# SELLAS Life Sciences ($SLS) — Due Diligence Memo

**As of:** 18 Sep 2026
**Ticker:** **SLS** — SELLAS Life Sciences Group, Inc. (NASDAQ)  
**CIK:** [0001390478](https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001390478)  
**Disclaimer:** Educational research for the SLS-Model app. Not investment, legal, or medical advice. Every material claim below is tagged **verified** / **partial** / **community** / **rejected** and linked where possible.

---

## Executive summary

SELLAS is a clinical-stage oncology company with two lead programs: **GPS (galinpepimut-S)**, a WT1-targeting immunotherapy in pivotal Phase 3 **REGAL** (AML CR2 maintenance), and **SLS-009 (tambiciclib)**, a selective CDK9 inhibitor in Phase 2 for AML (r/r + frontline expansion).

**Bull case (verified elements):** REGAL event pace (60 → 72 → 78 of 80) is slower than design assumptions; the Aug 11 update still said “approaching” 80; IDMC continued at interim; SLS-009 single-arm Ph2 remains favorable against contemporary external controls; $138.3M cash (Jun 2026); WT1 is NCI #1-ranked cancer antigen.

**Bear case (verified elements):** Arm-level REGAL HR is **non-identifiable** from blinded pooled counts; no 80th-event announcement is a public-status signal, not a disclosed event count; Onureg had modest commercial uptake despite a positive trial; rapid dilution took basic shares to ~201.9M; SLS-009 r/r evidence is single-arm, and Fatima 2026 raises its central historical mOS comparator from ~2.5m to 4.0m.

**Model framing:** Header strip uses a **biology-first ELN prognostic mixture** (readout marginal-arm HR ~0.50; Z ~3.09) with **live risk-adj equity $/sh** at default P(GPS)≈65% / P(SLS)≈55%. ELN groups construct marginal survival curves; they are not REGAL efficacy-test strata. Not a price target.

---

## Company & capital structure

| Field | Value | Tag | Source |
|-------|-------|-----|--------|
| Legal name | SELLAS Life Sciences Group, Inc. | verified | SEC filings |
| Cash (Jun 30, 2026) | **$138.3M** | verified | [Q2 2026 10-Q](https://www.sec.gov/Archives/edgar/data/1390478/000139047826000012/sls-20260630.htm) |
| Q2 2026 net loss | **$9.6M**; H1 operating cash use $16.4M | verified | Q2 2026 10-Q |
| Runway | ≥12 months from Q2 2026 filing (going concern) | verified | Q2 2026 10-Q |
| **Basic shares outstanding** | **~201.9M** (Aug 10, 2026) | verified | Q2 2026 10-Q |
| **FD modeled (app default)** | **~217.6M** (basic + 9.712M warrants + 2.649M options + 3.327M RSUs) | partial — model | Q2 2026 10-Q / Tab 3 |
| **ATM dilution stress (model)** | **~241.6M** (~217.6M FD + full $150M ATM at ~$6.25/sh) | partial — model | Valuation dilution-stress preset |
| ATM facility | Up to $150M authorized; unused through Q2 filing | verified | Q2 2026 10-Q |
| 3D Medicines arbitration | SELLAS claims dismissed Jul 24, 2026; ~$1.0M fees allocated to SELLAS | verified | Q2 2026 10-Q |

**Share-count narrative (canonical):** Use **basic outstanding ~201.9M** vs **FD modeled ~217.6M**.

**Equity $/sh identity (model):** `equity $/sh = (EV + cash) / FD shares` — cash default $138.3M.

### Other primary-source updates since 8 Jul 2026

- **Institutional ownership:** Vanguard reported 9,666,278 beneficially owned **warrants** (5.19%) and State Street reported 12,996,558 shares (7%), each as of Jun 30. These are ownership disclosures, not new issuance ([Vanguard 13G](https://www.sec.gov/Archives/edgar/data/1390478/000210011926001315/0002100119-26-001315.txt); [State Street 13G](https://www.sec.gov/Archives/edgar/data/1390478/000009375126000539/primary_doc.xml)).
- **SLS-009 registry:** Jul 29 version 15 changed a contact number only; Sep 3 version 16 expanded locations 26→32 and recruiting sites 10→12 without changing design, enrollment target, endpoints, dose or completion dates ([CT.gov history](https://clinicaltrials.gov/api/int/studies/NCT04588922/history); [version 16](https://clinicaltrials.gov/api/int/studies/NCT04588922/history/16)). This supports enrollment capacity, not efficacy.
- **PDAC posters:** three preclinical SLS-009 abstracts were accepted for AACR Pancreatic Cancer; no numerical efficacy data were disclosed by the cutoff, and proceedings were scheduled for Sep 25 ([SELLAS announcement](https://ir.sellaslifesciences.com/news/News-Details/2026/SELLAS-Life-Sciences-to-Present-Preclinical-Data-on-SLS009-in-Pancreatic-Ductal-Adenocarcinoma-at-the-2026-AACR-Conference-on-Pancreatic-Cancer/default.aspx); [AACR schedule](https://www.aacr.org/meeting/aacr-conference-on-pancreatic-cancer/abstracts/)). Track as exploratory optionality only.
- **Registry negatives:** REGAL had no in-window ClinicalTrials.gov revision ([history](https://clinicaltrials.gov/api/int/studies/NCT04229979/history)); site/contact changes and CTIS estimates do not alter the confirmed 126-randomized/event anchors.

---

## REGAL / GPS (Phase 3)

| Item | Detail | Tag |
|------|--------|-----|
| Trial | REGAL — GPS vs BAT in AML CR2, transplant-ineligible | verified |
| NCT | [NCT04229979](https://clinicaltrials.gov/study/NCT04229979) | verified |
| Design | Event-driven ITT OS, 126 randomized, 1:1, PH design alternative HR 0.636 at 80 deaths (one-sided α=0.025); primary Cox stratified by CR1 duration, poor-vs-other cytogenetics, CR2/CRp2 and MRD | verified — [Jamy & Cicic, *Future Oncol* 2025](https://pmc.ncbi.nlm.nih.gov/articles/PMC11760237/) and Aug 2025 company update |
| Interim | IDMC continued at 60 deaths (Jan 2025); HR ≈0.55 is a model translation of an assumed OBF boundary, not a disclosed result | verified continuation / model interpretation — [interim PR](https://www.globenewswire.com/news-release/2025/01/23/3014244/0/en/SELLAS-Life-Sciences-Announces-Positive-Outcome-of-Interim-Analysis-for-its-Pivotal-Phase-3-REGAL-Trial-of-GPS-in-Acute-Myeloid-Leukemia.html) |
| Event anchors | **60** @ ~m46; **72** @ ~m58; **78** @ ~m63 (11 May 2026) | verified — PRs |
| Final | 80 events — TBD | verified — protocol |
| Modality | WT1 peptide vaccine (MSK license); WT1 = NCI #1 antigen | verified — [Cheever 2009](https://pubmed.ncbi.nlm.nih.gov/19723653/) |

### Protocol dosing nuance

CT.gov currently lists GPS dosing "as follows, until disease relapse": injections 1–6 every 2 weeks (Weeks 0–10), injections 7–12 every 4 weeks (Weeks 14–34), injections 13–15 every 6 weeks (Weeks 40–52), injections 16–20 every 2 months in Year 2, and injection 21+ every 3 months in Year 3; "Patients who remain in remission after 2 years will be treated every 3 months (Q3M) until disease relapse" ([NCT04229979](https://clinicaltrials.gov/study/NCT04229979)). The Jamy/Cicic design paper verifies the 15-injection first-year induction/booster schedule and termination at relapse; CT.gov supplies the extended Year 2/Year 3 maintenance wording. The app valuation `years` input is therefore a **commercial average-duration / prevalence assumption**, not a protocol cap.

### Event anchors and optional status interpretation

| Events | Month | Source | Tag |
|--------|-------|--------|-----|
| 60 | ~46 | Jan 2025 interim PR | verified |
| 72 | ~58 | Dec 2025 PR | verified |
| 78 | ~63 (11 May 2026) | Q1 2026 PR | verified |
| Optional 78–79 interpretation | ~66 (11 Aug 2026) | Model assumption from Q2 phrase “approaching” 80; no numeric count/cutoff disclosed | model assumption (default on; toggle available) |
| No trigger/topline announcement found | ~67.3 (18 Sep 2026) | Official IR/SEC/registry search | partial — announcement status only; reporting can lag |
| 80 | TBD | protocol | verified |

**Model implementation caveats:** the engine uses expected balanced allocation **63/arm** for 126 randomized; the actual arm split is withheld. Independent WCLFU is used in expected observed deaths and risk sets; informative/differential loss is not identified. Patients alive and retained at cutoff are administrative censors, not biological losses, and treatment discontinuation/relapse does not end modeled OS follow-up. The transplant sensitivity moves survivors at a stylized month 6; actual post-randomization transplant timing and outcomes are unavailable. Poisson increments approximate a finite 126-participant event process. Because allocations and effects for the actual analysis factors are unavailable, the model uses an **unstratified marginal-arm score**. Poor cytogenetics is not equivalent to ELN adverse, and ELN labels are not score strata. The former unsourced 0.90 efficiency multiplier was removed. T80 is an event-time distribution; database lock and public announcement may occur later.

### OS follow-up / censoring judgment and central recalibration

- **REGAL-specific fact:** ClinicalTrials.gov says patients enter long-term recurrence and OS follow-up after treatment. Relapse terminates study treatment, not OS observation. The public 66-treatment-discontinuation count therefore cannot be used as 66 OS losses.
- **Regulatory frame:** FDA defines AML OS from randomization to death from any cause and censors a living participant at the last documented survival date. FDA's current oncology OS guidance explicitly distinguishes treatment discontinuation from study withdrawal and calls for continued OS follow-up after discontinuation, subsequent therapy and other intercurrent events.
- **External benchmark:** Parikh et al. (*JNCCN* 2021) found mean withdrawal/consent-loss or LTFU at final analysis of **5.8% experimental** and **8.5% control** among 13 reporting oncology registration trials (ranges **0.7–11.8%** and **1.1–19.2%**). The reporting subset was small and not AML-specific.
- **Judgment:** Best Available Guess now uses **10% independent common-arm OS WCLFU by month 36**, sampled over **2–15%** with SD 3 percentage points. Ten percent intentionally sits above the balanced benchmark (~7.2%) to hedge REGAL's small, international, open-label setting; it is not selected to maximize PoS. Zero is too confident, while the former 26% implied roughly one quarter independently lost by 36 months without supporting evidence.
- **Anchor tension and minimum recalibration:** Simply replacing 26% with 10% while freezing the prior ELN curves predicts about **62.6/78.3/82.2** deaths at m46/m58/m63, over the later anchors. Enrollment was not moved because midpoint 28 already reproduces the reported ~105 enrolled by m33. BAT inputs were not lifted because its modeled 3-year survival already presses historical no-HCT evidence. Instead, the central GPS durable allocations were moved within their predeclared ranges from **60/37/0%** to **74/51/0%** (favorable/intermediate/adverse), restoring the intended mix-weighted GPS durable mass from ~33% to **43.5%**. This one-axis recalibration produces **59.79/74.46/78.09** expected deaths and remains compatible with, but does not exactly hit, 60/72/78; the m58 expectation is high and the blinded arm split means the stronger GPS assignment is structural, not identified.
- **Transplant review:** The central sensitivity is now equal at **12% in both arms**. Later HCT is possible because eligibility excludes only patients with an immediately planned transplant, and ITT OS continues through HCT. The 12% rate and stylized month-6 transition remain assumptions; no REGAL arm-level HCT rate is public.

**Final central outputs (deterministic report, 1,000 draws, seed 85614317):**
- Point scenario at conditional median T80: **HR 0.503593**, **Z 3.090389**, **T80 m68.032990** (approximately Oct 2026).
- Modeled interim at m46: **HR 0.589562**, **Z 2.032229**—above the app's ~0.547 translated early-efficacy line and therefore compatible with the verified continuation; it is not the undisclosed interim result.
- Expected observed deaths: **59.785761 @ m46**, **74.456976 @ m58**, **78.092768 @ m63**, **79.813572 @ m66**. This passes the app's prespecified strict windows but does not force exact anchor equality.
- Continuation-conditioned uncertainty result: **P(significant) 74.4565%**, **P(failure) 25.5435%**; weighted median HR **0.545905**, 90% model interval **[0.477066, 0.634867]**.
- At point T80, modeled biological alive is **11.6286 BAT / 30.3518 GPS**; without an observed death is **13.6672 / 31.5108**; independent-LTFU censored is **3.3647 / 4.7411**. Biological alive overlaps follow-up categories and must not be added to them.
- The conditional T80 distribution is anchored to the disclosed 78-event history; the unanchored smooth point curve has **80.8220 expected observed deaths** at its median T80. That small mismatch is retained rather than forcing the curve through every count.
- These are model outputs under the declared ELN survival-mixture, WCLFU, enrollment, HCT and interim assumptions—not the unavailable stratified Cox result or observed arm-level counts.

### Biology-first vs neutral ridge

| Scenario | Readout HR (model) | Tag |
|----------|-------------------|-----|
| Biology-first ELN mixture | ~**0.50** (Z ~3.09) | model — unstratified marginal-arm score |
| Neutral-anchor ridge fits | ~**0.45–0.64** | model — identifiability ridge |
| HR≈1 “null effect” ridge | Rejected on biology + event pace | rejected |

**Identifiability:** Public data are **pooled** death totals only. Arm-level HR is **non-identified** without the split or strong structural assumptions (**verified** as a statistical fact; any point HR imports priors).

**Control-arm priors:** Kurosawa *Haematologica* 2010 whole-cohort no-HCT 3-yr OS ~14% (not pure CR2; CR2 subgroups higher) — **verified**. Ven-era salvage mOS ~8–12 mo (Stahl 2021) — **verified**.

### Van der Maas private-correspondence sensitivity

u/neo2551 reported a reply attributed to the Van der Maas study group giving **median OS 16.8m (95% CI 12.3–27.4)** and **3-year OS 18.6% (95% CI 10.7–32.2)** for a purportedly REGAL-like non-transplant cohort ([Reddit thread](https://www.reddit.com/r/sellaslifesciences/comments/1w0lasw/aml_cr2_non_transplant_survival_data_over_bbq_van/)). The underlying extract is not public, and the survival origin (relapse, CR2 achievement, or randomization), eligibility mapping and transplant/rescue handling remain unresolved.

The app therefore includes two named, explicitly non-central sensitivities:

- **VDM email — literal pair:** Weibull BAT calibrated to 16.8m/18.6% plus GPS Phase 2 CR2 16.3m/no plateau. It implies roughly 75/95/100 pooled deaths at m46/m58/m63 and marginal-arm readout HR ~0.99, materially overpredicting the announced events.
- **VDM BAT + anchor-fit GPS:** holds the reported BAT curve fixed and fits the app’s GPS family to 60/72/78 plus the optional Aug <80 interpretation. The grid point (~59/74/78 modeled events under the corrected engine) requires an extreme ~61% absolute GPS plateau with ~6.5m post-onset residual median and gives marginal-arm HR ~0.40. This demonstrates structural tension/non-identifiability; it does not validate the email statistics.

Neither scenario changes the central BAT prior.

### HLA / mixed-responder biology sensitivity

Primary sources support a broad but heterogeneous immune-response frame. GPS is a heteroclitic multivalent WT1 peptide vaccine designed for CD4/CD8 responses; the company deck describes CD4/CD8 immune responses across the majority of HLA types and applicability to ~90% of HLA types, while Maslak 2018 reports immune-response testing by CD4 proliferation, CD8 ELISPOT, and HLA-A*02 tetramer assay with 9/14 tested patients (64%) responding in at least one assay ([Blood Advances 2018](https://doi.org/10.1182/bloodadvances.2017014175)). The earlier Maslak pilot explains A*0201 CD8 epitopes plus HLA-DR class-II peptides, with no HLA subtype restriction in eligibility ([Blood 2010](https://pmc.ncbi.nlm.nih.gov/articles/PMC2910606/)). REGAL itself reports only blinded aggregate immunogenicity, not HLA-stratified OS.

Model implication: HLA/responder mix is a **speculative sensitivity**, not the default truth. It can make very high uniform GPS cure assumptions too simple: a moderate durable-responder plateau plus a longer benefited-but-uncured tail may fit biology better than assigning the same cure probability to every GPS patient. Do not treat community HLA decomposition as proven without unblinded, stratified REGAL data.

### Lead-time / left-truncation sensitivity (display only)

REGAL entry requires CR2→randomization **≤6 months** and **>6 months** life expectancy — a positively selected (left-truncated) cohort relative to from-CR2 literature clocks ([Suissa 2008](https://academic.oup.com/aje/article/167/4/492/233064); [CW IRM post](https://www.reddit.com/r/sellaslifesciences/comments/1tnh66g/why_the_randomization_window_leads_to_an/)).

| Clock | Role in app | Tag |
|-------|-------------|-----|
| **From randomization (IRM)** | Primary: `eventsAt`, `passesVerdict`, chart fit, HR gauges | model — locked to PR anchors |
| **Implied CR2-onset** | Display: ≈ max(0, IRM − lead), lead slider 0–6 mo (default **3**) | assumption — sensitivity |

**Does not change:** event engine, biology caps, IA non-stop interpretation, or valuation. Under proportional hazards a common lead-time shift leaves HR unchanged; it only reconciles absolute medians with Stahl/Kurosawa-style from-CR2 benchmarks. Event fit remains a **post-selection cohort** readout.

---

## SLS-009 (tambiciclib / CDK9)

| Item | Detail | Tag |
|------|--------|-----|
| NCT | [NCT04588922](https://clinicaltrials.gov/study/NCT04588922) | verified |
| Setting | Open-label single-arm Ph2 + Aza/Ven, post-Ven r/r AML-MR | verified |
| Key efficacy | ORR 46% (58% 1-prior-line); CR/CRi 29%; least-pretreated mOS **8.9 mo** | verified — ASH 2025 / [SEC 8-K](https://www.sec.gov/Archives/edgar/data/1390478/000139047826000004/sls-202603198xkexhibit991.htm) |
| Historical bench | Sponsor comparator ~2.4–2.6m; Fatima 2026 n=356: **4.0m overall**, 6.0m active Ven-containing salvage, 2.0m supportive care | verified / non-randomized — [Fatima 2026](https://doi.org/10.1038/s41408-026-01612-w) |
| Frontline | Randomized ~80-pt Ph2; **28 enrolled by Aug 11**, topline guided Q4 2026 | verified — [Q2 update](https://ir.sellaslifesciences.com/news/News-Details/2026/SELLAS-Life-Sciences-Reports-Second-Quarter-2026-Financial-Results-and-Provides-Corporate-Update/default.aspx) |
| Evidence grade | Single-arm vs historical — selection, responder association and temporal confounding | partial |

**Rejected:** Treating r/r single-arm OS fold as equivalent to a randomized registrational win.

---

## Valuation framework (model)

| Input | Default | Tag |
|-------|---------|-----|
| GPS starts (CR2 + CR1) | 2,800 + 5,500 /yr | community — CW / SEER funnel |
| GPS pen / price / years | 45% / $145K / 2.8 yr | assumption |
| SLS-009 pools | 9,000 FL + 3,500 r/r | community / estimate |
| SLS pen / price / years | 38% / $145K / 1.4 yr | assumption |
| Multiple | 5× peak | convention (oncology M&A ~4–8×) |
| WT1 platform lump | $2.5B | assumption |
| P(GPS) / P(SLS-009) | 65% / 55% | assumption — user priors |
| Cash | $138.3M | verified |
| FD shares | 217.6M | partial — model |

**Commercial duration caveat:** GPS and SLS-009 `years` inputs are average commercial years on therapy used to estimate the steady-state prevalent treated pool. For GPS, this should not be read as a REGAL protocol maximum: CT.gov extends GPS maintenance to Q2M in Year 2 and Q3M after 2 years until relapse.

**Identities:**

- `Peak = starts × penetration × years × price`
- `EV = (Peak_GPS + Peak_SLS) × multiple + platform` (peaks optionally × P(approval))
- `Equity $/sh = (EV + cash) / FD shares`

**Base risk-adj equity $/sh (app defaults):** ≈ **$46.96** (biology-first valuation preset, P(GPS)=65%, P(SLS)=55%, cash $138.3M, 217.6M FD). Gross @100% success ≈ **$69.13**/sh.

### Comparables

| Comp | Figure | Tag | Lesson |
|------|--------|-----|--------|
| Venclexta (venetoclax) | ~$2.58B sales 2024 | verified — AbbVie SEC | AML blockbuster ceiling |
| Gilead–Forty Seven (magrolimab) | ~$4.9B pre-approval | verified — [SEC](https://www.sec.gov/Archives/edgar/data/1667633/000110465920043980/a20-14980_68k.htm) | Buyers pay big pre-Ph3; Ph3 ENHANCE discontinued 2023 |
| Onureg (QUAZAR) | mOS 24.7 vs 14.8; sales not broken out | verified / partial | Closest GPS analog — clinical win, modest uptake |
| Regor CDK deal | $850M upfront for breast-cancer CDK portfolio; RGT-419B had 2/7 confirmed PR in measurable patients | primary transaction release | Remote M&A comparator—not AML or clinical equivalence |

**Rejected community claims:** “$5–20B guaranteed buyout”; “SLS worth $50+/sh on REGAL alone” without disclosed talks.

### External community model comparators

These are useful public-model comparators, **not model truth** and not arm-level REGAL evidence.

| Comparator | Verified source | What it models | Key takeaways / caveats |
|------------|-----------------|----------------|--------------------------|
| Vola Corvidae | [Article](https://vola-corvidae.com/artikel/monte_carlo_simulations_sls.html) · [code](https://github.com/Vola-Corvidae/medical-trial-Monte-Carlo-simulation) | Patient-level Weibull simulation | Article reports ~**77%**, but recalculation of the checked-in result artifact gives ~45% overall/~37% at the stated shape pair. Wall-clock seeding and artifact mismatch make 77% non-reproducible; sensitivity only. |
| MoAlbaek `Regal_modeling` V2 | [GitHub repo](https://github.com/moalbaek/Regal_modeling) · [result bundle](https://github.com/moalbaek/Regal_modeling/blob/main/data/regal_v2_result_bundle.json) | Seven GPS effect families, BAT strata, joint history likelihood, interim-continuation conditioning, protocol-factor log-rank, ESS gates | Aug 26 production bundle reports **91.97%** under balanced priors (91.53–92.33% across named priors). The bundle validates and tests pass, but posterior concentration in cure/responder-cure families is structural; no HR/T80 posterior is serialized. Named external sensitivity, not this app’s headline. |
| David Pham `regal-fitter` fork | [GitHub](https://github.com/davidpham87/regal-fitter) | Browser fork with final-HR intervals, KM overlays and worker pool | Aug defaults materially changed interim floor and BAT/GPS grids. No versioned result bundle under those defaults; web outputs require exported config/seed to cite quantitatively. |

### Reddit review since the 8 Jul commit

Only public/searchable material is covered; deleted/private comments and private Discord work cannot be audited.

- **BAT heterogeneity/control improvement:** [Confident-Web Jul 9 stress test](https://www.reddit.com/r/sellaslifesciences/comments/1urcojv/bat_4yr_os_and_5yr_os_to_the_actual_fits_and_a/), [bearish response](https://www.reddit.com/r/sellaslifesciences/comments/1urvbsu/heres_why_i_think_confident_webs_due_diligence/), [Remarkable-Big Part A](https://www.reddit.com/r/sellaslifesciences/comments/1uvevrn/remarkablebigs_bat_thread_part_a/) and the [Jul 17 control-drift analogy](https://www.reddit.com/r/sellaslifesciences/comments/1uz4jcp/gps_could_match_its_phase_2_survival_and_still/) support broad both-arm tail sensitivity, not their quoted PoS values.
- **Finite-event power:** the [Jul 12 Schoenfeld post](https://www.reddit.com/r/sellaslifesciences/comments/1uummii/ran_a_schoenfeld_power_coxcompression_model_on/) correctly emphasizes limited information at 80 events; its 63–65% mixture probability uses subjective weights and is not an external probability anchor.
- **Reporting lag:** the [Jul 18 clinical-research discussion](https://www.reddit.com/r/clinicalresearch/comments/1v09xg1/oncology_trial_time_between_final_event_to/) supports separating event time from database-lock/topline timing. Anonymous operational estimates are qualitative only.
- **Independent simulations:** the [Jul 27 Stochasty model](https://www.reddit.com/r/sellaslifesciences/comments/1v7m48i/results_of_a_monte_carlo_regal_simulation/) reported 78.1% raw/89.8% weighted and average HR 0.48, but benefit-constrained priors and simplified interim handling prevent importing those outputs. The [Jul 29 two-subgroup discussion](https://www.reddit.com/r/sellaslifesciences/comments/1v7pl92/) and [Jul 30 structural bear case](https://www.reddit.com/r/sellaslifesciences/comments/1vaqvtv/i_sold_my_sls_position_after_a_year_here_are_the/) reinforce explicit null/both-arm durable-survivor models.
- **Kugler/strong-control sensitivity:** the [Aug 13 reconciliation](https://www.reddit.com/r/sellaslifesciences/comments/1vmya4v/a_kugler_reconciliation_case_for_a_floor_of_gps/) constructs BAT 16m/27% 3-year OS and HR ~0.46–0.47; the source-to-REGAL adjustments and ~81–82% PoS remain model assumptions.
- **neo2551 control series:** [9m](https://www.reddit.com/r/sellaslifesciences/comments/1vrnyen/os_data_for_aml_cr2/), [8.2m](https://www.reddit.com/r/sellaslifesciences/comments/1vxt088/os_aml_cr2_without_transplant_data_82_months/), [10.8m](https://www.reddit.com/r/sellaslifesciences/comments/1vyr6ts/os_aml_cr2_without_transplant_data_multicenter/), [early venetoclax](https://www.reddit.com/r/sellaslifesciences/comments/1vzn4ll/os_aml_relapse_cr2_data_with_venetoclax_early/) and [Van der Maas correspondence](https://www.reddit.com/r/sellaslifesciences/comments/1w0lasw/aml_cr2_non_transplant_survival_data_over_bbq_van/) show a wide literature range and unresolved clock/population mapping. Only the VDM figures are added as named private-source sensitivities.
- **September confidence reversal:** [summary](https://www.reddit.com/r/sellaslifesciences/comments/1wdmtjt/the_discord_ddrama/), [moderator explanation](https://www.reddit.com/r/sellaslifesciences/comments/1wdn1cf/addressing_todays_concerns_the_discord_the_models/) and [counterclaim](https://www.reddit.com/r/sellaslifesciences/comments/1wdnqnb/a_couple_things/) report private-model estimates spanning roughly 33–80%. Mechanisms enter sensitivity analysis; private outputs, contributor trades and manipulation allegations do not.
- **Sep 12–13 independent views:** [12–14m BAT](https://www.reddit.com/r/sellaslifesciences/comments/1wedwyb/my_thoughts_on_regal_bat_survival_and_why_i_think/), [8m BAT](https://www.reddit.com/r/sellaslifesciences/comments/1wen7u9/dd_a_realistic_breakdown_of_sls_regal_phase_3_bat/), [constraint analysis](https://www.reddit.com/r/sellaslifesciences/comments/1wf9oku/regal_at_975_eventcount_maturity_gps_appears_more/) and [valuation/odds](https://www.reddit.com/r/sellaslifesciences/comments/1wfa2uw/valuation_odds_and_context_considerations/) remain scenarios. Weighted averages of subgroup medians are rejected as invalid mixture medians.

### New methods and salvage evidence

- **[Fatima 2026](https://doi.org/10.1038/s41408-026-01612-w) (n=356):** establishes the 4.0m overall / 6.0m active Ven-salvage / 2.0m supportive-care SLS-009 benchmark mixture; not a REGAL CR2 BAT cohort.
- **[Berdel 2026 HAM-VEN](https://doi.org/10.3324/haematol.2026.301102)** and **[Warraich 2026 post-HCT](https://doi.org/10.1002/ajh.70480):** durable survival is heavily transplant-conditioned; retain a separate transplant tail rather than lifting no-HCT BAT.
- **[Dumas 2026](https://doi.org/10.1111/bjh.70815) (n=317):** modern first-relapse salvage achieved similar CR2 and OS across VEN-AZA/cytarabine strategies, but roughly 55% of CR2 responders received HCT; no direct REGAL BAT-median change.
- **[Zhao 2026](https://doi.org/10.1016/j.jclinepi.2026.112439)** supports the app’s RMST output because updated oncology HRs were less stable under non-PH. **[Okumura 2026](https://doi.org/10.1093/jjco/hyag133)** supports piecewise/time-varying sensitivity; the existing delayed-effect/Fleming-Harrington controls remain sensitivity analyses rather than a new primary estimand.

---

## Epidemiology

| Fact | Value | Tag |
|------|-------|-----|
| US AML incidence | ~20,800/yr (SEER); ~22,720 (ACS 2026) | verified |
| Relapse after CR | >60% | verified — ACS |
| CR2 / CR1-nontransplant pools | ~3K / ~6K new/yr | community — CW DD from SEER funnel |

---

## WT1 platform

| Fact | Tag | Source |
|------|-----|--------|
| WT1 #1-ranked cancer antigen (NCI working group) | verified | [Cheever 2009](https://pubmed.ncbi.nlm.nih.gov/19723653/) |
| GPS multivalent HLA/CD4/CD8 design and heterogeneous immune response | verified / partial | [Maslak 2018](https://doi.org/10.1182/bloodadvances.2017014175) · [Maslak 2010](https://pmc.ncbi.nlm.nih.gov/articles/PMC2910606/) · SELLAS corp deck |
| GPS follow-ons: ovarian (Ph2 completed), mesothelioma, GPS-Plus, China license | verified | [Corp deck Feb 2026](https://s203.q4cdn.com/139585304/files/doc_presentations/2026/Feb/03/Sellas-Corporate-Overview-February-2026.pdf) |
| SLS-009 is CDK9, **not** WT1-targeted | verified | Company disclosures |

---

## Tag legend

| Tag | Meaning |
|-----|---------|
| **verified** | Primary source (SEC, PR, CT.gov, peer-reviewed) supports the claim as stated |
| **partial** | Directionally supported but incomplete, qualitative, or confounded |
| **community** | DD / Reddit synthesis — useful prior, not a filing fact |
| **rejected** | Contradicted by primary sources or statistically indefensible |
| **model** | App output / structural assumption — scenario, not a forecast |

---

## Primary references

1. [REGAL design — Jamy & Cicic, *Future Oncol* 2025 (PMC11760237)](https://pmc.ncbi.nlm.nih.gov/articles/PMC11760237/)
2. [REGAL CT.gov NCT04229979](https://clinicaltrials.gov/study/NCT04229979)
3. [SLS-009 CT.gov NCT04588922](https://clinicaltrials.gov/study/NCT04588922)
4. [Q1 2026 financials / 78-event update](https://www.globenewswire.com/news-release/2026/05/12/3293399/0/en/sellas-life-sciences-reports-first-quarter-2026-financial-results-and-provides-corporate-update.html)
5. [Q1 2026 10-Q](https://www.sec.gov/Archives/edgar/data/1390478/000139047826000008/sls-20260331.htm)
6. [Cheever 2009 — WT1 antigen ranking](https://pubmed.ncbi.nlm.nih.gov/19723653/)
7. [Gilead–Forty Seven SEC EX-99.1](https://www.sec.gov/Archives/edgar/data/1667633/000110465920043980/a20-14980_68k.htm)
8. [QUAZAR / Onureg — Wei et al., NEJM 2020](https://www.nejm.org/doi/full/10.1056/NEJMoa2001094)
9. [VIALE-A — DiNardo et al., NEJM 2020](https://pubmed.ncbi.nlm.nih.gov/32023337/)
10. [Kurosawa et al., *Haematologica* 2010](https://haematologica.org/article/view/5781)
11. [SELLAS corp deck Feb 2026](https://s203.q4cdn.com/139585304/files/doc_presentations/2026/Feb/03/Sellas-Corporate-Overview-February-2026.pdf)
12. Community DD framing — [CW Part 1](https://www.reddit.com/r/ValueInvesting/comments/1ri8rrb/sls_deepest_due_diligence_for_regal_trial_from_a/)
13. [Vola Corvidae public REGAL Monte Carlo](https://vola-corvidae.com/artikel/monte_carlo_simulations_sls.html)
14. [MoAlbaek REGAL modeling GitHub](https://github.com/moalbaek/Regal_modeling)
15. [Maslak 2018 — GPS Phase 2 CR1 / immune responses](https://doi.org/10.1182/bloodadvances.2017014175)
16. [Maslak 2010 — WT1 peptide vaccine / HLA rationale](https://pmc.ncbi.nlm.nih.gov/articles/PMC2910606/)
17. [Q2 2026 financials / REGAL “approaching 80” update](https://ir.sellaslifesciences.com/news/News-Details/2026/SELLAS-Life-Sciences-Reports-Second-Quarter-2026-Financial-Results-and-Provides-Corporate-Update/default.aspx)
18. [Q2 2026 10-Q](https://www.sec.gov/Archives/edgar/data/1390478/000139047826000012/sls-20260630.htm)
19. [Fatima et al. 2026 — outcomes after frontline Ven-HMA failure](https://doi.org/10.1038/s41408-026-01612-w)
20. [Berdel et al. 2026 — HAM-VEN salvage](https://doi.org/10.3324/haematol.2026.301102)
21. [Warraich et al. 2026 — post-Ven-HMA transplant outcomes](https://doi.org/10.1002/ajh.70480)
22. [Dumas et al. 2026 — VEN-AZA vs cytarabine salvage](https://doi.org/10.1111/bjh.70815)
23. [Zhao et al. 2026 — RMST versus HR stability](https://doi.org/10.1016/j.jclinepi.2026.112439)
24. [Okumura et al. 2026 — piecewise Bayesian non-PH analysis](https://doi.org/10.1093/jjco/hyag133)
25. [FDA — Approaches to Assessment of Overall Survival in Oncology Clinical Trials](https://www.fda.gov/media/188274/download)
26. [Parikh et al. 2021 — withdrawal, LTFU, discontinuation and censoring in oncology trials](https://doi.org/10.6004/jnccn.2021.7015)

Full clickable lists also live in each app tab’s **References** and the **Explain** tab (ELI5 → PhD).