Acute Myeloid Leukemia with Myelodysplasia-Related Changes

– Announced Positive Outcome of Interim Analysis for its Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML) with Next and Final Analysis Planned Upon Reaching 80 Events, Anticipated in 2025 – – Reported Positive Overall Survival and Overall Response Rate Data from the Ongoing Phase 2 Trial of SLS009 (Tambiciclib) in r/r AML – Full Data and FDA Regulatory Path Feedback Expected in 1H 2025 – – Raised $25 Million in Gross Proceeds in a Registered Direct Offering in January 2025 – NEW YORK, March 20, 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 reported financial results for the full year ended December 31, 2024, and provided a corporate update. “We are pleased with the progress of our pipeline as we continue to advance our two key assets through clinical development,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “The most anticipated milestones in 2025 will be the final analysis of our Phase 3 pivotal REGAL trial of GPS in acute myeloid leukemia (AML) and the full topline Phase 2 data of SLS009 in AML, both of which represent significant opportunities and offer hope to AML patients in need. If successful, the REGAL trial provides a pathway for regulatory approval in AML, and GPS could become a transformative treatment for patients in their second complete remission. Furthermore, the promising data from the ongoing Phase 2 trial of SLS009 has shown a 56% overall response rate (ORR) in AML patients with myelodysplasia-related changes (AML MRC) prospectively enrolled in two expansion cohorts, exceeding the prespecified target ORR of 33%. In the optimal dosing regimen of 30 mg BIW, the median overall survival (mOS) has not been reached but exceeds 7.7 months at the latest follow-up, where the expected mOS is historically approximately 2.5 months.” Dr. Stergiou continued, “We are especially encouraged by the multiple regulatory designations granted to our programs in 2024, including three FDA Rare Pediatric Disease Designations, one FDA Fast Track Designation, and two EMA Orphan Drug Designations, which reflect the significant potential impact of our therapies and provide valuable regulatory benefits that may accelerate development and potential approval. With strong regulatory recognition and two potentially pivotal inflection points ahead, we remain committed to driving innovation and delivering value to patients and shareholders.” Recent Highlights: Announced Positive Outcome of Interim Analysis for Phase 3 REGAL Trial of GPS in AML: The interim futility, efficacy, and safety analysis was designed to assess whether the therapy is safe, demonstrates potential efficacy, and merits continuation. The IDMC’s review supports the continuation of the study according to its original protocol. Based on this positive evaluation, GPS has shown preliminary signals of effectiveness, allowing the trial to advance toward completion. Fewer than 50% of enrolled patients were confirmed deceased after the median follow-up of 13.5 months, indicating a median survival of over 13.5 months in the trial vs. historical median survival of 6 months for conventional therapy, as reported in a similar Phase 2 study. The next and final analysis will be conducted once 80 events (deaths) are reached, further determining the potential of GPS in addressing the needs of AML patients. SELLAS anticipates that 80 events will be reached this year. Promising Data from Phase 2a Trial of SLS009 in Combination with Zanubrutinib in DLBCL: The trial, conducted and funded by GenFleet Therapeutics (Shanghai), Inc. (“Genfleet”), was an open-label single-arm multicenter Phase 2a study in China evaluating SLS009 in combination with BTK inhibitor, Brukinsa® (zanubrutinib) in r/r DLBCL. The results showed an overall response rate (ORR) of 67%, more than double the expected ORR of zanubrutinib alone. Among responders, one achieved complete response (CR), while three had partial response (PR) with target lesion shrinkages of 89%, 78%, and 56%, respectively. As of the last follow-up, after the median of 4.6 (range: 1.4 - 7.4) months follow-up, median overall survival (OS) was not reached, and 6 out of 9 patients were alive. GenFleet will determine the next steps in development around lymphoma as SELLAS’ focus remains on AML and spliceosome–chromatin mutations, including ASXL1 mutations. Raised $25.0 Million of Gross Proceeds from a Registered Direct Offering Priced At-the-Market under Nasdaq Rules: On January 28, 2025, SELLAS announced the closing of a $25 million registered direct offering with a single healthcare-focused institutional investor before deducting placement agent’s fees and related offering expenses. The net proceeds from the offering strengthens the Company’s financial position and will be used for working capital purposes and general corporate procedures, including the purchase of any pending or future acquisitions. 2024 Key Achievements: SLS009 (tambiciclib): highly selective CDK9 inhibitor The World Health Organization (WHO) approved “tambiciclib” as the recommended International Nonproprietary Name (INN) for SLS009. Reported positive data from the ongoing Phase 2 trial of SLS009 in r/r AML in Q4 2024. The median overall survival (mOS) has not been reached but exceeds 7.7 months at the latest follow-up, where the expected mOS is historically ~ 2.5 months. In expansion cohorts in patients with AML-myelodysplasia-related changes (AML-MRC) with ASXL1 mutation and mutations and cytogenic changes other than ASXL1, the ORR was 56% in 9 patients evaluable for efficacy, exceeding pre-specified target response rate of 33%. Presented data from Phase 2a trial of SLS009 in r/r AML at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition 2024. Completed enrollment in Phase 2a Trial of SLS009 in r/r AML: 30 patients relapsed after or refractory to venetoclax-based regiments were enrolled ahead of schedule in 5 centers across the US. Opened enrollment in additional Phase 2 cohorts in venetoclax combinations in r/r AML. Development of SLS009 continues with the opening of two new cohorts - AML MRC with ASXL1 mutations and AML with myelodysplasia-related changes other than ASXL1 mutations. These new cohorts are also open for enrollment of certain pediatric patients. Announced positive preclinical data indicating ASXL1 mutations as predictors of response to SLS009 in solid cancers. Published in Oncotarget, revealing the underlying mechanisms of action behind the anti-proliferative effects of SLS009 in various hematologic malignancies. Continued National Cancer Institute (NCI) Pediatric Preclinical in Vivo Testing (PIVOT) Program in pediatric tumors. Regulatory: Received multiple regulatory designations: for GPS, FDA Rare Pediatric Disease Designation (RPDD) for pediatric AML; and for SLS009, RPDD for pediatric AML, pediatric acute lymphoblastic leukemia (ALL), FDA Fast Track Designation for AML, and EMA orphan drug designation (ODD) for AML and peripheral T-cell lymphoma (PTCL). Financial Results for the Full Year 2024: R&D Expenses: Research and development expenses for the year ended December 31, 2024, were $19.1 million, compared to $24.0 million for the year ended December 31, 2023. The decrease was primarily due to decreases in clinical trial expenses, manufacturing costs and clinical drug supply purchases, and clinical and regulatory consulting costs primarily driven by the completion of enrollment in the REGAL study in the first quarter of 2024 and a decrease in employee-related expenses due to a decrease in headcount. G&A Expenses: General and administrative expenses for the year ended December 31, 2024, were $12.4 million, as compared to $13.9 million for the year ended December 31, 2023. The decrease was primarily due to a decrease in employee-related expenses due to a decrease in headcount, outside services and public company costs, and insurance premiums, partially offset by a one-time severance charge in 2024 and an increase in legal fees. Net Loss: The net loss was $30.9 million for the year ended December 31, 2024, or a basic and diluted loss per share of $0.50, as compared to a net loss of $37.3 million for the year ended December 31, 2023, or a basic and diluted loss per share of $1.34. Cash Position: As of December 31, 2024, cash and cash equivalents totaled approximately $13.9 million. Subsequent to December 31, 2024, on January 28, 2025, the Company received gross proceeds of $25.0 million from a registered direct offering priced at-the-market under Nasdaq rules. 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 www.sellaslifesciences.com. 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 Bruce Mackle Managing Director LifeSci Advisors, LLC SELLAS@lifesciadvisors.com

Data showcased at SABCS and ASH reflect progress and growth of Jazz's research and development in oncology and demonstrate ongoing efforts to redefine what is possible for cancer treatment DUBLIN , Dec. 3, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Company and its partners will present two abstracts at the 2024 San Antonio Breast Cancer Symposium (SABCS) from December 10-13 and 13 abstracts at the 66th Annual American Society of Hematology (ASH) Annual Meeting from December 7-10. A trial-in-progress poster presentation at SABCS outlines the trial design of the ongoing Phase 3 EmpowHER-303 trial (NCT06435429), which is evaluating the efficacy and safety of Ziihera® (zanidatamab-hrii) vs trastuzumab with chemotherapy in patients with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, trastuzumab deruxtecan. New data from a Phase 1b/2 study of zanidatamab plus evorpacept (NCT05027139) in patients with pre-treated HER2-positive and HER2-low metastatic breast cancer will be featured as a poster spotlight. "Following the recent FDA approval of Ziihera for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, we are pleased to present meaningful data at SABCS on the positive impact zanidatamab can have for patients with HER2-expressing cancers. We continue to advance our clinical program for zanidatamab with the goal to improve outcomes for patients with difficult-to-treat HER2-positive cancers. Our development program includes multiple ongoing Phase 3 trials evaluating 1L BTC, 1L GEA, with top-line PFS results expected in the second quarter of 2025, and metastatic breast cancer after T-DXd treatment, supporting the use of zanidatamab after other HER2-targeted therapies," said Rob Iannone , M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals . "Additionally, we look forward to highlighting 13 abstracts featuring oncology research at ASH 2024, which underscores our commitment to improving standards of care in blood cancer and other hematologic diseases." The full SABCS abstracts are available here. The Jazz and partner-supported presentations at SABCS 2024 are: Ziihera® (zanidatamab-hrii) Presentations Topic Author Presentation Details EmpowHER 303: A phase 3 study to evaluate the efficacy and safety of zanidatamab vs trastuzumab withchemotherapy in patients (pts) with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, trastuzumab deruxtecan Sara M Tolaney, et al. Presentation Type: Poster Session Abstract Number: SESS-1922 Date: Friday December 13, 2024 Time: 12:00-2:00 PM (PST) Zanidatamab in combination with evorpacept in HER2-positive and HER2-low metastatic breast cancer: Results from a phase 1b/2 study Alberto J Montero, et al. Presentation Type: Poster Spotlight Presentation Abstract Number: SESS-2007 Date: Thursday December 12, 2024 Time: 7:00-8:30 AM (PST) The full ASH abstracts are available here. The Jazz and partner-supported presentations at ASH 2024 are: Vyxeos® (daunorubicin and cytarabine) Presentations Topic Author Presentation Details A Randomized Comparison of CPX-351 and FLAG-Ida in Patients WithHigh-Risk Acute Myeloid Leukemia(AML)/Myelodysplastic Syndrome (MDS) And MDS-Related GeneMutations: A Subgroup Analysis of the UK NCRI AML19 Trial Priyanka Mehta , et al. Presentation Type: Oral Presentation Abstract Number: #55 Date: Saturday December 7, 2024 Time: 9:30 AM (PST) AML-MR Mutations Drive the Benefit of CPX-351 over 7+3 in the Pivotal Phase 3 AML Trial Shai O Shimony, et al. Presentation Type: Oral Presentation Abstract Number: #60 Date: Saturday December 7, 2024 Time: 10:45 AM (PST) Phase Ib/II Study of CPX-351 in Combination with Venetoclax in Patients with Newly Diagnosed, HighRisk Acute Myeloid Leukemia Emmanuel Almanza , et al. Presentation Type: Poster Presentation Abstract Number: #1511 Date: Saturday December 7, 2024 Time: 5:30-7:30 PM (PST) A Randomised Comparison of CPX-351 versus Standard Daunorubicin and Cytarabine plus FractionatedGemtuzumab Ozogamicin in Older AML Adults Without Known AdverseRisk Cytogenetics: Results of the NCRIAML18 Trial Steven Knapper , et al. Presentation Type: Oral Presentation Abstract Number: #59 Date: Saturday December 7, 2024 Time: 10:30 AM (PST) Phase 1/1b Dose Escalation and Expansion of CPX-351 in Combinationwith Gemtuzumab Ozogamicin in Newly Diagnosed Acute MyeloidLeukemia Onyee Chan , et al. Presentation Type: Poster Presentation Abstract Number: #4270 Date: Monday December 9, 2024 Time: 6:00-8:00 PM (PST) A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy IncludingGemtuzumab Ozogamicin (GO) to CPX-351 with GO – A report from the Children's Oncology Group Jessica A Pollard, et al. Presentation Type: Oral Presentation Abstract Number: #967 Date: Monday December 9, 2024 Time: 4:30 PM (PST) Combination of CPX-351 andGemtuzumab Ozogamicin (GO) inRelapsed Refractory (R/R) AcuteMyeloid Leukemia and PostHypomethylating Agent (HMA) FailureHigh-Risk Myelodysplastic Syndrome (HR-MDS) Jayastu Senapati , et al. Presentation Type: Poster Presentation Abstract Number: #2903 Date: Sunday December 8, 2024 Time: 6:00-8:00 PM (PST) Phase Ib/II Study of CPX-351 plusVenetoclax in Patients with Relapsed/Refractory Acute MyeloidLeukemia (AML) Vanthana Bharathi , et al. Presentation Type: Poster Presentation Abstract Number: #4272 Date: Monday December 9, 2024 Time: 6:00-8:00 PM (PST) Rapid, Reliable, and ComprehensiveIdentification of MDS-DefiningCytogenetic Changes By a FISH-Panel Containing Six Probes in a Real-World Population of Patients with Suspected AML Katayoon Shirneshan, et al. Presentation Type: Poster Presentation Abstract Number: #4308 Date: Monday December 9, 2024 Time: 6:00-8:00 PM (PST) Prospective Evaluation of the Impact ofMeasurable Residual Disease (MRD) by Error Corrected Next-GenerationSequencing (NGS) with CPX-351 inAcute Myeloid Leukemia (AML) David Sallman , et al. Presentation Type: Poster Presentation Abstract Number: #4332 Date: Monday December 9, 2024 Time: 6:00-8:00 PM (PST) A Phase 1 Study of CPX-351 Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated Acute Myeloid Leukemia Onyee Chan , et al. Presentation Type: Poster Presentation Abstract Number: #1520 Date: Saturday December 7, 2024 Time: 5:30-7:30 PM (PST) Defitelio® (defibrotide sodium) Presentations Topic Author Presentation Details Genetic Susceptibility in Sinusoidal Obstruction Syndrome/Veno-OcclusiveDisease Ioulia Mavrikou, et al. Presentation Type: Poster presentation Abstract Number: #4778 Date: Monday December 9, 2024 Time: 6:00-8:00 PM (PST) Defibrotide reduces hypercoagulablestate in patients with Sickle Cell Disease-Related Acute ChestSyndrome Edo Schaefer , et al. Presentation Type: Poster presentation Abstract Number: #2515 Date: Sunday December 8, 2024 Time: 6:00-8:00 PM (PST) About Ziihera® (zanidatamab-hrii) Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity ( CDC ), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States , Ziihera is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.1 The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1 Zanidatamab is not approved anywhere else in the world. Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule. The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. Important Safety Information for ZIIHERA® WARNING: EMBRYO-FETAL TOXICITY Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patientsof the risk and need for effective contraception. WARNINGS AND PRECAUTIONS Embryo-Fetal ToxicityZIIHERA can cause fetal harm when administered to a pregnant woman. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Verify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA. Advise pregnant women and females of reproductive potential that exposure to ZIIHERA during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment with ZIIHERA and for 4 months following the last dose of ZIIHERA. Left Ventricular DysfunctionZIIHERA can cause decreases in left ventricular ejection fraction (LVEF). LVEF declined by >10% and decreased to <50% in 4.3% of 233 patients. Left ventricular dysfunction (LVD) leading to permanent discontinuation of ZIIHERA was reported in 0.9% of patients. The median time to first occurrence of LVD was 5.6 months (range: 1.6 to 18.7). LVD resolved in 70% of patients. Assess LVEF prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold dose or permanently discontinue ZIIHERA based on severity of adverse reactions. The safety of ZIIHERA has not been established in patients with a baseline ejection fraction that is below 50%. Infusion-Related ReactionsZIIHERA can cause infusion-related reactions (IRRs). An IRR was reported in 31% of 233 patients treated with ZIIHERA as a single agent in clinical studies, including Grade 3 (0.4%), and Grade 2 (25%). IRRs leading to permanent discontinuation of ZIIHERA were reported in 0.4% of patients. IRRs occurred on the first day of dosing in 28% of patients; 97% of IRRs resolved within one day. Prior to each dose of ZIIHERA, administer premedications to prevent potential IRRs. Monitor patients for signs and symptoms of IRR during ZIIHERA administration and as clinically indicated after completion of infusion. Have medications and emergency equipment to treat IRRs available for immediate use. If an IRR occurs, slow, or stop the infusion, and administer appropriate medical management. Monitor patients until complete resolution of signs and symptoms before resuming. Permanently discontinue ZIIHERA in patients with recurrent severe or life-threatening IRRs. DiarrheaZIIHERA can cause severe diarrhea. Diarrhea was reported in 48% of 233 patients treated in clinical studies, including Grade 3 (6%) and Grade 2 (17%). If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Withhold or permanently discontinue ZIIHERA based on severity. ADVERSE REACTIONS Serious adverse reactions occurred in 53% of 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA. Serious adverse reactions in >2% of patients included biliary obstruction (15%), biliary tract infection (8%), sepsis (8%), pneumonia (5%), diarrhea (3.8%), gastric obstruction (3.8%), and fatigue (2.5%). A fatal adverse reaction of hepatic failure occurred in one patient who received ZIIHERA. The most common adverse reactions in 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA (≥20%) were diarrhea (50%), infusion-related reaction (35%), abdominal pain (29%), and fatigue (24%). USE IN SPECIFIC POPULATIONS Pediatric UseSafety and efficacy of ZIIHERA have not been established in pediatric patients. Geriatric UseOf the 80 patients who received ZIIHERA for unresectable or metastatic HER2-positive BTC, there were 39 (49%) patients 65 years of age and older. Thirty-seven (46%) were aged 65-74 years old and 2 (3%) were aged 75 years or older. No overall differences in safety or efficacy were observed between these patients and younger adult patients. About Vyxeos® (daunorubicin and cytarabine) liposome for injectionVyxeos is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor. In the U.S., Vyxeos (daunorubicin and cytarabine) liposome for injection is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.3 More information about Vyxeos in the United States, including Full Prescribing Information and BOXED Warning, is available here. Important Safety Information for VYXEOS® WARNING: VYXEOS has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute VYXEOS for other daunorubicin and/or cytarabine-containing products. VYXEOS should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine, or any of its ingredients. VYXEOS can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with VYXEOS. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding. VYXEOS can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as: shortness of breath or trouble breathing swelling or fluid retention, especially in the feet, ankles, or legs unusual tiredness VYXEOS may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as: trouble breathing severe itching skin rash or hives swelling of the face, lips, mouth, or tongue VYXEOS contains copper and may cause copper overload in patients with Wilson's disease or other copper-processing disorders. VYXEOS can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site. VYXEOS can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving VYXEOS. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of VYXEOS. The most common side effects are bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568. About Defitelio® (defibrotide sodium)In the U.S., Defitelio® (defibrotide sodium) injection 80mg/mL received U.S. Food and Drug Administration (FDA) marketing approval on March 30, 2016, and it is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT) and is the first and only FDA-approved therapy for patients with this rare, potentially fatal complication.6 Please see full Prescribing Information for Defitelio in the United States . In Europe, defibrotide is marketed under the name Defitelio® ▼ (defibrotide). In October 2013, the European Commission granted marketing authorization to Defitelio under exceptional circumstances for the treatment of severe VOD in patients after HSCT therapy. In Europe, Defitelio is indicated in patients over one month of age. ▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system found under section 4.8 of the SmPC (https://www.ema.europa.eu/en/documents/product-information/defitelio-epar-product-information_en.pdf) The full Summary of Product Characteristics of Defitelio in Europe is available here. Important Safety Information for Defitelio® Defitelio should not be given to patients who are: Currently taking anticoagulants or fibrinolytics Allergic to Defitelio or any of its ingredients Defitelio may increase the risk of bleeding in patients with VOD and should not be given to patients with active bleeding. During treatment with Defitelio, patients should be monitored for signs of bleeding. In the event that bleeding occurs during treatment with Defitelio, treatment should be temporarily or permanently stopped. Patients should tell the doctor right away about any signs or symptoms of hemorrhage such as unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision. Defitelio may cause allergic reactions including anaphylaxis. Patients who develop signs and symptoms of anaphylaxis such as trouble breathing, severe itching, skin rash or hives, or swelling of the face, lips, mouth or tongue should seek medical attention immediately. The most common side effects of Defitelio are decreased blood pressure, diarrhea, vomiting, nausea and nose bleeds. Defitelio is not approved for the prevention of VOD. It is not indicated in patients with hypersensitivity to defibrotide or any of its excipients or with concomitant use of thrombolytic therapy. About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases—often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Jazz Pharmaceuticals plc Caution Concerning Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to expectations of top-line PFS results in the second quarter of 2025 and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' 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 associated with pharmaceutical product development, and other risks and uncertainties affecting Jazz Pharmaceuticals and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including Jazz Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 2023 , as supplemented by our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 , and future filings and reports by Jazz Pharmaceuticals . Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' 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 or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals 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. Contacts: Jazz Media Contact: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc CorporateAffairsMediaInfo@jazzpharma.com Ireland +353 1 637 2141 U.S. +1 215 867 4948 Jazz Investor Contact: Jeff Macdonald Executive Director, Investor Relations Jazz Pharmaceuticals plc investorinfo@jazzpharma.com Ireland +353 1 634 3211 U.S. +1 650 496 2717 View original content to download multimedia:https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-to-present-advancements-in-solid-tumors-and-blood-cancer-research-at-san-antonio-breast-cancer-symposium-and-american-society-of-hematology-annual-meeting-302320929.html SOURCE Jazz Pharmaceuticals plc

- Presentation at ASH will Feature Results from the Phase 2a Trial of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia After Venetoclax Failure – - 50% Response Rate at the Selected Dose Level of 30 mg Twice a Week (BIW) – - 45 mg (Safety Dose) Once a Week of SLS009 Showed a Median Overall Survival (OS) of 5.5 Months vs. <2.5 Months with Standard of Care; 60 mg Once a Week and 30 mg BIW Median OS Not Reached - NEW YORK, Nov. 05, 2024 (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 data from its Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML) will be presented at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition, which is being held on December 7 –10, 2024, in San Diego, California. “We are excited to have SLS009 featured at the 2024 ASH meeting and are pleased with the very promising safety and efficacy results from the Phase 2a trial in r/r AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “Treatment with SLS009 in combination with azacitidine and venetoclax was well tolerated and led to a 50% response rate in the selected optimal dose. Clinical activity was even higher in patients with AML-myelodysplasia-related changes (AML-MRC) and in particular those with ASXL1 mutations, suggesting that this subset of patients may exhibit preferential sensitivity to SLS009. These findings contribute to the growing evidence supporting the potential of SLS009 to address unmet needs in difficult-to-treat populations, and future development efforts will focus on further exploring its impact in patients with AML-MRC.” Poster presentation details: Title: Phase 2a Study of SLS009, a Highly Selective CDK9 Inhibitor, In Combination with Azacitidine and Venetoclax for Relapsed/Refractory Acute Myeloid Leukemia After Prior Venetoclax Treatment Session Date and Time: Sunday, December 8, 2024, 6:00 PM - 8:00 PM PST Session Title: Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II Location: San Diego Convention Center, Halls G-H Lead Author: Joshua F. Zeidner, MD, University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC Abstract Number: 2877 The study enrolled 30 patients across three dosing levels (DLs) of SLS009:45 mg IV QW, DL2: 60 mg IV QW, and DL3: 30 mg IV BIW. SLS009 was well-tolerated across the DLs tested with no dose-limiting toxicities (DLTs) observed. Among 29 evaluable pts, 16 (55%) had ≥50% reduction in bone marrow (BM) blasts compared to baseline (DL1: 60%; DL2: 33%; DL3: 80%). Nine (31%) patients achieved an overall response (i.e., CR+CRi+MLFS), including 5 (17%) who achieved CR/CRi. The response rates per dose level were 10% in DL1, 33% in DL2, and 50% in DL3. All 9 responders had AML- Myelodysplasia Related (AML-MR) (9/23 of AMLMR pts responded) and 8/15 pts (53%) with somatic MR mutations responded. Among those with ASXL1 mutations, 5/9 (56%) achieved an overall response. 2/9 (22%) with TP53 mutations achieved a response including one patient with concomitant TP53 and ASXL1 mutation who had an ongoing response at data cut-off. Fifteen patients were still alive at the time of the data cutoff and the median OS for the trial has not been reached. For more information on the study, visit clinicaltrials.gov identifier NCT04588922. The accepted abstract is published and available on the ASH website here. 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 (formerly GFH009) - 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 www.sellaslifesciences.com. 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 28, 2024 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 Bruce Mackle Managing Director LifeSci Advisors, LLC SELLAS@lifesciadvisors.com