Author: Ravi Shankar

117 soil and 34 rock chip samples collected at the Vent Copper Project

CALGARY, Alberta, Sept. 22, 2026 (GLOBE NEWSWIRE) — Northern Discovery Metals Inc. (CSE: NOR) (FSE: M1V0) (“Northern Discovery” or the “Company”) is pleased to provide an update on its ongoing Stage 1 exploration program at the Vent Copper Project (“Vent” or the “Project”), located in the Alberni Mining Division on Vancouver Island, British Columbia. The field team has collected 117 soil samples and 34 rock chip samples to date as part of a program of geological mapping, prospecting and targeted sampling. The Company holds an option to acquire up to a 100% interest in the Project.

The work is being carried out by Geomap Exploration Inc. and follows the Company’s September 3, 2026 mobilization announcement. Stage 1 is designed to refine exploration priorities by examining the relationships between previously identified mineralization responses, geological contacts, structures, alteration and veining. The program was designed to initially focus on the Vent-Ken and Sentinel Peak areas and includes ground checks of priority magnetic and VLF-EM features.

Fieldwork to date has included systematic soil sampling and the examination and sampling of selected rock exposures. Preliminary field descriptions include volcanic and intrusive rocks, with localized chlorite alteration, quartz veining and minor pyrite noted at selected rock sampling sites. These observations will help inform the geological interpretation of the sampling results. Laboratory analysis is required to determine the potential for any metal content, and no assay results from the current program are reported in this release.

“The field team is building the geological and geochemical dataset we need to guide the next stage of exploration at Vent,” said Jared Suchan, Ph.D., P.Geo., Chief Executive Officer and Director of Northern Discovery Metals. “Our priority is to bring the sampling, geological observations and existing geophysical information together to identify where more detailed follow-up is warranted. This systematic approach will help us direct future work toward the strongest targets.”

Qualified Person Statement

Jared Suchan, Ph.D., P.Geo., Chief Executive Officer and Director of the Company, and a “Qualified Person” within the meaning of National Instrument 43-101 – Standards of Disclosure for Mineral Projects, has reviewed and approved the scientific and technical contents of this news release.

For a further discussion of the Company’s QA/QC and data verification procedures and processes, please see the technical report entitled, Technical Report on the Vent Copper Property, Alberni Mining Division, British Columbia, Canada, NTS Map 092F03W,” dated July 22, 2026, a copy of which may be obtained under the Company’s profile at www.sedarplus.ca.The Property is an exploration-stage mineral property with no current mineral resource or mineral reserve estimates.

About Northern Discovery Metals Inc.

Northern Discovery Metals Inc. is a mineral exploration company focused on the acquisition, exploration and advancement of mineral properties in Canada. The Company is exploring for copper at its Vent Project on Vancouver Island, British Columbia. Northern Discovery Metals intends to advance the Project through systematic exploration and evaluation of its mineral potential.

On Behalf of the Board of Directors

Jared Suchan

Chief Executive Officer and Director

Phone: (604) 294-3020

Email: info@northerndiscoverymetals.com

Cautionary Note Regarding Forward-Looking Statements

This news 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 statements that are not historical facts and are generally, but not always, identified by words such as “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential”, “scheduled”, “targeted”, “may”, “will”, “could”, “would” and similar expressions, or statements that certain events or conditions “will”, “may” or “could” occur. Forward-looking statements in this news release include, but are not limited to, statements regarding the expected timing, duration, scope and focus of the Stage 1 exploration program at the Property; the proposed geological mapping, prospecting and rock and soil sampling; the evaluation and follow-up of geochemical responses, magnetic and VLF-EM responses and other evidence encountered during the program; the integration of program results with existing geological, geochemical and geophysical information; the refinement of the Company’s geological model and ranking of priority areas; the potential identification of coherent geological and geochemical targets; the possible undertaking of focused induced-polarization or other ground geophysical work; the potential refinement and ranking of drill targets; and the Company’s plans to systematically explore, evaluate and advance the Property. 

Forward-looking statements are based on management’s current expectations, estimates, projections, assumptions and beliefs as of the date of this news release, including assumptions regarding the availability of personnel, contractors, equipment, supplies and financing on acceptable terms; the accuracy, reliability and completeness of historical and existing geological, geochemical and geophysical data; the ability to obtain and maintain all required permits, approvals and access arrangements; suitable weather, access and field conditions; the performance of Geomap and other contractors in accordance with applicable work plans; and the absence of material adverse changes in applicable laws, commodity prices, market conditions or the Company’s business and financial position. Although the Company considers these assumptions reasonable based on information currently available, they may prove to be incorrect. 

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from those anticipated in such statements. These risks and uncertainties include, among others: delays, interruptions, changes in scope or cost overruns affecting the exploration program; adverse weather, access, terrain, wildfire or other field conditions; the inability to secure or maintain permits, approvals, land access, personnel, contractors, equipment, supplies or sufficient financing; contractor performance and operational risks; accidents, environmental incidents and other hazards inherent in mineral exploration; the possibility that sampling, mapping, prospecting or geophysical work will not verify or explain historical anomalies, identify mineralization or produce coherent targets; the risk that geochemical or geophysical anomalies are not indicative of economic mineralization; uncertainties inherent in geological interpretation, data verification and the estimation of exploration potential; the preliminary nature of exploration results and the possibility that results from one area are not representative of the Property as a whole; title, option agreement and property access risks; fluctuations in commodity prices and market conditions; changes in laws, regulations, permitting requirements or government policies; competition for capital, personnel and equipment; and the additional risks described in the Company’s continuous disclosure filings with applicable securities regulatory authorities. There can be no assurance that the exploration program will proceed as currently contemplated, be completed on the expected timeline or at all, or achieve the anticipated results. Readers are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date hereof, and the Company undertakes no obligation to update or revise them to reflect new events or circumstances, except as required by applicable securities laws. 

The CSE has neither approved nor disapproved the information contained herein.

New Boise facility will help prepare the next generation of technicians for careers supporting advanced semiconductor manufacturing

NEW YORK, Sept. 22, 2026 (GLOBE NEWSWIRE) — With demand for skilled semiconductor technicians continuing to outpace supply, ABM (NYSE: ABM), a leading provider of facility, operations, production maintenance, and infrastructure solutions, today announced the grand opening of the ABM Technical Training Center in Boise, Idaho, one of the nation’s fastest-growing semiconductor manufacturing hubs. The center draws on the specialized semiconductor expertise ABM added through its acquisition of WGNSTAR earlier this year, further expanding ABM’s technical training capabilities to support the industry’s growing workforce needs.

The Boise center extends ABM’s existing semiconductor training footprint in Austin, Texas, and is expected to have capacity for approximately 500 participants annually at launch. It features a comprehensive, industry-aligned training program that combines instructor-led classroom learning, hands-on technical labs, and virtual reality simulations covering the core systems that support semiconductor manufacturing.

Developed by ABM semiconductor subject matter experts and endorsed by SEMI, the global industry association serving the electronics design and manufacturing supply chain, the program provides participants with the foundational knowledge and practical skills needed to succeed in entry-level technical roles across semiconductor manufacturing environments. Graduates will also earn an industry-recognized Swagelok certification as part of the curriculum.

“The future of American semiconductor manufacturing depends not only on building more fabrication plants, but on developing the workforce to operate them,” said Ed Marcil, President of Manufacturing & Distribution at ABM. “Across the industry, demand for qualified and credentialed technicians continues to outpace the available workforce, creating one of the biggest challenges facing manufacturers today. Through ABM’s new Technical Training Center, we are helping create faster pathways into technical careers because the industry’s ability to grow depends on the people who keep these operations running.”

Governor Brad Little added, “Idaho is a national leader in advanced semiconductor manufacturing, and investments like ABM’s Technical Training Center ensure we are preparing Idahoans to fill the good-paying jobs that industry is creating. By bringing hands-on training and industry-recognized credentials to Boise, ABM is helping build the skilled workforce we need to support innovation, strengthen our economy, and keep Idaho at the forefront of America’s semiconductor future. I appreciate ABM’s investment in Idaho and its commitment to preparing the next generation of technicians.”

Designed to complement existing education and workforce initiatives, the employer-agnostic program prepares participants for technical careers supporting semiconductor manufacturers, equipment suppliers, and facilities operators. By providing industry-aligned training before participants enter semiconductor environments, the program helps strengthen workforce readiness and better prepare technicians to contribute on the job.

About ABM

ABM (NYSE: ABM) is one of the world’s largest providers of integrated operations, production maintenance, facility, and infrastructure solutions. Through its manufacturing and distribution business, ABM helps many of the world’s leading manufacturers optimize production environments with specialized operations, maintenance, infrastructure, and workforce solutions.

ABM provides comprehensive support to the semiconductor industry, helping clients maintain critical manufacturing environments, improve operational performance, and develop the skilled workforce needed to support continued industry growth.

With more than 100,000 team members and over $8 billion in annual revenue, ABM serves clients across manufacturing and distribution, semiconductor, mission critical, commercial real estate, aviation, education, and other essential industries. ABM: Driving possibility, together.

For more information, visit www.abm.com.

Media contact:
Michael Valentino 
media@abm.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5e4ed491-5bd6-4744-aa50-81a26c04df51

ORLANDO, Fla., Sept. 22, 2026 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW) confirmed today that its outstanding warrants (NASDAQ:NTRBW) will expire on September 30, 2026 at 5PM ET as scheduled. The Company will not extend the expiration date and will not reprice the warrants.

Warrant holders may exercise at the current strike price of $6.43 per share until the expiration date. Warrants not exercised by that date will expire in their entirety and be removed from the NTRBW Nasdaq listing.

There are currently 910,904 warrants outstanding, representing $5,856,112 in potential proceeds to the Company if fully exercised at the $6.43 strike price.

Key dates and terms:

• Expiration date: September 30, 2026 5PM ET
• Strike price: $6.43 per warrant
• Warrants outstanding: 910,904
• No extension. No repricing.

Shareholders and warrant holders are advised to act before the deadline if they intend to exercise. Nutriband will continue to provide updates on Company developments in the coming weeks.

About Nutriband Inc.

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse deterrent fentanyl patch incorporating our AVERSA™ abuse deterrence technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words “believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s periodic and current reports on Form 10-K, Forms 10-Q and 8-K and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Contact Information:
Nutriband Inc.
Phone: 407-377-6695
Email: info@nutriband.com

Novacium was selected based on the performance of its very high-capacity GEN 3 and GEN 4 cylindrical cells, designed for high-capacity battery applications. The contract was awarded at the end of June 2026

MONTREAL and SOLAIZE, France, Sept. 22, 2026 (GLOBE NEWSWIRE) — HPQ Silicon Inc. (TSX-V: HPQ, OTCQB: HPQFF, FRA: O08) is pleased to inform its shareholders that its strategic partner, NOVACIUM SAS, a French deep-tech company specializing in green engineering of materials for energy applications, has announced that the French Army Technical Section (“STAT”) awarded it a contract ^[1] at the end of June 2026 for the development and supply of high-capacity prototype batteries to be evaluated in tactical radios. For procedural reasons, the award could not be announced prior to today.

From Initial Evaluation to Contract Award: More Than Eighteen Months of Technical Collaboration

In August 2024, STAT, the French Army organization responsible for evaluating and qualifying equipment for land forces, contacted Novacium after reviewing published results from cells developed using its silicon-based anode material. The organization sought to evaluate the possibility of integrating Novacium’s cells into the batteries used in its tactical radios.

Following six months of internal development, Novacium’s teams developed two battery prototypes, which were provided to STAT in April 2025. The initial results were conclusive: with comparable form factors and interfaces, energy capacity increased by 23% compared with the reference battery.

Image 1) Photos illustrating the use of Novacium’s high-capacity batteries

Building on these results, in September 2025 Novacium met with France’s Directorate General of Armaments (DGA), Defence Innovation Agency (AID), and STAT to propose a work program to develop very high-capacity prototype batteries.

Several months of discussions followed to refine the program around an ambitious objective: significantly increasing, or potentially doubling, the energy capacity of tactical radio batteries without modifying existing connectors, chargers, or interfaces. This work resulted in a contract award to Novacium at the end of June 2026.

Selection Based on the Performance of Novacium’s High-Capacity Cells

Novacium was selected based on the performance of its very high-capacity GEN 3 and GEN 4 cylindrical cells, designed for high-capacity battery applications. This distinctive energy density made it possible to propose a solution capable of meeting STAT’s objective: significantly increasing the operating time of tactical radios without disrupting existing charging infrastructure, procedures or the logistics chain.

The contract provides for delivery in successive batches, structured around operational field feedback (RETEX). The first batch of prototypes will undergo an evaluation campaign under operational conditions, after which STAT and Novacium will jointly prepare a detailed RETEX. Lessons learned from this evaluation will guide design adjustments before production of a second batch that will better reflect a series-production configuration.

Image 2) Novacium battery for tactical radios and GEN 4 21700 cells

“The award of this contract by STAT represents an important recognition of Novacium’s expertise in designing high-performance cells and batteries for demanding environments. We were selected because our GEN 3 and GEN 4 cells offer a distinctive energy density capable of meeting particularly demanding specifications. This program illustrates our strategy: applying our materials and battery expertise to critical defence and security applications,” said Dr. Jed Kraiem, Ph.D., Chief Operating Officer of Novacium.

Potential Applications with Other Allied Forces

The expertise deployed under this program (high-capacity cell integration, battery management system adaptation and enclosure design) could be applied to other battery formats for tactical radios used by the armed forces of NATO member countries. A successful evaluation by STAT could serve as a technical reference to support this approach. However, each adaptation would remain subject to the relevant platform’s specific requirements, qualification testing, and separate procurement decisions.

“Novacium’s selection by the French Army’s technical organization responsible for equipment evaluation and qualification represents an important step in validating its expertise,” said Bernard Tourillon, President and CEO of HPQ Silicon Inc., which serves as President of Novacium. “If the evaluation phase confirms the expected performance, this program could become a relevant technical reference for presenting the solution to other allied forces with comparable requirements. For HPQ, every advance Novacium makes in the defence sector also strengthens the strategic value of our 36.8% interest in Novacium, as well as the potential to commercialize in North America the technologies covered by our licensing agreement.”

This contract is part of the continued development of Novacium’s activities in the defence and autonomous systems sectors. It follows the August 19, 2026, announcement of a first order for battery packs intended to power drones to be delivered to a French Army regiment through LN’INNOV.

Additional Information:

[1] A “marché,” in the context of French public procurement, refers to a paid contract entered between a public purchaser and an economic operator to meet a requirement for works, supplies or services in exchange for a price or equivalent consideration. In this case, the contract awarded to Novacium covers the development and supply, in successive batches, of prototype batteries intended for evaluation by STAT. The financial terms and quantities covered by the contract are subject to confidentiality obligations and are not disclosed.

About Novacium SAS

Novacium is a French deep-tech company based in Solaize, specializing in the development and production of silicon-based anode materials for lithium-ion batteries using a proprietary process. Novacium also designs custom battery cells and packs for demanding applications, particularly in the defence, aerospace and portable energy sectors.

About HPQ Silicon

HPQ Silicon Inc. is a Quebec-based industrial issuer listed on the TSX Venture Exchange (TSX-V: HPQ), focused on innovation in advanced materials and the development of critical processes.

HPQ holds a strategic 36.8% interest in Novacium, its research, development and commercialization partner. Together, HPQ and Novacium are developing next-generation silicon-based anode materials (Gen3 and Gen4) for batteries, pursuing the commercialization of ENDURA+ lithium-ion cells, and developing innovative technologies for clean hydrogen production and the energy recovery of waste materials. HPQ holds the exclusive rights to commercialize these technologies in North America.

Cautionary Note Regarding Forward-Looking Information

This press release contains forward-looking statements based on certain assumptions regarding technological performance, market demand, permitting, financing, supply chains and economic conditions. These statements involve significant risks, including delays, regulatory issues, competition, availability of financing and macroeconomic uncertainties. Actual results could differ materially from those anticipated. Detailed risk factors are presented in HPQ’s Annual Information Form available on SEDAR+. Forward-looking statements are provided solely to outline management’s future expectations and objectives. A more detailed cautionary note regarding forward-looking information related to the HPQ Endura+ batteries project is available for download [here]. Additional information regarding the Company is available on SEDAR+ (www.sedarplus.ca) and on the Company’s website at www.hpqsilicon.com/.

Neither the TSX Venture Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.

Contact Information

NOVACIUM SAS
Dr. Jed Kraiem, Ph.D., Chief Operating Officer
info@novacium.com

HPQ Silicon Inc.
Bernard J. Tourillon, BAA, MBA, President and CEO
info@hpqsilicon.com

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/a8db8169-0afd-4ee5-945b-d6606238f077
https://www.globenewswire.com/NewsRoom/AttachmentNg/a4942b78-d043-4fe3-9c99-91b31b691b30 

AUSTIN, Texas, Sept. 22, 2026 (GLOBE NEWSWIRE) — SailPoint, Inc. (Nasdaq: SAIL), a leader in enterprise identity security, will host a live webcast and product demo for financial analysts and investors on Wednesday, October 14, 2026, at 12:00 p.m. Eastern Time.

The webcast will provide a comprehensive recap of the strategic product introductions and platform capabilities unveiled at Navigate, SailPoint’s premier annual identity security conference.

The webcast will be available on SailPoint’s website at investor.sailpoint.com.  A replay of the webcast will be available on the investor relations website for one year.

Additionally, keynotes and mainstage sessions live from Navigate in Austin (October 5–8) will be streamed in real-time, learn more at sailpoint.com/navigate/austin.

About SailPoint
SailPoint (Nasdaq: SAIL) is defining the new era of adaptive identity security. In a world where non-human identities now significantly outnumber humans, our AI-powered platform unifies identity, security, and data intelligence to protect today’s enterprise from advanced identity-based threats. We deliver the identity solution that spans both the breadth of identities and the depth of context needed to drive real-time access with confidence. Built on principles like zero-standing privilege and contextualized risk, our SailPoint platform transforms identity from a point of vulnerability into a powerful security advantage. Trusted by many of the world’s leading organizations, SailPoint secures the enterprise with intelligent, autonomous identity security.

Investor Relations Contact
Scott Schmitz, SVP IR
ir@sailpoint.com

Media Relations Contact
Shannon Paulk, Sr. Manager, Corporate Communications
shannon.paulk@sailpoint.com

• Patient screening for the Phase 2a study is expected to begin by the first quarter of 2027
• Filana has engaged a leading clinical research organization, has identified clinical trial sites, and is recruiting potential investigators
• Ongoing collaboration with the TSC Alliance and the broader TSC community is intended to support patient engagement and study execution

AUSTIN, Texas, Sept. 22, 2026 (GLOBE NEWSWIRE) — Filana Therapeutics, Inc. (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company currently focused on developing simufilam for the treatment of Tuberous Sclerosis Complex (TSC)-related epilepsy, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company’s investigational new drug (IND) application, enabling Filana to initiate a planned Phase 2a proof-of-concept study in patients aged 12 to 55 with TSC-related epilepsy. Patient screening is expected to begin by the first quarter of 2027.

“With the clinical hold lifted, we can now execute our development plan for simufilam in TSC-related epilepsy,” said Rick Barry, President and Chief Executive Officer of Filana. “While on hold, we completed key trial-readiness activities, including engaging a leading clinical research organization, identifying clinical trial sites, and recruiting potential investigators. With investigational drug supply in place, implementation of our Phase 2a study of simufilam is now able to progress expeditiously toward site initiation and patient enrollment.”

“Drug-resistant epilepsy remains a challenge for a majority of individuals affected by TSC,” said Kari Luther Rosbeck, President and Chief Executive Officer of the TSC Alliance. “Research investigating different molecular pathways involved in TSC offers hope for potential new options for those living with the disease. The TSC Alliance applauds Filana for their innovative work in exploring a new target mechanism and their plans to launch a clinical trial to test the effectiveness of that potential new treatment to help address a major unmet need for the TSC community.”

Planned Phase 2a Trial Design

Filana’s Phase 2a study is a 16-week multicenter, randomized, double-blind clinical trial to evaluate two doses of simufilam in patients with refractory TSC-related seizures. The study is planned to be conducted at 13 sites in the U.S. with a target enrollment of 40 subjects aged 12 to 55. All subjects who complete the double-blind treatment phase are eligible to participate in a 48-week extension study.

The study is designed to assess safety, tolerability, pharmacokinetics, and seizure-related measures, including seizure frequency, seizure intensity and duration, nighttime seizures, and sleep-related outcomes. Data from the study are expected to help inform the development path for simufilam in TSC-related epilepsy, including the design of future studies in younger patient populations.

Scientific Rationale

Simufilam is an oral small molecule intended to modulate the filamin A protein. The clinical evaluation of simufilam in TSC-related epilepsy is supported by findings from two preclinical mouse models. Initial studies were conducted in the laboratory of Angélique Bordey, PhD, Rothberg Professor of Neurosurgery at Yale School of Medicine and Senior Vice President, Neuroscience at Filana. Those studies showed that simufilam reduced seizure frequency in a mouse model of focal onset seizures involving TSC-related pathology¹. In a separate study conducted with the TSC Alliance Preclinical Consortium using a well-accepted TSC-knockout mouse model, simufilam attenuated the progression of seizure activity in a dose-dependent manner².

Filana holds an exclusive worldwide license from Yale University to intellectual property supporting the use of simufilam in TSC-related epilepsy.

About TSC and TSC-Related Epilepsy

TSC is a rare genetic disorder resulting from a mutation in the TSC1 or TSC2 gene. These mutations affect the mechanistic target of rapamycin (mTOR) pathway and can cause tumors to grow in multiple organs^3,4. Epilepsy is the most common health issue affecting the TSC community, with 80% to 90% of TSC patients experiencing seizures⁵. TSC-related epilepsy affects approximately 45,000 people in the U.S.^1,3. Most patients start having seizures within their first year of life¹. Even with multiple approved treatments, more than 60% of TSC patients remain refractory to antiepileptic therapy⁶.

About Filana Therapeutics, Inc.

Filana Therapeutics, Inc. (NASDAQ: FLNA), is a biotechnology company focused on developing novel, investigational therapies to modulate the filamin A protein for the treatment of central nervous system disorders, such as tuberous sclerosis complex (TSC)-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A.

For more information, please visit: https://www.FilanaTx.com

References:

1. Zhang L, Huang T, Teaw S, Nguyen LH, Hsieh LS, Wong X, Burns LH, Bordey A. Filamin A inhibition reduces seizure activity in a mouse model of focal cortical malformations. Science Translational Medicine. 2020;12(531):eaay0289. DOI: 10.1126/scitranslmed.aay0289
2. Stansley B, Islam MM, Aguiar DJ, Fuchs Z, Catron M, Morairty S, et al. The small molecule simufilam dose-dependently attenuates the worsening of seizures in a mouse model of tuberous sclerosis complex. Epilepsia. 2026;00:1–13. DOI: 10.1002/epi.70227
3. https://www.tscalliance.org/understanding-tsc/what-is-tsc/
4. https://www.tscalliance.org/understanding-tsc/genetics/
5. Crino P, Nathanson K, Henske EP. The tuberous sclerosis complex. N Engl J Med. 2006;355(13):1345-1356. DOI: 10.1056/NEJMra055323
6. Chu-Shore CJ, Major P, Camposano S, Muzykewicz D, Thiele EA. The natural history of epilepsy in tuberous sclerosis complex. Epilepsia. 2010;51(7):1236–1241. DOI: 10.1111/j.1528-1167.2009.02474.x

For More Information Contact:
Investors
Mike Moyer
mmoyer@lifesciadvisors.com

Filana Therapeutics
Eric Schoen, Chief Financial Officer
(512) 501-2450
ESchoen@FilanaTx.com
IR@FilanaTx.com

Cautionary Note Regarding Forward-Looking Statements:

This news release contains forward-looking statements that may include but are not limited to statements regarding: the timing and plans to initiate and conduct clinical studies with simufilam in TSC-related epilepsy; the design, structure, duration, objectives, endpoints, patient population, conduct, enrollment, completion, and potential results of our planned Phase 2a clinical trial; our ability to work with clinical research organizations, clinical sites, patient advocacy organizations, and the TSC community to advance the trial efficiently; the potential for simufilam as a treatment for TSC-related epilepsy and other potential indications; and the timing of anticipated milestones, including announcing study sites and screening patients. These statements may be identified by words such as “anticipate”, “before”, “believe”, “could”, “expect”, “forecast”, “intend”, “may”, “pending”, “plan”, “possible”, “potential”, “prepares for”, “will”, and other words and terms of similar meaning.

Such statements are based on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to our ability to initiate, enroll, conduct, and complete the planned Phase 2a study of simufilam in TSC-related epilepsy; our ability to engage clinical trial sites and participants; our ability to work effectively with clinical research organizations, vendors, investigators, patient advocacy organizations, and the TSC community; potential changes to the clinical trial protocol, trial design, endpoints, timing, patient population, or development plans; our ability to generate clinical data that support further development of simufilam; risks inherent in drug discovery and development; and other risks specific to Filana Therapeutics, Inc., as described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC’s website at www.sec.gov.

All of our pharmaceutical assets under development are investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates is approved or available for sale anywhere in the world.

Our clinical results from earlier-stage clinical trials or preclinical studies may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish.

We are in the business of new drug discovery and development. Our research and development activities are long, complex, costly and involve a high degree of risk. Holders of our common stock should carefully read our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q in their entirety, including the risk factors therein. Because risk is fundamental to the process of drug discovery and development, you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested.

Site II would add approximately $391 million in base-term contracted revenue to previously announced base-term contracted revenue of $1.25 billion for Site I. 

NEW YORK, NY, Sept. 22, 2026 (GLOBE NEWSWIRE) — Host Digital Inc. (NYSE American: HOST) (“Host Digital” or the “Company”), a vertically integrated digital infrastructure company that develops, acquires, owns, and operates institutional-quality, RightScaled data centers for artificial intelligence (“AI”) and high-performance computing (“HPC”), began trading on Friday, September 18 on the NYSE American under the ticker symbol “HOST.”

Host Digital also announced that it has signed a Preferential Rights Agreement with its Sponsor, which provides Host Digital with a right of first offer and a right of first refusal on qualifying data center projects held by its Sponsor. Host Digital expects to acquire from the Sponsor a second data center facility, also located in northeast Oklahoma (“Site II”). The Sponsor has signed a 12-year take-or-pay lease for Site II, with a publicly traded AI cloud provider, for approximately 20 MW of gross / 16 MW of critical IT load, representing approximately $391 million in base-term rent, or approximately $819 million over a total 22-year term assuming all renewal options are exercised, which is expected to be supported by a lease backstop from an investment-grade publicly listed U.S.-based global technology company.

Any contribution of Site II remains subject to negotiation and the execution of definitive agreements, and no assurance can be given that it will occur.

TRANSACTION AND LEASE HIGHLIGHTS

• Merger completed: Host Digital completed its merger with Host Digital Infrastructure LLC on September 17, 2026. Following the Closing of the priced offering, HOST’s outstanding share count is 48,088,414, which implies a market capitalization of $384,947,754.07 as of market close on September 21, 2026.
• Trading as HOST: Shares began trading on the NYSE American under the ticker symbol “HOST” on Friday, September 18, 2026.
• Site I: With the closing of the merger, Site I is now owned by Host Digital. The fully executed 15-year, take-or-pay lease is for 55 MW gross / 43 MW of critical IT load, representing approximately $1.25 billion in base-term contracted revenue, or approximately $3.2 billion over a 30-year total term if all renewal options are exercised, and a Year 1 contracted revenue of $67 million, with delivery expected in the first quarter of 2027. The terms also include a 3.0% annual rent escalator with the tenant bearing operating expenses. The lease is expected to be supported by a lease backstop from an investment-grade publicly listed U.S.-based global technology company.
• Site II: Host Digital expects to acquire from the Sponsor a second data center facility, also located in northeast Oklahoma (“Site II”), pursuant to its rights under the Preferential Rights Agreement. The Sponsor has signed a 12-year take-or-pay lease with a publicly traded AI cloud provider for approximately 20 MW gross / 16 MW of critical IT load, representing approximately $391 million in base-term rent, or approximately $819 million over a total 22-year term assuming all renewal options are exercised, and Year 1 contracted revenue of $28.3 million. The terms also include a 2.5% annual rent escalator with the tenant bearing operating expenses. The lease is expected to be supported by a lease backstop from a different investment-grade publicly listed U.S.-based global technology company. The contribution of Site II remains subject to negotiation and the execution of definitive agreements.[1]
• Sponsor relationship: Under the Preferential Rights Agreement, Sponsor provided the Company with a 24-month exclusive right of first offer and right of first refusal on qualifying data center assets from the Sponsor’s pipeline, which includes an additional 450 MW of RightScaled data center assets with the potential ability to be delivered to tenants in 2027, as well as longer-term, “land and expand” growth from both grid and behind-the-meter expansions at existing sites, followed by the potential development of larger scale projects which may potentially be delivered to tenants in 2028 and beyond.
• Differentiated approach: Host Digital expects to target a combination of RightScaled, 20-100 MW grid-powered assets with existing or near-term electricity in place, which it expects to be able to deliver to tenants in 2026, 2027 and 2028, and which can potentially be expanded with additional utility capacity and behind-the-meter private grid generation, along with larger scale opportunities which may potentially be delivered in 2028 and beyond. This “barbell” approach aims to accelerate revenue by emphasizing speed to power, while maximizing opportunities for scale over time. The Company focuses on rapidly delivering “turnkey” facilities, which go beyond a typical powered shell to meet tenants, chipmakers and end users where they are, in what the Company considers a “sweet spot” of development cost and lease rates.

“Host Digital is entering the public markets with the three things that matter most in AI infrastructure today: access to power, contracted demand, and a model we can repeat,” said Shawn Matthews, Chairman of Host Digital. “At our initial site, we have 43 MW of critical IT load committed under a long-term lease. We now have started negotiations to acquire a second energized and leased facility. If we complete that acquisition, Host Digital expects to have approximately 59.3 MW of total contracted critical IT load and an aggregate of $1.64 billion in base-term contracted revenue across the two sites. Our listing on the New York Stock Exchange American gives us a public-markets platform to continue building that portfolio with discipline.”

“Infrastructure is ultimately constrained by how quickly operators can secure power and bring capacity online,” said Harmol Samra, Chief Executive Officer of Host Digital. “The Host Digital platform’s strategy addresses this constraint. We target acquiring sites where power is already flowing or available in the near term, then develop against long-term contracted demand, rather than building speculative capacity and hoping tenants follow. Site II is exactly the type of asset our RightScaled strategy was designed to capture: energized infrastructure, a modular design, contracted demand, and a defined path to tenant delivery.”

Host Digital’s development model centers on RightScaled sites of approximately 20 MW to 100 MW with grid power available today or in the near term, supplemented by behind-the-meter generation where appropriate, and developed against long-term contracted demand from strong or credit-enhanced counterparties. The strategy is designed to bring new capacity to market in months rather than years while avoiding many of the interconnection, permitting, and infrastructure constraints facing larger greenfield developments.

Host Digital expects to own and control the core physical infrastructure at each facility, including the real estate, power and interconnection rights, utility agreements, electrical systems, and cooling infrastructure. Tenants are expected to control their own compute infrastructure and model layers, allowing Host Digital to operate as the underlying digital infrastructure and real estate platform rather than taking technology or compute risk.

PREFERENTIAL RIGHTS AGREEMENT

In connection with the closing of the merger, Host Digital entered into a Preferential Rights Agreement with its Sponsor, an entity formed and controlled by the founders of Host Digital Infrastructure LLC. For 24 months, the agreement gives Host Digital exclusive rights of first offer and first refusal on data center assets the Sponsor acquires or develops and intends to place in a public company vehicle. The Sponsor’s potential pipeline includes four additional sites with more than 450 MW of gross power capacity targeted for delivery in 2026 and 2027, including more than 350 MW of grid power and more than 100 MW of behind-the-meter capacity.

Any contributions of additional sites remain subject to negotiation and the execution of definitive agreements, and no assurance can be given that they will occur.

EXPERIENCED LEADERSHIP

Shawn Matthews
Chairman of the Board of Directors

Shawn Matthews has over 30 years of management experience in public and private corporations, with diverse experience across energy and financial sectors. His leadership experience includes serving as CEO of Cantor Fitzgerald & Co. from 2009 to 2018; as founder and CEO of Hondius Energy; as CEO of Mercator Power; and as sponsor of Terrestrial Energy and a former member of its board of directors. Mr. Matthews has deep expertise and connectivity across the energy and real estate sectors, and capital markets more broadly, and brings strong governance leadership to HOST.

Harmol Samra
Chief Executive Officer

Harmol Samra has over a decade of experience in real estate private equity and digital infrastructure development, and previously served in roles at Starwood Capital and ICONIQ Capital in San Francisco and New York. At ICONIQ, Mr. Samra helped build and oversee IPI Partners, which grew to become one of the largest data center development platforms in the world. At the time of its sale to Blue Owl in 2024, IPI had a portfolio of 82 data centers comprising more than 2.2 gigawatts of leased capacity globally. Mr. Samra has significant expertise in developing real estate and digital infrastructure projects, and deep relationships across the AI/HPC and AI infrastructure universe. Mr. Samra previously held investment and investment banking roles, respectively, at PGIM, the global asset management business of Prudential Financial, Inc., with over $1.4 trillion in assets under management, and Morgan Stanley.

ABOUT HOST DIGITAL

Host Digital Inc. (NYSE American: HOST) develops, acquires, owns, and operates institutional-quality data centers in the United States that support AI and HPC workloads. The Company focuses on RightScaled sites of 20 MW to 100 MW with existing or near-term access to power, leased under long-term contracts to strong or credit-enhanced counterparties. Host Digital seeks to own and control the real estate, power, and data center infrastructure at each site, and provides turnkey facilities where tenants select and deploy their own compute infrastructure and model layers.

Through its wholly owned subsidiaries, the Company also operates a portfolio of 19 natural and organic grocery stores across six states under the Ada’s Natural Market, Paradise Health & Nutrition, Mother Earth’s Storehouse, Greens Natural Foods, Ellwood Thompson’s, and GreenAcres Market brands. Healthy Choice Wellness Corp.’s natural and organic grocery business continues to operate as a division of the Company following the merger.

For more information, visit www.hostdigital.ai.

Footnote

1. Any contribution of Site II remains subject to negotiation and the execution of definitive agreements, and no assurance can be given that it will occur.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the proposed acquisition and development of one or more data center facilities, including the potential acquisition of Site II; the expected assets leases and other assets to be acquired from the Sponsor or any other third party; the timing of delivery of the Company’s data center facilities to tenants; anticipated contracted revenue, lease terms and renewal options; the Company’s development strategy and ability to execute and scale its business model; and the Sponsor’s potential pipeline and contribution of additional data center assets to the Company. Statements that are not historical facts are based on current estimates, assumptions and projections and are not guarantees of future performance. Words such as “anticipates,” “believes,” “expects,” “intends,” “may,” “plans,” “will,” “would,” “could” and similar expressions identify forward-looking statements, although not all forward-looking statements contain these words.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, including risks relating to the completion of the offering on the anticipated terms or at all; the Company’s ability to satisfy the applicable listing requirements; the Company’s ability to successfully integrate the businesses and realize the anticipated benefits of the offering; the Company’s ability to obtain required financing, complete development and deliver capacity on schedule; and other factors described in the Company’s filings with the SEC, including under the header “Risk Factors” in Exhibit 99.2 to the Current Report on Form 8-K filed with the SEC on September 17, 2026. The Company undertakes no obligation to update these statements except as required by law.

MEDIA CONTACT
Jessica Starman
jessica@elev8newmedia.com
888-461-2233

INVESTOR CONTACT
Jason Assad
info@bridge-comms.com

HOUSTON, Sept. 22, 2026 (GLOBE NEWSWIRE) — Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company developing multi-antigen recognizing (MAR)-T cell therapies for the treatment of hematologic malignancies and solid tumors, today highlighted the expanded infrastructure, technical expertise and manufacturing capabilities supporting its lead program, MT-601 (neldaleucel), following the combination of Cellipont Bioservices and Kincell Bio to form Kincellis Advanced Therapies.

Marker previously selected Cellipont Bioservices as its manufacturing partner for MT-601 (neldaleucel) to support the continued clinical development and prepare for potential pivotal-stage and commercial manufacturing requirements.

Kincellis was formed through the combination of Cellipont Bioservices and Kincell Bio, creating a U.S.-based contract development and manufacturing organization (CDMO) focused on cell therapies and other advanced modalities. Announced on September 17, 2026, the combination created a larger advanced-therapies CDMO with approximately 140,000 square feet of development and manufacturing infrastructure and 16 operational, qualified GMP manufacturing suites across three U.S. locations. The combined organization also brings together broader scientific and technical expertise, an expanded manufacturing network and additional financial resources to support programs from clinical development through commercial supply.

Marker believes these expanded capabilities further strengthen and de-risk the manufacturing foundation for MT-601 as the program advances toward later-stage clinical development.

“We congratulate the Cellipont and Kincell teams on the formation of Kincellis Advanced Therapies,” said Juan Vera, MD, President and Chief Executive Officer of Marker Therapeutics. “The combination creates a stronger manufacturing partner, and we look forward to continuing our work with the team as MT-601 advances into its next stage of clinical development.”

MT-601 (neldaleucel) is currently investigated in the Company’s Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897) in patients with lymphoma who have relapsed after anti-CD19 chimeric antigen receptor (CAR)-T cells or are not candidates for anti-CD19 CAR-T cell therapies. Marker previously reported a favorable safety profile and encouraging clinical activity from the dose-escalation portion of the study demonstrating a 66% objective response rate among 12 patients with Non-Hodgkin Lymphoma (NHL), with 50% achieving complete remission (Press Release, August 26, 2025).

“Establishing a robust and scalable manufacturing platform is an important component of advancing MT-601 through late-stage clinical development,” Dr. Vera continued. “Kincellis’ expanded U.S. footprint, advanced cell therapy expertise and capabilities spanning clinical development through potential commercial supply align well with our long-term strategy and the evolving manufacturing needs of the MT-601 program.”

“We are proud to continue supporting Marker and the advancement of MT-601,” said Darren Head, Chief Executive Officer of Kincellis Advanced Therapies. “Marker will continue to work with the team that understands its program, now supported by the broader expertise, resources and manufacturing network of Kincellis. This combination allows us to provide continuity today while preparing to support Marker’s evolving needs as the program advances.”

About Neldaleucel (MT-601)
The Company’s lead product, MT-601, is a multi-antigen recognizing (MAR) T cell product that utilizes a non-genetically modified approach that specifically targets six different tumor antigens upregulated in lymphoma cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGEA-4). Marker is currently investigating MT-601 in the Company-sponsored Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the treatment of patients with lymphoma who have relapsed after or are not candidates for anti-CD19 CAR-T cell therapies.

About APOLLO
The APOLLO trial (clinicaltrials.gov Identifier: NCT05798897) is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of neldaleucel (MT-601) in participants with relapsed or refractory lymphoma. The primary objective of the exploratory Phase 1 clinical trial is to evaluate the optimum dose, safety, and preliminary efficacy of neldaleucel in participants with various lymphoma subtypes. The APOLLO study is supported by the National Cancer Institute of the National Institutes of Health (Award Number R44CA291521) and the U.S. Department of War (formerly U.S. Department of Defense).

About MAR-T cells
The multi-antigen recognizing (MAR) T cell platform (formerly multiTAA-specific T cells) is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, MAR-T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since MAR-T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile compared to current engineered T cell approaches and may provide patients with meaningful clinical benefits.

About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a Houston, TX-based clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors. The Company was founded at Baylor College of Medicine, and clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic MAR-T cell products were well tolerated and demonstrated durable clinical responses. Marker’s goal is to introduce novel T cell therapies to the market and improve patient outcomes. To achieve these objectives, the Company prioritizes the preservation of financial resources and focuses on operational excellence. Marker’s unique T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research, including the National Cancer Institute of National Institutes of Health, U.S. Department of War, the FDA Orphan Drug program and the Cancer Prevention Research Institute of Texas (CPRIT).

To receive future press releases via email, please visit: https://www.markertherapeutics.com/email-alerts.

About Kincellis Advanced Therapies
Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA.

Forward-Looking Statements
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and the timing, conduct, interim results announcements and outcomes of our clinical trials of our product candidates, including neldaleucel (MT-601) for the treatment of patients with lymphoma. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at WWW.SEC.GOV. The Company assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release except as may be required by law.

Media and Investor Contact
Marker Therapeutics, Inc.
+1 (713) 400-6400
investor.relations@markertherapeutics.com

Approval of BRAVNETSA expands radioligand treatment options for adult patients with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

BEDFORD, Mass., Sept. 22, 2026 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that the U.S. Food and Drug Administration (FDA) has granted final approval for BRAVNETSA™ (lutetium Lu 177 dotatate), a bioequivalent and therapeutically equivalent radiopharmaceutical to LUTATHERA^® (lutetium Lu 177 dotatate). BRAVNETSA is indicated for the treatment of adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

“As the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to LUTATHERA approved in the United States, BRAVNETSA’s approval marks an important milestone for Lantheus as we continue to expand our radiopharmaceutical portfolio, bringing additional treatment options to people living with GEP-NETs,” said Mary Anne Heino, Executive Chairperson and CEO, Lantheus. “We are focused on a thoughtful launch and ensuring the right commercial and operational capabilities are in place to support reliable supply and broad patient access.”

BRAVNETSA was approved through the FDA’s Abbreviated New Drug Application (ANDA) pathway. As part of this review, BRAVNETSA is the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to the reference product, LUTATHERA.

“For more than 70 years, Lantheus has helped define what’s possible in radiopharmaceuticals. As the first radioligand therapy approved through the ANDA pathway, BRAVNETSA represents a breakthrough for our industry and opens a new regulatory pathway for innovation,” said Ludger Dinkelborg, PhD, Head of Research and Development, Lantheus. “Innovation comes in many forms, and this approval reflects Lantheus’ ability to apply our deep radiopharmaceutical expertise in navigating the ANDA process and gives clinicians another FDA-approved option to support treatment decisions based on each patient’s needs.”

Visit www.BRAVNETSAhcp.com for more information on when the product will be available.

About GEP-NETs

Neuroendocrine tumors (NETs) are rare, often slow-growing cancers that can develop throughout the body. A subset known as gastroenteropancreatic NETs (GEP-NETs) affects the digestive system and pancreas and may be functional or non-functional depending on hormone activity.¹ Over the last few decades, the incidence of GEP-NETs has increased significantly, with the prevalence in the U.S. estimated to be approximately 200,000 patients.² Because GEP-NETs often grow slowly and cause non-specific symptoms, up to 50% are initially misdiagnosed, with patients waiting an average of 4.3 years from symptom onset to diagnosis.^3,4  

About BRAVNETSA

BRAVNETSA (lutetium Lu 177 dotatate), previously referred to as PNT2003, is bioequivalent and therapeutically equivalent to LUTATHERA.

INDICATION

BRAVNETSA is indicated for the treatment of adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

Pediatric use information is approved for Advanced Accelerator Applications USA INC’s LUTATHERA (lutetium Lu 177 dotatate) injection for intravenous use. However, due to Advanced Accelerator Applications USA Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

IMPORTANT SAFETY INFORMATION IN ADULTS

WARNINGS AND PRECAUTIONS

Risk From Radiation Exposure

BRAVNETSA contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer.

Radioactivity may be detected in the urine for up to 30 days following BRAVNETSA administration. Minimize radiation exposure in patients, medical personnel, and household contacts during and after treatment with BRAVNETSA consistent with institutional good radiation safety practices, patient management procedures, Nuclear Regulatory Commission patient release guidance, and provide instructions to the patient for follow-up radiation protection at home.

Myelosuppression        

In NETTER-1, myelosuppression occurred more frequently in patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared with patients receiving high-dose, long-acting octreotide (all Grades/Grade 3 or 4): anemia (81%/0% vs 54%/1%), thrombocytopenia (53%/1% vs17%/0%), and neutropenia (26%/3% vs11%/0%). In NETTER-1, platelet nadir occurred at a median of 5.1 months following the first dose. Of the 59 patients who developed thrombocytopenia, 68% had platelet recovery to baseline or normal levels. The median time to platelet recovery was 2 months. Fifteen of the 19 patients in whom platelet recovery was not documented had post-nadir platelet counts. Among these 15 patients, 5 improved to Grade 1, 9 to Grade 2, and 1 to Grade 3. Monitor blood cell counts. Withhold dose, reduce dose, or permanently discontinue BRAVNETSA based on the severity of myelosuppression.

Secondary Myelodysplastic Syndrome and Leukemia

In NETTER-1, with a median follow-up time of 76 months in the main study, myelodysplastic syndrome (sMDS) was reported in 2.3% of patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared with no patients receiving high-dose, long-acting octreotide. In ERASMUS, 16 patients (2%) developed sMDS and 4 (0.5%) developed acute leukemia. The median time to onset was 29 months (9 to 45 months) for sMDS and 55 months (32 to 125 months) for acute leukemia.

Renal Toxicity

In ERASMUS, 8 patients (<1%) developed renal failure 3 to 36 months following lutetium Lu 177 dotatate injection. Two of these patients had underlying renal impairment or risk factors for renal failure (eg, diabetes or hypertension) and required dialysis. Administer the recommended amino acid solution before, during, and after BRAVNETSA to decrease the reabsorption of lutetium Lu 177 dotatate through the proximal tubules and decrease the radiation dose to the kidneys. Advise patients to hydrate and to urinate frequently before, on the day of, and the day after administration of BRAVNETSA. Monitor serum creatinine and calculated creatinine clearance. Withhold dose, reduce dose, or permanently discontinue BRAVNETSA based on the severity of renal toxicity. Patients with baseline renal impairment may be at increased risk of toxicity due to increased radiation exposure.

Hepatotoxicity

In ERASMUS, 2 patients (<1%) were reported to have hepatic tumor hemorrhage, edema, or necrosis, with 1 patient experiencing intrahepatic congestion and cholestasis. Patients with hepatic metastasis may be at increased risk of hepatotoxicity due to radiation exposure. Monitor transaminases, bilirubin, serum albumin, and the international normalized ratio during treatment. Withhold dose, reduce dose, or permanently discontinue BRAVNETSA based on the severity of hepatotoxicity.

Hypersensitivity Reactions

Hypersensitivity reactions, including angioedema, occurred in patients treated with lutetium Lu 177 dotatate injection. Monitor patients closely for signs and symptoms of hypersensitivity reactions, including anaphylaxis, during and following BRAVNETSA administration for a minimum of 2 hours in a setting where cardiopulmonary resuscitation medication and equipment are available. Discontinue the infusion upon the first observation of any signs or symptoms consistent with a severe hypersensitivity reaction and initiate appropriate therapy. Premedicate patients with a history of Grade 1 or 2 hypersensitivity reactions to BRAVNETSA before subsequent doses. Permanently discontinue BRAVNETSA in patients who experience Grade 3 or 4 hypersensitivity reactions.

Neuroendocrine Hormonal Crisis

Neuroendocrine hormonal crises, manifesting with flushing, diarrhea, bronchospasm, and hypotension, occurred in <1% of patients in ERASMUS and typically occurred during or within 24 hours following the initial lutetium Lu 177 dotatate injection dose. Two patients (<1%) were reported to have hypercalcemia. Monitor patients for flushing, diarrhea, hypotension, bronchoconstriction, or other signs and symptoms of tumor-related hormonal release. Administer intravenous somatostatin analogs, fluids, corticosteroids, and electrolytes as indicated.

Embryo-Fetal Toxicity

BRAVNETSA can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating BRAVNETSA. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BRAVNETSA and for 7 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BRAVNETSA and for 4 months after the last dose.

Risk of Infertility

BRAVNETSA may cause infertility in males and females. The recommended cumulative dose of 29.6 GBq of BRAVNETSA results in a radiation absorbed dose to the testes and ovaries within the range where temporary or permanent infertility can be expected following external beam radiotherapy.

ADVERSE REACTIONS

The most common Grades 3-4 adverse reactions (≥4% with a higher incidence in the BRAVNETSA arm) are lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia, and hypokalemia.

DRUG INTERACTIONS

Somatostatin Analogs

Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each BRAVNETSA dose. Administer short-and long-acting octreotide during BRAVNETSA treatment as recommended.

Glucocorticoids

Avoid repeated administration of high doses of glucocorticoids during treatment with BRAVNETSA.

USE IN SPECIFIC POPULATIONS

Advise patients not to breastfeed during BRAVNETSA treatment.

To report SUSPECTED ADVERSE REACTIONS, contact Lantheus at 1-800-362-2668 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for BRAVNETSA.

About Lantheus

Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and the United Kingdom, Lantheus has been providing radiopharmaceutical solutions for more than 70 years. For more information, visit www.lantheus.com.

Safe Harbor for Forward-Looking and Cautionary Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions 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 may be identified by their use of terms such as “expected,” “only,” “positioned,” “look forward,” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include: (i) our ability to successfully commercialize BRAVNETSA and achieve market adoption; (ii) the ability of our supply and distribution network to manufacture and deliver BRAVNETSA reliably; (iii) the existence, availability and profile of competing products; (iv) the outcome of pending or future litigation; and (v) the risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q).

References:

¹Neuroendocrine Tumors. Cleveland Clinic. Published June 26, 2024. Accessed May 22, 2025. https://my.clevelandclinic.org/health/diseases/22006-neuroendocrine-tumors-net

²Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589. PMID: 28448665; PMCID: PMC5824320.

³Kolarova T, et.al. P-136 Survey of challenges in access to diagnostics and treatment for neuroendocrine tumor patients (SCAN): Early diagnosis and treatment availability. Annals of Oncology, Volume 31, S134.

⁴Raphael MJ, Chan DL, Law C, Singh S. Principles of diagnosis and management of neuroendocrine tumours. CMAJ. 2017 Mar 13;189(10):E398-E404. doi: 10.1503/cmaj.160771. PMID: 28385820; PMCID: PMC5359105.

LUTATHERA^® is a registered trademark of Novartis AG and/or its affiliates.

Contacts:

Lantheus
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com

Melissa Downs
Executive Director, External Communications
646-975-2533
media@lantheus.com

SHENZHEN, CHINA, Sept. 22, 2026 (GLOBE NEWSWIRE) — Lianhe Sowell International Group Ltd (Nasdaq: LHSW) (the “Company”), a provider of industrial machine vision products and solutions in China, today announced that it has entered into a strategic cooperation agreement (the “Agreement”) with Kumquat Technology Co., Ltd. (“Kumquat Technology”), a subsidiary of Chery Group and the operating entity for its nationwide network of 1,000 4S stores, to promote intelligent equipment solutions across China’s automotive aftermarket.

Under the Agreement, the two companies will collaborate on intelligent equipment solutions covering 24 automotive aftermarket processes. Lianhe Sowell will provide complete sets of intelligent operating equipment, while Kumquat Technology will provide supporting automotive parts. The parties will also leverage their respective resources and capabilities to promote the solutions in the domestic market.

Kumquat Technology serves as the operating entity for Chery Group’s nationwide network of 1,000 4S stores, providing automotive aftermarket products and services through its extensive distribution and service network. Under the Agreement, Kumquat Technology will leverage this network to promote Lianhe Sowell’s intelligent equipment products to partner stores and downstream customers.

As part of the cooperation, demonstration sites for Lianhe Sowell’s intelligent equipment will be established at selected locations provided by Kumquat Technology, offering Kumquat Technology’s partner customers opportunities to experience the equipment and supporting product promotion.

Beyond the domestic market, the parties intend to explore overseas opportunities, with Kumquat Technology leading market development and operations and Lianhe Sowell providing products and technical support. The cooperation will also include cross-channel promotion of Kumquat Technology’s automotive aftermarket parts to Lianhe Sowell’s industry customers.

“We are pleased to establish this strategic cooperation with Kumquat Technology and expand the application of our intelligent equipment solutions across the automotive aftermarket,” said Mr. Yue Zhu, Chief Executive Officer and Director of the Company. “By combining Kumquat Technology’s automotive industry resources, channel network and aftermarket capabilities with our capabilities in intelligent equipment and industrial automation, we believe this cooperation can support the adoption of intelligent solutions across automotive aftermarket operations. We look forward to working together to develop a scalable model for intelligent upgrades in China and explore additional opportunities in international markets.”

About Lianhe Sowell International Group Ltd

Lianhe Sowell International Group Ltd (Nasdaq: LHSW) provides industrial vision and industrial robotics solutions. With expertise in the field of machine vision and intelligent equipment, the Company specializes in smart transportation, industrial automation, artificial intelligence, and machine vision. Committed to offering comprehensive intelligent solutions to customers worldwide, the Company continuously advances the intelligent transformation of various industries through technological innovation. For more information, please visit: https://sowellai.com/.

Forward-Looking Statement

This press release contains forward-looking statements. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as “may, “will, “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate,” “plan” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the uncertainties related to market conditions and other risk factors discussed in the Company’s filings with the SEC, which are available for review at www.sec.gov. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.

For more information, please contact:

Lianhe Sowell International Group Ltd
Email: ir@cnsoftweIl.com
WFS Investor Relations Inc.
Email: services@wfsir.com 
Phone: +1 628 283 9214