TSHA — what changed in the latest 10-Q
A section-by-section comparison of TSHA's newest periodic SEC filing (10-K/10-Q) against the prior same-form filing: paragraphs added and removed per section, with verbatim excerpts. Purely a deterministic text diff — no similarity scores, no directional read, not investment advice.
Comparing 10-Q · 2026-08-11 vs the prior 10-Q · 2026-05-06
| Section | Outcome | Added | Removed | Minor | Unchanged |
|---|---|---|---|---|---|
| MD&A | Text added/removed | +65 | −24 | ~18 | 68 |
| Market risk (Item 3) | No paragraph-level changes | 0 | 0 | 0 | 1 |
| Controls & procedures | Text added/removed | +2 | −1 | ~1 | 1 |
| Legal proceedings | Text added/removed | 0 | 0 | ~1 | 2 |
| Risk factors | No paragraph-level changes | 0 | 0 | 0 | 1 |
| Other information | Text added/removed | 0 | 0 | ~1 | 0 |
Counts are paragraphs; added/removed means text added or removed vs the prior filing — no direction or judgement implied.
Representative excerpts
Up to 5 excerpts of about 300 characters per section, quoted verbatim from the two SEC filings.
MD&A
Text added vs the prior filing · source: 10-Q · 2026-08-11
We have completed dosing of the 12 patients aged 6 to 21 years in Part A of both REVEAL trials, which includes eight patients in cohort two (high dose, 1x1015 total vg) and four patients in cohort one (low dose, 5.7x1014 total vg).
Longer-Term Results from Part A of REVEAL Trials as of May 2026 Data Cutoff
Developmental milestones are defined as a functional gain of one or more of the 28 milestones defined in the natural history study. This is the primary evidence of efficacy that will support our planned BLA submission and the FDA’s review of efficacy in the REVEAL pivotal trial. In REVEAL Part A, de…
The 12 patients treated in REVEAL Part A ranged from 6 to 21 years of age at dosing, with post-treatment follow-up spanning 12 to 30 months. We enrolled patients across a broad spectrum of disease severity, as assessed by the Clinical Global Impression-Severity, or CGI-S, scale, a 7-point, clinician…
As of the May 2026 data cutoff, 100% of the 12 patients in REVEAL Part A gained or regained ≥ one developmental milestone across the core functional domains of fine motor, gross motor and communication post-treatment with TSHA-102. These results were seen despite the broad range in age and disease s…
Text removed vs the prior filing · source: 10-Q · 2026-05-06
We have completed dosing of the 12 patients in Part A of both REVEAL trials, which includes eight patients in cohort two (high dose, 1x1015 total vg) and four patients in cohort one (low dose, 5.7x1014 total vg). We reported positive clinical data in May 2025, demonstrating that the first 10 patient…
be generally well tolerated with no treatment-related serious adverse events, or SAEs, or dose-limiting toxicities, or DLTs, in all patients treated in the REVEAL Phase 1/2 and REVEAL pivotal trials as of the May 2026 data cutoff.
An update on longer-term safety and efficacy data from the Part A REVEAL Phase 1/2 trials (n=12) is expected in the second quarter of 2026.
The TSHA-102 clinical development program is designed to support the potential future approval of TSHA-102 for a broad population of patients aged 2 years and older with Rett syndrome through an efficient and rigorously designed pathway. In close collaboration with the United States Food and Drug Ad…
The REVEAL pivotal trial, also known as Part B, is a single-arm, open-label study evaluating the efficacy and safety of TSHA-102 in females with Rett syndrome, with each patient serving as their own control. Each participant will receive a single administration of the high dose (1x1015 total vg) of …
Controls & procedures
Text added vs the prior filing · source: 10-Q · 2026-08-11
reasonable assurance that the information required to be disclosed by us in this Quarterly Report on Form 10-Q was (a) reported within the time periods specified by SEC rules and regulations, and (b) communicated to our management, including our Chief Executive Officer and Chief Financial Officer, t…
There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report on Form 10-Q that materially affected, or are reasonably likely to materially a…
Text removed vs the prior filing · source: 10-Q · 2026-05-06
During the three months ended March 31, 2026, we implemented an enterprise resource planning system, NetSuite, which resulted in certain changes to existing business processes and internal control over financial reporting. Other than this transition, there were no other changes in our internal contr…
How to read Risk Factors (Item 1A) in a 10-Q
A 10-Q risk-factor section usually takes one of three forms; this page classifies it as one of:
- Pointer — the filer states there have been no material changes and points back to the annual 10-K risk factors; there is no own risk text to compare this quarter.
- Partial update — the filer carves out specific updated risks ("except as set forth below"); the excerpts show exactly what is new this quarter.
- Restated in full — the quarter carries the complete risk-factor text. When the prior quarter was only a pointer there is no prior full text to diff against, so the page flags the section as restated instead.
This describes the filing structure only — it is never a judgement on whether risk went up or down.
Source: text-level diff of the two SEC EDGAR filings · deterministic (no AI-generated content) · for reference only · not investment advice