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:

"Sunesis Pharmaceuticals Inc. is developing a candidate for acute myelogenous leukemia (AML). It had a Phase 3 trial with vosaroxin in AML, but failed to meet its primary endpoint. Now Sunesis has about a $74M market cap. Vosaroxin was interesting because it is in a class of drugs that had never been used before as a cancer therapy. The company is hoping for a path forward. We think another Phase 2b would be required for the FDA, but management has submitted an application to the European Medicines Agency, and is trying to get approval in the European Union (EU) for a prespecified population—patients over 60 years of age. . .management is making the case for approval in the EU, and the company has shown investors that it has a shot. . .Sunesis has other products in the pipeline, including a partnered deal with Millennium Pharmaceuticals (a unit of Takeda Pharmaceutical) for MLN2480, a small-molecule tyrosine kinase inhibitor for solid tumors and melanoma. The candidate is orally bioavailable. It's a pan-RAF inhibitor. There are some other, earlier-stage programs in the pipeline as well. That aside, we're keeping our eyes on what happens with Europe. An approval would be the surprise upside to monitor." read more >

Matthew Andrews, Wells Fargo Securities (11/6/15)
"Prior to the Oct. 5 market open, Sunesis Pharmaceuticals Inc. reported financial results and provided a corporate update. . .we believe there is ample precedent for European approval of Qinprezo in relapsed/refractory acute myeloid leukemia based on a narrow miss on the overall survival endpoint in the VALOR study."

Hartaj Singh, BTIG Research (11/6/15)
"Sunesis Pharmaceuticals Inc. reported Q3/15 earnings yesterday and, after what can only be described as annus horribilis (since Oct. 1, 2014), the company's management gave investors a positive update on its ongoing preclinical, clinical, regulatory and pre-commercial activities. With the FDA 'tyranny of the p-value' decision behind it, we find it reassuring that Sunesis can focus on the multitude of operational variables it can control and on the European Medicines Association's less rigid approach to clinical drug development outcomes. We remain bullish."

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 >

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

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
Company's kinase inhibitor pipeline is poised to progress to the clinic in 2015 and 2016
Sunesis Pharmaceuticals Inc. Content