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companies to watch- 2013 Roundup Snapshot analyses of selected companies developing new life sciences products and technologies 1002 in patients with or without statin intolerance • November: announced positive Phase 2a results for ETC1002 as an add-on to statin therapy • November: at the American Heart Association meeting, presented positive Phase 2a results in patients with a history of statin intolerance COMING IN 2014 • initiate robust Phase 2b ETC-1002 add-on to statin therapy study (Q1) • announce results from two Phase 2b ETC-1002 clinical trials (Q4) • announce top-line results from nonclinical studies (Q4) • target several important medical meetings for data presentations (throughout 2014) October — Inovio Into and beyond a big partnership. A small-cap player in the cancer vaccine space, Inovio was just beginning its co-development alliance with Roche. Now, as it cements the relationship in clinical trials, the company is thinking even more strongly beyond its first partnering deal, anticipating others on the horizon. Contacted just three months after our coverage of Inovio, CEO J. Joseph Kim explains, "We completed our first Big Pharma partnership and progressed our Phase 3 program to the point of getting data. By all measurements — financial, technical, and clinical — it was a banner year. We expect 2014 to be an even better year and dwarf our 2013 accomplishments." Kim agrees a large factor in attracting Roche's interest is the potential of the company's T-cell targeting and boosting technology in future combination cancer immunotherapies — a potential $35 billion market, as projected by Citibank. Now, he says, Inovio is in "deep discussions" with Roche's peers in Big Pharma about partnering in that area and others. DEVELOPMENTS TO DATE • November — December: completed Roche codevelopment alliance, involving two of Inovio's clinical-stage products, one (INO-5150) for prostate cancer and the other (INO-1800) for chronic hepatitis B, a common cause of cirrhosis and liver cancer Present: In addition to focusing on lead products such as INO-3100 and INO-3112, the company is working with Roche to take INO-5150 to the clinic in a Phase 1 trial. INO1800 for chronic hepatitis B is about a year behind. COMING IN 2014 • First half: launch Phase 1 clinical trial of INO-5150 for prostate cancer, triggering the first milestone payment from Roche • First half: launch Phase 2 trials of nonpartnered product INO-3112, in advanced cervical and advanced head and neck cancers. Also, run small, uncontrolled exploratory 36 LifeScienceLeader.com February 2014 trials to prove comparable T-cell generation in other cancers and bolster the Cellectra Electroporation Delivery Technology platform concept • Midyear: report results from a current double-blind placebo-controlled Phase 2 efficacy study in cervical pre-cancer involving 150 patients — the first Phase 2 results from the company's pipeline November — Vivaldi Biosciences Victory in a sea of failures. That is Vivaldi's aim, as it plies its course in developing the only live vaccines among many competing candidates for prevention of pandemic and seasonal flu — namely, its live attenuated influenza vaccines (LAIVs). With few updates since Vivaldi's end-of-the-year appearance in Companies to Watch, CEO Douglass Given emphasizes the company's goals for the new year, which include raising more money. "Vivaldi's strategy to demonstrate clinical proofof-concept for its LAIVs for seasonal and pandemic influenza is realizable with venture financing, and offers investors an attractive valuation, potential for significant ownership, and an exit opportunity through partnering with a pharmaceutical company." Vivaldi is pursuing a cost-effective means of advancing its LAIV pipeline candidates, hoping to partner for further development and commercialization. COMING IN 2014 • follow-on investments in Series B financing round • initiate program to develop a preclinical LAIV candidate for highly pathogenic H7N9 influenza • advance clinical development of LAIVs for seasonal influenza to address unmet medical needs in elderly and/ or pediatric populations December — Proteon Therapeutics Relief for dialysis patients. That is what this developer of a drug to address vascular access failure intends to bestow. The last company to be featured in 2013 Companies to Watch has had scarce time for subsequent developments. But it has plenty of hopes for the new year. "Proteon is preparing to initiate Phase 3 of PRT-201 to address vascular access failure in hemodialysis patients, a serious unmet medical need in an orphan population," its president and CEO, Timothy Noyes, says modestly. Proteon is currently identifying sites to participate in the Phase 3 trial of PRT201 in chronic kidney disease patients undergoing surgical placement of an arteriovenous fistula for hemodialysis. The trial is scheduled for a mid-2014 commencement. About the same time, a Phase 1 trial investigating another application of PRT-201 will yield data. COMING IN 2014 • secure financing to complete AVF Phase 3 • initiate enrollment in AVF Phase 3 • conclude peripheral artery disease (PAD) trial and report data