Latest news with #AML
Iraq Business
8 hours ago
- Business
- Iraq Business
IMF Explains Iraq's Exchange Rate Arrangement
By John Lee. The International Monetary Fund (IMF) has issued a brief explainer on Iraq's exchange rate arrangement. As part of a follow-up to last week's report on the state of the Iraqi economy, the IMF clarified as follows: " Exchange Rate Arrangement "Iraq's de jure and de facto exchange rate arrangements are classified as a conventional peg arrangement. The Central Bank Law gives the Board of the Central Bank of Iraq (CBI) the authority to formulate exchange rate policy. "Effective February 8, 2023, the official exchange rate was set at ID 1,320 according to the closing prices of the daily bulletin of gold & main currencies published on the CBI website ( "There has been a change to Iraq's exchange system since the last Article IV Consultation. Iraq continues to avail itself of the transitional arrangements under Article XIV, Section 2 but no longer maintains any restrictions under this provision. Iraq does not maintain any current account exchange restrictions or MCPs [Managed Currency Pegs]. Starting January 2025, all international transactions have been routed through commercial banks via their correspondent banking relationships (CBRs). "The Central Bank of Iraq (CBI) replenishes these balances weekly based on foreign exchange demand and conducts audits to ensure that the allocated funds are used in compliance with AML/CFT regulations. Private banks are also encouraged to broaden their CBR networks, particularly with non-U.S. financial institutions. " Click here to download the full report. To browse our comprehensive library of reports on Iraq, click here. (Source: IMF)
See - Sada Elbalad
14 hours ago
- Business
- See - Sada Elbalad
Amid Rising Gold Price Disparity, Vietnamese Economist Urges Flexible Government Intervention for Market Stability
Waleed Farouk As the gap between domestic and global gold prices widens, Associate Professor Nguyen Huu Huan of the University of Economics in Ho Chi Minh City has called for flexible and phased government policies to regulate Vietnam's gold market. In an interview with Vietnam Economic Times, he emphasized the importance of balancing domestic market stability with the country's growing financial openness. Containing the Price Gap Between Domestic and Global Gold Markets Dr. Huan believes that proposals to increase gold imports to reduce the domestic-global price gap pose risks to foreign exchange reserves and exchange rate stability. Instead, he suggests that gold import quotas for licensed companies be tied to periods of trade or balance-of-payments surpluses, allowing for more imports when the economy is flush and limiting them during deficits. He also emphasized that import rights should remain with specialized gold businesses, selected based on their financial strength, production capacity, and market reputation. Granting import rights to state-owned banks, which are not directly engaged in gold trading, would create unnecessary intermediaries and widen the price gap. He further warned against repeating the pre-Decree No. 24 (issued in 2012) scenario, when excessive liberalization led to a proliferation of counterfeit and low-quality gold due to weak regulatory oversight. A Gold Credit Market: Unlocking Idle Capital for Development Dr. Huan proposed establishing a gold credit market as a mechanism to mobilize idle gold reserves hoarded by individuals and convert them into productive capital. Under this system, depositors would receive State Bank of Vietnam (SBV)-guaranteed gold ownership certificates, which could be traded or redeemed for physical gold later. This mechanism would enhance the government's ability to fund major infrastructure projects, such as high-speed railways and metro lines, without relying on foreign debt. It would also curb speculative behavior and reduce the public's demand for physical gold. In this context, Dr. Huan sees the creation of a gold exchange as a crucial step toward formalizing gold trading. Gold accounts could be linked to global benchmark prices, thereby narrowing the domestic-global price spread to less than 1%. A Roadmap for Building a Modern Gold Exchange in Vietnam Dr. Huan advocates a phased and cautious approach to developing Vietnam's gold exchange. This would begin with establishing a clear legal framework, including rules for trading, quality standards, custody and settlement mechanisms, and anti-money laundering (AML) protocols. He recommends starting with non-physical gold trading, supervised by the SBV and implemented through major financial institutions, to test digital infrastructure and settlement systems. Once this foundation is secure, physical gold trading could be introduced. In the medium term, advanced financial instruments such as futures and options could be added, while gradually broadening participation to include banks, investment institutions, and qualified retail investors. In the long term, Vietnam could offer complementary gold-backed financial services, including gold loans, insurance, and asset management. Linking the domestic gold exchange to international markets would further enhance Vietnam's status in the global financial system. Risk Management: A Pillar of Market and Financial System Stability The report stresses the need for robust regulatory oversight to prevent speculation, manipulation, and money laundering in the gold market—factors that could undermine macroeconomic stability and investor confidence. Recommended measures include establishing early warning systems, setting daily trading limits, regulating financial leverage, and integrating the exchange with the official banking settlement system. Full market transparency must be ensured through real-time publication of prices, trading volumes, and large transactions. Moreover, Dr. Huan calls for strict enforcement of AML regulations, anti-terror financing laws, and know-your-customer (KYC) protocols, especially for high-risk foreign transactions. Recommended Location: Ho Chi Minh City's International Financial Center The report concludes by recommending that the gold exchange be headquartered at the International Financial Center (IFC) in Ho Chi Minh City, citing its superior financial infrastructure, skilled workforce, and global market connectivity. Positioning the exchange in the IFC would attract international financial institutions, boost liquidity, and enhance market competitiveness. It would also support the development of a secure, digital, and transparent gold market that serves both investor needs and the broader goal of macroeconomic stability. read more CBE: Deposits in Local Currency Hit EGP 5.25 Trillion Morocco Plans to Spend $1 Billion to Mitigate Drought Effect Gov't Approves Final Version of State Ownership Policy Document Egypt's Economy Expected to Grow 5% by the end of 2022/23- Minister Qatar Agrees to Supply Germany with LNG for 15 Years Business Oil Prices Descend amid Anticipation of Additional US Strategic Petroleum Reserves Business Suez Canal Records $704 Million, Historically Highest Monthly Revenue Business Egypt's Stock Exchange Earns EGP 4.9 Billion on Tuesday Business Wheat delivery season commences on April 15 News Israeli-Linked Hadassah Clinic in Moscow Treats Wounded Iranian IRGC Fighters News China Launches Largest Ever Aircraft Carrier Sports Former Al Zamalek Player Ibrahim Shika Passes away after Long Battle with Cancer Videos & Features Tragedy Overshadows MC Alger Championship Celebration: One Fan Dead, 11 Injured After Stadium Fall Lifestyle Get to Know 2025 Eid Al Adha Prayer Times in Egypt News "Tensions Escalate: Iran Probes Allegations of Indian Tech Collaboration with Israeli Intelligence" News Flights suspended at Port Sudan Airport after Drone Attacks Arts & Culture Hawass Foundation Launches 1st Course to Teach Ancient Egyptian Language Videos & Features Video: Trending Lifestyle TikToker Valeria Márquez Shot Dead during Live Stream Technology 50-Year Soviet Spacecraft 'Kosmos 482' Crashes into Indian Ocean
Yahoo
18 hours ago
- Business
- Yahoo
SELLAS Meets All Primary Endpoints in Phase 2 Trial of SLS009 in r/r AML and Receives FDA Guidance to Advance into First-Line Therapy Study
The Trial Exceeded Target Overall Response Rate (ORR) of 20%, with 44% Response Rate Among Patients with Acute Myeloid Leukemia-Myelodysplasia-Related Changes (AML MR) Treated at Optimal Dose of 30 mg Twice a Week (BIW) and 50% in AML MR with Myelomonocytic/Myelomonoblastic (M4/M5) Subtype Median Overall Survival (mOS) of 8.9 Months in Patients with AML MR and 8.8 mOS in Relapsed or Refractory to Venetoclax-Based Regimens at 30 mg BIW Dose Level Surpasses the Historical Benchmark of 2.4 Months FDA Recommends Advancement towards a Trial Including Newly Diagnosed First-Line AML Patient Cohorts That May Support a New Drug Application; Trial Preparation Underway with Enrollment Expected to Begin by Q1 2026 NEW YORK, July 15, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ('SELLAS' or the 'Company'), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that is has met all primary endpoints in its Phase 2 trial of SLS009 (tambiciclib), a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML). The Phase 2 clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels, 45 mg and 60 mg. In the 60 mg dose cohort, patients were treated with either a 60 mg dose once per week or a 30 mg dose two times per week. The trial was expanded to include ASXL1-mutated AML patients as well as patients with myelodysplasia-related cytogenetic abnormalities other than ASXL1 mutations. The target response rate for this Phase 2 trial, at the optimal dose level, was at least 20% and a target median survival of at least 3 months. The primary endpoint for the trial was overall response rate (ORR), and key secondary endpoints included overall survival (OS), safety, and tolerability. The trial met all endpoints, demonstrating strong efficacy and favorable safety and tolerability with robust anti-tumor activity. Based on these data, the Company plans to advance SLS009 into a randomized trial that will expand into the newly diagnosed AML populations where earlier intervention may enhance therapeutic outcomes, as well as patients refractory to venetoclax and azacitidine, with the study to support a potential New Drug Application (NDA) with the FDA. 'We are excited to report that our Phase 2 trial met all key endpoints, with clinical responses and survival outcomes that exceed targeted expectations and historical benchmarks,' said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. 'AML remains an area of urgent unmet medical need, particularly for patients with relapsed or refractory disease, where standard treatments are often ineffective and poorly tolerated. What sets SLS009 apart is its consistent efficacy across a broad range of molecular subtypes. The remarkable response rates of 44% among AML MR patients, 50% among ASXL1-mutated AML MR, and 50% among M4/M5 patients at the optimal 30 mg BIW dose far exceed the targeted 20% benchmark. We saw a clear survival benefit with median OS reaching 8.8 months in patients refractory to venetoclax-based regimens in the cohort of patients with median 1 prior line of therapy, surpassing the historical median of 2.4 months and 4.1 months in cohorts with median 2 lines of prior therapy, versus 1.8 months reported in similar patient population. The treatment was also well-tolerated, with no dose-limiting toxicities across any treatment arm, validating both the biological selectivity and safety profile of our approach. We believe these data strongly support the potential of SLS009 to meaningfully extend life in patients with otherwise limited options, and we look forward to sharing these findings in more detail in the future. With the expected Phase 3 REGAL study final analysis by year-end, our galinpepimut-S (GPS) immunotherapy and SLS009 are complementary therapies that together enable us to hopefully address AML patients across the treatment spectrum — from early intervention to maintenance.' Key Phase 2 Results: Patients Characteristics: 54 evaluable r/r AML patients who previously failed venetoclax-based therapies were enrolled and treated with SLS009, and venetoclax/azacitidine; patients were enrolled across all five cohorts. Among the 54 treated patients, 47 had AML MR (87%) and 23 had ASXL1 mutations (43%). 47 out of 54 had AML MR (acute myeloid leukemia with myelodysplasia-related changes). Among AML MR patients,17 had myelomonocytic/myelomonoblastic subtype of AML (M4 and M5), representing 31% of all patients. All patients had adverse risk cytogenetics except one patient who had intermediate risk cytogenetics. The median age of all patients was 69. Median number of prior lines of therapy was 2. Efficacy: The results exceeded the pre-specified ORR threshold of 20%, demonstrating robust clinical activity and supporting advancement into late-stage development. The ORR in all evaluable patients was 33% across all cohorts and dose levels and 40% for the 30mg BIW dose level. At the 30 mg BIW dose, among AML MR patients, the ORR was 44%. The highest efficacy was observed among patients with ASXL1 mutations, with an ORR of 50% (9/18) at 30 mg BIW dose levels and M4/M5 patients with 50% (6/12) ORR. The mOS surpassed the historical benchmark of best available therapy of 2.4 months1 for patients who received one prior line of therapy and 1.8 months for those who received more than one prior line of therapy. The mOS for patients treated with 30mg BIW, with a median of 1 prior line of therapy, was 8.8 months, while the mOS in AML MR patients reached 8.9 months vs. 2.4 months with best available therapy. The mOS for cohorts with a median of 2 prior lines of therapies was 4.1 months vs.1.8 months with best available therapy. Safety: The addition of SLS009 to the venetoclax/azacitidine regimen was well tolerated and did not result in increased toxicities compared to ven/aza alone. No dose-limiting toxicities were observed across all dose levels. Front Line Trial Planning Underway Following FDA Guidance Following a productive end of Phase 2 meeting, the FDA recommended that SELLAS proceeds into a trial to include newly diagnosed, first-line AML patients eligible for venetoclax/azacitidine (aza/ven) therapy, where the agency believes clinical benefit might be greatest. The randomized 80-patient trial is currently in preparation and is expected to begin enrollment by Q1 2026. The trial will include two groups: Predictive biomarker cohort: Newly diagnosed patients unlikely to benefit from standard aza/ven therapy based on molecular profiling Early resistance cohort: Patients who initiate treatment with aza/ven but demonstrate confirmed lack of any response after two treatment cycles This precision approach allows SELLAS to target subpopulations with high unmet need and greatest potential for benefit. 'These SLS009 results represent an important advancement for patients with r/r AML, where treatment options remain limited and outcomes are often poor,' said Dr. Yair Levy, Director of Hematologic Malignancies Research at Texas Oncology Baylor University Medical Center. 'The response rates and survival outcomes are particularly compelling, especially given the consistency of responses across high-risk molecular subtypes and the favorable safety profile. What's especially encouraging is the opportunity to now explore this therapy in the first-line setting, where outcomes are often dictated by how patients respond to initial treatment. The FDA's recognition of this unmet need and its support for a trial in newly diagnosed patients reflects SLS009's potential to address a critical gap in AML care.' 'Following constructive FDA guidance, we are preparing the trial focused on newly diagnosed AML patients as well as those early refractory to venetoclax and azacitidine,' said Dragan Cicic, MD, Chief Development Officer of SELLAS. 'The study will include two groups – one comprising patients predicted not to benefit from standard aza/ven, based on cytogenetic risk factors, and a second comprising patients who begin aza/ven treatment but demonstrate confirmed resistance after two cycles. We believe earlier intervention with SLS009 may offer greater clinical benefit before patients' bone marrow reserve is depleted by disease or prior therapies, and before the disease evolves into more resistant and aggressive forms. Data from other recent clinical trials suggests meaningful differences in response rates between newly diagnosed and relapsed/refractory patients, reinforcing the importance of this strategic approach. In addition, our ongoing collaboration with one of the nation's most prestigious cancer centers continues to generate insights in genomics, proteomics, and transcriptomics, which will refine patient selection and our precision medicine strategy and help us unlock the full potential of SLS009 as we prepare to enter pivotal development.' Zainaldin et al, Leukemia and Lymphoma, 2022 About SELLAS Life Sciences Group, Inc. SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS' lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (tambiciclib) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. For more information on SELLAS, please visit Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are 'forward-looking statements,' including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as 'plan,' 'expect,' 'anticipate,' 'may,' 'might,' 'will,' 'should,' 'project,' 'believe,' 'estimate,' 'predict,' 'potential,' 'intend,' or 'continue' and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption 'Risk Factors' in SELLAS' Annual Report on Form 10-K filed on March 20, 2025 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking statements were made. Investor Contact John Fraunces Managing Director LifeSci Advisors, LLC jfraunces@
Business Upturn
20 hours ago
- Business
- Business Upturn
ACAMS Launches Enhanced CAMS Certification to Combat Evolving Financial Crime
Washington, DC, July 15, 2025 (GLOBE NEWSWIRE) — ACAMS, the global leader in anti-financial crime (AFC) certifications and training, today unveils its next generation Certified Anti-Money Laundering Specialist (CAMS) certification in response to the rapidly evolving financial crime landscape. The enhanced CAMS program offers a tailored learning experience, extended case studies in multiple industry segments, increased coverage of anti-money laundering (AML) tools and technologies, and a new exam simulator tool. For over 20 years, the CAMS certification has been the international gold standard for AML professionals. To date, the organization has certified more than 140,000 professionals in over 200 jurisdictions and territories, and in 14 languages. Building on this legacy, the next generation program reflects the rapid changes across the industry and the need to equip professionals to meet these challenges. 'The fight against money laundering knows no borders,' said Neil Sternthal, CEO of ACAMS. 'With our enhanced CAMS certification, we're not just keeping pace – we're staying ahead of the curve to help financial crime fighters meet the moment. Whether they're at a retail bank in New York or a payments firm in Singapore, CAMS equips professionals with the cutting-edge content and practical knowledge they need to combat financial crime globally.' The enhanced CAMS program was developed with extensive feedback from ACAMS' global member community and includes a modular learning experience centered around four self-paced courses that combine global AML standards with practical application and regional relevance. These core modular courses are: Understanding Risks and Methods of Financial Crime Global AFC Frameworks, Governance, and Regulations Building an AFC Compliance Program Tools and Technologies to Fight Financial Crime In addition to the core curriculum, CAMS candidates can choose two elective courses focused on a specific sector and jurisdiction. Sector case study options include Retail and Commercial Banking, Money Services Businesses (MSBs), Payment Service Providers (PSPs), and Virtual Asset Services Providers (VASPs); while jurisdictional options include U.S., UK, EU or Canada, offering an in-depth analysis of local AML regulatory framework. Additional sector case studies such as gaming, private banking and wealth management, with jurisdictions such as China, Australia, the UAE, and Japan, are planned to be offered soon. The enhanced CAMS program also features an upgraded exam simulation tool to help candidates confidently prepare for the CAMS exam, with progress tracking and over 1,000 practice questions. The updated certification is now available in English, with additional languages available in 2026. In addition to their certification, ACAMS members gain access to monthly continuing education webinars and resources such as white papers, infographics and best practice guide, with timely expert analysis of changes in the AFC space. To learn more about the enhanced CAMS certification program, visit . ### About ACAMS® ACAMS is the leading international membership organization dedicated to providing opportunities for anti-financial crime education, best practices, and peer-to-peer networking to AFC professionals globally. With over 115,000 current members across 200+ jurisdictions and territories, ACAMS is committed to the mission of combatting financial crime through the provision of anti-money laundering/counterterrorism-financing, anti-fraud and sanctions knowledge-sharing, thought leadership, risk-mitigation services, and platforms for public-private dialogue. The association's CAMS certification is the gold-standard qualification for AFC professionals. It also offers CGSS certification for sanctions professionals, CAFS certification for anti-fraud professionals, and CCAS certification for AFC practitioners in the crypto space. ACAMS' 60+ Chapters globally further amplify the association's mission through training and networking initiatives. Visit for more information. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Yahoo
20 hours ago
- Business
- Yahoo
SELLAS Meets All Primary Endpoints in Phase 2 Trial of SLS009 in r/r AML and Receives FDA Guidance to Advance into First-Line Therapy Study
The Trial Exceeded Target Overall Response Rate (ORR) of 20%, with 44% Response Rate Among Patients with Acute Myeloid Leukemia-Myelodysplasia-Related Changes (AML MR) Treated at Optimal Dose of 30 mg Twice a Week (BIW) and 50% in AML MR with Myelomonocytic/Myelomonoblastic (M4/M5) Subtype Median Overall Survival (mOS) of 8.9 Months in Patients with AML MR and 8.8 mOS in Relapsed or Refractory to Venetoclax-Based Regimens at 30 mg BIW Dose Level Surpasses the Historical Benchmark of 2.4 Months FDA Recommends Advancement towards a Trial Including Newly Diagnosed First-Line AML Patient Cohorts That May Support a New Drug Application; Trial Preparation Underway with Enrollment Expected to Begin by Q1 2026 NEW YORK, July 15, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ('SELLAS' or the 'Company'), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that is has met all primary endpoints in its Phase 2 trial of SLS009 (tambiciclib), a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML). The Phase 2 clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels, 45 mg and 60 mg. In the 60 mg dose cohort, patients were treated with either a 60 mg dose once per week or a 30 mg dose two times per week. The trial was expanded to include ASXL1-mutated AML patients as well as patients with myelodysplasia-related cytogenetic abnormalities other than ASXL1 mutations. The target response rate for this Phase 2 trial, at the optimal dose level, was at least 20% and a target median survival of at least 3 months. The primary endpoint for the trial was overall response rate (ORR), and key secondary endpoints included overall survival (OS), safety, and tolerability. The trial met all endpoints, demonstrating strong efficacy and favorable safety and tolerability with robust anti-tumor activity. Based on these data, the Company plans to advance SLS009 into a randomized trial that will expand into the newly diagnosed AML populations where earlier intervention may enhance therapeutic outcomes, as well as patients refractory to venetoclax and azacitidine, with the study to support a potential New Drug Application (NDA) with the FDA. 'We are excited to report that our Phase 2 trial met all key endpoints, with clinical responses and survival outcomes that exceed targeted expectations and historical benchmarks,' said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. 'AML remains an area of urgent unmet medical need, particularly for patients with relapsed or refractory disease, where standard treatments are often ineffective and poorly tolerated. What sets SLS009 apart is its consistent efficacy across a broad range of molecular subtypes. The remarkable response rates of 44% among AML MR patients, 50% among ASXL1-mutated AML MR, and 50% among M4/M5 patients at the optimal 30 mg BIW dose far exceed the targeted 20% benchmark. We saw a clear survival benefit with median OS reaching 8.8 months in patients refractory to venetoclax-based regimens in the cohort of patients with median 1 prior line of therapy, surpassing the historical median of 2.4 months and 4.1 months in cohorts with median 2 lines of prior therapy, versus 1.8 months reported in similar patient population. The treatment was also well-tolerated, with no dose-limiting toxicities across any treatment arm, validating both the biological selectivity and safety profile of our approach. We believe these data strongly support the potential of SLS009 to meaningfully extend life in patients with otherwise limited options, and we look forward to sharing these findings in more detail in the future. With the expected Phase 3 REGAL study final analysis by year-end, our galinpepimut-S (GPS) immunotherapy and SLS009 are complementary therapies that together enable us to hopefully address AML patients across the treatment spectrum — from early intervention to maintenance.' Key Phase 2 Results: Patients Characteristics: 54 evaluable r/r AML patients who previously failed venetoclax-based therapies were enrolled and treated with SLS009, and venetoclax/azacitidine; patients were enrolled across all five cohorts. Among the 54 treated patients, 47 had AML MR (87%) and 23 had ASXL1 mutations (43%). 47 out of 54 had AML MR (acute myeloid leukemia with myelodysplasia-related changes). Among AML MR patients,17 had myelomonocytic/myelomonoblastic subtype of AML (M4 and M5), representing 31% of all patients. All patients had adverse risk cytogenetics except one patient who had intermediate risk cytogenetics. The median age of all patients was 69. Median number of prior lines of therapy was 2. Efficacy: The results exceeded the pre-specified ORR threshold of 20%, demonstrating robust clinical activity and supporting advancement into late-stage development. The ORR in all evaluable patients was 33% across all cohorts and dose levels and 40% for the 30mg BIW dose level. At the 30 mg BIW dose, among AML MR patients, the ORR was 44%. The highest efficacy was observed among patients with ASXL1 mutations, with an ORR of 50% (9/18) at 30 mg BIW dose levels and M4/M5 patients with 50% (6/12) ORR. The mOS surpassed the historical benchmark of best available therapy of 2.4 months1 for patients who received one prior line of therapy and 1.8 months for those who received more than one prior line of therapy. The mOS for patients treated with 30mg BIW, with a median of 1 prior line of therapy, was 8.8 months, while the mOS in AML MR patients reached 8.9 months vs. 2.4 months with best available therapy. The mOS for cohorts with a median of 2 prior lines of therapies was 4.1 months vs.1.8 months with best available therapy. Safety: The addition of SLS009 to the venetoclax/azacitidine regimen was well tolerated and did not result in increased toxicities compared to ven/aza alone. No dose-limiting toxicities were observed across all dose levels. Front Line Trial Planning Underway Following FDA Guidance Following a productive end of Phase 2 meeting, the FDA recommended that SELLAS proceeds into a trial to include newly diagnosed, first-line AML patients eligible for venetoclax/azacitidine (aza/ven) therapy, where the agency believes clinical benefit might be greatest. The randomized 80-patient trial is currently in preparation and is expected to begin enrollment by Q1 2026. The trial will include two groups: Predictive biomarker cohort: Newly diagnosed patients unlikely to benefit from standard aza/ven therapy based on molecular profiling Early resistance cohort: Patients who initiate treatment with aza/ven but demonstrate confirmed lack of any response after two treatment cycles This precision approach allows SELLAS to target subpopulations with high unmet need and greatest potential for benefit. 'These SLS009 results represent an important advancement for patients with r/r AML, where treatment options remain limited and outcomes are often poor,' said Dr. Yair Levy, Director of Hematologic Malignancies Research at Texas Oncology Baylor University Medical Center. 'The response rates and survival outcomes are particularly compelling, especially given the consistency of responses across high-risk molecular subtypes and the favorable safety profile. What's especially encouraging is the opportunity to now explore this therapy in the first-line setting, where outcomes are often dictated by how patients respond to initial treatment. The FDA's recognition of this unmet need and its support for a trial in newly diagnosed patients reflects SLS009's potential to address a critical gap in AML care.' 'Following constructive FDA guidance, we are preparing the trial focused on newly diagnosed AML patients as well as those early refractory to venetoclax and azacitidine,' said Dragan Cicic, MD, Chief Development Officer of SELLAS. 'The study will include two groups – one comprising patients predicted not to benefit from standard aza/ven, based on cytogenetic risk factors, and a second comprising patients who begin aza/ven treatment but demonstrate confirmed resistance after two cycles. We believe earlier intervention with SLS009 may offer greater clinical benefit before patients' bone marrow reserve is depleted by disease or prior therapies, and before the disease evolves into more resistant and aggressive forms. Data from other recent clinical trials suggests meaningful differences in response rates between newly diagnosed and relapsed/refractory patients, reinforcing the importance of this strategic approach. In addition, our ongoing collaboration with one of the nation's most prestigious cancer centers continues to generate insights in genomics, proteomics, and transcriptomics, which will refine patient selection and our precision medicine strategy and help us unlock the full potential of SLS009 as we prepare to enter pivotal development.' Zainaldin et al, Leukemia and Lymphoma, 2022 About SELLAS Life Sciences Group, Inc. SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS' lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (tambiciclib) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. For more information on SELLAS, please visit Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are 'forward-looking statements,' including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as 'plan,' 'expect,' 'anticipate,' 'may,' 'might,' 'will,' 'should,' 'project,' 'believe,' 'estimate,' 'predict,' 'potential,' 'intend,' or 'continue' and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption 'Risk Factors' in SELLAS' Annual Report on Form 10-K filed on March 20, 2025 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking statements were made. Investor Contact John Fraunces Managing Director LifeSci Advisors, LLC jfraunces@
