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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Fintech
Fintech Pulse: Your Daily Industry Brief (Chime, ZBD, MiCA)
As we close out 2024, the fintech industry continues to deliver headlines that underscore its dynamism and innovation. From IPO aspirations to groundbreaking regulatory milestones, today’s updates highlight the transformative power of fintech partnerships, regulatory evolution, and disruptive technologies. Here’s what you need to know.
Chime’s Quiet Step Toward Public Markets
Chime, the U.S.-based financial technology startup best known for its digital banking services, has taken a significant step by filing confidential paperwork for an initial public offering (IPO). As one of the most valuable private fintechs in the U.S., Chime’s move could potentially signal a renewed appetite for fintech IPOs in a market that has been cautious following fluctuating valuations across the tech sector.
With a valuation that reportedly exceeded $25 billion in its last funding round, Chime’s IPO could set a new benchmark for the industry. Observers note that its strong customer base and revenue growth may make it an appealing choice for investors seeking to capitalize on the digital banking boom. However, the timing and success of the IPO will depend on broader market conditions and the regulatory landscape.
Source: Bloomberg
ZBD’s Pioneering Achievement: EU MiCA License Approval
ZBD, a fintech company specializing in Bitcoin Lightning network solutions, has made history by becoming the first to secure an EU MiCA (Markets in Crypto-Assets Regulation) license. This landmark approval by the Dutch regulator positions ZBD at the forefront of compliant crypto-fintech operations in Europe.
MiCA, which aims to harmonize the regulatory framework for crypto-assets across the EU, has been a focal point for industry players aiming to establish legitimacy and expand their offerings. ZBD’s achievement not only validates its operational rigor but also sets a precedent for other fintech firms navigating the evolving regulatory landscape.
Industry insiders view this as a strategic advantage for ZBD as it broadens its footprint in Europe. By leveraging its regulatory approval, the company can accelerate its product deployment and establish trust with institutional and retail users alike.
Source: Coindesk, PR Newswire
The Fintech-Credit Union Synergy: A Blueprint for Innovation
The convergence of fintechs and credit unions continues to reshape the financial services ecosystem. Collaborative initiatives, such as the one highlighted in the recent partnership between fintech innovators and credit unions, are proving to be a potent force in delivering tailored financial solutions.
This “dream team” approach allows credit unions to leverage fintech’s technological expertise while maintaining their community-focused ethos. Key areas of collaboration include digital payments, personalized financial management tools, and enhanced loan processing capabilities. These partnerships not only enhance member engagement but also enable credit unions to remain competitive in an increasingly digital-first financial environment.
Industry analysts emphasize that such collaborations underscore a broader trend of traditional financial institutions embracing fintech-driven solutions to bridge service gaps and foster innovation.
Source: PYMNTS
Tackling Student Loan Debt: A Fintech’s Mission
Student loan debt remains a pressing issue for millions of Americans, and a Rochester-based fintech aims to offer relief through its cloud-based platform. This innovative solution is designed to simplify loan management and provide borrowers with actionable insights to reduce their debt burden.
The platform’s features include repayment optimization tools, personalized financial education, and seamless integration with loan servicers. By addressing the complexities of student loan management, this fintech is empowering borrowers to make informed decisions and achieve financial stability.
As the student loan crisis continues to evolve, solutions like this highlight the critical role fintech can play in addressing systemic financial challenges while fostering financial literacy and inclusion.
Source: RBJ
Industry Implications and Takeaways
Today’s updates underscore several key themes shaping the fintech landscape:
- Regulatory Milestones: ZBD’s MiCA license approval exemplifies the importance of regulatory compliance in unlocking growth opportunities.
- Strategic Partnerships: The collaboration between fintechs and credit unions demonstrates the value of combining technological innovation with traditional financial models to drive customer-centric solutions.
- Market Opportunities: Chime’s IPO move reflects a potential revival in fintech public offerings, signaling confidence in the sector’s long-term prospects.
- Social Impact: Fintech’s ability to tackle systemic issues, such as student loan debt, showcases its role as a force for positive change.
The post Fintech Pulse: Your Daily Industry Brief (Chime, ZBD, MiCA) appeared first on News, Events, Advertising Options.
Fintech
SPAYZ.io prepares for iFX EXPO Dubai 2025
Leading global payments platform SPAYZ.io has confirmed it will be attending iFX EXPO Dubai 2025 on 14 to 16 January. Exhibiting at Stand 64 at Trade Centre Dubai, SPAYZ.io’s team of professionals will be on hand providing live demonstrations of its renowned payment services for payment providers. Attendees will also receive exclusive insight into SPAYZ.io’s plans for 2025 alongside early early access to its upcoming plans for the new year.
SPAYZ.io delivers a host of payment solutions that leverage the latest technological innovations and open access to the fastest growing emerging markets across Africa, Europe and Asia. Over the past year, there has been huge demand for its Open Banking and local payment method services, alongside bank transfers, mass payouts, online banking and e-wallets.
Yana Thakurta, Head of Business Development at SPAYZ.io commented: “We look forward to once again participating at iFX Dubai to expand our network of partners and clients. It’s a fantastic way to kick off the year, connecting with thousands of industry leaders from FOREX platforms to trading companies, and everything in between.
“Our key goal for iFX Dubai EXPO 2025 is to expand our portfolio of solutions and geographies. We’re using this as an opportunity to partner with like-minded entities who share our ambition to provide payment solutions that are truly global.”
Come meet SPAYZ.io’s team at the Trade Centre Dubai at Stand 64. You can also book a meeting slot with a member of a team.
The post SPAYZ.io prepares for iFX EXPO Dubai 2025 appeared first on News, Events, Advertising Options.
Fintech
Airtm Enhances Its Board of Directors with Two Strategic Appointments
Airtm, the most connected digital dollar account in the world, is proud to announce the addition of two distinguished industry leaders to its Board of Directors: Rafael de la Vega, Global SVP of Partnerships at Auctane, and Shivani Siroya, CEO & Founder of Tala. These appointments reflect Airtm’s commitment to innovation and financial inclusion as the company enters its next phase of growth.
“We are thrilled to welcome Rafael and Shivani to Airtm’s Board of Directors,” said Ruben Galindo Steckel, Co-founder and CEO of Airtm. “Their unique perspectives and proven track records will be invaluable as we continue scaling our platform to empower individuals and businesses in emerging markets. Together, we’ll push the boundaries of financial inclusion and innovation to create a more connected and equitable global economy. Rafael and Shivani bring a wealth of experience and strategic insight that will strengthen Airtm’s mission to connect emerging economies with the global market.”
Rafael de la Vega, a seasoned leader in fintech global partnerships and technology innovation, is currently the Global SVP of Partnerships at Auctane. With a proven track record of delivering scalable, impactful solutions at the intersection of fintech, innovation, and commerce, Rafael’s expertise will be pivotal as Airtm continues to grow. “Airtm has built a platform that breaks down barriers and opens up opportunities for people in emerging economies to connect to global markets. I am excited to contribute to its growth and help further its mission of fostering financial inclusion on a global scale,” said Rafael.
Shivani Siroya, CEO and Founder of Tala, is a pioneer in financial technology, renowned for empowering underserved communities through access to credit and essential financial tools. Her leadership in leveraging data-driven innovation aligns seamlessly with Airtm’s vision of creating more equitable financial opportunities. “Empowering underserved communities has always been at the core of my work, and Airtm’s mission resonates deeply with me. I’m thrilled to join the Board and work alongside such a dynamic team to expand access to financial tools that truly make a difference in people’s lives,” said Shivani.
The post Airtm Enhances Its Board of Directors with Two Strategic Appointments appeared first on News, Events, Advertising Options.
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