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Soligenix Poised to Announce US Commercialization Plans of SGX301 in the Treatment of Cutaneous T-Cell Lymphoma

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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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Copper State Credit Union Takes One Platform Approach with Jack Henry

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Jack Henry™ (Nasdaq: JHKY) announced today that Copper State Credit Union will leverage the company’s single technology platform to boost internal efficiencies and improve experiences.

Copper State Credit Union formed in 2020 from the merger of Canyon State Credit Union and Deer Valley Credit Union. Following the merger, the credit union managed multiple products across several different technology providers. This prompted the team to reevaluate their strategy and select Jack Henry as their enterprise technology provider. Jack Henry’s open infrastructure will automate and streamline operations, as well as integrate and optimize offerings.

“Jack Henry’s single platform approach allows us to consolidate our existing relationships into one organization with the option to tap into a vast ecosystem of fintech services,” said Robb Scott, President/CEO of Copper State Credit Union. “This enables us to continue to be innovative in our markets while remaining committed to delivering an exceptional member experience.”

Copper State Credit Union understands the importance of providing a convenient and simple digital experience for members. Their new digital banking platform will give members a complete view of all their finances in a single place. Part of this experience will include the ability to open new accounts and debit cards, manage credit scores, and receive instant payments. And, modern fraud and financial crimes prevention and detection solutions will protect members’ data and monitor transactional behavior.

“Our all-in strategy with Jack Henry ensures our members receive the connected services and resources they need to achieve financial prosperity and empowerment,” Scott continued. “The relationship frees up our internal resources to focus on finding ways to improve the financial lives of member-families within our community.”

Shanon McLachlan, president of Credit Union Solutions at Jack Henry, commented, “The beauty of our technology is the optionality and flexibility. Credit unions can choose to be in all-in with us like Copper State Credit Union or start by investing in their technology future one step at a time. Regardless, we continue to provide the support and services they need to help their members succeed.”

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Moomoo Wins “Best Stock Trading App” Award in 2024 FinTech Breakthrough Awards Program

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Moomoo Technologies Inc. today announced that FinTech Breakthrough recognized the company with its 2024 annual award of “Best Stock Trading App.”  Founded in 2018, moomoo is an investment and trading platform that empowers global investors with pro-grade, easy-to-use tools, data, and insights. With its sister brand, moomoo has over 21 million users globally and it provides users with the necessary information and technology to make more informed investment decisions.

As the FinTech sector becomes more crowded and companies struggle to stand out from the crowd with their products and services, the FinTech Breakthrough Awards help recognize and showcase FinTech innovators based on creativity, hard work, and technologies centered around their products, solutions, and services. Its committee selected winners based on their innovative performance, their impact on solving user needs and problems, and whether their ease of use management can scale at growth.

“We are thrilled to be recognized as the best stock trading app by FinTech Breakthrough as it supports our mission to provide all levels of investors with an intuitive and robust platform,” said Justin Zacks, Vice President of Strategies, Moomoo Technologies Inc.  “Backed by independent research, advanced technological development capabilities, and our unique digital-first business model, we want to level the playing field for retail investors. From powerful stock and option analysis tools to fully extended trading hours, moomoo serves both new and experienced traders.”

“Moomoos’ robust technologies help investors spot potential investment opportunities and make informed decisions. Investors at all levels are looking for in-depth data, market news and global insights,” said Steve Johansson, Managing Director, FinTech Breakthrough. “We want to recognize moomoo as ‘Best Stock Trading App!’ By striving to provide investors with the best online trading experiences possible, investors at any stage can make confident investment decisions backed by readily available data and insights.”

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Insights from Prague Gaming & TECH Summit 2024 Speakers (pre-event)

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As we approach the Prague Gaming & TECH Summit, we’ve connected with some of the event’s distinguished speakers to delve into the future of the gaming and tech industries. Their insights shed light on the shifting dynamics, underscoring the significance of adaptability, innovation, and strategic foresight.

We posed the following questions to our speakers:

  • What has been the most surprising or valuable lesson you’ve learned in your career within the gaming/tech sector?
  • Can you share a project or achievement in your career that you’re particularly proud of?
  • In your opinion, what are the biggest challenges facing the gaming and tech industries today?

Below, you’ll find a brief overview of their responses. For more in-depth insights, scroll down to read each speaker’s full reply.

#### Viktoria Soltesz: Mastering the Financial Game

Viktoria Soltesz, a pivotal figure in the payment solutions space, shared a crucial lesson from her career: the significance of a well-crafted payment plan. Through her work, Soltesz has observed the downfall of companies due to inadequate financial strategies, emphasizing that such pitfalls are easily avoidable with proper planning. Her recent book, “Moving Money – How Banks Think,” aims to demystify banking and payment processes for businesses, advocating for informed financial decision-making within the gaming and tech sectors.

#### Aleksandra Andrishak: The Power of Continuous Learning

Representing Slotsjudge, Editor in Chief Aleksandra Andrishak looks forward to delving into topics like iGaming and blockchain at the summit. Andrishak highlights the transformative work undertaken at Slotsjudge in 2023 and stresses the importance of perpetual learning in the fast-paced gaming industry. Her advice to newcomers is to embrace innovation and remain adaptable to stay ahead.

#### Jakub Tesar: Blockchain’s Expanding Horizon

Jakub Tesar predicts a promising future for blockchain technology, especially within the Ethereum ecosystem, and the rise of Web3. He envisions a world where gamers have greater control over virtual collectibles and in-game items, thanks to blockchain. Tesar anticipates GenAI revolutionizing game interactions and narratives, urging industry professionals to experiment with blockchain’s burgeoning use cases.

#### Kaspar Szymanski: Navigating SEO in the Gaming and Tech World

Kaspar Szymanski, with his rich background in Google Search, identifies the challenge of distinguishing brands in a saturated market. He argues for a focus on unique selling propositions and long-term growth strategies. At the summit, Szymanski aims to dispel SEO myths and offer actionable advice, emphasizing that SEO setbacks can lead to significant growth opportunities.

#### Jasmina Poglavc: Data-Driven Innovation in iGaming

Jazz underscores the impact of advanced data analytics and AI in enhancing the iGaming experience through personalized player engagement. She points out the challenges of data privacy and navigating the regulatory landscape, advocating for a shift towards more player-centric and responsible gaming practices.

These insights from our speakers highlight a common theme: the gaming and tech industries are at a critical juncture, facing challenges that span financial planning, regulatory navigation, and technological innovation. The Prague Gaming & TECH Summit stands as a pivotal platform for addressing these challenges, fostering dialogue, and paving the way for future advancements.

As we anticipate the rich discussions and networking opportunities at the summit, it’s clear that adaptability, continuous learning, and strategic planning are key to navigating the future of gaming and tech. Join us in Prague to explore these themes and more, shaping the trajectory of these dynamic industries.


Viktoria Soltesz – Founder at PSP Angels

What has been the most surprising or valuable lesson in your career within the gaming/tech sector?

In my career within the gaming/tech sector, one of the most valuable lessons I’ve learned is the importance of having a payment plan. While analyzing the financial and banking information of various companies, I noticed a recurring pattern: many companies that failed did so due to poor payment and banking practices. They often miscalculated risks, under-budgeted costs, or neglected to set up a proper payment plan. These errors in financial planning were common culprits behind their downfall. What surprised me the most was how easily these businesses could have avoided such failures with proper payment planning. It became evident that many businesses fail for avoidable reasons, and simply taking the time to understand and establish a payment plan can make a significant difference. By paying close attention to the flow of money and investing just a few hours in crafting a solid plan, a business can set itself on a path to success, outperforming much of its competition.

Can you tell us about a project or achievement in your career that you’re particularly proud of?

One of the achievements I’m particularly proud of in my career is the recent launch of my book, “Moving Money – How Banks Think,” which is now available on Amazon. This book is a valuable resource for businesses, emphasizing the often-overlooked importance of banking and payments in today’s competitive landscape. It provides insights into the intricacies of banking decisions, the history of payment systems, and practical guidance on managing funds more safely and cost-effectively. I’m excited to share this knowledge and help businesses make informed decisions in the realm of payments, especially those that are high-risk or startups.

What do you think are the biggest challenges facing the gaming and tech industries today?

In the gaming and tech industries today, one of the most significant challenges is undoubtedly related to payments. While these industries focus heavily on product development, market competition, and marketing strategies, the crucial aspect of payment planning often gets overlooked. This oversight can lead to businesses incurring unnecessary banking fees and facing unexpected operational risks. Understanding the complexities of banking and payment systems is crucial, yet it remains an area with limited knowledge for many in these sectors. Lack of knowledge in this domain can result in poor financial decision-making. As a payment expert, I have observed that addressing these payment-related challenges is essential for the long-term success and sustainability of businesses in the gaming and tech industries. By gaining a better understanding of how payments work and the reasoning behind banking decisions, these industries can navigate financial challenges more effectively and make informed choices, ultimately ensuring smoother operations and cost savings.

What are you most looking forward to at the Prague Gaming & TECH Summit?

I am greatly anticipating the upcoming Prague Gaming & TECH Summit for several compelling reasons. First and foremost, I’m excited about the high-quality content that will be presented during the event. It’s an excellent opportunity to gain valuable insights and knowledge about the gaming and tech industries.

Additionally, I’m looking forward to reconnecting with old acquaintances and making new connections. Networking is a fundamental aspect of such gatherings, allowing us to exchange ideas, share experiences, and forge new professional relationships.

Lastly, I’m eager to hear about the latest industry developments and gossip. Staying informed about the current trends and happenings within the gaming and tech sectors is essential for keeping a competitive edge in these dynamic industries.

Overall, the Prague Gaming & TECH Summit promises to be an enriching and engaging experience, offering valuable content, networking opportunities, and industry insights.


Aleksandra Andrishak – Editor in Chief at Slotsjudge

What are you most looking forward to at the Prague Gaming & TECH Summit?

The vegan catering! Jokes aside, Hipther events are renowned for their best-in-class networking, and I’m eagerly anticipating the opportunity to delve into topics such as iGaming, eSports, and Blockchain with top experts in the industry. This will mark my second collaboration on stage with Zoltan and the team, and I’m very much looking forward to it.

Can you tell us about a project or achievement in your career that you’re particularly proud of?

I’m honored to represent Slotsjudge at the Prague Gaming & TECH Summit 2024. I’m particularly proud of all the work we’ve accomplished with the team in 2023. This year, you can expect even more from us, including new features, a completely revamped website, and even more ways to have fun together with us if you’re a gaming enthusiast!

What advice would you give to someone starting their career in the gaming or tech industry?

Never stop learning. The gaming industry is one of those sectors where innovation occurs almost daily. To stay ahead of the curve, you cannot afford to become complacent. Continuously strive to expand your knowledge and skills. Good luck!


Jakub Tesar – Innovation, Digital & Emerging Tech Lead at EY

What are your top three predictions for the future of gaming and tech industries in the next five years?

  1. The Ethereum ecosystem will evolve into a hub for practical applications, driving large-scale enterprise adoption of blockchain technology.
  2. The growth of Web3 will empower users to have self-custody over virtual collectibles and in-game items, enabling the purchase of ‘phygital’ items that merge the physical and online worlds. This evolution will facilitate free trade on blockchain-powered marketplaces and allow brands to explore new monetization strategies for digital assets.
  3. Generative AI (GenAI) will revolutionize gaming experiences, enabling players to interact with non-player characters (NPCs) in more natural and dynamic ways, and experience storylines that adapt and evolve in real-time.

Can you share a recent innovation in the gaming/tech industry that excites you? What challenges do you think the industry needs to address? The integration of GenAI within gaming environments excites me the most. It offers unprecedented, natural-like interactions with GenAI-based NPCs and allows for fluid, dynamic storylines. However, the industry must navigate the ethical implications of AI, ensuring that these technologies are developed and used responsibly.

What has been the most surprising or valuable lesson in your career within the gaming/tech sector? In my career, the most valuable lesson has been the constant need for innovation and adaptability. The rapid pace at which technology evolves requires a perpetual learning mindset and the willingness to embrace change.

How do you see the role of AI and emerging technologies shaping the gaming and tech industries? AI and emerging technologies are set to fundamentally reshape the gaming and tech industries by introducing more immersive, interactive, and personalized experiences. These technologies will not only enhance gameplay but also offer new avenues for creativity and innovation within the sector.

What advice would you give to someone starting their career in the gaming or tech industry? Never stop learning. The gaming industry, in particular, is characterized by its rapid evolution and innovation. Staying informed and continually enhancing your skills is crucial to staying ahead in this competitive field.

What do you think are the biggest challenges facing the gaming and tech industries today? Addressing the ethical and societal implications of rapid technological advancement, including privacy concerns, data security, and the potential for misuse, remains a significant challenge.

How do you see regulations impacting the gaming and tech industries, and what changes would you like to see? Regulations need to strike a balance between fostering innovation and protecting consumers. I hope to see regulations evolve in a way that supports the ethical development of new technologies while ensuring they are accessible and beneficial to all.

What are you most looking forward to at the Prague Gaming & TECH Summit? I’m eagerly anticipating the opportunity to delve into the latest industry trends, connect with fellow professionals, and share insights on the evolving landscape of gaming and technology.

Is there a specific message or insight you hope attendees will take away from your session? I hope attendees recognize the enduring significance of blockchain technologies and are inspired to explore and experiment with their vast potential for innovative use cases.


Kaspar Szymanski – Founder of SearchBrothers

What do you think are the biggest challenges facing the gaming and tech industries today?

One of the primary challenges in an industry saturated with numerous market players offering similar web platforms and services is effectively defining and communicating a compelling unique selling proposition (USP). While brand building, prioritizing user experience, and optimizing website performance are essential, they are merely steps towards the ultimate goal of offering a service or product that isn’t readily available elsewhere. Moreover, developing a long-term strategy presents a significant challenge in an industry that tends to favor short-term success. The pressure of organizational and market demands often hinders decision-makers from adopting strategies focused on sustainable, gradual growth. This challenge is particularly evident in search engine optimization (SEO), where the goals of long-term growth and meeting immediate organizational needs must be aligned, as search engine algorithms prioritize actual ranking signals over organizational constraints.

What are you most looking forward to at the Prague Gaming & TECH Summit?

I am eager to share the unique insights into Google Search that I gained during my time working for Google, as well as my experiences as a consultant helping clients in competitive niches outperform their competitors. My presentation will include exciting real-life case studies, debunk several myths within the SEO industry, and provide attendees with actionable advice they can immediately apply. I am also looking forward to listening and learning from others, and eagerly anticipate addressing audience questions during the Q&A session following my presentation.

Is there a specific message or insight you hope attendees will take away from your session?

I want my audience to understand that Google penalties are not the end of the world and can be resolved. SEO setbacks, while initially unwelcome, can actually offer an opportunity for significant growth, potentially surpassing any previous rankings on Google Search. These moments can be a hidden blessing, revealing new paths to success. I invite anyone curious about the inner workings of Google Search, how it can benefit your website, and seeking genuine answers to their Google and SEO questions to join my session.


Jasmina Poglavc – Senior Product Manager at Gamanza Group AG & Freelance iGaming Consultant

Can you share a recent innovation in the gaming/tech industry that excites you, and what challenges do you think the industry needs to address?

My background in iGaming platforms and online operations has given me a unique perspective on the transformative potential of advanced data analytics and AI. These technologies promise significant changes, especially in real-time player engagement for iGaming platforms and operators. By analyzing player behavior, preferences, and patterns in real time, we can offer personalized promotions, customized gaming experiences, and targeted loyalty programs. This not only boosts player satisfaction but also optimizes revenue streams.

However, the full realization of these benefits faces challenges, primarily concerning data privacy and security. Protecting sensitive player information is paramount, and navigating the evolving regulatory landscape to align data-driven practices with compliance standards is equally crucial.

What has been the most surprising or valuable lesson in your career within the gaming/tech sector?

Adaptability has been the most valuable lesson in my career. The gaming and tech sectors are incredibly dynamic, with constant evolutions and innovations. Embracing change, remaining agile, and continuously seeking learning opportunities have been essential for navigating challenges and achieving success. Anticipating industry trends and staying informed about technological and regulatory developments are key to staying ahead.

What advice would you give to someone starting their career in the gaming or tech industry?

Stay curious and proactive. Embrace challenges as growth opportunities, keep up with industry trends, and cultivate a strong professional network. Innovation drives the gaming and tech industries, so developing a mindset that embraces change and fosters creativity is crucial.

What do you think are the biggest challenges facing the gaming and tech industries today?

The primary challenges include cybersecurity threats, talent acquisition and retention, and adapting to an evolving regulatory landscape. Balancing innovation with compliance is challenging, as regulations often lag behind technological advancements. A strategic, adaptive approach is essential for navigating these challenges, necessitating proactive engagement with regulators and an awareness of legal frameworks.

How do you see regulations impacting the gaming and tech industries, and what changes would you like to see?

The gaming industry, exemplified by the situation in Germany, faces challenges from overregulation, which can drive players toward unregulated, black-market operators. While regulations are crucial for ensuring fairness and consumer protection, too restrictive an environment can hinder the industry’s growth and inadvertently compromise player safety.

I advocate for regulations that evolve with technological advancements, are harmonized globally, and are developed in collaboration with industry stakeholders. This approach aims to balance consumer protection with innovation, ensuring a thriving, responsible gaming ecosystem.


Click here to register and unlock the door to endless possibilities at the Prague Gaming & TECH Summit. Your next big opportunity awaits!

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