TAMPA, Fla., Aug. 20, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced that management will present at the 27th Annual H.C. Wainwright Global Investment Conference taking place September 8-10, 2025 in New York City.James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences, is scheduled to present an overview and will be available for one ...

Core Insights - Merck's oncology segment is significantly driven by Keytruda, which accounted for over 50% of the company's pharmaceutical sales in the first half of 2025 [1][11] - Keytruda generated $15.16 billion in sales during the first half of 2025, reflecting a year-over-year increase of nearly 7% [2][11] - The company anticipates continued growth from Keytruda, particularly in early-stage lung cancer, despite some offset from weaker Gardasil sales in China and Japan [4][3] Sales and Growth - Full-year 2025 sales for Keytruda are estimated to reach $32.2 billion, indicating a year-over-year growth of 9.2% [2] - The drug's sales are bolstered by its rapid adoption in early-stage non-small cell lung cancer and sustained momentum in metastatic indications [3] Strategic Initiatives - Merck is exploring various strategies for long-term growth, including innovative immuno-oncology combinations and a personalized mRNA therapeutic cancer vaccine in collaboration with Moderna [5][6] - A subcutaneous formulation of Keytruda is under review in the U.S., which could extend its patent life [7] Competitive Landscape - Competitive pressure for Keytruda may increase, particularly with Summit Therapeutics' ivonescimab showing promising results in a phase III study, potentially positioning it as a new standard of care [8] Financial Performance - Year-to-date, Merck's shares have decreased by 15.3%, underperforming both the industry and the S&P 500 [10] - The company's shares are currently trading at a price/earnings ratio of 9.01, which is lower than the industry average of 14.45 [12] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings has increased slightly from $8.85 to $8.92 per share, while the estimate for 2026 has decreased from $9.65 to $9.59 [13]

Core Insights - Phio Pharmaceuticals reported its financial results for Q2 2025 and provided updates on its clinical trials, particularly for its lead product candidate PH-762, which utilizes INTASYL siRNA technology to target cancer treatment [1][4]. Clinical Progress - The ongoing Phase 1b clinical trial for PH-762 is evaluating its safety and tolerability in patients with various stages of cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma, with 15 patients treated across four cohorts [2][4]. - No dose-limiting toxicities or significant adverse effects have been reported, and all patients tolerated the treatment well, with no clinical progression observed during the trial [2][3]. Efficacy Results - Among the 13 patients with cutaneous squamous cell carcinoma, five achieved complete response (100% clearance), one had near complete response (>90% clearance), one had partial response (>50% clearance), and six had pathologic non-response (<50% clearance) [3]. - The patient with stage 4 metastatic Merkel cell carcinoma showed a pathological partial response (>50% clearance), while the melanoma patient did not respond (<50% clearance) [3]. Financial Overview - As of June 30, 2025, the company had cash and cash equivalents of approximately $10.8 million, an increase from $5.4 million at the end of 2024 [8]. - Research and development expenses for Q2 2025 were $1.1 million, up from $0.9 million in Q2 2024, primarily due to increased patient enrollment and higher consulting costs [9]. - General and administrative expenses for Q2 2025 were $1.2 million, compared to $1.0 million in the same period last year, driven by increased salary-related costs [11]. Net Loss - The net loss for Q2 2025 was $2.2 million, compared to $1.8 million in Q2 2024, attributed to rising research and development and administrative expenses [13]. Stockholder Equity - Total stockholders' equity increased to $10.1 million as of June 30, 2025, from $4.7 million at the end of 2024, reflecting the company's capital raising efforts [20][21].

Jason Lettmann | Chief Executive Officer Q2 2025 Results August 12, 2025 Jason Lettmann NASDAQ GS ALXO CEO, ALX Oncology © ALX Oncology Inc. All rights reserved. Forward-looking Statements Certain information set forth in this presentation contains "forward-looking information", under applicable laws collectively referred to herein as forward-looking statements. Except for statements of historical fact, information contained herein constitutes forward-looking statements and includes, but is not limited to t ...

Core Insights - Coherus Oncology reported a net revenue of $10.0 million for LOQTORZI, marking a 36% increase from Q1 2025, driven by higher patient demand and inventory restocking [1][6][11] - The company has a cash position of $238 million as of Q2 2025, providing a runway through 2026 for ongoing clinical programs [1][22] - Upcoming data readouts for CHS-114 and casdozokitug are expected in the first half of 2026, indicating progress in the oncology pipeline [1][2][7] Financial Performance - LOQTORZI net revenue increased from $7.3 million in Q1 2025 to $10.0 million in Q2 2025, compared to $3.8 million in Q2 2024 [6][11] - Total net revenue from continuing operations was approximately $10.3 million for Q2 2025, consistent with Q2 2024 [11] - The net loss from continuing operations for Q2 2025 was $44.9 million, a reduction from a net loss of $54.9 million in Q2 2024 [16] Pipeline Development - CHS-114, a cytolytic CCR8 antibody, is in Phase 1b studies, with initial data readouts expected in 1H 2026 [2][7] - Casdozokitug, an IL-27 antagonist, is being evaluated in multiple studies, with a focus on solid tumors [5][25] - The combination of LOQTORZI with internal pipeline candidates is aimed at expanding treatment indications [4][24] Recent Business Highlights - The divestiture of UDENYCA was completed in April 2025, generating $483.4 million in cash, which has been used to pay off significant financial obligations [9][10] - The company is focusing on maximizing LOQTORZI's potential in nasopharyngeal carcinoma, supported by a recent revision in NCCN guidelines granting it preferred status [6][24] Cash Position and Financial Obligations - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled $237.6 million, up from $126.0 million at the end of 2024 [22][33] - The company has settled a majority of UDENYCA-related obligations, which are expected to be resolved in a front-loaded manner over the remainder of 2025 and into 2026 [22]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $101.1 million, down from $129.4 million in Q2 2024, primarily due to the LabCorp transaction [20] - Total costs and expenses decreased to $119.3 million from $156 million year-over-year, contributing to an improved diagnostic operating loss of $18.2 million compared to $26.6 million in Q2 2024 [21] - Net loss for Q2 2025 was $148.4 million, or $0.19 per share, compared to a net loss of $10.3 million, or $0.01 per share, in Q2 2024 [26] Business Line Data and Key Metrics Changes - Diagnostics revenue included $24.9 million from oncology assets, with non-oncology business showing steady growth, particularly a 12% increase in 4Kscore volumes [20][21] - Pharmaceutical revenue increased to $55.7 million from $52.8 million in the previous year, driven by growth in Spanish and Mexican markets [22] - R&D expenses rose to $29.8 million from $23.7 million, reflecting increased investments in MODEX development programs [25] Market Data and Key Metrics Changes - BioReference's testing volume grew by 1.4% in 2025 compared to the previous year, with the 4Kscore test volume increasing approximately 12% year-over-year [13][20] - The Latin American business and Irish Contract Pharmaceutical Development and Manufacturing Unit continued to perform well, with increasing revenue and expanding margins despite foreign currency headwinds [7] Company Strategy and Development Direction - The company is focused on maximizing shareholder value through strategic capital deployment, partnerships, and asset sales, with a $200 million stock repurchase program in place [7][8] - The sale of oncology assets to LabCorp is expected to enhance BioReference's focus on core testing operations and improve financial performance [5][9] - The company aims to achieve cash flow breakeven and positive cash from operations in 2025, with expectations for the remaining BioReference business to reach profitability [21][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic initiatives and operational efficiencies being implemented, which are expected to yield significant cost savings [21][28] - The company anticipates closing the LabCorp transaction later this year, which will provide substantial cash inflow and further enhance operational focus [27][28] - Management highlighted the importance of ongoing R&D investments and collaborations to drive future growth, particularly in the pharmaceutical segment [25][73] Other Important Information - The FDA granted approval for a supplemental application for the 4Kscore test, which is expected to open new market opportunities [12] - The company has sufficient capital to support R&D efforts, with funding from strategic partners and non-dilutive sources [7] Q&A Session Summary Question: Insights on ANGELLA prescriptions and profit share - Management noted improvements in U.S. market prescription trends and expects sales to pick up in the remainder of the year [30][32] Question: EBITDA margin tracking and growth expectations - Management indicated ongoing improvements in the Diagnostics segment and expects to achieve cash flow positive status this year [33][34] Question: Differentiation of obesity treatment efforts - Management highlighted the unique metabolic benefits of their GLP-one glucagon receptor dual agonist and the convenience of oral formulations [39][41] Question: Size of patient population for obesity and NASH - Management confirmed focus on patients with biomarkers indicating obesity and NASH for upcoming Phase I studies [47][48] Question: BARDA revenue and future capital allocation - BARDA revenue for the quarter was $6.5 million, with expectations of $30 million to $35 million for the year [61][62] - Management discussed plans for capital allocation, emphasizing R&D investments and share repurchase programs [64][66]

Core Insights - Sensei Biotherapeutics, Inc. announced the presentation of clinical data from the Phase 1/2 trial of solnerstotug, both alone and in combination with Libtayo, at the ESMO Congress 2025 in Berlin [1] Company Overview - Sensei Biotherapeutics is a clinical stage biotechnology company focused on developing next-generation therapeutics for cancer patients [2] - The company utilizes its TMAb™ platform to create conditionally active therapeutics that target immunosuppressive signals in the tumor microenvironment [2] - Solnerstotug is the lead product candidate, designed to block the VISTA checkpoint selectively in low pH tumor environments, enhancing T cell activation [2]

Core Viewpoint - Portage Biotech Inc. reported a significant reduction in net loss for the fiscal year ended March 31, 2025, primarily due to decreased operating expenses and non-cash losses compared to the previous fiscal year [2][6]. Financial Performance - The company incurred a net loss of approximately $6.8 million in Fiscal 2025, a substantial decrease from a net loss of approximately $75.4 million in Fiscal 2024, marking a year-over-year reduction of approximately $68.6 million [2][13]. - Operating expenses totaled $7.4 million in Fiscal 2025, down from $18.2 million in Fiscal 2024, reflecting a decrease of $10.8 million [3][13]. Research and Development (R&D) Expenses - R&D expenses decreased by approximately $9.4 million, or about 75%, from approximately $12.5 million in Fiscal 2024 to approximately $3.1 million in Fiscal 2025 [4][13]. - Clinical trial costs decreased by approximately $3.4 million, from $5.2 million in Fiscal 2024 to $1.8 million in Fiscal 2025, due to a pause in enrollment in sponsored clinical trials [4]. - Manufacturing-related costs decreased from $1.8 million in Fiscal 2024 to $0.2 million in Fiscal 2025, linked to the deprioritization of the iNKT program [4]. General and Administrative (G&A) Expenses - G&A expenses decreased by approximately $1.4 million, or about 24.9%, from approximately $5.7 million in Fiscal 2024 to approximately $4.3 million in Fiscal 2025 [5][13]. - The decrease in G&A expenses was driven by reductions in non-cash share-based compensation, professional fees, and directors' fees [5]. Non-Cash Items and Impairments - The company recognized a net gain of approximately $0.6 million in Fiscal 2025, compared to a net loss of approximately $67.7 million in Fiscal 2024, primarily due to non-cash items [6][8]. - In Fiscal 2024, the company recognized full impairments totaling $57.9 million for iOx and $23.6 million for Tarus, contributing to the previous year's significant losses [7]. Cash Position and Liabilities - As of March 31, 2025, the company had cash and cash equivalents of approximately $1.7 million and total current liabilities of approximately $1.1 million [9][17].

Company Overview - OSE Immunotherapeutics is a biotech company focused on developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) to meet unmet patient needs [3] - The company collaborates with leading academic institutions and biopharmaceutical companies to create transformative medicines for serious diseases [3] Recent Developments - OSE Immunotherapeutics has launched its inaugural Newsletter aimed at individual shareholders and investors, marking the 10th anniversary of its listing on Euronext Paris [2] - The Newsletter will provide updates on company developments, insights into team efforts, and deeper discussions on topics typically covered in press releases [2] Communication Strategy - The Newsletter will be published regularly in both French and English and will be accessible in the "Investors" section of the OSE Immunotherapeutics website [2] - This initiative is intended to enhance communication with individual shareholders and express appreciation for their continued support [2]

Core Viewpoint - Imugene Limited has reported promising results from its Phase 1b clinical trial of azer-cel, an allogeneic CAR T-cell therapy for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), showing a 75% overall response rate and a 55% complete response rate [2][5][6]. Group 1: Clinical Trial Results - A total of six out of eleven evaluable patients achieved a Complete Response (CR), while three patients achieved a Partial Response (PR), leading to a best overall response rate of 75% [2][3]. - The duration of response is maturing, with the first patient remaining cancer-free at 15 months and others showing durable responses at 2, 5, and 11 months [6][7]. - The trial has expanded to include CAR T-naïve patients with other niche blood cancer indications, such as primary central nervous system lymphoma (PCNSL) [6][9]. Group 2: Regulatory and Development Plans - Imugene has received FDA Fast Track Designation for azer-cel in DLBCL, which facilitates the development and review process for drugs addressing serious conditions [5][8]. - The company plans to request a Type B (End of Phase 1) Meeting with the FDA in Q4 2025 to discuss data and designs for a pivotal trial [5][6]. Group 3: Market Context and Unmet Needs - DLBCL is the most common type of non-Hodgkin lymphoma, with approximately 160,000 global cases annually and a high unmet medical need, as around 60% of patients treated with existing therapies relapse [10]. - There are currently no CAR T-cell products approved for treating PCNSL, highlighting a significant opportunity for azer-cel in this area [10][11].