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Clene Inc.’s (NASDAQ: CLNN) CNM-Au8(R) Delivers Significant Survival Benefits in New Analyses of Healey ALS Platform Trial Data

  • Clene’s CNM-Au8® treatment was demonstrated to improve survival in ALS patients by up to 14.8 months.
  • The findings come from a post hoc analysis of the HEALEY ALS Platform Trial, comparing CNM-Au8 to a concurrently enrolled control.
  • Strong survival benefit was observed in patients meeting the planned criteria for Clene’s upcoming Phase 3 RESTORE-ALS trial.
  • The company is preparing to submit a New Drug Application (“NDA”) to the FDA later this year for potential accelerated approval, and further regulatory discussions and a confirmatory Phase 3 trial are planned for mid-2025.

Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), has released new data showing that its lead drug candidate, CNM-Au8, significantly extends survival in patients with ALS. The findings were derived from a cross-regimen post hoc analysis of long-term survival in HEALEY ALS Platform Trial participants (https://ibn.fm/EgWeb).

The study compared participants treated with CNM-Au8 30 mg (Regimen C) against those in Regimen A, which served as a large concurrent control group. Survival data was tracked over 48 months using public records and site reporting. The majority (78%) of patients in both groups received standard ALS treatments such as riluzole and edaravone, or both.

Key findings of the analysis include:

  • Patients in the CNM-Au8 30 mg group of Regimen C had a median survival of 951 days, compared to 753 days in the control group — a 6.5-month improvement. When adjusted for key variables such as baseline disease severity and biomarker levels, the restricted mean survival time (“RMST”) analysis showed a statistically significant 4.1-month increase in survival (p=0.045).
  • In patients with moderate to severe ALS, the median survival improvement was greater, rising from 589 days (Regimen A) to 951 days (a gain of 11.9 months). In this subgroup, the mortality risk was reduced by 44%, with an RMST improvement of 197 days.
  • The largest benefit was seen in patients meeting the criteria for Clene’s upcoming Phase 3 RESTORE-ALS trial. This group experienced a median survival of 1079 days, 14.8 months longer than the control group (628 days), a 49% reduction in mortality risk, and an RMST improvement of 215 days.

These results align with prior studies, including the 24-week HEALEY ALS Platform Trial double-blind period, the RESCUE-ALS trial, and Expanded Access Program data. Commenting on the findings, Merit Cudkowicz, M.D., M.Sc., Principal Investigator and sponsor of the HEALEY ALS Platform Trial, director of the Sean M. Healey & AMG Center for ALS, and executive director of the Mass General Brigham Neuroscience Institute, said, “The innovative design of the HEALEY ALS Platform Trial has enabled us to extract clear and meaningful survival data that helps make decisions about CNM-Au8 drug development.”

Clene is seeking to bring CNM-Au8 to market as soon as possible. The company is preparing to launch a confirmatory Phase 3 RESTORE-ALS trial in mid-2025, while also considering an accelerated approval pathway for CNM-Au8, following discussions with the FDA in late 2024. As part of this process, Clene will conduct additional biomarker analyses, focusing on neurofilament light chain (“NfL”) data—an important measure of ALS progression.

Rob Etherington, Clene’s President and CEO, expressed optimism about the results, stating that the survival benefit reinforces CNM-Au8’s potential to extend life for people living with ALS while also validating the company’s strategic direction as it prepares for the launch of the confirmatory Phase 3 RESTORE-ALS study in mid-2025. “We look forward to discussing these findings with the FDA as we advance toward potential commercialization,” he said.

For more information, visit the company’s website at www.Clene.com.

NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN

D-Wave Quantum Inc. (NYSE: QBTS) Demonstrates Quantum Supremacy on a Real-World Problem

  • D-Wave has shown quantum computational supremacy on a useful, real-world problem, a first in the industry, highlighting the potential of quantum computing for materials discovery and complex simulations beyond classical computational limits.
  • A peer-reviewed paper published in Science validates that D-Wave’s annealing quantum computer solved a magnetic materials simulation problem that is beyond the capabilities of classical supercomputers.
  • The simulation, which took minutes to solve on D-Wave’s system, would require nearly one million years and more electricity than the world’s annual consumption on a GPU-based supercomputer.
  • The Advantage2 annealing quantum computer prototype was used to achieve this milestone and is available for commercial use.

D-Wave Quantum Inc. (NYSE: QBTS) (“D-Wave”), a leader in quantum computing systems, software, and services, has confirmed a major milestone in quantum computing, demonstrating quantum computational supremacy on a practical, real-world problem. A newly published, peer-reviewed paper in Science validates that D-Wave’s annealing quantum computer outperformed a state-of-the-art classical supercomputer in simulating quantum dynamics in magnetic materials. The full study, titled “Beyond-Classical Computation in Quantum Simulation,” is available at https://ibn.fm/VEsx9.

This marks the first time quantum computing has been proven to surpass classical methods on a useful, real-world problem (https://ibn.fm/H94kF). Unlike previous claims that focused on abstract mathematical problems or random number generation, D-Wave’s work addresses computational challenges in materials science, a field with implications for medical imaging, superconductors, and electronics.

An international collaboration of scientists led by D-Wave used the company’s Advantage2 annealing quantum computer prototype to simulate quantum dynamics in programmable spin glasses—complex magnetic materials that are difficult to model using conventional methods. D-Wave compared the performance against the Frontier supercomputer at Oak Ridge National Laboratory, one of the most powerful classical supercomputers available.

The results were impressive — D-Wave’s system completed the most complex simulations in minutes. Performing the same computations on the classical supercomputer would have taken nearly one million years and consumed more electricity than the world’s total annual energy consumption.

According to Dr. Alan Baratz, CEO of D-Wave, this achievement underscores the capabilities of quantum annealing. “This is a remarkable day for quantum computing. Our demonstration of quantum computational supremacy on a useful problem is an industry first. All other claims of quantum systems outperforming classical computers have been disputed or involved random number generation of no practical value,” said Dr. Baratz. “Our achievement shows, without question, that D-Wave’s annealing quantum computers are now capable of solving useful problems beyond the reach of the world’s most powerful supercomputers. We are thrilled that D-Wave customers can use this technology today to realize tangible value from annealing quantum computers.”

The ability to accurately simulate quantum materials has broad implications. Magnetic materials play a crucial role in numerous industries, from healthcare to renewable energy. Understanding their behavior through quantum simulations could lead to breakthroughs in designing more efficient electronic components, optimizing medical imaging technologies, and improving energy storage solutions.

According to Dr. Andrew King, senior distinguished scientist at D-Wave, this research proves that D-Wave’s quantum computers can reliably solve complex materials simulation problems that could lead to discovery of new materials. “Through D-Wave’s technology, we can create and manipulate programmable quantum matter in ways that were impossible even a few years ago.”

“This is a significant milestone made possible through over 25 years of research and hardware development at D-Wave, two years of collaboration across 11 institutions worldwide, and more than 100,000 GPU and CPU hours of simulation on one of the world’s fastest supercomputers as well as computing clusters in collaborating institutions,” said Dr. Mohammad Amin, chief scientist at D-Wave. “Besides realizing Richard Feynman’s vision of simulating nature on a quantum computer, this research could open new frontiers for scientific discovery and quantum application development.”

The Advantage2 System

The study builds on earlier research published in Nature Physics (2022) and Nature (2023), which demonstrated that quantum annealing provides a computational speedup for optimization problems. These findings led to the development of Advantage2’s fast anneal feature, which played a crucial role in this latest breakthrough. D-Wave also continues to develop and advance its quantum hardware, with a current Advantage2 prototype quantum computer that is four times larger than the prototype used in this study.

D-Wave offers customers immediate access to the Advantage2 prototype quantum computer through D-Wave’s Leap™ quantum cloud service, allowing businesses and researchers to explore its capabilities today. The prototype provides substantial performance improvements from previous-generation AdvantageTM systems, including increased qubit coherence, connectivity, and energy scale, which enables higher-quality solutions to larger, more complex problems.

Industry Response

The results of the study have drawn interest from the broader scientific community. Dr. Seth Lloyd, Professor of Quantum Mechanical Engineering at MIT, commented: “Although large-scale, fully error-corrected quantum computers are years in the future, quantum annealers can probe the features of quantum systems today. In an elegant paper, the D-Wave group has used a large-scale quantum annealer to uncover patterns of entanglement in a complex quantum system that lie far beyond the reach of the most powerful classical computer.”

Other leading physicists, including Dr. Hidetoshi Nishimori (Tokyo Institute of Technology) and Dr. Juan Carrasquilla (ETH Zürich), have echoed similar sentiments, recognizing the significance of this breakthrough in advancing quantum computing research.

“This paper is not only a tour-de-force for experimental physics, it is also remarkable for the clarity of the results. The authors have addressed a problem that is regarded both as important and as very challenging to a classical computer,” said Dr. Victor Martin-Mayor, Professor of Theoretical Physics, Universidad Complutense de Madrid. “The team has shown that their quantum annealer performs better at this task than the state-of-the-art methods for classical simulation.”

About D-Wave Quantum Inc.

D-Wave is a leader in the development and delivery of quantum computing systems, software, and services. We are the world’s first commercial supplier of quantum computers, and the only company building both annealing and gate-model quantum computers. Our mission is to help customers realize the value of quantum, today. Our 5,000+ qubit Advantage quantum computers, the world’s largest, are available on-premises or via the cloud, supported by 99.9% availability and uptime. More than 100 organizations trust D-Wave with their toughest computational challenges. With over 200 million problems submitted to our Advantage and Advantage2 systems to date, our customers apply our technology to address use cases spanning optimization, artificial intelligence, research and more. Learn more about realizing the value of quantum computing today and how we’re shaping the quantum-driven industrial and societal advancements of tomorrow: www.dwavequantum.com.

NOTE TO INVESTORS: The latest news and updates relating to QBTS are available in the company’s newsroom at https://ibn.fm/QBTS

Forward Looking Statements

Certain statements in this press release are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management’s control, including the risks set forth under the heading “Risk Factors” discussed under the caption “Item 1A. Risk Factors” in Part I of our most recent Annual Report on Form 10-K or any updates discussed under the caption “Item 1A. Risk Factors” in Part II of our Quarterly Reports on Form 10-Q and in our other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this press release in making an investment decision, which are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.

Brera Holdings PLC (NASDAQ: BREA) Bolsters Advisory Board with the Addition of Famed Global Economist Dr. Arthur B. Laffer

  • Brera Holdings, an Ireland-based, international holding company focused on expanding its global portfolio of men’s and women’s sports s, has announced the appointment of Dr. Arthur B. Laffer to its Advisory Board.
  • With an economic lens, Dr. Laffer can provide strategic guidance on securing high-value sponsorship agreements, optimizing broadcasting rights negotiations, and leveraging government incentives to support Brera’s global expansion. Additionally, Dr. Laffer may help refine Brera’s financial modeling for player salary structures, transfer market efficiency, and overall profitability.
  • Dr. Laffer’s appointment points to Brera’s ambitions for the 2025 calendar year and follows the company’s recent investment in a Mozambican football club, along with 10 new signings in the 2024-2025 winter transfer window.

Brera Holdings (NASDAQ: BREA), an Ireland-based, international holding company focused on expanding its global portfolio of men’s and women’s sports clubs through a multi-club ownership (“MCO”) approach, has announced the addition of Dr. Arthur B. Laffer to its Advisory Board. His strategic input to the company can help develop Brera’s proprietary financial models to optimize player salaries, transfer fees, and overall profitability. In addition, his corporate and political networks could be integral in positioning Brera’s clubs as transatlantic brands, providing exposure to American investors (https://ibn.fm/J5alM).

“Dr. Laffer’s economic expertise and strategic insights into market expansion and asset monetization make him a powerful addition to our all-star Advisory Board,” noted Daniel McClory, Brera’s Executive Chairman. “His principles, including the Laffer Curve, offer a unique perspective on optimizing revenue while maintaining operational efficiency,” he added (https://ibn.fm/J5alM).

Dr. Laffer is recognized for creating and popularizing the Laffer Curve, which depicts the relationship between tax rates and revenue. Created back in 1974, this curve offers a visual representation of total tax revenue collected by governments as varying depending on tax rates. As such, it is often used to illustrate the argument that tax cuts can, if properly calculated, increase total tax revenue. Globally, this curve has influenced fiscal policy, and Brera believes that, with Dr. Laffer’s extensive experience advising U.S. policymakers, corporate leaders, and investors, he will bring a fresh economic dimension to Brera’s football expansion strategy. His advisory role is intended to focus on optimizing revenue streams, monetizing player assets, and ensuring sustainable club profitability (https://ibn.fm/J5alM).

Dr. Laffer will join Massimo Ferragamo, Alan Rothenberg, Giuseppe Rossi, Paul Tosetti, and Marshall Geller on Brera’s all-star Advisory Board, with his connections in finance, energy, and technology expected to be instrumental in accessing relationships for potential high-value sponsorship deals, broadcasting rights and government incentives. For Brera, his addition will help shape the company’s vision of maximizing player monetization, revenue streams, and international market penetration, particularly in and from Asia and North America.

“We were diligent in ensuring that Brera’s Advisory Board provides visionary leadership as we continue to drive our MCO strategy forward,” noted Mr. McClory (https://ibn.fm/J5alM).

Dr. Laffer’s appointment reflects Brera’s long-term vision of positioning football clubs as high-value global assets. This follows the company’s recent expansion efforts, including a signed letter of intent (“LOI”) to invest in a second Mozambican football club and securing 10 new player signings in the 2024-2025 winter transfer window.

For company information, visit the company’s website at www.BreraHoldings.com.

NOTE TO INVESTORS: The latest news and updates relating to BREA are available in the company’s newsroom at https://ibn.fm/BREA

Thumzup Media (NASDAQ: TZUP) Already Tops 700 Businesses Using New Social Media Marketing Solution

  • Thumzup Media deploys a proprietary social media marketing platform branded AdTech that drives influencers to slingshot the effectiveness of small-business advertising
  • The company is maintaining growth of more than 200% CAGR, currently representing more than 700 advertiser clients, with expectations of surpassing 1,000 during the coming financial reporting quarter
  • Thumzup has now uplisted to the Nasdaq stock index drawing more attention to its growing success in the social media marketing sector, a more-than-$500 billion digital revenue stream expected to pass the trillion-dollar mark by 2028

Social media marketing has grown exponentially since the turn of the century, when some 25 million social media identities existed worldwide. Last year’s Digital 2024: Global Overview Report by DataReportal (https://ibn.fm/zfypb) found that there were now well over 5 billion active social media user identities — an increase of more than 200 times during the past 25 years, with marketing tools adapting to the growth during that time.

The report found that nearly 53% of internet users said the primary reason they use social media is to find products to purchase or inspiration for purchases. And the trend only continues to grow — market analysts at Statista predict revenue generated by social commerce will hit the trillion-dollar mark by 2028 (https://ibn.fm/iatWr).

Social media branding and marketing innovator Thumzup (NASDAQ: TZUP) recently uplisted to the NASDAQ, further building its momentum as a solution to industry growth challenges through its proprietary AdTech platform, which significantly enhances the influencer recruiting and payment process. The company now represents more than 700 advertisers and expects to pass the 1,000-advertiser threshold during this year’s Q2 period.

As social media marketing growth attempts to accelerate, it is growing more sophisticated. More brands are competing online for consumers’ attention, and consumers are evolving in terms of their behaviors and preferences (https://ibn.fm/l6Sv3). Thumzup Media’s easy-to-use dashboard allows advertisers to programmatically customize their campaign, using a consumer-facing app to facilitate cash payment to social media users based on their posting success on advertisers’ behalf.

Thumzup also recently announced plans to integrate bitcoin as an additional payment option for gig economy workers.

“Our rapid growth to more than 700 advertisers, up from around 200 this time last year, is confirmation of the effectiveness of our disruptive advertising model,” Thumzup CEO Robert Steele stated in a company news release earlier this month (https://ibn.fm/V2YZW). “We are maintaining growth of more than 200% CAGR. … We are continuously growing and redefining how brands connect with consumers. By incentivizing engagement with direct cash rewards and harnessing a vast, untapped audience, we are delivering outsized value.”

For more information, visit the company’s website at www.ThumzupMedia.com.

NOTE TO INVESTORS: The latest news and updates relating to TZUP are available in the company’s newsroom at https://ibn.fm/TZUP

Adageis to Launch Series A Funding Round, Seeking $10M in Growth Capital

Adageis is opening a Series A funding round, capital raise, aiming to raise $10 million for growth and expansion.
The company previously closed a $2 million seed round in Q4 2024 to enhance operations and market reach.
Adageis expects to exceed growth targets for Q1 2025, with strong market adoption of its AI-powered platform designed to streamline healthcare operations, optimize revenue, and improve patient care outcomes.
The company has cut onboarding time from four weeks to one week, accelerating customer acquisition and revenue growth.

Adageis, a healthcare technology company reshaping patient care through flexible AI-centric software solutions for healthcare organizations, is launching a Series A funding round to raise $10 million in growth capital. This follows the company’s successful $2 million seed round at the end of Q4 2024, which supported backend improvements, expanded electronic health record (“EHR”) connectivity, and an increased sales force.

The company is targeting a total of $20 million in funding to fuel its next phase of growth, with a minimum investment of $250,000 required to participate. The capital will be allocated as follows:

40%: Expansion of SaaS platform team
45%: Development of a healthcare factoring division
15%: Technology upgrades to support fintech AI transition

Adageis is positioning itself as a key player in healthcare financial technology, helping providers optimize revenue and streamline operations. Representing the only offering of its kind in the healthcare sector, the company’s AI-powered ProActive Care Platform enables providers a more effective way to transition from traditional fee-for-service models to value-based care, improving both patient outcomes and financial performance.

The company’s Patented Risk Engine (“PRE”) enables predictive analytics for revenue performance, identifying patterns in patient care and financial incentives. Key financial benefits include:

Cash Flow Management: AI can predict revenue performance from quality incentives, enabling providers to factor accounts receivables for pay-per-performance payments.
Debt Leverage: Healthcare professionals can use AI-driven insights to access funding for operations and expansion, aggregating payments from insurance companies, ACOs, IPAs, and CINs.

Adageis’ fintech AI solutions are designed to simplify the complexities of insurance contracts, making it easier for providers to maximize reimbursements. By seamlessly integrating with widely used platforms like AthenaHealth, Cerner, eClinicalWorks, Allscripts, and Epic, the platform delivers an easy-to-use, efficient, and scalable solution for value-based care revenue optimization.

The company expects to exceed its Q1 2025 growth targets, highlighting market demand for its services. Up to date, the company reports 150,000 patient lives currently covered, 70 providers across two states using the platform, one awarded patent from the USPTO, integration with over 90 EHR systems and up to $75,000 per provider in additional value-based care revenue.

By the end of Q2 2025, Adageis anticipates:

580,000 patient lives covered
$100,000 in monthly recurring revenue
Two to three new clients onboarded per month

To support this expansion, the company has streamlined its onboarding process, reducing implementation time from four weeks to just one week.

With its upcoming Series A funding round, Adageis is positioning itself for significant expansion in the healthcare technology space, offering investors an opportunity to support a rapidly growing company in the evolving $19.27 billion healthcare AI market.

For more information, visit the company’s website at www.Adageis.com.

NOTE TO INVESTORS: The latest news and updates relating to Adageis are available in the company’s newsroom at https://ibn.fm/Adageis

Soligenix Inc. (NASDAQ: SNGX) Is ‘One to Watch’

  • Soligenix has multiple late-stage assets with orphan and fast-track designations, providing a clear regulatory pathway toward potential approvals.
  • The company’s pipeline has a total addressable market exceeding $2 billion, spanning rare diseases, inflammation, and biothreat applications.
  • Soligenix has benefited from significant non-dilutive government funding, which reduces operational expenses and financial risk while supporting its public health initiatives.
  • The company is well-positioned for multiple development and regulatory catalysts, and commercial milestones, with lead candidates in cutaneous T-cell lymphoma, psoriasis, oral mucositis, and Behçet’s disease.
  • Soligenix is led by an experienced management team with a strong track record of success.

Soligenix (NASDAQ: SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for rare diseases with high unmet medical needs. Operating through two key segments, the company’s Specialized BioTherapeutics division is dedicated to oncology and inflammation therapies, while its Public Health Solutions segment advances vaccines and therapeutics targeting biothreats and infectious diseases.

The company is actively advancing multiple late-stage clinical programs, including HyBryte™ (“SGX301”), a novel photodynamic therapy for cutaneous T-cell lymphoma (“CTCL”). Additional candidates in development target psoriasis (“SGX302”), oral mucositis (“SGX942”), and Behçet’s disease (“SGX945”), while its public health efforts focus on heat-stable vaccines for ricin poisoning (“RiVax®”), Ebola (“SuVax™”), and Marburg (“MarVax™”) viruses, that have been supported by non-dilutive government grants and contracts of approximately $60 million to date.

With a diversified pipeline, multiple orphan and fast-track designations, and collaborations with government agencies, Soligenix is uniquely positioned for potential regulatory approvals and commercialization.

The company is headquartered in Princeton, New Jersey.

Pipeline and Development Programs

Specialized BioTherapeutics

Soligenix’s Specialized BioTherapeutics division develops treatments for oncology and inflammatory diseases, focusing on conditions with few or no effective therapeutic options. HyBryte™ (synthetic hypericin) has completed a Phase 3 study for CTCL, demonstrating statistically significant efficacy, and a second confirmatory Phase 3 trial is actively enrolling patients to support potential regulatory submissions worldwide. If approved, it would be the first non-mutagenic photodynamic therapy for early-stage CTCL, addressing an unmet medical need. It has received orphan drug designations in the U.S. and Europe, as well as Fast Track designation in the U.S.

SGX302, a photodynamic therapy based on the same active ingredient as HyBryte™, is in clinical development for mild-to-moderate psoriasis, with positive Phase 1/2 proof-of-concept results, it is actively enrolling patients in a Phase 2a clinical trial.

SGX942, designed to reduce inflammation and tissue damage in oral mucositis associated with cancer treatment, is progressing as a potential first-in-class therapy.

SGX945, targeting aphthous ulcers in Behçet’s disease, is actively enrolling in a Phase 2a clinical trial and has received fast-track designation, highlighting the urgency of developing effective treatments for this rare inflammatory condition.

Public Health Solutions

The company’s Public Health Solutions segment focuses on medical countermeasures for biothreats and emerging infectious diseases, leveraging non-dilutive government funding to advance its programs. RiVax®, a ricin toxin vaccine, has demonstrated strong preclinical and early clinical results and may be eligible for government procurement under the Strategic National Stockpile initiative.

The company’s RiVax®, as well as its vaccine candidates for Ebola and Marburg viruses are based on its proprietary ThermoVax® technology, which stabilizes vaccines for long-term storage without refrigeration. This approach could be transformative in regions where maintaining cold-chain logistics is challenging.

The ongoing development of these vaccines is supported by funding from NIH, BARDA, and DTRA, with the potential for up to three priority review vouchers (“PRVs”) upon regulatory approval, to be used for future programs or sold. Notably, PRVs have previously sold for roughly $100 million.

Market Opportunity

Soligenix targets markets with significant commercial potential, focusing on rare diseases and biodefense applications. HyBryte™ addresses CTCL, a disease affecting over 68,000 patients across the U.S. and Europe, with a total market opportunity exceeding $250 million. SGX302, the company’s therapy for mild-to-moderate psoriasis, serves a much larger population, as over eight million people in the U.S. are affected by the condition, representing a global market opportunity exceeding $1 billion.

SGX942, developed for oral mucositis in head and neck cancer patients, is aimed at a market worth more than $500 million, while SGX945 for Behçet’s disease serves a niche segment valued at over $200 million worldwide.

In addition to its rare disease programs, Soligenix’s Public Health Solutions division has the potential to generate significant revenue through government procurement contracts. By focusing on both orphan drug markets and government-funded biodefense initiatives, Soligenix has positioned itself for sustained revenue growth through multiple high-value opportunities.

Leadership Team

Christopher J. Schaber, PhD, Chairman, President & CEO, brings to the company more than 35 years of experience in the biopharmaceutical industry. Before joining Soligenix, he held senior and operational leadership roles at Discovery Laboratories, Acute Therapeutics, Ohmeda Pharmaceuticals, The Liposome Company, and Wyeth Ayerst Laboratories. He has extensive expertise in drug development, regulatory affairs, and corporate strategy, positioning him to drive Soligenix’s growth and advancement toward commercialization.

Richard Straube, MD, Chief Medical Officer, has more than 35 years of experience in drug development and clinical research. Prior to joining Soligenix, he held key leadership roles at Stealth Peptides, INO Therapeutics, Ohmeda Pharmaceuticals, and Centocor. Throughout his career, he has played a crucial role in bringing innovative therapies to market, particularly in inflammatory diseases and immunology, making him a valuable asset in advancing Soligenix’s late-stage clinical programs.

Oreola Donini, PhD, Chief Scientific Officer, has more than 20 years of experience in pharmaceutical research and development, with expertise in immunology, inflammation, and rare diseases. Before joining Soligenix, she held leadership positions at Inimex Pharmaceuticals, ESSA Pharma, and Kinetek Pharmaceuticals, where she worked on novel drug discovery and translational medicine. Her experience in preclinical research and product development supports Soligenix’s continued innovation in biopharmaceuticals.

Jonathan Guarino, CPA, CGMA, Chief Financial Officer, has over 25 years of experience in corporate finance and strategic financial planning. Before joining Soligenix, he held financial leadership positions at Hepion Pharmaceuticals, Covance, BlackRock, and Barnes & Noble. His expertise in financial management, accounting, and capital markets plays a critical role in Soligenix’s financial strategy and operational efficiency.

NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at http://ibn.fm/SNGX

State of the Venture Debt Market and Outlook for 2025

As of March 2025, the venture debt market continues to experience rapid growth, fueled by evolving financing needs, technological advancements, and a dynamic economic landscape. According to Statista, the U.S. venture debt market is projected to reach $27.83 billion in 2025, with traditional venture debt accounting for approximately $23.94 billion of that total (Statista). This growth reflects an increasing demand for non-dilutive financing among startups and growth-stage companies seeking capital without giving up equity.

Startups are increasingly turning to venture debt as an attractive alternative to equity financing, particularly in capital-intensive sectors such as biotechnology, artificial intelligence, and climate technology. According to a report from Business Insider, this trend has been further amplified by volatile equity markets, encouraging founders to preserve ownership while still raising necessary funds (Business Insider).

The broader private debt market, which encompasses venture debt, has seen consistent growth in recent years. BlackRock’s 2025 Private Markets Outlook projects that private credit markets will continue to attract substantial capital inflows due to their potential for higher returns and portfolio diversification (BlackRock). Investors, particularly family offices and institutional funds, are shifting towards private credit, which includes venture debt, as a strategic alternative to traditional equity investments.

The rapid development of capital-intensive technologies like generative AI, biotech therapeutics, and clean energy solutions has created heightened demand for venture debt. According to Financial Times, many companies in these sectors require substantial upfront investment but may not yet be profitable, making venture debt a critical tool for bridging capital gaps without diluting ownership (Financial Times).

Several major venture debt deals have already been announced in 2025. In February, OpenAI secured $300 million in venture debt to support its AI infrastructure expansion. The financing round was led by Silicon Valley Bank (“SVB”) and JP Morgan, reflecting growing investor confidence in high-growth technology sectors (TechCrunch). Similarly, Sana Biotechnology, a leading cell engineering company, closed a $175 million venture debt round in January 2025 to accelerate the development of its next-generation cell therapies (GlobeNewsWire). The deal was facilitated by Hercules Capital, a prominent venture debt lender. In March, Rivian Automotive, a major player in the electric vehicle space, secured a $500 million line of credit from Bain Capital Credit to bolster production capacity and international expansion efforts (Electrek).

Despite broader macroeconomic uncertainties, venture debt markets appear poised for continued growth. Analysts from JP Morgan anticipate that moderate economic growth in 2025 will create a favorable climate for private credit expansion, driving increased demand for venture debt (J.P. Morgan). Institutional investors are increasingly pivoting toward private credit vehicles, including venture debt, as a means to achieve higher yields and greater diversification. According to a January 2025 report by Business Insider, family offices have accelerated their allocations to private credit, seeking stable returns despite broader equity market volatility (Business Insider).

Regulatory clarity is also expected to contribute to market growth. In February 2025, the U.S. Securities and Exchange Commission introduced updated guidelines for venture debt issuances, providing more robust protections for both lenders and borrowers (SEC). These regulations are expected to reduce default risk and encourage further capital deployment.

While economic conditions remain favorable, rising interest rates pose a potential challenge for the venture debt market. Higher borrowing costs could deter some startups from pursuing debt financing, especially those with uncertain revenue models. Additionally, as more lenders enter the venture debt space, competition has intensified, potentially pressuring lending terms and interest rates. According to BlackRock, increased competition may lead to a tightening of credit standards, limiting access for some early-stage companies (BlackRock).

The venture debt market in 2025 is poised for substantial growth, driven by increased demand for alternative financing, expanding private credit markets, and favorable regulatory changes. However, challenges such as rising interest rates and market saturation will require strategic navigation by both lenders and borrowers. Investors, lenders, and startups alike should remain agile in adapting to evolving market conditions, leveraging venture debt as a strategic tool for growth.

For those looking to gain deeper insights and engage with industry leaders, DealFlow Events will be hosting the Venture Debt Conference 2025 in New York City on April 10, 2025. This annual event brings together venture lenders, institutional investors, growth-stage companies, and financial professionals to discuss the latest trends and opportunities in the venture debt space. Attendees will have the unique opportunity to network with key stakeholders, hear firsthand about recent deals, and gain actionable insights into navigating the evolving landscape.  Companies seeking to learn about venture debt and other non-dilutive financing can attend for free.

More information about the event, including registration details, can be found at: Venture Debt Conference 2025

Clene Inc. (NASDAQ: CLNN) to Present CNM-Au8(R) Updates at 37th Annual Roth Conference

  • The 37th Annual Roth Conference, to be held March 16-18 in Dana Point, California, will showcase the broadest group of companies in the event’s history, with senior executives from approximately 500 companies across various industries, including business services, consumer, healthcare, insurance, sustainability and technology, media and entertainment.
  • Clene’s management will participate in a virtual fireside chat at 9:20 a.m. PST on March 18, as well as one-on-one investor meetings during the event.
  • During the fireside chat and in investor meetings, the company will detail recent achievements and next steps for lead drug candidate CNM-Au8 for ALS and MS.

Clene Inc. (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), will attend the 37th Annual Roth Conference, according to a company news release (https://ibn.fm/odbPx).

Clene’s management will participate in a virtual fireside chat on March 18, at 9:20 a.m. PST, as well as one-on-one investor meetings, to discuss the company’s latest achievements and the next steps for lead drug candidate CNM-Au8. Investors interested in participating can register online at https://ibn.fm/laAfp. After the event, the presentation will be available on Clene’s website, in the Events section (https://ibn.fm/MrZEK).

The 37th Annual Roth Conference will be held March 16-18, at The Laguna Cliffs Marriott, located in Dana Point, California. This premier event aims to provide a robust platform for institutional investors to connect with executive management from an array of public and private growth companies.

Clene’s CNM-Au8 is an oral suspension of gold nanocrystals designed to improve cellular energy production and utilization, which is critical for maintaining neuronal health. The drug candidate has been shown to improve central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the nicotinamide adenine dinucleotide (“NAD”) pathway while reducing oxidative stress. By targeting mitochondrial dysfunction, CNM-Au8 can provide neuroprotection and promote remyelination, potentially altering the course of neurodegenerative conditions.

Following encouraging clinical trial results, Clene is seeking to bring CNM-Au8 to market as soon as possible. In two Phase 2 clinical trials, RESCUE-ALS and HEALEY ALS Platform Trials, participants who were administered CNM-Au8 saw significant improvement in survival rates, delayed clinical worsening, and improvements in a combined assessment of function and survival. The company is now organizing a confirmatory Phase 3 trial (“RESTORE-ALS”) to evaluate the survival benefit of CNM-Au8, while preparing for a potential accelerated approval pathway for the drug candidate as per the additional written guidance received from the U.S. Food and Drug Administration (“FDA”) in late 2024.

Clene is preparing a New Drug Application (“NDA”) to submit to the FDA in the second half of 2025 to secure accelerated approval for CNM-Au8 for ALS. Clene is currently conducting further analyses recommended by the FDA regarding neurofilament light chain (“NfL”) data, a key biomarker for ALS, in its NIH-sponsored Expanded Access Program (“EAP”). To strengthen this analysis, the company signed an agreement with APST Research GmbH (“APST”) to leverage its extensive dataset to compare NfL levels in NIH-sponsored EAP participants treated with CNM-Au8 against matched historical ALS controls. The goal is to determine if CNM-Au8 treatment reduces NfL decline, and to demonstrate that the rate of NfL change is associated with survival in the NIH-sponsored EAP ALS population.

For more information, visit the company’s website at www.Clene.com.

NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN

Exciting Networking and Growth Opportunities at the 37th Annual ROTH Conference

The highly anticipated 37th Annual ROTH Conference, hosted by Roth Capital Partners, will bring together an influential gathering of investors, entrepreneurs, executives, and professionals from across a diverse range of industries. Taking place March 16-18, 2025, at the Laguna Cliffs Marriott in Dana Point, California, this premier event promises to provide participants with unmatched opportunities for networking, collaboration, and business growth.

This year’s conference will feature executives from over 500 public and private companies across a broad spectrum of sectors, including technology, healthcare, industrial growth, sustainability, media and entertainment, and more. The ROTH Conference is designed as a dynamic platform where industry leaders and investors can engage in high-impact discussions, exchange innovative ideas, and forge long-lasting business relationships.

“As we celebrate nearly four decades of fostering growth and collaboration, we remain committed to creating a robust environment where emerging companies can showcase their potential and industry giants can explore new opportunities,” said Byron Roth, Executive Chairman of Roth Capital Partners. “With an unparalleled lineup of presentations, panels, and networking activities, this year’s conference will continue to be a catalyst for innovation and investment.”

Key highlights of the 37th Annual ROTH Conference include:

  • 1-on-1 and small group meetings for in-depth company insights and investment discussions
  • Analyst-selected fireside chats, thematic industry panels, and high-profile keynote presentations
  • ROTH / CAF charity events, featuring athletic activities benefiting the Challenged Athletes Foundation, with all proceeds matched by ROTH
  • Engaging networking events including Private Consumer Day, live entertainment, and recreational activities such as pickleball, yoga, and golf

This exclusive, invite-only conference is a must-attend for investors looking to identify key opportunities and executives eager to present their companies to a network of decision-makers. From AI and technology to sustainability and consumer brands, the ROTH Conference provides a comprehensive view of today’s most promising industries.

“The ROTH Conference is more than just an event—it’s a launching pad for transformative partnerships,” said Sagar Sheth, CEO of Roth Capital Partners. “We’ve designed this year’s conference to create meaningful dialogues and drive the future of growth investing.”

The event is set to be a powerful nexus for innovation, with panels covering topics like AI infrastructure, capital markets, longevity and supplementation, energy, and consumer brand investing. Attendees will leave equipped with valuable insights to navigate the ever-evolving market landscape.

For more information and to register for the 37th Annual ROTH Conference, visit www.roth.com/oc2025.

Brera Holdings PLC (NASDAQ: BREA) Marks New Chapter with Signed LOI to Invest in Mozambican Moçambola 2024 Champion Black Bulls

  • Brera Holdings, an Ireland-based, international holding company, has signed a Letter of Intent (“LOI”) with owner Lalgy Transport to further invest in Black Bulls, a Mozambican football team and current Mocambola league champions in the top tier
  • Once fulfilled, Brera will become a co-owner of the club, assisting in enhancing its competitiveness and expanding opportunities for Mozambican football domestically, throughout Africa, and abroad

Brera Holdings (NASDAQ: BREA), an Ireland-based, international holding company focused on expanding its global portfolio of men’s and women’s sports clubs through a multi-club ownership (“MCO”) approach, just announced a signed Letter of Intent (“LOI”) with owner Lalgy Transport to further invest in Black Bulls, a Mozambican football team and the current champions of the top-tier Mocambola league. Upon the fulfillment of the investment, Brera will become a co-owner of the club, strengthening it, enhancing its competitiveness, and expanding opportunities for Mozambican football domestically, in Africa, and abroad (https://ibn.fm/ETBst).

This LOI points to Brera’s understanding of the African football market and the recognition of the continent’s potential. In March 2023, the company officially entered this market by establishing Brera Tchumene FC in Mozambique. The club would quickly rise to the First Division after winning its post-season tournament, which spoke to Brera’s keen talent eye, along with the support it offers its clubs and its players.

As of 2023, Mozambique had a population of 33.64 million and is seen as a deep reservoir of untapped football talent. Yet, its player infrastructure remained limited, with only one organization, Associação Black Bulls, actively focusing on cultivating young athletes. The gaps in this country present significant opportunities for new initiatives to develop talent and connect players with more competitive leagues globally, which is why Brera saw it fit to venture into this market.

“Our vision is to not only elevate Mozambique’s football landscape but also play a crucial role in Africa’s overall football ecosystem. We are building an operation that will attract talent, nurture excellence, and open doors for Mozambican players on the global stage,” noted Vasco Imperato, Brera Tchumene FC’s CEO (https://ibn.fm/Vq1yD).

Brera Tchumene FC will pause independent operations in official competitions following the Black Bulls’ LOI. The moves are designed to ensure sustainability, accelerate growth, and drive the long-term success of African football, optimizing resources for a stronger, more unified development pathway. It marks an exciting new chapter in the company’s mission to nurture elite talent and build lasting value in one of the world’s most promising regions (https://ibn.fm/ETBst).

Brera deeply appreciates the supporters, staff, and players of Brera Tchumene FC, whose passion and dedication have been instrumental in this journey. According to Brera’s management, their legacy will continue to inspire as Brera expands its commitment to fostering the next generation of African football stars and strengthening its global footprint in the sport.

For additional information, visit the company’s website at www.BreraHoldings.com.

NOTE TO INVESTORS: The latest news and updates relating to BREA are available in the company’s newsroom at https://ibn.fm/BREA

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