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Soligenix’s RiVax(R) Program Back in Focus After Deadly Ricin Toxin Intercepted Before Reaching White House

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New York, New York–(Newsfile Corp. – September 21, 2020) – Soligenix’s (NASDAQ: SNGX) RiVax® program is in focus after a failed attempt to send ricin-laced letters to the White House last week raised fresh concerns about the deadly toxin. Those letters, including others addressed to Texas law enforcement agencies, were intercepted before delivery on Thursday. That news helped focus attention toward Soligenix’s RiVax® program, which is considered the leading ricin-poisoning vaccine program in the world to protect against exposure to this deadly substance.

The interest in Soligenix’s (NASDAQ: SNGX) program started trending after it was announced that the lethal ricin toxin was again used to potentially harm government leaders. Letters to the White House were addressed to President Trump and were intercepted at the final off-site processing facility before being sent to the White House mailroom. All US mail that is addressed to the White House and other federal agencies in the Washington area are irradiated before final delivery and get processed through a sorting facility that samples the air for suspicious substances.

Despite the slim chances of ricin-laced packages reaching the White House, the event nonetheless highlights the importance of developing a vaccine against this deadly substance. Soligenix is leading that race.

RiVax® Program Timely And Necessary

The potentially deadly events again demonstrate the importance of developing a vaccine against a ricin toxin that is lethal and yet easily manufactured. Ricin, a white powder, can induce irreversible symptoms within four hours of exposure and may cause death within 48-72 hours.

Its mechanism of action causes cell death once it penetrates the cell membrane, and it typically penetrates cells within 4 hours of exposure. Depending on the route of exposure (ingestion, inhalation, or injection), ricin toxin produces different initial symptoms. Regardless of the exposure method, though, ricin poisoning will result in death with sufficient exposure 100% of the time. Currently, there are no FDA-approved prophylactic or post-exposure therapies for ricin toxin exposure.

At Soligenix, RiVax® is one of two biodefense programs being developed through its Public Health Solutions business segment. The other, ThermoVax®, is a critical component of making a vaccine candidate’s temperature stable. Combining the two programs, positions RiVax® as the most advanced development-stage ricin treatment vaccine platform in the world. It may also be the most promising means to protect against exposure to ricin during chemical warfare. That warfare can include domestic events like what occurred last week.

In Phase I studies, Soligenix demonstrated that RiVax®, containing an abbreviated version of ricin toxin A chain with no biological activity, induces a non-toxic immunogenic response, while also demonstrating safety and tolerability in healthy volunteers. Importantly, the antibodies induced through immunization with RiVax® demonstrated complete protection from a lethal dose of aerosolized ricin in a rhesus macaques vaccine trial. The company is expected to seek expedited FDA approval for the vaccine under the “Animal Rule” that relies on studies successfully conducted in non-human primates. The benefits are compelling.

RiVax® Therapeutic Benefits Presented

The vaccine’s therapeutic benefits were presented at the Fourth International Conference on Vaccines Research and Development Development in 2018. Posters showed that RiVax® induces the adaptive immune system to produce antibodies that recognize and bind ricin toxin, preventing it from getting inside cells and killing them. Intramuscular injection of RiVax® stimulates the production of IgG and other antibodies, which are produced and circulated within the body to eradicate ricin, whether inhaled, eaten, or injected.

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Further, the RiVax® vaccine candidate uses one of the safest vaccination approaches known – using a modified inactivated protein component of the ricin toxin itself to raise antibody responses, combined with an alum adjuvant to boost the body’s response to the vaccine. Also, RiVax® uses Soligenix’s proprietary ThermoVax® technology to create a vaccine which is stable for long-term storage (e.g., at least 12 months) even at very high temperatures (e.g., 40°C or 104°F). This means the RiVax® protein may be stored for long periods allowing it to be stockpiled for future use.

That stockpiling advantage is critical because potential therapies for ricin intoxication are generally limited for use within four hours of poisoning. Thus, because poisoning events are often of unknown origin and its point of delivery virtually limitless, a four-hour time limit for treatment is hugely problematic. In response, a strategically placed stockpile of RiVax® could be utilized for national defense and distributed quickly using a combination of logistical resources. Notably, to meet and finance a potential global opportunity for its vaccine candidate, Soligenix is earning tremendous financial support from outside agencies.

To date, RiVax® has been funded by non-dilutive grants awarded from the NIH (approximately $25 million thus far) and through a $21.2 million contract entered into with the NIH in 2014. Soligenix is also evaluating the opportunity to apply for a priority review voucher (PRV), which can be a valuable asset to the RiVax® program. These PRV’s are transferable, and recent PRV’s have sold for approximately $100 million in the biotech and pharma sector.

ThermoVax® Adds Critical Value RiVax®

A critical component that can potentially inspire an expedited review of RiVax® is ThermoVax®. One aspect of this proprietary stabilizing platform technology allows vaccines comprised of an aluminum salt adjutant to be kept out of cold storage without affecting its potency. The technique can be a breakthrough to eliminate the need for cold storage, and its applications can provide game-changing treatment in the battlefield, during extreme power-outage situations, and during large scale triage situations. It may also be instrumental in preventing large-scale domestic incidents.

ThermoVax® technology has already shown demonstrably positive results with RiVax®. Independent studies showed that ThermoVax® can provide potency protection for the RiVax® vaccine for at least one year at 104° Fahrenheit. Additionally, ThermoVax® demonstrated its ability to protect vaccine candidates’ potency to treat anthrax, HPV, and Ebola for at least twelve weeks at the same high temperatures.

Combining the two programs creates a compelling argument that the RiVax® program should be immediately brought to the desk of bio-defense decision-makers, who should evaluate the immediate and long-term threat from this easy to develop toxin. They should then take action to protect their citizens.

Most importantly, the benefits of ThermoVax® should not be underappreciated. It may offer the best solution to allow for easy storage and provide a unique ability to allow for a national and strategic stockpile of essential vaccines. It may be, by far, a best-in-class solution for multiple vaccine candidates.

Near-Term Catalysts For Soligenix

Currently trading at a sharp discount to analyst pricing models, Soligenix is well-positioned to further its growth by capitalizing on several clinical initiatives. Although RiVax® will get new attention this week, the company has at least four other programs targeting markets that can each generate hundreds of millions in potential peak revenues.

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Thus, even with risk discounts applied to its clinical programs and at least two potential catalysts expected by year’s end, that value may start to build ahead of the results.

Now, with RiVax® in focus, those forward-looking revenue models may be worthy of a new appraisal, enticing a revision to financial projections that placed potential revenue from RiVax® past 2023.

At the very least, RiVax® may offer another near-term catalyst for Soligenix and create a substantial revenue-generating opportunity from worldwide governments that are having to address national defense and security as a priority. The events last week may put an exclamation point on that initiative.

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Fintech Latvia Association Releases Fintech Pulse 2024: A Guide to Latvia’s Growing Fintech Hub

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The Fintech Latvia Association has launched the latest edition of its annual publication, Fintech Pulse 2024, unveiling insights and resources that position Latvia as a thriving hub for European fintech.

Announced at this year’s Fintech Forum, the magazine is now available in digital format, offering a comprehensive guide for fintech professionals and entrepreneurs navigating the Latvian market and exploring its advantages.

This issue covers essential topics, from support tools provided by Latvijas Banka and newcomer roadmaps to Riga’s investor resources and fintech education opportunities. Readers will find the latest fintech news from Latvia, coverage of this year’s key industry events, and member insights on the future of fintech. The Fintech Landscape section provides a comprehensive overview of the Latvian fintech ecosystem.

Tina Lūse, Managing Director of Fintech Latvia Association, expressed excitement about the ecosystem’s growth: “We are excited to unveil the third annual edition of Fintech Pulse. This year has been pivotal for our ecosystem, and together with public sector stakeholders, we are enhancing financial inclusion, democratizing investments, and driving innovation throughout the sector. This is a testament to Latvia’s emergence as a fintech hub, establishing itself as an equal partner in innovation and support within the Baltic region.”

Minister of Finance Arvils Ašeradens highlighted Latvia’s fintech potential in the magazine, stating: “Latvia has already made strides in adapting its regulatory framework to support a stable financial system. Now, we encourage financial market players to invest in modern technologies to meet the growing demand for inclusive financial services and solidify Latvia’s position in the fintech landscape. We are confident that with the combined offer of the government, Latvijas Banka and Riga city, we are a great place to start your next scalable European FinTech!”

Minister of Economics Viktors Valainis expressed Latvia’s ambition in the magazine, stating: “Latvia wants to become a WEB 3.0. innovation hub and solidify itself as one of the leaders of a newly regulated EU crypto-asset market. We welcome international companies to choose Latvia, a flexible and fast-paced country, where you can obtain a MICA license in just 3 months. Open your office in Latvia, receive a MICA license and serve the whole EU market!”

The Fintech Latvia Association brings together fintech and non-banking financial service providers to represent their interests at both the national and international levels. It promotes sustainable development in Latvia’s financial sector by fostering reliable, responsible, and long-term industry practices that earn trust from consumers and regulatory authorities. The association is committed to supporting innovation and growth opportunities within the fintech landscape.

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Quantum Security and the Financial Sector: Paving the Way for a Resilient Future

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The World Economic Forum (WEF) has released a pivotal white paper in collaboration with the Financial Conduct Authority (FCA), titled “Quantum Security for the Financial Sector: Informing Global Regulatory Approaches”. This January 2024 publication underscores the urgent need for global cooperation as the financial sector transitions from a digital economy to a quantum economy, highlighting both the immense opportunities and cybersecurity challenges posed by quantum computing.


Quantum: A Double-Edged Sword for Finance

Quantum computing offers transformative benefits for the financial sector, such as accelerated portfolio optimization, enhanced fraud detection, and improved risk management. Yet, it simultaneously threatens the very foundation of cybersecurity. With quantum’s ability to break traditional encryption methods, sensitive data and financial transactions face significant risks. The white paper warns that such vulnerabilities could erode trust in the financial system and destabilize global markets.

The urgency to prepare is evident, with some quantum threats, such as “Harvest Now, Decrypt Later” attacks, already emerging. Governments and regulators, including the United States with its National Security Memorandum on Quantum (2022), have begun advocating for quantum security readiness by 2035. However, as noted in the paper, transitioning to a quantum-secure infrastructure is a monumental task requiring unprecedented coordination between regulators, industry leaders, and technology providers.


A Collaborative Framework: Four Guiding Principles

To address the complex challenges posed by quantum technologies, the WEF and FCA have proposed four guiding principles to inform global regulatory and industry approaches:

  1. Reuse and Repurpose: Leverage existing regulatory frameworks and tools to address quantum risks, rather than creating entirely new systems.
  2. Establish Non-Negotiables: Define baseline requirements for quantum security, ensuring consistency and interoperability across organizations and jurisdictions.
  3. Increase Transparency: Foster open communication between regulators and industry players to share best practices, strategies, and knowledge.
  4. Avoid Fragmentation: Prioritize global collaboration to harmonize regulatory efforts and avoid inconsistencies that could burden multinational organizations.

These principles aim to create a unified, forward-looking strategy that balances innovation with security.


A Four-Phase Roadmap for Quantum Security

The white paper introduces a phased roadmap to help the financial sector transition toward quantum security:

  1. Prepare: Raise awareness of quantum risks, assess cryptographic infrastructure, and build internal capabilities.
  2. Clarify: Formalize engagement between stakeholders, map current regulations, and model the cost and complexities of transitioning to quantum-safe systems.
  3. Guide: Address regulatory gaps, translate technical standards into actionable frameworks, and develop industry-wide best practices.
  4. Transition and Monitor: Implement cryptographic management modernization and adopt iterative, adaptable regulatory approaches to remain resilient in the quantum economy.

This roadmap emphasizes adaptability, encouraging stakeholders to continuously refine their strategies as quantum technologies evolve.


The Path Forward: Collaboration as a Catalyst

The transition to a quantum-secure financial sector is not merely a technological shift but a comprehensive rethinking of how industries and regulators approach cybersecurity. The interconnected nature of global finance means that collaboration between mature and emerging markets is crucial to avoid vulnerabilities that could undermine the entire system.

Regulators and financial institutions must act with urgency. As Sebastian Buckup, Head of Network and Partnerships at the World Economic Forum, notes in the report:
“The quantum economy era is fast approaching, and we need a global public-private approach to address the complexities it will introduce. We welcome this opportunity to collaborate with the FCA to chart the roadmap for a seamless and secure transition for the financial services sector.”

Similarly, Suman Ziaullah, Head of Technology, Resilience, and Cyber at the FCA, emphasizes:
“Quantum computing presents considerable opportunities but also threats. The financial sector relies heavily on encryption to protect sensitive information, the exposure of which could cause significant harm to consumers and markets. Addressing this requires a truly collaborative effort to transition to a quantum-secure future.”


Global Impact: Ensuring Resilience in an Evolving Landscape

As quantum technologies mature, they will redefine the landscape of cybersecurity. The financial sector, as one of the most sensitive and interconnected industries, must prioritize preparedness to ensure stability, protect consumers, and maintain trust.

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The Quantum Security for the Financial Sector: Informing Global Regulatory Approaches white paper offers an essential foundation for continued dialogue and action. By adhering to the guiding principles and roadmap outlined in the report, stakeholders can navigate this transformation with foresight and cooperation.

The full report, published by the World Economic Forum, highlights the need for a unified global approach to quantum security, serving as a rallying call for industry and regulatory leaders alike.


Source: World Economic Forum, “Quantum Security for the Financial Sector: Informing Global Regulatory Approaches”, January 2024.

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Fintech Pulse: Daily Industry Brief – A Dive into Today’s Emerging Trends and Innovations

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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.

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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.

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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:

  1. Personalization and Inclusion: Products like Beacon’s wallet highlight the importance of understanding and addressing specific user needs.
  2. Collaborative Ecosystems: Partnerships, like that of MeaWallet and Integrated Finance, emphasize the power of collaboration in solving industry challenges.
  3. Emerging Technologies: Juniper Research’s predictions affirm the continued influence of blockchain, embedded finance, and instant payment networks.
  4. Security at the Core: The recognition of Nucleus Security underscores the essential role of cybersecurity in fintech.
  5. Market Transformation: OpenYield’s funding signifies the ongoing disruption of traditional financial markets, paving the way for broader accessibility.

 

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