Alector, Inc. Common Stock Morgan Stanley 24th Annual Global Healthcare Conference

People are still suffering from cancer, from neurodegenerative diseases, from metabolic disorders. In my view, innovation in medicine is helpful and essential regardless of where it is coming from. I hope to see continuous innovation from the U.S. and from anywhere else in the world. I think that innovation sort of promotes even more innovation. I do see positively. For us specifically, so far the main competition or the main innovation from China is coming from immunology and cancer. Neurodegeneration is a more complex field with less clear pathways of how to get approval and less obvious drug targets and drugs. At this point, we don't see as much competition, and based on the inbound interest that we have from large pharma, we are still sort of a significant force in innovative medicine for neurodegeneration.

We are actually trying to use the innovation in China instead of fear it, so we work extensively with Chinese companies on the research stage level. We are looking at conducting possibly even clinical trials in China, means we are focusing on Alzheimer's disease and Parkinson's disease, and the available population in China is significantly larger and sort of they are just starting now to get up sort of updated with regard to clinical trials. We are exploring clinical trials in China, and we are absolutely working with Chinese companies to advance our own programs.

Yes, we are implementing AI in every aspect of the company, and at this point, the main advantage or benefit is efficiency. We think we can achieve more with lower cost and fewer people. So if we are using AI to file our regulatory sort of applications, we are using AI to review business contracts. We are using AI to help design clinical trials. So every aspect of the company is assisted by AI. At this point, I think it's fair to say that actual drug discovery, like actual innovation, is still not there for AI. I don't think there are enough data to really predict a new drug target, means you can get help with analyzing a lot of sort of genetic data and clinical data, but I still think you need the human mind Sure to actually develop novel therapeutics.

And so at this point, we see AI as assisting with efficiency, but not really as much with actual innovation.

As a company that's sort of reentering the clinic in a few months, the most relevant for us is interactions with the FDA and the FDA in a way innovation or changes that we are really relying on are the Modernization Act. That reduces the amount of animal usage. Basically, the main costs in entering the clinic is non-human primate studies, and the FDA is proposing alternatives to non-human primates and maybe shorter toxicity studies, and we are sort of relying heavily on that. The second big thing is the surrogate biomarkers for clinical approval. I mean, so I think we are spending significant amount of time developing and trying to validate biomarkers as a sort of to both facilitate the sort of clinical development and ultimately clinical approval. I think the FDA is relying more and more on biomarkers, like the three anti-Abeta drugs that were- Sure approved, were initially approved based on surrogate biomarkers, the beta amyloid imaging.

I think more therapeutics are being approved based on cell-based biomarkers. That's something we are looking at. The third thing is the increased frequency of interactions with the FDA. The FDA advanced multiple tools like INTERACT and pre-IND meetings that enables us to elicit feedback before we design our clinical trials. We are using this extensively with asking the FDA what their expectations are, what would be accepted on them, both with regard to clinical design, with starting doses, with toxicity study, with how many species we need for our pre-IND programs. We are interacting very constantly with the FDA to elicit information.

Alector has not really changed conceptually and philosophically.

We were started as a company that is dedicated to cure neurodegenerative disorders, to eradicate Alzheimer's disease and Parkinson's disease and Lewy body dementia and frontotemporal dementia, and our commitment to this mission remains. We took six drugs to the clinic under a certain hypothesis that brain-specific immune checkpoints could provide effective therapeutics for Alzheimer's disease and other neurodegenerative disorders. This specific hypothesis didn't pan out so far, but we are continuing now. We are advancing enzyme replacement therapies for neurodegeneration, blocking misfolded proteins for neurodegeneration. We are continuing to explore hypotheses for neurodegeneration with multiple different targets. We are advancing technology that enable delivery of enzymes, RNA, siRNAs, and antibodies to the brain. Yes, we were a phase III company. We are a pre-clinical company now, but we expect to be in the clinic by early next year. We'll again become a clinical company.

Our mission has not changed, just the type of drug targets that we are advancing has evolved.

Okay, good. Can I just add one thing?