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Zura Bio Reports Third Quarter 2024 Financial Results and Recent Corporate Updates

In This Article:

  • Expect to initiate Phase 2 studies evaluating tibulizumab for the treatment of systemic sclerosis (SSc) in Q4 2024 and hidradenitis suppurativa (HS) in Q2 2025

  • Cash, cash equivalents and investments totaling $188.2 million as of September 30, 2024, are anticipated to support operations, as currently planned, through 2027

HENDERSON, Nev., November 07, 2024--(BUSINESS WIRE)--Zura Bio Limited (Nasdaq: ZURA) ("Zura Bio"), a clinical stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today reported financial results for the third quarter of 2024 and recent corporate updates.

"In the third quarter of 2024, we made significant progress toward initiating our first Phase 2 trial of tibulizumab in SSc. We’ve worked closely with our contract research organization (CRO) to begin trial readiness and prepare for site activation," said Robert Lisicki, CEO of Zura Bio. "Additionally, we've selected a CRO to support the anticipated Phase 2 trial initiation for tibulizumab in HS in the second quarter of 2025. We're excited to advance toward these milestones and highlight tibulizumab's potential as a best-in-class therapy for these underserved diseases."

RECENT UPDATES AND UPCOMING ANTICIPATED MILESTONES:

Tibulizumab

Systemic sclerosis

  • In September 2024, the protocol for the Phase 2 clinical program in systemic sclerosis was finalized.

  • The Orphan Drug Designation application was completed, and the request was submitted to the U.S. Food and Drug Administration (FDA) in Q4 2024.

  • The Phase 2 clinical trial of tibulizumab for the treatment of SSc is anticipated to initiate in Q4 2024.

Hidradenitis suppurativa

  • In September 2024, a third-party CRO was selected to oversee and conduct the Phase 2 clinical program in HS.

  • The Pre-IND meeting request was submitted in Q4 2024 and the IND submission to the FDA for a Phase 2 trial of tibulizumab in HS is expected in Q1 2025.

  • The Phase 2 trial of tibulizumab for the treatment of HS is anticipated to initiate in Q2 2025.

Crebankitug

  • Ongoing monitoring of external Phase 2 data releases from other companies relating to IL-7Rα inhibitors in development for conditions such as ulcerative colitis, atopic dermatitis and alopecia areata.

Torudokimab

  • Ongoing monitoring of external Phase 2 and Phase 3 IL-33/ST2 data releases from other companies related to asthma and chronic obstructive pulmonary disease.

Corporate Highlights

  • In August 2024, the company successfully completed a warrant exchange program, simplifying its capital structure.

  • As of September 2024, an "at-the-market" (ATM) program is in place, providing the company with increased financial flexibility.