Zenas BioPharma, Inc. Common Stock Morgan Stanley 24th Annual Global Healthcare Conference
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Welcome, everyone. Good afternoon. Thanks for being with us at this session of the Morgan Stanley Global Healthcare Conference. We are very excited to have Lonnie Moulder, CEO and Chairman of Zenas BioPharma, with us. I am Judah Frommer, one of the SMID biotech analysts here at Morgan Stanley. Let me just read a quick disclosure, and then we will jump into it. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. With that out of the way, Lonnie, the company has evolved over the past year. Maybe we can start with a high-level overview of how the pipeline and the balance sheet have deepened since we saw you here last.
Yeah. First of all, thank you for having us here. It has been a great day so far. This was number 13 of 14 or 15 meetings we are having. Let me just make a comment on our disclosures. I would refer you to our SEC filings, since we may be making some forward-looking statements here. Of course, the company has progressed quite a bit over the last year as we deepened our pipeline. If we talk just financially first, because you mentioned that, over the last year, we put in place a royalty financing with Royalty Pharma that helps us fund obexelimab and its launch. We executed on a pipe transaction. We then followed up with an equity offering and concurrent convertible note transaction and a term loan with Pharmakon.
We do have an active ATM. We use that judiciously, and we had two opportunities this year where two top mutual funds wanted to get a starter position, so we utilized the ATM twice that way. We ended the second quarter with about $674 million in cash. For us going forward, if our obexelimab for IgG4-RD is approved next year, we are eligible for $75 million more on the Royalty Pharma financing, and then we have the potential to tap into another $75 million on the Pharmakon term loan.
Got it. That would provide us cash through the second quarter of 2029.
Okay. With what we have going on in our pipeline that I will mention in just a moment.
That positions us really well. Priority number one, of course, for the company, now that we have a BLA under review with the FDA with a PDUFA date of late May, is preparing for the launch and then effectively launching obexelimab, if approved for IgG4-related disease in the U.S. Along the way, we are progressing other programs. I would highlight a few, and we will get into this more.
Sure. Of course, our two large phase III global programs in progressive MS for our BTK inhibitor, orelabrutinib, and then our newer molecule, ZB021.
It is an oral IL-17 inhibitor that is in the clinic now. In addition, we are expanding the obexelimab opportunity and have a lupus phase II-B study reporting out at the end of this year.
Okay, great. We will touch on all of it. Maybe just starting with obexelimab and IgG4-related disease, maybe just set the stage for us a bit with unmet need here and the advantages that a B-cell inhibitor can offer versus a depleter. You have talked about the dosing profile, the ability to pause therapy, but maybe just highlight that unmet need and what you are trying to solve here.
Yeah. If we back up and look at this disease, which it is a newer disease.
It was identified just about 20 years ago, and up until the recent approval, well, now just over a year, there were no approved drugs.
A few drugs were put into randomized phase III trials, but not by typical sponsors. They were really phase IV trials of older DMARDs that were not highly effective. Patients were treated primarily with steroids, which are highly effective. The problem with steroids, because this is a chronic disease, is chronic steroid administration just is not possible. It was identified that targeting B-cells, specifically with rituximab, could be beneficial. If you administer a regimen of rituximab, you can put a patient into remission, and if you periodically re-administer it, you can maintain that remission. The drug, though, has not been the subject of a phase III trial, so the evidence is not necessarily there for some payers, and it is not approved by the FDA, so it made it a challenge to get it for the vast majority of patients.
If you look at the IgG4-related disease market in the U.S.
there are about 20,000 patients who we know are diagnosed and are treated with a variety of different modalities. We believe the actual market may approach 30,000-40,000.
With 20,000 today and just over half of those patients flaring frequently enough that they require chronic therapy, the options are limited except for the approval now of UPLIZNA. If we think about that, the opportunity is really to bring to the clinicians and the patients an alternative. Today, when a patient is flaring, they think about administering a steroid, and then whether that is a patient that should get continuous therapy because they flared enough in the past and that they have a choice of UPLIZNA or rituximab, and much of that is driven by that clinician's experience and whether they can get a payer to pay for rituximab or not, which can be a challenge.
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