Conference Call 9/28/22; Cyrus Arman
Quote:So following this reasoning, we determined at end of our assessment, that in addition to our efforts in HIV, the clinical signals we generated in NASH and Oncology are the most promising and will be the focus of future clinical development for leronlimab. Specifically, the opportunity in NASH will be a priority from the organization standpoint. We believe the NASH market has many attractive features. And, in our assessment, our most promising clinical signal is in NASH and even on a risk adjusted basis for probability of success in the clinic, the NASH market represents a multibillion dollar valuation opportunity for Leronlimab, ...on its own. In addition to the broader NASH population, leronlimab, may also be in a unique position to address the sub population of NASH patients with both HIV and NASH. and in a moment, Scott will be describing what that particular opportunity looks like in more detail.
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.
19:45: In order to bolster our capabilities in both NASH and oncology, we have added additional scientific advisory board members, Dr. Jordon Lake and Yago Nieto who are experts in NASH and oncology respectively. Additionally, Dr. Stephan Gluk, formerly at Celgene and Regeneron has come on as both an SAB member and as an advisor to the company. Scott will be speaking more about these additions shortly. Internally we are seeking to bringing additional capabilities specifically within clinical, medical and quality functions.
2
