Tarsus Pharmaceuticals, Inc. Reports Second Quarter 2021 Financial Results and Provides Business and Clinical Updates

Announced positive results of the Saturn-1 pivotal trial evaluating TP-03 for the treatment of Demodex blepharitis; results presented at the 2021 American Society of Cataract and Refractive Surgery (ASCRS) conference

Initiated Saturn-2, second pivotal Phase 3 trial evaluating the safety and efficacy of TP-03 for the treatment of Demodex blepharitis; Saturn-2 trial design similar to Saturn-1, topline data expected in Q1 2022

Initiated the Phase 1 Callisto trial evaluating TP-05, a novel, oral, non-vaccine therapeutic, for the prevention of Lyme disease

Cash and equivalents of $177 million, plus TP-03 license receivables of $20 million as of June 30, 2021

IRVINE, Calif., Aug. 04, 2021 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), a late clinical-stage biopharmaceutical company whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced financial results and provided business and clinical updates for the quarter ended June 30, 2021.

“We have achieved significant milestones on our lead product and pipeline so far in 2021 with the positive read-out of the Saturn-1 data for TP-03 in Demodex blepharitis, the initiation of Saturn-2, and the initiation of the Callisto trial of TP-05 for the prevention of Lyme disease,” said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. “Interest from the physician community also continues to build, as new Saturn-1 data presented at the ASCRS 2021 Annual Meeting reinforced the strong potential clinical utility of TP-03 with a broad range of patients showing a substantial response. Additionally, results from the Titan and Atlas studies reinforce the prevalence and burden of Demodex blepharitis, suggesting that this disease could affect as many as 25 million Americans, with 80% of patients reporting a negative impact on daily life. We believe this data supports both the need and opportunity for an FDA-approved therapeutic treatment option.”

Recent Business Highlights and Corporate Update:

• Announced positive results of the Phase 2b/3 Saturn-1 pivotal trial studying TP-03 (lotilaner ophthalmic solution, 0.25%) in patients with Demodex blepharitis. All pre-specified primary and secondary endpoints were met, and complete resolution of Demodex blepharitis signs was demonstrated in many patients treated with TP-03 (lotilaner ophthalmic solution, 0.25%).
  • 81% of patients on TP-03 achieved a clinically meaningful collarette cure, defined as 0-10 collarettes per lid at day 43 compared to 23% of those on vehicle (p