Arrowhead Research (ARWR) presented on Friday at Biocentury’s Newsmakers in the Biotech Industry conference. Investors are paying close attention given an important data event in November for ARC-520 in chronic hepatitis B. Summarized below are key takeaways from the presentation and updates via social media:
- Arrowhead confirmed that ARC-520 has been well-tolerated at up to 4mg/kg in healthy patients. This surfaced last week in a note from RBC’s Michael Yee following conversations with management. According to Friday’s presentation, the company is still blinded to the final three doses in the phase 1 safety study.
- In the ongoing phase 2a study, the company has unblinded data from the 1mg/kg and 2 mg/kg cohorts. Dosing at 3 mk/kg is almost complete; the company remains blinded to this data (confirmed by @bioterp).
- Arrowhead has submitted a late-breaking abstract for AASLD’s The Liver Meeting (confirmed by @BioBreakout). The abstract would have been submitted prior to September 23. Late-breaking abstract text will be available on October 8th. Given management’s transparency with investors and analysts, it would not be surprising to see the company announce whether the abstract has been accepted prior to the 8th.
Data on the 1 and 2 mg/kg cohorts from the phase 2a trial will most likely be accepted for a late-breaker given that this study is high-profile. We would not expect 3mg/kg data in the abstract, however management has been clear that they will have this data – for press release or presentation – around The Liver Meeting, Nov. 7-11. Note that Arrowhead traditionally holds their quarterly conference call in conjunction with Fiscal 4Q/Full-Year earnings at mid-December. We would be surprised if ARWR waits this long to release the 3mg/kg results, but it is a possibility.
The fourth quarter remains an interesting time for ARWR.
Get PropThink’s research on ARWR here.
One or more of PropThink’s contributors are long ARWR.
