COGT — what changed in the latest 10-Q
A section-by-section comparison of COGT'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 · 2026-05-05 vs the prior 10-Q · 2025-11-07
| Section | Outcome | Added | Removed | Minor | Unchanged |
|---|---|---|---|---|---|
| MD&A | Text added/removed | +49 | −70 | ~11 | 37 |
| Market risk (Item 3) | Text added/removed | 0 | −1 | ~1 | 0 |
| Controls & procedures | Text added/removed | 0 | 0 | ~3 | 0 |
| Legal proceedings | No paragraph-level changes | 0 | 0 | 0 | 1 |
| Risk factors | No material changes reported (points to the 10-K) | — | — | — | — |
| 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 · 2026-05-05
We believe bezuclastinib represents a significant commercial opportunity across each of these indications. Based on internal analyses and external market research, we estimate a global annual market opportunity of over $4 billion for bezuclastinib in combination with sunitinib as a potential second-…
In addition to bezuclastinib, we have a growing portfolio of novel targeted therapy candidates. We initiated a Phase 1 dose escalation study of our CNS-penetrant, selective mutant ErbB2 inhibitor in the fourth quarter of 2025, and we initiated a Phase 1 dose escalation study of our potential best-in…
SM is driven by KIT D816V mutations causing a perpetual ‘on’ state within mast cells, a type of white blood cell, leading to proliferation and accumulation in various internal organs and bone marrow. Key biomarkers of SM include but are not limited to, elevated serum tryptase, high mast cell burden …
SUMMIT is our registration-directed randomized, global, multicenter, double-blind, placebo-controlled, multi-part Phase 2 clinical trial for patients with NonAdvSM. The study is designed to explore the safety and efficacy of bezuclastinib in patients with moderate to severe NonAdvSM, which includes …
We submitted the first New Drug Application (“NDA”) for bezuclastinib in patients with NonAdvSM in December 2025, which was accepted by the U.S. Food and Drug Administration ("FDA") in March 2026. The FDA assigned a Prescription Drug User Fee Act ("PDUFA") target action date of December 30, 2026. We…
Text removed vs the prior filing · source: 10-Q · 2025-11-07
The following is an illustration of the status of our current clinical and preclinical programs:
The vast majority of AdvSM and Non-AdvSM patients have a KIT D816V mutation. Patients with AdvSM have a significantly diminished lifespan with a median survival of less than 3.5 years. For patients with Non-AdvSM, while their lifespan may not be impacted by the disease, these patients suffer from a …
In the first quarter of 2025, we initiated an expanded access program in the United States for SM patients to receive investigational bezuclastinib after meeting certain eligibility criteria.
SUMMIT is our registration-directed randomized, global, multicenter, double-blind, placebo-controlled, multi-part Phase 2 clinical trial for patients with Non-AdvSM. The study is designed to explore the safety and efficacy of bezuclastinib in patients with moderate to severe Non-AdvSM, which include…
In July 2025, we announced positive top-line results from SUMMIT Part 2 demonstrating clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and objective measures of disease burden. We plan to p…
Market risk (Item 3)
Text removed vs the prior filing · source: 10-Q · 2025-11-07
On June 11, 2025, we entered into the Loan and Security Agreement with SLR and the lenders and guarantors party thereto. As of September 30, 2025, we had $50.0 million outstanding under the Loan and Security Agreement. Amounts outstanding under the Loan and Security Agreement bear interest at an ann…
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