Month: September 2026

Trappsol^® Cyclo™ did not achieve statistical significance but demonstrated a directionally favorable treatment effect versus placebo on the primary endpoint of change in the 4-domain NPC Clinical Severity Scale (4DNPCSS) at Week 96

A prespecified analysis in patients receiving background miglustat and/or leucine therapy, representing approximately 83% of the study population, showed a statistically significant effect on the 4DNPCSS

Trappsol^® Cyclo™ demonstrated a well-tolerated safety and tolerability profile consistent with previous studies, with no new safety signals observed

Based upon its previously announced pre-NDA meeting, the Company remains on track to submit the NDA in the fourth quarter of 2026, consistent with prior guidance

Company to host investor conference call and webcast today, September 30, at 8:30 a.m. ET

NEWARK, N.J., Sept. 30, 2026 (GLOBE NEWSWIRE) — Rafael Holdings, Inc. (NYSE: RFL) today announced topline efficacy and safety data from its Cyclo Therapeutics, LLC subsidiary’s pivotal Phase 3 TransportNPC™ study (CTD-TCNPC-301) evaluating Trappsol^® Cyclo™ (intravenous hydroxypropyl-β-cyclodextrin) in 94 patients diagnosed with Niemann-Pick Disease Type C (NPC). Trappsol^® Cyclo™ was well tolerated and demonstrated a directionally favorable treatment effect on the primary endpoint, although the result did not achieve statistical significance. Notably, a prespecified analysis in patients receiving background miglustat and/or leucine therapy demonstrated a statistically significant and clinically meaningful treatment benefit. Based upon its previously announced pre-NDA meeting with the FDA, the Company remains on track to submit an NDA for Trappsol^® Cyclo™ in the fourth quarter of 2026.

The Phase 3 TransportNPC^™ Study

The global, double-blind, placebo-controlled Phase 3 TransportNPC™ study (CTD-TCNPC-301) enrolled 94 patients with NPC, ranging in age from 3 to 70 years. Patients were randomized to receive 2000 mg/kg of Trappsol^® Cyclo™ administered intravenously every two weeks (n=63) or placebo (n=31) for a 96-week period to assess change in 4DNPCSS.

A prespecified analysis also evaluated change in 4DNPCSS among patients receiving background miglustat therapy and/or leucine (a food supplement available in some European countries), representing approximately 83% of the study population.

• Primary endpoint: Trappsol^® Cyclo™ demonstrated a directionally favorable treatment effect compared with placebo, indicating slowing of disease progression by 64% on change in 4DNPCSS at Week 96 (LS mean change from baseline of 0.46 vs 1.28 points; difference −0.81 points [95% CI −2.04, 0.41]; p=0.19), the result did not achieve statistical significance.
• Prespecified analysis: Among patients receiving background miglustat and/or leucine therapy (n=78), Trappsol^® Cyclo™ indicating slowing of disease progression by 71% compared with placebo at Week 96 (LS mean change from baseline of 0.46 vs 1.57 points; difference −1.11 points [95% CI −2.19, −0.02]; p=0.046).

Safety and Tolerability

Over the 96-week treatment period, the safety profile of Trappsol^® Cyclo™ was well tolerated. Adverse events were largely consistent with the underlying disease. Treatment-emergent adverse events (TEAEs) were reported as followed: Trappsol^® Cyclo™, 93.8%; placebo, 100.0%. Serious TEAEs occurred more frequently with Trappsol^® Cyclo™,35.9%, than with placebo 16.7%; however, serious TEAEs considered related to treatment were reported at similar rates 3.1% vs 3.3%. Hearing-related TEAEs were reported by 15.6% of participants receiving Trappsol^® Cyclo™ and 13.3% receiving placebo, and most were mild or moderate in severity. One treatment-related event of bilateral deafness in the Trappsol^® Cyclo™ group was severe. No TEAEs resulted in death, and one participant in the Trappsol^® Cyclo™ group discontinued the study early because of a TEAE.

Separate Overall Survival Analysis

The Company also conducted a separate overall survival analysis comparing patients with infantile-onset NPC treated with Trappsol^® Cyclo^™ across its clinical development program with well-matched external controls from the International Niemann-Pick Disease Registry (INPDR). The external control cohort included patients with similar baseline characteristics and disease progression. Results from the analysis provide supportive evidence of a treatment-associated survival benefit with Trappsol^® Cyclo™.

Specifically, these data indicated:

• INPDR comparison: Treatment with Trappsol^® Cyclo™ (n=41) was associated with an 85% reduction in the risk of mortality compared with matched INPDR controls (n=93), HR=0.154; 95% CI: 0.025-0.950; p=0.044.
• Expanded historical control analysis: In a secondary analysis that expanded the control group to include additional matched historical cohorts from published natural history studies (n=133), treatment with Trappsol^® Cyclo™ (n=41) was associated with a 94% reduction in the risk of mortality, HR=0.057; 95% CI: 0.011–0.306; p=0.0008.

The consistency and magnitude of the observed survival associations across both analyses provide additional supportive evidence for the potential clinical benefit of Trappsol^® Cyclo™ in patients with infantile-onset NPC.

“The Phase 3 TransportNPC study is the most comprehensive trial in NPC conducted to date,” said Dr. Karen Mullen, Chief Medical Officer of Rafael Holdings. “We believe the totality of the data shared today provide a compelling rationale for the continued advancement of Trappsol Cyclo and its potential to offer clinically meaningful treatment benefit for those living with this devastating disease. We remain steadfast in our efforts to advance Trappsol Cyclo and are deeply grateful to the clinical investigators, patients, and caregivers whose courage and commitment were vital to completing this study.”

“NPC is a devastating, heterogeneous disease, and preserving function and stabilizing symptoms are critical,” said Dr. Caroline Hastings, Professor of Pediatric Hematology and Neurology at UCSF Benioff Children’s Hospital Oakland. “As a clinician who has cared for these patients for many years, I am encouraged by the clinically meaningful TransportNPC results. The study was rigorously conducted, and its findings align with the two prior trials for Trappsol Cyclo across a decade of development. I am hopeful that these data can move us closer to delivering a much-needed therapeutic option for families facing profound unmet need.”

NDA On Track for Fourth Quarter 2026

The Company remains on track to submit an NDA for Trappsol^® Cyclo™ to the U.S. Food and Drug Administration in the fourth quarter of 2026 based upon its previously announced pre-NDA meeting. The topline data, complete dataset and overall survival analysis remain subject to full analysis and FDA regulatory review. The Company also plans to present the full results at an upcoming medical meeting.

Conference Call Information:

Date: Wednesday, September 30, 2026
Time: 8:30 a.m. ET

Domestic Dial-in Number: 1-877-425-9470

International Dial-in Number: 1-201-389-0878

Conference ID:13763049

Webcast Participant Link: https://viavid.webcasts.com/starthere.jsp?ei=1777956&tp_key=73c1065384

About Rafael Holdings, Inc.

Rafael Holdings, Inc. is a biotechnology company that develops pharmaceuticals and holds interests in clinical and early-stage companies that develop pharmaceuticals and medical devices. Our lead candidate is Trappsol^® Cyclo™, and we have completed a pivotal Phase 3 study in NPC and are preparing for a planned NDA submission later this year. Niemann-Pick Disease Type C (“NPC”) is a rare, fatal and progressive genetic disorder. We also hold interests in other clinical-stage and early-stage pharmaceutical development companies and an orthopedic-focused medical device company.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential, safety, efficacy, and regulatory and clinical progress of our product candidates; plans regarding the further evaluation of clinical data; and the potential of our pipeline. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors 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, including, but not limited to, the risk that the FDA may not accept for filing or approve an NDA for Trappsol^® Cyclo™ based on the available data, and those disclosed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended July 31, 2025, our subsequent Quarterly Reports on Form 10-Q, and our other filings with the SEC. These factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of 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.

Contact:
Barbara Ryan
Barbara.ryan@rafaelholdings.com
(203) 274-2825

Data from BASECAMP expected in Q1 2027

TORONTO, Sept. 30, 2026 (GLOBE NEWSWIRE) — Satellos Bioscience Inc. (NASDAQ: MSLE, TSX: MSCL), a clinical-stage drug development company developing life-improving medicines to treat degenerative muscle diseases, today announced that enrollment has been completed for BASECAMP, the company’s Phase 2 clinical trial evaluating forazapadin for the treatment of Duchenne muscular dystrophy (DMD) in ambulatory boys 7 to 10 years of age. Forazapadin is an orally administered, small molecule drug candidate designed to restore muscle regeneration in people living with DMD, facioscapulohumeral muscular dystrophy (FSHD) and potentially other degenerative muscle diseases.

“We are thrilled to announce that we have met and surpassed our enrollment target in BASECAMP in less than nine months from screening our first participant, reflecting the strong execution of our clinical program,” said Frank Gleeson, co-founder and chief executive officer of Satellos. “We believe BASECAMP could support discussions with the FDA regarding a potential accelerated development pathway for forazapadin. Given the significance and proximity of this opportunity, we believe it is important to be thoughtful and transparent in how we develop and communicate the results from the trial. We have therefore decided to take the time necessary to compile the most complete dataset possible. Accordingly, we are adjusting our previous plan for releasing data and now intend to share topline clinical data in the first quarter of 2027.”

“The enthusiasm and commitment of the Duchenne community have enabled us to exceed our enrollment target and build a robust global study,” said Wildon Farwell, M.D., chief medical officer of Satellos. “With multiple dose cohorts and a broad range of clinical, functional and biomarker assessments, we believe BASECAMP can generate a substantial body of data that we expect to help us better understand forazapadin, its potential as a novel treatment for Duchenne, and guide us in determining a potential path to approval. We are deeply grateful to the patients and families who have made this research possible.”

BASECAMP enrolled ambulatory boys 7 to 10 years of age across 18 clinical sites in the U.S., Canada, Australia, Belgium, Spain, Poland and Serbia. Participants were randomized 1:1:1 to receive either forazapadin 60 mg, forazapadin 120 mg or placebo. The study includes a 12-week placebo-controlled period, after which participants enter a 36-week randomized active-treatment period. Primary endpoints include safety, tolerability and the effect of forazapadin on muscle force as assessed by dynamometry. Secondary endpoints are intended to assess forazapadin’s impact on muscle quality, function and regeneration.

ABOUT FORAZAPADIN
Forazapadin is a proprietary, oral, small molecule drug candidate being developed by Satellos as a novel approach to regenerating skeletal muscle lost in degenerative muscle diseases or injury conditions. Forazapadin targets AAK1, a key protein identified by Satellos as believed to be capable of helping restore the body’s natural muscle repair and regeneration biology, a fundamental process that is disrupted in DMD, FSHD and other degenerative conditions. By inhibiting AAK1, forazapadin treatment aims to re-establish a biochemical signal believed to be involved in supporting muscle regeneration. Satellos is advancing forazapadin as a potential treatment for DMD that is independent of dystrophin and applicable regardless of exon mutation status as either a stand-alone or adjunctive therapy, with ongoing Phase 2 clinical studies including BASECAMP, a global, randomized, placebo-controlled study in pediatric participants, and TRAILHEAD, an open-label study in adult participants. A Phase 2 clinical study to evaluate the safety, efficacy and tolerability of forazapadin in adults with FSHD is expected to begin in the fourth quarter of 2026.

ABOUT SATELLOS BIOSCIENCE INC.
Satellos is a clinical-stage drug development company focused on restoring natural muscle repair and regeneration in degenerative muscle diseases. Through its research, Satellos has developed forazapadin, an orally administered small molecule AAK1 inhibitor designed to address deficits in muscle repair and regeneration. Forazapadin is being evaluated as a potential disease-modifying treatment for Duchenne muscular dystrophy (DMD) in two Phase 2 clinical trials, BASECAMP in pediatric participants with DMD and TRAILHEAD in adults living with DMD. The FDA also cleared an Investigational New Drug (IND) application for the clinical evaluation of forazapadin for the treatment of facioscapulohumeral muscular dystrophy (FSHD). The company has identified additional muscle diseases and injury conditions where restoring muscle repair and regeneration may have therapeutic benefit and plans to pursue these opportunities in future clinical development. For more information, visit www.satellos.com and connect with Satellos on X, LinkedIn, Facebook and Instagram.

NOTICE ON FORWARD-LOOKING STATEMENTS
This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Satellos and its business, which may include, but are not limited to, statements regarding the possibility of pursuing regulatory approval for forazapadin, including a potential accelerated approval pathway; anticipated benefits to patients from forazapadin; the enrollment in, advancement and timing of results of forazapadin through clinical trials, including the BASECAMP, TRAILHEAD and Phase 2 FSHD clinical trials, and the timing of release of related clinical trial data; the potential of Satellos’ approach in other degenerative muscle diseases and Satellos’ plans to pursue additional muscle diseases and injury conditions in future clinical development; Satellos’ technologies and drug development plans; and Satellos’ expectation for broader use of International Nonproprietary Name in future scientific, regulatory and corporate communications. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, occurrences or developments, are “forward-looking information or statements.” Often, but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “believe”, “plan”, “expect”, “intend”, “estimate”, “anticipate”, “potential”, “prospective”, “assert” or any variations (including negative or plural variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. These statements are based on assumptions and subject to risks and uncertainties. In making forward-looking statements, the Company has relied on various assumptions, including but not limited to: its ability to obtain future funding on favorable terms, if at all; obtaining positive results in its clinical trials; its ability to obtain necessary regulatory approvals; its ability to arrange for the manufacturing of its product candidates and technologies; and general business, market and economic conditions. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, risks relating to the pharmaceutical and bioscience industry (including the risks associated with preclinical and clinical trials and regulatory approvals), the research and development of therapeutics, the results of preclinical and clinical trials, general market conditions and equity markets, economic factors and management’s ability to manage and to operate the business of the Company generally, including inflation and the costs of operating a biopharma business, and those risks and uncertainties described in more detail in the “Risk Factors” section of Satellos’ Annual Information Form dated March 27, 2026, and amended and restated short form base shelf prospectus dated August 11, 2026 (each of which is located on Satellos’ SEDAR+ profile) and incorporated by reference in Satellos’ Form F-10 filed with the Securities and Exchange Commission on August 11, 2026, and in Satellos’ public filings on EDGAR (sec.gov) and SEDAR+ (sedarplus.ca). Although Satellos has 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 to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Satellos does not undertake any obligation to publicly update or revise any forward-looking statement, whether resulting from new information, future events, or otherwise.

CONTACTS
Investors: Caitlin Lowie, Vice President, Investor Relations & Communications, ir@satellos.com
Media: Emily Williams, Senior Director, Communications, media@satellos.com

Big Blackberry Flavor Meets Low-Sugar Refreshment in the New Salty Sips Easy-Drinking Vodka Cocktail

BEND, Ore., Sept. 30, 2026 (GLOBE NEWSWIRE) — 10 Barrel Brewing, the Bend-born craft beer brand known for bold beers, big personality, and bringing people together for a good time, by Tilray Brands, Inc. (NASDAQ: TLRY and TSX: TLRY), is excited to announce the launch of Salty Sips Blackberry Refresher, the latest addition to its growing portfolio of the Salty Sips ready-to-drink cocktails line.

Built for those looking for refreshing flavor without the heavy sweetness, Salty Sips Blackberry Refresher blends vodka, real fruit juice, a hint of mint and a pinch of sea salt into an easy-drinking, low sugar cocktail that’s crisp, balanced, and straight-up crushable. Crafted at 5.0% ABV, the new flavor delivers refreshing blackberry character and bright fruit notes, making it the perfect companion for warm afternoons, backyard hangs, river floats, and wherever the day takes you.

Inspired by the simple pleasure of fresh fruit and the refreshing kick of a lightly salted snack on a summer day, Blackberry Refresher continues the Salty Sips philosophy of delivering bold flavor with less sugar and an approachable ABV. Made with real fruit juice and a pinch of sea salt, the cocktail offers a clean, refreshing finish that keeps you coming back for another sip.

“The launch of Salty Sips Watermelon Refresher in the spring was such a hit with our fans that we were pumped to extend the product line with Blackberry Refresher, a product that feels both refreshing and flavorful without weighing you down,” said Moo Eakin, Senior Brand Manager at 10 Barrel Brewing Co. “The combination of real blackberry juice, vodka, and a pinch of sea salt creates a low-sugar, balanced cocktail that’s easy to enjoy whether you’re on the mountain, at the lake, or hanging with friends.”

The second member to the Salty Sips lineup follows the successful launch of Watermelon Refresher and builds the foundations of a portfolio of innovative cocktails designed for consumers seeking flavor-forward, easy-drinking options that fit today’s evolving lifestyles. With just 5.0% ABV and low sugar, Salty Sips Blackberry Refresher delivers a modern take on refreshment without sacrificing taste.

Salty Sips Blackberry Refresher is now available in convenient 4-packs in select markets across the Pacific Northwest, with expanded distribution planned in additional western U.S. markets.

For more information, visit 10 Barrel Brewing.

About 10 Barrel Brewing Co.

10 Barrel Brewing Company is a craft brewery based in Bend, Oregon, featuring innovative beers brewed locally at each of its four brewpub locations in Bend, Portland, and Boise. 10 Barrel has one simple mindset: Brew beer, drink beer, and have fun doing it. For more information, visit 10 Barrel Brewing and follow @10barrelbrewing on social.

About Tilray Brands

Tilray Brands, Inc. (“Tilray”) (Nasdaq: TLRY; TSX: TLRY), is a leading global lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia and Latin America that is leading as a transformative force at the nexus of cannabis, beverage, wellness, and entertainment elevating lives through moments of connection. Tilray’s mission is to be a leading premium lifestyle company with a house of brands and innovative products that inspire joy and create memorable experiences. Tilray’s unprecedented platform supports over 40 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods and craft beverages. 

For more information on how we are elevating lives through moments of connection, visit Tilray.com and follow @Tilray on all social platforms. 

Forward-Looking Statements

Certain statements in this communication that are not historical facts constitute forward-looking information or forward-looking statements (together, “forward-looking statements”) under Canadian and U.S. securities laws and within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be subject to the “safe harbor” created by those sections and other applicable laws. Forward-looking statements can be identified by words such as “forecast,” “future,” “should,” “could,” “enable,” “potential,” “contemplate,” “believe,” “anticipate,” “estimate,” “plan,” “expect,” “intend,” “may,” “project,” “will,” “would” and the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Certain material factors, estimates, goals, projections, or assumptions were used in drawing the conclusions contained in the forward-looking statements throughout this communication. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations. Many factors could cause actual results, performance, or achievement to be materially different from any forward-looking statements, and other risks and uncertainties not presently known to the Company or that the Company deems immaterial could also cause actual results or events to differ materially from those expressed in the forward-looking statements contained herein. For a more detailed discussion of these risks and other factors, see the most recently filed annual information form of Tilray and the Annual Report on Form 10-K (and other periodic reports filed with the SEC) of Tilray made with the SEC and available on EDGAR. The forward-looking statements included in this communication are made as of the date of this communication and the Company does not undertake any obligation to publicly update such forward-looking statements to reflect new information, subsequent events, or otherwise unless required by applicable securities laws.  

Tilray Brands Contacts:

Media:news@tilray.com

Investor Relations: investors@tilray.com

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/9fca0e2b-d49d-4d14-b6ad-1e8554228345
https://www.globenewswire.com/NewsRoom/AttachmentNg/83233953-e5ad-4b29-8258-930a654e2863

– Rademikibart significantly reduced the rate of treatment failure compared to placebo through one month by 81% (p=0.0122) –

– Rademikibart significantly reduced the rate of new moderate to severe COPD exacerbations through one month by 85% (p=0.030) –

– Rademikibart significantly reduced the rate of hospitalizations or emergency department visits for new acute COPD exacerbations by 100% (p=0.0137) –

– Rademikibart was well tolerated in COPD patients experiencing an acute exacerbation with a lower incidence of adverse events than placebo –

– Connect plans to engage with the U.S. Food and Drug Administration (FDA) to gain alignment on a Phase 3 program –

– Company to host a conference call to discuss the data today, September 30 at 8:00 a.m. ET –

SAN DIEGO, Sept. 30, 2026 (GLOBE NEWSWIRE) — Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today announced topline results from its global Phase 2 study evaluating rademikibart, the Company’s next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody as an add-on treatment for acute exacerbations in adult participants with chronic obstructive pulmonary disease (COPD) and type 2 inflammation.

“Topline data from our Seabreeze STAT COPD trial for rademikibart provides overwhelming evidence of the potential benefit early treatment with rademikibart may provide to COPD patients experiencing an acute exacerbation,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “2025 claims data indicate that COPD patients going to the emergency department (ED) due to an acute exacerbation generate approximately $6 billion in healthcare costs in the following 30 days due to return visits to the ED or hospital. This study demonstrated that rademikibart completely eliminated those return visits while decreasing new moderate to severe COPD exacerbations by 85% compared to placebo. These groundbreaking results provide a unique opportunity to differentiate rademikibart in COPD from all other approved biologics. We plan to engage with the FDA as soon as feasible regarding a Phase 3 registrational development program for rademikibart as add-on treatment for COPD.”

“Acute exacerbations continue to be a major driver of morbidity in COPD, and there remains a need for therapies that can improve outcomes following these events,” said Surya Bhatt, MD, Director of the University of Alabama at Birmingham, UAB Center for Lung Analytics and Imaging Research (CLAIR) in Birmingham, Alabama. “The reduction in COPD exacerbations is compelling, and the clinically meaningful increase in pulmonary function provides a very important improvement over standard-of-care and supports the potential for rademikibart to improve outcomes for COPD patients following an acute exacerbation and for chronic maintenance.”

Mario Castro MD, MPH, Professor of Medicine and Chief of the Division of Pulmonary, Critical Care and Sleep Medicine at the University of Kansas School of Medicine added, “One of the greatest challenges in COPD management is helping patients recover from an acute exacerbation and remain stable once they leave the hospital. The reductions in hospitalizations seen with rademikibart address a critical period when patients are at particularly high risk for worsening disease. By helping stabilize patients during the vulnerable post-exacerbation period, rademikibart has the potential to provide benefit in both acute and long-term disease management and meaningfully improve patient care.”

The Phase 2 Seabreeze STAT COPD study (CBP-201-207) is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of rademikibart as an adjunct to standard of care for acute exacerbations in participants with COPD and type 2 inflammation. The study enrolled 159 participants globally with an eosinophil count of ≥300 cells/μL who have experienced an acute COPD exacerbation. Participants were randomized 1:1 to receive either a single dose of rademikibart or placebo, administered subcutaneously in addition to standard of care. The primary endpoint was treatment failure, defined as death due to any cause, (re)admission to a hospital for COPD, emergency department (ED) (re)visit or unscheduled medical visit for worsening of COPD symptoms, or the necessity to intensify pharmacologic treatment within 28 days after randomization. Secondary endpoints included post-bronchodilator (post-BD) FEV₁ at Week 1 (key secondary), rate and time to new moderate and severe COPD exacerbations, change-from-baseline in clinical respiratory symptoms of COPD, post-BD FEV₁ at other timepoints, and incidence of adverse events for 8 weeks after dosing. For more information, please visit clinicaltrials.gov (identifier NCT06940154).

Key topline results include:

• Rademikibart significantly reduced the rate of treatment failure by 81% through Week 4 compared to placebo (p=0.0122)
• Rademikibart significantly reduced the rate of new moderate to severe COPD exacerbations by 85% through Week 4 compared to placebo (p=0.030)
• Rademikibart significantly reduced new visits to emergency departments and hospital admissions for new exacerbations by 100% through Week 4 compared to placebo (p=0.0137)
• Rademikibart significantly reduced the use of rescue inhalers from Week 2 through Week 7 and significantly improved COPD symptoms at Week 2 compared to placebo (Total Score, p=0.0197)
• Clinically meaningful 70 mL greater improvement in FEV₁ at Week 4 with rademikibart compared to placebo (p=0.1607)
• Rademikibart was well tolerated and no new safety signals were observed through the end of the study. The safety profile was comparable to placebo, with a lower incidence of adverse events and serious adverse events reported in the rademikibart arm compared to the placebo arm.

Company-Hosted Conference Call and Webcast

Connect will host a conference call and webcast today, September 30, 2026, at 8:00 a.m. ET. To access the conference call, please pre-register through here to receive dial-in information and a personal PIN to access the live call. Participants may access the live webcast here or from the Investors section of the Connect website at investors.connectbiopharma.com. An archive of the webcast and presentation will be available for approximately 90 days after the event.

About Rademikibart

Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). We believe that by binding with IL-4Rα, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway to achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis, asthma and COPD.

About Connect Biopharma

Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the Company is advancing rademikibart, a next-generation, potentially best-in-class antibody designed to target IL-4Rα. The Company is currently conducting global clinical studies of rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need. Connect has granted an exclusive license to Simcere Pharmaceutical Co., Ltd., for rademikibart in Greater China. Under the exclusive license and collaboration agreement, Connect is eligible to receive remaining milestone payments up to an aggregate amount of approximately $99 million upon the achievement of certain development, regulatory and commercial milestones. Connect is also eligible to receive royalties at tiered percentage rates up to low double-digit percentages on net sales in Greater China.

For more information visit www.connectbiopharma.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not of historical fact and include, without limitation, statements regarding future events, our future financial and operating results and related expectations, business strategy and plans, prospective products (as well as their potential to achieve a differentiated, competitive, or favorable benefit or profile or trend, including on safety, tolerability, improvement, maintenance, clinical response, dosing, efficacy and/or convenience), statements regarding the timing or results of any interim analysis or interim, topline or preliminary data and whether such analysis or data is indicative of safety, efficacy, final trial results or likelihood of regulatory approval for our product candidates, planned or expected meetings with the FDA or any other regulatory authorities, planned or expected product approval applications or approvals, anticipated milestones and milestone payments, expected data readouts and enrollments and the timing thereof, research and development plans and costs, potential future partnerships, expectations about existing partnerships, timing and likelihood of success, objectives of management for future operations, future results of anticipated product development efforts, adequacy of existing cash and potential partnership funding to fund operations and capital expenditure requirements, anticipated patient populations, market opportunities and potential pricing strategies for our prospective products, if approved, our plans for rademikibart, including potential indications, as well as statements regarding industry trends. These statements are based on management’s current expectations of future events only as of the date of this press release and are inherently subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among other things: the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results; whether we will need expanded or additional trials in order to obtain regulatory approval for our product candidates; the timing and outcome of any meetings with the FDA or other regulatory authorities regarding further development of our product candidates, including with respect to a potential Phase 3 program for rademikibart; our ability to obtain and maintain regulatory approval of our product candidates; existing regulations and regulatory developments in the U.S., the People’s Republic of China, Europe and other jurisdictions; our plans and ability to obtain, maintain, protect and enforce our intellectual property rights and our proprietary technologies, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; the degree of market acceptance of our product candidates, if approved, by physicians, patients, healthcare payors and others in the medical community; the impact on our business of adverse global macroeconomic and geopolitical conditions, including high interest rates, the inflationary environment, recessionary fears, foreign exchange rate volatility, instability in financial institutions, government shutdowns, changes in monetary policy, changes in trade policies, including tariffs and other trade restrictions or the threat of such actions, and rising geopolitical instability, including the conflicts in the Middle East and the related volatility in the price of oil and other commodity prices; as well as the risks and uncertainties described in Part I, “Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025, our subsequent Quarterly Reports on Form 10-Q and our other filings with the SEC .

Words such as “aim,” “anticipate,” “believe,” “commitments,” “continue,” “could,” “design,” “estimate,” “expect,” “feel,” “goal,” “intend,” “may,” “might,” “objective,” “optimistic,” “plan,” “potential,” “predict,” “promising,” “seek,” “should,” “target,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its expectations, projections or plans will be achieved. Actual results or outcomes, or the timing of such results or outcomes, may differ materially from those expressed or implied in our forward-looking statements due to the risks and uncertainties described above. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated herein. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You are cautioned not to place undue reliance on the scientific data presented or these forward-looking statements, which speak only as of the date hereof. Except as required by law, Connect Biopharma undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise.

This press release discusses our product candidate, rademikibart, which is under clinical investigation and has not yet been approved for marketing by the FDA, the National Medical Products Administration, or by any other regulatory agency. No representation is made as to the safety or effectiveness of rademikibart for the uses for which it is being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only.

Investor Relations Contact:

Alex Lobo
Precision AQ
Alex.lobo@precisionaq.com
(212) 698-8802

Media Contact:

Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310 or (646) 942-5604

TORONTO, Sept. 30, 2026 (GLOBE NEWSWIRE) — Alamos Gold Inc. (TSX:AGI; NYSE:AGI) (“Alamos” or the “Company”) plans to release its third quarter 2026 financial results after market close on Wednesday, October 28, 2026. Senior management will host a conference call on Thursday, October 29, 2026 at 10:00 am ET to discuss the results.

Participants may join the conference call via webcast or through the following dial-in numbers:

Via Webcast:

To view the live webcast, please register at www.alamosgold.com, or through the following link view webcast.

Via Phone:

Toronto and International:		(647) 495-7514
Toll free (Canada and the United States):		(888) 596-4144
Participant passcode:		1813237#

Alternatively, you may register your phone number here within 30 minutes of the scheduled start of the call to receive an instant automated call back.

A playback will be available until November 28, 2026 by dialling (647) 362-9199 or (800) 770-2030 within Canada and the United States. The passcode is 1813237#. The webcast will be archived at www.alamosgold.com.

About Alamos

Alamos is a Canadian-based intermediate gold producer with diversified production from three operations in North America. This includes the Island Gold District and Young-Davidson mine in northern Ontario, Canada, and the Mulatos District in Sonora State, Mexico. Additionally, the Company has a strong portfolio of growth projects including the IGD Expansion, and the Lynn Lake project in Manitoba, Canada. Alamos employs more than 2,400 people and is committed to the highest standards of sustainable development. The Company’s shares are traded on the TSX and NYSE under the symbol “AGI”.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Scott K. Parsons

Senior Vice President, Corporate Development & Investor Relations

(416) 368-9932 x 5439

Khalid Elhaj

Vice President, Business Development & Investor Relations

(416) 368-9932 x 5427

ir@alamosgold.com

The TSX and NYSE have not reviewed and do not accept responsibility for the adequacy or accuracy of this release.

TORONTO, Sept. 30, 2026 (GLOBE NEWSWIRE) — Alamos Gold Inc. (TSX:AGI; NYSE:AGI) (“Alamos” or the “Company”) plans to release its third quarter 2026 financial results after market close on Wednesday, October 28, 2026. Senior management will host a conference call on Thursday, October 29, 2026 at 10:00 am ET to discuss the results.

Participants may join the conference call via webcast or through the following dial-in numbers:

Via Webcast:

To view the live webcast, please register at www.alamosgold.com, or through the following link view webcast.

Via Phone:

Toronto and International:		(647) 495-7514
Toll free (Canada and the United States):		(888) 596-4144
Participant passcode:		1813237#

Alternatively, you may register your phone number here within 30 minutes of the scheduled start of the call to receive an instant automated call back.

A playback will be available until November 28, 2026 by dialling (647) 362-9199 or (800) 770-2030 within Canada and the United States. The passcode is 1813237#. The webcast will be archived at www.alamosgold.com.

About Alamos

Alamos is a Canadian-based intermediate gold producer with diversified production from three operations in North America. This includes the Island Gold District and Young-Davidson mine in northern Ontario, Canada, and the Mulatos District in Sonora State, Mexico. Additionally, the Company has a strong portfolio of growth projects including the IGD Expansion, and the Lynn Lake project in Manitoba, Canada. Alamos employs more than 2,400 people and is committed to the highest standards of sustainable development. The Company’s shares are traded on the TSX and NYSE under the symbol “AGI”.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Scott K. Parsons

Senior Vice President, Corporate Development & Investor Relations

(416) 368-9932 x 5439

Khalid Elhaj

Vice President, Business Development & Investor Relations

(416) 368-9932 x 5427

ir@alamosgold.com

The TSX and NYSE have not reviewed and do not accept responsibility for the adequacy or accuracy of this release.

Data from Phase 4 Open-Label, Single-Arm SYNCHRONICITY Trial will be presented in a late-breaking oral presentation during Uveitis Subspecialty Day 2026

Post-hoc analyses of baseline characteristics and efficacy outcomes in rescued and non-rescued patients from the Phase 4 NEW DAY trial will be presented in an on-demand ePoster

PRINCETON, N.J., Sept. 30, 2026 (GLOBE NEWSWIRE) — ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that data from SYNCHRONICITY, its Phase 4, open-label, single-arm clinical trial of Fluocinolone Acetonide Intravitreal Implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS) will be presented in a late-breaking oral presentation during Uveitis Subspecialty Day 2026, being held October 9, 2026 at the American Academy of Ophthalmology (AAO) 2026 Meeting in New Orleans. This follows the Company’s announcement of six-month topline results from the SYNCHRONICITY trial in July 2026. Additionally, the Company plans to present post-hoc analyses from the Phase 4 NEW DAY clinical trial of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema (DME) as an on-demand ePoster.

The AAO 2026 presentation details are as follows:

The Use of Fluocinolone Acetonide Implant in the Treatment of Chronic Noninfectious Posterior Segment Uveitis: Results of the Phase 4 SYNCHRONICITY Trial

• Date/Time: Uveitis Subspecialty Day, October 9, 4:50 p.m. ET
• Session: Section VIII: A Uveitis Lagniappe: Late Breaking Topics
• Presenter: David Almeida, MD, PhD, MBA, President and CEO of Erie Retina Research, and Principal Investigator in SYNCHRONICITY

Baseline Characteristics and Efficacy Outcomes in Rescued vs. Non-Rescued Patients After Fluocinolone Acetonide Implant in the Phase 4 NEW DAY Trial for DME

• Date/Time: Scientific poster available on demand
• Session: PO631
• Presenter: Christina Y Weng, MD, MBA, Professor and Alice R. McPherson Retina Research Foundation Chair in Ophthalmology, Baylor College of Medicine

The Company also plans to share an encore presentation of the Phase 4 SYNCHRONICITY results during a podium presentation by Victor Gonzalez, MD, on January 21, 2027, at the Hawaiian Eye & Retina 2027 Meeting.

INDICATIONS FOR ILUVIEN^® (fluocinolone acetonide intravitreal implant)

ILUVIEN is a corticosteroid indicated for:

• the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
• the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

IMPORTANT SAFETY INFORMATION FOR ILUVIEN CONTRAINDICATIONS 

• ILUVIEN is contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.
• ILUVIEN is contraindicated in patients with glaucoma who have cup to disc ratios of greater than 0.8.
• ILUVIEN is contraindicated in patients with known hypersensitivity to any components of this product.

WARNINGS AND PRECAUTIONS

• Intravitreal Injection-related Effects: Intravitreal injections, including those with ILUVIEN, have been associated with endophthalmitis, eye inflammation, increased or decreased intraocular pressure, and choroidal or retinal detachments. For patients with non-infectious uveitis affecting the posterior segment, hypotony has been observed within 24 hours of injection and has resolved within 2 weeks. Patients should be monitored following the intravitreal injection. Patients may experience temporary blurred vision after injection of the implant.
• Intraocular Pressure (IOP) Increase: Prolonged use of corticosteroids may result in the development of glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be routinely monitored during the course of the treatment.
• Cataracts: The use of corticosteroids may result in posterior subcapsular cataract formation.
• Delayed Corneal Wound Healing: The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation.
• Corneal and Scleral Melting: Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of ophthalmic corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation of the globe.
• Bacterial Infections: Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. Acute purulent or parasitic infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated.
• Viral Infections: Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
• Fungal Infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.
• Risk of Implant Migration: Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber.

ADVERSE REACTIONS

Diabetic Macular Edema
Ocular adverse reactions reported by greater than or equal to 1% of patients in the two combined 3-year clinical trials following injection of ILUVIEN for diabetic macular edema include: cataract (82%), myodesopsia (21%), eye pain (15%), conjunctival hemorrhage (13%), posterior capsule opacification (9%), eye irritation (8%), vitreous detachment (7%), conjunctivitis (4%), corneal oedema (4%), foreign body sensation in eyes (3%), eye pruritus (3%), ocular hyperaemia (3%), optic atrophy (2%), ocular discomfort (2%), photophobia (2%), retinal exudates (2%), anterior chamber cell (2%), and eye discharge (2%). Non-ocular adverse reactions reported by greater than or equal to 5% of patients include: anemia (11%), headache (9%), renal failure (9%), and pneumonia (7%)

Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline at any visit was seen in 34% of ILUVIEN patients versus 10% of sham patients. IOP elevation greater than or equal to 30 mm Hg was seen in 20% of ILUVIEN patients versus 4% of sham patients. 38% of the patients who received ILUVIEN were subsequently treated with IOP-lowering medications during the study versus 14% of sham patients. 5% of the patients who received ILUVIEN needed surgical intervention for elevated IOP versus 1% of sham patients

Cataracts and Cataract Surgery: The incidence of cataract development in patients who had a phakic study eye was higher in the ILUVIEN group (82%) compared with sham (50%). The median time of cataract being reported as an adverse event was approximately 12 months in the ILUVIEN group and 19 months in the sham group. Among these patients, 80% of ILUVIEN subjects versus 27% of sham-controlled subjects underwent cataract surgery, generally within the first 18 months (median month 15 for both ILUVIEN group and for sham) of the studies.

Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Ocular adverse reactions reported by greater than or equal to 1% of patients in the three combined clinical trials through 12 months following injection of fluocinolone acetonide intravitreal implant: cataract (56%), visual acuity reduced (15%), macular edema (11%), uveitis (10%), conjunctival hemorrhage (8%), eye pain (8%), hypotony of eye (7%), anterior chamber inflammation (5%), dry eye (4%), vitreous opacities (4%), conjunctivitis (4%), posterior capsule opacification (4%), ocular hyperemia (4%), vitreous haze (3%), foreign body sensation in eyes (3%), vitritis (3%), vitreous floaters (3%), eye pruritus (3%), conjunctival hyperemia (2%), ocular discomfort (2%), macular fibrosis (2%), glaucoma (2%), photopsia (2%), vitreous hemorrhage (2%), iridocyclitis (1%), eye inflammation (1%), choroiditis (1%), eye irritation (1%), visual field defect (1%), and lacrimation increased (1%). Non-ocular adverse reactions reported by greater than or equal to 2% of patients include: nasopharyngitis (5%), hypertension (3%), and arthralgia (2%).

Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline at any visit was seen in 22% of fluocinolone acetonide patients versus 12% of sham patients. IOP elevation greater than or equal to 30 mm Hg was seen in 12% of fluocinolone acetonide patients versus 3% of sham patients. 43% of the patients who received fluocinolone acetonide were subsequently treated with IOP-lowering medications during the study versus 41% of sham patients. 2% of the patients who received fluocinolone acetonide needed surgical intervention for elevated IOP versus 2% of sham patients.

Please see full Prescribing Information for ILUVIEN.

About ANI Pharmaceuticals, Inc.

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives” by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit https://www.anipharmaceuticals.com. 

Forward-Looking Statements

To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the Company’s strategy; its expectations regarding its future operations, financial position or revenues, including its 2026 financial guidance; its expectations regarding its share repurchase program; the results and timing of the Company’s preclinical studies, clinical trials, regulatory submissions and regulatory approvals; the commercialization and anticipated sales of the Company’s products, including current and planned product launches and any additional product launches from the Company’s generic pipeline; the Company’s estimates of the market opportunity and addressable patient populations for its products; the expansion and execution capabilities of the Company’s sales force for acute gouty arthritis for Cortrophin Gel; the Company’s anticipated growth opportunities, including for Cortrophin Gel and ILUVIEN; the Company’s positioning for continued shareholder value creation; anticipated R&D developments and clinical trial advances; and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” the negatives thereof, or other words of similar meaning, derivations of such words and the use of future dates.

Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: the ability of the Company’s approved products, including Cortrophin Gel and ILUVIEN, to achieve commercialization at levels of market acceptance that will allow the Company to maintain profitability; the Company’s ability to complete or achieve any or all of the intended benefits of acquisitions and investments, in a timely manner or at all; delays and disruptions in the production of the Company’s approved products; increased costs and potential loss of revenues if the Company needs to change suppliers due to the limited number of suppliers for its raw materials, active pharmaceutical ingredients, excipients, and other materials; delays and disruptions in the production of the Company’s approved products as a result of its reliance on single source third party contract manufacturing supply for certain of its key products, including Cortrophin Gel and ILUVIEN; delays or failure to obtain or maintain approvals by the FDA of the Company’s products; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies; risks that the Company may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of the Company’s products from both domestic and overseas sources due to supply chain disruptions or for any other reason, including increased costs due to tariffs or macroeconomic disruptions; the ability of the Company’s manufacturing partners to meet its product demands and timelines; the impact of changes or fluctuations in exchange rates; the Company’s ability to develop, license or acquire, and commercialize new products; the Company’s obligations in agreements under which it licenses, develops or commercializes rights to products or technology from third parties and its ability to maintain such licenses; the level of competition the Company faces and the legal, regulatory and/or legislative strategies employed by its competitors to prevent or delay competition from generic alternatives to branded products; the Company’s ability to protect its intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which the Company is, or may become, a party; the Company’s ability, and that of its suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; the Company’s ability to maintain the services of its key executives and other personnel; and general business and economic conditions, such as inflationary pressures, geopolitical conditions.

More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, and other periodic reports, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Relations:
Irina Koffler, Vice President, Investor Relations
T: 917-734-7387
E: Irina.koffler@anipharmaceuticals.com 

Media Relations:
Argot Partners
T: 212-600-1494
E: ani@argotpartners.com 

SOURCE: ANI Pharmaceuticals, Inc.

Fort recently acquired a 50.1% interest in Logia USA, which holds an exclusive U.S. license for automated fuel-integrity systems, positioning Logia USA to pursue commercialization of standby-power fuel maintenance solutions as the global data center market is projected to grow to approximately US$700 billion by 2034

Tel Aviv, Israel, Sept. 30, 2026 (GLOBE NEWSWIRE) — Nexera Technologies Ltd (“Nexera” or the “Company”) (Nasdaq: NEXR, NEXRW), a data-driven company operating on the Amazon Marketplace and expanding into the global homeland security sector through advanced artificial intelligence (“AI”)-driven solutions, today provided an overview of the previously announced transaction through which its majority-owned subsidiary, Fort Technology Inc. (TSXV: FORT) (Nasdaq: FRTT) (“Fort”), acquired a majority stake in Logia USA Inc. (“Logia USA”), a company focused on selling advanced fuel integrity solutions for data centers and other mission-critical facilities in the United States.

Taken together, the previously disclosed terms outline how Fort intends to bring Logia Israel Ltd.’s (“Logia Israel”) automated fuel-integrity systems into the U.S. data center market through Logia USA.

Why Data Centers

Fort and Logia USA are focused on a practical operational problem inside the data-center buildout: standby generators only protect uptime if the fuel in the tanks remains within specification when the grid fails. According to Fortune Business Insights, the global data center market is projected to grow from approximately US$300 billion in 2026 to approximately US$700 billion by 2034. The companies believe that continued data growth may increase demand for solutions that help ensure backup power systems perform when needed, and that maintaining fuel integrity is becoming an increasingly important operational priority.

Logia USA was formed to commercialize, in the United States, automated fuel maintenance and integrity systems developed by Logia Israel, an Israeli company wholly owned by Logia USA founder Yair Harel. Logia Israel’s systems are currently sold and deployed with leading companies in Israel, and its automated systems provide continuous monitoring and filtration designed to maintain fuel quality to ASTM D975 standards, supporting reliable generator performance when power fails.

The parties intend to expand these capabilities into the United States via Logia USA, with a primary focus on the data center sector and other mission-critical facilities. Logia USA is an early-stage company and has not yet commenced sales in the United States.

The Completed Transaction

On August 26, 2026, Fort completed the previously announced acquisition of 50.1% of the issued and outstanding equity of Logia USA. Following the closing:

• Fort holds 50.1% of Logia USA and the founder, Yair Harel, holds 49.9%.
• Consideration for the acquisition consisted of 132,603 newly issued Fort common shares having an aggregate value of approximately US$125,000.
• The transaction was disclosed as arm’s length, and no finder’s fee was payable.
• As of the date of the closing, Nexera held approximately 70.19% of the issued and outstanding common shares of Fort.

Exclusive U.S. License for Israeli Technology

In connection with the closing of the acquisition, Logia USA entered into a license agreement with Logia Israel. Under the license agreement, as previously disclosed:

• Logia Israel granted Logia USA an exclusive and sublicensable license for the development, manufacture and commercialization in the United States of automated fuel maintenance and integrity systems for standby power generation developed by or on behalf of Logia Israel.
• The license has an initial term of five years, which Logia USA may extend for two additional five-year periods.
• Logia USA is required to pay Logia Israel a licensing fee of US$125,000, funded from the first advance under Fort’s credit Facility (as defined below).
• Logia USA has outstanding liabilities of up to US$390,000 owed to Logia Israel.

The license provides Logia USA with the rights to pursue commercialization in the United States of technology currently sold and deployed in Israel.

Capital to Enter the U.S. Data Center Market

Also, in connection with the acquisition closing, Fort entered into a credit facility agreement with Logia USA (the “Facility”), which provides Logia USA with a credit facility of up to US$2.0 million to support Logia USA’s U.S. market entry, product development, operations and growth. As previously disclosed:

• The Facility will be advanced in eight tranches over the course of two years, tied to agreed operational and sales milestones.
• Interest will accrue at a rate of 6% per annum.
• The Facility matures on August 26, 2029, subject to earlier repayment upon occurrence of the first equity-rebalancing threshold.
• Funding under the Facility depends on achievement of the agreed milestones. There can be no assurance that any particular tranche will be advanced.

How the Pieces Fit Together

Taken together, the previously disclosed elements of the transaction form a single commercialization framework:

• Market: U.S. data centers and other mission-critical facilities that depend on standby generation.
• Product: automated fuel monitoring and filtration designed to support maintenance of diesel fuel quality in accordance with ASTM D975 specifications.
• Rights: exclusive, sublicensable U.S. license from Logia Israel to Logia USA.
• Ownership: Fort holds a 50.1% majority stake, with a performance path that can shift economics toward Mr. Harel if large, profitable U.S. sales materialize.
• Funding: an unsecured, milestone based US$2.0 million facility to support U.S. market entry, product development, operations and growth.
• Operating control of the U.S. vehicle: Mr. Harel remains the Chief Executive Officer of Logia USA.

Nexera’s interest in the opportunity is indirect, through its majority ownership of Fort. Through Logia USA, Fort has stated that it aims to support the commercialization and expansion of fuel integrity solutions across the United States, with a primary focus on the data center sector.

About Nexera Technologies Ltd

Nexera Technologies Ltd operates, through its subsidiaries, in the fields of advanced technologies for the global homeland security, or HLS, sector and e-commerce. Its operations are conducted through three principal lines of business: KeepZone AI Inc., or KeepZone, a wholly-owned subsidiary dedicated to distributing and promoting AI-powered homeland security technologies, including 3D imaging and electromagnetic threat detection, perimeter intrusion detection, counter-unmanned aircraft systems, and multi-layered security solutions for critical infrastructure and global markets; Fort Products Limited, a legacy consumer products operation focused on pest control and remedial products, which was sold to Fort Technology Inc., or Fort Technology, in July 2025 in exchange for a controlling equity interest, with the Company having since reduced its stake in Fort while retaining control and strategic involvement in related e-commerce activities; and its ongoing legacy e-commerce activities, consisting of data-driven online retail operations (primarily on the Amazon Marketplace) conducted through the Company’s other wholly-owned subsidiaries, including Smart Repair Pro and Top Rank Ltd.

For more information on Nexera Technologies, visit: https://nexera-tech.io/

Forward-Looking Statements Disclaimer

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe the Company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “should,” “could,” “seek,” “intend,” “plan,” “goal,” “estimate,” “anticipate,” or other comparable terms. For example, the Company is using forward-looking statements when discussing: Fort’s ability, through Logia USA, to commercialize and expand automatic fuel maintenance systems in the United States; the anticipated demand for fuel integrity solutions among data centers and other mission-critical facilities; the anticipated size and growth of the data center market and demand for fuel integrity and standby-power solutions; the ability of Logia USA’s systems to maintain diesel fuel quality in accordance with ASTM D975 standards and support reliable standby-generator performance; Logia USA’s ability to enter the U.S. market, commence and grow sales, attract customers, achieve operational and sales milestones and develop a sustainable and profitable business; the expected benefits, term, renewal, sublicensing arrangements and continued operation of the exclusive U.S. license granted by Logia Israel; Fort’s ability to fund Logia USA under the credit facility, the timing and availability of advances under the facility, Logia USA’s achievement of the conditions and milestones applicable to each tranche, and Logia USA’s use of such funding for market entry, product development, operations and growth; Logia USA’s ability to pay the license fee and satisfy its outstanding liabilities to Logia Israel; the potential achievement of the applicable cumulative sales and net-profit-margin thresholds under the equity rebalancing mechanism, the possible issuance of additional Logia USA shares to Mr. Harel, and the resulting reduction of Fort’s ownership interest in, or loss of control over, Logia USA; Fort’s and Logia USA’s ability to realize the anticipated strategic, operational and commercial benefits of the acquisition and related agreements; and the Company’s ability to realize anticipated benefits from its indirect interest in Logia USA through its ownership of Fort. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control. The Company’s actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause the Company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: the Company’s ability to adapt to significant future alterations in Amazon’s policies; the Company’s ability to sell its existing products and grow the Company’s brands and product offerings; the Company’s ability to meet its expectations regarding the revenue growth and the demand for e-commerce; the overall global economic environment; the impact of competition and new e-commerce technologies; general market, political and economic conditions in the countries in which the Company operates; projected capital expenditures and liquidity; the impact of possible changes in Amazon’s policies and terms of use; the impact of conditions in Israel; and the other risks and uncertainties described in the Company’s Annual Report on Form 20-F for the year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (“SEC”), on April 1, 2026, and the Company’s other filings with the SEC. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Relations Contact

Michal Efraty
Adi and Michal PR-IR
Investor Relations, Israel
michal@efraty.com 

FORM 8.5 (EPT/RI)

PUBLIC DEALING DISCLOSURE BY AN EXEMPT PRINCIPAL TRADER WITH RECOGNISED INTERMEDIARY STATUS DEALING IN A CLIENT-SERVING CAPACITY
Rule 8.5 of the Takeover Code (the “Code”)

1.        KEY INFORMATION

(a)        Name of exempt principal trader:	Investec Bank plc
(b)        Name of offeror/offeree in relation to whose relevant securities this form relates:         Use a separate form for each offeror/offeree	Gamma Communications Plc
(c)        Name of the party to the offer with which exempt principal trader is connected:	Investec is Joint Broker to Gamma Communications Plc
(d)        Date dealing undertaken:	29th September 2026
(e)        In addition to the company in 1(b) above, is the exempt principal trader making disclosures in respect of any other party to this offer?         If it is a cash offer or possible cash offer, state “N/A”	N/A

2.        DEALINGS BY THE EXEMPT PRINCIPAL TRADER

Where there have been dealings in more than one class of relevant securities of the offeror or offeree named in 1(b), copy table 2(a), (b), (c) or (d) (as appropriate) for each additional class of relevant security dealt in.

The currency of all prices and other monetary amounts should be stated.

(a)        Purchases and sales

Class of relevant security	Purchases/ sales	Total number of securities	Highest price per unit paid/received	Lowest price per unit paid/received
Ordinary shares	Purchases	15,564	1122.5	1122.5
Ordinary shares	Sales	15,564	1123.5	1122

(b)        Cash-settled derivative transactions

Class of relevant security	Product description e.g. CFD	Nature of dealing e.g. opening/closing a long/short position, increasing/reducing a long/short position	Number of reference securities	Price per unit
N/A	N/A	N/A	N/A	N/A

(c)        Stock-settled derivative transactions (including options)

(i)        Writing, selling, purchasing or varying

Class of relevant security	Product description e.g. call option	Writing, purchasing, selling, varying etc.	Number of securities to which option relates	Exercise price per unit	Type e.g. American, European etc.	Expiry date	Option money paid/ received per unit
N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

(ii)        Exercise

Class of relevant security	Product description e.g. call option	Exercising/ exercised against	Number of securities	Exercise price per unit
N/A	N/A	N/A	N/A	N/A

(d)        Other dealings (including subscribing for new securities)

Class of relevant security	Nature of dealing e.g. subscription, conversion	Details	Price per unit (if applicable)
N/A	N/A	N/A	N/A

3.        OTHER INFORMATION
        
(a)        Indemnity and other dealing arrangements

Details of any indemnity or option arrangement, or any agreement or understanding, formal or informal, relating to relevant securities which may be an inducement to deal or refrain from dealing entered into by the exempt principal trader making the disclosure and any party to the offer or any person acting in concert with a party to the offer: Irrevocable commitments and letters of intent should not be included. If there are no such agreements, arrangements or understandings, state “none”

None

(b)        Agreements, arrangements or understandings relating to options or derivatives

Details of any agreement, arrangement or understanding, formal or informal, between the exempt principal trader making the disclosure and any other person relating to: (i)        the voting rights of any relevant securities under any option; or (ii)        the voting rights or future acquisition or disposal of any relevant securities to which any derivative is referenced: If there are no such agreements, arrangements or understandings, state “none”

None

Date of disclosure:	30th September 2026
Contact name:	Abhishek Gawde
Telephone number:	+91-9923757332

Public disclosures under Rule 8 of the Code must be made to a Regulatory Information Service.

The Panel’s Market Surveillance Unit is available for consultation in relation to the Code’s dealing disclosure requirements on +44 (0)20 7638 0129.

The Code can be viewed on the Panel’s website at www.thetakeoverpanel.org.uk.

ATLANTA and LONDON, Sept. 30, 2026 (GLOBE NEWSWIRE) — Descartes Systems Group (Nasdaq:DSGX) (TSX:DSG), the global leader in uniting logistics-intensive businesses in commerce, will showcase its artificial intelligence (AI) and logistics technology innovations at its 2026 Innovation Forum, which takes place October 6–8 in Chicago. The innovations address time-consuming work across supply chain operations, including chasing shipment updates, rekeying trade documents and investigating delivery exceptions. Combining the connectivity and operationally ready data of the Descartes Global Logistics Network™ (Descartes GLN™) with logistics expertise and embedded AI, these capabilities help customers act faster, increase capacity and keep customer commitments on track.

“Too much of a logistics professional’s day can still be consumed by tracking down information, reconciling data and following up on routine tasks,” said Ken Wood, Executive Vice President, Product Management at Descartes. “Our AI innovations take on more of that operational legwork, giving people more time for the decisions, exceptions and customer relationships that require their expertise. At this year’s Innovation Forum, we’re showing how trusted data, logistics expertise and intelligent automation come together to help customers put AI to work with measurable results and appropriate human oversight.”

Some of the technology highlights at the event include:

Transportation Management

• AI agents that take on freight visibility follow-up. Descartes MacroPoint™ OpsForce automates driver engagement, restores interrupted tracking, confirms shipment milestones and collects missing proof-of-delivery documents. Previously reported customer results include an average 30% increase in no-touch tracking automation and 1.5x productivity gains for tracking teams, helping transportation providers manage more freight with less manual follow-up.

Fleet Performance Management

• Machine learning that increases delivery capacity. The Descartes Fleet Data Intelligence™ platform learns from actual delivery durations and route conditions to improve service time predictions. Early deployments increased route density by up to 30%, enabling fleets to schedule more stops within existing driver hours.
• Predictive AI to help reduce accidents. Descartes Fleet Safety™ draws on more than 40 billion miles of telemetry and 500,000 accident records to identify driver risk and guide targeted coaching. By combining predictive insights with training and monitoring workflows, the solution helps fleets intervene earlier to improve driver behavior and reduce preventable accidents.

Global Trade Intelligence

• AI-powered free trade qualification to uncover duty savings. Descartes Free Trade Intelligence combines AI-enabled analysis with rules of origin covering more than 250 regimes globally to help assess eligibility for preferential tariffs. Explainable recommendations and documented calculations support faster qualification, more informed sourcing decisions and audit readiness.
• AI-assisted screening that reduces false positives. Descartes Visual Compliance™ AI Assist uses machine learning to filter low-risk screening results and reduce unnecessary reviews. Configurable risk settings, human oversight and audit trails help compliance teams focus on potential threats while maintaining control over screening decisions.
• Conversational AI that accelerates global trade research. The Descartes Datamyne™ AI Agent answers natural-language questions with insights linked to supporting shipment records, helping teams evaluate suppliers, monitor competitors and identify market opportunities. It helps reduce research and analysis time, depending on user experience and query complexity.

Logistics Service Providers

• AI that turns shipment documents into operationally ready data. Descartes’ AI-powered Image Document Management interprets related commercial invoices, bills of lading and packing lists to prepare data for customs entries and shipment creation. Embedded AI agents reduce repetitive rekeying and manual corrections within the applications customers already use.
• Faster quoting to capture new business. Descartes Spot™ combines live carrier rates, fees and surcharges with quotation management, helping forwarders return 90% of customer quotes in under 30 seconds while evaluating shipping options and protecting margins.

Ecommerce Operations

• AI-driven purchasing and inventory planning. Descartes ForecastMine™ uses sales data to generate SKU-level demand forecasts and purchasing recommendations, including for bundles, kits and product variants. It flags slow-moving products and helps merchants reduce stockouts and excess inventory.

Descartes’ innovations will be showcased at a unique and interactive Technology Fair on October 6 from 6:00 PM-9:00 PM CT, offering attendees hands-on experience with its latest capabilities and solutions. After the Technology Fair, the company plans to donate monitors and flat screen televisions used at the event to Compudot, a national non-profit organization with a local office in Chicago that provides free computers, low-cost or free internet solutions, and technology education to schools for underserved youth and families to help them support educational goals for students.  

Through sessions, peer discussions and hands-on demonstrations, the Innovation Forum brings customers, partners and Descartes teams together to explore how technology can reduce operational friction across the shipment journey from order to delivery.

To learn more about event speakers, sessions and sponsors, visit 2026 Innovation Forum.

About Descartes

Descartes powers more responsive, efficient, secure and sustainable international and domestic supply chains by uniting logistics-intensive businesses on its Global Logistics Network (GLN). Shippers, carriers, and logistics service providers connect and collaborate on the GLN leveraging technology, data and AI to manage last mile deliveries, domestic and international shipments, transportation rating and payment, global trade research, customs compliance and a variety of regulatory processes. Learn more about Descartes at www.descartes.com and connect with us on LinkedIn and X.

Global Media Contact
Cara Strohack                                                                     
Tel: 226-750-8050                                 
cstrohack@descartes.com  

Cautionary Statement Regarding Forward-Looking Statements

This release contains forward-looking information within the meaning of applicable securities laws (“forward-looking statements”) that relate to Descartes’ logistics and supply chain solution offerings and potential benefits derived therefrom; the innovations Descartes intends to present at its Innovation Forum in Chicago; and other matters. Such forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, performance or achievements to differ materially from the anticipated results, performance or achievements or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the factors and assumptions discussed in the section entitled, “Certain Factors That May Affect Future Results” in documents filed with the Securities and Exchange Commission, the Ontario Securities Commission and other securities regulatory authorities across Canada including Descartes’ most recently filed annual and interim management’s discussion and analysis which are available under Descartes’ profile through the EDGAR website at http://www.sec.gov or through the SEDAR+ website at http://www.sedarplus.com/. If any such risks actually occur, they could, among other consequences, materially adversely affect our business, financial condition or results of operations. In that case, the trading price of our common shares could decline, perhaps materially. Readers are cautioned not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Forward-looking statements are provided for the purposes of providing information about management’s current expectations and plans relating to the future. Readers are cautioned that such information may not be appropriate for other purposes. Except as required by applicable law, Descartes does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements whether as a result of new information, future events, changed circumstances or otherwise.