SELLAS Anticipates Key Data from REGAL Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 12 2026
0mins
"The first quarter of 2026 marked an important period for SELLAS as we continued to execute across our clinical programs while preparing for the anticipated pivotal Phase 3 REGAL trial data readout," said Angelos Stergiou, CEO. "We are grateful for the ongoing commitment of the patients, caregivers, and investigators participating in the pivotal Phase 3 REGAL trial and we believe that the upcoming results, triggered by reaching the pre-specified 80th event, will be an important milestone for the Company. In parallel, we are generating increasingly compelling data with SLS009, including recent preclinical findings presented at AACR demonstrating potent, mechanistically driven activity in AML through suppression of key survival pathways such as MCL-1 and induction of apoptosis, including in high-risk genetic subtypes like TP53 and ASXL1 mutations. Importantly, we have begun dosing patients in our Phase 2 study of SLS009 in newly diagnosed, first-line AML, targeting high-risk populations unlikely to benefit from standard therapies, including venetoclax. With REGAL approaching its critical readout and SLS009 advancing across clinical and translational fronts, we believe that SELLAS is entering an exciting time with multiple, high-value potential catalysts that could transform the AML treatment landscape."
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Analyst Views on SLS
Wall Street analysts forecast SLS stock price to fall
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 9.180
Low
7.00
Averages
7.25
High
7.50
Current: 9.180
Low
7.00
Averages
7.25
High
7.50
About SLS
SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company. The Company is focused on the development of therapeutics for a range of cancer indications. The Company's product candidates are galinpepimut-S (GPS), a peptide immunotherapy directed against the Wilms tumor 1 (WT1), antigen, and SLS009, a selective small molecule cyclin-dependent kinase 9 (CDK9) inhibitor. GPS is a cancer immunotherapeutic agent licensed by Memorial Sloan Kettering Cancer Center (MSK), that targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy or in combination with other immunotherapeutic agents to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is developing SLS009, which is licensed by GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of mainland China, Hong Kong, Macau, and Taiwan.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Sellas Life Sciences Gains Cramer’s Bullish Endorsement
- Cramer’s Endorsement: CNBC's Jim Cramer labeled Sellas Life Sciences as a 'great spec' during Mad Money, giving it 'two thumbs up,' which contributed to a 7% surge in the stock on Thursday and an additional 2% rise in pre-market trading on Friday.
- Regal Trial Data Imminent: The Phase 3 Regal trial evaluating GPS in AML patients is nearing critical data release, having reached 78 out of 80 events required for final analysis, with CEO Stergiou indicating a higher likelihood of extended survival outcomes than initially projected.
- Progress on SLS009: Beyond GPS, Sellas' second AML drug, SLS009, is also under investor scrutiny, with Stergiou highlighting its 'astonishing' activity in difficult-to-treat AML populations and expecting topline data later this year, which could further bolster investor confidence.
- Retail Investor Sentiment: Retail sentiment for SLS on Stocktwits has turned 'bullish,' with a 50% increase in message volume over 24 hours, reflecting positive market reactions to Cramer’s endorsement and suggesting increased investor interest in the stock.
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- Competitive Landscape: In the drone industry, analysts indicate that other companies may present more attractive investment opportunities, especially with the presidential election potentially driving further growth in the sector.
- Industry Dynamics: Despite Joby Aviation's strong stock performance, analysts express concerns about its profitability, noting that the company is still operating at a loss, which necessitates careful evaluation of its long-term value by investors.
- Investor Confidence Boost: As interest in drone technology rises, Joby Aviation's market visibility improves, leading analysts to adopt an optimistic stance on its future investment prospects, which may attract more investor attention.
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- Clinical Trial Progress: The Regal study has reached 78 events, nearing the trigger for final analysis, with CEO Stergiou noting that the trial's longer-than-expected duration may suggest positive survival outcomes, which is crucial for investor confidence.
- Positive Market Reaction: Sellas shares surged 6% on Wednesday and rose another 2% on Thursday, reflecting strong market anticipation for the upcoming Regal data, which is expected to further boost the company's stock price and market recognition.
- Therapeutic Potential: Stergiou highlighted that GPS could emerge as a maintenance therapy option for AML patients, particularly given the current lack of effective CR2 maintenance treatments, underscoring GPS's importance in addressing unmet medical needs.
See More
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- GPS Therapy Outlook: Sellas's GPS therapy demonstrated a median survival of 21 months in a similar elderly AML population, with CEO Stergiou emphasizing that this supports the upcoming Regal trial, which, if successful, could significantly enhance the company's market position in AML treatment.
- Potential of SLS009: Stergiou highlighted SLS009's strong activity in TP53-mutated and venetoclax-resistant AML patients, with topline data expected later this year, potentially providing a new growth avenue for the company and boosting investor confidence.
- Investor Sentiment Optimistic: With SLS stock surging 330% over the past year, retail sentiment on Stocktwits remains extremely bullish, reflecting strong market anticipation for Sellas's future developments, especially ahead of the upcoming Regal trial data release.
See More
Sellas Nears Critical Data Milestone in AML Trial
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- Financial Status: In Q1, Sellas reported a net loss of $8.4 million, primarily due to increased R&D spending in preparation for a potential FDA filing, indicating the company's commitment to investing in new therapies at a critical juncture.
- Survival Rate Expectations: CEO Stergiou noted that survival trends in the REGAL trial appear stronger than expected, and if GPS can extend median overall survival from 8.1 months to 12.6 months, it will be deemed a success, positioning GPS as the first approved maintenance immunotherapy for AML patients.
- Market Sentiment: Retail sentiment for Sellas has trended 'extremely bullish' on Stocktwits, with high message volumes, as investors view the upcoming 80th event as one of the biggest near-term biotech catalysts, reflecting strong confidence in Sellas's future performance.
See More
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- Financing Dynamics: Retail investors indicated that heavy warrant activity may have injected $20 million to $30 million into Sellas' cash position while helping to clear the stock's warrant overhang, potentially enhancing the company's financial stability.
- Stock Price Volatility: Shares of Sellas Life Sciences plunged 16% on Thursday to close at $7.56, although they rose 4% in extended trading; this volatility sparked intense retail debate over short-term traders locking in profits, highlighting market sentiment fragility.
- Market Sentiment: According to Stocktwits, retail sentiment for Sellas saw a 254% surge in message volume over the past month, reflecting strong investor optimism for the upcoming Regal study data release, despite increased short-term stock price fluctuations.
- Upcoming Data Release: The imminent release of Sellas' Regal study AML data has drawn significant investor attention, with CEO Angelos Stergiou noting that the probability of success may increase over time, providing potential upside for the company's stock price.
See More
Sellas Life Sciences Gains Cramer’s Bullish Endorsement
- Cramer’s Endorsement: CNBC's Jim Cramer labeled Sellas Life Sciences as a 'great spec' during Mad Money, giving it 'two thumbs up,' which contributed to a 7% surge in the stock on Thursday and an additional 2% rise in pre-market trading on Friday.
- Regal Trial Data Imminent: The Phase 3 Regal trial evaluating GPS in AML patients is nearing critical data release, having reached 78 out of 80 events required for final analysis, with CEO Stergiou indicating a higher likelihood of extended survival outcomes than initially projected.
- Progress on SLS009: Beyond GPS, Sellas' second AML drug, SLS009, is also under investor scrutiny, with Stergiou highlighting its 'astonishing' activity in difficult-to-treat AML populations and expecting topline data later this year, which could further bolster investor confidence.
- Retail Investor Sentiment: Retail sentiment for SLS on Stocktwits has turned 'bullish,' with a 50% increase in message volume over 24 hours, reflecting positive market reactions to Cramer’s endorsement and suggesting increased investor interest in the stock.
See More
Investor Sentiments on Joby Aviation
- Investment Outlook: Joby Aviation is viewed as a promising investment, although market sentiment remains cautious; analysts suggest that the upcoming investment wave in the drone sector could benefit Joby significantly.
- Competitive Landscape: In the drone industry, analysts indicate that other companies may present more attractive investment opportunities, especially with the presidential election potentially driving further growth in the sector.
- Industry Dynamics: Despite Joby Aviation's strong stock performance, analysts express concerns about its profitability, noting that the company is still operating at a loss, which necessitates careful evaluation of its long-term value by investors.
- Investor Confidence Boost: As interest in drone technology rises, Joby Aviation's market visibility improves, leading analysts to adopt an optimistic stance on its future investment prospects, which may attract more investor attention.
See More
Sellas CEO Optimistic About GPS Data for NCCN Recognition
- Survival Data Highlights: Sellas reported that GPS treatment shows a median survival of 35.5 months in older AML patients, compared to just 5.4 months for those not receiving GPS, indicating significant potential for extending survival and possibly enhancing NCCN guideline recognition.
- Clinical Trial Progress: The Regal study has reached 78 events, nearing the trigger for final analysis, with CEO Stergiou noting that the trial's longer-than-expected duration may suggest positive survival outcomes, which is crucial for investor confidence.
- Positive Market Reaction: Sellas shares surged 6% on Wednesday and rose another 2% on Thursday, reflecting strong market anticipation for the upcoming Regal data, which is expected to further boost the company's stock price and market recognition.
- Therapeutic Potential: Stergiou highlighted that GPS could emerge as a maintenance therapy option for AML patients, particularly given the current lack of effective CR2 maintenance treatments, underscoring GPS's importance in addressing unmet medical needs.
See More
Sellas Life Sciences CEO Highlights New AML Treatment Data
- Survival Rates in AML: Recent data reveals that while 63% of high-risk elderly AML patients achieved remission at MD Anderson Cancer Center, only 15% proceeded to stem cell transplants, indicating a significant gap in effective treatment options that could hinder the company's therapeutic strategy.
- GPS Therapy Outlook: Sellas's GPS therapy demonstrated a median survival of 21 months in a similar elderly AML population, with CEO Stergiou emphasizing that this supports the upcoming Regal trial, which, if successful, could significantly enhance the company's market position in AML treatment.
- Potential of SLS009: Stergiou highlighted SLS009's strong activity in TP53-mutated and venetoclax-resistant AML patients, with topline data expected later this year, potentially providing a new growth avenue for the company and boosting investor confidence.
- Investor Sentiment Optimistic: With SLS stock surging 330% over the past year, retail sentiment on Stocktwits remains extremely bullish, reflecting strong market anticipation for Sellas's future developments, especially ahead of the upcoming Regal trial data release.
See More
Sellas Nears Critical Data Milestone in AML Trial
- Trial Progress: Sellas' REGAL trial in acute myeloid leukemia (AML) is only two events away from reaching the topline data readout stage, having recorded 78 deaths so far, with analysis expected to begin after the 80th event, which could significantly enhance GPS's market prospects.
- Financial Status: In Q1, Sellas reported a net loss of $8.4 million, primarily due to increased R&D spending in preparation for a potential FDA filing, indicating the company's commitment to investing in new therapies at a critical juncture.
- Survival Rate Expectations: CEO Stergiou noted that survival trends in the REGAL trial appear stronger than expected, and if GPS can extend median overall survival from 8.1 months to 12.6 months, it will be deemed a success, positioning GPS as the first approved maintenance immunotherapy for AML patients.
- Market Sentiment: Retail sentiment for Sellas has trended 'extremely bullish' on Stocktwits, with high message volumes, as investors view the upcoming 80th event as one of the biggest near-term biotech catalysts, reflecting strong confidence in Sellas's future performance.
See More
Sellas Stock Volatility and Financing Dynamics
- Financing Dynamics: Retail investors indicated that heavy warrant activity may have injected $20 million to $30 million into Sellas' cash position while helping to clear the stock's warrant overhang, potentially enhancing the company's financial stability.
- Stock Price Volatility: Shares of Sellas Life Sciences plunged 16% on Thursday to close at $7.56, although they rose 4% in extended trading; this volatility sparked intense retail debate over short-term traders locking in profits, highlighting market sentiment fragility.
- Market Sentiment: According to Stocktwits, retail sentiment for Sellas saw a 254% surge in message volume over the past month, reflecting strong investor optimism for the upcoming Regal study data release, despite increased short-term stock price fluctuations.
- Upcoming Data Release: The imminent release of Sellas' Regal study AML data has drawn significant investor attention, with CEO Angelos Stergiou noting that the probability of success may increase over time, providing potential upside for the company's stock price.
See More
