CABA · Cabaletta Bio, Inc.

📣 What CABA Says Is Next

• 4Q26 · “Cabaletta anticipates initiating this study in 4Q26.”
  Company press release, Aug 13, 2026 · SEC filing
• 2H27 · “If successful, Cabaletta plans to submit its first Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in 2H27, inclusive of data from the registrational cohort and the juvenile cohort which may facilitate the potential to be granted a Priority Review Voucher.”
  Company press release, Aug 13, 2026 · SEC filing
• mid-2027 · “Cabaletta continues to anticipate reporting data from the registrational, 17-patient dermatomyositis (DM) and antisynthetase syndrome (ASyS) cohort in mid-2027, including 14 adult DM patients and 3 adult ASyS patients.”
  Company press release, Aug 13, 2026 · SEC filing

Quoted word for word from the company's press releases filed with the SEC. Timing is the company's own guidance, not a BioRadar estimate.

🧪 Trial & FDA Catalysts

• Jul 2028 · Phase 2/3 · Recruiting · RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Sub
  Registry primary completion date, not a results date
• Jan 2029 · Phase 1/2 · Recruiting · A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Ch
  Registry primary completion date, not a results date
• Jul 2029 · Phase 2/3 · Recruiting · RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR
  Registry primary completion date, not a results date
• Sep 2029 · Phase 1/2 · Recruiting · RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Gen
  Registry primary completion date, not a results date
• Dec 2029 · Phase 1/2 · Recruiting · RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in
  Registry primary completion date, not a results date

📊 Drug Pipeline

Source: ClinicalTrials.gov trials sponsored by the company, one row per candidate at its most advanced registered trial. FDA approvals: Drugs@FDA. Wrong or missing drug? Report it

💰 Cash Runway & Dilution Risk

CABA holds $225.1M in cash and short-term investments (as of Jun 30, 2026) and burns about $42M/quarter from operations, an estimated runway of 16.1 months at that rate (BioRadar estimate, not company guidance).

Dilution pressure: 78 · High

• Cash runway 16 months +18
• ATM program on file since Aug 2025 +15
• Shelf registration (S-3, Aug 2025) +10
• Going-concern doubt in the latest 10-Q +15We have identified conditions that raise substantial doubt about our ability to continue as a going concern. 10-Q, Aug 2026
• Share count +85% in a year +20

Recent financing filings on SEC EDGAR:

• May 4, 2026 · Underwritten offering · 424B5
• Aug 7, 2025 · Shelf registration with ATM program, up to $150M · S-3
• Jun 12, 2025 · Underwritten offering · 424B5
• Jun 11, 2025 · Underwritten offering · 424B5
• Mar 21, 2024 · Shelf registration with ATM program, up to $200M · S-3ASR

Source: SEC EDGAR (XBRL cash flow and financing filings). Dilution Watch: every company ranked → · Get an alert when CABA files for a raise →

👥 Who Owns CABA

Share count 169,545,445 (latest 10-Q/10-K). Insiders: each officer's, director's and 10% owner's latest Form 3, 4 or 5, direct and indirect shares; options are not counted. 5%+ holders: latest Schedule 13D or 13G of each holder above 5%. Institutions: the total held by all 13F filers (Yahoo Finance); the table lists the largest (13F quarter ending 2026-06-30). Sources have different dates, so the split is approximate. Source: SEC EDGAR.

📈 Recent Insider Activity (Form 4)

Only open-market purchases (P) and sales (S) are trading decisions. Awards (A), option exercises (M) and tax withholding (F) are compensation mechanics. Source: SEC Form 4.