Tag: GlobeNewswire

Management call today at 3.30 pm CEST

Newron received the anticipated FDA written communication on clinical hold at U.S. study centers and is reviewing feedback and preparing its response

ENIGMA-TRS 1 enrollment expected to be completed by mid-October; topline 12-week data expected in Q1 2027

ENIGMA-TRS 2 enrollment continuing outside the U.S., with additional clinical sites being added as planned

FDA clinical hold remains in place at U.S. study centers; Newron intends to respond upon thorough review and analysis of FDA feedback

MILAN and MORRISTOWN, N.J., Oct. 08, 2026 (GLOBE NEWSWIRE) — Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that, further to its press release on September 25 2026, the Company has in the meantime received written communication from the U.S. Food and Drug Administration (FDA) regarding the clinical hold at U.S. study centers in its Phase 3 ENIGMA-TRS 2 study with evenamide. Newron is conducting a thorough review of the FDA’s feedback and the available data and intends to submit its response upon completion.

Newron continues to advance the Phase 3 ENIGMA-TRS development program. ENIGMA-TRS 1 enrollment is expected to be completed by mid-October, with topline 12-week data expected in Q1 2027. ENIGMA-TRS 2 enrollment continues outside the U.S. Additional clinical sites are being added as planned.

FDA Clinical Hold and ENIGMA-TRS Program Update

The FDA’s concern relates to the known risk that certain members of the class of sodium channel blockers may trigger arrhythmias which in turn can lead to serious cardiovascular events or seizures. Evenamide is a glutamate modulator via its action as a selective voltage-gated sodium channel blocker.

In its written communication, the FDA notes four deaths among patients treated with evenamide across all clinical studies with evenamide to date, compared with one death among patients receiving placebo. Of the four deaths among patients receiving evenamide, three were considered unrelated to evenamide by the study investigators, while one was considered “possibly related” because two autopsies could not identify a definitive cause of death. The four deaths have been characterized by the FDA as a potential safety signal based on the possibility of a fatal arrhythmic mechanism, which cannot be definitively excluded through post hoc adjudication. Evenamide is also known to result in a very small shortening of the QTc interval on an electrocardiogram (ECG). Unlike QTc prolongation, there is no established risk or intervention threshold for QTc shortening, and a standard screening ECG does not reliably exclude latent sodium-channel disorders in asymptomatic patients.

Newron is reviewing the FDA’s feedback and the full body of safety data generated across the evenamide development program, which includes more than 10,000 ECGs from approximately 700 evenamide-treated subjects and input from independent cardiac electrophysiologists. Newron has not observed a pattern of cardiac abnormalities or arrhythmias in the preclinical and clinical safety data generated with evenamide to date. This includes a thorough QT study and more than 5,000 ECGs from over 700 patients with schizophrenia. As part of its response, Newron is also evaluating additional cardiac screening and monitoring measures for ENIGMA-TRS 2.

“We remain confident in the ENIGMA-TRS studies and encouraged by the program’s progress. Our belief in the potential of evenamide and its novel mechanism for patients with treatment-resistant schizophrenia remains strong,” said Ravi Anand, MD, Chief Medical Officer of Newron. “Patient safety is our utmost priority. Our team is working with high commitment to complete a thorough review of the FDA’s feedback and the available data, and to submit our response upon its completion. Our assessment is supported by the substantial body of preclinical and clinical safety data generated with evenamide. To date, we have not observed a pattern of cardiac abnormalities or arrhythmias. The four deaths among patients treated with evenamide represent an incidence of 0.56%, compared with one death and an incidence of 0.27% among patients receiving placebo. When adjusted for duration of treatment, the mortality rate was 1.31 per 100 patient-years for evenamide compared with 1.81 per 100 patient-years for placebo.”

Professor Dr. Peter Falkai, Chair Department of Psychiatry and Psychotherapy, LMU University of Munich, stated: “Schizophrenia is a tragic disease that affects patients in the teenage (males) and early twenties (females) and has a devastating effect on their lives. In addition to multiple episodes of psychosis and hospitalization, patients need to take antipsychotic medication with debilitating side-effects that makes them suffer from cardiac, hormonal, metabolic and motor disorders. Furthermore, schizophrenia reduces life-expectancy by about 10 years. TRS, a more severe form of the disease in which patients do not respond to any medication, reduces longevity by about 20 years.”

Investor Update Conference Call
Management will provide a brief update on the FDA clinical hold and ENIGMA-TRS development program. The call will be recorded and take place today at 3.30 pm CEST.

The access details:

Switzerland / Europe United Kingdom United States	+41 (0) 58 310 50 00 +44 (0) 203 059 58 63 +1 (1) 631 570 56 13

Other international numbers available here.

About ENIGMA-TRS 
ENIGMA-TRS 1 is an ongoing, international, 52-week, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy, tolerability, and safety of the 15mg BID and 30mg BID therapeutic doses of evenamide compared to placebo. Patients on second-generation antipsychotics, including clozapine, will meet Treatment Response and Resistance Psychosis international consensus criteria for TRS. The study is expected to have enrolled at least 600 patients in the study by mid-October 2026, at study centers in 20 countries in Europe, Asia, Latin America, and Canada.

The primary assessment of efficacy and safety of ENIGMA-TRS 1 will be performed 12 weeks after randomization to treatment. Following this initial period, the study will continue to be double-blind and placebo-controlled until the 26- and 52-week time points. The primary efficacy endpoint of the trial will be the change from baseline in the Positive and Negative Syndrome Scale (PANSS) scores at 12 weeks. Newron expects to announce results from the 12-week primary endpoint assessment in Q1 2027.

ENIGMA-TRS 2 is taking place at centers in the U.S. and selected additional countries with the same screening procedure as the ENIGMA-TRS 1 trial. ENIGMA-TRS 2 will include at least 400 patients in a 12-week, randomized, double-blind, placebo-controlled Phase 3 study, designed to evaluate the efficacy, tolerability, and safety of the 15mg BID dose of evenamide compared to placebo. In December 2025, ENIGMA-TRS 2 was initiated in the U.S., following approvals from the U.S, Food and Drug Administration (FDA) and the Institutional Review Board (IRB). The efficacy and safety analysis will be performed at the 12-week point following successful completion of the study. On April 29, 2026, Newron reported a hold by the FDA on the enrollment of new patients in the U.S. sites of the study. While U.S. patients entered screening, no U.S. patients have been dosed with evenamide, in the study.

About Newron Pharmaceuticals
Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently developed in the global pivotal ENIGMA-TRS Phase 3 development program. Clinical trial results to date demonstrate the benefits of this drug candidate in TRS as well as poorly responding patient population, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron’s first marketed product, Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea. The product is commercialized by Newron’s partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. For more information, please visit: https://www.newron.com and connect with us on LinkedIn.

For more information, please contact:

Newron
Stefan Weber – CEO; +39 02 6103 46 26, pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com

Switzerland
Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe
Anne Hennecke / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu

USA
John Fraunces, LifeSci Advisors; +1 917 355 2395, jfraunces@lifesciadvisors.com

Important Notices
This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

Leadership investment supports expanded hospital commercial push

POMPANO BEACH, Fla., Oct. 08, 2026 (GLOBE NEWSWIRE) — BioStem Technologies, Inc. (Nasdaq: BSEM) (“BioStem” or the “Company”), a leading regenerative medicine company focused on the development, manufacturing, and commercialization of perinatal tissue allograft products, today announced its Chair and Chief Executive Officer, Jason Matuszewski, and Chief Operating Officer, Andrew Van Vurst, each exercised a portion of their outstanding options to purchase 250,000 shares of BioStem common stock at an exercise price of $2.00 per share, for a total of 500,000 shares and an aggregate purchase price of approximately $1 million.

“This is an exciting and important time for the Company,” said Mr. Matuszewski. “Hospitals are increasingly seeking wound care and surgical solutions that are clinically supported, reliably supplied, and economically sensible and we believe we have built one of the broadest perinatal allograft portfolios in the industry to meet exactly that need. Exercising these options reflects my continued confidence in the Company, our team and the potential for our technology. I believe this capital will support broader sales coverage, expanded hospital formulary coverage, and the inventory needed to support new accounts.  I am proud to reiterate my support and remain highly committed to creating long-term value for fellow shareholders.”

“Our role on the operations side is to help ensure that growth does not outpace our ability to deliver, and we’ve built BioStem with that objective in mind,” said Mr. Van Vurst. “I see the progress every day, in our production, quality processes, and supply planning. We believe the additional capital will help support the inventory and infrastructure needed to serve new hospital accounts, and we remain focused on consistent execution for the customers and patients who rely on our products.”

Forward-Looking Statements:

Certain statements in this press release may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified using words such as “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate”, “plan,” “outlook,” “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements in this press release include, without limitation, statements regarding the application of new capital received by the Company, the Company’s ability to meet market needs and the Company’s growth prospects.

Forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties which could cause actual results or outcomes to differ materially from the expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: the Company’s ability to maintain compliance with Nasdaq’s continued listing standards; the Company’s ability to obtain financing on terms acceptable to it, or at all; the impact of any changes in applicable laws or regulations; the Company’s accounts receivable collection risk and concentration; the Company’s ability to maintain production of its products in sufficient quantities to meet demand; and the possibility that the Company may be adversely affected by other general economic, business, and/or competitive factors. There may be additional risks which the Company is presently unaware of or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company undertakes no duty to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

About BioStem Technologies, Inc. (Nasdaq: BSEM): BioStem Technologies, Inc. is a publicly traded, biomedical innovator, focused on developing, manufacturing and commercializing advanced allograft solutions derived from perinatal tissue. The company leverages its industry-leading proprietary BioRetain®, CryoTek® and SteriTek® processing technologies, designed to optimize the preservation of the natural properties of these tissues, supporting their use in clinical settings. Its allografts are used by clinicians across a wide range of specialties. With a growing portfolio of products, expanding clinical research initiatives, and a national commercial footprint, BioStem is committed to advancing innovation in regenerative medicine.

BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the Association for Advancing Tissue and Biologics (“AATB”). These systems and procedures are established in compliance with current Good Tissue Practices (“cGTP”) and current Good Manufacturing Practices (“cGMP”). BioStem’s portfolio of quality brands includes its Neox®, Clarix®, VENDAJE® and American Amnion™ product lines.

Join BioStem’s Distribution List & Social Media:
To follow the latest developments at BioStem, sign up for the Company’s email distribution list HERE, and follow us on X and LinkedIn.

Contact BioStem:
Website: www.biostemtechnologies.com
E-Mail: pr@biostemtech.com
X: @BSEM_Tech
Facebook: BioStemTechnologies
Phone: 954-380-8342

Investor Relations:
Philip Trip Taylor, Gilmartin Group
ir@biostemtech.com

New Platform Enhancements and AI-Powered Capabilities Can Help Pest Control Operators Improve Efficiency, Strengthen Customer Experiences, and Drive Profitable Growth

ORLANDO, Fla., Oct. 08, 2026 (GLOBE NEWSWIRE) — FieldRoutes, a ServiceTitan product and leading cloud-based and mobile SaaS provider for field service businesses, is announcing today, at Ignite 2026, FieldRoutes’ annual user conference, its next phase of product innovation, including continued enhancements across dispatch and routing, mobile, reporting, billing and sales, alongside new AI-powered capabilities designed to help pest control operators run more efficient and profitable businesses.

“Pest control operators need technology that keeps pace with the way their businesses are evolving, and we’re continuing to invest in FieldRoutes with that goal in mind,” said Scott Traina, General Manager of Property Care at ServiceTitan. “By strengthening the workflows our customers rely on every day and bringing AI into the moments where it can make a meaningful difference, we’re helping operators spend less time on manual work, make better decisions, and focus on delivering great service and growing their businesses.”

Over the past 18 months, FieldRoutes has focused on strengthening the foundation of its platform through improvements to reliability, architecture, data infrastructure and core workflows. Building on that work, FieldRoutes is now taking a balanced approach to innovation that combines continued improvements to the workflows operators rely on every day with AI designed to save time and improve business outcomes.

Recent and upcoming FieldRoutes innovations are focused on the workflows pest control operators rely on every day, including:

• AI-driven Command Center for smarter business decisions: Upcoming capabilities can bring conversational analytics, customizable dashboards, and proactive monitoring together to help operators uncover insights across their business, identify emerging issues and opportunities, and make more informed decisions.
• Revenue Retention to identify at-risk customers sooner: Upcoming capabilities can surface data-driven indicators of potential churn and help teams understand the signals behind them, giving operators an opportunity to strengthen customer relationships and retain valuable accounts before they’re lost.
• Smarter dispatch and routing: Improve route visibility, map performance, and scheduling workflows to help teams manage field operations more efficiently, with upcoming intelligent dispatch capabilities designed to help identify opportunities to fill same-day openings when cancellations occur.
• More flexible revenue and sales workflows: Give operators greater flexibility to manage and grow revenue through enhancements across billing, prepayments, autopay, territory management, and sales controls.

Looking ahead, FieldRoutes plans to continue bringing AI into specific workflows where it can save time and improve business outcomes. Together, these investments are designed to help operators spend less time searching for information and managing manual processes, identify opportunities and challenges sooner, and make more informed decisions across their businesses.

As ServiceTitan continues investing across its property care portfolio, FieldRoutes will remain focused on serving local and regional pest control operators that prioritize turnkey configuration and purpose-built workflows. FieldRoutes and ServiceTitan will both continue to receive product investment and innovation, giving operators options as their businesses and technology needs evolve.

For more information about FieldRoutes and announcements from Ignite 2026, follow Ignite’s Live Blog here.

About FieldRoutes
FieldRoutes, a ServiceTitan product, is a leading cloud-based and mobile SaaS provider for field service businesses. FieldRoutes’ platform automates many aspects of field service operations for enterprise and small business customers with office management, advanced route optimization, payment processing, digital sales, marketing, and customer acquisition capabilities. Field service providers across the country rely on FieldRoutes to provide them with data-driven insights to become more efficient and drive revenue to their business, so they can grow quickly, scale intelligently, and serve their customers relentlessly.

© 2026 Field Service Holdings, LLC. All rights reserved. FieldRoutes, PestRoutes, and all FieldRoutes and PestRoutes product and service names mentioned herein are registered trademarks or unregistered trademarks of Field Service Holdings, LLC or its affiliates in the United States and other countries. Other brand names and marks mentioned herein are for identification purposes only and may be the trademarks of their respective holder(s).

Press Contact
Sarah Cantu
press@fieldroutes.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact contained in this press release may be forward-looking statements. These include statements regarding the plans of ServiceTitan, Inc. (“ServiceTitan”) for current or future FieldRoutes products, services or features, including Command Center, Revenue Retention, intelligent dispatch, enhancements to dispatch and routing, mobile, reporting, billing and sales workflows, and other AI-powered and agentic functionality or features; the expected availability, timing, capabilities and benefits of those products, services and features; plans to bring AI into additional workflows; plans for continued product investment and innovation in FieldRoutes and ServiceTitan; and ServiceTitan’s market positioning, customer focus and business strategy across its property care portfolio. They also include statements identified by words such as “expects,” “anticipates,” “believes,” “plans,” “intends,” “will,” “upcoming,” “looking ahead,” “designed to,” and similar expressions. These forward-looking statements are not promises or guarantees of future results. They are based on current expectations only and are subject to various risks and uncertainties, including those described in ServiceTitan’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as updated in its other filings with the U.S. Securities and Exchange Commission from time to time. Actual results may differ materially from those anticipated in these statements due to several factors, including those referenced in ServiceTitan’s filings with the U.S. Securities and Exchange Commission. Products, services or features described in this press release that are not currently generally available, including those described as “upcoming,” may not be delivered on the anticipated timeline or at all. Purchasing decisions should be based on products, services and features that are currently generally available. Forward-looking statements, including those made during the Ignite 2026 keynote sessions and any replay of them, speak only as of the date they are made, and ServiceTitan undertakes no obligation to update any forward-looking statements, except as required by law.

VANCOUVER, British Columbia, Oct. 08, 2026 (GLOBE NEWSWIRE) — Xali Gold Corp. (TSXV:XGC) (“Xali Gold” or the “Company”) is pleased to announce that a public information workshop was successfully completed on October 7, 2026, as part of the Ficha Técnica Ambiental (“FTA”) approval process for the planned drilling program at its Pico Machay Gold Project (“Pico Machay” or the “Project”) in Peru. Completion of the workshop marks an important step toward submission of the Company’s FTA application.

The workshop was organized by Peru’s Ministry of Energy and Mines (“MINEM”), in coordination with the executives of the department of Energy and Mines of the Regional Government of Huancavelica and the Company. Approximately 60 residents attended from the various annexes of the Comunidad Campesina de Salcca Santa Ana (“Santa Ana community”) within the Project’s area of influence, including the presidents of five of its six annexes, the community president and two members of the community’s governing board, and the president of the alpaca breeders’ association.

Participants had the opportunity to hear directly from and ask questions of government representatives, Geades Consultores, the Company’s Peru-based environmental consultant, and Xali Gold’s team. Discussions covered the proposed drilling program, environmental and social aspects of exploration, applicable laws and measures to protect community interests, as well as the Company’s broader exploration and potential development plans.

“Completion of this workshop is an important step in advancing our exploration permit application and continuing an open dialogue with the Santa Ana community,” said Joanne Freeze, President and CEO of Xali Gold. “The participation and questions raised demonstrate the community’s interest in understanding the proposed work, how the environment will be protected and the laws that govern our activities. We thank all community members who attended, MINEM, the Regional Government of Huancavelica, Geades Consultores and our team for their contributions.”

Image 1: Public information workshop with members of the Santa Ana community, government representatives, environmental consultants and Xali Gold’s team on October 7, 2026.

FTA Process and Next Steps

As reported in Xali Gold’s September 17, 2026 news release, the Company completed two technical meetings with Peru’s MINEM to obtain guidance on updated FTA requirements. Xali Gold also engaged Embellie Advisory LLC to assess potential effects of the proposed drilling on the collective rights of indigenous or native community members and assist with the related application requirements.

With the workshop now completed, the Company is working to finalize its FTA application, with submission targeted for next week. Based on guidance received, the review and approval process is anticipated to take approximately 10 days following submission, although actual timing remains subject to the regulatory process.

The planned 3,000-metre diamond drill program includes approximately 2,000 metres of drilling to twin selected historical reverse-circulation holes. This work is intended to support an updated mineral resource estimate and subsequent Preliminary Economic Assessment.

Ongoing Community Engagement

The workshop builds on the community authorization announced in Xali Gold’s July 9, 2026 news release. At an extraordinary assembly held on June 28, 2026, the Santa Ana community authorized the Company to undertake drilling, exploration and environmental studies at Pico Machay.

Xali Gold remains committed to ongoing engagement with the community as the Project advances, with an emphasis on transparent communication, respect for local priorities and opportunities for community participation.

About Pico Machay

Located within the Southern Peru Epithermal Gold-Silver Belt, Pico Machay sits in a historically productive mining district in the Western Cordillera of the Andes (click here for location map). The Project benefits from existing infrastructure and a mining-friendly community eager to partner on sustainable development.

Xali Gold remains confident in the significant upside potential at Pico Machay, which hosts a historical resource and several untested exploration targets on the Project. Various historical engineering studies at Pico Machay were completed through 2009 and evaluated the potential for a low-cost, low strip-ratio, open-pit heap-leach operation. Given that those studies were based on a long-term gold price of $700/oz and several exploration targets remain untested, Xali Gold considers the upside potential to be very strong.

About Xali Gold

Xali Gold is a gold and silver exploration company focused on advancing opportunities in the Americas. The Company is focused on the exploration and development of Pico Machay, an advanced exploration-stage gold project in Peru with a near-term production goal. 

The Company’s approach to community engagement and responsible development is guided by strong governance principles and Board oversight that support long-term stakeholder relationships.

Joanne C. Freeze, P.Geo. is a Qualified Person as defined by National Instrument 43-101 and has reviewed and approved the contents of this release.

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

On behalf of the Board of Xali Gold Corp.

“Joanne Freeze” P.Geo.
President, CEO and Director

For further information please contact:
Joanne Freeze, President & CEO                                
Tel: + 1 (604) 512-3359                                                                 
info@xaligold.com                

Forward-looking Disclaimer
This press release contains forward-looking information within the meaning of Canadian securities laws (“forward-looking statements”). Forward-looking statements are typically identified by words such as: believe, expect, anticipate, intend, estimate, plans, postulate and similar expressions, or are those, which, by their nature, refer to future events. All statements that are not statements of historical fact are forward-looking statements.

Forward-looking statements in this press release include, without limitation, statements regarding: the finalization and submission of the FTA application, including the anticipated submission approximately one week after the public workshop; the anticipated review and approval period of approximately 10 days following submission and receipt of approval, if at all; the completion of final preparations for drilling; the commencement, scope, timing and completion of the planned 3,000-metre diamond drill program, including approximately 2,000 metres of drilling to twin selected historical reverse-circulation holes; the anticipated contribution of the drilling program to an updated mineral resource estimate and subsequent Preliminary Economic Assessment; ongoing community engagement and opportunities for community participation; and the continued exploration, advancement and potential development of the Project.

These forward-looking statements are made as of the date of this press release. Although the Company believes the forward-looking statements in this press release are reasonable, it can give no assurance that the expectations and assumptions in such statements will prove to be correct. The Company cautions investors that any forward-looking statements by the Company are not guarantees of future results or performance, and are subject to risks, uncertainties, assumptions and other factors which could cause events or outcomes to differ materially from those expressed or implied by such forward-looking statements.

Known risk factors and assumptions include risks associated with exploration and project development; accessing further funding and related dilution: continuing its projected growth, or being fully able to implement its business strategies; the calculation of mineral resources and additional work required to convert historical resources to current mineral resources; the nature, quality and quantity of any mineral deposits that may be located on the project; operational risks associated with mining and mineral processing; fluctuations in metal prices and assumptions including costs; title matters; government regulation; obtaining and renewing necessary consents, authorizations, licenses and permits; environmental liability and insurance; reliance on key personnel; local community opposition; currency fluctuations; labour disputes; competition; variations in market conditions, and the volatility of our common share price and volume; future sales of shares by existing shareholders; and other risk factors described in Xali Gold’s MD&A and other filings with Canadian securities regulators, which may be viewed at www.sedarplus.ca. Although we have attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended.

There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Xali Gold expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b16bc583-d325-4aa2-ab94-f0e9810064dc

New Intelligence Layer Helps Contractors Identify Operational Challenges, Make Smarter Decisions, and Drive Profitable Growth

ORLANDO, Fla., Oct. 08, 2026 (GLOBE NEWSWIRE) — Aspire Software, a ServiceTitan company and leading software provider for landscape businesses, today announced that it will unveil Command Center at Ignite 2026, Aspire’s annual user conference, with limited access opening to a limited group of Aspire customers. A new intelligence layer across Aspire, Command Center gives landscape contractors a near real-time view of their operations, helping them identify issues and opportunities sooner, make more informed decisions, improve efficiency, and drive profitable growth.

“Landscape contractors have an incredible amount of data across their businesses, but the real value comes from being able to understand what that data is telling them and use it to make better decisions,” said Vahe Kuzoyan, Co-Founder and President of ServiceTitan. “Command Center is designed to bring intelligence to the forefront, helping contractors understand what’s happening across their operations, identify opportunities sooner, and focus their attention where it can have the greatest impact on their business.”

Rather than relying on static reports, overnight data synchronization, or third-party analytics tools, contractors can access near real-time insights across individual branches or their entire business, helping them identify issues and opportunities and make more informed decisions.

By bringing together Aspire’s foundational business data with Atlas, ServiceTitan’s conversational agent, Command Center is purpose-built for the way landscape businesses operate. Contractors can ask questions about their business, create customized dashboards, and proactively identify opportunities to improve performance, with an experience that becomes more tailored to the needs of their business over time.

Command Center will introduce new AI-powered capabilities designed to:

• Turn business data into actionable insights: Give contractors a near real-time view of operational and financial performance across their business, helping them identify issues and opportunities and determine where action may be needed.
• Simplify business intelligence with conversational AI: Enable users to ask Atlas questions about their business data in plain English and generate customized charts and dashboards without specialized technical expertise.
• Proactively identify operational challenges: Surface issues such as declining crew productivity, overdue invoices, and eroding contract margins through automated alerts delivered via email.
• Build customized alerts and dashboards: Allow users to describe the information they want to monitor in plain English, create alerts tailored to their business, and access ready-made dashboards without relying on dedicated analysts or complex reporting tools.

Command Center early access will be limited to 100 Aspire customers, with general availability expected early next year. For more information about Aspire Software, Command Center, and Ignite, follow Ignite’s Live Blog here.

About Aspire Software
Aspire Software, a ServiceTitan company, offers business management software for landscape maintenance, landscape construction, and snow & ice management companies. Aspire’s cloud-based SaaS solution helps field service companies manage, create, and execute against their business opportunities and challenges. Aspire helps contractors change the way they manage their business to enable them to provide better service, improve margins, and increase productivity. For more information, please visit http://www.youraspire.com.

© 2026 Aspire Software. All rights reserved. Aspire Software, the Aspire Software logo, and all Aspire Software product and service names mentioned herein are registered trademarks or unregistered trademarks of Aspire Software in the United States and other countries. Other brand names and marks mentioned herein are for identification purposes only and may be the trademarks of their respective holder(s).

Press Contact
Sarah Cantu
press@youraspire.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact contained in this press release may be forward-looking statements. These include statements regarding the plans of Aspire Software and its parent company, ServiceTitan, Inc. (“ServiceTitan”), for current or future products, services or features, including Command Center, Atlas, and other AI-powered and agentic functionality or features; the expected availability, timing, capabilities and benefits of those products, services and features, including their ability to deliver near real-time insights, surface operational issues, and become more tailored to a business over time; and Aspire and ServiceTitan’s market positioning and business strategy. They also include statements identified by words such as “expects,” “anticipates,” “believes,” “plans,” “intends,” “will,” “designed to,” and similar expressions. These forward-looking statements are not promises or guarantees of future results. They are based on current expectations only and are subject to various risks and uncertainties, including those described in ServiceTitan’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as updated in its other filings with the U.S. Securities and Exchange Commission from time to time. Actual results may differ materially from those anticipated in these statements due to several factors, including those referenced in ServiceTitan’s filings with the U.S. Securities and Exchange Commission. Products, services or features described in this press release that are not currently generally available may not be delivered on the anticipated timeline or at all. Purchasing decisions should be based on products, services and features that are currently generally available. Forward-looking statements, including those made during the Ignite 2026 keynote sessions and any replay of them, speak only as of the date they are made, and neither Aspire nor ServiceTitan undertakes any obligation to update any forward-looking statements, except as required by law.

CAMBRIDGE, Mass., Oct. 08, 2026 (GLOBE NEWSWIRE) — Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today announced that the first patient has been dosed in its pivotal Phase 2 study of CLN-049, a novel, investigational FLT3 T cell engager, in patients with relapsed/refractory acute myeloid leukemia (AML).

“Patients with relapsed or refractory AML continue to face poor outcomes and limited treatment options, underscoring the urgent need for new treatment approaches that can benefit a broad range of patients,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “We believe CLN-049 has the potential to offer a novel immunotherapeutic approach for patients with AML. With this Phase 2 study now underway, we look forward to further evaluating the potential role of CLN-049 for this difficult-to-treat disease.”

The Phase 2 study is designed to evaluate CLN-049 in patients with relapsed/refractory AML who have received up to two lines of prior therapy. Following a successful End-of-Phase 1 meeting with the U.S. FDA, the potentially registrational study incorporates a brief dose-optimization phase evaluating two target dose levels of CLN-049, followed by seamless advancement to a single-arm expansion cohort at the recommended Phase 2 dose. The study also includes an exploratory cohort evaluating CLN-049 in patients with newly diagnosed TP53-mutated AML. The company expects to provide an update from the Phase 1 dose escalation study of CLN-049 in patients with relapsed/refractory AML in December.

In parallel, the company is initiating a Phase 1/2 study evaluating the combination of CLN-049, azacitidine, and venetoclax in patients with newly diagnosed AML.

About CLN-049

CLN-049 is a novel, investigational FLT3xCD3 T cell engager. CLN-049 is designed to target FLT3-expressing leukemia cells, offering a new immunotherapeutic approach for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CLN-049 binds to both mutated and non-mutated FLT3, allowing targeted action regardless of FLT3 mutational status, making the investigational treatment widely applicable to a broad population.

CLN-049 is being studied in a Phase 1/2, open-label, multicenter, multiple ascending dose study evaluating safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of intravenously (IV) administered CLN-049 in patients with relapsed/refractory AML or MDS (NCT05143996).

CLN-049 is also being studied in a Phase 1/2, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and PD of IV-administered CLN-049 in combination with azacitidine and venetoclax in patients with newly diagnosed AML (NCT07722767).

CLN-049 has received Orphan Drug designation and Fast Track designation from the U.S. FDA for the treatment of relapsed/refractory AML.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow, and the most common form of acute leukemia in adults.¹ It is characterized by the rapid growth of abnormal white blood cells that crowd out healthy cells, leading to infections, fatigue, and bleeding.² Each year in the U.S., approximately 23,000 people are diagnosed with AML, and about half as many lives are lost to the disease.³ Globally, AML affects an estimated 145,000 people annually, with approximately 130,000 deaths.⁴

Despite recent advances, outcomes for patients with AML remain poor, particularly for those with relapsed or refractory disease, where five-year survival is 10% or less.⁵ Patients with high-risk genetic features, such as complex karyotype or TP53 mutations, face especially limited options.^6,7 Intensive treatments like chemotherapy and stem cell transplantation may be inaccessible for many older patients due to severe side effects.⁷ Currently, there are no approved immunotherapies for AML, underscoring the urgent need for novel therapeutic approaches that can improve outcomes for patients and their families facing this life-threatening disease.

About Cullinan Therapeutics

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company developing potential first- or best-in-class, disease-modifying T cell engagers for autoimmune diseases and cancer. Cullinan pursues promising therapeutic targets while leveraging core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, Cullinan is advancing its mission to deliver new standards of care for patients. Learn more about Cullinan at https://cullinantherapeutics.com/, and follow Cullinan on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding: our clinical development plans and timelines for CLN-049, the clinical and therapeutic potential of CLN-049, the strategy of CLN-049, our research and development activities, and other statements that are not historical facts. The words “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “potential,” “project,” “pursue,” “will,” 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 of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any INDs, NDAs or other global regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared or approved on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics on our business and operations; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.

Contacts

Investors
Nick Smith
+1 401.241.3516
nsmith@cullinantx.com

Media 
Rose Weldon
+1 215.801.7644
rweldon@cullinantx.com

References

1. American Association for Cancer Research. (2025). Acute Myeloid Leukemia. https://www.aacr.org/patients-caregivers/cancer/acute-myeloid-leukemia/
2. Leptidis, J., et al. (2014). Fatal cardiac tamponade as the first manifestation of acute myeloid leukemia. Am J Emerg Med 32(10). https://doi.org/10.1016/j.ajem.2014.02.045
3. National Cancer Institute. (2025). Cancer Stat Facts: Leukemia — Acute Myeloid Leukemia (AML). https://seer.cancer.gov/statfacts/html/amyl.html
4. Zhou, Y., et al. (2024). Global, regional, and national burden of acute myeloid leukemia, 1990–2021: A systematic analysis for the Global Burden of Disease Study 2021. Biomarker Research, 12(101). https://doi.org/10.1186/s40364-024-00649-y
5. Moore, CG., et al. (2025). Treatment of Relapsed/Refractory AML—Novel Treatment Options Including Immunotherapy. Am J Hematol. (100)2. https://doi.org/10.1002/ajh.27584
6. Shahzad, M., et al. (2024). What have we learned about TP53-mutated acute myeloid leukemia?. Blood Cancer J. 14(202). https://doi.org/10.1038/s41408-024-01186-5
7. Kantarjian, H., et al. (2021). Acute myeloid leukemia: current progress and future directions. Blood Cancer J. 11(2). https://doi.org/10.1038/s41408-021-00425-3 

SAGUENAY, Quebec, Oct. 08, 2026 (GLOBE NEWSWIRE) — Arianne Phosphate (the “Company” or “Arianne”) (TSX VENTURE: DAN; OTCQB: DRRSF; FRANKFURT: JE9N), a development-stage phosphate mining company, advancing the Lac à Paul project in Quebec’s Saguenay-Lac-Saint-Jean region, is pleased to announce the receipt of positive test results from a Western-based battery materials maker, advancing its goal of a fully integrated North American battery supply chain. The purified phosphoric acid (“PPA”) tested was produced through Arianne’s previously announced joint venture with Travertine Technologies Inc. (“Travertine”), combining Arianne’s high-purity, low-contaminant phosphate concentrate with Travertine’s proprietary process for producing PPA while allowing for the recapture of the sulphuric acid used in the process.

As previously announced (see Press Release dated July 9, 2026), Arianne shipped PPA samples to potential customers covering three separate industries: a CAM producer for ultimate use in LFP (lithium-iron-phosphate) batteries, a diversified industrial chemicals producer that uses PPA for water treatment and pulp & paper applications and a specialized liquid fertilizer producer. The samples were produced at pilot scale by the Arianne-Travertine partnership. The CAM producer referenced in that release has now completed preliminary testing and confirmed that the PPA meets the indicative specifications required for its LFP CAM production.

“Having our PPA meet the specifications of a CAM producer is a significant milestone for Arianne and our Travertine JV project,” said Brian Ostroff, Head of Strategic & Business Initiatives at Arianne Phosphate. “The LFP battery has some of the most demanding purity requirements of any application for phosphoric acid and these results validate what we have been saying for some time: our high-purity, low-contaminant phosphate concentrate allows for the production of a PPA suited for the most demanding applications. With LFP demand growing rapidly and the West looking to reduce its reliance on a single source of supply, being able to offer a Western-sourced PPA is something we believe will be of considerable interest.”

Aside from its use in the LFP battery, PPA is a necessary ingredient for many applications required in everyday use. Food additives, pharmaceuticals, semiconductor production and water treatment are all reliant on access to this critical liquid and Western production currently does not meet industry’s requirement. Further complicating supply challenges are the current disruptions to the global supply of sulphur, a necessary component in the processing of many commodities, including phosphate concentrate into all downstream products.

Arianne Phosphate’s Lac à Paul project is situated in Quebec, Canada and hosts the world’s largest greenfield phosphate deposit. Being igneous, the ore body is geologically rare and allows for the easy transformation into a high-quality, premium-priced PPA. As the West’s only permitted greenfield phosphate mine, Arianne can address the growing demand for this critical material and do so from geopolitically secure jurisdiction. The Company’s JV project with Travertine will also greatly reduce (95%) the requirements of sulphuric acid and potentially significantly reduce OpEx costs associated with PPA production.

In April, Arianne announced that it had entered into an option agreement on behalf of the future Arianne/Travertine JV for a facility to be used as a demonstration plant for the production of PPA using this proprietary process (see Press Release dated April 21, 2026). The facility is based in the Saguenay-Lac-Saint-Jean region of Quebec, Canada; easy trucking distance from Arianne’s future mine site. Advancing this project has the potential to form a Canadian supply chain for LFP battery materials, from phosphate mine to production of acid, and ultimately to the cathode. Like most battery technologies, China currently dominates LFP production and, as the West continues to adopt the LFP for electric vehicles, energy storage and defense applications, production from other geographies will be necessary.

About Arianne Phosphate:
Arianne Phosphate (“Arianne Phosphate Inc.”) (www.arianne-inc.com) is developing the Lac à Paul phosphate deposits located approximately 200 km north of the Saguenay/Lac St. Jean area of Quebec, Canada. These deposits will produce a high-quality igneous apatite concentrate grading 39% P₂O₅ with little or no contaminants (Feasibility Study released in 2013).

About Travertine: 
Travertine was founded in 2022 to solve one or the most pressing problems in the mining industry: producing vital elements without creating mountains of waste. Their proprietary electrochemical technology completely converts phosphate ore concentrate into valuable products – phosphoric acid, cementitious materials, and co-produced critical elements – closing the loop between the extraction and construction industries for cleaner chemical production. Their gypsum-free, solvent-free process will become the standard for next generation, cleaner purified phosphoric acid production. To learn more, visit www.travertinetech.com. 

Qualified Person
Raphael Gaudreault, eng., Qualified Person by Regulation 43-101, has approved the technical information in this release. Mr. Gaudreault is also the Company’s Chief Operating Officer.

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

Contact Information:

Technical	Info
Raphael Gaudreault	Brian Ostroff
Chief Operating Officer	Head of Strategic & Business Initiatives
Tel.: 418-590-1318	Tel.: 514-928-9952
raphael.gaudreault@arianne-inc.com	brian.ostroff@arianne-inc.com

Follow Arianne on:
Facebook: https://www.facebook.com/ariannephosphate
Twitter: http://twitter.com/arianne_dan
YouTube: http://www.youtube.com/user/ArianneResources
Flickr: http://www.flickr.com/photos/arianneresources
Resource Investing News: http://resourceinvestingnews.com/?s=Arianne

Cautionary Statements Regarding Forward Looking Information

This news release contains “forward-looking statements” and “forward-looking information” within the meaning of applicable securities regulations in Canada and the United States (collectively, “forward-looking information”). Forward-looking information includes, but is not limited to, the Company’s anticipated quality and production of the apatite concentrate at the Lac à Paul project. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects, “is expected”, “budget”, “scheduled”, “estimates”, forecasts”, “intends”, “anticipates”, or “believes”, or the negatives thereof or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, or “will” be taken, occur or be achieved.

Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking information, including but not limited to: unforeseen delays in the execution of the definitive agreements in connection with the credit facility extension or in obtaining regulatory approval; inability to complete the credit facilities extension by the Closing Date; volatile stock price; risks related to changes in commodity prices; sources and cost of power facilities; the estimation of initial and sustaining capital requirements; the estimation of labour and operating costs; the general global markets and economic conditions; the risk associated with exploration, development and operations of mineral deposits; the estimation of mineral reserves and resources; the risks associated with uninsurable risks arising during the course of exploration, development and production; risks associated with currency fluctuations; environmental risks; competition faced in securing experienced personnel; access to adequate infrastructure to support mining, processing, development and exploration activities; the risks associated with changes in the mining regulatory regime governing the Company; completion of the environmental assessment process; risks related to regulatory and permitting delays; risks related to potential conflicts of interest; the reliance on key personnel; financing, capitalization and liquidity risks including the risk that the financing necessary to fund continued exploration and development activities at Lac à Paul project may not be available on satisfactory terms, or at all; the risk of potential dilution through the issue of common shares; the risk of litigation.

Forward-looking information is based on assumptions management believes to be reasonable at the time such statements are made, including but not limited to, the material terms of the credit facility extension having been agreed to by the parties, continued exploration activities, no material adverse change in commodity prices, exploration and development plans proceeding in accordance with plans and such plans achieving their stated expected outcomes, receipt of required regulatory approval, and such other assumptions and factors as set out herein. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in the forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such forward-looking information. Accordingly, readers should not place undue reliance on forward-looking information. Forward-looking information is made as of the date of this press release, and the Company does not undertake to update such forward-looking information except in accordance with applicable securities laws.

– Repayment of Existing Loan Facility Completed –

– Strengthens Financial Flexibility with Access to Funding for Corporate and Commercial Activities –

– Expect Completion of Enrollment in Phase 3 4WARD trial by Year-End 2026 and Topline Data in H1 2028 –

BOSTON, Oct. 08, 2026 (GLOBE NEWSWIRE) — X4 Pharmaceuticals (Nasdaq: XFOR), a company focused on improving the lives of people with rare hematology diseases, today announced that it has entered into a senior secured term loan facility of up to $150 million with K2 HealthVentures LLC (“K2HV”), an alternative investment firm that provides flexible, long-term financing solutions in the life sciences and healthcare industries. The K2HV facility replaces a prior loan agreement and strengthens X4’s financial flexibility.

The first tranche of $80 million funded at closing and was used to repay in full all obligations, including $75 million of principal and related fees, under the Company’s prior loan and security agreement, along with associated closing costs. An additional $70 million may be made available to X4 at the Company’s request, subject to approval by K2HV and other conditions. The new K2HV facility provides a larger total facility size, a longer interest-only period, and a 48-month maturity to support corporate activities, including the potential future commercial launch of mavorixafor in chronic neutropenia.

“Our partnership with K2 HealthVentures strengthens our capital position and gives us a solid financial foundation as we advance mavorixafor toward potential FDA approval and a commercial launch in chronic neutropenia,” said David Kirske, Chief Financial Officer of X4. “The new structure provides additional flexibility on more favorable terms and is aligned with our strategic priorities. We expect to reach several key milestones in the near term, including completing enrollment in our Phase 3 4WARD trial this year and reporting topline results in the first half of 2028. We are executing with focus, discipline, and a clear line of sight to what matters most.”

“We are pleased to partner with X4 Pharmaceuticals as it advances mavorixafor for the potential treatment of people living with rare hematology diseases. This financing reflects our strategy of serving as a long-term financing partner to innovative life sciences companies, and we look forward to supporting X4’s next phase of growth,” said Parag Shah, Founding Managing Director and Chief Executive Officer of K2 HealthVentures.

Additional details regarding the loan agreement will be included in filings with the U.S. Securities and Exchange Commission (SEC). For more information, please visit the Company’s Investor website, which includes SEC filings and other data sources.

About X4 Pharmaceuticals

X4 Pharmaceuticals is a company focused on improving the lives of people with rare hematology diseases by developing and commercializing innovative therapies in areas with significant unmet needs. Leveraging expertise in diseases of the immune system and CXCR4 biology, X4 has successfully developed mavorixafor, an orally available CXCR4 antagonist that is approved in the U.S. and EU as XOLREMDI^® for patients with WHIM syndrome. The Company is currently conducting a global, pivotal Phase 3 clinical trial (4WARD) evaluating mavorixafor in chronic neutropenic disorders. The U.S. FDA has granted Fast Track designation to mavorixafor for the treatment of chronic neutropenia. X4 is headquartered in Boston, Massachusetts. For more information, please visit www.x4pharma.com.

X4 Forward Looking Statements

This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by the words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target,” or other similar terms or expressions that concern X4’s expectations, strategy, plans, or intentions. Forward-looking statements include, without limitation, implied or express statements regarding the anticipated use of proceeds from the K2HV loan facility, the availability of additional tranches under the facility, the potential extension of the interest-only period, the sufficiency of the Company’s cash resources and its expected cash runway, the potential addressable market for moderate and severe chronic neutropenia, the expected timing for completion of enrollment in, and topline data from, the 4WARD trial, the timing for launch of mavorixafor in chronic neutropenia and future plans for the Company. Any forward-looking statements in this press release are based on management’s current expectations and beliefs. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond X4’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: X4 may not satisfy the conditions required to access additional tranches under the K2HV facility or obtain K2HV’s approval of such draws; X4 may be unable to comply with the covenants under the loan agreement, including minimum cash and minimum revenue covenants; the interest-only period may not be extended if first commercial U.S. sales of mavorixafor in chronic neutropenia are not achieved on the anticipated timeline; changes in the prime rate may increase X4’s interest expense; enrollment in the 4WARD trial may not be completed, and topline data may not be reported, within the expected timeframes, or at all; and other risks and uncertainties, including those described in the section entitled “Risk Factors” in X4’s most recent Annual Report on X4’s Form 10-K, as well as in other filings X4 makes with the Securities and Exchange Commission, including its quarterly reports on Form 10-Q, from time to time. X4 undertakes no obligation to update the information contained in this press release to reflect new events or circumstances, except as required by law.

X4 Investor Contact:
Remy Bernarda
Jenny Kobin
IR Advisory Solutions
IR@X4pharma.com

Source: X4 Pharmaceuticals, Inc.

Maximizes Customer Value With More Kilowatt Hours Per Year

OREM, Utah, Oct. 08, 2026 (GLOBE NEWSWIRE) — SunPower Inc. (“SunPower,” or Nasdaq: “SPWR”) a solar technology, services, and installation company, today announced a new Monolith platform product, the Monolith II next-generation premium high-wattage panel, designed as part of its Joint Development Agreement (JDA) with REC and exclusive to SunPower. Monolith II set the latest SunPower panel power record since its 333-watt record in 2009. Monolith II maximizes total kilowatt hours (KWh) per year, literally the actual “payback” of solar systems.

SunPower successfully commercialized Monolith, a 470-watt panel developed by the SunPower-REC JDA. The Monolith panel uses REC’s advanced N-Type Heterojunction (HJT) cell technology, which provides superior power output and annual energy production, exceptional aesthetics and a solid 25-year warrantee. Monolith II panels produce 522 watts from the first Monolith footprint and weight by encapsulating REC’s N-Type HJT wafer technology in a “bifacial” panel with glass on both the front and back sides to illuminate the cells from both sides.

Starbucks: SunPower used commercial size bifacial panels on 67 Starbuck’s stores to maximize the annual energy (kWh) and economic output from a given store footprint. The panels receive full sunlight on the top and reflected sunlight on the bottom

T.J. Rodgers, SunPower CEO, said, “Our partners at REC have done it again, enabling us to offer our new customers the market’s most powerful residential panel, as well as offering our 415,000 legacy customers an attractive system upgrade. Monolith II weighs less than 50 pounds, as mandated by OSHA for single-worker installation, yet produces 522 watts. To illustrate customer value, my backyard vineyard has three rows replaced with 56 SunPower 360-watt panels that produce 20,160 watts. With Monolith II, the system will produce 29,323 watts, or 46 kWh of extra energy per day, worth $3,345 per year in California.”

Brian Ghiglia, REC Americas VP of Sales, said, “We are excited to continue our R&D collaboration with SunPower which provides us with early engineering data so we can rapidly improve our solar technology.”

Surinder S. Bedi, SunPower’s Executive Vice President of Quality, Engineering and Customer Success, concluded, “With five years of personal experience building bifacial commercial systems, I cannot wait to get our first Monolith II installation done this month on the roof of a Cobalt Silicon Valley customer who will allow us to compare Monolith vs Monolith II side by side.”

About SunPower
SunPower (Nasdaq: SPWR) is a solar technology, services, and installation company focused on delivering reliable and affordable energy solutions. Through its national operating platform and specialized subsidiaries, SunPower serves residential, commercial, new-home, and multifamily customers across the United States. For more information visit www.sunpower.com.

About REC Solar:
Founded in 1996, REC Group is an international pioneering solar energy company dedicated to empowering consumers with clean, affordable solar power. As Solar’s Most Trusted, REC is committed to high quality, innovation, and a low carbon footprint in the solar materials and solar panels it manufactures. Headquartered in Norway with operational headquarters in Singapore, REC also has regional hubs in North America, Europe, and Asia-Pacific. For more information visit www.recgroup.com.

Forward Looking Statements
This press release contains forward-looking statements, including statements concerning the equity for interest exchange and related impacts of the transactions. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “seek,” “plan,” “project,” “target,” “looking ahead,” “look to,” “move into,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements represent SunPower’s current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing SunPower’s estimates as of any subsequent date. Forward-looking statements are subject to risks, uncertainties, and assumptions. If the risks materialize or assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Risks include, but are not limited to market risks, trends and conditions. These risks are not exhaustive. For additional information on these risks and uncertainties and other potential factors that could cause actual results to differ from the results predicted, readers should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of our annual report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on April 14, 2026, our quarterly reports on Form 10-Q filed with the SEC, and other documents that we have filed with, or will file with, the SEC. Such filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements in this press release speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SunPower assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

Company Contact:

Sioban Hickie
VP Investor Relations
IR@sunpower.com
(801) 515-8727

Source: SunPower Inc.

A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/7a1d04fa-4b91-4e2b-8ed3-a5f66b8f03a1
https://www.globenewswire.com/NewsRoom/AttachmentNg/2a90f2a1-a8f7-499f-9b81-69b2f0ad0cb0

Nutriband files new non-provisional patent application to strengthen intellectual property protection of its AVERSA™ transdermal abuse deterrent technology being developed for patches containing opioids and stimulants with a potential for abuse.

Nutriband’s AVERSA™ abuse-deterrent technology consists of a proprietary aversive agent coating that employs taste aversion to deter oral abuse and reduce accidental exposure.

ORLANDO, Fla., Oct. 08, 2026 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB) today announced that it has filed a non-provisional utility patent application with the U.S. Patent and Trademark Office (USPTO) to further strengthen Nutriband’s intellectual property protection for its AVERSA™ abuse deterrent transdermal technology.

This new patent application covers improved aversive formulations and coating application methods to enhance the abuse deterrent properties of Nutriband’s AVERSA™ transdermal technology and make it even more difficult to defeat. If this new patent is subsequently granted, it could significantly extend the patent protection for products that utilize Nutriband’s AVERSA™ abuse deterrent technology as the statutory patent term of a US patent is 20 years from the non-provisional filing date. If granted, the worldwide (PCT) patent protection for AVERSA™-based products such as AVERSA™ FENTANYL could be extended to 2046.

The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

Nutriband’s AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as opioids, while making sure that these drugs remain accessible to those patients who really need them.

About AVERSA™ Abuse-Deterrent Transdermal Technology

Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, including opioids and stimulant drugs, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

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-deterrent 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 Form S-1, Forms 10-K’s and Forms 10-Q’s, 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

SOURCE: Nutriband Inc.