Faeth Therapeutics, Inc. Common Stock 12th Annual Cantor Fitzgerald Global Healthcare Conference

Yeah. Thank you very much, everyone. Faeth is a company focused on multi-node inhibition of crucial cancer pathways. We're starting with the PI3K/AKT/mTOR pathway, the most frequently mutated pathway in all of cancer, where we have two oral small molecules targeting PI3K-alpha, TORC1, and TORC2. We've seen a 47% overall response rate in our phase I-B, including some complete responses with good tolerability as well, particularly along the key dimensions of hyperglycemia and stomatitis. We're currently ongoing with a phase II in endometrial cancer, which I'm sure we'll talk about, and phase I-B, phase II in breast cancer as well. We're well-funded. We recently raised $200 million in a PIPE and have over $186 million in cash as of Q2, and focused firmly on the future.

Yeah. It's always a question that I get, which is, how can you have such low stomatitis, low hyperglycemia? The real answer is, our route-of-administration advantage, being oral, also confers a PK advantage. If you think about an intravenous drug, an intravenous drug, by necessity, is dosed once weekly usually, right? When dosed, you must give the entire bolus of drug at the beginning of the week.

That leads to a very high Cmax.

Then quickly falling below IC90, in gedatolisib's case, in about 14-15 hours in a given week. Because we're dosed orally- every time we dose, which is Monday, Tuesday, Wednesday, we don't have as quite of a high of a peak, not even close.

They're 50X IC90. We're 2-3X IC90. But we are staying in that efficacious range for longer.

Greater target coverage without the peak means less stomatitis.

The hyperglycemia is really related to multi-node inhibition and pulsatile dosing, both of which we share with gedatolisib.

Yeah. Maybe I'll link it back to your last question, which is Yeah how could you see such low rates of AEs?

One of the bear cases that I always heard on Faeth was, well, the doses are too low. They're placebo. Yeah. That was one of the reasons why we put out the PK/PD poster.

The poster that Lee's referring to is a poster we put out at the STOP Cancer conference that showed skin punch biopsies in clinical subjects showing full pathway shutdown at the 200 mg, 3 mg doses that we've chosen in our phase II in endometrial cancer. What that poster shows is whether you look at human skin punch biopsies, whether you look at tumor in vivo levels of inhibition, or you look at IC90, all three of those kind of metrics all triangulate to a similar zone. In either one of those three, we are above those thresholds for significant periods of time.

I think it conclusively showed that we're not at a placebo dose, that the dose is indeed active, that it is indeed shutting down the pathway in many patients, and that we're excited to see what that results in the endometrial study.