
Venture Global Announces Final Investment Decision and Financial Close for Phase 1 of CP2 LNG
'We are extremely proud to have taken FID on our third greenfield project in under 6 years with over $80 billion in capital markets transactions executed to date,' said Venture Global CEO Mike Sabel. 'This success would not be possible without the dedication and relentless execution of the entire Venture Global team. Our significant early investments and work on the project make CP2 the most advanced project at FID to date. This project, fully owned by Venture Global and our shareholders, is expected to deliver reliable American LNG to the world beginning in 2027.'
CP2 will have a peak production capacity of 28 MTPA. Phase 1 has contracted long-term SPAs with customers in Europe, Asia and the rest of the world. Accordingly, CP2 is a strategically important project to global energy supply and security. Venture Global now has a total contracted capacity of 43.5 MTPA across all three of its projects in Louisiana.
The lender group for the construction financing is comprised of the world's leading banks, signaling significant demand for U.S. LNG investment not only in the United States but also in Europe and Asia. The lender group includes: Bank of America, Barclays, Bayern LB, BBVA, CIBC, Deutsche Bank, FirstBank, Flagstar, Goldman Sachs, Helaba, ICBC, ING, Intesa, J.P. Morgan, LBBW, Mizuho, MUFG, Natixis, NBC, Nord LB, Raymond James, RBC, Regions, Santander, Scotiabank, SMBC, Standard Chartered, Truist and Wells Fargo.
ING and Santander served as Lead Arrangers for CP2 LNG Phase 1's Construction Term Loan and Working Capital Facility, while Bank of America and Scotiabank served as Lead Arrangers for CP2 LNG Phase 1's Equity Bridge Loan. Latham & Watkins LLP served as counsel to Venture Global and Skadden, Arps, Slate, Meagher & Flom LLP served as counsel to lenders across all facilities.
About Venture Global
Venture Global is an American producer and exporter of low-cost U.S. liquefied natural gas (LNG) with over 100 MTPA of capacity in production, construction, or development. Venture Global began producing LNG from its first facility in 2022 and is now one of the largest LNG exporters in the United States. The company's vertically integrated business includes assets across the LNG supply chain including LNG production, natural gas transport, shipping and regasification. The company's first three projects, Calcasieu Pass, Plaquemines LNG, and CP2 LNG, are located in Louisiana along the U.S. Gulf Coast. Venture Global is developing Carbon Capture and Sequestration projects at each of its LNG facilities.
Forward-looking Statements
This press release contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the 'Securities Act'), and Section 21E of the Securities Exchange Act of 1934, as amended (the 'Exchange Act'). All statements, other than statements of historical facts, included herein are 'forward-looking statements.' In some cases, forward-looking statements can be identified by terminology such as 'may,' 'might,' 'will,' 'could,' 'should,' 'expect,' 'plan,' 'project,' 'intend,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'potential,' 'pursue,' 'target,' 'continue,' the negative of such terms or other comparable terminology.
These forward-looking statements, which are subject to risks, uncertainties and assumptions about us, may include statements about our future performance, our contracts, our anticipated growth strategies and anticipated trends impacting our business. These statements are only predictions based on our current expectations and projections about future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include our need for significant additional capital to construct and complete future projects and related assets, and our potential inability to secure such financing on acceptable terms, or at all; our potential inability to accurately estimate costs for our projects, and the risk that the construction and operations of natural gas pipelines and pipeline connections for our projects suffer cost overruns and delays related to obtaining regulatory approvals, development risks, labor costs, unavailability of skilled workers, operational hazards and other risks; the uncertainty regarding the future of global trade dynamics, international trade agreements and the United States' position on international trade, including the effects of tariffs; our dependence on our EPC and other contractors for the successful completion of our projects, including the potential inability of our contractors to perform their obligations under their contracts; various economic and political factors, including opposition by environmental or other public interest groups, or the lack of local government and community support required for our projects, which could negatively affect the permitting status, timing or overall development, construction and operation of our projects; and risks related to other factors discussed under 'Item 1A.—Risk Factors' of our annual report on Form 10-K for the year ended December 31, 2024 as filed with the Securities and Exchange Commission ('SEC') and any subsequent reports filed with the SEC.
Any forward-looking statements contained herein speak only as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date. We undertake no obligation to update these statements to reflect subsequent events or circumstances, except as may be required by law.

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Cision Canada
6 minutes ago
- Cision Canada
Hospitality Gets High-Tech: The Future of Hotel Investment Is AI Automation
NEW YORK, Aug. 4, 2025 /CNW/ -- The hospitality industry is undergoing a major transformation powered by artificial intelligence (AI) and robotics, with hotels using automation reporting 30–40% reductions in operational costs, improved guest experiences and better revenue management. The AI in hospitality market size is expected to see exponential growth to $1.46 billion in 2029 at a compound annual growth rate (CAGR) of 57.8% while the global hospitality robotics market is projected to grow from $24.38 billion this year to $107.24 billion in 2034. Leading this shift is Nightfood Holdings Inc. (OTCQB: NGTF) (Profile), a pioneer hospitality entity that combines hotel ownership with AI-driven Robotics-as-a-Service (RaaS) The company recently announced plans to acquire a 155-room Holiday Inn in Victorville, California, its first model property integrating guest-facing robots such as food-delivery concierges and laundry assistants, a proprietary system provided by SGTF subsidiary Skytech. Nightfood has also established a strategic partnership with Bear Robotics to scale automation across its portfolio, which includes an estimated $80 million in assets. Nightfood joins a growing number of leading companies, including Tesla Inc. (NASDAQ: TSLA), SoFi Technologies Inc. (NASDAQ: SOFI), NVIDIA Corp. (NASDAQ: NVDA) and UiPath Inc. (NYSE: PATH), that are leveraging groundbreaking AI and robotics to innovate in their respective industries. Nightfood Holdings is a pioneer hospitality entity that combines hotel ownership with AI-driven Robotics-as-a-Service (RaaS). The company is strategically assembling an $80 million portfolio of institutional-grade hotels through targeted acquisitions. NGTF is executing a dual-revenue strategy that pairs recurring RaaS income with long-term real estate value creation. Nightfood Holdings is capitalizing on a first-mover advantage by integrating robotics and AI into hotel operations at a foundational level. With a seasoned team of executives who have developed more than 50 hotels and managed more than 130 hospitality assets, Nightfood Holdings brings deep industry expertise to every aspect of its growth strategy. Click here to view the custom infographic of the Nightfood Holdings editorial. AI, Robotics Revolutionizing Hospitality Business Research reports that "AI is transforming the hotel industry by optimizing revenue management, personalizing guest experiences, enhancing cybersecurity, and automating operations." The report notes that future AI in the hotel industry, which includes AI-driven sustainability, biometric check-ins, metaverse hotel previews and more, will lead to compound annual growth rate (CAGR) of more than 50% in the space in the coming years. Market Research Futures projects that the hospitality robot market will experience a CAGR of more than 71% through 2034 with robotics in hospitality seeing rising levels of trust, acceptance and understanding. "Guests are increasingly demanding personalized experiences when they travel," the report states. "They want to be able to tailor their stay to their own needs and preferences. Hospitality robots can help to provide personalized guest experiences by offering a variety of services, such as personalized recommendations for restaurants, activities, and attractions; real-time information about hotel amenities and services; the ability to control their room temperature, lighting and other settings. By providing personalized guest experiences, hospitality robots can help to increase guest satisfaction and loyalty." These impressive trajectories reflect widespread adoption across hotels, resorts, restaurants and cruise operations seeking cost savings, enhanced service and recovery from staffing shortages. Smart companies such as Nightfood Holdings are capitalizing on these trends, leveraging their expertise and resources to become leaders in the hospitality transformation. A Bold Real Estate Vision Nightfood Holdings is strategically assembling an $80 million property portfolio through targeted acquisitions, creating a scalable foundation for its next-generation hospitality platform. By acquiring high-visibility, branded properties in key growth markets, the company is focused on creating a strategic collection of real estate and leading the way in operational innovation. This focused expansion not only builds asset value but also allows for consistent delivery of elevated guest experiences and operating efficiency. Nightfood just announced that it is "on track to finalize due diligence and enter definitive agreements for the acquisition of two flagship hotel properties in Victorville and Rancho Mirage, California. Combined, these transactions represent approximately $80 million in institutional-grade real estate assets and serve as a cornerstone of the company's vertically integrated hospitality and automation strategy." The 155-room Victorville property is currently a Holiday Inn. Nightfood earlier signed a letter of intent to purchase the property for approximately $41 million, with plans to convert it into a Courtyard by Marriott. The hotel will serve as a flagship property in the company's portfolio, showcasing operational enhancements and property upgrades intended to boost revenue and brand recognition. Victorville's strategic location, along one of the busiest transportation corridors between Los Angeles and Las Vegas, positions the property for strong occupancy and long-term performance. Building on that momentum, Nightfood signed a second letter of intent to acquire a Hilton Garden Inn in Rancho Mirage, California, for roughly $37 million. The property sits adjacent to Disney's highly anticipated Cotino residential and resort development, a location expected to benefit from substantial traffic and tourism in the coming years. By investing in a branded, upscale asset in such a premium corridor, Nightfood is enhancing both the value and visibility of its growing portfolio. According to the company, both properties will be integrated into Nightfood's AI automation platform, serving as operational environments for robotic deployments, data collection and revenue optimization. Together, these acquisitions demonstrate the company's focus on institutional-quality assets with strong brand affiliations and location advantages. Each addition to the portfolio is carefully selected to support scalability, ensure stable cash flow and serve as a platform for long-term growth. As Nightfood continues to expand its holdings, it is creating a strong and differentiated position in the hospitality real estate space, anchored by quality, operational excellence and future-ready infrastructure. Nightfood Holdings is executing a dual-revenue strategy that pairs recurring RaaS income with long-term real estate value creation. At the core of this approach is the deployment of AI-powered service robots that automate essential hospitality functions, such as food and amenity delivery, linen transport and cleaning, across the company's hotel properties. These robotic systems are offered on a subscription basis, creating a predictable and scalable revenue stream that is not tied to seasonal occupancy or nightly rates. Through its Skytech Automated Solutions division, Nightfood is developing and installing robots specifically engineered for the hospitality sector. These include concierge robots that interact directly with guests, autonomous carts that transport laundry and supplies, and cleaning bots that operate efficiently in common areas. By reducing labor demands and increasing operational efficiency, RaaS technology enables hotels to streamline staffing, cut costs and improve the guest experience, all while generating monthly recurring revenue. This recurring revenue model is being embedded into properties the company is acquiring, including its planned flagship hotels in Victorville and Rancho Mirage, California. These hotels will serve as model sites where the RaaS platform can be refined and demonstrated at scale. The ultimate goal is to license and deploy Nightfood's robotic systems across a broader network of third-party hotel operators, enabling expansion of the RaaS model beyond company-owned properties. By combining high-impact automation with direct ownership of real estate assets, Nightfood is creating a vertically integrated business model. The RaaS component delivers consistent, technology-driven revenue, while hotel ownership provides asset appreciation and brand equity. This synergy positions the company to benefit from both short-term income and long-term value creation in a transforming hospitality landscape. Pioneering the Future of Tech-Enabled Hospitality Nightfood Holdings is capitalizing on a first-mover advantage by integrating robotics and AI into hotel operations at a foundational level. Through its proprietary RaaS platform, the company is deploying guest-facing and back-of-house service robots that perform tasks such as food and linen delivery, cleaning and concierge support. These robotic systems are not add-ons but core operational components, designed to streamline workflows, reduce labor costs and enhance the overall guest experience. By owning and operating its initial properties, Nightfood can rapidly prototype and refine its automation technologies in live environments before offering them to third-party operators. This vertically integrated strategy allows for the seamless fusion of real estate operations with tech deployment, creating a hospitality model that is both operationally efficient and easily scalable. Unlike traditional hotel-management companies or pure-play robotics firms, Nightfood is positioned to generate recurring revenue from automation while also benefiting from asset value appreciation. With pilot programs underway and a growing ecosystem of robotics, AI and strategic partnerships, the company is laying the groundwork for broad market adoption, setting a new standard for how hotels operate in the AI era. Experienced Leadership Driving Strategic Growth With a seasoned team of executives who have developed more than 50 hotels and managed more than 130 hospitality assets, Nightfood Holdings brings deep industry expertise to every aspect of its growth strategy. The leadership team combines decades of experience in hotel operations, finance and real estate development, enabling the company to identify high-potential properties, negotiate favorable deal terms and execute value-enhancing improvements with precision. This hands-on knowledge ensures that acquisitions are not only strategic but also aligned with long-term growth and operational efficiency. The company's strong operational background also facilitates effective integration of new properties into the portfolio while maintaining high standards of service and performance. Nightfood's disciplined approach to capital allocation underpins its ability to scale without overextending. Each acquisition is selected based on rigorous financial modeling, brand potential, and operational upside. By targeting institutional-grade assets in markets with long-term demand drivers, Nightfood ensures both stability and room for innovation. This measured approach minimizes risk while maximizing value creation, allowing the company to balance growth ambitions with sustainable financial management. Paired with its focus on technology integration and recurring revenue through automation, the company's leadership is executing a clear, focused strategy that balances growth with financial prudence and positions it well for long-term success. Shaping the Future with AI, Robotics In addition to Nightfood's innovation, recent announcements from top-tier tech companies highlight a pivotal moment in the evolution of AI and robotics. As these industry innovators integrate advanced AI systems into their offerings, they are not only enhancing performance and efficiency but also establishing themselves at the forefront of a rapidly evolving global market. Tesla Inc. announced its most recent developments in AI and robotics during its Q2 2025 earnings report. "Q2 2025 was a seminal point in Tesla's history: the beginning of our transition from leading the electric vehicle and renewable energy industries to also becoming a leader in AI, robotics and related services," the report stated. "Our first Robotaxi service launched in Austin in June. While the service is limited in scope, we believe our approach to autonomy, a camera-only architecture with neural networks trained on data from our global fleet of millions of vehicles, allows us to continually improve safety, rapidly scale the network and improve profitability." SoFi Technologies Inc. announced that it expanded access to alternative investments funds to provide investors with exposure to multiple private companies that include AI. The company is leveling the financial playing field by offering investment minimums starting at $10. The announcement noted that SoFi has partnered with Templum to give members access to privately held companies via the Cosmos Fund, with asset classes offering sole exposure to top tech companies including SpaceX, Databricks and xAI. NVIDIA Corp. has released NVIDIA Isaac GR00T N1.5, the first update to the company's open, generalized, fully customizable foundation model for humanoid reasoning and skills; NVIDIA Isaac GR00T-Dreams, a blueprint for generating synthetic motion data; and NVIDIA Blackwell systems to accelerate humanoid robot development. "Physical AI and robotics will bring about the next industrial revolution," said Jensen Huang, founder and CEO of NVIDIA. "From AI brains for robots to simulated worlds to practice in or AI supercomputers for training foundation models, NVIDIA provides building blocks for every stage of the robotics development journey." UiPath Inc. has been recognized as a leader in the 2025 Gartner(R) Magic Quadrant(TM) for Robotic Process Automation. This marks the seventh consecutive year UiPath has earned this distinction, with the company being positioned highest for its ability to execute. Gartner's evaluation highlighted UiPath's leadership in agentic automation, where intelligent software agents can perceive, reason and act autonomously to achieve complex business objectives. This recognition underscores UiPath's ongoing commitment to advancing AI-driven automation solutions. Together, these companies reflect the breadth and impact of AI integration across sectors. As the AI and robotics revolution continues to unfold, these advancements signal a profound transformation in how we live, work and invest. For more information, visit Nightfood Holdings (NGTF). NetworkNewsWire ("NNW") is a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. 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Cision Canada
6 minutes ago
- Cision Canada
Late-Stage Pipeline Wins Boost Investor Confidence in High-Growth Therapeutic Areas
NEW YORK, Aug. 4, 2025 /CNW/ -- As America's population ages, chronic and rare diseases are emerging as a pressing healthcare challenge — one that disproportionately affects older adults. With more than 30 million Americans living with a rare disease, the need for accurate diagnoses and effective treatments is growing urgent. Many of these conditions remain without FDA-approved therapies, and symptoms in seniors are often misattributed to typical aging, leading to years-long diagnostic delays. Recognizing this crisis, the Trump administration's "Make America Healthy Again" initiatives have emphasized improving access to treatments and accelerating medical innovation. Advancing this mission, Soligenix Inc. (NASDAQ: SNGX) (Profile) is making strides with its HyBryte(TM) platform, a novel therapy aimed at treating cutaneous T-cell lymphoma (CTCL), a rare skin cancer that primarily affects older adults. With successful U.S.-based manufacturing of HyBryte's active ingredient now in place, Soligenix exemplifies the kind of domestic innovation poised to make a meaningful impact on this underserved patient population. The company is one of several impressive companies committed to making an impact in the pharmaceutical space, including Pfizer Inc. (NYSE: PFE), Merck & Co Inc. (NYSE: MRK), Bristol-Myers Squibb Co. (NYSE: BMY) and Insmed Inc. (NASDAQ: INSM). Soligenix Inc.'s HyBryte platform represents a promising therapeutic option for cutaneous T-cell lymphoma, a rare cancer that often affects older adults. A second confirmatory phase 3 clinical trial for HyBryte is underway and represents a pivotal step in advancing the therapy toward global commercialization for the treatment of early-stage CTCL. HyBryte received both U.S. and EU orphan drug designations as well as Fast Track status from the FDA, underscoring the serious unmet medical need it addresses. A critical attribute of HyBryte in the treatment of CTCL is its consistently strong safety profile, demonstrated across multiple clinical studies. Click here to view the custom infographic of the Soligenix Inc. editorial. Continued Investment in Rare Diseases Is Key Chronic rare diseases are emerging as a major challenge within the aging U.S. population. As life expectancy increases, so too does the complexity of healthcare needs, particularly when it comes to conditions that are both long-lasting and difficult to diagnose. Tens of millions of Americans are facing life with a rare disease, and many of them are seniors whose symptoms can easily be dismissed as normal signs of aging. Because rare diseases often present subtly or mimic more common age-related issues, diagnosis in older adults can be delayed by years, hindering access to effective care and worsening outcomes. Compounding the issue is the limited availability of FDA-approved treatments. With thousands of rare diseases identified, the vast majority remain without approved therapies, underscoring the importance of continued investment in research and development. Seniors, in particular, are vulnerable to underdiagnosis and undertreatment, especially when the healthcare system is not attuned to the nuanced presentation of rare conditions in older adults. In response, the "Make America Healthy Again" initiative has spotlighted the growing burden of chronic and rare diseases. Through targeted policies aimed at accelerating research, improving diagnostic tools and expanding access to care, these efforts seek to address the needs of older Americans grappling with complex, often overlooked, health challenges. Companies such as Soligenix Inc. are rising to meet this need. The firm's HyBryte program represents a promising therapeutic option for cutaneous T-cell lymphoma, a rare cancer that often affects older adults. Soligenix has recently completed the successful U.S. manufacturing transfer of HyBryte's active ingredient, advancing its mission to bring effective, innovative treatments to patients most in need. A Rare Cancer with Unmet Needs Cutaneous T-cell lymphoma (CTCL) is a rare form of non-Hodgkin's lymphoma (NHL) that primarily affects the skin. Unlike other lymphomas, CTCL involves malignant T-cells that migrate to the skin's surface, forming patches, lesions or tumors. This chronic cancer most commonly appears in older adults, making it particularly relevant to the aging population. Despite its rarity, CTCL remains a serious medical concern, affecting more than 40,000 NHL patients globally. There is currently no known cure for CTCL, and treatment is often limited to managing symptoms and slowing disease progression. The most prevalent subtype of CTCL is mycosis fungoides (MF), which accounts for approximately 90% of all CTCL cases. In its early stages (I–IIA), MF has a relatively high five-year survival rate of 88%, but it remains a lifelong illness. As a chronic condition with no approved first-line therapy for early-stage patients, CTCL represents a clear unmet medical need. The global market opportunity for CTCL therapies in the seven major markets (the United States, EU4, the United Kingdom and Japan) was estimated at about $995 million in 2024, with the U.S. accounting for some 70% of that. In addition, DelveInsight notes that "the expected launch of therapies such as HyBryte . . . will also boost the CTCL market growth." Without these new therapies, effective treatment options remain limited, especially for those diagnosed in the early stages. Many patients undergo a series of therapies with limited success, underscoring the need for innovative, targeted treatments. Soligenix's HyBryte (synthetic hypericin) offers a promising solution as a potential first-line therapy for early-stage CTCL. By addressing this critical gap in care, HyBryte has the potential to significantly improve quality of life for thousands of patients and become a leading treatment option in this underserved market. Bolstering the Case for HyBryte Soligenix's second confirmatory phase 3 clinical trial for HyBryte, known as FLASH2, is currently underway and represents a pivotal step in advancing the therapy toward global commercialization for the treatment of early-stage CTCL. Designed to reinforce the positive findings of the initial FLASH study, FLASH2 has been accepted by the European Medicines Agency (EMA), while discussions with the U.S. Food and Drug Administration (FDA) remain ongoing. This validation by European regulators underscores the robustness of the trial design and its alignment with international standards for therapeutic approval. The FLASH2 study maintains a similar structure to its predecessor but features an extended double-blind, placebo-controlled treatment duration of 18 weeks, three times longer than the original six-week period in the first FLASH trial. This longer timeline is expected to provide even more comprehensive data on HyBryte's safety and efficacy. Importantly, key elements such as the patient inclusion and exclusion criteria and the primary endpoint remain consistent between the two studies, supporting the integrity and comparability of the trial outcomes. Approximately 80 patients will be enrolled across clinical sites in both the United States and Europe. This multinational approach is intended to support broad regulatory submissions and pave the way for HyBryte's commercial launch on a global scale. With enrollment progressing on schedule, Soligenix anticipates reporting top-line results in 2026, data that could significantly bolster the case for HyBryte as the first approved front-line treatment for early-stage CTCL. As Soligenix continues to advance this promising therapy, FLASH2 stands as a potentially transformational milestone in the company's effort to address a long-standing unmet medical need within the rare disease and oncology communities. A Critical Advancement in Treatment Soligenix's HyBryte achieved positive, statistically significant results in its first phase 3 clinical trial, known as the FLASH study, marking a critical advancement in the treatment of early-stage CTCL. HyBryte received both U.S. and EU orphan drug designations as well as Fast Track status from the FDA, underscoring the serious unmet medical need it addresses. Unlike many CTCL therapies that require a year or more to demonstrate efficacy, HyBryte showed a statistically significant treatment response in just six weeks, with response rates improving to 40% at 12 weeks and 49% at 18 weeks. The therapy demonstrated effectiveness across both patch and deeper plaque lesions, an important distinction given that many current early-stage CTCL treatments are primarily effective only on patch-type manifestations. This broader lesion response highlights HyBryte's unique therapeutic potential within a complex and varied disease presentation. The study's design and outcomes also reflect the treatment's clinical promise as a practical, noninvasive solution that could change the standard of care for CTCL patients. Safety and tolerability further set HyBryte apart. The FLASH trial reported minimal adverse events, a significant benefit when compared to other CTCL therapies that are often associated with both acute and chronic side effects. This favorable safety profile may make HyBryte especially appealing to older patients who are frequently managing multiple health conditions. Additionally, HyBryte's use of visible fluorescent light rather than ultraviolet (UV) light avoids the carcinogenic risks typically associated with conventional phototherapy. This novel light-based activation of synthetic hypericin enhances patient safety while maintaining therapeutic efficacy. Collectively, the FLASH and FLASH2 study results position HyBryte as a strong candidate to become the first approved front-line treatment for early-stage CTCL, offering a faster, safer, and more effective alternative to existing therapies. Consistent, Strong and Safe A critical attribute of HyBryte in the treatment of CTCL is its consistently strong safety profile, demonstrated across multiple clinical studies. Unlike many current therapies for early-stage CTCL, which are typically associated with severe and sometimes fatal side effects, HyBryte has been well tolerated and shows no evidence of safety concerns to date. Its mechanism of action is not linked to DNA damage, a significant distinction that positions it as a potentially safer alternative in a treatment landscape where many options carry risks such as melanoma, other malignancies, severe skin damage and premature skin aging. This favorable safety profile is especially relevant given that all currently available CTCL therapies are only approved following the failure of other treatments, and none have been approved for front-line use. In this context, safety becomes a decisive factor in selecting a treatment course, particularly for older adults who are often managing multiple health conditions. HyBryte's minimal systemic absorption, non-mutagenic compound and use of a non-carcinogenic visible light source make it uniquely positioned as a safe and effective treatment option. As the CTCL community awaits a first-line therapy, HyBryte stands out as a promising candidate capable of meeting both efficacy and safety demands. In addition to its strong clinical profile, HyBryte represents a significant commercial opportunity in an area of high unmet medical need. With an estimated global CTCL market potential exceeding $990 million, the therapy is well positioned to address a meaningful segment of the CTCL population. As development advances, HyBryte offers the potential not only to improve patient outcomes but also to establish itself as a valuable new standard in CTCL treatment. Advancing Rare Disease Care In an era where precision medicine and urgent unmet needs converge, several pharmaceutical leaders are stepping up with bold new advances in cancer and complex disease treatment, from improving survival outcomes in prostate and lung cancer to advancing novel therapies for pulmonary hypertension. These developments reflect a broader commitment across the life sciences industry to accelerate innovation and deliver life-extending, quality-of-life-enhancing options for patients with high-need conditions. Pfizer Inc. is reporting positive topline results from the overall survival (OS) analysis from its phase 3 EMBARK study. The study evaluated XTANDI(R) (enzalutamide), in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with biochemical recurrence (BCR) at high risk for metastasis. The announcement was made with Astellas Pharma U.S. Inc. XTANDI is the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in nmHSPC with high-risk biochemical recurrence BCR. Merck & Co Inc. announced that the first patient has been dosed in the IDeate-Prostate01 phase 3 trial. The phase 3 study evaluates the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression during or after treatment with an androgen receptor pathway inhibitor. I-DXd is being jointly developed by Merck and Daiichi Sankyo. While localized prostate cancer has a five-year survival rate of more than 90%, survival decreases to 31% in the advanced or metastatic stage, the company noted, reinforcing the need for new approaches to improve outcomes. Bristol-Myers Squibb Co. has received critical approval from the European Commission (EC) for a key perioperative regimen. The regimen is for neoadjuvant Opdivo (R) (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%. The EU approval is based on results from the CheckMate-77T trial, which showed perioperative Opdivo improved event-free survival compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo. Insmed Inc. announced positive topline results from its randomized, double-blind, placebo-controlled phase 2b study evaluating the efficacy and safety of treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension (PAH). According to the announcement, the study met primary and all secondary efficacy endpoints. Insmed noted that it plans to immediately engage with the U.S. Food and Drug Administration regarding a phase 3 trial design for PAH. Insmed plans to initiate a phase 3 trial in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) before the end of 2025 and a phase 3 trial in patients with PAH in early 2026. These announcements spotlight the momentum building across rare-disease research, with these companies contributing key pieces to the larger puzzle of patient-centered medical breakthroughs. As regulatory engagement continues and phase 3 trials advance, the coming years may bring meaningful shifts in standard-of-care therapies, offering hope to patients facing some of the most challenging diagnoses in medicine today. For more information, visit Soligenix Inc. NetworkNewsWire ("NNW") is a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. 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National Post
6 minutes ago
- National Post
Cyera Unveils AI Guardian: First Complete Solution to Secure Any Type of AI with Deep, Data-Centric Insight
Article content Sorry, your browser doesn't support embedded videos. Article content Cyera expands its Data Security Platform with AI Security Posture Management and AI Runtime Protection to help enterprises accelerate AI adoption Article content Article content NEW YORK — Cyera, the fastest growing data security company, today launched AI Guardian, the first complete solution built to secure any type of AI—with a rich lens into the data it touches, whether at rest or in-motion. AI Guardian expands Cyera's industry-leading platform to meet the urgent needs of enterprises adopting AI at scale, anchored by two core products: AI-SPM, providing inventory on all AI assets at a granular level, and AI Runtime Protection, monitoring and responding to AI data risks in real-time. Article content The launch comes at a pivotal moment, as enterprises rapidly scale AI initiatives while facing new security and operational risks. According to Forrester, enterprises are expanding their use of AI, with 61% using genAI or genAI and predictive AI. In the last 12 months, 23% of enterprises have seen an increase in AI-based cyberattacks with 20% also having innovation halted or slowed due to unforeseen AI risk.* Article content 'Data is the heart and soul of AI—secure it, and enterprises can keep pushing boundaries without losing control or risking exposure,' said Yotam Segev, Co-Founder and CEO of Cyera. 'That's why we built AI Guardian on the same principles as our Data Security Platform – we're going beyond surface level visibility and the basic question of 'what AI is being used' to uncovering who has access and what data is being used. With this level of protection every business can move AI forward with clarity, confidence, and control.' Article content and Article content AI Runtime Protection Article content work in tandem with Cyera's DSPM and OmniDLP products (respectively), giving enterprises full visibility into their AI risks, providing: Article content Broad coverage: discover and manage risk across all types of AI systems – whether public (e.g., ChatGPT), embedded in SaaS (e.g., Microsoft Copilot), or homegrown (e.g., LLMs built on Amazon Bedrock) Deep visibility: see not just which AI models are in use, but exactly what sensitive data they can access, and by which users, applications, or agents Real-time detection & response: act fast, with precise, low-noise insights; automatically detect and block prompt injection, data misuse, and unauthorized access as it happens Proactive compliance readiness: align with regulations and compliance frameworks, including the EU AI Act and US executive orders, with policy enforcement and auditability Article content As part of today's launch is Cyera's Omni AI, a powerful, conversational AI tool that puts data security insight at your fingertips. Built for speed and clarity, Omni AI analyzes millions of records across the enterprise data surface in seconds, enabling users to uncover top remediation opportunities, identify data minimization actions, generate stakeholder-ready security reports, and more—all through natural language prompts. Article content AI-SPM is in private beta, and AI Runtime Protection is available for early access; Omni AI is available via private beta. To learn more about AI Guardian, go to or check out our blog post for more. Article content About Cyera Article content Cyera is the world's leading AI-native data security platform. Its platform gives organizations a complete view of where their data lives, how it's used, and how to keep it safe, so they can reduce risk and unlock the full value of their data, wherever it is. Backed by more than $1.3 billion in funding from top-tier investors including Accel, Coatue, Cyberstarts, Georgian, Lightspeed, and Sequoia, Cyera's unified data security platform helps businesses discover, secure, and leverage their most valuable asset – data – and eliminate blind spots, cut alert noise, and protect sensitive information across the cloud, SaaS, databases, AI ecosystems, and on-premise environments. Recent innovations like Cyera's Omni DLP extend this platform with adaptive, AI-native data loss protection, bringing real-time intelligence and contextual understanding to how data moves and is used across the enterprise. Article content Article content Article content Article content