Month: September 2026

SHAKOPEE, Minn., Sept. 14, 2026 (GLOBE NEWSWIRE) — Canterbury Park Holding Corporation (“Canterbury” or the “Company”) (NASDAQ: CPHC), today announced that the Company’s Board of Directors, pursuant to its dividend policy, approved a quarterly cash dividend of $0.07 per share that will be paid on October 14, 2026 to stockholders of record on September 30, 2026. At this quarterly rate, the annual dividend is equivalent to $0.28 per common share.

About Canterbury Park

Canterbury Park Holding Corporation (Nasdaq: CPHC) owns and operates Canterbury Park Racetrack and Casino in Shakopee, Minnesota, the only thoroughbred and quarter horse racing facility in the State. The Company generally offers live racing from May to September. The Casino hosts card games 24 hours a day, seven days a week, dealing both poker and table games. The Company also conducts year-round wagering on simulcast horse racing and hosts a variety of other entertainment and special events at its Shakopee facility. The Company is also pursuing a strategy to enhance shareholder value by the ongoing development of approximately 140 acres of underutilized land surrounding the Racetrack that was originally designated for a project known as Canterbury Commons™. The Company is pursuing several mixed-use development opportunities for the remaining underutilized land, directly and through joint ventures. For more information about the Company, please visit www.canterburypark.com.

Cautionary Statement

From time to time, in press releases and in other communications to shareholders or the investing public, Canterbury Park Holding Corporation may make forward-looking statements concerning possible or anticipated future financial performance, business activities or plans based on management’s beliefs and assumptions. These forward looking statements are typically preceded by the words such as “believes,” “expects,” “anticipates,” “intends” or similar expressions. Shareholders and the investing public should understand that these forward-looking statements are subject to risks and uncertainties, including those disclosed in our periodic filings with the Securities and Exchange Commission, which could cause actual performance, activities, future dividends or plans after the date the statements are made to differ significantly from those indicated in the forward-looking statements when made.

Investor Contact:

Randy Dehmer                                                        
Senior Vice President and Chief Financial Officer                        
Canterbury Park Holding Corporation                                
952-233-4828 or investorrelations@canterburypark.com

— Topline Phase 1 data shows generally favorable safety and tolerability profile of AGMB-447 —

— Pharmacokinetic profile confirms efficient lung restriction with low systemic exposure and high exposure of AGMB-447 in the lung, in line with prior results observed in healthy participants —

— Robust target engagement of ALK5 observed with AGMB-447 in IPF patients —

— Clinical Trial Application (CTA) for INSPIRIA Phase 2 study in IPF patients submitted; Company intends to initiate study before year-end —

Antwerp, Belgium, September 14, 2026 – Agomab Therapeutics NV (‘Agomab’), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced positive results of the Phase 1 study of AGMB-447 in IPF patients. AGMB-447 is an investigational inhaled lung-restricted small molecule inhibitor of ALK5 (or TGFβR1) intended for the treatment of Idiopathic Pulmonary Fibrosis (IPF).¹

The Phase 1 study of AGMB-447 is a three-part, double-blind, randomized, placebo-controlled single ascending dose (SAD; Part A; dose range: 1 mg QD (once daily) to 20 mg QD) and multiple ascending dose (MAD; Part B; dose range: 1 mg QD to 6 mg BID (twice daily)) study in healthy participants and multiple dose study in IPF patients (Part C; dose range: 4.5 mg BID to 6 mg BID). AGMB-447 was administered via nebulization, as a single dose in the SAD, over seven days in Part B and over 14 days in Part C.

A total of 10 IPF patients were included in Part C. In line with the data in healthy participants reported previously, AGMB-447 was observed to have a generally favorable safety and tolerability profile in IPF patients at 4.5 mg BID. While a higher incidence of adverse events was reported at 6 mg BID, no new specific safety signals were identified, and no systemic safety signals were detected at any dose. The most frequently reported adverse events were cough and bronchospasm. Cough episodes were short and mostly limited to the inhalation period. Furthermore, no increase in the severity of disease-related cough was reported at any dose over the 14-day dosing period.

Low systemic but high pulmonary exposure of AGMB-447 was also measured in IPF patients, supporting its lung-restricted pharmacokinetic (PK) profile. In IPF patients, daily doses of 4.5 mg BID achieved average bronchoalveolar lavage (BAL) fluid levels above IC₉₀ for at least 6 hours post-inhalation, and above IC₅₀ for 24 hours, in line with the PK profile observed in healthy participants.

In IPF patients, pSMAD3 reduction in BAL cells of >50% was achieved at the 4.5 mg BID dose, indicating robust target engagement in line with the results observed previously in healthy participants and supporting further clinical development of AGMB-447 for the treatment of IPF.

“We are very pleased with the Phase 1 results of AGMB-447 in patients with IPF announced today. In line with the positive interim data in healthy participants announced earlier this year, the data indicated a generally favorable safety, tolerability and PK profile of AGMB-447 and provided proof-of-mechanism of TGFβ/ALK5 inhibition in the lungs of IPF patients,” said Philippe Wiesel, Chief Medical Officer at Agomab. “We believe that by blocking the TGFβ/ALK5 pathway locally in the lung, AGMB-447 has the potential to offer a potent anti-fibrotic therapy to IPF patients. The extensive data collected in our broad Phase 1 program supports the initiation of our Phase 2 INSPIRIA study later this year.”

The company also announced the design of INSPIRIA, its planned Phase 2 study with AGMB-447 in IPF. INSPIRIA is a 24-week Phase 2, randomized, double-blind, placebo-controlled study in approximately 120 patients with confirmed IPF. Patients will be randomized 2:1 to receive AGMB-447 4 mg twice daily or placebo, administered by inhalation on top of standard of care. The study is designed to evaluate the safety, pharmacokinetics and efficacy of AGMB-447 in IPF patients. The primary endpoint will be the change from baseline in forced vital capacity at Week 24. The CTA for INSPIRIA has been submitted, and the study is anticipated to begin in the second half of 2026 across a large European site network.

“We have long known that the TGFβ pathway is a central driver of fibrosis in IPF. Targeting this key pathway through ALK5 inhibition with AGMB-447 is a promising approach. With a convenient twice-daily dosing schedule, AGMB-447 could represent an attractive option for monotherapy or combination therapy with systemic standard of care therapies. The INSPIRIA study is designed to further explore the therapeutic potential of this novel inhaled approach in people living with IPF,” said Toby Maher, M.D., PhD, Professor of Clinical Medicine at Keck School of Medicine of USC.

Agomab intends to present detailed Phase 1 results at a future scientific conference.

AGMB-447 is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established. 

About IPF
Idiopathic Pulmonary Fibrosis (IPF) is a devastating disease affecting approximately 255,000 patients in the U.S., Japan, and the largest European markets (EU4+UK). IPF is characterized by unregulated production of fibrotic, scar-like tissue that builds up in the scaffolding of the lungs. As a result, the fibrotic lung becomes stiff, hampers the patient’s ability to breathe and reduces the absorption of inhaled oxygen in the blood. Despite the commercial availability of three approved therapies, without a lung transplant, the median survival following diagnosis is only 3-5 years. Moreover, these therapies do not halt but only slow down disease progression and have side effects that reduce tolerability and lead to treatment discontinuations.

About AGMB-447
AGMB-447 is an inhaled lung-restricted small molecule inhibitor of ALK5 (or TGFβR1) intended for the treatment of Idiopathic Pulmonary Fibrosis (IPF). TGFβ is the master regulator of fibrosis, which is the key mechanism driving IPF disease progression. AGMB-447 is specifically designed to inhibit ALK5 in the lung while avoiding clinically relevant systemic exposure through local administration via inhalation and rapid hydrolyzation in plasma into one main metabolite inactive in cells. Through AGMB-447, Agomab aims to offer a potentially safe and effective novel anti-fibrotic therapeutic option to IPF patients.

About Agomab
Agomab is a clinical-stage biopharmaceutical company focused on developing novel disease-modifying therapies for fibro-inflammatory diseases with high unmet medical need. Agomab’s product candidates are designed to target established, potent pathways and utilize organ-restricted approaches, with the aim of increasing efficacy while minimizing safety liabilities. Fostering a culture of excellence, Agomab’s mission is to pioneer therapeutics that aim to resolve fibro-inflammation and restore organ function to enable people with these disorders to live fuller and healthier lives.

Cautionary Note regarding Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are often identified by terms such as “continue,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. “Forward-looking statements” include, without limitation, statements regarding the potential of AGMB-447 for the treatment of IPF, the design of the planned Phase 2 clinical trial with AGMB-447 for IPF, our expectation to initiate our Phase 2 clinical trial of AGMB-447 in IPF in the second half of 2026, and our interactions with regulatory authorities. Forward-looking statements are based on Agomab’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to the results of our clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements for product candidates; the impact of governmental laws and regulations on our business; and disruptions caused by our reliance on third party suppliers and service providers. These and other risks and uncertainties are described more fully in our filings and reports with the SEC, including in our most recent annual report on Form 20‐F filed with the SEC and our subsequent filings and reports filed with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Agomab undertakes no duty to update such information except as required under applicable law. Readers should not rely upon the information in this announcement as current or accurate after its publication date.

Contacts
Investors
Sofie Van Gijsel
VP of Investor Relations
E-Mail: sofie.vangijsel@agomab.com
Phone: +1 781 296 1143
        
Media
Gretchen Schweitzer
Trophic Communications
E-Mail: agomab@trophic.eu 
Phone: +49 172 861 8540

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¹ Study Details | Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF | ClinicalTrials.gov

Collaboration to evaluate MicronJet™ with NurExone exosomes across ophthalmic and aesthetic applications in multi-billion-dollar markets

TORONTO and HAIFA, Israel, Sept. 14, 2026 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a biopharmaceutical company developing exosome-based regenerative therapies, announces that its Israeli subsidiary, NurExone Biologic Ltd., has entered into a Memorandum of Understanding (the “MOU”) with NanoPass Technologies Ltd. (“NanoPass”), a medical device company specializing in precision delivery, to evaluate the integration of NanoPass’s MicronJet™ platform with NurExone’s exosome formulations for eye and skin applications.

NurExone’s exosomes are designed to act as biological delivery vehicles, targeting damaged tissue either on their own or carrying therapeutic cargo. NanoPass’s FDA-cleared MicronJet™ intradermal delivery platform provides precise, controlled and safe placement at the site of administration (leveraging advanced MEMS technology silicon-crystal pyramids).

Ophthalmology

NurExone is developing ExoPTEN for optic nerve damage, including glaucoma-related indications, following preclinical studies showing improvements in retinal function and retinal ganglion cell survival compared with controls.

The companies plan to evaluate NanoPass’s MicronJet™ technology for suprachoroidal delivery in a preclinical study comparing it with existing administration methods. The study will assess whether NanoPass’s platform can provide a practical, minimally invasive and consistent administration method that could support future clinical use, scale-up and commercialization. Precise delivery is important in the eye, and the suprachoroidal space offers a way to place treatment close to the retina and optic nerve while limiting exposure to other parts of the eye.

Dermatology and Aesthetics

The companies also plan to evaluate the use of MicronJet™ for intradermal delivery of NurExone’s exosome formulations for skincare and aesthetic applications.

A challenge in these applications is getting the exosomes beyond the skin’s natural barrier. Rather than remaining on the surface, NanoPass’s intradermal delivery technology is designed to place the formulation directly into the skin in a controlled and minimally invasive way.

For NurExone’s U.S. subsidiary, Exo-Top Inc., the collaboration could support development of an integrated exosome-and-delivery product that is straightforward for professional use and potentially easier to standardize and scale across applications such as skin rejuvenation and other aesthetic uses. The broader global regenerative aesthetics market is experiencing rapid expansion and is projected to grow from approximately US$17.7 billion in 2026 to approximately US$28.9 billion by 2030.¹

Collaboration Terms

Under the MOU, the companies will evaluate NanoPass’s MicronJet™ platform with NurExone’s MSC-derived exosome formulations. Each party will fund its own activities; NurExone will own the preclinical proof-of-concept results, with newly developed IP jointly owned.

CEO Commentaries

“Our exosome platform is designed to work across multiple indications, and NanoPass gives us an opportunity to test an additional administration approach where localized delivery may be especially useful,” said Dr. Lior Shaltiel, Chief Executive Officer of NurExone. “For eye and skin applications, we will evaluate whether the combination can create a practical, consistent and easy-to-use product format for future clinical and commercial use. ExoPTEN’s acute spinal cord injury program is advancing through a separate minimally invasive administration approach.”

“Exosomes are emerging as an important new class of biological products, and we believe they represent a significant new opportunity for our delivery platform,” said Daniel Levitats, Chief Executive Officer of NanoPass Technologies. “NurExone gives us the opportunity to evaluate MicronJet™ across both therapeutic and commercial exosome applications and potentially establish a new area of use for a technology already supported by extensive clinical experience.”

The MOU does not obligate either party to enter into a definitive commercial agreement and may be terminated by either party without cause on 30 days’ written notice. The full details of the collaboration agreement and the Company’s ongoing corporate and financial roadmaps can be accessed by visiting the Company’s website at www.nurexone.com and its SEDAR+ profile at www.sedarplus.ca.

About NanoPass Technologies Ltd.

NanoPass Technologies Ltd. is a global medical device company pioneering precision intradermal drug delivery. The company developed MicronJet™, the first FDA-cleared device specifically designed for true intradermal delivery (<1 mm), enabling accurate, consistent, and safe delivery into the dermis.

Supported by over 70 clinical studies and millions of successful treatments worldwide, NanoPass collaborates with pharmaceutical companies, researchers, and physicians all over the world to improve vaccine delivery, biologics administration, and regenerative aesthetic treatments.

Follow NanoPass on Linkedin, Instagram. Contact: info@nanopass.com

About NurExone

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

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

For more information, please contact:

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

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

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

Neither the 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.

FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements are often, but not always, identified by words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “potential” and similar expressions.

Forward-looking statements in this press release include, without limitation, statements relating to: the collaboration between NurExone and NanoPass; the planned evaluation of NanoPass’s MicronJet™ platform with NurExone’s exosome formulations; the timing, scope and results of planned preclinical studies; the potential use of the combined technologies in ophthalmic, dermatology, facial nerve and aesthetic applications; the potential for the collaboration to support future clinical development, scale-up, commercialization and integrated exosome products; the potential expansion of NanoPass’s platform into exosome-based applications; the potential benefits of precise and standardized administration; the expected continuation and advancement of NurExone’s acute spinal cord injury program; and the potential benefits of the non-shop and intellectual property arrangements under the MOU; the parties’ ability to carry out the contemplated work plans; and third-party projections regarding growth in the regenerative aesthetics market.

Forward-looking statements are based on management’s current expectations and assumptions as of the date of this press release, including assumptions regarding: the ability of the parties to carry out the planned evaluation and preclinical studies; the continued availability of capital, personnel, materials and third-party service providers on commercially reasonable terms; that the MicronJet™ platform will be compatible with NurExone’s exosome formulations; that preclinical results will support further development; that the parties will continue to cooperate under the terms of the MOU; that regulatory, manufacturing and commercial development activities will proceed as currently contemplated; and that market demand for exosome-based therapeutic and aesthetic applications will develop as anticipated.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements, including, without limitation: early-stage development risk; the risk that planned studies may be delayed, modified or not completed; the risk that the MicronJet™ platform may not demonstrate the expected compatibility, delivery characteristics or development advantages with NurExone’s exosome formulations; the risk that preclinical results may not support further development or may not be predictive of clinical outcomes; regulatory review timing and outcomes; manufacturing, scale-up and commercialization risks; dependence on third-party collaborators, suppliers and counterparties; intellectual property risks; financing and market conditions; and the risks described in the Company’s continuous disclosure filings available under the Company’s SEDAR+ profile at www.sedarplus.ca. Readers are cautioned not to place undue reliance on forward-looking statements. Although the forward-looking statements contained in this press release are based on assumptions that management believes are reasonable as of the date hereof, actual results may differ materially. These forward-looking statements are made as of the date of this press release, and the Company undertakes no obligation to update or revise them except as required by applicable law.

¹ The Business Research Company, Regenerative Aesthetics Global Market Report 2026 (February 12, 2026), available through Global Information, Inc. at https://www.giiresearch.com/report/tbrc1957739-regenerative-aesthetics-global-market-report.html

Post hoc analyses of SION-719 PreciSION CF subset showed a mean placebo-adjusted sweat chloride reduction of up to -8.6 mmol/L consistent with NBD1 biological activity

Dual combination Phase 2a trial expected to initiate in first quarter of 2027

46% workforce reduction and other cost-saving measures prioritize advancing the dual combination program and extend cash runway into the second half of 2029

Sionna to host conference call today at 4:30 p.m. ET

WALTHAM, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) — Sionna Therapeutics, Inc. (Nasdaq: SION), a clinical-stage biopharmaceutical company on a mission to develop novel medicines for cystic fibrosis (CF), today announced plans to advance SION-451 + SION-2222, its preferred proprietary dual combination, into the AscenSION CF Phase 2a proof-of-concept (POC) trial, and results from the company’s post hoc analysis of the PreciSION CF Phase 2a trial. The decision to advance SION-451 + SION-2222 follows an extensive review of clinical, pharmacokinetic (PK) and nonclinical data from PreciSION CF. Learnings from that trial and the previous Phase 1 dual combination trial will inform the development strategy for the dual combination.

“It was important for us to take the time to complete a comprehensive post hoc data analysis to better understand the SION-719 PreciSION CF trial results and their potential implications before determining the right path forward for our dual combination,” said Mike Cloonan, President and Chief Executive Officer of Sionna. “The analysis identified important factors that we believe complicated interpretation of the trial and may have blunted the impact of NBD1 stabilization. The post hoc findings, together with the favorable Phase 1 results for SION-451 + SION-2222, support advancing the dual combination into Phase 2a. We have been inspired by the CF community, whose voices continue to reinforce the need for new treatment options.”

“Despite the substantial progress made, there remains a significant need for new options for people with CF,” said Gregory S. Sawicki, M.D., M.P.H., Director of the Cystic Fibrosis Center at Boston Children’s Hospital and Associate Professor of Pediatrics at Harvard Medical School. “Directly stabilizing NBD1 continues to represent a differentiated approach to addressing the underlying biology of CF. I’m excited to see Sionna proceed with a Phase 2a trial of SION-451 + SION-2222, which will be an important next step in further exploring whether the NBD1 biology can translate into meaningful benefit for people with CF.”

Post Hoc Analysis of SION-719 PreciSION CF Phase 2a Clinical Trial
PreciSION CF Phase 2a (NCT07108153) was a randomized, double-blind, placebo-controlled, crossover trial that evaluated the safety and tolerability of SION-719 when added to Trikafta^® in 15 adult participants with CF homozygous for F508del. Change in sweat chloride, an important measure of CFTR function, was the key activity endpoint. As previously announced, the trial did not achieve its key activity endpoint, and Sionna is not advancing SION-719 as an add-on to SOC.

Following the announcement of topline results, Sionna conducted a comprehensive analysis of the clinical, PK, and nonclinical data to better understand the PreciSION CF outcome, including implications for the NBD1 mechanism and the SION-451 + SION-2222 dual combination.

The primary analysis in the trial assessed placebo-adjusted sweat chloride change using Day 1 as baseline. A prespecified secondary analysis assessed placebo-adjusted sweat chloride change using the baseline measured at the start of each treatment period. Across the 14 evaluable participants, results were similar under both methodologies, with placebo-adjusted sweat chloride changes of -1.0 mmol/L in the primary analysis and -1.1 mmol/L in the secondary analysis.

The post hoc analysis identified three factors that may have confounded the observed treatment effect:

• PK outliers: Three participants had drug exposures (one with SION-719 and two with the components of Trikafta (elexacaftor/tezacaftor/ivacaftor; ETI) at key timepoints consistent with non-adherence. Excluding these confounded participants resulted in mean placebo-adjusted sweat chloride change of -8.6 mmol/L using the secondary analysis of baseline measured at the start of each treatment period. The Company believes the secondary analysis to assess sweat chloride best accounts for variability observed between treatment periods.
• Trikafta Exposure Levels: ETI exposures were lower during SION-719 treatment periods, with mean exposures of all three components declining by approximately 25-30% on average while remaining relatively stable during placebo periods.
• CFTR Channel Biology: Post hoc analysis of preclinical CFHBE assay data suggests that the interaction between an NBD1 stabilizer, like SION-719, and a potentiator, like ivacaftor, may have blunted the additional benefit of NBD1 stabilization. This interaction is not observed when an NBD1 stabilizer is combined with complementary correctors targeting TMD1 or ICL4.

Sionna believes these analyses suggest that SION-719 was biologically active in the trial, but that PK outliers and complex interactions between SION-719 and Trikafta may have affected the observed outcome and blunted a potential treatment signal.

SION-451 + SION-2222 Dual Combination Phase 2 Development Plan
Sionna plans to advance SION-451 + SION-2222 into the AscenSION CF Phase 2a POC trial. The Company continues to believe that directly stabilizing NBD1 in combination with a complementary CFTR modulator has the potential to meaningfully improve CFTR function.

The AscenSION CF POC will be an open-label trial evaluating adults with CF homozygous for F508del treated with SION-451 + SION-2222 for 28 days. Participants will switch from Trikafta to SION-451 + SION-2222, and the trial will assess sweat chloride, safety, and PK. The design will incorporate key learnings from PreciSION CF with respect to dosing adherence and sweat chloride variability, and the trial is expected to initiate in the first quarter of 2027.

The decision to advance SION-451 + SION-2222 is supported by results from the Phase 1 healthy volunteer trial of SION-451-based dual combinations, for which the Company announced topline results on August 10, 2026. The trial achieved its safety, tolerability, and PK objectives. SION-451 + SION-2222 was identified as the preferred dual combination based on target exposure coverage, and the go-forward SION-451 twice daily (BID) + SION-2222 once daily (QD) regimen demonstrated a favorable tolerability profile. Phase 1 exposures of the planned doses were within the range associated with meaningful improvement in CFTR function in Sionna’s CFHBE assay.

Corporate Update
Following the completion of a comprehensive review of its operations, Sionna’s Board of Directors has approved a workforce reduction of approximately 46% and the Company has implemented other cost-saving measures to focus its resources on advancing SION-451 + SION-2222 and extend its operating runway. Sionna expects to retain the core clinical, scientific, regulatory, technical, and corporate capabilities required to advance the dual combination program. The Company currently estimates it will incur aggregate restructuring and related charges of approximately $6.4 million.

Sionna ended Q2 2026 with approximately $268.3 million in cash, cash equivalents, and marketable securities. The Company estimates that the workforce reduction, discontinuation of investment in SION-719 as an add-on to standard of care, and other cost-saving measures will extend its cash runway into the second half of 2029.

Webcast Details
Sionna Therapeutics’ live webcast will begin at 4:30 p.m. ET today, September 14th, 2026, and can be accessed via this link. Participants who prefer to listen via telephone, or ask a question, may register on Sionna’s Investor Relations website or by clicking here. A replay will be available on the “Events” page in the “Investors” section of Sionna’s website at https://investors.sionnatx.com/news-events/events.

About Sionna Therapeutics
Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis (CF) by developing novel medicines that normalize the function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. Sionna’s goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR’s nucleotide binding domain 1 (NBD1), which Sionna believes is central to potentially unlocking meaningful improvements in clinical outcomes and quality of life for people with CF. For more information about Sionna, visit www.sionnatx.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Sionna’s beliefs and expectations regarding: its goal of transforming the treatment paradigm for CF; its interpretation of the results of the PreciSION CF trial and the impact of potential confounding factors on the interpretation of those results; the potential for NBD1 stabilization to improve CFTR function and produce clinical benefit, including beliefs about biological activity of SION-719 in PreciSION CF and the translatability of preclinical and in vitro assay data to clinical outcomes; the objectives, design, timing, initiation and conduct of a planned Phase 2a proof-of-concept trial of SION-451 + SION-2222; the therapeutic potential, clinical benefits and safety of SION-451 + SION-2222; the expected timing, scope, costs and benefits of the workforce reduction and other cost-saving measures; the Company’s ability to retain the capabilities and personnel needed to advance SION-451 + SION-2222 and operate as a public company; the Company’s expected cash runway; and other statements that are not historical facts.

In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential” or “continue,” or the negative of these terms or other similar expressions. Any forward-looking statements are based on management’s current expectations and beliefs and are subject to risks, uncertainties and important factors that may cause actual events or results to differ materially, including uncertainties inherent in developing product candidates; interpreting the PreciSION CF results and potential confounding factors; the inherent limitations of post hoc analyses, which are exploratory and may not reliably predict future outcomes; the risk that in vitro and preclinical data may not translate to clinical benefit; the risk that results observed with one compound may not be predictive of results with a different compound or combination; and designing and conducting the planned Phase 2a trial. Additional risks include the Company’s ability to demonstrate that its candidates are safe and effective; obtain regulatory feedback or approvals; achieve anticipated restructuring savings and runway extension; retain key personnel and capabilities following the workforce reduction; secure sufficient funding; and respond to general economic, industry and market conditions. These risks and uncertainties are described in “Risk Factors” in Sionna’s most recent Quarterly Report on Form 10-Q and subsequent filings with the Securities and Exchange Commission. The events and circumstances reflected in the forward-looking statements may not be achieved or occur. Any forward-looking statements represent Sionna’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Sionna disclaims any obligation to update any forward-looking statements except as required by law. No representations or warranties, express or implied, are made about the accuracy of any such forward-looking statements.

Media Contact
Sarah Spencer
media@sionnatx.com

Investor Contact
Juliet Labadorf
ir@sionnatx.com

KIRKLAND, Wash., Sept. 14, 2026 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a leading wearable medical device and digital healthcare company, today reported financial results for the first quarter of fiscal year 2027, which ended July 31, 2026.

Financial Highlights

• Generated revenue of $31.0 million in F1Q27, an increase of 60% compared to the prior year period.
• Expanded gross margin to 56.5% in F1Q27 compared to 45.7% in the prior year period.
• Increased FY27 revenue guidance to $141 million, representing growth of 48% compared to FY26.

“Kestra delivered another strong quarter of financial performance, generating revenue growth of 60% while expanding gross margin to over 56%,” said Brian Webster, President and CEO. “We remain confident that our focus on innovation and commercial expansion positions Kestra to generate durable, top-tier growth for years to come. Our team is executing on its commitments to prescribers and their patients and we believe this will continue to drive market expansion and advance Kestra on its path to market leadership.”

First Quarter Fiscal 2027 Financial Results

• Total revenue was $31.0 million, an increase of 60% compared to the prior year period.
  • Revenue growth was driven by several factors, including wearable cardioverter defibrillator (WCD) market expansion, competitive share gains, new sales territories, higher mix of in-network patients, and ongoing improvements in revenue cycle management capabilities.
• Gross profit was $17.5 million compared to $8.9 million in the prior year period.
  • Gross margin expanded to 56.5% compared to 45.7% in the prior year period, driven by volume leverage, a higher mix of in-network patients and execution of planned cost improvement programs.
• GAAP operating expenses were $55.2 million compared to $37.7 million in the prior year period.
  • Excluding non-recurring costs and share-based compensation expense, adjusted operating expenses* were $44.2 million compared to $30.3 million in the prior year period. The increase was primarily attributable to growth in expenses related to the company’s commercial expansion and accelerated investment in key R&D programs.
• GAAP net loss was $44.1 million compared to GAAP net loss of $25.8 million in the prior year period.
  • Adjusted EBITDA* loss was $24.0 million compared to an adjusted EBITDA loss of $19.4 million in the prior year period.
• Cash and cash equivalents, and investments totaled $244.7 million as of July 31, 2026.
  • Including committed unused availability under the company’s term loan agreement, Kestra has total liquidity of approximately $320 million.

^{*Adjusted operating expenses and adjusted EBITDA are non-GAAP financial measures. See “Use of Non-GAAP Financial Measures” below for additional information. Reconciliations of adjusted operating expenses and adjusted EBITDA to the most directly comparable GAAP measure are included in this press release.}

Fiscal Year 2027 Revenue Guidance
Kestra is increasing its FY27 revenue guidance to $141 million, representing growth of 48% compared to FY26. This compares to prior FY27 revenue guidance of $137 million.

Webcast and Conference Call
Kestra will host a conference call today at 4:30 p.m. Eastern Time to discuss financial results. A live and archived webcast of the event will be available in the “Events” section of the investor relations website.

About Kestra
Kestra Medical Technologies, Ltd. is a leading wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, visit www.kestramedical.com.

Use of Non-GAAP Financial Measures
This press release contains certain financial information that is not presented in conformity with U.S. generally accepted accounting principles (“GAAP”), including adjusted operating expense and adjusted EBITDA. The non-GAAP financial measures are provided as supplemental information to Kestra’s financial measures presented in this press release that are calculated and presented in accordance with GAAP.

Adjusted operating expense is calculated as operating expenses, as adjusted to exclude share-based compensation expense and non-recurring expenses. Adjusted EBITDA is calculated as net income (loss), as adjusted to exclude other income/expense (including interest), income tax expense (benefit), depreciation and amortization expense, share-based compensation expense, and non-recurring expenses. Both metrics are presented because management believes they will allow investors to view Kestra’s performance in a manner similar to the method used by management to evaluate Kestra’s performance for both strategic and annual operating planning. Management believes that in order to properly understand short-term and long-term financial trends, it is helpful for investors to understand the impact of the items excluded from the calculation of adjusted operating expenses and adjusted EBITDA, in addition to considering Kestra’s GAAP financial measures. The excluded items vary in frequency and/or impact on our results of operations and management believes that the excluded items are not reflective of our ongoing core business operations and financial condition. Excluding such items allows investors and analysts to compare our operating performance to other companies in our industry and to compare our period-over-period results.

The non-GAAP financial measures used by Kestra may not be the same or calculated in the same manner as those used and calculated by other companies. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for Kestra’s financial results prepared and reported in accordance with GAAP. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures included in this press release, and not to rely on any single financial measure to evaluate our business. A reconciliation of adjusted operating expenses and adjusted EBITDA reported in this press release to the most comparable respective GAAP measure for the respective periods appears in the tables captioned “Reconciliation of GAAP Operating Expenses to Adjusted Operating Expenses” and “Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA” later in this release. Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers.

Forward-Looking Statements
Except where otherwise noted, the information contained in this press release is as of September 14, 2026. Statements in this press release and on the related teleconference that express a belief, expectation or intention, as well as those that are not historical fact, are forward-looking statements. Except as required by law, Kestra undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about, among other topics, our anticipated operating and financial performance, including financial guidance and projections; business plans, strategy, goals and prospects, potential growth, and expectations for our products. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions, and we cannot ensure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “continue,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “advance,” “remain,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Kestra’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: risks related to our limited operating history and history of net losses; our ability to successfully achieve substantial market adoption of our products; competitive pressures; our ability to adapt our manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; product defects or complaints and related liability; our ability to obtain and maintain adequate coverage and reimbursement levels for our products; our ability to comply with changing laws and regulatory requirements and resulting costs; our dependence on a limited number of suppliers; risks and uncertainties related to market conditions; and other risks and uncertainties, including those described under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2026 and other filings filed or to be filed with the U.S. Securities and Exchange Commission (“SEC”). These filings, when made, are available on the Investor Relations section of our website at https://investors.kestramedical.com/ and on the SEC’s website at https://sec.gov/.

KESTRA MEDICAL TECHNOLOGIES, LTD. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share amounts) (unaudited)
		Three Months Ended July 31,
		2026				2025
Revenue		$	30,971			$	19,371
Cost of revenue			13,473				10,520
Gross profit			17,498				8,851
Operating expenses:
Research and development			6,796				4,001
Selling, general and administrative			48,359				33,728
Total operating expenses			55,155				37,729
Loss from operations			(37,657	)			(28,878	)
Other expense (income):
Interest expense			1,929				1,912
Interest income			(2,125	)			(2,167	)
Other expense (income), net			272				(2,830	)
Loss on extinguishment of debt			6,304				—
Net loss before provision for income taxes			(44,037	)			(25,793	)
Provision for income taxes			50				33
Net loss attributable to common shareholders, basic and diluted		$	(44,087	)		$	(25,826	)
Net loss per share attributable to common shareholders, basic and diluted		$	(0.75	)		$	(0.50	)
Weighted-average common shares outstanding, basic and diluted			58,566,467				51,304,599
Other comprehensive loss:
Net loss		$	(44,087	)		$	(25,826	)
Unrealized loss on marketable securities			(253	)		—
Comprehensive loss		$	(44,340	)		$	(25,826	)

KESTRA MEDICAL TECHNOLOGIES, LTD. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts) (unaudited)
		July 31,				April 30,
		2026				2026
Assets
Current assets
Cash and cash equivalents		$	68,558			$	99,710
Short-term investments			130,353			$	96,724
Accounts receivable, net			15,406				14,542
Disposable medical equipment supplies			7,438				6,706
Prepaid expenses and other current assets			4,518				4,677
Total current assets			226,273				222,359
Long-term investments			45,791				65,767
Right-of-use assets			3,263				3,364
Deposits			1,842				1,761
Restricted cash			334				334
Property and equipment, net			63,656				59,090
Other long-term assets			6,196				5,790
Total assets		$	347,355			$	358,465
Liabilities and Shareholders’ Equity
Current liabilities
Accounts payable		$	25,961			$	27,295
Accrued liabilities			22,285				23,046
Operating lease liabilities, current portion			23				31
Total current liabilities			48,269				50,372
Operating lease liabilities, net of current portion			3,928				4,111
Warrant liabilities		—					1,369
Other long-term liabilities			306				306
Long-term debt, net			72,495				42,649
Total liabilities			124,998				98,807
Commitments and contingencies
Shareholders’ equity
Common Shares, $1.00 par value; 100,000,000 shares authorized as of July 31, 2026 and April 30, 2026; 59,271,885 issued and outstanding as of July 31, 2026 and 58,383,924 shares issued and outstanding as of April 30, 2026			59,272				58,384
Additional paid-in capital			859,504				853,353
Accumulated other comprehensive loss			(471	)			(218	)
Accumulated deficit			(695,948	)			(651,861	)
Total shareholders’ equity			222,357				259,658
Total liabilities and shareholders’ equity		$	347,355			$	358,465

KESTRA MEDICAL TECHNOLOGIES, LTD. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) (unaudited)
		Three Months Ended July 31,
		2026				2025
Cash flows from operating activities
Net loss		$	(44,087	)		$	(25,826	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			2,664				2,028
Loss on disposal of property and equipment			292				280
Reserve for equipment and supplies			1,464				412
(Recovery) provision for uncollectible accounts receivable			(817	)			613
Amortization (accretion) of premiums (discounts) on securities, net			(890	)		—
Loss on extinguishment of debt			6,304			—
Amortization of debt discounts and issuance costs			408				469
Share-based compensation expense			9,517				4,579
Non-cash lease expense			103				61
Change in fair value of warrant liabilities			251				(2,909	)
Changes in operating assets and liabilities:
Disposable medical equipment supplies			(908	)			(460	)
Prepaid expenses and other current assets			246				140
Accounts receivable			(48	)			(1,777	)
Accounts payable			(1,879	)			(2,896	)
Accrued liabilities			(4,727	)			(860	)
Operating lease liabilities			(190	)			(138	)
Other long-term assets			2				10
Net cash used in operating activities			(32,295	)			(26,274	)
Cash flows from investing activities
Purchases of property and equipment			(8,335	)			(8,166	)
Deposits for medical rental equipment		—					(103	)
Refund of deposits for medical rental equipment		—					37
Purchase of marketable securities			(13,017	)			—
Net cash used in investing activities			(21,352	)			(8,232	)
Cash flows from financing activities
Proceeds from issuance of long-term debt			75,000			—
Payment of debt issuance costs			(3,193	)		—
Repayment of long-term debt			(46,395	)		—
Payment of early termination fee on debt repayment			(3,758	)
Payment of IPO offering costs			—				(1,875	)
Payment of equity issuance costs			(415	)		—
Deemed dividend for payments to third party on behalf of shareholder			(172	)		—
Proceeds from stock option exercises			1,140			—
Proceeds from Employee Stock Purchase Plan			1,298			—
Tax withholdings on restricted stock unit vesting			(1,010	)		—
Net cash provided by (used in) financing activities			22,495				(1,875	)
Net decrease in cash, cash equivalents and restricted cash			(31,152	)			(36,381	)
Cash, cash equivalents and restricted cash
Beginning of period			100,044				237,929
End of period		$	68,892			$	201,548

RECONCILIATION OF CASH AND CASH EQUIVALENTS TO CASH, CASH EQUIVALENTS, AND INVESTMENTS (in thousands) (unaudited)
		Three Months Ended July 31,
		2026				2025
Cash and cash equivalents		$	68,558			$	201,214
Add: Short-term investments			130,353			—
Add: Long-term investments			45,791			—
Cash, cash equivalents, and investments		$	244,702			$	201,214

RECONCILIATION OF GAAP NET LOSS TO ADJUSTED EBITDA (in thousands) (unaudited)
		Three Months Ended July 31,
		2026				2025
GAAP Net loss		$	(44,087	)		$	(25,826	)
Non-GAAP Adjustments:
Interest expense			1,929				1,912
Interest income			(2,125	)			(2,167	)
Other expense (income)			272				(2,830	)
Provision for income taxes			50				33
Depreciation expense			2,664				2,028
Share-based compensation expense			9,517				4,579
Loss on extinguishment of debt			6,304				—
Non-recurring expenses			1,430				2,866
Adjusted EBITDA		$	(24,046	)		$	(19,405	)

RECONCILIATION OF GAAP OPERATING EXPENSES TO ADJUSTED OPERATING EXPENSES (in thousands) (unaudited)
		Three Months Ended July 31,
		2026				2025
GAAP Operating Expenses		$	55,155			$	37,729
Non-GAAP Adjustments:
Share-based compensation expense			9,517				4,579
Non-recurring expenses			1,430				2,866
Adjusted Operating Expenses		$	44,208			$	30,284

CONTACT: Investor Relations
Neil Bhalodkar
neil.bhalodkar@kestramedical.com

Industry-leading QA/RA excellence accelerates patient access to Biodesix Lab testing, which helps improve overall outcomes for patients with lung nodules

LOUISVILLE, Colo., Sept. 14, 2026 (GLOBE NEWSWIRE) — Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostics solutions company, today announced that Brianna Phillips, Vice President of Quality and Regulatory Affairs at Biodesix, will be presenting at the upcoming Regulatory Affairs Professionals Society (RAPS) and Society of Clinical Research Associates (SOCRA) Annual Meetings.

These important professional society meetings put a spotlight on the material influence and need for Quality Affairs and Regulatory Affairs (QA/RA) expertise in the medical diagnostics segment. Under Brianna’s leadership, Biodesix QA/RA is a strategic, differentiating advantage for the company’s five on-market diagnostic blood tests. Excellence in QA/RA has helped propel Biodesix in transforming the healthcare pathway for patients with indeterminate lung nodules.

For the past 12 years, while leading the QA/RA team at Biodesix, Brianna has established the full portfolio of QA/RA accreditations for two Biodesix Labs: CLIA, CAP, NYS CLEP, ISO 13485, and FDA. She also led the company’s efforts in establishing a Good Manufacturing Practices (GMP) FDA-registered facility. Her team has completed countless successful audits by domestic auditing bodies as well as international pharmaceutical partners’ auditors.

These Lab certifications, the track record of successful audits and improvements to processes, and the high bar for excellence in quality standards are a remarkable achievement in that of the tens of thousands of labs nationally, there are only ~1,135 NYS CLEP labs and only ~7,000 CAP-accredited labs, cementing Biodesix Labs into a rare class of diagnostics peers.

At their root, the Biodesix Quality Management System and Regulatory Compliance processes are critical to accelerate patient care excellence as well as patient access to the Nodify Lung^® Nodule Risk Assessment and IQLung^® Cancer Risk Assessment testing portfolios. These tests have already impacted the lives of more than 100,000 patients in a few short years.

With her unique breadth and depth in QA/RA across multiple medical industry segments, Brianna will be sharing her expertise at these September events:

Regulatory Affairs Professionals Society (RAPS), Annual Convergence Event, Charlotte NC:

• Preconference Workshops: Regulatory Leadership Bootcamp: A Skills–Based Accelerator for Early to Mid–Career Professionals
    Tuesday, September 15, 2026, 8:30 AM – 4:00 PM EDT
• Hiring in the Age of AI: How Hiring Managers Can Assess Great Talent
   Thursday, September 17, 2026, 1:00 PM – 2:00 PM EDT

Society of Clinical Research Associates (SOCRA) Annual Meeting, Denver, CO: 

• The Power Pair: Regulatory + Clinical Development as Catalysts for Rapid, Compliant Growth
    Saturday, September 26, 2026, 10:50 AM – 11:35 AM MST. Brianna will be joined on this panel by Biodesix VP of Clinical Development, Niki Givens.

Brianna’s impact goes far beyond Biodesix and the healthcare providers and patients that benefit from the company’s blood tests today. Additionally, she offers her leadership to the next generation of QA/RA professionals as a member of the QA/RA Advisory Board for the Biomedical Engineering Department at the University of Colorado Denver | Anschutz, as Guest Professor for the Quality Certificate Program at CU Anschutz, and as Chair-Elect of the Colorado Chapter of RAPS.

About Biodesix:

Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests, including Nodify Lung^® Nodule Risk Assessment and IQLung^® Cancer Treatment Guidance, support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. For more information, visit biodesix.com and KnowYourNodule.com.

Biodesix Contacts:
Media:
Natalie St. Denis, Director Corporate Communications
natalie.stdenis@biodesix.com
(720) 925-9285

Investors:
Chris Brinzey, Partner, ICR
chris.brinzey@icrhealthcare.com
(339) 970-2843

Conference call scheduled for Tuesday, September 15, 2026, at 8:30 a.m. Eastern Time (ET)

CARSON CITY, Nev., Sept. 14, 2026 (GLOBE NEWSWIRE) — BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, today announced that the Company will host a conference call and webcast on Tuesday, September 15, 2026 at 8:30am ET to discuss topline results from its Phase 2 ADDRESS-LC trial (NCT06847191) evaluating its investigational drug candidate bezisterim, an oral drug that crosses the blood-brain barrier and is believed to reduce inflammation and improve insulin sensitivity, in Long COVID.

Michael Peluso, MD, MHS, Associate Professor of Medicine, University of California, San Francisco, and an investigator in the trial, and Ezra Spier, Long COVID patient advocate and a patient advisor on the ADDRESS-LC trial, will be guest speakers at the event. A live Q&A session with management will follow the presentation.

Registration Details

Date:                   September 15, 2026
Time:                   8:30am ET
Registration:        Click here

A replay will be available on the BioVie website following the event.

About the ADDRESS-LC trial

The Phase 2 ADDRESS-LC study (NCT06847191), which is fully funded by a grant from the U.S. Department of War (DoW), is a randomized (1:1), placebo-controlled, signal-finding proof-of-concept, multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with Long COVID who have cognitive impairment sequelae and fatigue. The study compared bezisterim, administered as a 20 mg oral capsule twice daily, with a matching placebo to assess its effects on neurocognitive and fatigue-related symptoms. The trial evaluated 22 clinical outcome measures, with no single endpoint pre-specified as the primary determinant of study success. Endpoints include assessing changes in overall clinical benefit, subjective and objective cognitive function, fatigue, sleep disturbance, Quality of Life and PEM. As a signal-finding study, the trial was designed to identify efficacy signals, measure treatment effect magnitude, and identify patient subgroups most likely to benefit, to inform the design of future Phase 3 trials.

About Bezisterim

Bezisterim (NE3107) is an investigational oral drug that crosses the blood-brain barrier and works to reduce inflammation and improve insulin sensitivity without suppressing the immune system and with a low risk of drug-drug interactions. By modulating key pathways involved in neuroinflammation (ERK, NFκB, TNFα), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease (PD), Long COVID (LC), and Alzheimer’s disease (AD).

In PD, BioVie completed the SUNRISE-PD trial, which enrolled 57 patients to establish proof of mechanism and proof of concept in individuals with early-stage disease who had not previously been treated with carbidopa/levodopa. Topline results showed that patients treated with bezisterim experienced improvements with blood-based markers of inflammation, as well as a broad range of biomarkers associated with cellular health and neuronal integrity. Clinically, patients treated with bezisterim demonstrated greater improvements than those receiving placebo across multiple measures of daily functioning, motor symptoms, and non-motor symptoms.

For LC, the ADDRESS-LC trial enrolled approximately 200 patients to evaluate whether bezisterim may help reduce brain fog, fatigue, and other lingering neurological symptoms associated with LC. The hypothesis being studied is that these symptoms may be triggered by persistent circulation of spike protein fragments that trigger inflammation via NFκB activation (which bezisterim has been shown to modulate).

In AD, BioVie has conducted Phase 2 and Phase 3 trials. Preliminary data from these trials suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with AD.

Terms of the U.S. Department of War (DoW) Award

The work is supported by the Assistant Secretary of War for Health Affairs and endorsed by the DoW by a fully funded award in the amount of $13.13 million through the Peer-Reviewed Medical Research Program (PRMRP) under Award No. HT9425-24-1-0113. Opinions, interpretations, conclusions and recommendations in this press release are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the DoW.

About BioVie Inc.

BioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company focused on developing therapies for neurological disorders and advanced liver disease. Its lead investigational drug candidate, bezisterim (NE3107), targets neuroinflammation and insulin resistance, which are believed to be key drivers of Alzheimer’s and Parkinson’s disease. Bezisterim is also being studied for Long COVID, where persistent inflammation is thought to underlie symptoms such as brain fog and fatigue.

In liver disease, BioVie is advancing BIV201, a continuous infusion of terlipressin treatment that has received FDA Orphan and Fast Track designations. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, and the Company plans to study BIV201 in a Phase 3 trial for the reduction of further decompensation in patients with cirrhosis and ascites. For more information, visit www.bioviepharma.com.

Forward-Looking Statements

This press release contains forward-looking statements, which may be identified by words such as “expect,” “look forward to,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” “will,” “project,” “potential,” “may,” or words of similar meaning. Forward-looking statements in this release include, but are not limited to, statements regarding: the potential for bezisterim to address unmet clinical needs in Long COVID and Parkinson’s disease; the design and conduct of future clinical trials, including a potentially pivotal Phase 3 trial; the potential clinical significance of subgroup analyses and biomarker observations; and the Company’s ability to advance bezisterim through clinical development. The clinical endpoints reported in this release are exploratory in nature. The Phase 2 ADDRESS-LC trial did not achieve statistical significance on any endpoint in the overall intent-to-treat population; statistically significant results were observed only in pre-specified subgroup analyses. Subgroup analyses are hypothesis-generating and may not be replicated in future trials. Changes in biomarkers may not correlate with clinical benefit or support regulatory approval. The FDA has not validated these endpoints as surrogate endpoints for Long COVID. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to risks related to the early stage of development of bezisterim and other product candidates, the possibility that results observed in this Phase 2 study of 203 patients may not be replicated in larger or longer-duration trials, the exploratory nature of subgroup analyses, the Company’s ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, the possibility that clinical trial results may not be indicative of results in subsequent or larger trials, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company’s control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.

For Investor Relations Inquiries:
        
Contact:
Chuck Padala
Managing Director, LifeSci Advisors, LLC
chuck@lifesciadvisors.com

For Media Inquiries:
        
Contact:
Melyssa Weible
Managing Partner, Elixir Health Public Relations
mweible@elixirhealthpr.com

SOUTHAMPTON, Pa., Sept. 14, 2026 (GLOBE NEWSWIRE) — Environmental Tectonics Corporation (OTCID: ETCC) (“ETC” or the “Company”) announced that it was awarded three contracts totaling $11.7 million. ETC’s Aircrew Training Systems business unit (“ATS”) was awarded two contracts. The first contract is for the system upgrade of the United States Navy Spatial Disorientation research device. The second contract is for the delivery of a Hypobaric Chamber for an international customer. In addition, ETC Sterilizations Systems Unit has been awarded a contract from a global medical device manufacturer. The contract is for the fabrication and installation of a large-capacity vacuum drying chamber. 

“These contracts represent the continuing strong relationship ETC has with its global aeromedical and sterilizer systems customers,” stated Robert Laurent, Jr., ETC’s Chief Executive Officer and President.

About ETC:
ETC designs, manufactures, and sells software driven products and services used to recreate and monitor the physiological effects of motion on humans, and equipment to control, modify, simulate and measure environmental conditions. Our products include aircrew training systems (aeromedical, tactical combat, and general), disaster management systems, sterilizers (steam and gas), environmental testing and simulation systems, and other products that involve similar manufacturing techniques and engineering technologies. ETC’s unique ability to offer complete systems, designed and produced to high technical standards, sets it apart from its competition. ETC is headquartered in Southampton, PA. For more information about ETC, visit http://www.etcusa.com/.

Forward-looking Statements
This news release contains forward-looking statements, which are based on management’s expectations and are subject to uncertainties and changes in circumstances. Words and expressions reflecting something other than historical fact are intended to identify forward-looking statements, and these statements may include words such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, “future”, “predict”, “potential”, “intend”, or “continue”, and similar expressions. We base our forward-looking statements on our current expectations and projections about future events or future financial performance. Our forward-looking statements are subject to known and unknown risks, uncertainties and assumptions about ETC and its subsidiaries that may cause actual results to be materially different from any future results implied by these forward-looking statements. We caution you not to place undue reliance on these forward-looking statements.

CONTACT: Contact: Tim Kennedy, CFO
Phone: (215) 355-9100 
E-mail: info@etcusa.com

• All six Cohort 1 (low dose BB-301) patients have completed the full 12-month post-treatment follow-up period, and Cohort 2 (high dose BB-301) is fully enrolled with all three patients having been safely treated
• A Type C meeting was held with the U.S. Food and Drug Administration in 3Q2026 to discuss the BB-301 pivotal study design, and meeting minutes are anticipated in October
• Additional interim clinical study results from the ongoing BB-301 Phase 1b/2a trial have been accepted for late-breaking presentation at the Annual Congress of the European Society of Gene and Cell Therapy (ESGCT) in Hamburg, Germany taking place on October 27-30, 2026
• Well-capitalized with cash, as of June 30, 2026, of approximately $180 million.

HAYWARD, Calif., Sept. 14, 2026 (GLOBE NEWSWIRE) — Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or the “Company”), a clinical-stage biotechnology company developing disease-modifying genetic medicines for life-threatening, genetically defined diseases, based on its proprietary “Silence and Replace” DNA-directed RNA interference (“ddRNAi”) platform, today announced financial results for its full fiscal year ended June 30, 2026, and provided an update on recent regulatory interactions and upcoming clinical data presentations.

“This has been an important year of clinical execution for Benitec and for the continued development of BB-301,” said Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec. “Over the course of the year, we completed the follow-up of all six patients in Cohort 1 and fully enrolled Cohort 2, while continuing the regulatory interactions required to prepare BB-301 for advancement into a pivotal trial. The consistency and durability of the clinical benefit observed to date, together with the discussions we have had with the FDA regarding pivotal study plans, continue to strengthen our conviction in the potential of BB-301 to meaningfully alter the course of OPMD-related dysphagia. We are grateful to the patients, families and investigators who have enabled this progress, and we look forward to building on this momentum as we work toward the planned initiation of the pivotal study in mid-2027.”

Clinical Highlights

The Company continues to advance BB-301 through clinical development in the ongoing Phase 1b/2a Clinical Study evaluating the safety and clinical efficacy of locally-administered BB-301 for the treatment of OPMD-related dysphagia.

Interim Clinical Study Update

• All six Cohort 1 (low dose BB-301) patients have completed the full 12-month post-treatment follow-up period, and Cohort 2 (high dose BB-301) is fully enrolled with all three patients having been safely treated
• Clinically meaningful improvements (combined with a favorable safety profile) were observed across patient-reported swallowing symptom evaluations and X-ray based swallowing function evaluations, including improved throat closing ability, throat emptying ability, throat muscle relaxation, and functional swallowing ability
• Interim clinical results for Cohort 1 and Cohort 2 will be presented at the 33rd Annual Congress of the European Society of Gene & Cell Therapy in Hamburg, Germany, October 27-30, 2026

Regulatory Update

• A Type C meeting was held with the U.S. Food and Drug Administration in 3Q2026 to discuss the BB-301 pivotal study design, and meeting minutes are anticipated in October

Upcoming Catalysts

• Presentation of interim clinical results from the Phase 1b/2a study at the ESGCT Annual Congress in Hamburg, Germany, October 27-30, 2026.
• Benitec anticipates initiating the BB-301 pivotal trial in mid-2027.

Financial Highlights

Full Year 2026 Financial Results

For the year ended June 30, 2026, the Company reported total expenses of $51.2 million compared to $41.8 million for the year ended June 30, 2025. Research and development expenses were $23.4 million in 2026, up from $18.3 million in 2025, and were primarily related to the ongoing clinical development of BB-301 for the treatment of OPMD. The increase in research and development expenses primarily reflected higher share-based compensation of $6.3 million and increased payroll of $2.2 million, partially offset by a reduction in contract manufacturing activity of $3.8 million.

General and administrative expenses totaled $27.8 million in 2026 compared to $23.4 million in 2025. The increase was primarily driven by higher share-based compensation of $2.7 million and an increase in payroll of $0.8 million.

The net loss from operations for the year ended June 30, 2026, was $51.2 million compared to $41.8 million for the prior year. Net loss attributable to shareholders for the year ended June 30, 2026 was $45.5 million, or $0.98 per basic and diluted share, compared to a net loss of $37.9 million, or $1.05 per basic and diluted share, for the year ended June 30, 2025. As of June 30, 2026, the Company had $180.0 million in cash and cash equivalents.

About BB-301

BB-301 is a novel, modified AAV9 capsid expressing a unique, single bifunctional construct promoting co-expression of both codon-optimized Poly-A Binding Protein Nuclear-1 (PABPN1) and two small inhibitory RNAs (siRNAs) against mutant PABPN1 (the causative gene for OPMD). The two siRNAs are modeled into microRNA backbones to silence expression of faulty mutant PABPN1, while allowing expression of the codon-optimized PABPN1 to replace the mutant with a functional version of the protein. BB-301 is administered locally, in a one-time procedure, to the muscles in the throat that drive the swallowing process, an approach designed to maximize local benefit and minimize systemic exposure. We believe the silence and replace mechanism of BB-301 is uniquely positioned for the treatment of OPMD by slowing or halting mutant PABPN1 expression while simultaneously providing a functional replacement protein. BB-301 has received Orphan Drug Designation from the EMA and Orphan Drug and Fast Track Designations from the FDA and is currently being evaluated in a Phase 1b/2a, first-in-human, open-label dose escalation study to evaluate the safety and clinical activity of intramuscular doses of BB-301 administered to subjects with OPMD (NCT06185673).

About Benitec Biopharma Inc.

Benitec Biopharma Inc. (NASDAQ: BNTC) is a clinical-stage biotechnology company developing disease-modifying genetic medicines designed to improve the lives of people with life-threatening, genetically defined diseases. The company’s proprietary “Silence and Replace” DNA-directed RNA interference (ddRNAi) platform combines RNA interference, or RNAi, with gene therapy to create medicines designed to facilitate sustained silencing of disease-causing genes and simultaneous delivery of replacement genes that restore normal cellular function following a single administration. The company’s lead investigational candidate, BB-301, is the first and only disease-modifying genetic medicine in clinical development for the treatment of Oculopharyngeal Muscular Dystrophy (OPMD)-related dysphagia. For additional information, visit www.benitec.com.

Forward Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release include forward-looking statements, including statements regarding Benitec’s plans to develop and commercialize its product candidates, the timing of the completion of preclinical and clinical trials, the timing of the availability of data from our clinical trials, the timing and sufficiency of patient enrollment and dosing in clinical trials, the timing of expected regulatory filings and other regulatory steps, and the clinical utility and potential attributes and benefits of ddRNAi and Benitec’s product candidates, and other forward-looking statements.

These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: the success of our plans to develop and potentially commercialize our product candidates; the timing of the completion of preclinical studies and clinical trials; the timing and sufficiency of patient enrollment and dosing in any future clinical trials; the timing of the availability of data from our clinical trials; the timing and outcome of regulatory filings and approvals; the development of novel AAV vectors; our potential future out-licenses and collaborations; the plans of licensees of our technology; the clinical utility and potential attributes and benefits of ddRNAi and our product candidates, including the potential duration of treatment effects and the potential for a “one shot” cure; our intellectual property position and the duration of our patent portfolio; expenses, ongoing losses, future revenue, capital needs and needs for additional financing, and our ability to access additional financing given market conditions and other factors; the length of time over which we expect our cash and cash equivalents to be sufficient to execute on our business plan; unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other governmental authorities; regulatory developments in the United States of America; the Company’s ability to protect and enforce its patents and other intellectual property rights; the Company’s dependence on its relationships with its collaboration partners and other third parties; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace and market competition; reliance on third party manufacturers and suppliers, and the risks associated with manufacturing complexity, supply interruptions, and compliance with current good manufacturing practices, sales, marketing and distribution requirements for our product candidates; greater than expected expenses; including expenses relating to litigation or strategic activities; our incurrence of significant losses and the uncertainty of our ability to achieve or sustain profitability or generate any revenue; the Company’s ability to satisfy its capital needs through increasing revenue and obtaining additional financing; the impact of local, regional, national and international economic conditions and events; including geopolitical instability, and risks associated with conducting business and seeking regulatory approvals in international markets; our ability to attract and retain key management, scientific, and technical personnel; cyber-security threats and vulnerabilities in our and our third parties’ information technology systems; the impact of legislative and regulatory reforms affecting drug pricing and reimbursement, including Medicare drug-price negotiation and government pricing frameworks; potential product liability claims arising from the use of our product candidates in clinical trials or following any future marketing approval; physicians, patients, third-party payers, or others in the medical community may not be receptive to our product candidates, and we may not generate any future revenue from the sale or licensing of our product candidates; and disruptions to U.S. government agency operations, including FDA staffing changes; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission. The Company disclaims any intent or obligation to update these forward-looking statements.

Investor Relations Contact:
Candice Masse
astr partners
candice.masse@astrpartners.com

Media Contact:
Audra Friis
Sam Brown Healthcare Communications
(917) 519-9577
audrafriis@sambrown.com

Source: Benitec Biopharma Inc.

BENITEC BIOPHARMA INC. Consolidated Balance Sheets (in thousands, except par value and share amounts)
		June 30, 2026				June 30, 2025
Assets
Current assets:
Cash and cash equivalents		$	179,972			$	97,744
Restricted cash			114				113
Trade and other receivables			4				33
Prepaid and other assets			1,595				628
Total current assets			181,685				98,518
Property and equipment, net			178				131
Deposits			55				55
Prepaid and other assets			12				28
Right-of-use assets			693				860
Total assets		$	182,623			$	99,592
Liabilities and Stockholders’ Equity
Current liabilities:
Trade and other payables		$	4,295			$	1,022
Accrued employee benefits			553				426
Lease liabilities, current portion			496				354
Total current liabilities			5,344				1,802
Lease liabilities, less current portion			266				495
Total liabilities			5,610				2,297
Stockholders’ equity:
Preferred stock, $0.0001 par value—5,000,000 shares authorized; no shares issued or outstanding at June 30, 2026 and June 30, 2025, respectively			—				—
Common stock, $0.0001 par value—160,000,000 shares authorized; 34,416,834 and 26,250,469 shares issued and outstanding at June 30, 2026 and June 30, 2025, respectively			3				2
Additional paid-in capital			451,695				326,308
Accumulated deficit			(273,722	)			(228,176	)
Accumulated other comprehensive loss			(963	)			(839	)
Total stockholders’ equity			177,013				97,295
Total liabilities and stockholders’ equity		$	182,623			$	99,592

BENITEC BIOPHARMA INC. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts)
		Year Ended
		June 30,
		2026				2025
Operating expenses:
Research and development			23,388				18,332
General and administrative			27,804				23,433
Total operating expenses			51,192				41,765
Loss from operations			(51,192	)			(41,765	)
Other income (loss):
Foreign currency transaction gain (loss)			120				(71	)
Interest income, net			5,569				3,286
Other expense, net			(43	)			(131	)
Gain on extinguishment of liabilities			—				764
Total other income, net			5,646				3,848
Net loss		$	(45,546	)		$	(37,917	)
Other comprehensive income:
Unrealized foreign currency translation gain (loss)			(124	)			53
Total other comprehensive income (loss)			(124	)			53
Total comprehensive loss		$	(45,670	)		$	(37,864	)
Net loss		$	(45,546	)		$	(37,917	)
Net loss attributable to common shareholders		$	(45,546	)		$	(37,917	)
Net loss per share:
Basic and diluted		$	(0.98	)		$	(1.05	)
Weighted average number of shares outstanding:
Basic and diluted			46,558,162				36,209,271

PRESS RELEASE

September 14th, 2026

RCI BANQUE LAUNCHES A DUAL-TRANCHE BOND ISSUE IN EURO: 750 MILLION MATURING IN 2031 AND 500 MILLION MATURING IN 2033

RCI Banque, operating under its commercial brand Mobilize Financial Services, priced a €1.25 billion dual-tranche bond offering comprising a €750 million February 2031 bond with a 4.625% coupon and a €500 million November 2033 bond with a 5.00% coupon.

The issuance was very well received by investors, with the shorter tranche attracting around €1.6 billion of demand from more than 110 accounts and the longer tranche generating approximately €1.1 billion of orders from over 90 investors.

Contact

Analysts and Investors Financial communication + 33(0) 1 76 88 81 74 contact_investor@rcibanque.com

About Mobilize Financial Services   
Attentive to the needs of all its customers, Mobilize Financial Services, a subsidiary of Renault Group, creates innovative financial services to build sustainable mobility for all. Mobilize Financial Services, which began operations nearly 100 years ago, is the commercial brand of RCI Banque SA, a French bank specializing in automotive financing and services for customers and networks of Renault Group, and also for the brands Nissan and Mitsubishi in several countries.   
With operations in 35 countries and nearly 4,000 employees, Mobilize Financial Services financed more than 1,270,556 contracts (new and used vehicles) at the end of 2025 and sold 3.6 million services. At the end of 2025, average earning assets stood at 59.3 billion euros of financing and pre-tax earnings at 1,181 million euros.    
Since 2012, the Group has deployed a deposit-taking business in several countries. At the end of 2025, net deposits amounted to 29.9 billion euros, or 46.8 % of the company’s net assets.    
To find out more about Mobilize Financial Services: www.mobilize-fs.com/   
Follow us on Twitter: @Mobilize_FS  

Attachment

• EN – CP DT 4Y4M €750M Feb-2031&7Y2M €500M Nov-2033