The REACT trial consists of two parallel, randomized studies; the Hypertonic Saline Study and the Dornase Alfa Study.
Health outcomes among people with cystic fibrosis (CF) have been steadily improving, most recently with the advent of highly effective modulator therapy (HEMT). While therapies like hypertonic saline (HS) and dornase alfa (DA) improved outcomes in the past, they are often burdensome. Now that almost 90% of the North American CF population is being treated with elexacaftor/tezacaftor/ivacaftor (ETI) or vanzacaftor/tezacaftor/deutivacaftor (VTD), this trial will evaluate whether these newer treatments make daily HS or DA unnecessary. The trial begins with a 6-week run-in period where participants continue ETI or VTD but stop using HS and DA. Eligible participants are then assigned to either the HS Study or the DA Study for one year. Within those groups, they are randomized to either daily use of HS or DA or as needed use only during respiratory illnesses. The study aims to find out if lung health is similar between children and teens taking HEMT who use HS or DA treatments daily and those who use HS or DA treatments only when they are sick.

Start Date15 Sep 2026

Sponsor / Collaborator

Seattle Children's Hospital

[+1]

NCT07432373

/ RecruitingNot ApplicableIIT

Comparative Analysis of Intrapleural Alteplase-Tyloxapol vs Intrapleural Alteplase-DNase in Pleural Infection (ALTON-PI)

Pneumonia, thought to be the chief aetiological process in the development of pleural space infection, is defined as an infection of the lung parenchyma with an estimated annual incidence rate of 5-11 cases per 1000 population, with around 50,000 hospital admissions in the U.K. per year. Parapneumonic effusions caused by an infection of the pleural membranes occur in 40-57% of cases of pneumonia. A variable percentage (10-20%) of parapneumonic effusions progresses to empyema (pus) and/or abscess formation (encapsulation). Pleural infection is associated with significant morbidity and mortality, which may be as high as 20-35% in immunocompromised patients.
Standard treatment of these collections in adults involves antibiotic therapy, adequate drainage of infected fluid, and surgical intervention if conservative management fails. Appropriate treatment is adequate drainage via an intercostal catheter (ICC) with antibiotic therapy for parapneumonic effusions requiring clearance. Frequently, simple ICC drainage is ineffective due to the presence of loculations, formed predominantly by fibrinous material deposited in the fibrinopurulent phase of empyema, preventing free drainage of infected pleural fluid. The presence of fibrinous septae in the pleural space, known as loculations, may result in inadequate drainage of effusions and, therefore, nonresolution of infection and systemic sepsis. Surgical intervention (VATS or open) is usually required to clear loculations and resolve infection without adequate intercostal catheter drainage.
Although the success rate of surgical intervention remains high, the morbidity and mortality of both VATS and open thoracotomy are of concern, particularly in a cohort of patients who may be older and with significant comorbidity. Less invasive therapies, which promote pleural space drainage and effective resolution of pleural infection, are therefore likely to be of considerable clinical utility.
The MIST 2 trial has established intrapleural therapy as the mainstay of CPEE treatment, hence avoiding surgery and decreasing the length of hospitalization; however, little is known about the correct dosage needed for tPA and Dornase Alfa/Deoxyribonuclease (DNase). Dose and duration of intrapleural therapy based on MIST 2 involve multiple dosing and can be time-consuming for health care providers. Nevertheless, treatment of pleural infection with fibrinolytic therapy has been incorporated in the British Thoracic Society guideline 2023.
Another study in 2022 by Cheong et al. used a modified regimen of intrapleural alteplase 16 mg t-PA with 5 mg DNase for three doses administered sequentially within 24 h. In this study, a modified regimen of t-PA and DNase offers an alternative therapeutic option for patients who are unfit or refuse surgical intervention but have persistent pleural infection. They have demonstrated similar treatment success comparable to other studies, as evidenced by improved pleural fluid drainage and reduced pleural opacity on day 7 chest x-ray, approximately 50% from the baseline. The mechanism of action of t-PA and DNase in the pleural cavity remains unclear. Studies suggested that IPFT may trigger the monocyte chemoattractant protein 1 (MCP-1) pathway, which promotes pleural fluid formation and subsequently causes a therapeutic lavage effect that increases pleural fluid drainage.

Start Date01 Apr 2026

Sponsor / Collaborator

University of Kebangsaan Malaysia

[+1]

NCT06723717

/ RecruitingPhase 2IIT

Efficacy of Daily IV Administration of Dornase Alfa up to 14 Days Post Subarachnoid Hemorrhage on Functional Independence at 6 Months: a PROBE Multicenter Open-label Randomized Controlled Trial

Subarachnoid hemorrhage due to aneurysm rupture (SAH) results in high mortality, while survivors frequently suffer reduced quality of life and even loss of autonomy, particularly in the active population. A significant proportion of this morbidity and mortality is linked to the occurrence of delayed cerebral ischemia (DCI), defined as a new focal neurological deficit or reduced level of consciousness unrelated to the treatment of the aneurysm or a concomitant condition.
DCI mainly occurs between days 4 and 14 after SAH, with an estimated incidence of 30%, and is significantly associated with an unfavorable functional prognosis at 3 months. Currently, the only treatment for post-SAH DCI is to prevent or reverse the onset of vasospasm, with limited efficacy, for example through nimodipine administration or hemodynamic optimization. However, according to existing data, vasospasm is not the only cause of DCI, as it may occur elsewhere than in the arterial territory affected by vasospasm, or even in the absence of any vasospasm at all. Recent reviews of the literature highlight the role of microvascular thrombo-inflammation in the pathophysiology of DCI.
This phenomenon begins as soon as SAH occurs, with the appearance of multiple microvascular obstructions responsible for ischemia of downstream territories and loss of distal autoregulatory capacity. Among the effectors of thrombo-inflammation, the NETose phenomenon (production of NETs - Neutrophil Extracellular Traps or extracellular DNA network) has recently been associated with the onset of DCI. Indeed, the concentration of NETs increases in the cerebrospinal fluid (CSF) and blood of SAH patients, and correlates with the severity of the hemorrhage. Furthermore, intravenous or intraperitoneal administration of DNAse in an animal model of SAH has been shown to reduce NET concentration and improve functional prognosis by acting directly on cerebral perfusion through the reduction of micro-thrombosis.
In humans, recombinant DNAse (dornase alfa, Pulmozyme®) has marketing authorization for inhaled administration in cystic fibrosis. The toxicology report accompanying the marketing authorization demonstrates the absence of serious side effects following administration of high IV doses of Pulmozyme® in monkeys and rats. Other studies evaluating IV administration of bovine DNAse at high doses report no complications.
In 1999, a study was published evaluating intravenous (IV) Pulmozyme® in lupus patients, reporting no serious adverse events (SAEs) among the 14 patients receiving the treatment. We are currently conducting a clinical trial of the same molecule in IV administration in patients treated with mechanical thrombectomy and IV thrombolysis for ischemic stroke (NCT04785066).
This study is the first randomized clinical trial to target NETs as effectors of the thrombo-inflammation responsible for post-HSA DCI.

Start Date26 Sep 2025

Sponsor / Collaborator

Fondation Ophtalmologique Adolphe de Rothschild

100 Clinical Results associated with Dornase Alfa

100 Translational Medicine associated with Dornase Alfa

100 Patents (Medical) associated with Dornase Alfa

1,723

Literatures (Medical) associated with Dornase Alfa

01 Oct 2026·BIOMATERIALS

Oral cascade–responsive nanomedicine to disrupt macrophage–neutrophil crosstalk for intestinal barrier repair

Article

Author: Han, Xiaoyu ; Liu, Yang ; Cao, Jinsong ; Wang, Yinsong ; Liu, Yongkang ; Shen, Yujun ; Cheng, Yuanyuan ; Wu, Dandan ; Yu, Ying ; Liu, Qiyao ; Wang, Yuhan

Intestinal barrier dysfunction underlies inflammatory bowel disease (IBD) and is driven, in part, by pathological crosstalk between macrophages and neutrophils that sustains pro-inflammatory cytokine release and excessive formation of neutrophil extracellular trap (NET). In this study, an oral cascade-responsive nanomedicine, PLBD, was developed to co-deliver the prostaglandin D₂ receptor agonist BW245C and the NET scavenger DNase I with precise spatiotemporal control and minimal off-target release. PLBD comprises mucus-penetrating, reactive oxygen species (ROS)-sensitive liposomes (LBD) formulated from DSPE-SeSe-PEG, which co-encapsulate BW245C and DNase I, and a microbiota-degradable pectin shell providing gastrointestinal protection. After oral administration, the pectin coating facilitates colonic accumulation and undergoes microbiota-mediated fermentation, whereas the exposed PEGylated liposomes penetrate the mucus barrier. In the ROS-rich inflammatory microenvironment, cleavage of the Se-Se linker triggers the synchronous release of payloads. Functionally, released BW245C facilitates a functional shift in macrophages toward an anti-inflammatory M2-like state while DNase I degrades dysregulated NETs, interrupting the inflammatory loop. In murine models of intestinal barrier dysfunction, PLBD restores epithelial barrier integrity, reduces bacterial translocation, rebalances gut microbiota, attenuates IBD and systemic inflammation. Together, this work validates macrophage-neutrophil crosstalk as a tractable therapeutic target and provide a safe, orally translatable biomaterials strategy for intestinal barrier repair.

01 Aug 2026·FREE RADICAL BIOLOGY AND MEDICINE

The IL-33/ST2 axis promotes sepsis-induced lung injury by modulating NETs formation via the ATF4/REDD1 signaling pathway

Article

Author: Zheng, Yingfang ; Li, Cheng ; Huang, Qianrui ; Yang, Bin ; Ran, Xiao ; Ke, Shun ; Dai, Hongkai ; Li, Yongsheng

BACKGROUND:

Neutrophil extracellular traps (NETs) can mediate sepsis-induced lung injury, but the upstream regulatory mechanisms remain unclear. IL-33 is involved in neutrophil activation and may serve as an upstream regulator of NET formation. Therefore, this study aims to elucidate the molecular mechanism by which the IL-33/ST2 axis regulates NET formation to mediate sepsis-induced lung injury.

METHODS:

A mouse model of sepsis-induced lung injury was established using the CLP method to assess lung damage and NETs formation. The destructive effect of NETs on the endothelial barrier was examined through DNase I intervention and HUVECs cell experiments. IL-33 or ST2 gene knockout mice were used to investigate the role of the IL-33/ST2 axis in sepsis-induced lung injury and its regulatory effect on NETs formation. Differentially expressed genes were identified via transcriptome sequencing of mouse neutrophils, and the downstream molecular mechanism of IL-33-induced NETs formation was explored by silencing or overexpressing REDD1 in dHL-60 cells.

RESULTS:

In septic mice, neutrophil infiltration and elevated levels of NETs were observed in lung tissue, accompanied by pulmonary edema and increased vascular permeability. These injuries were reversed by DNase I intervention. The IL-33/ST2 signaling axis was activated in septic mice, and knockout of either the IL-33 or ST2 gene alleviated lung injury, reduced endothelial barrier disruption, and inhibited NETs formation. In vitro experiments and transcriptome sequencing results demonstrated that IL-33 induces NETs formation in neutrophils through the ST2 receptor, and the ATF4/REDD1 signaling pathway is the key downstream mechanism by which IL-33 promotes NETs formation.

CONCLUSION:

This study demonstrates that IL-33/ST2 signaling leads to activation of the PERK/eIF2α/ATF4 pathway in neutrophils, upregulates REDD1 to induce NETosis triggered by oxidative stress, and thereby disrupts the pulmonary vascular endothelial barrier, exacerbating sepsis-induced lung injury.

INTRODUCTION:

01 Aug 2026·PHYTOMEDICINE

Shegan Mahuang Decoction ameliorates pulmonary fibrosis progression by inhibiting CCL3-mediated NETosis

Article

Author: Qu, Jiao ; Du, Haojie ; Zhou, Wencheng ; Liu, Zhengcheng ; Wang, Zhisen ; Zhao, Wanjun ; Zhang, Tao ; Sun, Yang

BACKGROUND:

Pulmonary fibrosis (PF) represents a spectrum of chronic lung disorders for which effective therapeutic options remain limited. Shegan Mahuang Decoction (SGMH) is a traditional Chinese medicine with potential therapeutic effects for respiratory system diseases. The precise mechanism of SGMH in treating PF has not yet been elucidated.

PURPOSE:

This study aims to investigate the effectiveness and mechanism of SGMH in the treatment of PF.

METHODS:

To investigate the effect of SGMH on PF, we established a mouse model and assessed inflammatory and neutrophil extracellular traps (NETs)-related markers. The target gene of SGMH was screened through integrated multi-omics analysis. The mechanisms of SGMH were explored through a series of experiments, encompassing NETs depletion with DNase I, the Pad4^-/- mouse model, and pharmacological modulation via intraperitoneal administration of recombinant CCL3 (rCCL3) or a CCL3 neutralizing antibody (anti-CCL3).

RESULTS:

SGMH ameliorated Bleomycin-induced lung tissue damage. It also inhibited pulmonary inflammation and NETs formation. Both DNase I-mediated NETs clearance and the Pad4^-/- mice model showed that SGMH could not further ameliorate PF, indicating that SGMH blocks the PF development by inhibiting NETs formation. Multi-omics analysis and experimental validation found that SGMH inhibits NETs formation by targeting CCL3. Administration of rCCL3 restored NETs formation and attenuated the anti-fibrotic effect of SGMH. Moreover, treatment with anti-CCL3 alone inhibited PF, whereas its combination with SGMH did not further enhance the therapeutic effect.

CONCLUSION:

This study demonstrated that SGMH ameliorates PF progression by inhibiting CCL3-mediated NETosis, suggesting its potential clinical application for PF treatment.

News (Medical) associated with Dornase Alfa

15 Jun 2026

·www.globenewswire.com

Dyadic Highlights Accelerated Interest in C1 Biomanufacturing Platform Amid Ebola Preparedness Activities and Growing Commercial Adoption

Company’s C1 platform may help address urgent need for rapid, scalable vaccine and antibody manufacturing while supporting broader commercialization across life sciences, food, nutrition and industrial marketsJUPITER, Fla., June 15, 2026 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (Nasdaq: DYAI), d/b/a Dyadic Applied BioSolutions (“Dyadic” or the “Company”), a biotechnology company focused on the development and commercialization of scalable microbial protein production platforms, today highlighted increasing interest in its proprietary C1 protein production platform as global infectious disease preparedness efforts intensify in response to the ongoing Bundibugyo Ebola virus (BDBV) outbreak and as the Company continues to advance commercial adoption across multiple high-growth markets. The recent Ebola-related preparedness activity has brought renewed attention to one of the most important challenges in global health: the ability to rapidly manufacture vaccines, monoclonal antibodies and other biologics at sufficient scale and affordable cost. Dyadic believes its C1 platform is well positioned to help address this challenge through rapid strain development, high expression levels, flexible microbial manufacturing and reduced production timelines. Dyadic’s C1 platform has demonstrated the ability to progress from receipt of a codon-optimized viral gene sequence to purified recombinant antigen or monoclonal antibody in approximately 15 days. The Company believes this speed may be particularly important during infectious disease outbreaks, where response time, manufacturing capacity and equitable access can directly affect preparedness outcomes. “Recent outbreaks continue to demonstrate that speed matters,” said Mark A. Emalfarb, Chief Executive Officer of Dyadic Applied BioSolutions. “Scientific discovery alone is not enough. Vaccines and antibody therapies that cannot be manufactured quickly, affordably and at sufficient scale are unable to reach the people who need them most. A vaccine or antibody that is unavailable or unaffordable is 100% ineffective. Manufacturing matters.” Ebola Preparedness Creates Timely Interest in Rapid Biomanufacturing The Bundibugyo Ebola virus outbreak has led to enhanced surveillance, traveler screening, border monitoring and other public health measures associated with international travel and large public gatherings, such as the FIFA World Cup. These activities underscore the need for technologies that can support the rapid development, production and release of vaccines and antibody therapies during infectious disease threats. Dyadic is experiencing growing interest in the potential application of its C1 microbial protein production platform for Ebola-related vaccine antigen and monoclonal antibody development programs. This interest reflects the growing need for technologies that can support rapid, scalable and cost-effective biologics manufacturing during infectious disease outbreaks. Dyadic’s recently announced collaboration with Scripps Research represents one important track. The collaboration combines Scripps’ expertise in computational antigen design and viral immunology with Dyadic’s C1 protein production platform. Together, the organizations are evaluating approaches that may accelerate the development and production of vaccine antigens and monoclonal antibody candidates for infectious diseases, including Ebola, hantaviruses and other emerging viral threats. A second track involves research proposals submitted in response to CEPI’s Ebola funding call that incorporate Dyadic’s C1 platform to support vaccine development and manufacturing. These submissions are focused on evaluating the potential use of C1 to support rapid vaccine antigen development and scalable manufacturing for Ebola preparedness. A third track involves an additional monoclonal antibody initiative with Fondazione Biotecnopolo di Siena and the European Vaccines Hub. This initiative is focused on antibody programs targeting Ebola and hantavirus infections and further highlights the potential application of Dyadic’s C1 platform beyond vaccine antigen production and into scalable monoclonal antibody manufacturing. Together, these three tracks underscore the growing relevance of Dyadic’s C1 platform in infectious disease preparedness, spanning vaccine antigen development, monoclonal antibody production and scalable biologics manufacturing. C1 Platform Addresses a Critical Bottleneck: Manufacturing Dyadic believes that as artificial intelligence has the potential to accelerate the discovery of new antibodies, antigens, enzymes and other proteins, scalable manufacturing platforms can play an increasingly important role in converting scientific innovation into real-world products. The Company believes the C1 platform’s rapid strain development, high expression levels, use of standard microbial bioreactors, flexible manufacturing profile and potential cost advantages can help support regional manufacturing initiatives focused on vaccines, monoclonal antibodies and other biologics. Through collaborations and grants involving organizations such as CEPI, the Gates Foundation, the European Vaccines Hub and Fondazione Biotecnopolo di Siena, Dyadic continues to advance and further validate its C1 platform. In addition, Dyadic’s DYAI-100 clinical study demonstrated that C1-produced antigens were generally safe and well tolerated, supporting the potential use of the platform for recombinant protein-based vaccine applications. “Ebola preparedness is a timely example of why Dyadic’s platform matters,” Emalfarb said. “But the opportunity is much broader. The same capabilities being evaluated for outbreak preparedness are also being used to support commercial products across life sciences, food, nutrition and industrial markets.” Commercial Adoption Expands Beyond Pandemic Preparedness While infectious disease preparedness provides a high-profile and urgent use case for Dyadic’s technology, the Company is also leveraging its protein production capabilities to commercialize recombinant proteins and enzymes across multiple markets. Recent commercial and development milestones include: Launch of recombinant human albumin through Proliant Health & BiologicalsCommercialization of recombinant DNase I through Fermbox BioGlobal distribution activities through IBT BioservicesCommercialization of recombinant bovine chymosin through InzymesAdvancement of recombinant transferrin and growth factor products targeting cell culture media, cultivated meat, biomanufacturing and other high-growth life sciences applications Dyadic believes these programs demonstrate that its C1 and Dapibus™ platforms are not limited to one disease, one product or one market. Instead, the Company is pursuing a diversified commercialization strategy that may include product sales, licensing, royalties, funded collaborations, supply relationships and strategic partnerships. Multiple Markets, Multiple Shots on Goal Dyadic’s C1 and Dapibus™ platforms are being developed to support recombinant protein production across several major categories: Biopharmaceutical and Pandemic Preparedness: vaccine antigens, monoclonal antibodies, infectious disease response and regional biologics manufacturing. Life Sciences and Biomanufacturing: recombinant albumin, DNase I, transferrin, growth factors, diagnostics, cell culture media and bioprocessing inputs. Food, Nutrition and Wellness: animal-free proteins, dairy and other enzymes, precision fermentation ingredients and sustainable nutrition applications. Industrial Biotechnology: enzymes and specialty proteins for industrial processes, sustainability-focused manufacturing and bioindustrial applications. The Company believes this multi-market approach provides several potential pathways for long-term value creation while reducing dependence on any single clinical program, outbreak event or commercial product. Dyadic Positioned at the Intersection of Global Health, AI and Scalable Protein Manufacturing Dyadic believes the convergence of emerging infectious disease preparedness, AI-enabled protein discovery, and growing demand for animal-free and recombinant proteins is creating an opportunity for its scalable dual protein production platforms across global health and commercial markets. As governments, global health organizations, biotechnology companies and academic institutions evaluate approaches to outbreak preparedness and equitable access to biologics, Dyadic believes manufacturing capacity, scalability, speed and cost efficiency are becoming increasingly important considerations. “What makes this particularly exciting for Dyadic is that we have two complementary protein production platforms designed to serve distinct but significant markets,” Emalfarb said. “Our C1 platform is focused on life sciences and biopharmaceutical applications, including pandemic preparedness, vaccine antigens, monoclonal antibodies, other biologics, diagnostics and cell culture inputs. Our Dapibus™ platform is designed to support the commercialization of recombinant proteins and enzymes across food, nutrition, wellness and bioindustrial markets, including animal-free ingredients, precision fermentation, specialty enzymes and industrial biotechnology applications. Together, these platforms are targeting current addressable market opportunities that Dyadic estimates exceed $25 billion across life sciences, food/nutrition, wellness and bioindustrial applications. As demand continues to grow for biologics, animal-free proteins, cell culture inputs and industrial enzymes, we believe Dyadic’s platforms are increasingly well positioned to support both global health initiatives and commercial market opportunities.” About Dyadic Applied BioSolutions Dyadic Applied BioSolutions is a global biotechnology company that aims to develop and commercialize scalable, non-animal protein production platforms to meet growing global demand across the life sciences, food and nutrition, and bio-industrial markets. These high-value proteins are designed to enable customers to develop more efficient, scalable, and sustainable products. Dyadic’s proprietary Dapibus™ and C1 expression systems support rapid, cost-effective, and flexible manufacturing. For more information, please visit http://www.dyadic.com. Safe Harbor Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, including those regarding Dyadic International’s expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance, such as the success of our clinical trial and interest in our protein production platforms, our research projects and third-party collaborations, as well as the availability of necessary funding. Forward-looking statements generally can be identified by use of the words “expect,” “should,” “intend,” “anticipate,” “will,” “project,” “may,” “might,” “potential,” or “continue” and other similar terms or variations of them or similar terminology. Dyadic International, Inc., and its subsidiaries caution readers that any forward-looking information is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking information. Such statements reflect the current views of our management with respect to our operations, results of operations and future financial performance. Forward-looking statements involve many risks, uncertainties, or other factors beyond Dyadic’s control. These factors include, but are not limited to (i) our history of net losses; (ii) market and regulatory acceptance of our microbial protein production platforms and other technologies; (iii) failure to commercialize our microbial protein production platforms or our other technologies; (iv) competition, including from alternative technologies; (v) the results of nonclinical studies and clinical trials; (vi) our capital needs; (vii) changes in global economic and financial conditions; (viii) our reliance on information technology; (ix) our dependence on third parties; (x) government regulations and environmental, social and governance issues; (xi) intellectual property risks; (xii) our ability to comply with the listing standards of the Nasdaq Stock Market LLC; and (xii) other factors discussed in Dyadic’s publicly available filings, including information set forth under the caption “Risk Factors” in Dyadic’s annual report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 25, 2026, as amended on April 30, 2026, and quarterly report on Form 10-Q filed with the SEC on May 13, 2026, as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at www.dyadic.com. The forward-looking statements contained in this press release are made only as of the date hereof, and except as required by law, we undertake no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in our expectations. Media contacts: Dyadic Applied BioSolutions:Ping RawsonChief Financial OfficerPhone: (561) 743-8333Email: ir@dyadic.com

Vaccine

19 May 2026

·www.biospace.com

Halia Therapeutics Appoints Gary Sabin as Executive Chairman and Adds Three Independent Directors to Board

Industry leaders join at a pivotal moment as company advances HT-6184 toward a pivotal trial in MDS and prepares Phase 2a initiation for HT-4253 in Alzheimer's disease LEHI, Utah , May 19, 2026 /PRNewswire/ -- Halia Therapeutics, Inc., The Genetic Resilience Company™ , a clinical-stage biopharmaceutical company advancing first-in-class inflammation therapies anchored in protective human genetics, today announced the appointment of Gary Sabin as Executive Chairman of the Board of Directors. Mr. Sabin has been a member of Halia's Board of Directors since January 2025. The company also announced the additions of Preston Campbell, MD, David Checketts, and Mary Beckerle, PhD, as independent members of the board. The expanded board joins Halia at a defining moment for the company, as it advances HT-6184 toward pivotal development in lower-risk myelodysplastic syndromes and continues to build its broader pipeline across inflammation-driven diseases. Earlier this month, Halia announced final Phase 2 data for HT-6184 in lower-risk MDS, as well as the appointment of Han Myint, MD, FACP, as Chief Medical Officer, further strengthening the company's clinical and leadership foundation for its next phase of growth. "We are pleased to formally expand Gary's leadership role to Executive Chairman and to welcome Preston, David, and Mary to the board," said David J. Bearss, PhD, Chief Executive Officer of Halia Therapeutics. "Since joining our board in January 2025, Gary has been a highly engaged strategic partner, and his experience in capital markets, governance, and company-building has already contributed meaningfully to Halia's growth. Together with the additions of Preston, David, and Mary and following the recent advancement of our lower-risk MDS program and appointment of Dr. Han Myint as Chief Medical Officer, we are continuing to strengthen the leadership, scientific and strategic capabilities needed to advance HT-6184 toward pivotal development, expand our pipeline and support the company's next phase of growth, financing and partnering." "Halia's platform is the rare combination of a clear, genetically validated mechanism and clinical data that already supports its potential," said Gary Sabin, Executive Chairman. "Over the past year, I have had the opportunity to work closely with David, the leadership team, and the board, and I am excited to deepen that engagement as Executive Chairman, while helping build the company for long-term success." About the New Directors Gary B. Sabin — Executive Chairman Gary B. Sabin joined Halia's Board of Directors in January 2025 and now serves as Executive Chairman, bringing more than four decades of leadership in capital markets and asset-intensive businesses. He previously served as Chairman and CEO of Excel Realty Trust and Excel Trust, both of which were listed on the New York Stock Exchange, and is founder and chairman of Sabin Holdings, an Asia-Pacific-focused real estate investment firm. He has served on the boards of public companies including CareTrust REIT and Extra Space Storage and nonprofits including the Cystic Fibrosis Foundation, where he served for 20 years, including as Vice Chairman of the Board and Chairman of the Executive Committee. During his tenure, the Foundation was instrumental in facilitating FDA approval of several new therapies, including the disease-modifying drug Trikafta, as well as Tobi, Pulmozyme, Symdeko, Orkambi, Kalydeco, and Cayston. He holds a Master's in Management from Stanford University (Sloan Fellow) and a BS in Finance from Brigham Young University. At Halia, Mr. Sabin brings capital markets perspective, public-company governance experience, and executive discipline, and is working closely with leadership on financing, strategy, and growth. Preston W. Campbell III, MD Preston W. Campbell III, MD, is a physician-executive and former President and CEO of the Cystic Fibrosis Foundation (2015–2019). Dr. Campbell brings to Halia clinical development, patient-registry, and translational medicine experience aligned with the company's genetically informed pipeline. Over more than two decades at the Foundation, including as EVP for Medical Affairs, he oversaw research, drug discovery and development, the accredited care-center network, and the national patient registry, infrastructure behind many of the pivotal studies in cystic fibrosis. He trained in pediatrics and pediatric pulmonology at Vanderbilt and has more than 25 years of clinical experience in cystic fibrosis at institutions, including Johns Hopkins. David W. Checketts David W. Checketts is a veteran chief executive and investor with more than four decades of experience across sports, media, entertainment, and private equity. Mr. Checketts adds brand-building, governance, and capital formation experience as Halia transitions to a growth-stage organization. He became president and general manager of the Utah Jazz at age 28, then the youngest chief executive in NBA history, and later served as President and CEO of Madison Square Garden, overseeing its sports franchises and media networks. He subsequently served as Chairman and CEO of Legends Hospitality, managing partner of Checketts Partners Investment Management, and was a founding board member of JetBlue Airways. Mary C. Beckerle, PhD Mary C. Beckerle, PhD, is a cancer biologist and scientific leader who served as CEO of Huntsman Cancer Institute (2006–2025). She is Distinguished Professor of Biology and Oncological Sciences at the University of Utah. She joined the University of Utah faculty in 1986 and is recognized for pioneering research on cell adhesion, migration, invasion, and metastasis. She serves on the boards of Johnson & Johnson and Exelixis, is an elected member of the National Academy of Sciences, and has served on the Advisory Committee to the Director of the National Institutes of Health. The new directors join existing board members Keoni Kauwe, PhD, Co-founder, and David J. Bearss, PhD, Chief Executive Officer. About Halia Therapeutics Halia Therapeutics is a clinical-stage platform company focused on inflammation biology. The company's platform is anchored in protective human genetics that identified the LRRK2 -> RAB10 -> NEK7 -> NLRP3 axis as a source of human disease resilience. Halia is translating that biology into a pipeline of first-in-class programs, including HT-6184 in lower-risk myelodysplastic syndromes and additional hematologic indications, HT-4253 for Alzheimer's disease in APOE4 carriers, HT-6105 targeting residual inflammatory risk via hsCRP reduction, and HT-10068 for metabolic disease. To learn more, visit haliatx.com . Contacts Taylor Avei Director of Business Development Halia Therapeutics tavei@haliatx.com Investor Relations: Leigh Salvo New Street Investor Relations leigh@newstreetir.com View original content to download multimedia: SOURCE Halia Therapeutics

Executive ChangePhase 2Drug Approval

04 Mar 2026

·www.globenewswire.com

Dyadic and Fermbox Bio Launch First Product Under Expanded Collaboration: Animal-Origin-Free Recombinant DNase I (RNase-Free)

JUPITER, Fla. and BENGALURU, India, March 04, 2026 (GLOBE NEWSWIRE) -- Dyadic Applied BioSolutions (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a global biotechnology company producing precision-engineered, animal-free proteins and enzymes for life science, food and nutrition, and bio-industrial uses, and Fermbox Bio (“Fermbox”), a biotech research and manufacturing company developing sustainable bio-based products through precision fermentation and advanced biotechnology tools, today announced the commercial launch of animal-origin-free Recombinant DNase I (RNase-free). This represents the first commercialized product under the companies expanded collaboration announced in 2025 and marks another step in Dyadic’s accelerating transition from platform development to commercial product expansion and recurring revenue growth. Produced using Dyadic’s proprietary high-yield fungal microbial expression platforms and Fermbox Bio’s scale-up and biomanufacturing capabilities, Recombinant DNase I (RNase-free) is currently available in research grade with a cGMP-grade version in development to support biopharmaceutical manufacturing and cell and gene therapy applications. “Launching animal-origin-free Recombinant DNase I marks an important first step in translating our expanded collaboration with Fermbox Bio into commercial products,” said Joe Hazelton, President & COO of Dyadic Applied BioSolutions. “This milestone demonstrates the strength of our microbial expression platforms and our shared ability to bring high-quality, scalable recombinant enzymes and proteins to research and biomanufacturing customers worldwide.” Recombinant DNase I (RNase-free) is an endonuclease enzyme used for nucleic-acid clean-up and sample preparation workflows where residual DNA can interfere with analytical results. Its RNase-free specification supports RNA integrity in sensitive RNA workflows across biological research, biotechnology, and molecular diagnostics. DNase I (RNase-free) is a strategically important enzyme and the first in a planned series of recombinant enzymes and proteins expected to be commercially introduced throughout 2026. Planned pipeline products under the collaboration include recombinant α-lactalbumin, recombinant transferrin, recombinant human FGF-2, recombinant human lactoferrin, and additional recombinant proteins expressed using Dyadic’s fungal microbial platforms. The initial portfolio targets high-demand segments in cell culture media, media supplementation, and molecular biology reagents, supporting applications such as cell and gene therapy (CGT), vaccine and monoclonal antibody manufacturing, regenerative medicine, and advanced biologics development. Under the collaboration framework, Dyadic provides its fungal microbial expression platforms, production strains, and development support, while Fermbox Bio leads downstream process development, scale-up, and manufacturing. The companies are aligned on global commercialization to serve research and biomanufacturing customers worldwide. About Dyadic Applied BioSolutions Dyadic Applied BioSolutions is a global biotechnology company that uses its proprietary microbial platforms to produce recombinant proteins that are sold or licensed to partners across the life sciences, food and nutrition, and bio-industrial markets. These high-quality proteins are designed to enable customers to develop more efficient, scalable, and sustainable products. Dyadic’s C1 and Dapibus™ expression systems support flexible, cost-effective manufacturing, and are the foundation of a growing portfolio of commercial and partnered programs. For more information about Dyadic, please visit www.dyadic.com About Fermbox Bio Fermbox Bio is a biotechnology research and manufacturing company based in India with a subsidiary in the USA. The company develops sustainable bio-based products using precision fermentation and advanced biotechnology. For more information about Fermbox Bio, please visit www.fermbox.bio Safe Harbor Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, including those regarding Dyadic’s expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance, such as the success of Dyadic’s clinical trial and interest in its protein production platforms, Dyadic’s research projects and third-party collaborations, as well as the availability of necessary funding. Forward-looking statements involve many risks, uncertainties or other factors beyond Dyadic’s control. These factors include, but are not limited to, the following: (i) Dyadic’s history of net losses; (ii) market and regulatory acceptance of Dyadic’s microbial protein production platforms and other technologies; (iii) failure to commercialize Dyadic’s microbial protein production platforms or its other technologies; (iv) competition, including from alternative technologies; (v) the results of nonclinical studies and clinical trials; (vi) Dyadic’s capital needs; (vii) changes in global economic and financial conditions; (viii) Dyadic’s reliance on information technology; (ix) Dyadic’s dependence on third parties; (x) government regulations and environmental, social and governance issues; (xi) intellectual property risks; and (xii) Dyadic’s ability to comply with the listing standards of the Nasdaq Stock Market LLC. For a more complete description of the risks that could cause Dyadic’s actual results to differ from its current expectations, please see the section entitled “Risk Factors” in Dyadic’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at www.dyadic.com. All forward-looking statements speak only as of the date made, and except as required by applicable law, Dyadic assumes no obligation to publicly update any such forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in Dyadic’s expectations. Company contacts:Dyadic Applied BioSolutions:Joe HazeltonPresident & COOEmail: info@dyadic.com Fermbox Bio:Mr. Binod DagaPresident Business development & Strategic PartnershipsEmail: Info@fermbox.bio

Gene Therapy

100 Deals associated with Dornase Alfa

External Link

KEGG	Wiki	ATC	Drug Bank
D03896	Dornase Alfa	R05CB13	DB00003

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cystic Fibrosis	United States	Genentech, Inc.	30 Dec 1993

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Empyema, Pleural	Phase 3	Italy	Hoffmann-La Roche, Inc.	01 Oct 2007
Pleural Effusion	Phase 3	Italy	Hoffmann-La Roche, Inc.	01 Oct 2007
Chronic graft-versus-host disease	Phase 2	United States	Genentech, Inc.	01 Apr 2016
Sjogren's Syndrome	Phase 2	United States	Genentech, Inc.	01 Jul 2014
Asthma	Phase 2	United States	The Feinstein Institutes for Medical Research	01 Aug 2012
Sinusitis	Phase 2	United States	Genentech, Inc.	01 Dec 2006
Acute asthma	Phase 2	United States	Genentech, Inc.	01 Jan 2004
Post Acute COVID 19 Syndrome	Phase 1	Canada	Hoffmann-La Roche, Inc.	25 Dec 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04359654 (Pubmed \| Elife)	Phase 2	COVID-19 C-reactive protein (CRP) \| lymphocyte counts \| cf-DNA ... View more	39	Dornase alfa + Best Available Care	loxudemzta(ueoblnngrd) = sulmpbcefn mleamntgww (wzniithtkg ) View more	Positive	16 Jul 2024
				Best Available Care	loxudemzta(ueoblnngrd) = nqalqhtbvz mleamntgww (wzniithtkg ) View more
NCT04915586 (Pubmed \| BMC Pulm Med)	Not Applicable	Pleural Diseases	30	16 mg t-PA with 5 mg DNase	mipspwdoeq(nasntalnjo) = xhgedtowna vhjjcostys (umobibyxkk, 8.8 - 32.7) View more	Positive	17 May 2022
MIST-2 (ERS2021)	Not Applicable	Pleural Diseases	30	16mg t-PA and 5mg DNase	ftvhidyksp(pfloekgnjj) = ikiabnxavl sodoyvudgy (wdwlpocjko, 905 - 2360)	-	05 Sep 2021
NCT02702518 (CTgov)	Phase 1/2	Dry Eye Syndromes \| Chronic graft-versus-host disease \| Graft vs Host Disease	58	rhDNase I (rhDNase I)	mpeztjcivq(tqxyuiqoss) = glnwldznjj dmlbjeopzm (jksxelhkhx, rbpcizduwd - mcbburwmgi) View more	-	10 Aug 2021
				Vehicle (Vehicle)	mpeztjcivq(tqxyuiqoss) = ilhjowjdvq dmlbjeopzm (jksxelhkhx, krklnyawzn - ysmskbatbf) View more
NCT04402970 (Pubmed \| Front Immunol)	Phase 3	COVID-19	30	Treatment group	fbhtcrodnu(yljylodylk): P-Value = 0.038	-	01 Jan 2021
				Control group
NCT01717742 (CTgov)	Phase 3	Empyema, Pleural	97	tPA (Intervention)	yzbxpskuih(plhitgjxon) = bknvwvzexn wzftgyfvuj (lzotrrjbxi, 4.9) View more	-	03 Apr 2020
				tPA (Control)	yzbxpskuih(plhitgjxon) = kkghbworjp wzftgyfvuj (lzotrrjbxi, 5.3) View more
NCT02193490 (CTgov)	Phase 1/2	Sjogren's Syndrome	47	DNase (DNase)	bvyhtovmtm(xnvfwtxkkz) = metjzoofog xqghwhpfwd (xwapqzaoce, jvnkpmhlsf - swenfouryc) View more	-	05 Nov 2019
				Vehicle (Vehicle)	bvyhtovmtm(xnvfwtxkkz) = ynzmcwfxgx xqghwhpfwd (xwapqzaoce, fpnxqwhctc - qyjbgwhbdp) View more
NCT01952470 (CTgov)	Phase 2	Lung transplant rejection \| Acute lower respiratory tract infection	32	Dornase Alfa (Dornase Alfa)	dvnpdepwuj(uxofkxbkfh) = aivppfzgyq ntnustmbju (dfgkcsznho, 1.97) View more	-	28 Aug 2019
				Isotonic Saline. (Isotonic Saline)	dvnpdepwuj(uxofkxbkfh) = rklfunnxdu ntnustmbju (dfgkcsznho, 2.33) View more
NCT01356147 (PVAIN, CTgov)	Phase 4	Ventilator associated bacterial pneumonia \| Infectious Lung Disorder	11	Placebo (Sham Placebo)	igwylncpnu(jczhgqhcnh) = kogldzvfjz kmxtmwffmm (mbzxjpzmtq, ugxihainyx - hcjiydifsx) View more	-	08 Feb 2017
				Dornase alfa (Dornase Alfa)	igwylncpnu(jczhgqhcnh) = ckehaegzhu kmxtmwffmm (mbzxjpzmtq, rvcopdyjhc - xnmykfdddg) View more
NCT00419380 (CTgov)	Phase 4	Otitis Media	41	dornase alfa (Dornase Alfa (Pulmozyme®))	whsnsfwsos = vwfclrgskz htbgzjkhzw (xflegvmpcs, ktgnlyetjh - mvxtcmoxek) View more	-	27 Mar 2015
				dornase alfa (Ofloxin)	whsnsfwsos = iyuuogrcrs htbgzjkhzw (xflegvmpcs, xrgbxrahhh - tonyvfzmrv) View more

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