Sellas Lifesciences - Cancer Moonshot in the process of squeezing! Hand written DD!

Disclaimer: This is for entertainment and information purposes only. I might be a moron, do your own research, not financial advice. Biotech is inherently risky, invest at your own discretion. TLDR: Severely undervalued biotech with strong clinically proven pipeline, platform potential, powerful partnerships, healthy financials and explosive set up with high short interest, cost to borrow, insane call volume, REG-SHO threshold, potentially negative free float!!! De-risked pipeline with two shots on goal, clear survival benefits, two first in class drugs with multi-cancer potential… The pipeline:  SLS has two candidates in the pipeline, their lead P3 asset Galinpepimut-S(GPS) is an antigen-based immunotherapy against the WT1 target.  WT1 is present in 20+ cancers from blood to ovarian, oesophageal, lung,... The national cancer institute designated it the most important and most promising immunotherapy target to research! [https://pmc.ncbi.nlm.nih.gov/articles/PMC5779623/](https://pmc.ncbi.nlm.nih.gov/articles/PMC5779623/) The drug was developed at Memorial Sloan Kettering Cancer Center using a completely novel approach. It is composed of four peptide strands, the peptides were artificially mutated to create a stronger immune response and tested in computer simulations.  It is paired with an immunostimulant adjuvant and targets both helper and killer lymphocytes for a durable full spectrum immune response.  The drug design fulfills all criteria for the perfect therapeutic of the future if you read the concluding part of this review: [https://pmc.ncbi.nlm.nih.gov/articles/PMC7950068/](https://pmc.ncbi.nlm.nih.gov/articles/PMC7950068/) Earlier trials not only demonstrated the strong and broad immune responses but also showed a statistically significant survival benefit in acute myeloid leukemia CR2 (21 months vs expected 4 months).  GPS is currently evaluated in the phase 3 REGAL trial in very sick AML patients in second remission not able to get a stem cell transplant.  [https://pubmed.ncbi.nlm.nih.gov/39606837/](https://pubmed.ncbi.nlm.nih.gov/39606837/) Stem-cell transplant is the only cure for AML right now! Patients who are too sick or unable to get a transplant for other reasons have dismal outcomes and almost all of them die within a year or less.  New drugs such as Venetoclax can enable patients to reach transplant but in the absence of transplant they don’t produce durable survival outcomes. Expected median overall survival in these cohorts is around 8 months. [https://onlinelibrary.wiley.com/doi/10.1111/bjh.18229](https://onlinelibrary.wiley.com/doi/10.1111/bjh.18229) [https://acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.34608](https://acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.34608) GPS is compared to the physician's best choice of treatment(BAT) as there are no currently approved drugs in this setting!  BAT can consist of Venetoclax containing regiments, low dose chemo or even observation! The trial is event driven, meaning the timing of readouts depends on the death rate of patients. The statistical analysis plan involves 90% power at final analysis with 80 deaths and a HR of 0,64 and 12,6 months mOS vs 8 months… An interim analysis was conducted when 60 out of 127 patients were deceased in 12/2024, at this point pooled median survival was already exceeding 13,5 months showing increased survival in the whole cohort. Here's the kicker: On 12/26/2025 one year after the IA there were only 72 patients confirmed deceased!   These survival numbers are completely unheard off! Factoring in the fact that about 25% of control patients are on observation only and the fact that none of the other available BAT drugs have demonstrated improved survival or even got FDA approval in this setting its safe to conclude that Galinpepimut is driving survival!  These interim snapshots significantly de-risk the REGAL trial! [https://www.globenewswire.com/news-release/2025/12/29/3210926/0/en/SELLAS-Life-Sciences-Provides-Update-on-Pivotal-Phase-3-REGAL-Trial-of-Galinpepimut-S-GPS-in-Acute-Myeloid-Leukemia-AML.html](https://www.globenewswire.com/news-release/2025/12/29/3210926/0/en/SELLAS-Life-Sciences-Provides-Update-on-Pivotal-Phase-3-REGAL-Trial-of-Galinpepimut-S-GPS-in-Acute-Myeloid-Leukemia-AML.html) The secondary asset is a small molecule cancer drug targeting CDK9 called Tambiciclib/SLS009.  Like GPS it is first in class as it is the only highly selective, non-toxic CDK9 inhibitor in clinical trials right now. Older CDK9 inhibitors failed because of toxicity, SLS009 showed no dose limiting toxicities at three times the active dose. A phase II in acute myeloid leukemia patients resistant to conventional therapies showed a remarkable survival benefit and far exceeded the bench marks for efficacy, patients expected to live 2,5 months lived for over 8 months, this prompted the FDA to move SLS009 into a frontline AML trial. The P2 is still ongoing and involves pediatric patients, a strong signal that the FDA believes in the safety and efficacy. [https://www.cancernetwork.com/view/tambiciclib-displays-survival-benefit-enhanced-orr-in-aml-mrc](https://www.cancernetwork.com/view/tambiciclib-displays-survival-benefit-enhanced-orr-in-aml-mrc) SLS009 like GPS is a multi-cancer play and has shown promise in pre-clinical trials in colon cancer. It works very well in TP53 mutated cell lines that are resistant to most conventional chemotherapeutics and specifically targets ASX1 mutations found across many different tumors. [https://ashpublications.org/blood/article/146/Supplement%201/6802/556150/Tambiciclib-SLS009-a-novel-potent-CDK9-inhibitor](https://ashpublications.org/blood/article/146/Supplement%201/6802/556150/Tambiciclib-SLS009-a-novel-potent-CDK9-inhibitor) [https://ascopubs.org/doi/10.1200/JCO.2025.43.16\_suppl.3121](https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3121) All in all the pipeline is very strong, two first in class multi-cancer drugs with promising pre-clinical and clinical data. Both drugs met hard survival based endpoints in previous trials as opposed to surrogate parameters. Both drugs have orphan designation signalling unmet need and regulatory confidence.  Both are currently being evaluated in AML because the unmet need is greatest and a survival benefit can rapidly be demonstrated, opening the door for further applications. SLS is partnered with Thermo-Fisher for the REGAL trial, the leading developer and manufacturer of advanced molecular diagnostics. This partnership provides the platform to rapidly identify patients who are likely to benefit from their drugs.  [https://www.thermofisher.com/de/de/home/clinical/preclinical-companion-diagnostic-development/oncomine-oncology/ngs-hemato-oncology/rapid-ngs-myelomatch-trial.html](https://www.thermofisher.com/de/de/home/clinical/preclinical-companion-diagnostic-development/oncomine-oncology/ngs-hemato-oncology/rapid-ngs-myelomatch-trial.html) [https://www.pfizer.com/news/press-release/press-release-detail/thermo-fisher-scientific-pfizer-partner-expand-localized](https://www.pfizer.com/news/press-release/press-release-detail/thermo-fisher-scientific-pfizer-partner-expand-localized) This allows a big pharma buyer to easily unlock the full potential of both drugs by applying for biomarker based approval. GPS can rapidly expand into AML first remission, myelodysplastic syndromes, solid tumors... This pipeline instantly positions a buyer as the strongest player in precision-oncology!  Big pharma is facing a massive patent cliff, the top selling drug Keytruda is raking in 25B in annual revenue and will become available cheaply in a year. GPS is the next big thing in immunotherapies and comes at the perfect time to fill the gap Keytruda is leaving.  GPS has been tested in combination with immune checkpoint inhibitors such as Keytruda with promising results and could indirectly extend the patent by taking over a large market share. [https://www.targetedonc.com/view/phase-1-study-of-galinpepimut-s-and-nivolumab-meets-primary-end-point-in-mpm](https://www.targetedonc.com/view/phase-1-study-of-galinpepimut-s-and-nivolumab-meets-primary-end-point-in-mpm) SLS is in a strong position with slim management, low cash burn, zero debt, runway into 2027… [https://ir.sellaslifesciences.com/news/News-Details/2025/SELLAS-Life-Sciences-Reports-Third-Quarter-2025-Financial-Results-and-Provides-Corporate-Update/default.aspx](https://ir.sellaslifesciences.com/news/News-Details/2025/SELLAS-Life-Sciences-Reports-Third-Quarter-2025-Financial-Results-and-Provides-Corporate-Update/default.aspx) Why is this company so damn cheap? As a small cap bio SLS had to raise capital in the past and was forced to resort to abusive hedge funds in the form of Anson capital. These entities abused dilutive funding to cover their naked shorts and kill retail sentiment. [https://www.trustnodes.com/2025/11/03/gme-shortseller-turns-on-anson-as-tradfi-dirt-spills-out](https://www.trustnodes.com/2025/11/03/gme-shortseller-turns-on-anson-as-tradfi-dirt-spills-out) The tables are now turning however, the stock is trading at 3 year highs as the market starts waking up to the increased survival.  Most of the short positions are underwater, institutional ownership is at an all time high, the put/call ratio is at 0,04, cost to borrow is well into the triple digits, almost no short shares are available, SLS is listed on REG-SHO, textbook short-squeeze set up… [https://fintel.io/so/us/sls](https://fintel.io/so/us/sls) [https://www.nasdaqtrader.com/trader.aspx?id=regshothreshold](https://www.nasdaqtrader.com/trader.aspx?id=regshothreshold) The float of 140 million shares is extremely stretched with close to 60 million shares open interest in calls, 40 million shares sold short(likely 60M+ with the fail to deliver and dark pool volume), 37M institutional ownership and a large number of retail diamond hands determined to hold until a buyout is announced… This stock is still trading well below par value at this stage with \~500M market cap, the gamma and short exposure alone is enough to send this to the double digits ahead of data readouts and the data is de-risked and potentially revolutionary. This type of set up is extremely rare and explosive! DYOR! NFA! Good luck everyone.