Fintech
Soligenix Poised to Announce US Commercialization Plans of SGX301 in the Treatment of Cutaneous T-Cell Lymphoma
New York, New York–(Newsfile Corp. – January 25, 2021) – PCG Digital: Advancing health care innovation is a cornerstone of thorough public health policy. Researching and developing new treatments for unmet medical needs has become increasingly important as the world continues to battle through the worst pandemic in our lifetime. While the news and focus of health innovation continues to be largely on COVID-19, medical breakthroughs continue to progress across the board.
Soligenix, Inc. (NASDAQ: SNGX) is one such biopharmaceutical company that has made big strides against unmet medical needs. Recently, the company released data from the Phase 3 FLASH clinical trial of its SGX301 candidate for the treatment of cutaneous T-cell lymphoma (CTCL), which showed strong positive effects.
What is CTCL?
Cutaneous T-cell lymphoma (CTCL) is a rare form of non-Hodgkin’s lymphoma, which impacts a vital part of the immune system: white blood cells or T-cells. Patients with CTCL develop abnormalities within their T-cells, which makes the cells attack the skin. This leads to visible skin rashes, which feature redness and can be slightly raised, feature scaliness, and even form tumors.
There are two main types of CTCL: Mycosis fungoides (MF) and Sezary syndrome (SS). MF is the early-stage and most common version of CTCL, which features an 88% 5-year survival rate. On the other hand, SS is the more serious and advanced stage version of CTCL, which sees its 5-year survival rate plummet to 24%.
Over 40,000 non-Hodgkin’s lymphoma patients around the world currently suffer from some form of CTCL and there are no approved cures. According to the Cutaneous Lymphoma Foundation, there is an average of 3,000 new cases of CTCL reported in the U.S. every year and roughly 16,000-20,000 Americans currently suffer from mycosis fungoides. Soligenix notes that the total addressable global market for CTCL is around $250 million, with an estimated > $75 million coming from the United States.
SGX301 Phase 3 Data Shows Strong Efficacy
Soligenix’s SGX301 is a novel first-in-class photodynamic therapy for early-stage CTCL, known as mycosis fungoides. Synthetic hypericin is the key active ingredient in SGX301, which is a powerful photosensitizer that can be topically applied to areas on the skin impacted by CTCL. After the topical is absorbed by the impacted T-cells for 16-to-24 hours, it is activated by safe, visible fluorescent light.
Fluorescent lighting is used instead of ultraviolet for a couple of reasons. First, the visible light emitted by fluorescent can penetrate deeper into the skin compared to ultraviolet. Secondly, ultraviolet lighting has carcinogenic properties that can cause other more deadly skin cancers, such as melanoma.
During Soligenix’s Phase 3 FLASH trial for SGX301, a total of 169 patients with either Stage IA, IB, or IIA CTCL were enrolled in the clinical trial. The Phase 3 trial was a randomized, double-blind, and placebo-controlled study, which featured three treatment cycles. Treatments were delivered twice a week for the first six weeks of the trial, with a treatment response determination at the end of week eight of the trial.
After the first six weeks and completion of Cycle 1, SGX301 showed a statistically significant treatment response (p=0.04) compared to the patients that were administered the placebo. Thus, the Cycle 1 process reached its primary endpoint.
Soligenix noted that positive treatment responses only continued to show significant improvement during Cycle 2’s open-label treatment cycle after 12 weeks. It is important to note that SGX301 proved to be statistically significant through Cycle 2 in both patch and deeper plaque lesions. This further supports fluorescent lighting and its ability to deeply penetrate the skin. The same statistically significant improvements continued into the 18th week, which marked the completion of the optional Cycle 3 treatment.
Unlike other forms of phototherapies that use ultraviolet light, SGX301’s Phase 3 FLASH trial showed no mutagenic risks. This truly makes Soligenix’s SGX301 candidate a significant step in treating early-stage CTCL. Not only did the trial show a very clear and meaningful statistical benefit in treating CTCL, but its safety profile far exceeds second-line and off-label treatments.
SGX301 Commercialization: Daavlin-Soligenix Strategic Partnership
Now that SGX301 has shown to be a major potential gamechanger in the treatment against CTCL, Soligenix is preparing its US commercialization plans. On January 7, 2021, Soligenix made one of its biggest steps towards SGX301 commercialization after entering into a strategic partnership with Daavlin.
Daavlin is a 40-year-old, Bryan, Ohio-based company with a rich history of innovation and development within phototherapy. The company provides a rather extensive line of products and services to healthcare providers around the globe.
Under the terms of the agreement, Soligenix and Daavlin secured a long-term supply and distribution agreement of a commercially-ready light device that is critical to SGX301’s success in treating CTCL.
Once the U.S. FDA has approved SGX301, Soligenix will focus on promoting its SGX301 treatment and the Daavlin-supplied companion light device. Daavlin will exclusively sell the lighting device to Soligenix, physicians, and patients.
“Daavlin brings technical, manufacturing, and commercial capabilities in both the US and Europe that will assist us in rapidly and efficiently distributing the SGX301 companion light device upon approval by FDA,” stated Christopher J. Schaber, Ph.D., President, and Chief Executive Officer of Soligenix. “Seamless integration of the drug product and companion light device for physicians and patients is critical to the commercial success of SGX301 and working with Daavlin will help us achieve that operational excellence.”
SGX301 Commercialization Funding: Pontifax Financing Deal
Aside from qualified strategic partnerships, ample funding and capital allocation are required to successfully launch a new treatment. In December 2020, Soligenix announced a $20 million strategic convertible debt financing agreement with Pontifax Medison Debt Financing, a healthcare-focused venture, and debt fund.
Under the terms of the financing, Soligenix will have the ability to access up to $20 million in convertible debt financing broken up into three tranches. The funding is set to mature over a four-and-a-half-year period and will carry an interest-only period for the first two years of the deal.
Soligenix has accessed the first tranche of $10 million and will have the option to draw an additional $5 million in a second tranche any time over the next twelve months. The third tranche will also carry $5 million in funding and will be available upon the filing of the SGX301 new drug application (subject to conditions).
Pontifax has the option to convert outstanding drawn funds from the first two tranches into common shares of Soligenix at a conversion price of $4.10 per share. If certain conditions are met, Soligenix will have the ability to force the conversion at a price of $4.92 per share.
“The access to less dilutive capital provided by this facility is designed to increase our financial flexibility as we continue to advance our rare disease pipeline, and build toward commercialization in the United States with SGX301 for the treatment of cutaneous T-cell lymphoma (CTCL) and SGX942 for the treatment of oral mucositis in head and neck cancer patients,” stated Christopher J. Schaber, Ph.D., President and Chief Executive Officer of Soligenix.
Overall, Soligenix is continuing to show its expertise in the research and development of treatments for unmet medical needs. The company’s SGX301 candidate to treat early-stage CTCL is a gamechanger, as it provides several very clear advantages over the second-tier treatments available today. With primary endpoints being met throughout its successful Phase 3 FLASH trial, Soligenix has made the case for the FDA to approve SGX301. Considering the funding and strategic partnership deals with Pontifax and Daavlin respectively, Soligenix has established an ecosystem to successfully roll out SGX301 to the $75 million addressable US CCTL market.
Join the Soligenix investor webcast event scheduled for Tuesday, January 26, 2021 from 2:30-4:00 PM Eastern Standard Time (EST). Management plans to detail further information about their commercialization plans, and an opportunity for investors’ Q&A after the presentation. Check the link below to be a part of the investor webcast on Tuesday.
Live Event: https://sqps.onstreamsecure.com/origin/enliven/players/Soligenix.html
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The fintech landscape continues to redefine itself, driven by innovation, partnerships, and groundbreaking strategies. Today’s roundup focuses on the latest digital wallet offerings, evolving payment trends, strategic collaborations, and notable funding achievements. This editorial explores the broader implications of these developments, casting light on how they shape the future of fintech and beyond.
Beacon’s Digital Wallet for Immigrants: A Gateway to Financial Inclusion
Beacon Financial, a leading player in financial technology, recently launched a digital wallet tailored to meet the unique needs of immigrants moving to Canada. This offering bridges a critical gap, enabling seamless financial integration for newcomers navigating a foreign system.
By combining intuitive technology with user-centric features, Beacon aims to empower immigrants with tools for payments, savings, and remittances. This aligns with the growing demand for tailored financial products that resonate with specific demographics.
Op-Ed Insight:
Financial inclusion is more than just a buzzword; it’s a moral imperative in the fintech space. Products like Beacon’s digital wallet highlight the industry’s potential to create tangible change. As global migration trends increase, such offerings could inspire similar initiatives worldwide.
Source: Fintech Futures.
Juniper Research Highlights 2025’s Payment Trends
Juniper Research’s latest report unveils pivotal payment trends poised to dominate in 2025. Central themes include the adoption of instant payment networks, a surge in embedded finance solutions, and the rise of crypto-backed financial products.
The research underscores the rapid adoption of real-time payment systems, fueled by increasing consumer demand for speed and efficiency. Meanwhile, embedded finance promises to blur the lines between traditional banking and non-financial services, delivering personalized and context-specific solutions.
Op-Ed Insight:
As the lines between financial services and technology continue to blur, these trends emphasize the industry’s shift toward convenience and personalization. The growing role of crypto-based solutions reflects an evolving consumer mindset, where decentralization and digital-first experiences gain precedence.
Source: Juniper Research.
MeaWallet and Integrated Finance Partner to Revolutionize Digital Wallets
MeaWallet, a prominent fintech solutions provider, has partnered with Integrated Finance to advance digital wallet capabilities and secure card data access for fintech companies. This collaboration focuses on empowering fintechs to deliver better, safer digital payment experiences.
MeaWallet’s role as a technology enabler aligns seamlessly with Integrated Finance’s goal of simplifying complex financial infrastructures. Together, they aim to create scalable, robust platforms for secure payment solutions.
Op-Ed Insight:
Partnerships like this underscore the importance of collaboration in driving innovation. As security concerns grow in tandem with digital payment adoption, solutions addressing these challenges are essential for maintaining consumer trust. The fintech ecosystem thrives when synergy and innovation coalesce.
Source: MeaWallet News.
Nucleus Security Among Deloitte’s Fastest-Growing Companies
Nucleus Security has achieved a remarkable milestone, ranking 85th on Deloitte’s 2024 Technology Fast 500 list. This achievement is attributed to its robust cybersecurity solutions, which cater to the increasingly digital fintech environment.
With cyberattacks becoming more sophisticated, fintech companies are under immense pressure to safeguard their platforms. Nucleus Security’s growth reflects the rising demand for comprehensive, scalable security solutions that protect sensitive financial data.
Op-Ed Insight:
In a digital-first world, robust cybersecurity isn’t optional—it’s fundamental. The recognition of companies like Nucleus Security signals the growing importance of protecting fintech infrastructure as the industry scales globally.
Source: PR Newswire.
OpenYield Secures Funding to Transform the Bond Market
OpenYield has announced a successful funding round, aiming to revolutionize the bond market through innovative technology. The platform promises greater transparency, efficiency, and accessibility in fixed-income investments.
This funding underscores the growing appetite for digitizing traditionally opaque financial markets. By leveraging cutting-edge technology, OpenYield seeks to democratize bond investments, making them accessible to a broader audience.
Op-Ed Insight:
The bond market, long viewed as complex and inaccessible, is ripe for disruption. OpenYield’s efforts to modernize this space highlight fintech’s transformative potential to democratize finance and empower individual investors.
Source: PR Newswire.
Key Takeaways: Shaping the Future of Fintech
Today’s developments underscore several critical themes in the fintech landscape:
- Personalization and Inclusion: Products like Beacon’s wallet highlight the importance of understanding and addressing specific user needs.
- Collaborative Ecosystems: Partnerships, like that of MeaWallet and Integrated Finance, emphasize the power of collaboration in solving industry challenges.
- Emerging Technologies: Juniper Research’s predictions affirm the continued influence of blockchain, embedded finance, and instant payment networks.
- Security at the Core: The recognition of Nucleus Security underscores the essential role of cybersecurity in fintech.
- Market Transformation: OpenYield’s funding signifies the ongoing disruption of traditional financial markets, paving the way for broader accessibility.
The post Fintech Pulse: Daily Industry Brief – A Dive into Today’s Emerging Trends and Innovations appeared first on News, Events, Advertising Options.
As fintech continues to reshape the global financial landscape, today’s briefing highlights pivotal developments, strategic expansions, and innovative launches across the industry. This op-ed explores the latest advancements with commentary on their potential impacts and challenges.
Finastra Data Breach: A Wake-Up Call for Fintech Security
Source: KrebsOnSecurity
The cybersecurity landscape is buzzing after Finastra, one of the largest financial technology providers globally, confirmed an investigation into a potential data breach. Reports suggest unauthorized access to its systems, raising concerns about data security across its client base, which includes thousands of banks and financial institutions worldwide.
Implications and Challenges
While the details of the breach remain sparse, this incident underscores a glaring vulnerability in the fintech sector—cybersecurity. As financial services increasingly rely on interconnected ecosystems, breaches like these threaten not only individual institutions but also the trust customers place in fintech platforms.
The key takeaway for the fintech industry is clear: proactive cybersecurity strategies must go beyond compliance. Real-time threat detection, robust encryption standards, and regular audits are no longer optional but essential for maintaining operational integrity.
Future Considerations
This breach could trigger a domino effect, prompting regulators to tighten security standards and requiring fintech companies to double down on investments in data protection. Startups and mid-tier players, often lacking extensive cybersecurity budgets, may face significant pressure to keep pace.
PayPal Resurrects Money Pooling Feature
Source: TechCrunch
In a bid to stay ahead of the competition, PayPal is reintroducing its Money Pooling feature, a popular tool that was discontinued in 2021. The feature allows users to pool funds collectively, catering to families, small businesses, and social groups.
Strategic Revival
This move reflects PayPal’s commitment to customer-centric innovation. By reinstating a feature beloved by its user base, the company seeks to reclaim market share lost to emerging competitors offering similar functionalities.
Broader Industry Impacts
Money pooling represents a broader trend in fintech—customized solutions that cater to niche needs. This reintroduction may inspire competitors like Venmo and CashApp to refine their collaborative payment offerings.
While this move strengthens PayPal’s ecosystem, its success will depend on seamless integration with existing services and robust fraud prevention mechanisms to avoid abuse of the feature.
Santander Expands Fintech Reach in Mexico
Source: Yahoo Finance
Santander is making waves in the Latin American fintech space with the launch of a dedicated fintech unit in Mexico. The initiative aims to capitalize on Mexico’s growing fintech adoption and digital payments market, valued at billions of dollars annually.
Strategic Significance
Santander’s expansion into Mexico highlights the region’s untapped potential. Latin America is a burgeoning market for fintech, driven by increasing smartphone penetration, a youthful demographic, and demand for accessible financial services.
Challenges on the Horizon
While Mexico offers immense opportunities, regulatory complexities and market competition from local players like Clip and Konfío pose significant challenges. Santander will need to blend its global expertise with local adaptability to succeed in this dynamic market.
2024 Global Fintech Awards: Spotlighting Excellence
Source: PRNewswire
Benzinga has announced the winners of the 2024 Global Fintech Awards, honoring companies and individuals driving innovation in financial technology. This year’s winners spanned categories like blockchain, artificial intelligence, and payment solutions.
Recognizing Industry Leaders
Awards like these highlight the collaborative spirit and entrepreneurial drive fueling fintech growth. Recognizing trailblazers not only motivates incumbents but also inspires startups to push the boundaries of innovation.
What It Means for the Ecosystem
The awards also bring attention to emerging technologies. Categories such as blockchain and AI signal the industry’s continued focus on leveraging cutting-edge tech for efficiency and scalability.
Commonwealth Central Credit Union Partners with Jack Henry
Source: FinTech Futures
Commonwealth Central Credit Union (CCCU) has announced a partnership with Jack Henry, a leading financial technology provider, for a comprehensive tech upgrade. The collaboration focuses on enhancing member experience through improved digital services.
Modernizing Member Experiences
Credit unions have often lagged behind major banks in adopting advanced digital solutions. By partnering with Jack Henry, CCCU aims to bridge this gap, offering members streamlined services such as mobile banking, automated lending, and personalized financial tools.
A Growing Trend
This partnership reflects a broader trend in the financial industry—credit unions and smaller banks embracing fintech to remain competitive. As customer expectations evolve, partnerships like this may become the norm rather than the exception.
Key Takeaways for the Fintech Industry
- Cybersecurity is Critical: The Finastra breach underscores the need for robust security measures.
- Innovation Drives Loyalty: PayPal’s revival of its Money Pooling feature highlights the importance of listening to customers.
- Regional Opportunities: Santander’s expansion into Mexico showcases the untapped potential of emerging markets.
- Recognition Matters: Awards like Benzinga’s provide valuable visibility for companies and individuals shaping the industry.
- Partnerships Foster Growth: Collaborations between credit unions and fintech companies signify a trend towards modernized financial solutions.
The post Fintech Pulse: Industry Updates, Innovations, and Strategic Moves appeared first on News, Events, Advertising Options.
The fintech sector continues its relentless drive toward innovation and market dominance. Today’s highlights include a record-breaking customer milestone for Revolut, groundbreaking fintech solutions for women in the EU, open entries for the PayTech Awards 2025, implications of political shifts on funding, and notable recognition at the US FinTech Awards.
Revolut Hits 50 Million Customers: A Global Fintech Giant’s Milestone
Source: Revolut
Revolut, the UK-based financial super app, has achieved a monumental feat: surpassing 50 million customers worldwide. This milestone underscores its position as a leader in the global fintech landscape, furthering its ambition to create the world’s first truly global bank.
Key to this success has been Revolut’s strategy of expanding its offerings, from banking to travel and crypto services, all within a seamless user experience. The company’s recent ventures into emerging markets such as Latin America and Asia demonstrate its intent to bridge financial services gaps while retaining competitive differentiation through technology.
This milestone is not just a triumph for Revolut but a signal of fintech’s capacity to redefine traditional banking. It reinforces the narrative that digital-first strategies, customer-centric innovation, and international scalability can challenge long-standing financial institutions.
PayTech Awards 2025: Celebrating Excellence in Innovation
Source: FinTech Futures
The PayTech Awards 2025 are officially open for entries, promising to spotlight the brightest minds and most innovative projects in the payment technology sector. These awards are a testament to the industry’s commitment to advancing secure, seamless, and scalable payment systems.
This year, the focus is on emerging technologies that redefine how businesses and consumers interact financially. Categories will recognize achievements across multiple domains, including sustainability in payments, AI-driven solutions, and partnerships that push boundaries.
As fintech companies prepare their entries, the awards provide a timely reminder of the sector’s ongoing evolution and the collaborative efforts required to achieve meaningful breakthroughs.
U.S. Politics and the Fintech Sector: A New Era of Funding?
Source: American Banker
The U.S. fintech sector might witness an infusion of optimism as speculation about a second Trump presidency gains momentum. The Trump-era policies of deregulation and venture capital encouragement are remembered as catalysts for unprecedented fintech growth during his first term.
While it remains uncertain how regulatory landscapes will shift, the possibility of a more relaxed approach toward fintech compliance could rejuvenate funding inflows. Investors and startups alike are watching closely, weighing the potential benefits against long-term risks tied to reduced oversight.
A politically charged backdrop often spells volatility, but for fintech, it may also spell opportunity. Preparing to adapt quickly will be crucial for startups and established players in the face of any regulatory pivot.
Klara AI and Unlimit: Addressing the €1.3 Trillion Female Economy
Source: FF News
Klara AI has teamed up with Unlimit to launch a fintech solution aimed at empowering women across the EU. This collaboration targets the €1.3 trillion female economy by addressing the unique financial needs of women entrepreneurs and consumers.
The solution promises to integrate AI-powered tools with streamlined financial management services, enabling users to access credit, manage investments, and scale businesses effectively. By tailoring services to the underserved female demographic, the partnership hopes to drive financial inclusion and support economic growth.
This initiative stands as a blueprint for fintechs exploring niche markets, proving that innovation tailored to specific segments can yield transformative results.
Autire: Accounting Tech of the Year at US FinTech Awards
Source: Business Wire
Autire, a rising star in financial technology, has been crowned ‘Accounting Tech of the Year’ at the US FinTech Awards 2024. The award recognizes Autire’s ability to blend cutting-edge AI with intuitive user interfaces, delivering unparalleled accounting solutions for businesses of all sizes.
Autire’s platform has gained traction for automating complex accounting tasks, ensuring compliance, and delivering actionable insights through real-time analytics. Its emphasis on reducing administrative burdens for SMEs has been particularly impactful, enabling entrepreneurs to focus on growth rather than bookkeeping.
The recognition not only cements Autire’s reputation but also highlights the role of AI-driven accounting solutions in reshaping business operations globally.
Final Thoughts: A Fintech Revolution in Full Swing
From customer milestones to policy-driven opportunities, the fintech ecosystem is in constant evolution. Revolut’s ascent to 50 million users signals growing consumer trust in digital platforms. The PayTech Awards continue to inspire innovation, while political shifts could redefine the regulatory landscape. Initiatives like Klara AI and Unlimit emphasize the power of targeted solutions, and companies like Autire show how niche technologies can achieve broad impact.
The next phase of fintech growth will likely hinge on inclusivity, adaptability, and innovation—pillars that today’s news stories exemplify.
The post Fintech Pulse: Milestones, Partnerships, and Transformations in Fintech appeared first on .
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