• A strategic rebranding has positioned Newton Golf as a forward-thinking entity committed to enhancing golfers’ performance through meticulously engineered products.
• Central to Newton Golf’s product lineup are the Newton Gravity Putters and Newton Motion Shafts.
• The company is committed to developing tools that not only enhance performance but also make the game more enjoyable.

In the ever-evolving landscape of golf equipment, Newton Golf (NASDAQ: SPGC) has emerged as a beacon of innovation and quality. Formerly operating under the name Sacks Parente Golf, the company underwent a strategic rebranding to align more closely with its mission of integrating advanced physics principles into golf-equipment design. This transformation has positioned Newton Golf as a forward-thinking entity committed to enhancing golfers’ performance through meticulously engineered products.

The rebranding initiative was officially announced late last year, marking a significant milestone in the company’s evolution (https://ibn.fm/Y1m4p). By consolidating its putter and shaft divisions under the Newton Golf umbrella, the company signaled a unified approach to product development and brand identity. This restructuring was not merely a change in name but a reflection of Newton Golf’s dedication to creating equipment that leverages the laws of physics to benefit golfers of all skill levels.

Central to Newton Golf’s product lineup are the Newton Gravity Putters and Newton Motion Shafts (https://ibn.fm/9gDMT). The gravity putters are renowned for their ultra-low balance point (“ULBP”) technology, a feature that promotes a smoother, more controlled putting stroke. This innovation has garnered attention on professional tours, with several PGA Tour champions integrating these putters into their games. The motion shafts are designed to optimize energy transfer and enhance swing consistency, embodying the company’s commitment to precision engineering.

A cornerstone of Newton Golf’s philosophy is its dedication to domestic manufacturing. All products are proudly made in the United States, with putters manufactured in Camarillo, California, and shafts handcrafted in St. Joseph, Missouri. This commitment ensures stringent quality control and supports local economies, reinforcing the company’s ethos of integrity and excellence.

The company’s vision extends beyond product innovation, encompassing a broader mission to make golf equipment that works smarter for all golfers. By focusing on the principles of physics, Newton Golf aims to develop tools that not only enhance performance but also make the game more enjoyable. This approach reflects a modern yet timeless blend of design and functionality, appealing to both traditionalists and contemporary golfers.

In addition to product development, Newton Golf places a strong emphasis on customer engagement and education. Through its website and various media outlets, the company provides insights into equipment technology, helping golfers make informed decisions about their gear. This educational approach fosters a community of informed consumers who appreciate the nuances of golf equipment and its impact on performance.

Newton Golf’s rebranding and strategic initiatives have not gone unnoticed in the golf industry. Several reputable golf publications have featured the company’s products, giving accolades for their innovative designs and performance benefits. These endorsements serve as a testament to Newton Golf’s commitment to excellence and its role as a leader in golf-equipment innovation.

Looking ahead, Newton Golf is poised to continue its trajectory of growth and innovation. With plans to expand its product offerings and further integrate advanced technologies into its designs, the company is set to solidify its position as a pioneer in the golf-equipment industry. Golfers can anticipate new developments that align with Newton Golf’s mission to make the game more accessible, enjoyable, and rewarding.

For more information, visit www.NewtonGolfCo.com.

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

• Calidi’s RTNova platform leverages engineered enveloped vaccinia viruses designed for systemic delivery.
• Calidi’s groundbreaking virotherapy holds “immense promise in revolutionizing the treatment landscape for cancer patients with advanced solid tumors,” says CEO.

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage biotechnology company at the forefront of developing innovative immunotherapies for cancer treatment. Most recently, the company has captured the spotlight for the development of its proprietary systemic platform, RTNova (https://ibn.fm/Z4pM3). The platform represents a significant advancement in systemic virotherapy, particularly in the utilization of enveloped virotherapies to target metastatic tumors across the body.

Antitumor virotherapy employs viruses that selectively infect and destroy cancer cells while sparing normal tissues. However, a significant challenge in the administration of these viruses is their rapid neutralization by the immune system, limiting their therapeutic efficacy.

To address this challenge, Calidi designed an innovative vaccinia virus strain enveloped with a human cell membrane (extracellular enveloped virus or EEV), providing protection in the bloodstream while targeting distant tumors (https://ibn.fm/c5fWc). Once inside the tumor, virotherapies are designed to selectively replicate and destroy tumor cells. This process activates an immune response and helps train the immune system to recognize and target future cancer cells. Additionally, the platform can target distant tumors and then act as a viral vector to deliver specific gene therapies to tumor sites.

“Calidi’s groundbreaking systemic enveloped virotherapy holds immense promise in revolutionizing the treatment landscape for cancer patients with lung cancer and metastatic advanced solid tumors,” said Allan Camaisa, Calidi Biotherapeutics CEO and board chair. “By providing protection to the virus during administration, our antitumor virotherapy is able to reach and attack the tumor sites and then activate the immune system. This is the first antitumor virotherapy with systemic administration that shows the potential for real efficacy in the clinic.”

Calidi’s innovative approach builds upon years of experience in using stem cells to protect antitumor viruses from neutralization by the patient’s immune system.

In addition to the RTNova platform, Calidi is advancing other clinical programs, including CLD-101 (NeuroNova) and CLD-201 (SuperNova), which are in various stages of development. These programs utilize stem cell–based platforms to deliver antitumor viruses, aiming to treat multiple oncology indications, such as high-grade gliomas and solid tumors. The company’s commitment to pioneering the future of cancer treatment is exemplified by its collaboration with City of Hope, where the fourth and final cohort of patients are being dosed in a phase 1 clinical trial evaluating neural stem cells carrying a tumor-killing adenovirus to treat recurrent high-grade glioma patients. Calidi also recently announced that Northwestern University commenced recruitment for a Phase 1b/2 trial using Calidi’s NeuroNova drug candidate in a multidosing strategy to treat newly diagnosed high-grade glioma.

Calidi Biotherapeutics’ dedication to harnessing the power of antitumor virotherapy positions the company as a leader in the field of cancer immunotherapy. By developing its systemic delivery mechanisms and leveraging the unique properties of enveloped viruses, Calidi is developing treatments that not only target tumors directly but also stimulate the body’s immune system to fight cancer more effectively. As its development programs progress, Calidi continues to make significant strides toward transforming the standard of care for patients with advanced and metastatic cancers.

For more information, visit www.CalidiBio.com.

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

• The Q1 Virtual Investor Summit will focus on microcap companies that are undervalued, and aim to create connections between leading investors and microcap companies
• Clene’s presentation will be given by CEO Rob Etherington and CFO Morgan Brown
• Clene’s participation in the event comes as the company is moving closer to submitting a New Drug Application to the FDA to secure potential accelerated approval for CNM-Au8^® for ALS
• The company recently partnered with German-based APST Research GmbH to analyze neurofilament light chain (“NfL”) data for evaluating CNM-Au8 efficacy in ALS patients.

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 Q1 Virtual Investor Summit event on March 11 to showcase its latest achievements and outline the next steps for lead drug candidate CNM-Au8 (https://ibn.fm/YHqIv).

The company’s presentation will be given by CEO Rob Etherington and CFO Morgan Brown. The presentation starts at 1 p.m. ET. Anyone interested in participating can register at https://ibn.fm/7tHle.

The Q1 Investor Summit will consist of company presentations between 9 a.m. and 4 p.m. ET, along with one-on-one meetings between 8 a.m. and 4 p.m. An exclusive event for investors who specialize in small and microcap stocks, the Summit is a unique opportunity for investors to be introduced to and speak with management at some of the most attractive small companies, learn from various subject matter experts, and see what their peers are doing in this market. This quarter’s event focuses on microcap companies that are undervalued.

Clene’s participation in the event comes as the company is moving closer to submitting an NDA (New Drug Application) to the Food and Drug Administration (“FDA”) in the second half of 2025 to secure potential accelerated approval for CNM-Au8 for ALS.

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 pathway while reducing oxidative stress. By targeting mitochondrial dysfunction, CNM-Au8 can provide neuroprotection and promote remyelination.

The drug candidate has a robust safety profile and has provided evidence of survival benefit from two independent, randomized, double-blind, placebo-controlled clinical trials so far. In these two Phase 2 clinical trials, RESCUE-ALS and the HEALEY ALS Platform Trial, Regimen C, participants who were administered CNM-Au8 saw significant improvement in survival rates, delayed time to clinical worsening, and improvements on the combined assessment of function and survival compared to placebo. These results are supported by declines in the key plasma biomarker, NfL.

The company recently signed an agreement with APST Research GmbH (“APST”) to further analyze NfL data. The data will support analyses recommended by the FDA on the effects of CNM-Au8 in an additional cohort of ALS patients. Clene will use APST’s extensive dataset to compare NfL levels in NIH-sponsored Expanded Access Protocol (“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, which would further strengthen Clene’s case for regulatory approval.

There is currently no cure available for ALS, and treatments can only help slow down the disease progression, manage the symptoms, and prevent unnecessary complications. CNM-Au8 can help increase and improve survival rates in ALS patients by enabling the body’s main systems, primarily breathing, to continue. An accelerated approval pathway for CNM-Au8 would offer hope and help obtain the best outcome for people living with ALS, the company believes. According to CDC statistics, approximately 5,000 Americans are diagnosed with ALS each year, and about 30,000 people are currently living with the disease in the U.S. alone (https://ibn.fm/A0t4F).

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

The 6th KOL & MSL Expertise Summit, held on February 26-27, 2025, in Philadelphia, convened professionals from the pharmaceutical and biotechnology sectors to delve into the evolving dynamics between Key Opinion Leaders (“KOLs”) and Medical Science Liaisons (“MSLs”). The summit offered a platform for in-depth discussions on enhancing collaboration, refining insight programs, and aligning strategies with business objectives.

Key Sessions and Speakers:

Build Core Competencies in Business Acumen and Strategic Thinking: Adeola Davis, Director of Learning & Development, Medical Affairs, Acadia Pharma, discussed strategies to enhance MSLs’ understanding of business operations, fostering a collaborative mindset aligned with corporate objectives.

Elevate MSL Performance with Well-Structured Collaborations with Medical Information Teams: Jason Bain, Medical Science Liaison, Exact Sciences, highlighted the importance of integrating Medical Information scientists into product teams to expedite responses to complex inquiries and improve partnership structures.

PANEL: Determine the Top Priorities for a Successful Insight Program: This panel focused on training MSLs to effectively gather and analyze insights, setting new standards for scientific exchange. Panelists included:

• Carl De Luca, Director, Field Medical Affairs – Oncology, Regeneron
• Ryan Van Puffelen, Senior Marketing Manager, KOL & Society Strategy, Johnson & Johnson

For those who could not attend, the summit is available on-demand, providing access to all sessions and discussions at your convenience.

• A hidden investor opportunity, Thumzup Media Corporation is starting to overturn the social media branding and marketing industry with an innovative approach to small business advertising
• The company expects to grow its advertiser network 10x by the end of the year, the first step toward getting 10% of America’s small businesses to advertise on the platform and directing 20% of their ad budgets to Thumzup
• This goal follows the 230% advertiser base growth seen in 2024, coupled with the company’s market expansion to South Florida and Greater Los Angeles

Thumzup (NASDAQ: TZUP), a Los Angeles-based company, is democratizing the $200 billion social media advertising industry with an increasingly popular platform designed to connect small-business advertisers directly with everyday social media users. The innovative approach has already attracted a growing list of customers, and the company has now listed on Nasdaq (https://ibn.fm/a9tlo).

Thumzup leverages a robust programmatic advertiser dashboard coupled with a consumer-facing App that allows individuals to get paid cash for posting about participating advertisers on major social media outlets. Given its integrations with Instagram, TikTok, and X (formerly Twitter), along with attribution tools and industry-leading analytics, Thumzup has managed to offer something unique in the market, a value proposition that its Founder and CEO, Robert Steele, believes will help the company reach its goal of a tenfold increase in advertisers over the next 12 months (https://ibn.fm/lQaZX).

In a recent letter to shareholders, Mr. Steele highlighted a 230% advertiser base growth for the 2024 calendar year. This meant that Thumzup crossed the 600 active advertisers mark and plans to grow the numbers substantially in 2025. The company also successfully listed on the Nasdaq and upsized its public offering to $8.2 million. These milestones were primarily driven by the company’s unique value proposition, product differentiation, and strong market positioning (https://ibn.fm/ZLQ7I).

Steele explained that Thumzup set out on an aggressive market expansion plan for 2024, having expanded to South Florida and Greater Los Angeles. The plan is now to scale nationwide with extended social media integrations, and its recently launched analytics tools based on customer feedback. In addition, following board approval in January 2025, the company approved a strategy to allocate up to 90% of liquid assets to Bitcoin (“BTC”). Currently, the company holds 19.106 BTC (https://ibn.fm/ZLQ7I).

Thumzup’s initial but consistent growth has made the company optimistic that it will realize and surpass its 2025 goal, with an approach that only Thumzup offers. For small-cap investors, this represents a still hidden opportunity to jump on an accelerating train that is redefining digital advertising.

“The future value proposition of Thumzup is immense. Just as hundreds of billions of dollars in value were created by democratizing ridesharing and hospitality, our platform can democratize the $200 billion social media advertising industry. To our knowledge, no one else is doing what we do,” noted Mr. Steele (https://ibn.fm/e2lny).

For company information, visit 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

The Pennsylvania Cannabis Convention (“PACC”) is gearing up to bring together growers, traders, brands, and enthusiasts to explore the legal cannabis sector in Pennsylvania on March 30, 2025. This event is a must-visit for those involved in the local cannabis industry, offering attendees in-depth insights into every aspect of the PA medical program. Registrations are open, and PA patients can attend the PACC for free.

For the March 30 event, PACC has partnered with NECANN, a renowned leader in hosting cannabis networking events. NECANN events are recognized as some of the premier cannabis gatherings on the East Coast, providing high ROI B2B opportunities. Each year, these events draw over 9,000 attendees, offering a platform for discovering new business and investment opportunities across the cannabis sector.

The event will take place at the David L. Lawrence Convention Center, covering nearly eight acres of space in downtown Pittsburgh. The venue offers an exceptional environment for events, meetings, and exhibitions, ensuring an unparalleled experience for all attendees.

With the expertise of NECANN, PACC is poised to create a vibrant and sustainable networking and business platform for local cannabis brands, growers, and retailers. The attendee list will include both startups and seasoned cannabis players, as well as key decision-makers within the industry. Exhibitors will have the opportunity to showcase their products and services while pitching their brands across various industry verticals. Licensed cultivators will present their innovative ideas and technologies, while investors can use the platform to discover new investment opportunities. Small businesses and newcomers will also have the chance to connect with industry veterans and forge lasting business relationships.

Ethos, the event’s presenting sponsor, includes a family of brands such as Natural Selections and Eleven, and will provide valuable insights on how enhanced cannabis products can help individuals improve their well-being.

To learn more, please visit https://ibn.fm/Uv0YK

The 9th Digital Strategy & Innovation for Medical Affairs Summit, held on February 26-27, 2025, in Philadelphia, brought together industry leaders to explore the transformative role of digital technologies in medical affairs. The event featured insightful discussions on artificial intelligence (“AI”), patient engagement, and innovative strategies to navigate the evolving technological landscape.

Key Sessions and Speakers:

Bridge Patient Care Gaps with AI-Driven, Omnichannel Engagement: This session delved into how AI-powered strategies are revolutionizing healthcare professional (“HCP”) engagement to address patient care gaps. Speakers included:

• Kyle Roderick, SVP of Medical Affairs at Doximity
• Amit Phull, Chief Physician Experience Officer at Doximity
• Div Khetia, VP, Head of Medical Affairs Channel Excellence at Pfizer

Utilize AI and Data Insights to Build Your Digitalization Roadmap: Nita Thingalaya, Lead Innovation and Evidence, Specialty Care, Sanofi, provided strategies for integrating AI processes by evaluating company capacity, logistics, and budget.

PANEL: Enhance Patient Autonomy by Using Advanced Technologies: This panel discussed how digital tools like wearable devices and electronic health records empower patients. Panelists included:

• Hiral Patel, System Director, Innovation Activation and Enablement, Endeavor Health
• Peter Covitz, Executive Director, Head Digital Innovation, Data Generation & Managed Access, Alexion Pharmaceuticals

Gain Efficiencies Through Fractional Medical Utilization: Mary Hames, CEO, BioLogic Pharma Solutions, explored the benefits of adopting fractional medical affairs teams for pre-commercial assets, highlighting how AI-powered tools can enhance productivity and strategic decision-making.

For those unable to attend, the summit is available on-demand.

Stay tuned for future events and continue to engage with the latest advancements in medical affairs.

• Brera Holdings, an Ireland-based, international holding company with a global portfolio of men’s and women’s sports clubs, just closed 10 new signings for its clubs in the 2024-2025 transfer window, 8 for the men’s teams and 2 for the women’s teams
• The company’s management believes that these new signings will bring fresh energy and expertise to their respective teams, positioning them for a successful second half of the season
• The signings follow an independent CFA’s valuation report projecting Brera’s revenues will triple in 2025

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, announced its new signings for its portfolio clubs ahead of the spring championship. According to its management, these additions reflect the company’s ongoing commitment to player development and expanding talent pathways, mainly from Africa and Eastern Europe (https://ibn.fm/7TLll).

The clubs that will benefit from these transfers include those in North Macedonia: Brera Strumica (mens), and Brera Tiverija (womens). The signees include Fodey Tavali (midfielder), Dragan Bilbia (defender), Fahd Nzengue (forward), Hadji Drame (right wing), Filip Mihailov (midfielder/attacker), Zoran Ivanovski (wing), Hristijan Jankuloski (defender) and Mihail Milevski (midfielder/defender), to cover the men’s team. Christine Nafula (forward) and Danche Karpuzzovska (midfielder/forward) will be the new additions to the women’s team.

The women’s team currently ranks first in their league, earning the title “winter champions.” Their two new additions, its management notes, will look to strengthen its position and defend its title this spring. In addition, the new signings, overall, will bring fresh energy and expertise into the respective teams, positioning them for a successful second half of the season (https://ibn.fm/7TLll).

These signings follow analyst projections that Brera’s revenues will triple in 2025. It was projected by an independent CFA report that for the 2025 financial year, the company will realize revenues of between $6.3 million and $9.8 million. While primarily influenced by the SS Juve Stabia acquisition of “The Second Team of Naples” in Italy’s Serie B, signings for the male and female teams in its portfolio also boost shareholder confidence and help drive the company’s earnings going forward.

“Brera Holdings made a strategic move with the Juve Stabia acquisition, and while challenges remain, the company is positioning itself for significant revenue growth,” noted Sascha P. Czerwenka, CFA, for 247MarketNews.com. “If operational improvements continue as expected, the stock could see a major re-rating, presenting a compelling opportunity for investors,”he added (https://ibn.fm/kf4Jr).

Brera remains committed to building competitive squads with diverse international talent, with its expansion into markers such as Asia and Africa being a testament to that.

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

• Forschungszentrum Jülich scientists have already leveraged D-Wave’s technology for research on protein folding, electron interactions and quantum physics.
• The Advantage™ system features over 5,000 qubits and 15-way connectivity, advancing quantum optimization research.
• The quantum system will be linked to JUPITER, Europe’s first exascale supercomputer, potentially enabling novel computational applications.
• The system will be upgraded to D-Wave’s next-generation Advantage2™ quantum processor when available, which D-Wave expects will deliver doubled coherence time, higher qubit connectivity and 40% improvement in energy scaling.
• The collaboration is anticipated to take the use of quantum technology to a new level, according to Prof. Kristel Michielsen, head of JUNIQ & Quantum Computing at the Jülich Supercomputing Centre.

D-Wave Quantum Inc. (NYSE: QBTS) (“D-Wave”), a leader in quantum computing systems, software, and services, and the first supplier of production-grade quantum computers, recently announced that the Jülich Supercomputing Centre (“JSC”) at Forschungszentrum Jülich (“FZJ”) has become the world’s first high-performance computing (“HPC”) center to purchase a D-Wave^TM Advantage annealing quantum computing system (https://ibn.fm/KGsAg).

The D-Wave system will be housed at the JSC, which provides computing resources for European researchers on supercomputers. JUNIQ, JSC’s European quantum computing infrastructure, gains complete access to all aspects of the D-Wave Advantage system.

“The D-Wave Advantage system has played a pioneering role in the development of quantum optimization, both through its contribution to breakthrough research and the development of enterprise-grade solutions across numerous industries,” said Prof. Thomas Lippert, director of JSC. “D-Wave stands alone as the only quantum vendor solving real-world problems today, and we’re thrilled to be the first HPC center in Europe to own its groundbreaking annealing quantum computer.”

The Advantage system acquired by JSC features:

• 5,000+ superconducting qubits
• 15-way qubit connectivity, allowing for more efficient quantum optimization
• Annealing-based quantum computing, designed for tackling real-world problems

FZJ plans to integrate the system with JUPITER, Europe’s first exascale supercomputer, which is under construction at JSC. FZJ expects JUPITER to exceed the threshold of one quintillion calculations per second. Once the integration is complete, FZJ and D-Wave expect it will be the world’s first coupling of an annealing quantum computer with an exascale supercomputer, providing a first-of-a-kind opportunity for tackling the world’s toughest computational problems. By linking D-Wave’s quantum technology with JUPITER, JSC may pave the way for advances in AI optimization, materials science and chemistry, financial modeling and logistics.

“With D-Wave’s innovative technology, the integration of the system into JUNIQ and its future coupling with the exascale supercomputer JUPITER, we will take the use of quantum technology in Jülich, and on behalf of Germany and Europe, to a new level,” said Prof. Kristel Michielsen, head of JUNIQ & Quantum Computing at JSC. “Our experts are familiar with hosting the system, and JUNIQ’s scientific users have already been able to conduct remarkable research. We look forward to the further use of D-Wave and its coupling with the new exascale supercomputer generation, which we hope will enable us to look at scientific questions in a completely new way and solve real-world problems.”

The acquisition builds on FZJ’s history of leveraging D-Wave’s quantum systems for cutting-edge scientific research. Some key past projects include:

• Protein Folding Studies: Researchers at Lund University in Sweden and JSC used D-Wave’s quantum computer to study protein folding, a critical area in understanding diseases like Alzheimer’s and Parkinson’s. The research was recognized in Physical Review Research.
• Electron Interaction Research: In 2024, JSC and colleagues from Slovenia demonstrated how an annealing quantum computer can directly simulate electron interactions, with results published in Nature Communications.
• Quantum Cosmology Simulations: A collaboration between JSC, University of Leeds and the Institute of Science and Technology Austria used D-Wave’s system to gain insights into the formation of the universe, with findings published in Nature Physics.

JSC’s D-Wave system is set to be upgraded to Advantage2, D-Wave’s next-generation quantum computer, once available, which is expected to deliver doubled coherence time, higher qubit connectivity and 40% improvement in energy scaling. This upgrade will further enhance JSC’s quantum computing capabilities, allowing for the pursuit of more complex problem-solving and scientific breakthroughs.

“JSC’s renowned HPC computing expertise combined with our transformational annealing quantum computing technology creates a powerful synergy,” said Dr. Alan Baratz, CEO of D-Wave. “We are excited to see the innovations and applications that we expect will continue to emerge from this important collaboration.”

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 systems and Advantage2^TM prototype 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.

• Clene is partnering with APST Research GmbH to analyze neurofilament light chain (“NfL”) data for evaluating CNM-Au8^® in ALS patients.
• APST maintains one of the largest ALS biomarker databases, with data from over 4,300 ALS patients, including clinical outcomes and biomarker tracking.
• The analysis will compare NfL changes in the NIH-sponsored Expanded Access Program (“EAP”) participants with historical ALS patient data to assess CNM-Au8’s potential efficacy.
• Clene plans to submit its statistical analysis plan to the FDA, aiming for filing of an NDA for potential accelerated approval in the second half of 2025.
• No significant safety concerns have been reported across over 800 participant years of CNM-Au8 treatment.

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”), has signed an agreement with APST Research GmbH (“APST”) to support analyses of CNM-Au8’s effects on NfL decline in participants in ongoing EAPs (https://ibn.fm/2IwhG). The analyses were recommended by the U.S. Food and Drug Administration (“FDA”) to support Clene’s data package for a potential accelerated approval application.

Based in Germany, APST operates one of the largest ALS biomarker repositories, with data on over 4,300 ALS patients, including demographic information, motor function, and NfL biomarkers. This collaboration will provide Clene with robust comparative data to assess CNM-Au8’s potential efficacy in reducing NfL levels. Neurofilament light chain is a well-established biomarker for neuronal damage. In ALS, elevated NfL levels indicate disease progression and neuronal degeneration. Tracking how NfL levels change over time provides insight into whether a drug is slowing disease progression.

Under this agreement, Clene will use APST’s extensive dataset to compare NfL levels in NIH EAP participants treated with CNM-Au8 against historical ALS controls. The NfL dataset Clene is analyzing includes data from more than 1,625 ALS patients, aligning the biomarker data of NfL to clinical ALSFRS-R assessments, slow vital capacity (“SVC”), and clinical events such as ventilation support and nutrition intervention. 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 people living with ALS, which could strengthen Clene’s case for regulatory approval.

Commenting on the agreement, APST’s founder and CEO Thomas Meyer, a renowned ALS key opinion leader, emphasized the value of real-world biomarker data, noting that the collaboration advances ALS research and clinical development. “Our extensive and robust data collection empowers pharmaceutical companies to advance their clinical research and trials, driving us toward a deeper understanding of ALS disease progression” Meyer said.

Clene has provided CNM-Au8 treatment to nearly 500 ALS patients through its three EAP programs, collecting real-world evidence to assess the drug’s impact. Key aspects of Clene’s NfL analysis plan to be submitted to the FDA include:

• Comparing NfL changes in NIH-sponsored EAP participants to control data from APST.
• Analyzing correlations between NfL levels and patient survival rates.
• Supporting the case for FDA accelerated approval of CNM-Au8 in ALS treatment.

Clene plans to submit a new drug application (“NDA”) to the FDA in the second half of 2025 for potential accelerated approval. The NDA will contain data on NfL changes and survival with CNM-Au8 treatment, including results of this study.

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 pathway while reducing oxidative stress. By targeting mitochondrial dysfunction, CNM-Au8 can provide neuroprotection and promote remyelination. Across 800 participant years of CNM-Au8 treatment, no significant safety concerns or adverse events have been reported. Investigators have not identified any serious adverse events linked to the treatment.

“We are excited to enter into this endeavor with one of the world’s largest ALS NfL datasets in order to supplement available biomarker NfL data from our NIH-sponsored EAP, and to support the existing clinical study data for the potential review of an application for approval of CNM-Au8 in ALS via an accelerated regulatory pathway,” said Clene’s CEO, Rob Etherington. “We remain dedicated to the ALS community and are honored to continue our efforts to help critically ill patients and their families.”

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