RE:RE:RE:Quick Summary I would agree, but just pointed it out because if any new biotech/cancer analysts were to start covering it, they would model out and discount back the various markets they think they can ultimately penetrate - even if they are a a few years further down the road from the lead indications. If they formalize thinking about it this way for further studies later, it would actually have an economic benefit to the valuation exercise an analyst might do.
The adjuvant treatment angle could even be more than just ovarian ultimately. As we are all surmising, today's call was solid, well scripted and didn't have any real surprises (except maybe the pharma ingredient shortage for F8). There was nothing negative, but for the real value-enhancing data it only narrowed down the timeline to May finalization of 1a and in to 1b, which is what we expected anyway. I suppose the "no issues" with first 3 patients is a solid safety data point that provides further confidence around moving to 1b and some element that the POC is trending in the right direction.
Now if we could only get volume moving up and buyers getting interested!! Next stop would be annual or the completion of 1a. I still hope that once they finish 1a, they get a few KOLs on the call to discuss the significance -- maybe get MD Anderson on the call to place the science she's seen in the context of other therapies and how she's seeing it's potential place if 1b is solid. They really need to pull out these kind of extra inning efforts to get out from the capital market hole they're in.
qwerty22 wrote: Hard to see that making much difference short/medium term to the clinical program. It would require a whole new different set of trials than the ones they envisage now. Bigger, longer, more expensive. It's probably more of a bargaining tool in partnership discussions. Something to help potentials see the scope of this drug. I'm not sure this is exactly right but I think we should be thinking about the adjuvant treatment market say in ovarian cancer.
Wino115 wrote: One important fact Marsolais slipped in to his discussion was that the importance of the new pre-clinical data was twofold -- one, the CSC data showed (essentially proved) that using sort1 does bypass resistance since nothing works on CSC --at least in vivo. Second, showing the additional chemo and chemo combo both performing better than carboplat alone, along with the VM/anti-metastatic properties, means they've opened up the possibility to use this approach much earlier in the treatment plan. They mentioned they convened their "cancer brain trust" to think through the market placement issues along with other topics.
That latter point would enlarge the potential market they are going after quite a bit. I have to commend them for looking at ways to show the industry that if sort1 is what they think, and this PDC is what they think as far as the MOAs, it opens up numerous commercial opportunities that are enormous for them. That significance around the presentations was not fully apparent to me. I now look forward to seeing those posters, but if you have Rothemburg confiming that type of usage in the clinic, that is a very important fact.
scarlet1967 wrote:
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.