Oncology:
It seems the MTD will be at 300mg/m2 which is about 10 times more intracellular concentration of the docetaxel alone, it is worth mentioning they had so far no DLT events for 300mg/m2 so one can assume it is safe yet rather large amount of intracellular concentration of the agent will be accumulating in the cancer cells. They are forecasting another 2 or three months before the MTD is finalized (6 more patients will be dosed). During the cycles they gathered among others the level of sortilin expressions among dosed patients and based on their finding they made changes to cancer indications which will be studied during phase1b the net effect was more patients(70, versus 40) will be enrolled but also more cancers so the potential market for their drug if approved is much larger.
They have been in touch with many Chinese companies who are interested in the out licensing of their PDC some are even happy to start the collaborations before phase1a results, other none Chinese companies could also be interested in their Sort1 targeted delivery as a carrier for their drugs.
NASH:
They will be submitting an amended protocol to the FDA. The new protocol will include a Phase 2b/3 seamless which will be enrolling 350 patients analyzing the efficacy of Tesamorelin by then if the results are satisfactory another 1094 patients will be added to the study so the total number of patients will not change but by amending the protocol they will be de-risking the whole process and less initial financial burden to the company. They are estimating some $50M cost for the phase2b/3 stage which is about one third of the total cost of the whole phase 3 trial. They are actively looking for a partner with capability and resources for the protocol failing that they will be starting the first part themselves.
Legacy drugs:
Trogarzo’s sales came short due to the pandemic, $ 6,001M versus $ 6,628M in the previous quarter, they have received pricing and reimbursement approval in Israel which they are happy with but it seems like they are renegotiating the pricing in France. Egrifta had a good quarter, $12,753 versus $11,224 in the previous quarter and overall they seem to see more interest for the drugs post covid. They have now in house sale force which the company believes will be leading to superior performance and faster growth from their commercial portfolio. They are predicting better sale numbers for 2022.
” $79 million and $84 million for full fiscal 2022, or growth of the commercial portfolio to be in the range of 13% and 20% as compared to FY2021.”
Another interesting news was “Excess Visceral Fat Real-World Evidence (RWE) Study”, the purpose of this study is:
“(1) To determine the utility of WC’s ability to predict cardiovascular risk scores, liver fat, liver fibrosis, and abnormal glucose homeostasis across the full VAMOS population and subgroups (2) Identify common clinical data points in today’s standard of care that can be used to assess a patient’s risk of having excess visceral fat. The VAMOS results are expected to direct clinicians on why and which patients in their practice should be screened for excess visceral fat and treatment.”
I believe they want to bring to doctors’ attention the significance of visceral fat in causation of many serious diseases.
They had as at November 30 2021, $40,354,000 in cash, bonds and money market funds compared to as of August 31, 2021, $51,584,000 considering the payment of a $5,000,000 milestone related to the launch of Trogarzo in Europe, as well as $3,306,000 in interest on the convertible unsecured senior notes it seems to me they still are applying strict cost control.
So my biased or not take from the call is they are approaching a safe MTD with rather large (10 X more than cytotoxic agent alone)intracellular concentration of docetaxel which has created interest among various companies and planning to expand the phase1b to more cancers thus potentially much bigger market. They are planning a much more feasible approach to their NASH asset, less initial costs before full commitment and if results are satisfactory those costs will be absorbed in the overall cost of the program. The legacy drugs should generate better revenues going forward which can partially fund the R$D programs together with strict cost control. Also quite a bit of interest form various companies already for their oncology program. The selling today to me is a result of very impatient investors who are not happy to wait for Phase1a results, possibly soon Chinese partnership agreements, better sales and a potential NASH partnership.