Category: Bioscience

Clovis Oncology files $200M shelf registration

BOULDER – Biopharmaceutical company Clovis Oncology Inc. (Nasdaq: CLVS) on Friday filed a shelf registration for up to $200 million-worth of securities, replacing a similar registration from 2013 that is expiring.

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

Friday’s filing notes that through the registration the company could offer some combination of common stock, preferred stock, warrants and/or debt securities not to exceed $200 million.

In its first-quarter earnings report, Clovis reported cash and cash equivalents of $220.4 million. Company officials also noted in the report that Clovis, as of March 31, had existing working capital to fund operations through at least the next 12 months, indicating that an offering from Friday’s registration isn’t likely imminent.

Clovis shares took a hit Friday, dropping 7.4 percent from Thursday’s close to $14.11.

Clovis is developing a variety of cancer drugs, including rucaparib, for which the company plans to complete its new drug application submission to the U.S. Food and Drug Administration as it seeks approval for the drug in the treatment of ovarian cancer.

The company announced in May that it was eliminating 35 percent of staff and contractor positions. That move was in response to the company pulling the plug on lung cancer drug candidate rociletinib after receiving notice that the company would not receive accelerated FDA approval for the drug.

2 CSU researchers win Boettcher Foundation biomedical grants

FORT COLLINS — Two Colorado State University researchers who study tiny organisms and their roles in viruses and cancer have received awards that will fund three years of research for their laboratories.

Rushika Perera, an assistant professor of virology in the College of Veterinary Medicine and Biomedical Sciences, and Tim Stasevich, an assistant professor of biochemistry and molecular biology in CSU’s College of Natural Sciences, each received $225,000 Webb-Waring Biomedical Research awards through the Denver-based Boettcher Foundation.

The foundation announced this week that the scientists will join the 2016 class of Boettcher Investigators, 10 early-career researchers who are getting established in their fields. The foundation will support their work as they become competitive for major awards from federal and private sources.

For the past three years, Perera has run a lab at CSU’s Foothills Campus, studying how dengue, chikungunya, yellow fever and Zika viruses behave in their mosquito hosts. Stasevich’s lab develops fluorescence microscopy techniques to image proteins in living cells in order to better understand genetic processes and subsequently control and correct gene misregulation. His team will study how epigenetics in particular contribute to cancer development.

Fort Collins-based VetDC posts positive results for canine cancer drug

FORT COLLINS — VetDC Inc. announced Tuesday that the Fort Collins-based company has concluded a field study that yielded promising results for its drug Tanovea that is intended to treat lymphoma in dogs.

While lymphoma is widely considered one of the most common cancers seen in dogs and cats, there are no FDA-approved lymphoma treatments in the United States. The current standard of care for lymphoma treatment is a multidrug chemotherapy regimen —referred to as CHOP — which typically requires 12 to 16 visits.

The veterinary cancer therapeutics company said its drug Tanovea, in combination with doxorubicin — a commonly used generic chemotherapy agent —  delivered an 81 percent response rate when tested on 54 dogs with lymphoma.

The Tanovea/doxorubicin combination was found to be generally safe and well tolerated in this study, with gastrointestinal and hematologic adverse effects being the most common events reported.

“We are encouraged by the results seen in this study, and we are working closely with the veterinary oncology community and regulatory authorities to introduce this important new advancement for the benefit of dogs with lymphoma Steven Roy, VetDC’s chief executive, said in a prepared statement.

Tanovea is currently under regulatory review with the FDA Center for Veterinary Medicine and is not yet approved for commercial sale.

Array BioPharma plans cancer-drug regulatory filing this month following Phase 3 results

BOULDER — Officials for Array BioPharma  (Nasdaq: ARRY) on Monday afternoon said they plan to file for regulatory approval with the U.S. Food and Drug Administration later this month for the use of binimetinib in the treatment of NRAS-mutant melanoma.

Array announced full results of its Phase 3 NEMO trial, which showed median progression-free survival in patients receiving binimetinib of 2.8 months versus 1.5 months with chemotherapy drug dacarbazine.

The company had unveiled preliminary results of the trial showing similar numbers in December, causing Boulder-based Array’s share price to shoot up 35 percent.

Array shares had enjoyed an early spike Monday after the company announced over the weekend a partnership with Pierre Fabre and Merck to jointly initiate a Phase 3 clinical trial looking at the use of Array drugs binimetinib and encorafenib in conjunction with Merck offering Erbitux in the treatment of BRAF-mutant colorectal cancer. But shares tapered off following the NEMO trial announcement.

Array shares closed at $3.84, up 5 cents from Friday’s close.

The NEMO trial showed an overall response rate of 15 percent in patients receiving binimetinib versus a 7 percent rate in those receiving dacarbazine. Disease control rate was 58 percent for binimetinib patients versus 25 percent for dacarbazine. The median overall survival showed no statistically significant difference for binimetinib versus dacarbazine but was estimated at 11 months for the former and 10.1 months for the latter.

“The NEMO trial results demonstrate the potential of binimetinib to help slow disease progression in this patient population, an often overlooked subset without treatment options beyond immunotherapy,” Array chief medical officer Victor Sandor said in a release from the company.

In the colorectal cancer trial, Array will act as global sponsor of the study. Pierre Fabre, which last year licensed commercial rights to binimetinib and encorafenib in Europe and other global markets, will fund 40 percent of the trial, dubbed the BEACON CRC trial. Merck owns Erbitux outside the United States and Canada and will supply the drug to all trial sites outside of the U.S. and Canada.

The announcement of the BEACON BRC trial came in conjunction with positive results from a phase 2 trial looking at binimetinib in the treatment of colorectal cancer.

Boulder biopharma miRagen Therapeutics names 2 new execs

BOULDER — MiRagen Therapeutics Inc., a clinical-stage biopharmaceutical company based in Boulder, has appointed Adam Levy as its chief business officer and Chris Morl as chief operating officer, as the company moves into human clinical trials for two of its products.

Morl has been miRagen’s chief business officer since May 2013.

Levy has 16 years of advisory experience primarily in the life sciences sector. He was vice president at Wedbush Securities where he served since 2013 in the health-care investment banking group. He has expertise in corporate strategy, mergers and acquisitions, and partnering with experience in completing more than $30 billion in financing and advisory transactions.

MiRagen is using micro-RNA genetic material to develop drugs capable of treating a variety of illnesses.

Bill Marshall, miRagen’s president and chief executive, said the two appointments will enhance the company’s capabilities as it progresses into first-in-human clinical trials for MRG-106 and MRG-201.

MRG-106 is designed to reduce the proliferation of cancer in lymphoma cells, and MRG-201 targets another micro-RNA to treat cardiac, renal, hepatic and pulmonary fibrosis and systemic sclerosis.

For certain cardiovascular disease programs, miRagen has a collaboration and license agreement with Servier, an independent French research-based pharmaceutical company. MiRagen retains all rights for the Servier-partnered programs in the U.S. and Japan.

GlobeImmune receives delisting warning from Nasdaq

LOUISVILLE — The Nasdaq stock exchange this week issued a delisting warning to troubled Louisville biopharmaceutical company GlobeImmune (Nasdaq: GBIM).

GlobeImmune officials disclosed the letter in a filing with the U.S. Securities and Exchange Commission.

Nasdaq notified GlobeImmune that it has fallen out of compliance with one of its rules that requires companies included on the Nasdaq Capital Markets listings to maintain minimum stockholders equity of $2.5 million. In GlobeImmune’s most recent financial results for the quarter ending March 31, the company reported stockholders equity (total assets minus total liabilities) of $2.15 million, down from about $3 million at the end of 2015.

The company also falls shy of alternative benchmarks for market cap and net income from continuing operations. Market cap for Nasdaq CM companies must remain above $35 million, while net income from continuing operations for the most recent fiscal year must have been $500,000 or greater.

GlobeImmune’s market cap, using Friday’s closing price of $1.32 per share, is only roughly $7.6 million. It posted a net loss from continuing operations for 2015 of $2.7 million.

GlobeImmune has 45 days to submit a plan for regaining compliance. If the plan is accepted by Nasdaq, the company would have 180 days from the original notice to regain compliance or face delisting, potentially impairing the liquidity of GlobeImmune shares and limiting the company’s access to capital markets.

In the company’s first-quarter earnings report last week, 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.

Having laid off all but six employees last summer, GlobeImmune’s most-recent quarterly report states that the company has only 2.5 full-time employees left. Vice president Jeffrey Dekker and a scientist remain 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.

The company’s slide largely began a year ago, when results of a trial for its Hepatitis B drug candidate being developed with Gilead failed to show a reduction of the disease at the end of a 24-week study.

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.

Encision continues to trim losses

BOULDER — Encision Inc. (PK: ECIA), a Boulder-based medical device company that owns  patented surgical technology designed to prevent stray electrosurgical burns during minimally invasive surgery, on Monday posted net revenue of $2.289 million and a net loss of $282,000 for its fourth quarter that ended March 31.

That loss, which amounted to 3 cents per share, compares with revenue of $2.307 million and a net loss of $349,000, or 3 cents a share, in the same quarter a year ago.

Gross margin on net revenue was 45.8 percent in the fiscal 2016 fourth quarter and 51.2 percent in the fiscal 2015 fourth quarter.

For the just-ended fiscal year, the company posted net revenue of $9.336 million and a net loss of $880,000 or 8 cents per share. These results compare with net revenue of $9.671 million and a net loss of $1.383 million, or $ 13 cents per share, in the same quarter a year ago.

“Continued improvements by our manufacturing operations are narrowing the gap on losses as we drive to profitability,” said Greg Trudel, Encision’s president and chief executive, in a statement that accompanied the earnings report. “Our gross margins progressively improved throughout FY16 despite reduced volumes. We have eliminated legacy inventories of obsolete and slow moving products and are in a position for a promising FY17.”

GlobeImmune shares crater on 1Q earnings report

LOUISVILLE — GlobeImmune Inc.’s share price lost nearly half its value Thursday morning after company officials disclosed that they could shut down the company if a strategic alternative, such as a buyer, is not found “in the near future.”

In the Louisville-based biopharmaceutical company’s first-quarter earnings report, officials said the company had $8.7 million in cash and equivalents as of March 31, enough to operate the company as a going concern through the middle of next year as it seeks out those strategic alternatives. But they also stated that a decision to wind down the company’s operations would burn through that cash faster.

Shares of GlobeImmune (Nasdaq: GBIM), which closed at $1.96 Wednesday, opened at $1.37 Thursday morning after the earnings report and sank as low as $1.04. The company’s stock price rebounded slightly by mid-morning but was still down 36 percent by mid-afternoon.

GlobeImmune reported a first-quarter net loss of $862,000, down from $1.6 million for the same period a year ago, thanks mainly to lower compensation expense due to laying off all but six employees last summer.  The loss amounted to 15 cents per share.

The company had revenue of $943,000 in the first quarter, down from $1.2 million a year earlier.

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.

The company’s tailspin began a year ago, when results of a trial for its Hepatitis B drug candidate being developed with Gilead failed to show a reduction of the disease at the end of a 24-week study. That news came on May 27, causing shares to plunge more than 50 percent in value that day from a closing price of $8.24 the day before.

Two weeks later, the company announced that it would lay off most of its workforce to conserve capital. In February of this year, the company announced that CEO Timothy Rodell would begin working part-time and have his $405,000 annual salary cut in half in further efforts to preserve cash.

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.

Clovis Oncology laying off 35 percent of employees

BOULDER — Clovis Oncology Inc. said Wednesday that it will reduce its staff and contractor positions by 35 percent by the end of the year as it pulls the plug on its lung cancer drug candidate, rociletinib, after receiving notice that it will not be approved by the Food and Drug Administration.

Boulder-based Clovis (Nasdaq: CLVS), which has 309 full-time employees worldwide, made the announcement in its first-quarter financial report in which it incurred a loss of $83.4 million, or $2.17 per share, compared with a net loss of $63.1 million, or $1.86 per share, for the first quarter of 2015.

Clovis is reducing its staff, eliminating contractor positions and delaying or eliminating planned new positions, according to the report. Clovis, which also has offices in San Francisco and the United Kingdom, employs about 90 people in Boulder, though it’s unclear how many of them will be affected by the job cuts.

“We are very disappointed in the outcome for rociletinib, as there is a need for additional options for this difficult to treat disease,” Patrick J. Mahaffy, Clovis’ president and chief executive, said in a prepared statement.

In a recent meeting with the FDA, Clovis was notified that it could anticipate receiving a notice by June that its application for the drug would not be approved.

In anticipation of receiving the notice, Clovis terminated enrollment in all ongoing clinical studies of rociletinib. Clovis will continue to provide the drug to patients whose clinicians recommend continuing rociletinib therapy. In addition, Clovis has withdrawn its application to market the drug in Europe.

Clovis plans to focus its drug candidate rucaparib that would treat ovarian cancer. The company intends to maintain its sales force in the United States in in preparation for the potential U.S. launch of rucaparib.

Clovis recently entered into a clinical trial collaboration with Genentech, a member of the Roche Group, to evaluate a novel combination therapy of Genentech’s investigational cancer immunotherapy atezolizumab and rucaparib for the treatment of gynecological cancers, with a focus on ovarian cancer. The Phase 1b trial is planned to begin enrolling patients during the second half of 2016.

Also during the second half of 2016, the company intends to initiate a study of rucaparib in prostate cancer patients, as well as a study in advanced ovarian cancer.

Clovis will continue its collaboration with Les Laboratoires Servier Servier on the global clinical development of lucitanib outside of China, initially targeting advanced breast cancer.

Editor’s note: An earlier version of this story incorrectly stated that rociletinib is intended to treat ovarian cancer.

Patent for Zika, West Nile treatment among UNC awards

GREELEY — A patent to create a potential treatment for Zika and West Nile viruses is among innovation awards announced Thursday by a University of Northern Colorado office.

The inaugural awards recognizing innovation disclosures, intellectual property and commercialization activities are presented by UNC’s Office of Innovation Development and Enterprise Advancement (IDEA), which helps faculty and students get their ideas into the marketplace.

Susan Keenan won the Patent Award for her and her Colorado State University colleagues’  granted patent, “Thioxothiazolindine Inhibitors,” a potential treatment for a genus of viruses called flavivirus that include Zika, West Nile, dengue, tick-borne encephalitis and yellow fever. Keenan is seeking corporate-development partners for the work.

Elysia Clemens won the Innovator of the Year award for Apprentice, a software application in  desktop and mobile versions for managing field-based experiences such as internships for students and supervisors.

Michael Mosher won the Invention of the Year award for development of an in-line sensor on brewing vats. The device measures unwanted compounds that spoil flavor as beer is brewing, allowing for adjustments to be made without pulling samples and conducting hands-on analysis that other techniques require. Mosher, who also oversees UNC’s Brewing Laboratory Science program, also is seeking corporate-development partners.

Reid Hayward won an Innovation of the Year award for his work with UNC’s Cancer Rehabilitation Institute and creation of the Clinical Cancer Exercise Specialist training program, which will be licensed soon to a United Kingdom-based company.

Braeden Ayres and Trevor Lovell were named Student Innovators of the Year for “Project Osorhythm,” a music- education app designed to effectively teach rhythm concepts and skills. The project won UNC’s first-ever Spark Competition to encourage music innovations. The project won a $1,500 grant.

IDEA also recognized more than 50 innovators who submitted innovation disclosures since IDEA’s inception in 2014 as well as the Innovation@UNC teams, which have created 13 new programs that have received funding as part of a university initiative.

IDEA, Innovation@UNC and UNC BizHub, an incubator for educational and entrepreneurial services to help build sustainable businesses, are part of UNC’s continued focus on innovation.