Managing Director and Senior Equity Analyst at Raymond James
Dane Leone is a Managing Director and Senior Equity Analyst at Raymond James, specializing in the biotechnology sector within healthcare. He covers a broad range of biotech companies, including notable names like Ocular Therapeutix, and manages coverage across 59 stocks, maintaining a 54.45% success rate and earning a 4.33-star rating on TipRanks, where he is ranked #1380 out of 9,845 analysts. With over 20 years of experience, Leone joined Raymond James as managing director in 2018 after establishing himself as a leading equity research analyst, and he has since been recognized for his in-depth sector expertise and value-driven analysis. He maintains professional industry credentials and brings a deep background in equity research to support investment outcomes.
Inquired about the design of the vudalimab study in frontline non-small cell lung cancer, including dosing, patient population, and result timelines.
The company detailed the Phase IB/II study design, which will test two doses in patients with 0-49% PD-L1 status both in the US and ex-US. Dose selection is informed by prior studies, but a timeline for results is currently unpredictable.
Questioned the reproducibility and scalability of the CAR-T program's results, particularly the manufacturing success in a decentralized model. Asked for specifics on upcoming data presentations at ASH and the timeline for seeing true multicenter results.
At ASH, more data will be presented, including for more patients and longer durability up to 15 months. The company is confident in scaling its standardized Cocoon manufacturing system, stating that variability comes from patient cells, not the process. The model involves using centers like Landmark Bio in Boston to serve multiple hospitals, which is the plan for U.S. expansion.
Dane Leone of Raymond James posed a devil's advocate question about how a physician would frame the risk-benefit profile to a patient who might end up needing both ongoing steroid drops and supplemental anti-VEGF injections after receiving ADVM-022.
Dr. Arshad Khanani explained that such a case would represent a 'super high need' patient with very aggressive disease. He argued that even in this scenario, the patient is still benefiting from the continuous delivery of aflibercept from ADVM-022 and would likely require fewer supplemental injections than they would have on standard of care alone. The conversation would focus on the overall reduction in treatment burden and disease control, which still represents a significant win.