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AlphaTON Capital Releases Market Update on its Strong Balance Sheet and Cash Position with No Debt
Globenewswire· 2026-01-29 15:08
Core Insights - AlphaTON Capital Corp. reported $24.5 million in assets, with $11 million in cash and no debt or convertible securities, indicating a strong financial position [1][5] - The company has 23.4 million shares outstanding and has made a $4 million deposit towards acquiring 576 Nvidia B300 GPUs for AI revenue production [5] - AlphaTON is focused on scaling the Telegram super-app, targeting an addressable market of one billion monthly active users, while managing a strategic reserve of digital assets [2] Financial Position - Total assets amount to $24.5 million [5] - Cash reserves stand at $11 million [5] - The company has no outstanding debt or convertible securities, reflecting a solid balance sheet [5] Share Structure - AlphaTON has 23.4 million shares outstanding, which provides insight into its market capitalization and shareholder structure [5] Strategic Investments - The company has made a $4 million deposit for Nvidia B300 GPUs, which are intended for AI revenue production, indicating a commitment to technological advancement [5] - AlphaTON's strategy includes direct digital asset acquisition, validator operations, and investments in decentralized finance protocols and gaming platforms [2] Leadership and Governance - The company is led by CEO Brittany Kaiser, Executive Chairman Enzo Villani, and Chief Business Development Officer Yury Mitin, emphasizing a strong management team [2]
Immutep Quarterly Activities Report Q2 FY26
Globenewswire· 2026-01-29 13:00
Core Insights - Immutep Limited has made significant progress in its immunotherapy development, particularly with eftilagimod alfa (efti), through a strategic collaboration with Dr. Reddy's Laboratories for commercialization outside key markets [3][5][6] Efti Development Program in Oncology - The strategic collaboration with Dr. Reddy's includes an upfront payment of USD 20 million (~AUD 30.2 million) and potential milestone payments of up to USD 349.5 million (~AUD 528.4 million) [5][6] - Efti is currently under evaluation in a Phase III trial (TACTI-004) for first-line non-small cell lung cancer (1L NSCLC), with strong operational progress reported [4][8] - The combination of efti with KEYTRUDA and chemotherapy has shown a 61.7% overall response rate (ORR) in patients with low and no PD-L1 expression, significantly higher than the historical control of 40.8% [14] - The EFTISARC-NEO Phase II trial met its primary endpoint with a median tumor hyalinization/fibrosis of 51.5%, indicating potential for improved survival outcomes in soft tissue sarcoma [17][20] Financial Summary - As of December 31, 2025, the company reported a strong cash position of approximately AUD 99.1 million, which will extend its cash reach into Q2 CY2027 [35][40] - The company received EUR 2.59 million (~AUD 4.6 million) in R&D tax incentives from the French government to support ongoing clinical development [36] - Total cash outflows for R&D activities during the quarter were AUD 9.9 million, a decrease from AUD 15.8 million in the previous quarter [37] Intellectual Property - Immutep was granted four patents during the quarter, including a new patent in New Zealand for a binding assay related to LAG-3 protein and three new patents for IMP761 in Brazil and Japan [32] Corporate Activities - The company successfully held its Annual General Meeting (AGM), with all resolutions approved by shareholders, reflecting strong support for its strategic objectives [33]
BioVaxys Reports Positive Phase 2 Data for Maveropepimut (MVP-S) + Pembrolizumab and Low-Dose Cyclophosphamide in Metastatic Bladder Cancer
Thenewswire· 2026-01-29 13:00
Core Insights - BioVaxys Technology Corp. announced positive findings from a Phase 2 clinical study of maveropepimut-S (MVP-S) in combination with pembrolizumab and low-dose cyclophosphamide for advanced or metastatic bladder cancer, reinforcing the potential of MVP-S to enhance checkpoint inhibitor activity across multiple solid tumor indications [1][4] Group 1: Clinical Study Findings - The Phase 2 study assessed the safety, tolerability, and clinical activity of the combination regimen in patients with metastatic bladder cancer, including those who had progressed on prior anti-PD1/PD-L1 therapies [2] - Key findings indicate that combining MVP-S with checkpoint inhibitors can expand antigen-specific T cell responses, reduce regulatory T-cell activity, and amplify anti-tumor activity [2] - Of 17 evaluable subjects, five showed objective responses, including 2 confirmed complete responses (CRs) and 3 partial responses (PRs), with notable responses in patients previously resistant to checkpoint inhibitors [5] Group 2: MVP-S Mechanism and Composition - MVP-S is a DPX-based immunotherapy that includes multiple survivin-derived peptides, a T-helper peptide, and an innate immune stimulant, promoting efficient antigen uptake and robust T-cell activation [3] - The DPX platform employs a novel, non-aqueous, lipid-in-oil formulation that mimics natural immune processes, resulting in durable immune responses without systemic release at the injection site [3] Group 3: Market Context and Future Opportunities - The encouraging results from the Phase 2 study support advancing MVP-S toward Phase 3 development in ovarian cancer and exploring broader partnering opportunities across additional indications [4] - Major anti-PD1 therapies, such as Merck's Keytruda and Bristol Myers Squibb's Opdivo, are approaching significant patent expirations by 2028, creating opportunities for MVP-S in a competitive market [4] - BioVaxys continues to advance its oncology pipeline, with MVP-S demonstrating consistent tolerability and immune activation across various cancer indications [6]
Agenus (NasdaqCM:AGEN) Update / briefing Transcript
2026-01-28 22:02
Summary of Agenus Stakeholder Webcast Company Overview - **Company**: Agenus - **Industry**: Biotechnology, specifically focused on immuno-oncology treatments Key Points and Arguments Collaboration with Zydus Lifesciences - Agenus has closed a collaboration with Zydus Lifesciences, enhancing operational capabilities and securing long-term US-based biologics manufacturing capacity [3][4] - The collaboration involves the sale of Agenus's Emeryville facility and equity at a premium, providing necessary capital for strategic execution [3][4] - Zydus Lifesciences, valued at $10 billion, lacked a US biologics manufacturing facility, making this partnership crucial for both companies [18][19] Patient Access and Regulatory Developments - France's reimbursed AAC program has expanded to include sarcoma and ovarian cancer, allowing eligible patients access to BOT/BAL with full government reimbursement [5][11] - The urgency for patient access is emphasized, as confirmatory trials can take a long time, and patients need immediate options [6][11] - The societal burden of colorectal cancer is increasing, with it now being the leading cause of cancer-related deaths in individuals under 50, highlighting the need for innovative treatments [9] Clinical Trials and Efficacy - The BATMAN trial, a global phase 3 study for MSS metastatic colorectal cancer, is set to launch soon, with high expectations for quick enrollment based on previous trial data [10][11] - Early data from phase 1 and 2 trials involving nearly 500 patients show promising efficacy for BOT/BAL, particularly in historically resistant cancers [10][11] - The combination of BOT and BAL is showing potential in treating sarcomas, which have limited treatment options and are often immune-cold tumors [49][50] Medical Affairs and Infrastructure - Agenus is scaling up its medical affairs capabilities to support growing interest from physicians and patients, ensuring responsible access to treatments [12][57] - The company is hiring medical scientific liaisons to facilitate communication between sites and manage compassionate access requests [70][71] - Real-world data from compassionate access programs will be crucial for regulatory submissions and understanding treatment efficacy in broader populations [72] Future Priorities - Key priorities for 2026 include expanding patient access, preparing for global regulatory filings, and advancing the BATMAN trial [11][36] - There is a strong commitment to meeting the moral responsibility of providing access to treatments for patients in need [36][75] Additional Important Content - The collaboration with Zydus is seen as a strategic move to ensure that scientific momentum is matched by operational execution, particularly in oncology where treatment options are limited [39] - The role of immunotherapy is expanding, with a shift away from traditional chemotherapy towards more innovative treatments like BOT/BAL [12][60] - The importance of capturing real-world data and ensuring patient safety and efficacy is emphasized as the company moves forward with its initiatives [72][74] This summary encapsulates the critical discussions and insights shared during the Agenus stakeholder webcast, highlighting the company's strategic direction, collaborations, and commitment to patient care in the evolving landscape of oncology.
Aptevo Therapeutics(APVO) - Prospectus
2026-01-28 21:05
As filed with the Securities and Exchange Commission on January 28, 2026 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 APTEVO THERAPEUTICS INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 81-1567056 (I.R.S. Employer Identification Number) 2401 4th Avenue ...
PDS Biotech Announces Presentation of Preliminary Results from Phase 2 Study of IL-12 Tumor Targeted Immunocytokine (PDS01ADC) in 3rd Line Metastatic Castration Resistant Prostate Cancer by the NCI
Globenewswire· 2026-01-28 13:45
Core Insights - The study led by the National Cancer Institute (NCI) demonstrated a median progression-free survival (PFS) of 9.6 months for the investigational drug PDS01ADC in patients with metastatic castration-resistant prostate cancer (mCRPC) [1][2] - The combination therapy showed a median PSA decline of 40%, with 6 out of 16 patients achieving more than a 50% decline [2] - PDS Biotech aims to advance PDS01ADC as a key component of its immuno-oncology pipeline, reinforcing its potential to enhance existing therapies across various solid tumor types [3] Company Overview - PDS Biotechnology Corporation is a late-stage immunotherapy company focused on transforming immune responses to cancer [4] - The company has initiated a pivotal clinical trial for its lead program targeting advanced HPV16-positive head and neck squamous cell cancers [4] - PDS Biotech's lead investigational therapy, PDS0101 (Versamune HPV), is being developed in combination with standard immune checkpoint inhibitors and PDS01ADC [4]
BriaCell Patients' Images Show Regression and Resolution of Metastasized Tumors and Immune Activation
Globenewswire· 2026-01-28 12:30
Core Viewpoint - BriaCell Therapeutics Corp. has released new imaging data demonstrating the effectiveness of its Bria-IMT treatment in resolving metastatic breast cancer lesions in patients with various organ involvements, highlighting potential improvements in patient survival rates [1][3]. Patient Outcomes - Patient 11-018, a 66-year-old woman with ER+/PR+/HER2+ metastatic breast cancer, has survived 27 months post-enrollment after receiving 35 cycles of Bria-IMT, showing complete resolution of temporal lobe metastasis and significant improvement in orbital lesions [4][5]. - Patient 15-005, a 44-year-old woman with ER+/PR+/HER2- metastatic breast cancer, remains alive 27 months after study entry, achieving stable disease after 6 cycles of therapy [7]. - Patient 15-006, a 64-year-old woman with ER+/PR-/HER2- metastatic breast cancer, has survived 25 months post-enrollment after receiving treatment, with initial hepatic metastasis [11]. Mechanism of Action - The CD8 ImmunoPET imaging confirms that BriaCell's treatment activates CD8+ cytotoxic T cells, which infiltrate tumors, potentially enhancing long-term survival even after patients exit the study [3]. Study Details - The Phase 2 study included 54 heavily pre-treated metastatic breast cancer patients, with a median of six prior therapies. No Bria-IMT related discontinuations have been reported, and 37 patients received the formulation currently being evaluated in a pivotal Phase 3 study [16].
BriaCell Highlights Extended >18-47 Months Survival in Phase 2 Metastatic Breast Cancer Patients
Globenewswire· 2026-01-27 12:30
Core Insights - BriaCell Therapeutics Corp. has announced positive Phase 2 survival data for its Bria-IMT regimen, showing multiple patients with metastatic breast cancer exceeding expected survival benchmarks, with 9 cases surpassing 18 months of survival as of the last assessment [1][8]. Patient Data Summary - The Phase 2 study included 54 heavily pre-treated metastatic breast cancer patients, with a median of six prior therapies. The median overall survival was reported as 13.4 months, increasing to 15.6 months for patients treated post-2022 [10]. - Notable patients include: - Patient 11-018: 66-year-old woman with ER+/PR+/HER2+ metastatic breast cancer, achieved complete resolution of brain metastasis after 35 cycles of therapy, remains in follow-up 27 months post-enrollment [4]. - Patient 15-005: 44-year-old woman with ER+/PR+/HER2- metastatic breast cancer, achieved stable disease after 6 cycles, remains in follow-up 27 months post-enrollment [5]. - Patient 15-006: 64-year-old woman with ER+/PR-/HER2- metastatic breast cancer, remains in follow-up 25 months post-enrollment [6]. Clinical Significance - The data indicates that 9 out of 25 patients treated since 2022 remain alive between 18 to 47 months post-enrollment, significantly exceeding benchmarks for standard care therapies in similar patient populations [8]. - No Bria-IMT related discontinuations have been reported to date, and the regimen continues under Fast Track Designation from the US FDA [8]. Expert Commentary - Dr. Adam M. Brufsky highlighted the potential of the Bria-IMT regimen for treating late-stage metastatic breast cancer, emphasizing the need for effective treatment options for heavily pre-treated patients [7]. - Dr. William V. Williams, President and CEO of BriaCell, expressed optimism about confirming these findings in the ongoing pivotal Phase 3 study, which has overall survival as its primary endpoint [9].
Greenwich LifeSciences Provides Update on FLAMINGO-01 Cash Burn Rate and Financing Strategy
Globenewswire· 2026-01-27 11:00
Core Viewpoint - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, while also updating on its cash burn rate and financing strategy [1][2]. Financial Updates - The Company raised more than its 2025 cash burn rate of approximately $9.5 million through its ATM financing, resulting in a year-end cash balance of approximately $6 million as of December 31, 2025 [2]. - As of January 23, 2026, the cash balance increased to approximately $12.5 million after raising about $7 million in the first three weeks of January 2026 [2]. - The current cash balance may cover the Company's cash needs for all of 2026, considering the projected increase in cash needs over the previous years [3]. Clinical Trial Progress - FLAMINGO-01 has screened over 1,000 patients, with a current screening rate of approximately 600 patients per year [4]. - The non-HLA-A*02 arm is fully enrolled, with 250 patients receiving GLSI-100, which represents a significant increase in treated patients compared to the Phase IIb trial [4]. - Preliminary analysis indicates an approximately 80% reduction in recurrence rates after the Primary Immunization Series (PIS) is completed, aligning with Phase IIb trial results [7]. Immunotherapy Details - GLSI-100 is designed to elicit a potent immune response, with the PIS involving six injections over the first six months, followed by five booster injections every six months [4][13]. - The safety profile and immune response trends in non-HLA-A*02 patients are similar to those observed in HLA-A*02 patients from the FLAMINGO-01 trial and the Phase IIb study [7]. Future Financing Strategy - The Company plans to continue using the ATM to sustain or grow its cash balance, potentially reducing the need for large financing in the near term [3]. - Continued use of the ATM may facilitate access to non-dilutive funding options, such as strategic partnerships or debt financing, to support FLAMINGO-01 and future commercial activities [3].
Tivic to Showcase Strategic Pivot and Forward Outlook on Advancing Entolimod(TM) to Commercialization at DealFlow Discovery Conference
Accessnewswire· 2026-01-26 15:10
CEO Presentation to Include Updates and Further Information on the Following Topics: rd FREMONT, CA / ACCESS Newswire / January 26, 2026 / Tivic Health® Systems, Inc. (Nasdaq:TIVC), a late-stage immunotherapeutics company, today announced that the company's CEO will present at the 3 Annual DealFlow Discovery Conference, set to take place on January 28-29, 2026 in Atlantic City, New Jersey. Event Details Investors interested in scheduling a meeting with the Tivic's management team should request an investor ...