Quick Summary Oncology:
They are very positive about Sort1 technology so far, TH1902 offering a different PK profile with potential better tolerability and efficacy, the patient enrolling is going well, the study is proceeding well.
All for CRO’s are screening for patients, the reason for announcement of part1 phase1 in Q4 and not earlier is they need to wait three months for additional testing before updating the market regarding safety and potential efficacy results.
NASH:
Agencies were pleased what they saw in NASH data, during early interactions with agencies the company was actually told to consider general NASH also that idea was backed by KOLs.
They have a ready to proceed phase 3 NASH trial both in Europe and US, as they have to include a futility analysis(increases the cost by 25%) and enroll more patients the cost of the trial will be higher than anticipated so they are exploring the options to partner up for the program, as per the CEO they are in a position of strength during the negotiations with interested partners which have already started, they also have strong patent for NAFLD/NASH, during Q&A the CEO confirmed absent any partner they certainly won’t give up on NASH as they have worked hard to get the protocol to where it is now.
Also they are starting a trial in 2022 investigating Tesamorelin’s roll in PLWH with cognition impairment lasting 6 months.
Sales:
Egrifta sales was better than expected despite the pandemic, SV was up over 10% compared to a year ago with better margins than Egrifta.
Trogarzo’s sales was down 6% YOY due to among others lower unit sales as patients were told to stay at home during pandemic, also last year they had big orders in the beginning of the year as pharmacy’s were building up their inventory due to the pandemic.
They are optimistic about sales going forward and the negotiations in Europe will now resume.
Financial position:
They have about $57M almost equal to end of February (last Q) so the cash burn was almost zero, going forward they believe the SGNA and R&D expenses will be steady until they start the NASH phase 3 trial.
Overall business plans:
They want to build up a talented team by bringing skilled employees to progress with R&D and commercial part of business.
Due to pandemic they are increasing resources to handle the pandemic related complexity, for instance patients prerequisite specifically for Trogarzo was down during 2020, first half 2021 so they added recruits with marketing skills to mitigate the issue.