Thread by @ErikOtto2

Biotech thread of the day; $INFI. This company has a first-in-class, oral, once-daily, immuno-oncology development candidate that selectively inhibits PI3K-gamma. I think the valuation of this company is not reflective of the massive market opportunity for this drug. 1/10

Today $INFI showed positive results showing 85% increase in response rates and 57% vs 14% DCR in PD-L1 low patients with urothelial cancer. As this is a controlled study, I believe this demonstrates that the drug is active in this PD-L1 negative population. 2/10

Further bolstering the contention that the drug is active is data from their TNBC study, shown here. This is a 69.2% ORR vs 56% on the historical control. Some responses appear to be deepening over time and more data is forthcoming from this study this year. 3/10

I mean shown here.

Here is a slide from the company showing their data across all their studies. Noteworthy here is an additional study done by $RCUS where Eganelisib triplet performed much better than the doublet comparator. 4/10

So what’s the big deal? Eganelisib is designed to enhance the efficacy of immuno-oncology agents such as checkpoint inhibitors (projected to be >$40 B per year by 2024). That doesn’t include the ~half of patients that are PD-L1 negative. 5/10

PD-L1 negative patients is a potentially a huge new market not only for Eganelisib, but also for whatever checkpoint they are partnered with. Partnering with $INFI could be worth billions to big pharma companies if they are the checkpoint used in P3 trials. 6/10

In other words, $INFI has significant scarcity value. They are the only PI3K-gamma in clinical development as far as I am aware. 7/10

This is also an oral drug. $INFI is contemplating a tumor agnostic P3 study showing benefit across PD-L1 negative patients. They could rapidly capture significant market share across many indications. Hard to see this company worth <$10B MC if successful. 8/10

There will be some concerns because the urothelial abstract data shows some hepatotoxicity (high rate of ALT elevations) but the company claims most of that was mitigated with a dose reduction. Importantly, we haven’t seen this as a concern in TNBC studies to date. 9/10

There are a fair number of risks here; most notably a possible imminent financing, but also the ALT elevations could become problematic. But risk / reward looks very attractive IMO. Please do your own due diligence and invest at your own risk. 10/10