Zenas BioPharma, Inc. Common Stock Citigroup’s Biopharma Back to School Summit 2026

Great. Thank you, Yigal. We appreciate the invitation and being here at the Citi conference that we've attended many years in a row and at various companies along the way.

Today we're here at Zenas. We've had a good day with investors. I thought it would be good maybe to start out with a few comments. Of course, we'll be making some forward-looking statements. I would refer anyone to our SEC filings. As a company, before we get into, I think some of the things that people have in mind, some of the topical items, is to step back and what are we building here? Right now in 2026, if you look at Zenas, we have two late-stage programs that are substantial. One of them, obexelimab, is under review with the FDA for IgG4-related disease with a PDUFA date of May of 2027.

Three additional programs that have great potential, that we brought into the company through our business development activities, and a team that we've assembled that, many people who we've worked with previously that have brought medicines across the finish line and ultimately commercialized successfully, and an infrastructure that's global in scope from a development standpoint. We conduct all of our trials globally. Finally, the company's well-positioned from a cash position. If you take our last reported cash of over $670 million and, with an obexelimab approval, an additional $75 million coming in from Pharmakon and $75 million from Royalty Pharma, we would have a cash runway through the second quarter of 2029. So well-positioned. Just look out five years. With execution, we have the potential approval of three molecules across multiple indications, in large markets totaling over $50 billion in sales globally.

I think we're well-positioned. Now what we need to do is execute. What's in the near term? Meaning even the next quarter and the next couple of quarters for obexelimab, as I mentioned, the IgG4-RD BLA is under review. We have an investor event coming up September 29th, where Dr. Guy Katz from Massachusetts General Hospital, an IgG4-related disease expert, will cover clinical data. Management will describe all of our commercialization activities and how we view the market. Then in October, we have the IgG4-RD Symposium. In November, the American College of Rheumatology Conference. We've submitted to those meetings our open-label extension data from the original INDIGO phase III IgG4-related disease trial. People may recall that in that phase III trial, we had a flare protection rate of about three-quarters, about three-quarters of the patients.

We previously reported in the open-label extension, the OLE, that at the 6-month point, we were protecting over 90% of the patients, and we are really excited to share the 12-month data at these medical conferences. In addition, the vaccine substudy data where in the open-label extension, we are looking at the administration of either flu or COVID vaccines, and how that can be utilized in patients that are on obexelimab. Then, of course, people are well aware of our lupus program, our SunStone-SLE phase IIb top-line results in the biomarker population and the overall population will be available in the fourth quarter. The orelabrutinib phase III program is ongoing, both the PPMS study, PriMroSe, and the MONARCH SPMS study. ZB001, that is garnering quite a bit of interest now because we are in the clinic.

Our oral IL-17 inhibitor will have the SAD and the MAD study results, that safety tolerability and pharmacokinetics, in the fourth quarter as we prepare to move into a patient clinical program next year and report results in a patient setting. ZB014, the anti-CD19 FcγRIIb long-acting molecule will have SAD and MAD studies up and running next year with clinical data. Then finally, our ZB022 brain-penetrant TYK2 inhibitor, part of our neuroimmuno franchise, will have clinical data next year. So a lot going on.

Yeah. So what I had mentioned was that we previously reported the patients who had achieved 6 months on therapy in the open-label extension, that the flare protection was over 90%. It was 92%. Okay. You will have to stay tuned for what the data will be.

I would say, I am not going to categorize it as an improvement because that is about as good as it gets.

Okay. Fair enough. You will see the data when it comes out, and what we will be sharing is the 12-month flare probabilities, and people can assess that data when it is available.

Yeah. I would back up and just look at the whole treatment paradigm and how it is evolving for IgG4-related disease patients. As you know, historically, glucocorticoids, an intensive steroid dosing regimen, and then tapering the dosing down, is what was used in patients who flared. That is still used in a reasonable number of patients. Over time, it was determined that targeting B cells was effective, and that was with rituximab. The challenge with rituximab has always been that it is not FDA approved, and there is not data from a randomized phase III controlled trial. It does work, but it is many times hard to obtain and get it paid for. As you mentioned, another drug has launched, and that has now been in the marketplace for just over a year.

It is still early days of the first and only approved drug, so there is a lot of market development still to take place. When I speak to market development, that covers several areas. One important area is diagnosis. So an improvement in diagnosing patients. We believe there are 30,000 to 40,000 patients that have IgG4-related disease in the U.S., but the actual diagnosed and treated population today is 20,000. So how does the diagnosis rate increase? How are patients identified and brought into the treatment market? Then the other aspect of the market is, because historically there were no approved drugs and what was used were steroids, and steroids just cannot be administered chronically, the market was intermittent administration of steroids. So patient flares treat their flare. Some patients maybe give them low-dose steroids for a period of time, but that is just not sustainable.