Cabaletta Bio
Market cap $280M 215.7M shares (10-Q, Oct 30, 2026) × $1.30 close Nov 6, 2026
Most recent annual filing: 2026-01-15
- PV / SLE Cellares manufacturing2H 2026PV / SLE Cellares manufacturing, 2H 2026, routine
- RESET program aggregate safety /Nov 8–10, 2026RESET program aggregate safety /, Nov 8–10, 2026, notable
- myositis program DM pivotal topline2H 2027myositis program DM pivotal topline, 2H 2027, major
- Rese-cel (CABA-201) - Myositis BLA1Q 2028Rese-cel (CABA-201) - Myositis BLA, 1Q 2028, material
- Myositis BLA filing1Q 2028Myositis BLA filing, 1Q 2028, notable
- Myositis BLA JDM filing1Q 2028Myositis BLA JDM filing, 1Q 2028, notable
Bar width shows how precise the guidance is — a pin is a stated date, a wide band a six-month window. Deeper blue means more of the thesis rides on the event; it is not a view on the stock.
Pipeline (8 active programs)
Technology platforms
CABA
Cabaletta Approach to B cell Ablation (CABA) platform using the CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) approach, designed to reset the immune system via deep B cell depletion. Focus area: broad range of autoimmune diseases with B cell involvement.
Targets: CD19
Cell Shuttle · Cellares
Cellares Cell Shuttle — automated, closed, end-to-end CAR T cell manufacturing platform designed to improve reproducibility, scalability, and process control for autologous cell therapy production; applied to rese-cel manufacturing in the RESET clinical program
LentiVector · Oxford Biomedica
Oxford Biomedica lentiviral vector delivery platform licensed for rese-cel and DSG3-CAART programs in autoimmune diseases
Capital (as filed)
- Cash
- $299M cash and cash equivalents · Sep 30, 2026 (10-Q)
- Operating cash flow
- −$42.7M quarter Jun 30, 2026 → Sep 30, 2026, year-to-date difference (10-Q)
- As stated in coverage
- $299M cash, runway 1Q28 per the update of Nov 5, 2026 — the company's own words as read there, not the filed figure
Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.
Biotech Distilled coverage (10)
- 2026-09-15 UPDATE: Cabaletta Bio (CABA) - The Warrant Wall Came Down, and It Paid 🔒 Paid
- 2026-08-14 UPDATE: Cabaletta Bio (CABA) - Down 24% on No Bad News 🔒 Paid
- 2026-06-03 UPDATE: Cabaletta Bio (CABA) - The Third Gate Just Cracked Open
- 2026-05-15 UPDATE: Cabaletta Bio (CABA) - The No-Chemo Gambit Actually Worked at the Lowest Dose 🔒 Paid
- 2026-05-04 UPDATE: Cabaletta Bio (CABA) - The Dilution Gap Just Closed. And Eli Lilly Brought a Chair.
- 2026-04-29 UPDATE: Cabaletta Bio (CABA) - The Factory Just Got Locked In for a Decade 🔒 Paid
- 2026-03-29 UPDATE: Cabaletta Bio (CABA) - The FDA Hits the Brakes on the Fast Track 🔒 Paid
- 2026-02-21 UPDATE: Cabaletta (CABA) - The Smart Money is Anchoring 🔒 Paid
- 2026-01-13 Update: Cabaletta Bio (CABA) – The 2026 Strategy Reset 🔒 Paid
- 2026-01-08 Cabaletta Bio (CABA): Scientific Due Diligence for Rese-Cel and Pipeline Products
Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.
Verdict history (10 calls)
Every verdict Biotech Distilled has published on Cabaletta Bio, oldest first — the full history, never a selection. How calls are scored: the track record.
- 2026-01-08 Watch Cabaletta Bio (CABA): Scientific Due Diligence for Rese-Cel and Pipeline Products Great science but tough timing — the dilution gap and going concern warning argue for waiting until after the inevitable capital raise before entering.
- 2026-01-13 Watch Update: Cabaletta Bio (CABA) – The 2026 Strategy Reset FDA alignment on the Myositis registrational cohort is a de-risking event, but the dilution gap remains open and the BLA timeline confirms a 2026 capital raise is needed.
- 2026-02-21 Watch UPDATE: Cabaletta (CABA) - The Smart Money is Anchoring Elite institutional holders (Cormorant, Millennium, T. Rowe) provide comfort but the dilution gap is still real; wait for the financing overhang to clear before taking a position.
- 2026-03-29 Watch UPDATE: Cabaletta Bio (CABA) - The FDA Hits the Brakes on the Fast Track FDA pushback on the Myositis single-arm external-control design elevates regulatory risk; wait for the Q2/Q3 capital raise and FDA design blessing before entering.
- 2026-04-29 Watch UPDATE: Cabaletta Bio (CABA) - The Factory Just Got Locked In for a Decade The 10-year Cellares commercial supply deal meaningfully de-risks manufacturing, but the dilution gap and FDA registry-control pushback remain unresolved; watching ASGCT May 14 before moving off Watch List.
- 2026-05-04 Watch speculative UPDATE: Cabaletta Bio (CABA) - The Dilution Gap Just Closed. And Eli Lilly Brought a Chair. The $150M raise at near-market pricing with Eli Lilly on the cover page closes the dilution gap and validates M&A optionality, making the entry case real despite remaining FDA registry-control and BIOSECURE risks.
- 2026-05-15 Speculative buy speculative UPDATE: Cabaletta Bio (CABA) - The No-Chemo Gambit Actually Worked at the Lowest Dose PC-free PV data (2/4 drug-free responses) and Cellares bioequivalence data clear two of three gating questions; stock dip to $3.61 post-ASGCT is a cleaner entry, with EULAR as the next major catalyst.
- 2026-06-03 Buy core UPDATE: Cabaletta Bio (CABA) - The Third Gate Just Cracked Open SSc named as second pivotal indication, 1.5-year DM durability data, and JDM PRV optionality broaden the BLA path and reduce binary regulatory risk, justifying an upgrade from speculative to core buy at $3.58.
- 2026-08-14 Buy core UPDATE: Cabaletta Bio (CABA) - Down 24% on No Bad News The -24% drawdown is driven by warrant mechanics and regulatory patience rather than fundamental deterioration; the thesis remains intact at $2.71 with $225M cash, two registrational shots, and the warrant wall expiring September 12.
- 2026-09-15 Buy core UPDATE: Cabaletta Bio (CABA) - The Warrant Wall Came Down, and It Paid 46M warrants exercised for ~$115M gross removes the dated technical overhang and extends runway well past the mid-2027 registrational readout, while the FDA registry-control question remains the key unresolved risk.
- Long call · opened May 15, 2026 at $3.31 · -60.7% vs XBI +16.5% (Nov 6, 2026)
Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.
Timing, in the company's words (3 quotes from 3 filings)
Sentences quoted verbatim from the company's SEC filings, newest filing first. Each sits under the filing it appeared in; the "matched to" tag names the calendar row it was read for.
-
-
“The registrational, 17-patient dermatomyositis (DM) and antisynthetase syndrome (ASyS) cohort, which incorporates an outpatient dosing option, is expected to deliver topline results in the second half of 2027 to support a planned Biologics License Application (BLA) submission in myositis to the U.S. Food and Drug Administration (FDA) in the first quarter of 2028.”
matched to RESET-Myositis · topline data · read as first quarter of 2028
-
-
-
“Registrational RESET-Myositis data on track for mid-2027 to support first potential BLA submission for rese-cel in 2H27”
matched to RESET-Myositis · topline data · read as mid-2027
-
-
-
“Registrational RESET-Myositis data on track for mid-2027 to support first potential BLA submission for rese-cel in 2H27”
matched to Myositis · Planned BLA submission · read as mid-2027
-
Timing sentences quoted from the company's own SEC filings, each under the filing it appeared in. The 'matched to' tag is the calendar row the sentence was read for; the filing is the source. Not investment advice.
Filings & releases (26)
SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from May 4, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →
- Nov 5, 2026ReleaseCabaletta Bio Reports Third Quarter 2026 Financial Results and Provides Business UpdateSummary on the 8-K
- Nov 5, 20268-KCurrent report: results of operations · EX-99.1Cabaletta's Q3 earnings reveal a 3Q enrollment slowdown in the myositis registrational cohort — blamed on Novartis/BMS competitor safety events — pushing the BLA submission to 1Q28, while $299.4M in cash buys runway to that date and ACR drops one-year DM durability data this Sunday.
- Nov 5, 202610-QQuarterly reportSummary on the 8-K
- Sep 14, 20268-KCurrent report: other events→ BD updateThe $2.50 warrant wall I flagged in August as the loudest near-term technical overhang just resolved in the best possible way: ~46M warrants exercised at expiry, ~$128M in total proceeds coming in, and the mechanical lid on CABA is gone.
- Sep 1, 2026ReleaseCabaletta Bio to Participate in Upcoming Investor Conferences
- Aug 13, 2026ReleaseCabaletta Bio Reports Second Quarter 2026 Financial Results and Provides Business UpdateBD extracted 2 program updates from this document → CABA pipeline
- Aug 13, 20268-KCurrent report: results of operations · EX-99.1
- Aug 13, 202610-QQuarterly report
- Jun 11, 20268-KCurrent report: charter / bylaws / fiscal year, shareholder vote
- Jun 3, 2026ReleaseCabaletta Bio Announces New Rese-cel Data and Development Updates Across Autoimmune Portfolio, Including Encouraging Early PC-Free Lupus Findings, at EULAR 2026 CongressBD extracted 2 program updates from this document → CABA pipeline
- Jun 3, 20268-KCurrent report: Reg FD disclosure, other events · EX-99.1
- Jun 1, 2026DEFA14AProxy soliciting material
- May 14, 2026ReleaseCabaletta Bio Reports First Quarter 2026 Financial Results and Provides Business Update
- May 14, 2026ReleaseCabaletta Bio Presents Preconditioning-free Clinical Data and Automated Manufacturing Translational Data for Rese-cel at ASGCT 2026 Annual Meeting
- May 14, 20268-KCurrent report: results of operations · EX-99.1
- May 14, 20268-KCurrent report: Reg FD disclosure, other events · EX-99.1
- May 14, 202610-QQuarterly report
- May 4, 2026ReleaseCabaletta Bio Announces Pricing of $150 Million Underwritten Offering
- May 4, 20268-KCurrent report: material agreement, results of operations, other events · EX-99.1
- May 4, 20268-KCurrent report: other events
- May 4, 2026424B5Prospectus supplement (offering)
- Apr 28, 2026DEFA14AProxy soliciting material
- Apr 28, 2026DEF 14AProxy statement
- Apr 20, 20268-KCurrent report: other events · EX-99.1
- Mar 23, 20268-KCurrent report: results of operations, Reg FD disclosure · EX-99.1
- Mar 23, 202610-KAnnual report
18 more filings (13G holder notices, S-8, proxy material, SEC correspondence …)
- Nov 6, 2026SCHEDULE 13G/A13G amendment
- Nov 6, 2026SCHEDULE 13G/A13G amendment
- Oct 30, 2026SCHEDULE 13G/A13G amendment
- Oct 27, 2026SCHEDULE 13G/A13G amendment
- Aug 14, 2026SCHEDULE 13G/A13G amendment
- Aug 14, 2026SCHEDULE 13G/A13G amendment
- Aug 14, 2026SCHEDULE 13G/A13G amendment
- Aug 12, 2026SCHEDULE 13G/A13G amendment
- Aug 12, 2026SCHEDULE 13GPassive >5% holder (13G)
- Jul 31, 2026SCHEDULE 13GPassive >5% holder (13G)
- Jul 27, 2026SCHEDULE 13GPassive >5% holder (13G)
- Jul 23, 2026SCHEDULE 13G/A13G amendment
- Jun 5, 2026SCHEDULE 13G/A13G amendment
- Jun 4, 2026SCHEDULE 13G/A13G amendment
- May 15, 2026SCHEDULE 13G/A13G amendment
- Apr 28, 2026ARSAnnual report to shareholders
- Apr 17, 2026PRE 14APRE 14A
- Mar 23, 2026S-8Employee plan registration