RZLT: Awaiting FDA REZOLUTion

研报英文原文证据摘录

RZLT: Awaiting FDA REZOLUTion

May 13, 2026

Debjit Chattopadhyay, Ph.D. debjit.chattopadhyay@guggenheimpartners.com RZLT: Awaiting FDA REZOLUTion

212 823 6584

Moritz Reiterer, Ph.D. Key Message: In our most recent conversation with the company following the 3Q

moritz.reiterer@guggenheimpartners.com earnings release, mgmt reiterated their belief that cHI submission is viable, with clarity

212 372 6368 by mid-26. cHI approval based on real world / OLE data, while not in our model, would

Ry Forseth, Ph.D. represent the best-case outcome, paving the path for a potential PRV. Based on recent

ry.forseth@guggenheimpartners.com transactions, a PRV sale could yield ~$200M, which could materially increase the stock

212 518 9226 price, given the RZLT current market cap of $337M. Per mgmt, FDA: (1) did not bring up

Hannah Wei or request a new study or a repeat RCT; (2) suggested an iterative approach to sunRIZE

hannah.wei@guggenheimpartners.com data analysis / review; (3) valued the opinion of advocacy / KOLs. On tHI from which we

212 518 5896 anticipate topline data during 2H26: (1) tHI clinical trial was not discussed or brought up

by the agency; (2) mgmt expects a single trial AKA upLIFT to be sufficient for BLA, with

potential approval in 2027, which is our Base case.

Recent clinical updates RZLT BUY

Rezolute, Inc. The company presented the additional sunRIZE Ph3 data at the Pediatric Endocrine Society

Sector: Biotechnology (PES) 2026 annual meeting. Our take on the data can be found HERE.

Earnings Release Valuation

Share Price $3.30

Our $6/share PT values RZLT using a 10-year DCF analysis. Our DCF utilizes a WACC Price Target $6.00

of 12.8% and terminal growth rate of 0%, which are consistent with similar, late-stage rare

disease companies under our coverage.