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TRAX

First Tracks BiotherapeuticsN/A
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-05-14
Investor release

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Earnings documents stored for TRAX.

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Investor releaseQuarter not tagged2026-05-14

First Tracks Biotherapeutics Announces First Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire

First Tracks launched April 20th with a two-year cash-runway to advance ANB033 through celiac disease and eosinophilic esophagitis Phase 1b data and plans to initiate Phase 2 trials across four indications SAN DIEGO, May 14, 2026 (GLOBE NEWSWIRE) -- First Tracks Biotherapeutics, Inc. (Nasdaq: TRAX), a clinical-stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “First Tracks Bio launched to advance a focused, high-value immunology portfolio that can create meaningful impact and a future where autoimmune diseases no longer define a patient’s life,” said Daniel Faga, president and chief executive officer. “We remain committed to executing with speed, rigor and financial discipline with a focus on ANB033, a CD122 antagonist, as we prepare for multiple clinical readouts in celiac disease and eosinophilic esophagitis. Additionally, we completed a productive End-of-Phase 2 meeting for rosnilimab with FDA, and we are assessing ROE-maximizing strategic options for this asset, including potential for development in rheumatoid arthritis and other indications.” ANB033 (CD122 antagonist) Phase 1b trial in celiac disease ongoing 60-patient trial assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) across two different cohorts Cohort 1 (n=30) is a gluten-challenge study to assess the prevention of mucosal damage through six weeks Cohort 2 (n=30) is a study to assess the possibility of mucosal healing through 12 weeks Top-line Phase 1b data anticipated in Q4 2026 Phase 1b trial in eosinophilic esophagitis ongoing 50-patient cohort assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) through 12 weeks Top-line Phase 1b data anticipated in mid-2027 Rosnilimab (Pathogenic T Cell Depleter) Completed End-of-Phase 2 (EOP2) meeting with FDA in Q1 2026. The agency provided constructive feedback on a registrational Phase 3 path in rheumatoid arthritis (RA), a disease with significant remaining patient unmet need Currently assessing ROE-maximizing strategic options that may include a global partnership, out-license or asset financing to progress the potential development of rosnilimab in RA and other indications...

Investor releaseQuarter not tagged2026-05-13

Anaptys Announces First Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire

Completed spin-off of First Tracks Biotherapeutics, Inc., its former biopharma operations business Now exclusively manages the financial collaborations for Jemperli with GSK and imsidolimab with Vanda Announced appointment of Chris Murphy as CFO Announced appointments of Susannah Gray, former CFO of Royalty Pharma, and Owen Hughes, current CEO of XOMA Royalty, to its Board of Directors SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a company focused on managing the financial collaborations for Jemperli with GSK and imsidolimab with Vanda, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “Following the completion of the spin-off of First Tracks Bio in late April, Anaptys now exclusively manages the financial collaborations for Jemperli and imsidolimab, with streamlined operations requiring limited FTEs, minimal operating expenses and delivering an EBIT margin greater than 95%,” said Daniel Faga, president and chief executive officer. “With Chris Murphy joining as CFO, who brings deep business development and investment banking experience, our priority continues to be to protect our two royalty streams and return their value to shareholders.” GSK Jemperli Financial Collaboration GSK announced strong commercial performance for Jemperli ($313 million/£232 million in Q1 2026 sales, with >40% year-over-year growth1) Anaptys continues to expect to achieve >$390 million in annualized Jemperli royalties payable to Anaptys as early as 2029 at GSK’s peak sales guidance of >$2.7 billion2 Anaptys estimates Sagard will have accrued ~$275 million in royalties and sales milestones through Q1 2026 and anticipates paydown of the remaining ~$325 million non-recourse debt monetization by the end of Q2 20273 Substantial GSK investment in additional monotherapy and potential combination trials for Jemperli, including: AZUR-1 – pivotal Phase 2 – dostarlimab monotherapy in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer Data expected in H2 2026; U.S. FDA Breakthrough Therapy Designation Received an FDA Commissioner’s National Priority Voucher (CNPV) in Nov. 2025 allowing for only a one to two-month sBLA review timeline for US FDA approval AZUR-2 – pivotal Phase 3 – dostarlimab versus standard of care in untreated TN40 or stage III dMMR/ MSI-H resectable colon cancer Data expec...

As of 2026-05-30 • Updated weeklySource: Earnings sourceIngestion runbook