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04/16/22 12:44 PM

#242112 RE: DewDiligence #242104

I haven’t followed the U2 or Ukoniq data much but have closely followed results for ublituximab in relapsing MS. I’ve felt that ublituximab will ultimately bring more value to the company and recently bought some shares and more recently sold $9 puts — maybe I should have waited until Monday.

Over the years I have had > 150 patients on rituxan and Ocrevus. Ublituximab has many similarities and a few differences with these other medications. All are extremely effective in treating patients with relapsing remitting MS and earlly to mid secondary progressive MS. Unfortunately, they don’t do much for late or inactive MS and ocrevus has been underwhelming for PPMS though a few patients may have stabilized a bit. Increased risk of infection with immunosenescence has led me to use less in older patients.

Ublituximab has fantastic clinical trial data and was compared to aubagio, a weaker medication that still has fair efficacy and is about equal to the older platform drugs like rebif.

I expect fda approval in September for relapsing MS. Ocrevus will still dominate but ublituximab has one definite advantage. Infusion time is two hours less for ublituximab. That is preferable for patients wanting les butt in chair time and infusion centers that will be able to have more rapid turnaround time. I expect 1/3 ofnew anti-CD20 MS prescriptions to be the new drug by mid 2023. Some ocrevus patients to may want to switch due to less time I the infusion suite but most will likely remain. Ultimately, formulary positioning will drive uptake as much as patient/ doctor desires. Therefore I expect peak sales of 600 -800 million for ms

Tgtx has no MS sales force and limited marketing team now. Several reps from other MS companies have have asked my opinions of ublituximab prospects so I think they are hiring some people in preparation. However, I think there is a very high chance that they license or sell the drug ( or even the company). If so I think BMY or MKKGYor JNJ are prime candidates as they already have a sales force for other MS drugs. Roche has Ocrevus. NVS has another CD-20 drug Kesimpta and BIIB has a share of ocrevus so are unlikely.

I will need to investigate Weiss and the BOD a little more