Sunesis Pharmaceuticals Inc.

Sunesis Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. The company has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer.

Expert Comments:

Hartaj Singh, BTIG Research (10/8/15)
"The strength of Sunesis Pharmaceuticals Inc.'s VALOR data and high unmet need in acute myelogenous leukemia elderly patients coupled with a valuation disconnect continues to underpin our Buy thesis. . .we continue to be intrigued by the company's pipeline of kinase inhibitors with data for these programs in Q4/15 and a Phase 1 initiation in Q1/16."

Matthew Andrews, Wells Fargo Securities (10/5/15)
"While the November 'triple' meeting will highlight preclinical data for Sunesis Pharmaceuticals Inc.'s two kinase inhibitors, SNS-062, a BTK inhibitor, and SNS-229/SNS-510, a PDK1 inhibitor, of most interest is the company filing the Qinprezo (vosaroxin) marketing authorization application (MAA) in Europe. Once the MAA is filed and accepted, the clock starts ticking toward a Committee for Medicinal Products for Human Uses decision by late Q316-early Q4/16."

"Sunesis Pharmaceuticals Inc. is in the acute myelogenous leukemia (AML) space. We're the only shop on Wall Street with a Buy on it. The company had very good data in its pivotal Phase 3 trial, the largest trial ever run in AML, but the compound, vosaroxin, missed its primary endpoint by a hair's breadth. . .stratified analysis showed significant prolonged survival among patients over age 60 who were treated with vosaroxin. . .using stratified analysis for the endpoint probably would have propelled the company to a $1B market cap right now. . .we think there's a 60% chance the European Medicines Agency (EMA) will approve vosaroxin. . .I think Sunesis is getting ready to file a new drug application (NDA) with the EMA. At that point, historical data suggests an 85% probability of success for oncology programs. Therefore, at about $1.11/share, Sunesis is significantly undervalued. Given the visibility into the EMA drug approval process (which gives feedback at 90, 120, 150 and 180 days, and a determination at 210 days), the share price should be at least $3–4. That's based on our assumption of $200–250M in peak, non-U.S. sales five years after approval." read more >

"Sunesis Pharmaceuticals Inc. is one example of a company working effectively [to develop a combined, generalized cancer medication]. Although the data from its recent trial wasn't optimal, it had some interesting results from a subset of the study. . .Sunesis was encouraged by European Union regulatory staff to submit for approval. Qinprezo was effective with a subset of patients, especially those over 60 years old. Although we believe there is considerable risk around using subset results for approval, there was already precedent by the European agency. We will watch for the European Union decision, expected toward the end of 2016. . .keep your eye on Sunesis' response rates in acute myeloid leukemia (AML). Its medication may have wider applications than some of the other really good AML drugs that are much more targeted." read more >

"Sunesis Pharmaceuticals Inc. has been through a couple of life cycles now. It had a couple of programs in the early 2000s that didn't progress in the clinic, and so it reorganized, retooled and brought forward its Qinprezo (vosaroxin) compound in acute myeloid leukemia (AML). It got all the way through Phase 3 with its VALOR trial, and got negative topline results, unfortunately. I will give the company credit; it does have a path forward in Europe, where it has a shot at approval. . .Europeans are more flexible on their approval pathways, so this compound, if it gets approved in Europe, could help Sunesis bounce back from its current levels. . .the precedent for approval across the pond with a subset of Qinprezo data, censored for stem cell transplant in AML, does exist." read more >

Matthew Andrews, Wells Fargo Securities (7/31/15)
"While Sunesis Pharmaceuticals Inc. will discuss its potential options with its advisers in the coming weeks, a new Phase 3 study in early relapse/refractory patients 60 years or older (where Qinprezo's benefit appears most robust and clear) may ultimately be the company's best option to enable a future new drug application filing. . .Sunesis ended Q2/15 with $39.6M in cash (has roughly $19M available in its At The Market financing vehicle), which it believes is sufficient to fund operations to mid-2016."

More Expert Comments

Experts Following This Company

Matthew Andrews, Equity Senior Analyst – Wells Fargo Securities
Reni Benjamin, Senior Biotechnology Analyst – H.C. Wainwright & Co.
Mara Goldstein, Senior Analyst – Cantor Fitzgerald
Alan Leong, CEO – BioWatch News
David Nierengarten, Research Analyst – Wedbush
Joseph Pantginis, Senior Analyst – ROTH Capital Partners
Hartaj Singh, Biotechnology Analyst – BTIG Research
George Zavoico, Senior Equity Analyst – JonesTrading International Services LLC

The information provided above is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.
Investing Highlights
Totality of VALOR data shows compelling risk-benefit trade-off in disease with significant unmet need
Relapsed/refractory AML is a significant commercial opportunity with no approved agents
Our kinase inhibitor pipeline is poised to progress to the clinic in 2015 and 2016
catalyst Calendar
Sunesis Pharmaceuticals Inc. Content