs in the United States. Array is approaching several near-term milestones, including what the company expects to be positive results from a phase 3 trial and a projected regulatory filing of binimetinib in combination with encorafenib.

CSU researchers to study Swiss firm’s attempt to fight Zika virus

FORT COLLINS — Researchers at Colorado State University will conduct federally sponsored tests of a Swiss company’s citrus-based insecticide to see if it’s effective against mosquitoes carrying the Zika virus.

The research is being sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. CSU researchers, working under NIAID’s preclinical services program, will test the repellency and insecticidal properties of nootkatone, an insecticide produced by Evolva (SIX: EVE), a company based in Reinach, Switzerland. Data from the studies will supplement Evolva’s research to fulfill Environmental Protection Agency requirements for the commercial launch of nootkatone in the United States.

Zika is one of a number of mosquito-borne viruses, which include both dengue and chikungunya, that are transmitted by two species of mosquito. The World Health Organization and the federal Centers for Disease Control and Prevention have declared the virus a public health emergency because it is associated with potentially severe neuropathogenic and neurodevelopmental conditions in humans.

CDC research already has shown that nootkatone repels and kills a mosquito that can transmit Zika and yellow fever, as well as the black-legged tick that transmits Lyme disease.

Evolva also produces the sweetener known as stevia. Nootkatone can be extracted in minute quantities from the skin of grapefruit or the bark of the Alaska yellow cedar, or produced on an industrial scale from brewing via yeast fermentation.

Fort Collins-based St. Renatus gains FDA approval for dental anesthetic

FORT COLLINS — St. Renatus LLC, a Fort Collins-based biopharmaceutical company, has received FDA approval for its first product, a dental anesthetic.

Kovanaze allows dental anesthesia to be administered through a nasal spray without using a needle. It is designed for use in procedures involving most of the upper teeth.

“For more than 100 years, the dental industry has delivered dental anesthesia using a needle injection. Now, through the efforts of a dedicated team, we have developed a revolutionary needle-free method for delivering pulpal anesthesia,” said Steve Merrick, St. Renatus’ chief executive.

Kovanaze is intended for use in dentistry as a topical anesthetic, delivered in the nasal cavity to achieve pulpal, or tooth nerve, anesthesia.

St. Renatus was formed in 2008 and has raised approximately $40 million in funding to pursue the development and approval of the nasal mist.

Investment firm buys majority stake in Firefly Medical

FORT COLLINS — Carlton-Harvey Group, a Georgia-based private-equity firm, has acquired a majority stake in Fort Collins medical-device startup Firefly Medical Inc., as the latter aims to significantly scale up sales.

Carlton-Harvey invested $2.5 million in Firefly, according to a recent regulatory filing, and Firefly co-founder Patrick Bols said Wednesday that there is also an undisclosed loan commitment aside from the equity portion.

Bols, who has served as chief executive for the past year, becomes chairman of the Firefly board with the new transaction. CHG principal Trevor Carlton, meanwhile, will take over as CEO of Firefly, and CHG principal Stuart Harvey becomes president.

Firefly, 320 E. Vine Dr., will keep its branding, and all eight employees who were with the company prior to the CHG investment will remain.

“Everybody still has a very important job to do here,” Bols said.

The addition of Carlton and Harvey, as well as a new sales manager, boosts the company’s employee count to 11, and Bols said the intent is to add two more employees this year and three to five more in 2017. The new cash infusion will be used largely to beef up sales and marketing, including internationally.

“The most important part of this transaction is we’ll now have seasoned executives managing the company,” Bols said.

Founded in 2013 by Bols, Steve Schmutzer and Keith Burge, Firefly makes a device called the IVEA that aims to replace the standard pole from which IV bags are hung in order to improve patient mobility, nursing staff efficiency and safety for both patients and caregivers.

Firefly officially launched the device in May of last year. Bols declined to disclose revenue.

“Almost immediately we recognized that the IVEA is a solution that could transform the industry,” Carlton said in a news release. “It’s a great story and a great product, and we look forward to working with Firefly to make the IVEA the new standard of care in hospitals around the world.”

Correction: The original version of this story mis-labeled Carlton-Harvey Group as a Fort Collins-based firm. We regret the error.

German firm Sartorius acquires Broomfield-based ViroCyt

BROOMFIELD — Life-science startup ViroCyt LLC announced on Friday that the company has been acquired by Germany-based Sartorius, an international provider of pharmaceutical and laboratory tools.

Sartorius paid $16 million for Broomfield-based ViroCyt in the cash deal.

ViroCyt president and CEO Robert Kline said in an interview Friday that the company will maintain its branding and continue to operate as a standalone company for the foreseeable future. He said all 12 employees, including him, will be retained.

Formed in late 2012 as a spinoff of Boulder-based InDevR, ViroCyt develops instrumentation and reagents that allow for the quantification of virus particles in a given sample in just minutes. The company is projected to achieve more than $3 million in sales this year.

“We’ve really been able to fine-tune and improve our technology to the point that I think it’s a really good solution for a number of opportunities and applications in the biotech world,” Kline said. “But as a small company we don’t have the reach to get to all of the opportunities. … (The acquisition) is a great opportunity to accelerate the scaling of our business.”

ViroCyt, which initially was based in Denver, launched with $3 million in venture capital, led by High Country Venture in Boulder. The company last year added another $3.5 million round. The company moved to Boulder in late 2013 before moving again to Broomfield last November to accommodate growth.

Eight of ViroCyt’s employees are based at the company’s headquarters at 100 Technology Drive in Broomfield, with the rest spread throughout the country. Kline said the acquisition by Sartorius should mean more hiring locally.

“The whole idea behind the partnership is to grow the business, so over time we will be adding resources,” Kline said.

Nivalis Therapeutics files for $142.5M shelf registration

BOULDER – Nivalis Therapeutics Inc. (Nasdaq: NVLS), which is developing a drug to combat cystic fibrosis, on Wednesday filed a shelf registration for up to $142.5 million-worth of securities.

The filing gives the Boulder-based company the flexibility to conduct an offer more quickly at some point in the future if Nivalis were to need cash or market conditions became favorable for an offering.

Wednesday’s filing notes that the company could offer some combination of common stock, preferred stock or debt securities not to exceed $125 million. The company also registered 3.7 million shares that could be sold by selling stockholders worth up to $17.5 million, though the company itself would not receive proceeds from the sale of those shares.

Nivalis raised $88.55 million through an initial public offering early last year. In the company’s first-quarter earnings report this year reported cash, cash equivalents and marketable securities of $80.2 million. The company said it should have enough cash to fund a current Phase 2 clinical trial for N91115 and operations of the company through the middle of next year when it starts enrolling patients for a Phase 3 trial.

Nivalis earlier this year was granted Fast Track designation for N91115 from the U.S. Food and Drug Administration, which provides for accelerated review of drugs intended to treat serious or non-life-threatening conditions and unmet medical conditions.

Nivalis shares were down 6.5 percent in afternoon trading Wednesday to $4.37 apiece.