Quick Summary
Oncology:
No DLTs so far at 300mg/m2, 3 patients already have been treated with the drug, three additional patients are enrolled they are planning to start the Phase1b(basket trial)by the end of the May. CEO and CMO are very encouraged by preclinical results and planning to seek accelerated approval for one or more indications if results are promising so they can commercialize the drug as soon as possible. They believed the drug is safe at 300mg/m2 which is the equivalent of up to 10 times of intra cellular concentration of Docetaxel alone and that will be the RP2D for phase 1b and possibly later stages of the trial.
They are talking to Chinese companies but it seems they want to see efficacy results before entering any partnership.
NASH:
The CEO stated the potentials for their NASH asset is based on three elements, MOA(what they believe they already have and would like to prove it by initiating the phase2b/3 trial ), overcoming the manufacturing issue for F8(competitive administration method) which should be resolved anytime before end of 2022 and resolving the funding either by partnership agreement or none dilutive fund rising. They are still waiting for the agency’s feed back on the proposed phase2b/3 trial design
which is expected in few weeks.
Sales and cash:
Egrifta is doing very well with good margins.
Trogarzo’s sales seems to be stagnant however they are trying to commercialize the drug in several more European jurisdictions including France, they rejected Germany’s reimbursement proposal as it wasn’t feasible.
Despite setting up the infrastructure for Trogarzo’s commercializations and ongoing R&D expenses they still have about 34 millions compared with 40 millions last quarter.
Overall they seem positive on the oncology and sales. As for NASH it seems like they are planning to go ahead with it despite the manufacturing issues.