MELBOURNE, Australia, Aug. 25, 2025 (GLOBE NEWSWIRE) -- Propanc Biopharma, Inc. (Nasdaq: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, today announced a shareholder update including recent corporate developments and forecast for 2025/26. As a result of completing a recent initial public offering and up-listing to Nasdaq, the Company is entering a transformational stage as it prepares for the adv ...

Summary of Imugene (ILA) 2025 Extraordinary General Meeting Company Overview - **Company**: Imugene (ILA) - **Industry**: Clinical stage cancer therapeutics - **Focus**: Development of CAR T cell therapies and oncolytic viruses targeting blood cancers Key Points from the Meeting Meeting Structure and Attendance - The meeting was hybrid, allowing both in-person and virtual participation [1][2] - A quorum was established, and the meeting was declared open by the executive chairman, Paul Hopper [1][2] Resolutions and Voting - **Resolution 1**: Ratification of the prior issue of 68,200,000 placement shares - Votes: 21,900,000 in favor (92.3%), 1,400,000 against, 7.6% abstained [12] - **Resolution 2**: Approval to issue up to 51,100,000 placement attaching options at an exercise price of 43¢ - Votes: 27,700,000 in favor, 1,600,000 against, 7.6% abstained [14] - **Resolution 3**: Approval to issue up to 45.4 million new shares at a price of 33¢ per share and up to 34 million attaching options - Votes: 19.5 million in favor, 1.5 million against, 18,000 abstained [17] Financial and Operational Highlights - The company has reduced its workforce from around 100 to the low twenties to cut costs [25][26] - Imugene has out-licensed its manufacturing to a CDMO called Kinsel to offset costs [25] Clinical Development Updates - Focus on allogeneic CAR T cell therapy targeting blood cancers, specifically relapsed diffuse large B cell lymphoma - Reported a 79% overall response rate, with some patients cancer-free for over 16 months [24][25] - Anticipates initiating a pivotal Phase 2/3 registrational study in 2026 after meeting with the FDA [25][28] Upcoming Milestones - Continued data release from Phase 1b studies and submission for various FDA designations to expedite pivotal studies [28][29] - Plans to meet with the FDA in Q4 of the current year to strategize on the pivotal study [28] General Remarks - The company continues to participate in major scientific conferences to showcase data and explore partnering opportunities [26] - No questions were raised from shareholders during the meeting [30][31] Additional Important Information - The results of the voting will be sent to the ASX once available [31] - The meeting concluded with appreciation for shareholder support [31]

Core Viewpoint - Propanc Biopharma, Inc. has successfully completed an underwritten public offering of 1,000,000 shares at a price of $4.00 per share, raising a total of $4 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The shares commenced trading on the Nasdaq Capital Market under the ticker symbol "PPCB" on August 15, 2025 [1]. - The offering included a 45-day option for the underwriter to purchase an additional 150,000 shares at the public offering price [2]. - The closing of the initial public offering occurred on August 18, 2025 [2]. Group 2: Management and Legal Counsel - D. Boral Capital LLC and Craft Capital Management LLC served as the book running managers for the offering [3]. - Legal counsel for the Company was provided by Brunson Chandler & Jones PLLC, while Sichenzia Ross Ference Carmel LLP acted as counsel to the underwriters [3]. Group 3: Company Overview - Propanc Biopharma, Inc. is focused on developing novel cancer treatments aimed at preventing recurrence and metastasis of solid tumors, particularly targeting pancreatic, ovarian, and colorectal cancers [6]. - The company's approach utilizes pancreatic proenzymes to target and eradicate cancer stem cells [6][7].

Core Viewpoint - Ascentage Pharma has received FDA and EMA clearance for the GLORA-4 study, a Phase III trial for lisaftoclax in combination with azacitidine for treating higher-risk myelodysplastic syndrome (HR-MDS), marking a significant step towards addressing unmet medical needs in this area [1][2][3] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on developing novel therapies for cancer, with a strong pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway [11][12] Study Details - The GLORA-4 study is a global, multi-center, randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of lisaftoclax combined with azacitidine compared to placebo plus azacitidine in newly diagnosed adult patients with HR-MDS [3][4] - This study is the second registrational Phase III trial for lisaftoclax to receive clearance from both the FDA and EMA, with simultaneous patient enrollment across multiple countries [2][3] Clinical Need - There is a significant unmet clinical need for targeted therapies in first-line treatment for higher-risk MDS, as current options like hypomethylating agents (HMA) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) have limitations [3][5] - The overall response rate (ORR) for HMAs is only 30-40%, with a complete response (CR) rate of 10-17%, highlighting the urgent need for innovative therapies [5][9] Clinical Data - Earlier studies of lisaftoclax in combination with azacitidine showed an ORR of 75%, significantly higher than HMAs alone, with a favorable safety profile and low incidence of severe hematologic toxicities [8][9] - The combination therapy demonstrated a low requirement for dose adjustments and no treatment-related mortalities within 60 days, indicating its potential as a superior treatment option [8][9] Expert Commentary - Experts emphasize the challenges in treating higher-risk MDS due to the limited efficacy of current therapies and the absence of breakthrough treatments in the last two decades, underscoring the importance of the GLORA-4 study [9][10]

Core Viewpoint - Ascentage Pharma has received FDA and EMA clearance for the GLORA-4 study, a Phase III trial of lisaftoclax in combination with azacitidine for treating higher-risk myelodysplastic syndrome (HR-MDS), marking a significant step towards addressing unmet medical needs in this area [1][2][3] Company Overview - Ascentage Pharma is a global, commercial stage biopharmaceutical company focused on developing novel therapies for cancer [1][11] - The company has a robust pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway [12][14] Study Details - The GLORA-4 study is a global, multi-center, randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of lisaftoclax combined with azacitidine compared to placebo plus azacitidine in newly diagnosed adult patients with HR-MDS [3][4] - This study is notable as it is the second registrational Phase III study of lisaftoclax to receive clearance from both the FDA and EMA [2][3] Clinical Need - There is a significant unmet clinical need for targeted therapies in first-line treatment of higher-risk MDS, as current options like hypomethylating agents (HMA) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) have limitations [3][5][9] - The overall response rate (ORR) for HMAs is only 30-40%, with a complete response (CR) rate of 10-17%, highlighting the need for more effective treatments [5][9] Lisaftoclax Profile - Lisaftoclax is a proprietary, orally administered Bcl-2 selective inhibitor that has shown promising clinical benefits and tolerability in earlier studies [6][8] - The drug is already approved in China for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have received prior systemic therapy [7][14] Clinical Data - Clinical data presented at major conferences indicated an ORR of 75% for the combination of lisaftoclax and azacitidine in treatment-naïve MDS, significantly higher than HMAs alone [8] - The combination therapy demonstrated a favorable safety profile with low incidence of severe hematologic toxicities [8][9] Global Collaboration - The GLORA-4 trial is being co-led by prominent researchers from leading institutions, including The University of Texas MD Anderson Cancer Center and Peking University [3][4]

Core Insights - Cellectar Biosciences plans to submit a New Drug Application (NDA) to the U.S. FDA for accelerated approval of iopofosine I 131 for the treatment of Waldenstrom Macroglobulinemia (WM), contingent on sufficient funding and the initiation of a confirmatory trial [1][3] - The company is also working towards a potential submission for Conditional Market Authorization (CMA) in the EU, with a decision expected in late Q3 or early Q4 2025 [1][3] - Cellectar is advancing CLR 125 into a Phase 1 trial for triple-negative breast cancer (TNBC) by late 2025 [1][3] Corporate Highlights - The company reported a statistically significant major response rate in the Phase 2b CLOVER WaM clinical trial for iopofosine I 131, with a follow-up data set that includes 12-month results [3][4] - iopofosine I 131 has received FDA Breakthrough Therapy Designation, indicating its potential as a first-in-class cancer targeting agent [3][4] - Cellectar is in discussions with potential partners for licensing iopofosine I 131 to secure funding for the NDA submission and confirmatory study [3][4] Financial Performance - As of June 30, 2025, Cellectar had cash and cash equivalents of approximately $11.0 million, down from $23.3 million at the end of 2024 [7][14] - Research and Development (R&D) expenses for Q2 2025 were approximately $2.4 million, a decrease from $7.3 million in Q2 2024, primarily due to reduced clinical project costs [7][5] - The net loss for Q2 2025 was $5.4 million, or $3.39 per share, compared to a net loss of $0.9 million, or $0.77 per share, in Q2 2024 [7][16]

Core Insights - Moleculin Biotech, Inc. is making significant progress in its Phase 2B/3 MIRACLE trial for Annamycin, targeting relapsed or refractory acute myeloid leukemia (AML) with an expected data readout before the end of 2025 [1][2][21] Clinical Development Updates - The MIRACLE trial is expanding with over 20 additional clinical sites expected to begin recruitment by the end of Q3 2025, including locations in the US, Europe, and the Middle East [1][7] - The trial utilizes an adaptive design, with the first 75 to 90 subjects randomized to receive different doses of Annamycin combined with high-dose cytarabine [6][10] - Preliminary efficacy data is expected to be unblinded for the first 45 subjects treated before the end of 2025, with a second unblinding anticipated in the first half of 2026 [8] Financial Results - For Q2 2025, the company reported a research and development expense of $3.6 million, down from $4.1 million in Q2 2024, primarily due to reduced clinical trial activity [18] - General and administrative expenses remained stable at $2.1 million for both Q2 2025 and Q2 2024 [18] - As of June 30, 2025, the company had cash and cash equivalents of $7.6 million, which is expected to fund operations into Q4 2025 [19] Annamycin Development Milestones - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML and soft tissue sarcoma [15] - Positive topline results from the U.S. Phase 1B/2 trial for Annamycin in treating soft tissue sarcoma lung metastases showed a median overall survival of 13.5 months, compared to 8-12 months for standard treatments [13] Intellectual Property and Strategic Partnerships - The company has bolstered its intellectual property portfolio with a notice of intent to grant a new European patent for Annamycin [7] - An industry veteran has been engaged to explore strategic partnerships related to Annamycin [7]

Core Insights - SELLAS Life Sciences Group, Inc. is advancing its pipeline for Acute Myeloid Leukemia (AML) with positive results from Phase 2 trials and a recommendation to continue Phase 3 trials without modification [1][3][4] Clinical Developments - The Phase 2 trial of SLS009 achieved a 44% response rate in patients with Acute Myeloid Leukemia-Myelodysplasia-Related Changes (AML-MRC), significantly exceeding the targeted 20% overall response rate [2][4] - The FDA has recommended advancing SLS009 into a first-line AML trial, with enrollment expected to begin by Q1 2026 [1][5] - The final analysis of the Phase 3 REGAL trial for GPS is anticipated by year-end 2025, with no safety concerns identified [1][3] Financial Performance - As of June 30, 2025, the company reported cash and cash equivalents of approximately $25.3 million, with an additional $4.0 million received from warrant exercises in July 2025 [1][13] - Research and development expenses for Q2 2025 were $3.9 million, a decrease from $5.2 million in Q2 2024, primarily due to reduced clinical trial expenses [10] - The net loss for Q2 2025 was $6.6 million, compared to a net loss of $7.5 million in Q2 2024, indicating improved financial performance [12] Corporate Updates - The company has expanded its Scientific Advisory Board with three new members, enhancing its strategic guidance in oncology [7] - SELLAS has been included in the Russell 3000 and Russell 2000 indexes, which track the performance of the largest publicly traded U.S. companies [8]

Commercial Performance - 2Q 2025 net product revenues reached $18.1 million, a 6.2% increase compared to $17.0 million in the same quarter of 2024 [16, 58] - Total 1H 2025 net product revenue was $35.5 million, up from $34.9 million during the 1H of 2024 [16] Pipeline Progress - LOTIS-7 data showed a 93.3% ORR (Overall Response Rate) and an 86.7% CR (Complete Response) rate across 30 efficacy evaluable patients when ZYNLONTA was combined with glofitamab [16, 53] - Updated MZL IIT data presented at ICML demonstrate an 85% ORR and a 69% CR rate [16] - LOTIS-5 is on track to reach pre-specified PFS (Progression-Free Survival) events by the end of 2025 [16] Corporate Update - The company secured $100 million in private placement, extending the expected cash runway into 2028 [16] - A strategic prioritization was implemented, resulting in a 30% reduction in force and one-time charges of $13.1 million, including $6.7 million in employee severance and $6.4 million in non-cash impairment of assets related to the UK facility closure [16] - The company's cash balance was $264.6 million as of June 30, 2025 [16, 58] LOTIS-7 Trial Safety - In the LOTIS-7 Phase 1b trial, 56.1% of patients experienced Grade 3/4 TEAEs (Treatment-Emergent Adverse Events) [47] - Cytokine Release Syndrome (CRS) of any grade was observed in 39% of patients [49] - ICANS (Immune effector Cell-Associated Neurotoxicity Syndrome) of any grade was observed in 7.3% of patients [49] ZYNLONTA Market Potential - ZYNLONTA has a U S peak revenue potential of $600 million to $1 billion in DLBCL (Diffuse Large B-Cell Lymphoma) and indolent lymphomas [21, 22]

Core Viewpoint - Tempest Therapeutics, Inc. reported progress in its clinical oncology portfolio, including the clearance to initiate a pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma (HCC) in China, and is actively exploring strategic alternatives to maximize value for stockholders and patients [2][5]. Recent Highlights - Clearance received to proceed with pivotal trial of amezalpat combination therapy for first-line HCC in China [5]. - Orphan drug designation granted by the European Medicines Agency (EMA) for amezalpat for HCC treatment [5]. - New mechanism-of-action data for amezalpat presented at the 2025 AACR Annual Meeting [5]. - Orphan Drug designation granted by the FDA for TPST-1495 for familial adenomatous polyposis (FAP) [5]. Financial Results Second Quarter 2025 - Cash and cash equivalents decreased to $14.3 million from $30.3 million as of December 31, 2024, primarily due to cash used in operating activities [6]. - Net loss for the quarter was $7.9 million, with a net loss per share of $2.07, compared to a net loss of $9.6 million and $5.52 per share for the same period in 2024 [6][15]. - Research and development expenses were $3.9 million, down from $5.8 million in the same quarter of 2024 [6]. - General and administrative expenses increased to $4.1 million from $3.7 million in the same period of 2024, mainly due to one-time separation costs [7]. Year-to-Date - For the six months ended June 30, 2025, net loss was $18.7 million, with a net loss per share of $5.17, compared to $17.5 million and $10.15 per share for the same period in 2024 [11]. - Research and development expenses for the six months were $11.5 million, up from $10.2 million in 2024 [11]. - General and administrative expenses remained stable at $7.4 million compared to the same period in 2024 [11]. Balance Sheet Overview - Total assets decreased to $24.5 million as of June 30, 2025, from $41.5 million at the end of 2024 [13]. - Current liabilities decreased to $7.1 million from $14.2 million as of December 31, 2024 [13]. - Stockholders' equity decreased to $9.8 million from $19.1 million at the end of 2024, with an accumulated deficit of $225.8 million [13].