Author: Ravi Shankar

Successful parallel production process maintains consistency while doubling exosome yield without increasing manufacturing time

TORONTO and HAIFA, Israel, Oct. 22, 2026 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a biopharmaceutical company developing exosome-based regenerative therapies for central nervous system injuries, today announced that it doubled exosome production by successfully operating two bioreactors in parallel, while maintaining the same overall production time, process consistency and comparable exosome quality.   The achievement marks an important step in NurExone’s strategy to build scalable exosome manufacturing capabilities through its wholly owned U.S. subsidiary, Exo-Top Inc. (“Exo-Top”), and its manufacturing collaboration with Made Scientific.

NurExone is pursuing a modular approach that enables manufacturing capacity to expand by adding standardized production units in parallel (scaling out approach), rather than engineering larger bioreactor vessels (scaling up approach). This strategy has the potential to protect capital investments, accelerate development timelines, and allow production to match commercial demand, subject to successful validation and implementation.

“Our goal is to make increasing exosome production straightforward and robust,” said Dr. Tali Kizhner, Director of Research and Development at NurExone. “We have invested hundreds of hours in studying and optimizing our manufacturing process. This run shows that we successfully replicated that process to increase output while ensuring manufacturing of high-quality product, with similar characteristics and critical quality attributes (CQAs). The achieved milestone provides us a strong foundation for expanding production capabilities even further.”

Table 1: Comparative Quality and Potency Metrics Across Production Runs

Product characteristic	Single Run A		Single Run B		Parallel Run (Two bioreactors)
Particle size (nm)	140–145		130–145		135–140
Surface electrical charge (mV)	−44.75		−45.6		−49.8
Identity markers (CD9, CD63, CD81, TSG101)	Detected		Detected		Detected
Purity (Protein impurities removed)	>95%		>95%		>95%
Anti-inflammatory activityi	<10⁹		<10⁹		<10⁹
Relative Exosome Yield (above 1013 exosomes per single bioreactor)	100%		100%		200%

As shown in Table 1, the exosomes produced in the parallel run retained comparable physical characteristics, the same identifying proteins and anti-inflammatory activity, providing initial evidence that greater output can be achieved while maintaining consistency.

“Scalable manufacturing is critical in positioning NurExone as a leader in this rapidly evolving exosome-based field. Demonstrating that two bioreactors can operate in parallel to double yield while maintaining process consistency strengthens our ability to respond to future demand and achieve market leadership,” said Dr. Lior Shaltiel, Chief Executive Officer of NurExone. “Through Exo-Top and our U.S. manufacturing collaborations, we are building the high-efficiency capabilities required to support both our internal therapeutic pipeline and potential business-to-business commercial opportunities for naïve exosomes.”

Supporting Therapeutic Development and Commercial Opportunities

NurExone is pursuing a dual-track strategy that combines the development of regulated exosome-based therapies with commercial opportunities for naïve mesenchymal stromal cell-derived exosomes through Exo-Top.

Its lead therapeutic candidate, ExoPTEN, is being developed for acute spinal cord injury and optic nerve damage. In parallel, Exo-Top is advancing manufacturing and commercial collaborations involving naïve exosomes for potential applications beyond the Company’s drug development pipeline.

About NurExone

NurExone is a TSX Venture Exchange (“TSXV”), OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve damage. Regulatory milestones, including obtaining the Orphan Drug Designation from the U.S. FDA and European EMA, facilitate the Company’s roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company aims to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy.

For additional information and a brief interview, please watch Who is NurExone?, visit www.nurexone.com or follow NurExone on LinkedIn, X (formerly Twitter), Facebook, or YouTube.

For more information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com

Russo Partners LLC
Investor and Media Relations – United States
215 Park Ave S, Suite 1905
New York, NY 10003
Phone: 212-845-4200
Email: nurexone@russopartnersllc.com

Dr. Eva Reuter
Investor Relations – Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu

FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements are based on expectations, estimates and projections as of the date of this press release and are generally identifiable by words such as “may,” “will,” “could,” “should,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “continue,” “advance” and similar expressions.

Forward-looking statements in this press release include statements concerning: the potential scalability, repeatability and consistency of the Company’s modular exosome manufacturing approach; the potential to expand manufacturing capacity by operating additional standardized production units in parallel; the potential technical, timing, capital and risk-management benefits of that approach; the Company’s plans to validate, develop and expand its manufacturing capabilities through Exo-Top and with third-party collaborators, including Made Scientific; the ability of the Company’s manufacturing capabilities to support its internal therapeutic pipeline and potential business-to-business supply opportunities; future demand for naïve exosomes; the continued development of ExoPTEN for acute spinal cord injury and optic nerve damage; and the Company’s broader development, regulatory, clinical and commercialization plans for exosome-based therapies, exosome products and targeted delivery systems.

These forward-looking statements are based on material assumptions including that: the reported production-run data and the Company’s interpretation of those data are accurate and complete; the parallel production results can be reproduced in additional runs and at greater scale; the selected analytical results are appropriate indicators of product comparability; the Company will be able to validate its processes and meet applicable quality, regulatory and manufacturing standards; additional bioreactors, facilities, materials, personnel, funding and collaborators will be available on acceptable terms; arrangements with Made Scientific and other counterparties will progress as contemplated; demand for naïve exosomes and related services will develop; and the Company will be able to advance ExoPTEN and its other programs as currently contemplated.

Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results to differ materially, including: the preliminary and limited nature of the reported production results; the risk that the results will not be reproduced in additional runs or at larger scale; variability inherent in biological manufacturing; the risk that parallel production will not result in consistent quality attributes, regulatory acceptance, lower costs, shorter timelines or reduced operational risk; equipment, contamination, process-failure, supply-chain, facility, personnel and quality-control risks; the need for further process development, validation and technology transfer; the inability to secure sufficient financing, materials, personnel, facilities or collaborators; delays, changes or termination affecting arrangements with Made Scientific or other counterparties; the absence of commercial orders or sufficient market demand; competition and technological change; regulatory, clinical-development, intellectual-property and commercialization risks; and the risks discussed under the heading “Risk Factors” on pages 44 to 51 of the Company’s annual information form dated August 27, 2024 and other continuous disclosure documents available under the Company’s SEDAR+ profile, copies of which are available under the Company’s SEDAR+ profile at www.sedarplus.ca.

The production results described in this press release do not establish commercial-scale manufacturing capability or regulatory compliance and should not be interpreted as demonstrating that the Company can manufacture products consistently at commercial scale. ExoPTEN is an investigational product candidate, has not been approved for commercial use or for the treatment of any condition by any regulatory authority, and its safety and efficacy in humans have not been established. Although the Company believes that the expectations and assumptions reflected in the forward-looking statements are reasonable, there can be no assurance that the anticipated activities, benefits, demand or results will occur or be achieved. Readers should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date of this press release, and the Company disclaims any obligation to update or revise them except as required by applicable law.

Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

ⁱ Particle concentration (particles/mL) needed to reduce IL-6, an inflammatory signaling protein, by 50%. Lower concentrations indicate greater potency. The results are reported as thresholds, not exact values.

MANITOWOC, Wis., Oct. 22, 2026 (GLOBE NEWSWIRE) — Orion Energy Systems, Inc. (NASDAQ: OESX) (Orion Lighting), a provider of energy-efficient LED lighting, electrical vehicle charging station, and maintenance services solutions, will host a conference call and webcast to review its fiscal 2027 second quarter results on Thursday, November 5, 2026, at 10:00 a.m. ET. Orion will release its results prior to the market’s opening that morning.

Webcast and Call Details
Date / Time: Thursday, November 5, 2026, at 10:00 a.m. ET
Live Call Registration: https://register-conf.media-server.com/register/BId664f6fcc4d548fabdfb92d50077908e
Live call participants must pre-register using the URL above to receive the dial-in information. Anyone can re-register if they lose the dial-in or PIN #.
Webcast & Replay: https://register-conf.media-server.com/register/BId664f6fcc4d548fabdfb92d50077908e

About Orion Energy Systems (at www.orionlighting.com)
Orion provides energy efficient LED lighting and controls, electrical vehicle (EV) charging solutions, and electrical maintenance services. Orion specializes in turnkey design-through-installation solutions for large national customers as well as projects through ESCO and distribution partners. Orion is committed to helping customers achieve their business, financial and environmental goals with high quality, innovative and safe solutions delivered with high levels of customer service and reliability.

Engage with Us
X: @OrionLighting and @OrionLightingIR
StockTwits: @OESX_IR

Investor Relations Contacts
Per Brodin, CFO	Robert Ferri
Orion Energy Systems, Inc.	Robert Ferri Partners
pbrodin@oesx.com	(415) 575-1589 robert.ferri@robertferri.com

ENGLEWOOD, Colo., Oct. 22, 2026 (GLOBE NEWSWIRE) — Gevo, Inc. (NASDAQ: GEVO) today provided a business update announcing strong growth of its carbon business and its anticipated delivery of over $50 million in revenue for 2026 from the carbon business and independent of U.S. federal government incentives such as the Section 45Z Clean Fuel Production Credit. The planned expansion of Gevo North Dakota (GND), expected to occur in 2028, could approximately double revenues from the carbon business and the other revenue streams from GND.

“I believe we’ve cracked the code for low-carbon fuels that drop into existing infrastructure while creating value from the carbon attributes beyond the fuel itself,” said Gevo Chief Executive Officer Paul Bloom. “For years, we’ve been building toward this moment. We are getting value from every component of our business – the fuel, the protein and the oil coproducts, and now, the carbon.”

During the third quarter, Gevo monetized environmental attributes through compliance and voluntary carbon markets, including the sale of banked Canadian Clean Fuel Regulation (CFR) credits generated from qualifying low-carbon ethanol volumes. The CFR credit transactions unlocked approximately $20 million of revenue from previously delivered volumes. Not including the previously banked CFR credits, the carbon business is expected to contribute $30 million of revenue annually based on current production rates and market conditions. Taken together, Gevo’s carbon business alone is expected to deliver over $50 million of revenue in 2026.

“Carbon has real value in the marketplace independent of the Section 45Z tax credit incentives,” said Bloom. “We are generating strong earnings through participation in compliance and voluntary carbon markets today and believe that the opportunity can grow significantly as we expand our production platform.”

Business Highlights

• Approximately $20 million of revenue was unlocked during the third quarter of 2026 through the sale of essentially all banked CFR credits that were generated in 2025 and the first half of 2026
• Going forward, the carbon business is expected to contribute $30 million annually towards revenue based on current production rates and market conditions, which would expand as the business grows
• This growth in the carbon business is expected to be a significant contributor to third quarter and 2026 financial results as it is expected to deliver over $50 million of revenue in 2026
• Continued growth of the carbon business includes growth in voluntary carbon markets such as the spot and multi-year deals with leading carbon market intermediaries including ClimeFi and CEEZER
• In addition to the revenues from the carbon business, Gevo sold $70 million worth of Section 45Z tax credits for 2026, which is substantially all of the Section 45Z tax credits expected to be produced from our renewable natural gas (RNG) and low-carbon ethanol in 2026
• Debottlenecking to increase GND ethanol capacity and carbon capture by 10-15% is on track to be completed and commissioned ahead of schedule in the fourth quarter of 2026 and deliver increases for the full year 2027
• GND expansion initiative to approximately double capacity is anticipated to reach final investment decision (FID) in the fourth quarter of 2026, with expected completion in 2028

Gevo expects the planned expansion of GND to increase ethanol production to 150 million gallons per year and to allow the capture and permanent storage of over 400,000 tons per year of carbon dioxide. Subject to completion and performance of the expansion, applicable market conditions and the availability of pathways to monetize carbon attributes, Gevo believes the revenue from fuels, coproducts and carbon business could approximately double as the expansion comes online.

Low-carbon ethanol is also a prerequisite for alcohol-to-jet sustainable aviation fuel (SAF) production. The planned GND expansion would increase the volume of low-carbon ethanol to meet increasing demand in low-carbon fuel markets and provide additional feedstock for anticipated future SAF production while expanding the carbon business from both initiatives.

“We are building a carbon and low-carbon fuels platform that can extend across ethanol, SAF, renewable hydrocarbons, racing fuels and chemicals, ” Bloom continued. “Our objective is to maximize the value of every product and every carbon attribute we generate and put Gevo in a position of financial strength in order to help finance our growth and deliver returns to shareholders.”

About Gevo North Dakota’s Carbon Project

At Gevo North Dakota, carbon dioxide (CO₂) from fermentation is stored more than a mile beneath the plant, with permanence exceeding 1,000 years and no pipeline needed. Each stored ton can generate a carbon dioxide removal (CDR) credit, which companies buy to offset emissions. According to CDR.fyi, across the CDR market, only about 3% of roughly 50 million contracted tons has been delivered. Gevo is among those delivering CDR credits, serving customers such as Nasdaq and Whirlpool. Amgen and PayPal appear on its registry as well through purchases from intermediaries.

About Gevo

Gevo is a next-generation diversified energy company committed to fueling America’s future with cost-effective, drop-in fuels that contribute to energy security, abate carbon, and strengthen rural communities to drive economic growth. Gevo’s innovative technology can be used to make a variety of renewable products, including sustainable aviation fuel (SAF), motor fuels, chemicals, and other materials that provide U.S.-made solutions. Gevo’s business model includes developing, financing, and operating production facilities that create jobs and revitalize communities. Gevo owns and operates an ethanol plant with an adjacent carbon capture and storage (CCS) facility and Class VI carbon-storage well. Gevo also owns and operates one of the largest dairy-based renewable natural gas (RNG) facilities in the United States, turning by-products into clean, reliable energy. Additionally, Gevo developed the world’s first production facility for specialty alcohol-to-jet (ATJ) fuels and chemicals operating since 2012. Gevo is currently developing the world’s first large-scale ATJ facility to be co-located at our North Dakota site. Gevo’s market-driven “pay-for-performance” approach regarding carbon and other sustainability attributes helps deliver value to our local economies. Through its Verity subsidiary, Gevo provides transparency, accountability, and efficiency in tracking, measuring, and verifying various attributes throughout the supply chain. By strengthening rural economies, Gevo is working to secure a self-sufficient future and to make sure value is brought to the market.

For more information, please visit www.gevo.com.

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to a variety of matters, including, without limitation, anticipated levels of revenue from Gevo’s carbon business; the timing, completion and expected effects of the planned Gevo North Dakota expansion; the potential growth of Gevo’s carbon business; future carbon market opportunities; and the Company’s strategy, financial position and growth plans, and other statements that are not purely statements of historical fact. These forward-looking statements are made based on the current beliefs, expectations and assumptions of the management of Gevo and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Gevo undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Gevo believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Gevo in general, see the risk disclosures in our most recent Annual Report on Form 10-K and in subsequent reports on Forms 10-Q and 8-K and other filings made with the U.S. Securities and Exchange Commission by Gevo.

Media Contact
Communications@gevo.com

IR Contact
IR@Gevo.com

Seasoned executive brings global leadership experience to advance EagleBank’s people strategy and support long-term growth

BETHESDA, Md., Oct. 22, 2026 (GLOBE NEWSWIRE) — EagleBank (NASDAQ: EGBN), one of the largest community banks in the Washington, D.C. region, today announced the appointment of Corey S. Muñoz, Ph.D., as Executive Vice President and Chief People Officer, effective November 16, 2026.

Muñoz will join EagleBank’s executive leadership team and report directly to Chief Executive Officer and President Stephen Curley. He will shape the people strategy and develop the leadership and organizational capabilities needed to advance the Bank’s strategic plan and support sustainable growth.

“EagleBank’s continued success will be shaped by our ability to attract, develop and retain exceptional people,” said Stephen Curley, President and Chief Executive Officer of Eagle Bancorp and EagleBank. “Corey brings deep experience transforming complex organizations, strengthening leadership pipelines and aligning talent strategy with business priorities. His appointment reinforces our commitment to developing the leadership and capabilities that will support our growth and advance our strategic plan.”

“EagleBank has built a strong franchise and distinctive culture through its people, customer relationships and commitment to the communities it serves,” said Muñoz. “I look forward to building on that foundation by developing talent, creating opportunities for employees and supporting the Bank’s long-term success.”

Executive Background

Most recently, Muñoz served as Global Vice President, People & Organization at Mars, Incorporated, where he led talent development strategies serving more than 140,000 associates across 80-plus countries and expanded organizational capabilities through technology and AI-enabled learning systems.

Previously, he was Partner, People & Culture at KPMG, leading talent management, employee engagement, leadership development and organizational transformation. As the New Jersey Office Managing Partner, he also oversaw operations and employee engagement for approximately 2,200 professionals.

Earlier, Muñoz was Vice President of Human Resources for Corporate Offices and Wholesale Banking at TD Bank Group, directing talent strategy, leadership development and succession planning across Risk, Finance, Legal and Wholesale Banking. He also held senior human resources and leadership development roles at BAE Systems.

Muñoz holds a Ph.D. in Industrial/Organizational Psychology and an M.S. in Psychology from the University of Georgia, a B.A. in Psychology from Oklahoma State University and an Executive Coaching Certification from Columbia University.

EagleBank Contact
Vikki Kayne
Chief Marketing Officer
301.986.1800

About Eagle Bancorp, Inc. and EagleBank
Eagle Bancorp, Inc. is the holding company for EagleBank, which commenced operations in 1998. EagleBank is headquartered in Bethesda, Maryland, and conducts full service commercial banking through 12 offices, located in Suburban, Maryland, Washington, D.C. and Northern Virginia. EagleBank focuses on building relationships with businesses, professionals and individuals in its marketplace.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/51ce95d2-c9f7-41b3-aa9d-75c0311607fe

MCLEAN, Va., Oct. 22, 2026 (GLOBE NEWSWIRE) — Cycurion, Inc. (NASDAQ: CYCU) (“Cycurion” or the “Company”), a leading AI-driven, tech-enabled cybersecurity solutions provider, today announced that it will host an earnings conference call on Monday, November 16, 2026, to discuss financial results for the third quarter ended September 30, 2026.

Management will review third quarter results and the Company’s recent operational and strategic progress, including growth in its public safety and cybersecurity platforms, key contract wins, and the path toward improved financial performance.

Conference Call Details

• Date: Monday, November 16, 2026
• Time: 9:30 AM ET
• Format: Prepared remarks by management, followed by responses to pre-submitted written questions.

The Company will not accept live oral questions on the call. Investors and other interested parties may submit questions in writing to investors@cycurion.com no later than Friday, November 13, 2026 at 5:00 p.m. Eastern Time. Management will address selected written questions during the call.

Dial-in and webcast information will be provided in a subsequent release and posted on the Company’s investor relations page.

“We are extremely pleased to host this earnings call and to open a more regular dialogue with our shareholders,” said L. Kevin Kelly, Chairman and Chief Executive Officer. “This is an important milestone as we continue to scale the business, advance our predictive cybersecurity platform, and execute on the contracts and acquisitions that are expanding our revenue base and public safety footprint. We look forward to sharing our progress and responding to questions submitted in writing.”

The Company intends to issue its third-quarter financial results prior to the call. A replay and transcript will be made available following the event.

About Cycurion, Inc. 

Based in McLean, Virginia, Cycurion (NASDAQ: CYCU) is a forward-thinking provider of IT cybersecurity solutions and AI, committed to delivering secure, reliable, and innovative services to clients worldwide. Specializing in cybersecurity, program management, and business continuity, Cycurion harnesses its AI-enhanced ARx platform and expert team to empower clients and safeguard their operations. Along with its subsidiaries, Axxum Technologies LLC, Cloudburst Security LLC, and Cycurion Innovation, Inc., Cycurion serves government, healthcare, and corporate clients committed to securing the digital future. For more information, visit www.cycurion.com. 

Certain statements in this press release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Such statements include, but are not limited to, statements regarding the acceleration of the Company’s inorganic growth strategy through potential acquisitions and strategic transactions; the continued execution of the Company’s contracted backlog; the timing, amount and likelihood of realizing revenues associated with our contracted backlog; and other statements that are not historical facts, including statements which may be accompanied by words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions intended to identify such forward-looking statements. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Cycurion and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to, risks related to customer performance and satisfaction, contract modifications, delays or terminations, and the Company’s ability to fulfill contractual obligations, the outcomes of the Company’s investigations, any potential legal proceedings, or the future performance of the Company’s stock. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K filed by Cycurion with the U.S. Securities and Exchange Commission. Cycurion anticipates that subsequent events and developments may cause its plans, intentions, and expectations to change. Cycurion assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as expressly required by law. Forward-looking statements speak only as of the date they are made and should not be relied upon as representing Cycurion’s plans and expectations as of any subsequent date. 

Cycurion Investor Relations: 
(888) 341-6680 
investors@cycurion.com 

Cycurion Media Relations: 
(888) 341-6680 
media@cycurion.com 

Quantum X Labs’ QEC decoder delivers 12–13% fewer logical errors on NVIDIA CUDA-Q using Google hardware data; LayerQake reduces maximum cumulative error 15- to 21-fold and measurement bias to below 6% across three IBM quantum processors

TEL AVIV, Israel, Oct. 22, 2026 (GLOBE NEWSWIRE) — Gix Internet Ltd. (Nasdaq: GIXI; TASE: GIX) (“Gix” or the “Company”), a dual-listed technology company, today announced two recent technology milestones reported by Quantum X Labs Inc. (“Quantum X Labs” or “QXL”), in which Gix holds approximately 13% (2,818,585 shares).

Quantum X Labs announced that its quantum error-correction (QEC) decoder is now deployed and running on NVIDIA CUDA-Q, the open platform for hybrid quantum-classical supercomputing. Leveraging the CUDA-Q QEC library, the decoder made 12–13% fewer logical errors than the platform’s standard matching decoder (PyMatching) on Google’s publicly released quantum hardware data. In tests on Google’s public surface-code dataset (10,000 held-out runs of five error-correction rounds at code distances 3 and 5), the QXL decoder made 12.7% fewer logical errors than PyMatching at distance 3 and 12.1% fewer at distance 5. In a separate 25-round streaming evaluation designed to receive error data round by round, the streaming decoder achieved an observed logical error rate approximately 6% lower than PyMatching at distance 3 and 9% lower at distance 5. “This milestone demonstrates that QXL’s decoder technology can operate within a leading quantum computing software environment and deliver encouraging results on real experimental data,” said Prof. Nir Sharon, Chief Scientist of Quantum X Labs. Quantum X Labs plans, as a next step, to run the decoder in a real-time QEC pipeline on a system utilizing an NVIDIA NVQLink connection.

In addition, Quantum X Labs’ quantum cybersecurity operation, QuantumQ Security, reported the experimental validation of its LayerQake technology on three operational IBM quantum processors: ibm_fez, ibm_kingston and ibm_marrakesh. In a pre-registered, reproducible test that met both of QXL’s predefined success criteria on all three processors, LayerQake reduced measurement bias from approximately 11% to 15% to below 6% on each of the three processors and demonstrated a 15- to 21-fold reduction in maximum cumulative error. These improvements were achieved using LayerQake’s problem-independent calibration approach, which is designed to mitigate hardware-induced inaccuracies without requiring a calibration methodology tailored to each individual computational problem.

Gix Internet holds a minority interest in QXL and does not control QXL’s business, operations or strategy, and there can be no assurance that any technological or commercial progress by QXL will result in any benefit to Gix Internet or its shareholders. Gix has not independently verified the technical test results reported by QXL.

About Quantum X Labs Inc.

Quantum X Labs Inc. and its subsidiaries are focused on quantum technology, digital advertising and computing and enterprise artificial intelligence (AI) solutions. Quantum X Labs Ltd. is focused on developing and promoting quantum algorithms for the transportation, drug discovery and security segments as well as developing quantum- based GPS replacement and quantum atom accuracy solutions. Gix Media develops a variety of technological software solutions, which perform automation, optimization and monetization of internet campaigns, for the purposes of acquiring and routing internet user traffic to its customers. Metagramm is a developer of grammatical error correction software and offers tools for writing and reviewing, grammar, spelling, punctuation and style features, as well as translation and multilingual dictionaries, using artificial intelligence and machine learning technology.

For more information about Quantum X Labs, visit https://quantumxlabs.xyz/

About Gix Internet Ltd.

Gix Internet Ltd. is a technology company that is listed on the Nasdaq Capital Market under the symbol GIXI and on the Tel Aviv Stock Exchange under the symbol GIX. Its operating focus is deliverz.ai, a wholly-owned company that develops an AI-powered management and orchestration layer for robots, people and autonomous systems, commercially proven today in hospital logistics. The platform combines management software with autonomous mobile robots and human couriers to schedule and assign internal deliveries in real time – by location, priority and availability – from a central operations system. It is built for last-mile movement inside complex, high-traffic facilities such as hospitals, is in commercial use at Sheba Medical Center, and is being introduced to U.S. healthcare organizations. Gix’s broader strategy is to extend the same management architecture to additional autonomous systems and complex physical operating environments. Gix also holds a strategic minority stake in Quantum X Labs Inc., a separately listed company. For more information, visit https://www.gix-internet.com/.

About deliverz.ai

deliverz.ai is defining the future of healthcare logistics automation with an end-to-end, AI-powered orchestration platform that unifies autonomous robots, human transport teams, and hospital workflows into a single intelligent system. Robot-agnostic and built to scale, deliverz.ai automates and optimizes logistics across any workflow and within any environment, increasing throughput, reducing costs, and improving both patient and staff experience. Delivered through a flexible Software as a Service (SaaS) and Robotics as a Service (RaaS) model, deliverz.ai provides the intelligent logistics backbone for hospitals, making operations smarter, faster, and patient-centered. For more information, visit https://www.deliverz.ai

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Gix’s strategic and business plans, technology, relationships, objectives and expectations for its business, growth, the impact of trends on and interest in its business, intellectual property, products and its future results, operations and financial performance and condition and may be identified by the use of words such as “may,” “seek,” “will,” “consider,” “likely,” “assume,” “estimate,” “expect,” “anticipate,” “intend,” “believe,” “do not believe,” “aim,” “predict,” “plan,” “project,” “continue,” “potential,” “guidance,” “objective,” “outlook,” “trends,” “future,” “could,” “would,” “should,” “target,” “on track” or their negatives or variations, and similar terminology and words of similar import, generally involve future or forward-looking statements. For example, the Company is using forward-looking statements when it discusses QXL’s plans to run its QEC decoder in a real-time QEC pipeline on a system utilizing an NVIDIA NVQLink connection; the potential of QXL’s QEC decoder and LayerQake technologies to reduce logical errors, measurement bias and cumulative errors and improve the reliability of quantum computing results; and the further development, validation and potential commercialization of QXL’s quantum computing and quantum cybersecurity technologies. The reported test results may not be replicated in further testing or in other environments, and there can be no assurance that QXL’s QEC decoder or LayerQake technologies will be successfully developed, validated or commercialized. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s registration statement on Form 20-F (File No. 001-43362), as amended, as filed with the SEC on June 18, 2026, and in subsequent filings with the SEC. For a description of risks affecting QXL, reference is made to QXL’s filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Gix is not responsible for the content of third-party websites. IBM, IBM Quantum and the names of IBM quantum processors are trademarks of International Business Machines Corporation; IBM is not affiliated with, and has not endorsed, Gix, QXL or the results described in this press release.

Investor Relations Contact:
Michal Efraty
Investor Relations
michal@efraty.com

More than half of U.S. business leaders reported increased scam and authorized fraud activity over the past year as fraudsters use AI to scale attacks and exploit trusted relationships

CHICAGO, Oct. 22, 2026 (GLOBE NEWSWIRE) — New findings from TransUnion’s (NYSE: TRU) latest global Top Fraud Trends Report show that fraudsters are increasingly exploiting the trust associated with legitimate identities and brands rather than creating fake ones. As the threat evolves, organizations face growing financial consequences, with business leaders estimating fraud losses equivalent to nearly 7% of annual revenue in the past year. Meanwhile, advances in AI and automation are helping criminals open fraudulent accounts, infiltrate existing ones and undermine customer relationships at greater scale.

TransUnion’s report, Fraud in the Age of Continuous Trust, found that 81% of suspected digital fraud globally in H1 2026 occurred during interactions with existing customers, as fraudsters exploit trusted relationships and established accounts.

“As fraudsters increasingly exploit trusted relationships beyond onboarding, organizations need to move to a more connected understanding of trust,” said Brian Killeen, vice president of global identity solutions at TransUnion.” Harnessing intelligence across the customer lifecycle and applying context to each interaction is critical to identifying emerging threats and enabling trusted interactions.”

Additional findings from the report indicate trust is being manipulated at scale through existing communication channels. Nearly one in five outbound business-to-consumer calls with U.S. mobile carriers was spoofed in the first half of 2026, demonstrating how fraudsters can exploit phone network vulnerabilities to impersonate trusted organizations and enable account takeover and payment fraud. Similarly, six in 10 business leaders indicated their customers were victimized by text spoofing in the last year, further illustrating the widespread exploitation of trusted communication channels.

Together, these findings demonstrate how fraudsters increasingly operate outside the enterprise, using communication channels such as phone calls and text messages to manipulate consumers directly on their devices. These scams are often designed to convince victims to open new accounts or grant access to existing ones, fueling a growing wave of scam and authorized fraud, with 35% of U.S. business leaders identifying it as the
leading source of fraud losses.

Scam/Authorized Fraud Was Cited as the Leading Source of Fraud Losses in the U.S. and Worldwide
Business leaders citing these fraud types as their organization’s largest source of losses in the past year

	Account Takeover Fraud	First-Party Fraud	Scam/Authorized Fraud	Synthetic Identity Fraud	Third-Party Fraud
U.S.	16%	18%	35%	18%	9%
Global	17%	15%	29%	18%	17%

Source: TransUnion business fraud survey, June 2026

The study also examined where fraud occurs across the customer lifecycle and how risks differ by industry. Key findings include:

• Retail: Account creation risk is especially high due to promotion abuse, as customers often need accounts to access discounts. At the same time, retailers typically use lower-friction identity verification to remain competitive.
• Financial Services: While account creation presents immediate risk of fraud, transaction related activities pose even greater risk. This underscores the importance of connecting identity, behavioral and transactional intelligence to identify emerging threats throughout the customer relationship
• Gaming (online gambling and betting): Fraud risk remains high throughout the customer lifecycle. While strong identity verification helps reduce some threats, fraudsters still target new accounts for bonus abuse, with additional risks emerging during account logins and transactions.

“Fraud risk is shaped by context. Across industries, these findings show how threats evolve throughout the customer journey, revealing where organizations are most exposed and why effective fraud prevention must adapt to the specific interaction and threat,” said Clint Lowry, vice president of global fraud strategy at TransUnion.

AI is Accelerating Fraud, Demanding Faster, More Adaptive Defenses

The report also shows that fraud is becoming more adaptive and harder to contain. AI has fundamentally changed the economics of fraud by automating activities that once required significant human effort, including creating identities, generating content and targeting victims. This allows fraudsters to accelerate and scale their attacks faster than organizations can adapt their detection capabilities and mitigation strategies.

Forty three percent of U.S. business leaders said the growing scale and sophistication of fraud is placing significant or severe pressure on their organizations. Synthetic identity fraud is a key concern, with 67% expecting it to increase over the next two years and 53% citing it as the threat they are least prepared to address.

In the U.S., 51% of business leaders reported increased scam and authorized fraud activity over the past year. U.S. lenders face an estimated $2.4 billion in exposure tied to synthetic identities as of June 30, 2026.

Killeen added, “AI is accelerating the pace at which fraudsters develop, scale and adapt their attacks. To keep pace, organizations must shorten the time between detecting emerging threats, learning from them and adapting their defenses, turning intelligence into action before vulnerabilities can be exploited.”

To learn more about the findings in Fraud in the Age of Continuous Trust, click here.

To learn more about how TransUnion Fraud Solutions help organizations identify emerging fraud earlier, strengthen digital trust and protect customer relationships while maintaining friction-right experiences, click here.

About TransUnion (NYSE: TRU)

TransUnion is a global information and insights company with over 13,000 associates operating in more than 30 countries. We make trust possible by ensuring each person is reliably represented in the marketplace. We do this with a Tru™ picture of each person: an actionable view of consumers, stewarded with care. Through our acquisitions and technology investments, we have developed innovative solutions that extend beyond our strong foundation in core credit into areas such as marketing, fraud, risk and advanced analytics. As a result, consumers and businesses can transact with confidence and achieve great things. We call this Information for Good® — and it leads to economic opportunity, great experiences and personal empowerment for millions of people around the world.

http://www.transunion.com/business

Contact	Dave Blumberg TransUnion
E-mail	david.blumberg@transunion.com
Telephone	312-972-6646

As frontier AI vendors and hyperscalers raise prices, retire models and step back from group AI, Convaa.ai^™ gives CIOs, CISOs and CFOs an IT-controlled path to put entire workforces — and their partners — on AI. Acquisition activity in Israel and Silicon Valley underscores the value of enterprise footprint and data security.

RESEARCH TRIANGLE PARK, N.C., Oct. 22, 2026 (GLOBE NEWSWIRE) — Data443 Risk Mitigation, Inc. (OTCPK: ATDS) (“Data443” or the “Company”), a data security and privacy software company for “All Things Data Security,” today announced Convaa.ai^™, its enterprise AI collaboration platform for regulated organizations that want their entire workforce — and the partners, suppliers and customers they work with — productive on AI without handing company data, budgets or model choices to a single outside vendor.

Convaa.ai^™ is built around people. Employees and outside participants work with AI together, live, in one environment. Protection of the organization’s data is part of the foundation, not an add-on: the business decides who participates, which models are used, and what data those models can reach.

Who Convaa.ai^™ is built for

• Regulated mid-size and large enterprises — financial services, healthcare, legal, defense and government contractors, and manufacturing, typically with 1,000 to 25,000 employees.
• Work that crosses company lines — organizations that work every day with partners, suppliers, outside counsel, auditors and customers.
• Compute already owned — enterprises with on-premises or private-cloud infrastructure, including GPU capacity that sits largely idle.
• Buyers — CIOs, CISOs and CFOs, with IT operations and AI leaders as day-to-day owners.
• The problems they bring — shadow AI, per-seat AI costs that grow with headcount, company data leaving the building, overlapping chat, meeting and AI tools, and dependence on a single model vendor.

What Convaa.ai^™ does

• Live, multi-person AI sessions — several people prompt, review and refine AI work in the same session, in real time.
• Multi-company by design — employees and people from other organizations work together, with each participant’s access governed by the host company’s policy.
• Models of different kinds — commercial and open-source models side by side, chosen by the business rather than by a single AI vendor.
• Local inference, GPUs used sparingly — designed to run on infrastructure the enterprise already owns, drawing on GPU capacity only where a workload requires it.
• Tailored model training, built in — organizations can train and tailor language models on their own data without sending that data to a third party.
• IT-controlled end to end — deployment, users, models, data access and retention are administered by the enterprise’s own IT operations.

Where Convaa.ai^™ challenges frontier AI vendors and hyperscalers

• Cost tied to compute already owned, not to headcount. Microsoft raised list prices for its Microsoft 365 commercial suites effective July 1, 2026, citing added AI capabilities, and lists Microsoft 365 Copilot as a $30 per user per month add-on, paid yearly. A 2026 Cast AI report on Kubernetes environments put average GPU utilization at 5%. Convaa.ai^™ is designed to put compute the enterprise already owns to work, so AI use can expand on capacity the business has already paid for.
• Data stays under the enterprise’s control. When AI runs on a provider’s servers, the provider — and the legal obligations it faces — can determine what is kept. In May 2025, a federal court in The New York Times Co. v. Microsoft Corp. et al. ordered OpenAI to preserve ChatGPT output logs, including data OpenAI had committed to delete. Convaa.ai^™ runs in-house, with retention set by the enterprise’s own IT.
• The business chooses the models — and keeps the capability. Vendors set model life cycles: in February 2026, OpenAI retired GPT-4o, GPT-4.1, GPT-4.1 mini and o4-mini from ChatGPT. Gartner predicts that by 2028, 70% of enterprises will abandon agentic AI built by vendor forward-deployed engineering, “trapped by soaring costs and unable to evolve it on their own.” Convaa.ai^™ runs commercial and open-source models side by side and builds model training into the product, so the capability stays inside the business.
• People work with AI together. In July 2026, OpenAI stopped allowing new group chats in ChatGPT, and in August 2026, Microsoft removed Group Chats from its consumer Copilot app. Live sessions with many people, across companies, are the core function of Convaa.ai^™. Data443 is not aware of any commercial or open-source platform that combines live, multi-organization collaboration with AI models of different kinds under the full control of a business’s own IT operations.

M&A is driving the market

Much of the market’s interest in enterprise AI and data security is being driven by acquisitions, and the most active corridor runs between Israel and Silicon Valley. Acquirers are paying for an established enterprise footprint and trusted control of sensitive data.

• Israel. In October 2026, Proofpoint agreed to acquire Varonis — an Israeli-founded data security company and a direct competitor of Data443 — for approximately $6.3 billion. Google completed its $32 billion acquisition of Wiz in March 2026, and Palo Alto Networks completed its acquisition of CyberArk in February 2026. ServiceNow agreed in December 2025 to acquire Armis for $7.75 billion, and in July 2026 Cyera agreed to acquire Oasis Security, which secures AI agents and other machine identities, in a deal reported at $1 billion. Israeli cyber exits reached approximately $72.6 billion in 2025, including signed deals, according to Cybertech Global and IVC.
• Silicon Valley. Veeam’s $1.725 billion acquisition of Securiti AI, a data security, privacy and AI governance company, closed in December 2025. Like Data443, Securiti came up through the RSA Conference startup programs: Data443’s ClassiDocs was selected for the 2018 RSA Conference Early Stage Expo, and Securiti won the RSA Conference Innovation Sandbox in 2020. In October 2026, Anthropic agreed to license technology from and bring on team members of Opaque, a confidential computing and AI company that has been developing standards for sovereign and on-premises AI deployments. Acquirers spent at least $119.8 billion on U.S. venture-backed companies through late June 2026, putting the year on pace for a record, according to Crunchbase.

Data443 believes the greenfield opportunity — enterprise workforces not yet onboarded to AI under IT control — will remain open for some time, and that companies with an established enterprise footprint are best positioned to capture it, both in winning customers and in acquisitions. Convaa.ai^™ is built on the same data classification, discovery and policy foundation the Company has shipped to enterprise and government customers for nearly a decade. Data443 serves more than 10,000 customers in over 100 countries and has expanded that foundation through asset acquisitions including Cyren, ArcMail, FileFacets and TacitRed.

Video and audio

Video and audio capabilities are expected to be released shortly. Because the work in Convaa.ai^™ is collaborative from the start, those capabilities are designed to remove the need for separate chat and meeting tools such as Microsoft Teams, Slack and Webex — keeping conversations, meetings and AI work in one environment the enterprise controls.

Availability

Convaa.ai^™ is available today at https://convaa.ai. Enterprises seeking to deploy Convaa.ai^™ on their own infrastructure can find information at https://data443.com.

“Every enterprise wants its people on AI, and the frontier vendors and hyperscalers sell it one seat at a time, on their servers, on their model schedule,” said Jason Remillard, Chief Executive Officer and Founder of Data443. “Prices are rising, models get retired on the vendor’s timeline, and the largest providers have stepped back from people working with AI together. Convaa.ai^™ runs in-house, on compute you already own, with the models you choose — your employees, partners and customers in the same session. The deal activity in Israel and the Valley shows where the value sits: enterprise footprint and trusted control of data. That is the foundation Data443 has built for a decade, and it positions us to compete for customers and in consolidation.”

About Data443 Risk Mitigation, Inc.

Data443 Risk Mitigation, Inc. (OTCPK: ATDS) provides software and services to enable secure data across devices and databases, both at rest and in transit, locally, on a network, or in the cloud. We are All Things Data Security^™. With over 10,000 customers in more than 100 countries, Data443 offers a modern approach to data governance and security by identifying and protecting all sensitive data, regardless of location, platform, or format. Data443’s framework helps customers prioritize risk, identify security gaps, and implement effective data protection and privacy management strategies. Data443 is headquartered in Research Triangle Park, North Carolina. For more information, visit https://data443.com.

Contacts

Investor Relations
Matthew Abenante
ir@data443.com
Follow us on LinkedIn: https://www.linkedin.com/company/data443-risk-mitigation-inc/
Sign up for our Investor Newsletter: https://data443.com/investor-email-alerts/

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements other than statements of historical fact, including statements regarding the anticipated capabilities, performance, availability, deployment, cost characteristics, customer adoption and commercial reception of Convaa.ai^™; the expected timing, capabilities and release of the video and audio features of Convaa.ai^™; the ability of Convaa.ai^™ to operate on customer-owned infrastructure, use local inference and reduce the need for other collaboration tools; trends in enterprise adoption of artificial intelligence; the competitive landscape for AI collaboration products; industry consolidation and merger and acquisition activity, and the Company’s positioning to win customers and to participate in such activity; and the Company’s plans for its artificial intelligence product portfolio. Words such as “anticipate,” “believe,” “continue,” “could,” “designed to,” “expect,” “intend,” “may,” “plan,” “potential,” “seek,” “should,” “will,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements are based on management’s current expectations and assumptions, are not guarantees of future performance, and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others: the Company’s history of losses, limited cash resources, need for additional financing and any substantial doubt about its ability to continue as a going concern; the early stage of commercial adoption of the Company’s artificial intelligence products and the possibility that Convaa.ai^™ does not achieve market acceptance; the possibility that Convaa.ai^™ does not perform as designed, including in customer-managed environments, does not deliver anticipated cost savings, or contains defects or vulnerabilities; the possibility that video and audio capabilities are delayed, changed or not released; the Company’s dependence on third-party artificial intelligence models, including commercial and open-source models, and on customer infrastructure, whose availability, performance and terms may change; the possibility that competitors, including larger and better-capitalized companies, introduce or reintroduce comparable capabilities; the possibility that third-party data, forecasts and reports cited in this press release, including reports of announced transactions, prove inaccurate, or that announced transactions are not completed; the possibility that the Company does not identify, enter into or complete any acquisition or other strategic transaction, or does so on terms that are not favorable; rapid technological change and intense competition; the evolving legal and regulatory treatment of artificial intelligence, data privacy and cybersecurity; the Company’s ability to integrate acquired assets and technologies; the Company’s ability to protect its intellectual property; cybersecurity incidents affecting the Company or its customers; the Company’s dependence on key personnel; risks relating to the limited trading market for, and volatility of, the Company’s common stock, which may be considered a “penny stock,” and potential dilution from future financings; risks relating to the Company’s pending strategic transactions, including that they may not be completed on the anticipated terms or timeline or at all; and the other risks described under “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and its subsequent Quarterly Reports on Form 10-Q and other reports filed with the Securities and Exchange Commission, available at www.sec.gov. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this press release. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

“DATA443,” “All Things Data Security” and “Convaa.ai” are trademarks of Data443 Risk Mitigation, Inc. Microsoft, Teams and Copilot are trademarks of Microsoft Corporation; OpenAI and ChatGPT are trademarks of OpenAI; Slack is a trademark of Slack Technologies, LLC; Webex is a trademark of Cisco Systems, Inc. Gartner is a registered trademark of Gartner, Inc. and/or its affiliates. All other product names, trademarks and registered trademarks are the property of their respective owners. Use of these names, trademarks and brands does not imply endorsement.

Preliminary Unaudited Third Quarter Revenue Increased 256% Sequentially to Approximately $1.22 Million, Supported by Continued Arbli^™ Growth and the Commercial Launch of REZENOPY^™

Two FDA-Approved Commercial Products Position Company for Continued Sequential Revenue Growth

High Gross Margins and Established Commercial Infrastructure Provide Operating Leverage Potential as Company Targets Profitability in 2027

COMMACK, NY, Oct. 22, 2026 (GLOBE NEWSWIRE) — SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX) (“Scienture”), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through the development, commercialization, and distribution of novel specialty products that address unmet market needs, today issued the following letter to shareholders.

Key Commercial and Financial Achievements During the First Nine Months of 2026

• 256% Sequential Revenue Growth: Reported preliminary, unaudited third-quarter 2026 revenue of approximately $1.22 million, compared to $343,639 in the second quarter, reflecting accelerating commercial momentum following the launch of the Scienture’s second commercial product.
• Successful Launch of Second FDA-Approved Product: Commercially launched REZENOPY^™ in August 2026, with initial wholesale shipments contributing to third-quarter revenue and establishing a second commercial revenue stream.
• 74% Sequential Increase in Arbli^™ Wholesale Unit Sales: Continued to drive commercial adoption and increasing wholesale demand for Arbli^™ during the third quarter of 2026.
• Expanded Institutional Adoption: Secured formulary additions for Arbli^™ at more than ten (10) leading U.S. pediatric academic medical centers, strengthening the product’s presence within important healthcare institutions.
• Expanded REZENOPY^™ Distribution: Advanced commercialization through a strategic distribution partnership focused on addiction treatment centers, broadening the product’s potential market reach.
• High Gross Margin Profile: Reported gross margins of approximately 97.7% in the second quarter of 2026, supporting the potential for meaningful operating leverage as revenue increases.
• Broad Commercial Market Access: REZENOPY^™ GPO agreements provide access to more than 5,000 healthcare facilities, with commercial payer and government access potentially reaching over 100 million covered lives, while Arbli^™ continues to expand its formulary placements and payer coverage, supporting broader adoption of both products.
• Strengthened Intellectual Property Portfolio: Secured U.S. patent protection for REZENOPY^™ extending into 2041, complementing Arbli^™ patent protection until 2041.

Dear Fellow Shareholders,

The first nine months of 2026 have marked a transformational period for Scienture as we transitioned into a multi-product commercial pharmaceutical company, accelerated revenue growth, and expanded the market presence of our two FDA-approved products. We believe these achievements have established a strong foundation for the next phase of our growth and represent meaningful progress toward our objective of achieving profitability in 2027.

Our preliminary, unaudited third-quarter 2026 revenue reached approximately $1.22 million, representing a 256% sequential increase over the second quarter. This performance was supported by continued commercial growth in Arbli^™, including a 74% sequential increase in wholesale unit sales, alongside initial wholesale shipments of REZENOPY^™ following its August 2026 commercial launch.

Importantly, we believe this momentum is only beginning to reflect the commercial potential of our expanding product portfolio. We believe the continued commercial traction of Arbli^™, combined with the early-stage commercialization of REZENOPY^™, positions us well to deliver continued sequential revenue growth as both products scale.

Over the past several quarters, we have invested in establishing the commercial infrastructure necessary to support our products, including sales resources, wholesale distribution, institutional market access, and payer relationships. As revenue increases, we believe this existing infrastructure, combined with our historically high gross margins, provides an opportunity to meaningfully improve operating performance without a proportionate increase in expenses.

Building Momentum Across Two FDA-Approved Commercial Products

Arbli^™ Continues to Expand Its Commercial Footprint

Arbli^™ (losartan potassium) Oral Suspension is the first and only FDA-approved, ready-to-use oral liquid formulation of losartan, addressing an established U.S. market representing approximately $218 million in annual sales and more than 73 million prescriptions, according to August 2026 IQVIA data.

This mature market has long been dominated by oral solid (tablet) formulations from generic manufacturers, with the original branded product (Cozaar) now largely genericized. The vast majority of prescriptions are tablets, leaving a meaningful underserved segment of patients, particularly elderly individuals, pediatric patients age six and older, and others with dysphagia or difficulty swallowing, who previously relied on inconsistent pharmacy compounding.

Arbli^™ addresses this unmet need through a standardized, FDA-approved oral liquid formulation that eliminates the variability associated with pharmacy compounding while offering flexible dosing, convenient room-temperature storage, and an approved 24-month shelf life. We believe these attributes provide meaningful advantages for physicians, patients, and healthcare institutions seeking consistent and convenient treatment options.

During the third quarter of 2026, Arbli^™ wholesale unit sales increased 74% sequentially, reflecting continued progress in expanding commercial demand. We have also secured the addition of Arbli^™ to the formularies of more than ten (10) leading U.S. pediatric academic medical centers, an important milestone in establishing the product within key institutional treatment settings.

We believe these developments provide a foundation for continued market share gains as we pursue additional formulary placements, broaden physician awareness, and expand patient access. Arbli^™ also benefits from U.S. patent protection extending into 2041, supporting its long-term commercial potential.

REZENOPY^™ Establishes a Second Revenue Growth Opportunity

The commercial launch of REZENOPY^™ (naloxone hydrochloride) Nasal Spray 10 mg in August 2026 represented another important milestone in Scienture’s evolution into a multi-product commercial pharmaceutical company.

According to IQVIA data (August 2026), the U.S. naloxone nasal spray market represents approximately $137 million in annual sales, with approximately 9 million units sold annually, has historically been led by lower-dose products, including Narcan® 4 mg, alongside other approved formulations and generic alternatives. The ongoing opioid crisis, particularly the prevalence of potent synthetic opioids such as fentanyl, continues to underscore the importance of access to opioid overdose reversal treatments.

REZENOPY^™ is the highest-dose FDA-approved naloxone nasal spray available in the United States, delivering 10 mg of naloxone in a single-use device for the emergency treatment of known or suspected opioid overdose. The product combines the established naloxone molecule and familiar nasal spray delivery method with a differentiated higher-dose formulation, providing an additional treatment option for healthcare providers and emergency responders.

Through our collaboration with Summit Biosciences, a subsidiary of Kindeva Drug Delivery, Scienture holds exclusive U.S. commercialization rights to REZENOPY^™, supporting our strategy to establish a differentiated presence in the naloxone market.

Initial wholesale shipments contributed to our third-quarter revenue growth, and we are focused on expanding distribution and adoption through our strategic commercialization relationships, including channels serving addiction treatment centers and healthcare institutions.

As REZENOPY^™ progresses beyond its initial launch phase, we believe increasing market access and product adoption can support continued revenue growth alongside Arbli^™. REZENOPY^™ also benefits from U.S. patent protection extending into 2041, supporting its long-term commercial potential.

High Gross Margins and Operating Leverage Support Our Path Toward Profitability

Beyond our commercial achievements, we view one of the most compelling aspects of Scienture’s business model as the potential for significant operating leverage as revenue scales.

We believe we have made meaningful progress in improving our financial performance and operating cost structure. During the second quarter of 2026, operating expenses decreased approximately 41% to $3.0 million, compared to $5.2 million in the prior-year period. Our operating loss improved approximately 48% to $2.7 million, compared to $5.2 million in the second quarter of 2025, while net loss narrowed approximately 58% to $2.8 million, compared to $6.7 million in the prior-year period.

Importantly, we reported gross margins of approximately 97.7% during the second quarter of 2026, demonstrating the attractive economics of our commercial product portfolio. We believe these historically high gross margins, combined with continued revenue growth and disciplined expense management, provide an opportunity to further reduce operating losses as sales scale.

We have already established much of the commercial infrastructure required to support both products, including national sales resources, wholesale distribution relationships, and institutional market access. As sales volumes increase, we believe we can leverage these existing capabilities without a proportionate increase in operating expenses.

Our focus remains on maximizing the revenue potential of the commercial platform we have built while maintaining financial discipline. We believe the combination of accelerating revenue growth, high gross margins, and an improved operating cost structure positions Scienture to make meaningful progress toward our objective of achieving profitability in 2027.

Expanding Market Access and Strengthening Our Commercial Platform

A key component of our strategy has been establishing the distribution and market access capabilities necessary to support sustained commercial growth of both Arbli^™ and REZENOPY^™.

For REZENOPY^™, group purchasing organization (“GPO”) agreements provide access to more than 5,000 healthcare facilities, while commercial payer coverage and government access through CMS have the potential to reach more than 100 million covered lives.

Arbli^™ also continues to gain commercial traction, with wholesale unit sales increasing 74% sequentially in the third quarter. We secured additional formulary placements, expanded commercial access, and built on prior GPO and payer coverage wins, including expansions reaching approximately 12.5 million additional covered lives.

Together, these developments, supported by our national sales resources and wholesale distribution capabilities, strengthen our commercial platform. We believe this infrastructure will enable us to scale revenue more efficiently, improve operating leverage, and support our goal of achieving profitability in 2027.

Competitive Advantages Position Scienture for Continued Market Share Gains

We believe Scienture is well positioned to capture market share in established pharmaceutical markets through a combination of differentiated FDA-approved products, long-term intellectual property protection, and an established commercial infrastructure.

Our competitive advantage is built on three key strengths: differentiated 505(b)(2)-style formulations that address unmet patient needs within large, established markets; U.S. patent protection extending into 2041 for Arbli^™ and REZENOPY^™; and a focused commercial platform encompassing national sales resources, GPO and payer relationships, wholesale distribution, institutional formulary access, and patient support capabilities.

Our strategy for increasing market share centers on expanding institutional and hospital formulary adoption, broadening payer coverage, strengthening physician engagement, and increasing product utilization across retail and institutional channels. We believe these initiatives will help drive continued sequential sales growth while leveraging our existing commercial infrastructure.

Importantly, both products address established markets with meaningful opportunities for penetration. Even modest market share gains within the approximately $218 million U.S. losartan market, combined with increasing adoption in the approximately $137million naloxone nasal spray market, could translate into meaningful incremental revenue. Given our historically high gross margins, we believe these opportunities can contribute significantly to improving operating performance as sales scale.

Early commercial results, including the 74% sequential increase in Arbli^™ wholesale unit sales and initial REZENOPY^™ revenue contributions, reinforce our confidence in this strategy.

Looking Ahead: Continued Revenue Growth and Profitability in 2027

As we move through the remainder of 2026 and into 2027, our priorities remain centered on accelerating revenue growth, expanding commercial adoption, and improving operating performance.

For Arbli^™, we intend to build on recent institutional formulary wins, broaden physician engagement, and increase patient access across pediatric and cardiovascular treatment settings.

For REZENOPY^™, our focus is on expanding distribution, increasing institutional and treatment-center adoption, and building upon the initial commercial revenue generated following its launch.

We believe the combination of these initiatives positions Scienture to sustain sequential revenue growth as both products continue to scale. Our historically high gross margins and established commercial infrastructure provide the potential for meaningful operating leverage as sales increase, supporting our objective of achieving profitability in 2027.

Positioned for the Next Phase of Growth

Scienture today is a fundamentally different company than it was at the beginning of 2026. We have two FDA-approved products generating commercial revenue, expanding institutional adoption, established distribution and market access capabilities, and a high-margin business model designed to benefit from increasing sales volumes.

We believe the next phase of our growth will be defined by our ability to translate these commercial achievements into sustained revenue growth, improving financial performance, and ultimately profitability.

While meaningful work remains ahead, we are encouraged by the progress we have made and confident in the opportunities before us. Our focus remains on disciplined execution, responsible capital allocation, and building a sustainable specialty pharmaceutical company capable of delivering long-term shareholder value.

We thank our shareholders for their continued confidence and support and look forward to providing additional updates as we advance our commercial and financial objectives.

Sincerely,

Narasimhan Mani
President and Co-Chief Executive Officer

Shankar Hariharan
Executive Chairman and Co-Chief Executive Officer

About Arbli^™

Arbli^™ is a novel proprietary formulation of losartan, a widely prescribed angiotensin receptor blocker (ARB) for hypertension. It is the first and only liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage. Arbli^™ is FDA-approved for the treatment of hypertension in patients greater than six years old, for reducing the risk of stroke in patients with hypertension and left ventricular hypertrophy, and for treating diabetic nephropathy in certain patients with type 2 diabetes. By offering a safe, effective, and convenient liquid alternative, Arbli^™ provides a tailored solution for patients who require or prefer a liquid formulation. As an FDA-approved product, Arbli^™ provides consistent quality and dosing accuracy, addressing the risks and inconsistencies often associated with extemporaneously compounded losartan prescriptions. Arbli^™ has two issued patents from the USPTO, which are also listed in the FDA Orangebook.

Arbli^™ is the first and only oral liquid formulation of losartan approved by the U.S. FDA. Arbli^™ comes in a 165 mL bottle as a peppermint flavored suspension that does not require refrigeration and has been approved for a shelf life of 24 months from the date of manufacture when stored at room temperature.

INDICATION

Arbli^™ is an angiotensin II receptor blocker (ARB) indicated for:

• Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
• Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy.
• Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.

IMPORTANT SAFETY INFORMATION

• Do not take Arbli^™ when pregnant. When pregnancy is detected, discontinue Arbli^™ as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Arbli^™ can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
• Do not co-administer Arbli^™ with aliskiren in patients with diabetes. Avoid use of aliskiren with Arbli^™ in patients with renal impairment (GFR <60 mL/min).
• Do not administer Arbli^™ in patients with severe hepatic impairment. Arbli^™ has not been studied in patients with severe hepatic impairment.
• The most common adverse reactions are (incidence ≥2% and greater than placebo): dizziness, upper respiratory infection, nasal congestion, and back pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Scienture at 1-833-754-4917.

Please see the full Prescribing Information for complete product information. For more information, talk to your healthcare provider.

About Hypertension

Hypertension (high blood pressure) is a cardiovascular condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher). According to the CDC, hypertension, or high blood pressure, affects nearly half of adults in the United States, or approximately 119.9 million people. Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher. Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the U.S. Factors that increase the risk of having high blood pressure include: older age, genetics, being overweight or obese, not being physically active, high-salt diet and drinking too much alcohol. Hypertension is clinically diagnosed if, when blood pressure is measured on two different days, the systolic blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood pressure readings on both days is ≥ 90 mmHg.

About REZENOPY^™

REZENOPY^™ (naloxone hydrochloride) Nasal Spray 10mg, is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. It is intended for immediate administration as emergency therapy in settings where opioids may be present.

REZENOPY^™ nasal spray is for intranasal use only and is supplied as a carton containing two (2) blister packages each with a single spray device.

IMPORTANT SAFETY INFORMATION

REZENOPY^™ (naloxone hydrochloride) Nasal Spray 10 mg is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. It is intended for immediate administration as emergency therapy in settings where opioids may be present and is not a substitute for emergency medical care.

Important Safety Information

• Contraindications: REZENOPY^™ nasal spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.
• Warnings and Precautions:
  
  • Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer additional doses as necessary while awaiting emergency medical assistance.
  • Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.
  • Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid-dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal.
  • Risk of Cardiovascular Effects: Abrupt postoperative reversal of opioid depression may result in adverse cardiovascular effects. These events have primarily occurred in patients who had pre-existing cardiovascular disorders or received other drugs that may have similar adverse cardiovascular effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.
• Adverse Reactions: The following adverse reactions were observed in a REZENOPY^™ nasal spray clinical study: upper abdominal pain, nasopharyngitis, and dysgeusia.

For complete product information, including Patient Information, please refer to the full Prescribing Information.

About Scienture Holdings, Inc.

SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), through its wholly owned subsidiary, Scienture, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Scienture, LLC is a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit: www.scientureholdings.com and www.scienture.com.

Cautionary Statements Regarding Forward-Looking Statements

This press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch, the success those products may have in the marketplace, such as Arbli^™ and REZENOPY^™, and our strategies related to those products. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Stock Market LLC; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K, as amended, and subsequent reports filed with the Securities and Exchange Commission.

Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.

Contact:

SCIENTURE HOLDINGS, INC.
20 Austin Blvd
Commack, NY 11725
Email: IR@Scienture.com

• Seasoned legal and compliance executive brings global product launch, strategic transaction and international operational experience as Candel prepares for its planned Biologics License Application (BLA) submission and potential commercialization

NEEDHAM, Mass., Oct. 22, 2026 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, today announced the appointment of Maria Ostrovsky as General Counsel, effective November 3, 2026. Ms. Ostrovsky has 20 years of legal experience, most of it in the life sciences industry. She will oversee Candel’s legal and compliance functions, including corporate governance, and report to Candel’s President and Chief Executive Officer.

Ms. Ostrovsky joins Candel at a pivotal stage in the Company’s evolution, as it advances its clinical pipeline, prepares for a planned BLA submission for aglatimagene besadenovec (aglatimagene) in intermediate- to high-risk localized prostate cancer in the fourth quarter of 2026, and builds the capabilities needed to support potential commercialization, if approved.

“Maria brings a highly relevant combination of legal, compliance, global product launch and strategic transaction experience,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. “She has supported oncology launches in the United States and globally, built a healthcare compliance program at a commercial-stage biotech, and helped guide acquisition diligence, post-merger integration and international operations. As we prepare for our planned BLA submission and potential commercialization of aglatimagene, if approved, Maria will help us build scalable legal, governance and compliance capabilities for Candel’s next stage of growth. I am delighted to welcome her to our leadership team.”

“Candel is at an inflection point, with its first planned BLA submission ahead and a pipeline spanning several difficult-to-treat cancers,” said Maria Ostrovsky. “I am excited to join the leadership team and help establish the legal and compliance foundation needed to support Candel’s continued growth, potential transition toward commercialization and mission to bring new treatment options to patients.”

Ms. Ostrovsky most recently served as Senior Vice President, General Counsel and Chief Compliance Officer at Deciphera Pharmaceuticals (Deciphera), where she led the global legal and compliance function, built the company’s healthcare compliance program, contributed to two global product launches, supported acquisition diligence and post-merger integration, and oversaw a broad range of strategic and biotechnology transactions. She also built and led a U.S.- and EU-based legal and compliance team. She joined Deciphera in 2019. Before that, she held legal and compliance roles at TESARO, Inc. and at Takeda Pharmaceutical Company Limited (formerly Millennium Pharmaceuticals), where she supported oncology product launches in the United States and globally. Earlier in her career, she was a litigation associate at Cooley LLP and Cleary Gottlieb Steen & Hamilton LLP. Ms. Ostrovsky earned a J.D. from the University of Pennsylvania Law School and a B.A. from Middlebury College.

About aglatimagene besadenovec

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several nonclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority for any use.

About Candel Therapeutics

Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. Aglatimagene besadenovec (aglatimagene) is the lead product candidate from the adenovirus platform. The Company completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the FDA and published in The Lancet Oncology. The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC.

Linoserpaturev is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma, evaluating the effects of repeat linoserpaturev injections. Initial results were published in Nature and Science Translational Medicine and linoserpaturev received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.

For more information about Candel, visit: www.candeltx.com.

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat, solid tumors; and expectations regarding the potential benefits conferred by regulatory designations. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; the timing of expected BLA submissions; that final data from the Company’s nonclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to commercialize any approved product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; the impact of the Company’s existing and any future indebtedness on its ability to operate its business; the Company’s ability to access any future tranches under its debt facility and to comply with all of its obligations thereunder; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

Investor Contact
Theodore Jenkins
Vice President, Investor Relations, and Business Development
Candel Therapeutics, Inc.
tjenkins@candeltx.com

Media Contact
Ben Shannon
ICR Healthcare
CandelPR@icrhealthcare.com