GTHP — what changed in the latest 10-Q
A section-by-section comparison of GTHP'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 · 2026-05-15 vs the prior 10-Q · 2025-11-13
| Section | Outcome | Added | Removed | Minor | Unchanged |
|---|---|---|---|---|---|
| MD&A | Text added/removed | +49 | −63 | ~8 | 28 |
| Market risk (Item 3) | No paragraph-level changes | 0 | 0 | 0 | 1 |
| Controls & procedures | Text added/removed | 0 | 0 | ~2 | 0 |
| Legal proceedings | No paragraph-level changes | 0 | 0 | 0 | 1 |
| Risk factors | No material changes reported (points to the 10-K) | — | — | — | — |
Counts are paragraphs; added/removed means text added or removed vs the prior filing — no direction or judgement implied.
Not shown (absent or not faithfully extractable): Other information
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 · 2026-05-15
We have not yet obtained clearance or approval from the U.S. FDA. However, we have completed patient enrollment in the clinical trial required to support an application for FDA approval to market and sell LuViva in the United States. As of April 2026, the status of the FDA application is as follows:
Approximately 480 patients were enrolled, of whom 428 were evaluable for efficacy analysis. Both totals satisfy the a priori criteria as set forth in the study protocol.
No adverse events related to the use of LuViva have been reported.
All four clinical study sites adhered to the study protocol and completed required case report forms in accordance with FDA standards.
Close-out activities have been completed at all sites, and all LuViva devices have been retrieved in good working order.
Text removed vs the prior filing · source: 10-Q · 2025-11-13
results related with the termination of the license agreement with SMI and potential partnership agreement with other parties;
In the United States, the Company is actively pursuing FDA approval by conducting a clinical trial involving approximately 400 study participants, with the exact number depending in part on the numbers of women in the study both with and without cervical disease. The study protocol was drafted with …
On August 13, 2025 the Company announced that it had surpassed the minimum number of enrolled subjects, both for each individual site and for the entire study. Based on this achievement, data analysis has begun. The initial analysis will focus on determining the number of study subjects with and wit…
As of November 1, 2025, approximately 460 patients have been enrolled and tested, which is above the target minimum number needed to file the application with the FDA. Analysis of these data indicate that enough women both with and without cervical disease have been enrolled and tested.
There have not been any adverse events reported related to the use of LuViva.
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