SLS — what changed in the latest 10-Q
A section-by-section comparison of SLS'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 · 2026-05-12 vs the prior 10-Q · 2025-11-12
| Section | Outcome | Added | Removed | Minor | Unchanged |
|---|---|---|---|---|---|
| MD&A | Text added/removed | +22 | −35 | ~16 | 24 |
| Market risk (Item 3) | Text added/removed | +1 | 0 | ~2 | 17 |
| Controls & procedures | Text added/removed | +1 | 0 | ~2 | 17 |
| Legal proceedings | Text added/removed | +1 | 0 | ~2 | 17 |
| Risk factors | Text added/removed | +1 | 0 | ~2 | 17 |
| Other information | Text added/removed | +1 | 0 | ~2 | 17 |
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 · 2026-05-12
SLS009, or Tambiciclib: Highly Selective Next Generation CDK9 Inhibitor
In July 2025, we announced that the Phase 2 trial of SLS009 in r/r AML met all primary endpoints and received FDA guidance to advance into a first-line therapy study. The overall response rate, or ORR, in 54 evaluable patients was 33% across all cohorts and dose levels, 40% for the 30 mg BIW dose le…
Following a productive end of Phase 2 meeting, the FDA recommended that we proceed into a clinical trial to include newly diagnosed, first-line AML patients eligible for aza/ven therapy, where the FDA noted clinical benefit might be greatest. The randomized 80-patient Phase 2 clinical trial is curre…
In January 2026, we announced that we entered into an agreement with IMPACT-AML, a European collaborative initiative dedicated to advancing innovative treatments for patients with AML. Under the agreement, the IMPACT-AML network will conduct a clinical study evaluating SLS009, enabling access to mul…
For SLS009, the FDA granted Orphan Drug Product designations in AML and peripheral T-cell lymphoma, or PTCL, and Fast Track designations for r/r AML and r/r PTCL. The FDA granted RPD designation to SLS009 for the treatment of pediatric acute lymphoblastic leukemia, or ALL, in June 2024 and the FDA g…
Text removed vs the prior filing · source: 10-Q · 2025-11-12
In the fourth quarter of 2023, we completed enrollment in the 45 mg (safety) dose cohort in the Phase 2a study and reported positive initial topline data. At that time, we also commenced enrollment in the 60 mg dose cohort with patients randomized to one of two groups, 60 mg fixed dose once weekly o…
During the trial, we identified potential biomarkers currently undergoing testing as predictive markers in the most recent portion of the study. In May 2024, we announced additional preliminary data from the Phase 2a trial of SLS009 in r/r AML and successful filing of a provisional patent applicatio…
In July 2025, we announced that the Phase 2 trial of SLS009 in r/r AML met all primary endpoints and received FDA guidance to advance our first-line therapy study. The overall response rate, or ORR, in 54 evaluable patients was 33% across all cohorts and dose levels, 40% for the 30 mg BIW dose level…
MR with Myelomonocytic/Myelomonoblastic, or M4/M5, patients with an ORR of 50% (6/12). The median overall survival, or mOS, reached 8.9 months in patients with AML MR and 8.8 months in patients r/r to venetoclax-based regimens at a 30 mg BIW dose level, surpassing the historical benchmark of ~2.4 mo…
In addition, following a productive end of Phase 2 meeting, the FDA recommended that we proceed into a trial to include newly diagnosed, first-line AML patients eligible for aza/ven therapy, where the FDA noted clinical benefit might be greatest. The randomized 80-patient trial is currently in prepa…
Market risk (Item 3)
Text added vs the prior filing · source: 10-Q · 2026-05-12
•changes in applicable laws, regulatory actions, judicial decisions, accounting standards, and tariffs or trade restrictions;
Controls & procedures
Text added vs the prior filing · source: 10-Q · 2026-05-12
•changes in applicable laws, regulatory actions, judicial decisions, accounting standards, and tariffs or trade restrictions;
Legal proceedings
Text added vs the prior filing · source: 10-Q · 2026-05-12
•changes in applicable laws, regulatory actions, judicial decisions, accounting standards, and tariffs or trade restrictions;
Risk factors
Text added vs the prior filing · source: 10-Q · 2026-05-12
•changes in applicable laws, regulatory actions, judicial decisions, accounting standards, and tariffs or trade restrictions;
Other information
Text added vs the prior filing · source: 10-Q · 2026-05-12
•changes in applicable laws, regulatory actions, judicial decisions, accounting standards, and tariffs or trade restrictions;
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