This is from 9/28/22 Conference Call:
From the beginning, until now, the plan has not changed. How could Cyrus have been so confident back in September.
On 10/31/22, in the Webcast, Cyrus said:
and from 12/7/22 R&D update:
Cyrus' goals have not changed since he started. He scripted the end from the beginning.
Quote:17:50: So the near term financing requirements for the company will be focused on re-entering clinical trials for NASH as expeditiously as possible. Now while we do plan to continue development in oncology, our focus will be toward certain solid tumors to insure that we can collect sufficient data in enough patients within select indications, namely, colorectal cancer, breast cancer and potentially in non-small cell lung cancer with combination agents. We said colorectal cancer or CRC, we will be looking at the metastatic, microsatellite stable population. This represents about 85% of all the diagnosed cases of CRC. This particular segment of CRC hasn't seen any meaningful therapeutic advancement in nearly a decade. Yet, the Survival rates in that population have considerable room for improvement. In breast cancer, rather than focus on only the mTNBC population, which really only represents about 15% of the total growth cancer market and has seen increased competition advancements in check point inhibitors and antibody drug conjugates, we are going expand our focus into Hormone receptor positive HER2 negative population which stands for roughly about 70% of the total market. We believe that mCRC and mTNBC each represent large opportunity for leronlimab, and we believe that the mechanistic rationale for using the drug in those populations is quite strong for a CCR5 inhibitor. Let me be clear, that we intend to run these cancer studies over sufficient period of time to generate a robust and meaningful clinical data set that a potential partner would find compelling.
From the beginning, until now, the plan has not changed. How could Cyrus have been so confident back in September.
On 10/31/22, in the Webcast, Cyrus said:
Quote:10:00: Regarding Oncology, as we discussed in our last quarterly call, we plan to focus on Colo-Rectal and Breast Cancer, where we already have a Fast Track Designation for mTNBC. Our Pooled Data in the Relapsed Refractory TNBC population showed promising survival data that we plan to follow up on. I want to re-iterate that NASH and solid tumors, each represent multi billion dollar valuation opportunities for the company, and we believe that Leronlimab has the potential to become the standard of care in these indications in the future.
and from 12/7/22 R&D update:
Quote:1:31: 40: So in terms of what potential time lines can look like, I think it's really important to highlight that from a value-creation standpoint, and I've mentioned this before, we truly do need to generate a large robust and what I call unequivocal data set that will leave no questions left on the table, right? And that a strategic partner would find attractive and attractive enough to do a real value-accretive deal with the company.
1:32:14: And so we've gone through and knocked out what the potential time lines are across each of the different areas that we presented on today. And we're -- as I mentioned before, NASH & Oncology are our priorities. However, because this is all going to be funding dependent, we're going to focus on NASH initially and work with co-development partners to the extent that we can to develop in oncology.
1:32: 44: So what do we expect in 2023? So our largest priority is the removal of the clinical hold in HIV. This is essentially a gating step for us to be able to get back to normal operations as a company and do what biotech companies do, which is advanced therapeutics and try to bring them to market.
1:33:10: Following the lift of the clinical hold, we expect financing to fund operations and to achieve this value inflection point that I've just alluded to. We intend on initiating a new NASH trial. We would like to commit to an investment in and advance longer-acting CCR5 molecules, as this is potentially the future of at least certainly HIV therapy, as Dr. Sacha presented.
1:33:35: We continue to contribute in medical meetings and peer-reviewed publications. Again, the CD02 trial data is in process for that right now. We're going to continue to reshape our team and our capabilities in order to meet our goals. And at some point following the achievement of earlier metrics listed on the slide, we're starting a corporate rebranding as well.[/i
Cyrus' goals have not changed since he started. He scripted the end from the beginning.
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