Category: Bioscience

Array BioPharma strikes rights deal with Japanese firm worth up to $76M-plus

BOULDER – Array BioPharma Inc. (Nasdaq: ARRY) on Thursday announced that it has struck a deal with a Tokyo-based firm to develop and commercialize an Array-invented drug in Asia for use in pain treatment.

The deal includes $12 million upfront for Boulder-based Array and up to $64 million in milestone payments, plus double-digit royalties on sales.

The Japanese firm, Asahi Kasei Pharma Corp., will have rights to develop and commercialize ARRY-954 for pain, inflammation and other non-cancer indications. Array retains the rights to the drug in the treatment of cancer.

Array also retains all rights to the drug, which is in the preclinical stage, outside of Asia, though the company has announced no plans at this point to develop the drug further on its own.

Array shares, which have languished in recent months, had climbed nearly 5 percent to $3.05 by early afternoon trading Thursday on news of the deal.

ARRY-954 is a Tropomyosin receptor kinase A (TrkA) inhibitor that in preclinical studies has shown the ability to block pain responses in models representing various difficult-to-treat pain conditions such as osteoarthritis pain and chronic low back pain.

“We are excited to partner our TrkA for inflammation/pain program with Asahi Kasei Pharma,” Array CEO Ron Squarer said in a release. “Asahi Kasei Pharma is committed to advancing the program into clinical development, which will unlock its potential future value.”

Array’s proceeds from the deal can be used for any program at the company.

Array drug binimetinib is in Phase 3 clinical trials looking at its use in treating two different types of melanoma as well as ovarian cancer. The company is planning to file with the U.S. Food and Drug Administration for approval to market the drug for use by NRAS melanoma patients in the first half of this year.

AstraZeneca, meanwhile, is conducting advanced trials on Array cancer drug selumetinib as well.

PanTheryx lands $53M investment from Pegasus Capital Advisors

BOULDER — PanTheryx Inc. on Wednesday announced that it has received a $53 million equity investment from Pegasus Capital Advisors that will help boost the worldwide rollout of the Boulder-based company’s product that treats infectious diarrhea.

The cash infusion will help not only with ongoing product development but also PanTheryx’s intent to acquire other firms. President and chief executive Mark Braman said the company could close its first acquisition by the end of April, a move that will allow PanTheryx to bring its manufacturing — currently contracted out to sites in the United States and Malaysia — in-house.

“We’re certainly excited to have completed the transaction with Pegasus,” Braman said. “It will be a big help for the company going forward.”

Braman said he couldn’t comment on the structure of the equity deal or whether the new investment by Pegasus represents a minority or majority stake.

Pegasus manages roughly $1.8 billion in assets, investing in companies focused on areas of global resource scarcity like energy, waste, food, water and health.

“We view PanTheryx as the cornerstone of our life sciences and microbiome strategy and a platform through which we can partner with other innovative companies that are reimagining traditional approaches to health and wellness,” Pegasus chairman and president Craig Cogut said in a press release.

Founded in 2007, PanTheryx launched its flagship product, DiaResQ, last year in the United States in Passport Health Clinics, which offer advice, immunizations, vaccinations and travel insurance for those traveling abroad. In addition to rolling out internationally in Malaysia, Singapore and Brunei, PanTheryx also launched its product on Amazon earlier this month. The Amazon launch was key given that a large portion of PanTheryx’s business in the United States comes from international travelers.

“In most cases, consumers do a lot of planning when they’re making an international trip in particular,” Braman said. “It’s more of a planned purchase.”

He said retail distribution will start later this year and accelerate rapidly in the first quarter of 2017. Distribution to Mexico, the Philippines, Indonesia and Pakistan will all begin yet in the first half of this year, meanwhile.

PanTheryx has 17 employees, including 13 in Boulder. Braman said he expects the total number to grow by 15 to 20 people by the end of the year, with two-thirds of the new hires in the United States.

The privately held company doesn’t disclose revenue, but Braman said sales are going well so far and that, perhaps more importantly, initial feedback on effectiveness has been strong.

“We’re very encouraged by the results we’re seeing,” Braman said.

GlobeImmune shares slide 15 percent on earnings report

LOUISVILLE — Shares of GlobeImmune Inc. stock were down 15 percent Wednesday after the company’s year-end earnings report, which included a $2.8 million net loss.

Company officials, in the earnings report, stated that the troubled Louisville-based pharmaceutical company (Nasdaq: GBIM) continues to seek strategic transactions that would help maximize shareholder value.

The company’s 2015 loss amounted to 48 cents per share, compared with a loss of $8.04 per share, or $23.4 million, in 2014. Revenue, meanwhile, climbed from $6 million in 2014 to $6.5 million in 2015.

Revenue was boosted by $1.8 million in licensing revenue for its GI-6200 program with Celgene. Lower research and development expense and reduced salary expense due to layoffs last year also contributed to the net loss shrinking.

GlobeImmune last August slashed its staff from 22 to six employees in an effort to preserve cash after negative trial results for its hepatitis B drug candidate. Last month, it was announced that CEO Timothy Rodell would start working part-time on March 1 and receive only half of his annual salary of $405,000 to help preserve capital.

The company finished 2015 with $9.9 million in cash and cash equivalents, enough, company officials said, to operate through the end of the year as it continues to look for strategic alternatives.

GlobeImmune shares were trading at $1.86 apiece in mid-afternoon trading Wednesday after trading above $10 for a period last April.

GMO debate to highlight Food and Ag Summit

LOVELAND — An afternoon debate over genetically modified organisms, their safety and labeling will be among the features of BizWest’s inaugural Food and Ag Summit, to be held March 30 in Loveland.

The all-day event will bring together representatives of Colorado’s agriculture and natural-foods organizations and companies to offer the latest insights affecting the future of the food and agriculture sectors. The summit, to be held at The Ranch’s First National Bank building, 5280 Arena Circle, will offer information on new technologies and trends, networking with producers and providers, and discussion on such topics as the Food Safety Modernization Act, finding the right people at the right price, financing, global trade, regenerative agriculture and immigration issues.

Debating the hot-button issue of GMOs will be CSU professor Patrick Byrne, Colorado Corn Growers Association board president Dave Eckhart, Compass Natural Marketing owner Steve Hoffman and Rebekah Lyle, director of marketing for White Wave’s Silk plant-based foods and beverages.

Registration for $49 can be made online. Admission will cost $59 at the door.

Contact Sandy Powell at 970-232-3144 or spowell@bizwestmedia.com for information about sponsorship, vendor booths and corporate tables.

SuviCa uses undergrads to test cancer drug on the fly

Rack one up for the fruit flies — and the concept of involving undergrads in front-line research, as well.

Both the flies and the students who work with them were instrumental in bringing Boulder biotechnology company SuviCa Inc. roughly $1.5 million in federal funding to develop a treatment for head and neck cancer last fall. The University of Colorado Boulder technology transfer company, headed by Tin Tin Su, its chief science officer and a CU professor, has a drug candidate known now as SVC112 that helps prevent regrowth of cancerous cells following radiation therapy.

While at least a couple years away from any human testing, Su said the money will help the fledgling company develop the drug as far as financially feasible. Su said the Phase II Small Business Innovation Research (SBIR) contract from the National Cancer Institute may help get the drug to the beginning of human testing, although certainly other funding would be necessary at that point.

“We would like to keep it as long as possible,” said Su about the company’s first drug candidate. “We still have a lot of work in proof of concept in the lab and in animal models, and we’re hoping to raise money to get there.

“If we get appropriate funding, and the data looks good, I would say about two years (until the drug could begin to be tested on people). That’s an educated guess.”

SVC112 is a small molecule that targets ribosomes, which create proteins inside of cells. Essentially, the researchers hope to inhibit cancerous cells that have been treated by radiation from replicating themselves, a far too common occurrence after radiation treatment.

The drug could have more far-ranging application, as Su said working on neck and head (not brain) cancer was more of a means to an end, as SVC112 and other drug candidates at SuviCa may have more extensive application.

“You don’t hear a lot about it (neck and head cancer) and, because it’s often neglected, patients have greater needs for a new therapy,” Su said. “The specificity (of the cancer) comes less from the drug” and more from a business model suggested by regulatory paths.

The use of fruit flies — or Drosophila melanogaster for those in the know — in medical research is not new, but certainly Su’s approach in bringing in undergraduates to this first phase of potential drug identification is raising some eyebrows.

“That is our first line of attack, and the reason is they (fruit flies) share about 70 percent disease-relevant genes with us,” she said. “They are very easy to manipulate; we can change genes in fruit flies almost at will. It’s cheap and fast.”

Undergraduate evaluation of the fruit fly screening was very much a part of identifying SVC112, and the courses designed by Su for her students have attracted funding by the Howard Hughes Institute to forward the curriculum to reach a larger student population at CU.

“It’s getting a lot of attention,” Su said. “Giving the students hands-on experience in doing front-line research really gives them better perspective than traditional lab work.”

The idea also was crucial in putting together a rather unique and talented SuviCa team, as well. CEO Judy Hemberger, who was co-founder and chief operating officer of Pharmion Corp. prior to its sale to Celgene for $2.9 billion, said the unique screening technique, and its advantages in inexpensively putting drug candidates into the pipeline, initially drew her to the company.

“I’ve probably served on 19 different boards,” said Hemberger, who has more than 30 years of experience in the pharmaceutical industry, with expertise including clinical development, global regulatory and early commercialization. “When I saw what Tin Tin’s techniques offered, I was on board.”

Today, Hemberger points to a uniquely integrated team of researchers and managers well versed in early drug development as the feature that really makes SuviCa, founded in 2010, really hum.

For instance, Bert Pronk, SuviCa’s vice president for preclinical development who has more than 25 years’ of experience in research and drug development for various oncology indications in academic and industry environments, also was instrumental in developing SVC112. The SuviCa team also includes clinicians and scientists at CU-Boulder, the University of Colorado Cancer Center, CU Anschutz Medical Campus and Colorado State University, several of whom have published a Phase I clinical study (dosage response) on a similar drug inhibiting post-radiation cancer cell growth.

“We’ve always been able to use money very, very effectively,” Hemberger said. “That’s one of the things that brings this team together: the desire to create low-cost, effective cancer treatments.”

Su’s research in her lab at CU-Boulder also may have revealed something many cancer specialists were not aware of, a communication between dying cells and their nearby counterparts. “We still don’t understand how they work,” she said, “but they (appear to) send signals to their neighbors, telling them not to die.”

But Su is hopeful that the current screening process matched with top-end researchers may have a solution.

“We’re building a so-called pipeline,”
she said. “We have other new entrants
at different states and are tweaking
them now.”

Loveland-based Heska doubles profit, posts record revenue

LOVELAND – Heska Corp. (Nasdaq: HSKA) doubled net income in 2015 and enjoyed record revenue for the year, according to the company’s year-end earnings report released Thursday.

The Loveland-based provider of veterinary diagnostic and specialty products reported 2015 net income of $5.2 million, or 74 cents per diluted share, up from $2.6 million, or 41 cents per share, for 2014.

Revenue for the year climbed 16 percent to $104.6 million.

For the fourth quarter, Heska saw net income of $2 million, or 28 cents per share, up from $829,000, or 12 cents per share, in 2014.

The company finished 2015 with $6.9 million in cash and $22.4 million in working capital. The company grew stockholders equity during the year from $53.1 million to $63.5 million.

Despite the fourth-quarter numbers beating analysts’ expectations, however, Heska’s share price was down 7.2 percent to $31.20 in mid-afternoon trading.

Anonymous donor contributes $20M toward CSU research facility

FORT COLLINS — An anonymous racehorse breeder has donated $20 million to Colorado State University to build a regenerative medicine research facility, fulfilling a $65 million matching challenge from lead donors and fellow horse aficionados John and Leslie Malone.

In December 2014, the Malones pledged $42.5 million — the largest cash gift in CSU history — for the planned facility. The gift was prompted by their interest in stem-cell therapy and its effectiveness in treating equine joint problems; the Malones raise world-class dressage horses and thoroughbred racehorses.

The donations allow construction of the CSU Institute for Biologic Translational Therapies, which promises to tap the body’s healing powers for innovative treatments that improve animal and human health. Groundbreaking will occur later this year; an exact date has not been set.

On Feb. 13, CSU announced its first $1 billion campaign to generate philanthropic support for teaching, research, outreach and veterinary clinical services. The university is more than halfway to fulfilling that goal with help from the sizeable gifts for regenerative research.

CSU professor Wayne McIlwraith and Barbara Cox Anthony, chair of CSU’s orthopaedic research, are leading the planning effort for the facility.

McIlwraith and his veterinary colleagues have treated joint problems in horses owned by the Malones and by the anonymous donor.

AntriaBio, Korean firm reach pact on diabetes drug

LOUISVILLE — Biopharmaceutical company AntriaBio Inc. is collaborating with a new specialty health-care firm based in Seoul, South Korea, allowing it to manufacture and sell one of its diabetes drugs, according to documents filed Wednesday with the U.S. Securities and Exchange Commission.

Under the agreement, AntriaBio (OTCQB: ANTB) will give pH Pharma Co. Ltd. an exclusive, transferable license to make and sell its drug AB101 in eight countries in Southeast Asia — but the license will become effective only after pH Pharma has purchased a minimum of $8 million in AntriaBio securities, according to the SEC document. The companies also agreed to work together to use AntriaBio’s proprietary microsphere platform for various therapeutic opportunities.

Under the terms of the stock purchase, pH agreed to buy $1 million in AntriaBio preferred stock, then $1 million more by March 31, and to negotiate to buy at least $6 million of its common stock.

AntriaBio completed two $2 million funding rounds in 2015, partly to pay for clinical studies of AB101, which is a once-a-week basal insulin for treatment of type 1 and type 2 diabetes.

The company began operations at 1450 Infinite Drive in early 2014 in hopes of resurrecting AB101, which originally was being developed by shuttered Fort Collins-based company PR Pharmaceuticals Inc. AntriaBio bought that company’s intellectual property and assets in 2013 after PR Pharmaceuticals filed for Chapter 11 bankruptcy in 2008 and eventually went out of business.

AB101 has been formulated with a polymer in biodegradable microspheres for use in patients with types 1 and 2 diabetes who require basal insulin replacement therapy for the control of hyperglycemia.

AntriaBio’s shares closed at $1.04 on Wednesday after opening at $1.02.

Visium to invest up to $60.5 million in Boulder-based SomaLogic

BOULDER — SomaLogic Inc., on Tuesday announced that the company has raised up to $60.5 million in equity and debt financing from Visium Healthcare Partners to help the growing Boulder-based firm accelerate the rollout of its diagnostic tests to hospitals and medical clinics.

Specifics of the funding related to milestones and the size of the equity stake were not disclosed.

SomaLogic makes a SOMAscan assay that can be used to analyze a variety of biological samples and quickly and accurately read out thousands of proteins present for the purposes of diagnosing and understanding the biology of diseases.

Founded in 2000, SomaLogic began marketing the SOMAscan assay to universities and pharmaceutical companies in early 2012 to aid in their research-and-development activities. But the new funding will aid SomaScan in its push to sell its first tests for diagnostic uses over the next few months.

“We believe that SomaLogic is an incredibly compelling emerging healthcare company and expect that this investment will help accelerate the realization of their ambitious vision and vast potential,” Visium partner Avi Amin said in a release.

Founded in 2000, SomaLogic has been growing rapidly, adding 60 employees over the past two years. The company now employs about 160 people, about 150 of whom are in Boulder. The company has now raised about $250 million since its founding — about two-thirds of which has come in the form of equity and the other third in contract research and development and milestone payments.

In addition to the expansion into diagnostics, the company is getting ready to expand its physical presence in Boulder. The company occupies a pair of buildings on Wilderness Place and part of a third. The company is planning to exit the third building in June and expand into a larger space in another building close by that will bring SomaLogic’s total space to 75,000 square feet.

“We basically have a little campus we’re building here is what it amounts to,” company spokesman Fintan Steele said.

CHD Bioscience raises $1.7M as FDA approval, commercialization near

FORT COLLINS — CHD Bioscience Inc., closed recently on a $1.7 million equity funding round as the Fort Collins company moves toward commercialization of its first product later this year.

CEO Mike Handley said in a phone interview Monday that if all goes well, approval of the company’s first product by the U.S. Food and Drug Administration could come by mid-year.

Officials for CHD, which has developed an antimicrobial agent it calls Veriox, envision a wide range of uses for the technology, including in orthopedics, wound care and dermatology.

Assuming FDA approvals, the first product headed for market is a small-bone implant made of polymer and titanium materials that is coated with CHD’s proprietary ingredient, which would help mitigate against infections. The implant is for use in the repair of damaged or disfigured fingers and toes, and is made to allow the bone to fuse to the device and straighten out.

But CHD isn’t exactly diving full-on into the medical device industry. Rather, the initial product is aimed at a relatively small market as sort of a proof of concept. If CHD can prove the device’s worth in small-bone procedures, the company would most likely seek to sell its antimicrobial coating to implant manufacturers for large-bone procedures like spine, knee and hip, for which the markets are in the billions of dollars.

“If we demonstrate that this product works in small bones … then it’s logical that it would work in large bones,” Handley said.

While CHD in its current form has been around only a few years, the company’s roots date back to 1997. Founded as Chata Biosystems, the company sold off its original core business — and name — to Texas-based Boval LP in 2011 so CHD could focus on the antimicrobial technology discovered by founder Ed Neas. Boval-owned Chata, which is now based in Loveland, makes customized solutions used by pharmaceutical companies for research-and-development testing.

CHD has raised $15 million since 2011 to develop Veriox. The new funding will serve as a bridge to a larger raise later this year. The new money will be used to continue product development and get ready for FDA approval. The next round, Handley said, will be used to help with commercialization of the small-bone implant as well as to continue developing other uses of the same active drug but in different formulations.

In wound care, CHD’s product could be used to coat bandages and wound dressings to prevent, or even treat, infections. In dermatology, the product would be completely therapeutic and used to treat drug-resistant infections.

CHD has 12 employees, and will likely grow once the next funding round is secured. The company currently contracts out manufacturing, though it’s possible that could change down the road as commercialization comes to fruition.

“We haven’t ruled out manufacturing it here,” Handley said.

Correction: The original version of this story mistakenly listed CHD Biosciences’ founding as 1977. The company started in 1997.