Fintech
Soligenix’s Upcoming Catalysts Highlight Growth Potential as it Sheds Light on its Commercialization of SGX301
New York, New York–(Newsfile Corp. – February 9, 2021) – PCG Digital: Soligenix (NASDAQ: SNGX) continues to build excitement for its SGX301 candidate following strong Phase 3 data and commercialization plans. The company recently held an investor webcast to further explain the company’s plans for commercializing its ground-breaking SGX301 candidate for the treatment of cutaneous T-cell lymphoma (CTCL).
Here are some key takeaways from the commercialization Q&A:
1. Soligenix will commercialize SGX301 in the U.S. on its own
During the presentation, the company noted that after conducting necessary due diligence and simulating different routes to commercialization, it was determined that a partnership would not be the best solution for shareholders. The licensing landscape and CTCL’s small, orphan market were the key drivers behind the decision. Considering that the average biopharmaceutical licensing deal, a Phase 3 licensor will typically retain no more than 40% of the product’s value, it did not make sense to give up so much value when the market is small and highly specialized to begin. However, Soligenix CEO Dr. Chris Schaber noted the company continues discussions regarding partnerships for ex-U.S. rights to SGX301.
The company has submitted its proposed brand name, HyBryte, and logo for SGX301 to the FDA for review and approval.
2. SGX301 marketing and sales force size and costs
CTCL’s small, orphan market will not require Soligenix to build out a massive marketing and sales force. The uniqueness and ability to serve an unmet medical need are the key selling points in the CTCL treatment space. As a result, Soligenix estimates the need for a sales team consisting of around 20 people. The company estimates that pre-launch costs will come in around $7 million, with annual sales and marketing costs coming in below $10 million.
3. Ample cash reserves to carry SGX301 through commercialization
During the webcast, management was asked if the company’s current cash reserves were sufficient enough to carry SGX301 through the commercialization process. After the previously-announced financing deal with Pontifax, the company continues to be well-capitalized for the commercialization process. It was revealed that the company currently maintains a cash balance of in excess of $20 million and also has a $20 million ATM with B. Riley.
“Based on this strategic capital structure, we are well-positioned for success and really have no need for a large capital raise anytime soon,” noted CFO Jonathan Guarino during the webcast.
4. Daavlin partnership for companion light device
On January 7, 2021, Soligenix first announced its strategic partnership with Daavlin, an Ohio-based company with a 40-year history in phototherapy. Daavlin has an extensive product line that is delivered to healthcare providers worldwide.
Under the strategic partnership, Daavlin will supply and distribute a commercially-ready companion light device that is critical to the success of SGX301 in treating CTCL. The companion light device is a derivative of an existing, 510K-approved product. Unlike other phototherapies, Daavlin’s light device does not require a dedicated room or any complex wiring. In fact, the device can be stored and moved out of the way when not in use.
The Daavlin companion device will be sold directly to physicians initially, as treatments will be conducted in a doctor’s office. However, Soligenix management notes that the company does intend to offer a house-use version of the Daavlin device down the road. However, it is important to note that Daavlin’s UV devices are already approved for home use.
5. Soligenix estimates peak U.S. sales of SGX301 to hit $90 million
The pricing of SGX301 continues to be evaluated and will not be finalized until closer to the U.S. launch. However, management did note that an existing, inferior treatment, Valchor, was being considered as a benchmark price. Valchor’s price is roughly $3,500 per WAC/tube and generates estimated annual sales of around $40 million.
Given the unique nature of SGX301 and its ability to serve as an early-stage treatment for CTCL, the company primary market research has shown that four out of five dermatologists are likely to prescribe the product, if/when approved. With Valchor as a benchmark, Soligenix estimates SGX301 will have peak U.S. net annual sales that exceed $90 million.
SGX301 Commercialization Timeline with Multiple Near Term Catalysts Anticipated
As SGX301 begins its commercialization phase, there will be several important milestones over the coming months that could serve to be significant catalysts for Soligenix. The first milestone to watch for will be the initial submission of the rolling New Drug Application (NDA). The NDA, along with the completed Clinical Study Report, is estimated to be handed over to the FDA during the second quarter of 2021.
Under the Prescription Drug User Fee Act, or PDUFA, the FDA is required to review new drug applications within a 10-month period. If the new drug has been given fast track designation, the FDA deadline to review the application is only six months.
SGX301 has already been granted fast track designation and orphan drug status. As a result, the FDA will have six months from the date that Soligenix officially files the NDA. Just as an example, this means that even if the NDA is filed at the end of June, a review will take place around the end of the year. The official U.S. commercial launch is estimated to occur during the second half of 2022.
Aside from the rolling NDA filing, resulting FDA review, and official commercial launch in 2022, investors will have a few other potential catalysts in the shorter-term. Soligenix announced that it has submitted abstracts to present on SGX301 to the American Academy of Dermatology Meeting in March 2021 and to the Society for Investigative Dermatology Meeting in May 2021. Management notes its plans to submit its manuscript to the JAMA Dermatology journal this year as well.
Zack’s Research Updates Soligenix with a Positive Report
Two days after Soligenix’s webcast, Zack’s Small-Cap Research issued an updated research report on the company.
Zack’s notes, that based on its probability-adjusted discounted cash flow (DCF) model (which estimates future revenues from SGX301, CiVax, etc.), there is significant potential price appreciation for SNGX.
“The webinar on SGX301 provided a comprehensive overview of the company’s plans for commercializing SGX301, including encouraging data from primary market research with physicians and initial revenue projections. As discussed, there are a number of upcoming milestones for the company as it relates to SGX301, with perhaps the most important being the submission of the rolling NDA, which should begin in the second quarter of 2021.”
The full report can be found here.
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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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