Zenas BioPharma, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference

It's great to be here. Thank you for the invitation.

Absolutely. We're looking forward to a really productive day.

It's a jam-packed schedule, so thank you.

Excellent. I'll just refer you to our SEC filing, since we may be making some forward-looking statements today.

I have just a few introductory comments here. For our pipeline, we have a lot that is going to occur in the next several months, and I just want to give people a sense of what's coming. First of all, we have, of course, our BLA under review for obexelimab for IgG4-related disease, with a PDUFA date at the end of May and a lot of activity preparing for the potential launch of that drug in this important indication. We have an upcoming investor event on September 29th and invitations have gone out, and additional invitations will go out where we have Dr. Guy Katz from Mass General, who will be talking about the disease, the obexelimab clinical data in IgG4-related disease.

We'll outline more details on our commercial planning and execution and how we view the marketplace. We'll then follow that up with some clinical evidence at both the International Symposium on IgG4-Related Disease in Boston, hosted by Dr. John Stone out of Massachusetts General Hospital. This is the gathering the world's experts on IgG4-related disease, followed by the American College of Rheumatology Conference. Data that will be coming out of those conferences includes our open label extension, flare protection data. You may recall that the INDIGO phase III study for IgG4-related disease with obexelimab reported out the randomized control portion of the study, but all patients had the opportunity to enter a 3-year open label extension, and important data from that is the probability of 12-month flare. So we'll have that data.

We had previously reported the 6-month flare protection at 92%, which I think really sets us up well to make a difference here in this disease over time with extended information from the OLE. A vaccine sub-study dataset will be available. The vaccine sub-study involves patients that are in the open label extension, where their obexelimab is paused over time, and they're administered a flu vaccine, a COVID vaccine, or both, given 2 weeks to elicit a vaccine response. Antibody titers are measured for protection, and then the drug is restarted. We think that's really important information for clinicians over time. We'll have the SunStone Lupus, SLE, phase IIb top-line results for the overall and biomarker population reporting out in the fourth quarter. We're looking forward to that.

As you know, we're in 2 large phase III trials for our other late-stage molecule, orelabrutinib, the highly brain-penetrant BTK inhibitor, both a primary progressive MS or PPMS and a non-active or nrSPMS trial. I'll wrap up on this slide with the introduction that ZB021, our oral IL-17AA/AF inhibitor, is moving rapidly through phase I through the SAD cohorts. We're now into the MAD or multiple ascending dose study cohorts. In the fourth quarter, we will report out the safety, tolerability, exposure, all the information one would get from a PK study. With a validated mechanism such as IL-17, we think that's really important to identify that we have a medicine that can move forward into development. Next year we'll move into a proof of concept study in a patient population.

ZB014 is our extended half-life molecule that also binds CD19 and FcγRIIb, just like obexelimab. That half-life extension preclinically would suggest that it could be monthly dosing in humans. Obviously we'll investigate that next year as we move into the SAD and MAD studies and report some data out of the SAD study. ZB022, our brain-penetrant TYK2 inhibitor, we're doing IND-enabling work now, and that'll move into the clinic next year.

As you described, this mechanism is novel. The antibody binds the CD19, which is prevalent on a large range of B-cell lineage, of course, and anchors the antibody so that the Fc portion of the antibody can bind FcγRIIb. FcγRIIb, otherwise known as CD32B- is really the only inhibitory pathway in B cells.