Aurora Spine Corporation Announces Participation at the North American Spine Society Annual Meeting




Aurora Spine Corporation Announces Participation at the North American Spine Society Annual Meeting

Company to Showcase Cutting-Edge Innovations at Booth #1622 

CARLSBAD, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a leader in the development of groundbreaking medical devices for spinal surgery, today announced its participation at the 2025 North American Spine Society (“NASS”) Annual Meeting. The event will take place from November 14-16, 2025, at the Colorado Convention Center, in Denver, Colorado. Aurora Spine will be exhibiting at Booth #1622. 

The North American Spine Society is a global multidisciplinary medical society that utilizes education, research, and advocacy to foster the highest quality, ethical, and evidence-based spine care.  NASS gathers spine professionals from around the world, offering a unique platform for Aurora to showcase its latest innovations.

At this year’s event, the company will feature its newly launched Hydra ANATOMIC. ELEVATED. RIGID. OSTEOFIXATION Facet Fusion System for facet joint-related pain or instability and DEXA-L, a stand-alone device for anterior lumbar interbody fusion (ALIF) procedures, which is part of Aurora’s patented DEXA™ Technology Platform, which offers patient-matched implants designed to align with individual bone density and T-Score, ushering in a new era of personalized spinal care.

“We are excited to attend NASS 2025 and to showcase our cutting-edge, proprietary products we’ve developed, especially the recently launched Hydra and DEXA-L product lines,” said Trent Northcutt, President and CEO of Aurora Spine. “We’ve worked diligently to bring new, proprietary technologies to market that are transforming spinal surgery, and we can’t wait to share them with the industry at NASS 2025.”

Laszlo Garamszegi, Chief Technology Officer, added: “We’re particularly excited to showcase the DEXA-L implant line, which is the first of its kind in the world and is the first spinal implant that is a bone-mimicking™ structural implant helping doctors match the implant to the patient’s bone density and quality. These products are game-changing for spine surgeons and their patients, and we are proud to be presenting them at NASS 2025 and connecting with industry professionals in attendance.”

Visit Aurora Spine at Booth #1622 to witness live demonstrations and engage with the team on how these innovations are reshaping spinal surgery.

About Aurora Spine

Aurora Spine is focused on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies. Additional information can be accessed at www.aurora-spine.com or www.aurorapaincare.com.

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

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the proposed use and success of the company’s products in surgical procedures. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward-looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

Contact:

Aurora Spine Corporation

Trent Northcutt

President and Chief Executive Officer

(760) 424-2004

Chad Clouse

Chief Financial Officer

(760) 424-2004

www.aurora-spine.com

Investor Relations

Adam Lowensteiner

Lytham Partners

Phone: (646) 829-9702

Email: asapf@lythampartners.com

Anteris Announces Results for the Third Quarter of 2025




Anteris Announces Results for the Third Quarter of 2025

MINNEAPOLIS, Minn. and BRISBANE, Australia , Nov. 12, 2025 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended September 30, 2025, and provided a corporate update.

Third Quarter 2025 Highlights

• Continued FDA engagement during the Quarter to advance the IDE for the PARADIGM Trial, with FDA approval to commence U.S. recruitment^* announced in November 2025
• Advanced European regulatory activities to initiate the PARADIGM Trial across multiple countries, with the first PARADIGM patients treated in Denmark following regulatory approval from the Danish Medicines Agency in October 2025
• Progressed site and operational readiness across the United States, Europe and Canada ahead of anticipated trial enrolment
• Strengthened operational and quality systems while advancing manufacturing scale-up to support clinical activities including ISO 13485 certification for DurAVR^® THV production
• Received approval from the Company’s stockholders for ASX Limited’s grant to the Company of a waiver from ASX Listing Rule 7.1

“Third Quarter activities were critical to set the company on its path for the rest of the year and into 2026. The company made significant progress on the regulatory front with approvals to start the PARADIGM pivotal study being achieved in both Europe and the U.S. in Q4 as a result,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.

Business & Operations

DurAVR^® THV Commercialisation Update

Activities supporting the launch of the PARADIGM Trial

During the third quarter of 2025, the company maintained positive engagement with the United States Food and Drug Administration (FDA) to advance the Investigational Device Exemption (IDE) for the PARADIGM Trial, submitting a formal response to address requests for additional information, including a completed simulated use study. FDA approval to commence patient recruitment^* in the United States was subsequently announced in November 2025.

Anteris also advanced European regulatory activities aimed at securing approval to commence the PARADIGM Trial in countries including Germany, France and the Netherlands, with the first European approval secured in Denmark in October 2025. In parallel, cross-functional teams completed site and operational readiness activities, namely investigator training, study material preparation, and logistical set up, ahead of anticipated enrolment and pending receipt of regulatory clearance and Institutional Review Board (IRB) approval. The first PARADIGM patients were enrolled and treated in Denmark following regulatory approval from the Danish Medicines Agency in October 2025.  

The Company continued strengthening its operational infrastructure during the quarter, advancing quality management system (QMS) buildout to support upcoming clinical activities and future ISO 13485 certification. Key quality procedures and standard operating documents were released to establish the framework for a mature, compliant system and to mitigate audit risk. In parallel, manufacturing scale-up activities progressed, including cross-training of inspection personnel, expansion of clean room capacity, and ongoing process development initiatives for projected DurAVR^® THV demand.

The financial results for Anteris for the quarter ended September 30, 2025, are reviewed below. All amounts in $ refer to U.S. dollars.

The Company’s net operating cash outflows for the nine months ended September 30, 2025, were $59.3 million, in line with the increase in clinical, regulatory and manufacturing requirements to support the PARADIGM Trial. Reflecting this clinical focus, the key areas of the Company’s operating expenditure for the three months ended September 30, 2025, were as follows:

• R&D expenses were $16.8 million.

The key activities undertaken were the preparatory activities linked to the PARADIGM Trial, including regulatory work regarding the IDE and extensive engagement with planned investigators at clinical trial sites by the Clinical Specialist Team, who work directly with physicians in the Cath Lab to support appropriate use of the device and procedural success. Additionally, there were further costs associated with upscaling of manufacturing capabilities, including completion of design validation processes and documentation, and continued portfolio development aimed at driving long-term growth beyond the current products.

• Selling, general and administrative expenses were $5.8 million.

The Company held $9.1 million of cash and cash equivalents as of September 30, 2025.

Anteris refers to the detailed Financial Information contained in its Form 10-Q filing including the Management Discussion & Analysis and the Risks.

About the PARADIGM Trial

The PARADIGM Trial is a prospective randomized controlled trial (RCT) which will evaluate the safety and effectiveness of the DurAVR^® THV compared to commercially available transcatheter aortic valve replacements (TAVRs).

This head-to-head study will enrol approximately 1,000 patients across the United States, Europe and Canada in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR^® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.

The PARADIGM Trial is designed to provide the robust clinical evidence required to support an application to the FDA for Premarket Approval (PMA) in the United States, with CE Mark approval anticipated to progress in parallel to the PMA.

For further information about the PARADIGM Trial, please refer to ClinicalTrials.gov (ClinicalTrials.gov ID NCT07194265).

*Subject to Institutional Review Board (IRB) approval

About Anteris

Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.

Anteris’ lead product, the DurAVR^® Transcatheter Heart Valve (THV), was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR^® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR^® THV is made using a single piece of molded ADAPT^® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT^® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR^® THV System is comprised of the DurAVR^® valve, the ADAPT^® tissue, and the balloon-expandable ComASUR^® Delivery System.

Forward-Looking Statements

This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts, including the objectives of, plans for and size of Anteris’ studies and trials. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.

For more information:

Surrozen Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)




Surrozen Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) — Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a biotechnology company pioneering targeted therapeutics that selectively modulate the Wnt pathway, with a focus on severe eye diseases, today announced that on November 6, 2025, Surrozen granted inducement stock option awards covering an aggregate of 50,000 shares of Surrozen common stock to the newly appointed Chief Financial Officer, Andrew P. Maleki, as an inducement material to acceptance of employment with Surrozen.

The awards were granted under Surrozen’s 2025 Equity Inducement Plan and provides for the granting of equity awards to new employees of Surrozen in accordance with Nasdaq Listing Rule 5635(c)(4). The grant was approved by the Surrozen Board of Directors on November 6, 2025. The grant provides for the purchase of shares of Surrozen common stock at a price of $12.94 per share, the closing price per share of Surrozen common stock as reported by Nasdaq on November 12, 2025.

The stock option awards vest over a four-year period, with 25 percent of the shares underlying the award vesting on the first anniversary of the award’s vesting commencement date based on the employee date of hire, and the remaining shares vesting ratably each month on the same date as the vesting commencement date (or if there is no corresponding day, on the last day of the month), subject to the employee’s continuous service as of each such vesting date. The awards were granted as an inducement material to the new employee entering into employment with Surrozen, in accordance with Nasdaq Listing Rule 5635(c)(4).

About Surrozen
Surrozen is a biotechnology company, pioneering a new class of Wnt-based therapeutics designed to repair and restore tissue function, focused in ophthalmology. Built on deep scientific expertise and a proprietary antibody-engineering platform, Surrozen develops multifunctional biologics that selectively activate Wnt signaling — alone or in combination with other key disease pathways — to address serious ophthalmic diseases with high unmet medical need. Our approach aims to deliver best-in-class, durable therapies that have the potential to transform patient outcomes and create significant long-term value. For more information, visit www.surrozen.com.

Forward-Looking Statements 
This press release contains certain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally are accompanied by words such as “will,” “plan,” “intend,” “potential,” “expect,” “could,” or the negative of these words and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding Surrozen’s discovery, research and development activities, in particular its development plans for its product candidates (including anticipated clinical development plans and timelines, the availability of data, the potential for such product candidates to be used to treat human disease or address unmet needs in serious eye diseases, as well as the potential benefits and potential differentiation from existing therapies of such product candidates); Surrozen’s intention to submit an IND application for SZN-8141 in 2026; and expectations regarding Surrozen’s partnership with Boehringer Ingelheim, including the potential for future success-based development, regulatory, and commercial milestone payments, in addition to mid-single digit to low-double digit royalties on sales. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management of Surrozen and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Surrozen. These forward-looking statements are subject to a number of risks and uncertainties, including the initiation, cost, timing, progress and results of research and development activities, preclinical and clinical trials with respect to its product candidates and potential future drug candidates; the Company’s ability to fund its preclinical and clinical trials and development efforts, whether with existing funds or through additional fundraising; Surrozen’s ability to identify, develop and commercialize drug candidates; Surrozen’s ability to successfully complete preclinical and clinical studies for its product candidates; the effects that arise from volatility in global economic, political, regulatory and market conditions; and all other factors discussed in Surrozen’s Annual Report on Form 10-K for the year ended December 31, 2024 filed, and Surrozen’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 filed with the Securities and Exchange Commission (“SEC”) under the heading “Risk Factors,” and other documents Surrozen has filed, or will file, with the SEC. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Surrozen presently does not know, or that Surrozen currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Surrozen’s expectations, plans, or forecasts of future events and views as of the date of this press release. Surrozen anticipates that subsequent events and developments will cause its assessments to change. However, while Surrozen may elect to update these forward-looking statements at some point in the future, Surrozen specifically disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Surrozen’s assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Investor/Media Contact:
Email: Investorinfo@surrozen.com

Novartis Phase III trial for next-generation malaria treatment KLU156 (GanLum) meets primary endpoint, with potential to combat antimalarial resistance




Novartis Phase III trial for next-generation malaria treatment KLU156 (GanLum) meets primary endpoint, with potential to combat antimalarial resistance

• Phase III trial for KLU156 (ganaplacide/lumefantrine, or GanLum), meets primary endpoint of non-inferiority to standard of care Coartem® (artemether-lumefantrine)
• Demonstrates PCR-corrected cure rate of 97.4% based on estimand method, equating to 99.2% under conventional per protocol analysis
• If approved, GanLum would represent first major innovation in malaria treatment since 1999, with potential to kill drug-resistant parasites and block transmission
• Novel ingredient in GanLum, ganaplacide, has entirely new mechanism of action, discovered after screening 2.3 million molecules
• Highlights Novartis long-term commitment to combating malaria, with more than 1.1 billion treatment courses of Coartem provided largely at no profit, and multiple novel antimalarial compounds in development

Basel, November 12, 2025 – Novartis today announced positive results from KALUMA, a Phase III study for new malaria treatment KLU156 (ganaplacide/lumefantrine, or GanLum). The novel non-artemisinin antimalarial, which was developed with Medicines for Malaria Venture (MMV), met the study’s primary endpoint of non-inferiority to the current standard of care. The treatment achieved a 97.4% PCR-corrected cure rate using an estimand framework, compared to 94.0% with standard of care. This equates to cure rates of 99.2% and 96.7% respectively based on conventional per protocol analysis.

The trial studied 1,688 adults and children across 34 sites in 12 African countries, with GanLum given as a sachet of granules once a day for three days. Additional analysis indicated the treatment was highly effective against mutant malaria parasites associated with partial drug resistance. The treatment was also found to have a rapid response against mature gametocytes, the sexual stage of the parasite’s lifecycle responsible for onward transmission. 

The findings come amid urgent calls to tackle the growing threat of antimalarial drug resistance in Africa.¹ Data were presented at the American Society of Tropical Medicine and Hygiene annual meeting 2025.²

“GanLum could represent the biggest advance in malaria treatment for decades, with high efficacy against multiple forms of the parasite as well as the ability to kill mutant strains that are showing signs of resistance to current medicines,” said Dr Abdoulaye Djimdé, Professor of Parasitology and Mycology at the University of Science, Techniques and Technologies of Bamako, Mali. “Drug resistance is a growing threat to Africa, so new treatment options can’t come a moment too soon.”

GanLum is a combination of two compounds, attacking the malaria parasite on multiple fronts: ganaplacide, a novel compound with an entirely new mechanism of action, and a new once-daily formulation of existing antimalarial lumefantrine, a longer-acting treatment. 

Ganaplacide is understood to work by disrupting the parasite’s internal protein transport systems, which are essential for its survival inside red blood cells.³ It belongs to a class of compounds called imidazolopiperazines, first identified as potential antimalarials after a groundbreaking screen of 2.3 million molecules to find drug candidates at Novartis labs in San Diego, California.

“Drug-resistant parasites threaten the efficacy of medicines that have helped to control malaria for decades,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “Together with our partners, we’ve gone further to develop a new class of antimalarial with an entirely new mechanism of action, which has the potential to both treat the disease and block transmission. We look forward to working with health authorities to bring this innovation to patients as soon as possible, helping close a critical gap in malaria care for those who need it most.”

Novartis plans to seek regulatory approvals from health authorities for GanLum as soon as possible. The combination therapy was granted Fast Track Designation and Orphan Drug Designation by the U.S. Food and Drug Administration in 2022. If authorized by regulators, GanLum would represent the first major innovation in malaria treatment since artemisinin-based combination therapies, the current gold standard treatments, were introduced more than 25 years ago.⁴

The treatment was developed by Novartis with the scientific and financial support of MMV, and within the framework of the WANECAM2 consortium, which is funded by the European & Developing Countries Clinical Trials Partnership Programme supported by the European Union, with co-funding from the German Aerospace Center and the UK Department of Health and Social Care.

“Antimalarial drug resistance is a ticking clock—without action today, lives will be lost,” said Dr Martin Fitchet, CEO of MMV. “GanLum’s Phase III results are a key step towards a new tool to help stay ahead of resistance. Working with Novartis and our partners, we’re committed to turning this promise into impact.”

About the KALUMA study
The KALUMA (NCT05842954) study was a Phase III randomized, open-label, multicenter study to compare efficacy, safety and tolerability of GanLum with Coartem® (artemether-lumefantrine), the standard of care, in the treatment of acute, uncomplicated malaria due to Plasmodium falciparum in adults and children. The trial studied 1,668 adults and children ≥ 10kg with acute, uncomplicated malaria due to Plasmodium falciparum, with or without mixed plasmodium infection, at 34 trial sites across 12 countries in sub-Saharan Africa. Patients treated with GanLum were given a once-daily dose for three days, as a sachet of granules. The primary analysis was conducted using an ‘estimand’ approach, a conservative approach required to support regulatory submissions, which considers patients who discontinue the study or for whom PCR data is missing at the time of the primary analysis to have failed the treatment. A conventional ‘per protocol’ approach, which excludes these patients from the analysis, is the standard methodology used in clinical trials for antimalarials, and more easily allows for comparison to historical trials and other antimalarial drugs. The principal stratum estimand consisted of patients who took a complete course of study treatment (at least 80% of study medication) and took non-study treatment with antimalarial activity prior to day 29 only in case of recrudescence. Results found:

• GanLum was non-inferior to the standard of care, meeting its primary and key secondary endpoint.
• PCR-corrected adequate clinical and parasitological response at Day 29 (proportion of patients free from clinical symptoms and baseline parasites 28 days after the start of treatment, corrected by excluding new infections) was 97.4% for GanLum, compared to 94.0% with the standard of care. Under a conventional per protocol analysis, conducted post hoc, this represents a cure rate of 99.2%, compared to 96.7% with the standard of care.
• Uncorrected adequate clinical and parasitological response at Day 29 (proportion of patients free of clinical symptoms and any parasites 28 days after the start of treatment, regardless of whether a recurrence was due to recrudescence or new infection) was 85.3% for GanLum, compared to 82.1% for the standard of care.
• The safety profile was similar to standard of care and adverse events were generally consistent with the underlying disease.

About malaria 
Malaria is a life-threatening disease caused by a parasite and spread to humans by some types of mosquitoes. According to the most recent WHO data, there were 263 million cases of malaria and 597,000 deaths in 2023, almost all of them in Africa. Children under 5 years old accounted for about three in four malaria deaths in the region.⁵ 

About Novartis in malaria innovation 
Novartis has built the industry’s largest pipeline of treatments to control or eliminate malaria and neglected tropical diseases,⁶ backed by nearly USD 500 million in funding for global health R&D since 2021. This includes four new non-artemisinin antimalarial compounds with the potential to combat rising drug resistance. Novartis has delivered more than 1.1 billion treatment courses of its antimalarial Coartem since 1999, mostly at no profit, and earlier this year launched Coartem Baby, the first malaria treatment for newborns and young infants.

About MMV
MMV is a Swiss non-profit product development partnership. MMV works “end-to-end” to discover, develop and deliver affordable and accessible medicines to treat, prevent and eliminate malaria. Since 1999, over 1.3 billion people have benefited from MMV’s co-developed medicines. With malaria still killing 600,000 each year, MMV brings partners together to close the remaining gaps in antimalarial access and innovation.

For more information, visit www.mmv.org. Follow MMV on social media: X, LinkedIn, YouTube and Facebook 

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis 
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

Reimagine medicine with us: Visit us at www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

References

1. Rosenthal, Philip J et al. The emergence of artemisinin partial resistance in Africa: how do we respond? The Lancet Infectious Diseases, Volume 24, Issue 9, e591 – e600.
2. Winnips, C., et al. KALUMA – A pivotal Phase III trial to evaluate the efficacy, safety and tolerability of the novel anti-malarial drug ganaplacide-lumefantrine (KLU156) in uncomplicated malaria, Presented at Annual Meeting of the American Society of Tropical Medicine and Hygiene, November 12, 2025.
3. LaMonte GM, et al. Pan-active imidazolopiperazine antimalarials target the Plasmodium falciparum intracellular secretory pathway. Nat Commun. 2020 Apr 14;11(1):1780; Brancucci NMB, et al. An all-in-one pipeline for the in vitro discovery and in vivo testing of Plasmodium falciparum malaria transmission blocking drugs. Nat Commun. 2025 Jul 25;16(1):6884; Gal IR, et al. Drug Interaction Studies of Cabamiquine:Ganaplacide Combination against Hepatic Plasmodium berghei. ACS Infect Dis. 2025 Jan 10;11(1):69-79.
4. Premji ZG. Coartem: the journey to the clinic. Malar J. 2009 Oct 12;8 Suppl 1(Suppl 1):S3.
5. WHO. Malaria.
6. Access to Medicine Foundation. Access to Medicine Index 2024.  

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MaxCyte Announces Planned CFO Transition in 2026




MaxCyte Announces Planned CFO Transition in 2026

Company initiates search for successor

ROCKVILLE, Md., Nov. 12, 2025 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics, today announced that Chief Financial Officer Douglas Swirsky has informed the Company of his decision to transition from his role in the first half of 2026. Mr. Swirsky and the Company are working closely to ensure a smooth and orderly transition, and he will remain Chief Financial Officer until a successor has been appointed. The Company has initiated a structured search process to identify Mr. Swirsky’s successor. Following the transition period, Mr. Swirsky will continue in an advisory capacity to support strategic initiatives and ensure continuity.  

“Doug has been an exceptional partner to MaxCyte, having played a key role in advancing our strategy, strengthening our team, and enhancing our capabilities,” said Maher Masoud, Chief Executive Officer. “We appreciate Doug’s decision to provide ample notice and flexibility for a thoughtful and orderly transition.”

“It’s been a privilege to serve as CFO of MaxCyte,” said Douglas Swirsky. “After thoughtful consideration, Maher and I have agreed that this is the right time for me to transition from MaxCyte. I’m incredibly proud of what we’ve accomplished together and confident in the Company’s continued success under Maher. I look forward to supporting a seamless handoff to my successor.”

The transition is not expected to impact the Company’s operations, results, financial reporting cadence or strategic priorities.

About MaxCyte

At MaxCyte®, we are committed to building better cells together. As a leading cell-engineering company, we are driving the discovery, development and commercialization of next-generation cell therapies. Our best-in-class Flow Electroporation® technology and SeQure DX™ gene editing risk assessment services enable precise, efficient and scalable cell engineering. Supported by expert scientific, technical and regulatory guidance, our platform empowers researchers from around the world to engineer diverse cell types and payloads, accelerating the development of safe and effective treatments for human health. For more than 25 years, we’ve been advancing cell engineering, shaping the future of medicine. Learn more at maxcyte.com and follow us on X and LinkedIn.

MaxCyte Contacts:

Investor Relations
Gilmartin Group
David Deuchler, CFA
+1 415-937-5400
ir@maxcyte.com

Media Contact
Oak Street Communications
Kristen White
kristen@oakstreetcommunications.com
415.608.6060

Oruka Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update




Oruka Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update

ORKA-001 Phase 1 results presented at EADV show potential for once-per-year dosing, higher efficacy and off-treatment remission

Over $500M cash and equivalents provides runway over one year past three key readouts: ORKA-001 Phase 2a and 2b (EVERLAST-A and -B), and ORKA-002 Phase 2

ORKA-002 Phase 1 trial ongoing, with data to be presented around YE 2025

ORKA-001 Phase 2a trial enrolling well with data expected 2H 2026

MENLO PARK, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) — Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today reported third quarter 2025 financial results and provided a corporate update.

“We had a very successful quarter where we released our first clinical data as a company and extended our cash runway beyond additional Phase 2 clinical readouts,” commented Lawrence Klein, PhD, Chief Executive Officer of Oruka. “We are seeing increased interest in both of our co-lead programs, with additional appreciation that each could become a very impactful medicine in psoriatic disease and beyond. We’re excited by our continued rapid progress advancing both ORKA-001 and -002 and look forward to sharing our first Phase 2 data in 2026.”

Third Quarter Business and Pipeline Updates

ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody

• In September 2025, at the European Academy of Dermatology and Venerology (EADV) Congress, the Company presented interim Phase 1 results in a late-breaking oral session. ORKA-001 demonstrated a half-life of approximately 100 days, greater than three times that of risankizumab, and a Cmax that exceeded risankizumab at an equivalent dose, both of which increase the likelihood of achieving once-yearly dosing, higher efficacy, and extended off-treatment remissions. Single doses of ORKA-001 also showed complete and sustained inhibition of STAT3 signaling, a downstream marker of IL-23 activity. ORKA-001 was well tolerated across all dose levels, with a favorable safety profile consistent with the anti-IL-23 class. The study is ongoing.
• Enrollment is progressing well in EVERLAST-A, a randomized, double-blind, placebo-controlled Phase 2a trial of ORKA-001 in moderate to severe PsO. Additional details of the study design were presented in an oral presentation at the EADV Congress. EVERLAST-A is designed to provide evidence of ORKA-001’s potential for yearly dosing, greater efficacy, and extended off-treatment remissions. The Company expects to share PASI 100 data at Week 16 for all patients, as well as response duration data out to approximately one year for some patients, in 2H 2026.
• Oruka plans to initiate a dose-ranging Phase 2b trial of ORKA-001, EVERLAST-B, in 1H 2026. EVERLAST-B will evaluate three dose levels of ORKA-001: 37.5 mg at Week 0, 300 mg at Weeks 0 and 4, and 600 mg at Weeks 0 and 4, versus placebo. The primary endpoint is PASI 100 at Week 16. To expedite development, EVERLAST-B dosing is projected to begin enrolling before the completion of EVERLAST-A.

ORKA-002: a novel half-life extended IL-17A/F monoclonal antibody

• The Phase 1 trial of ORKA-002 is ongoing. The trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and PK of ORKA-002 in approximately 24 healthy volunteers. The Company expects to share interim data from this trial, including initial PK data, around YE 2025.
• The Company intends to begin a Phase 2 trial of ORKA-002 in moderate-to-severe PsO in 1H 2026. The Company also is planning for a Phase 2 trial in hidradenitis suppurativa (HS), which is included in cash runway forecasts.

Additional programs and updates

• The Company completed a $180M PIPE financing, extending runway over one year past three Phase 2 catalysts: the ORKA-001 Phase 2a and 2b studies (EVERLAST-A and -B), and the ORKA-002 Phase 2 study in PsO.
• ORKA-021 (ORKA-002 → ORKA-001): Oruka continues to advance a sequential combination regimen of ORKA-002 and ORKA-001, which could deliver rapid and deep responses with an ideal maintenance profile. ORKA-021 could create another opportunity for the Company to define the best possible regimen for the treatment of psoriatic disease.
• ORKA-003: The Company continues to progress ORKA-003 through preclinical development.

Third Quarter 2025 Financial Results

Cash Position: As of September 30, 2025, Oruka had available cash, cash equivalents, and marketable securities of $500.9 million. Net cash used in operating activities was $21.6 million for the third quarter of 2025.

Research and Development (R&D) expenses: R&D expenses totaled $29.0 million and $25.7 million for the third quarters of 2025 and 2024, respectively. The increase was primarily related to employee compensation-related expenses, including stock-based compensation to support the Company’s plaque psoriasis programs. These expenses include $8.3 million and $7.8 million of non-cash stock-based compensation for the third quarters of 2025 and 2024, respectively, of which $6.6 million and $7.3 million, respectively, relate to Paruka warrant obligation.

General and Administrative (G&A) expenses: G&A expenses totaled $5.1 million and $3.8 million for the third quarters of 2025 and 2024, respectively. The increases were primarily related to employee compensation-related expenses, including stock-based compensation, professional and consulting fees to support the growth in our operations, and costs associated with being a public company.

Other income, net: Other income, net was $3.8 million and $0.8 million for the third quarters of 2025 and 2024, respectively. The increase is primarily due to higher interest income in the third quarter of 2025 from the Company’s investment in marketable securities.

Net loss: Net loss totaled $30.3 million and $28.6 million for the third quarters of 2025 and 2024, respectively, which includes non-cash stock-based compensation of $10.2 million and $9.0 million for the third quarters of 2025 and 2024, respectively

Shares Outstanding: Oruka has approximately 67.1 million shares of the Company’s common stock and common stock equivalents issued and outstanding, including shares of common stock underlying pre-funded warrants and non-voting convertible preferred stock.

About Oruka Therapeutics 

Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. 

Forward Looking Statements 

Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001, ORKA-002 and ORKA-021, including timelines to clinical and data release milestones, trial and site initiation timelines, and the details of its planned clinical studies, as well as the potential exposures and dosing interval of ORKA-001 and cash runway. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. 

Investor Contact:  
Alan Lada  
(650)-606-7911  
alan.lada@orukatx.com

GE HealthCare and RadNet’s DeepHealth Division Sign Letter of Intent to Advance Innovation and Adoption of AI-Powered Imaging Across Multiple Modalities and Remote Scanning




GE HealthCare and RadNet’s DeepHealth Division Sign Letter of Intent to Advance Innovation and Adoption of AI-Powered Imaging Across Multiple Modalities and Remote Scanning

• Collaboration aims to expand existing U.S. relationship combining GE HealthCare’s mammography systems with DeepHealth’s Breast Suite to include a worldwide distribution arrangement
• Intends to integrate GE HealthCare’s ultrasound imaging with DeepHealth’s AI-powered Thyroid Suite for intelligent clinical decision support and advanced automation
• Creates a proposed offering combining DeepHealth’s remote scanning solution, TechLive™, with GE HealthCare’s ultrasound product portfolio to simplify complex workflows and expand reach of expert care

LOS ANGELES, Nov. 12, 2025 (GLOBE NEWSWIRE) — Today, GE HealthCare (Nasdaq: GEHC) and DeepHealth, Inc., a global leader in AI-powered health informatics and a wholly owned subsidiary of RadNet, Inc. (Nasdaq: RDNT), announced their intention to expand their existing strategic collaboration to further the innovation, commercialization and adoption of AI across multiple imaging modalities. The companies plan to broaden their existing collaboration to include a wider suite of AI tools aimed at enhancing breast cancer care and extending these offerings to new regions outside the United States. The companies also plan to work together to bring new automation and remote connectivity tools to ultrasound, helping to enhance diagnostic confidence and expanding access to expert care across diverse settings.

The expanded collaboration builds on the joint initiative first announced in 2024, which united DeepHealth’s AI-powered breast cancer screening workflow solution with GE HealthCare’s Senographe Pristina™ mammography system to enhance image interpretation and improve operational efficiency.

This next phase of the relationship aims to expand the successful collaboration in three areas:

• By extending access to breast cancer solutions worldwide.
• Integrating GE HealthCare’s ultrasound imaging with DeepHealth’s AI-powered Thyroid Suite for intelligent clinical decision support and reporting automation.
• Bringing DeepHealth’s TechLive™ remote scanning solution together with GE HealthCare’s ultrasound portfolio.

The two companies aspire to empower clinicians and technologists, optimize patient pathways and improve patient access and outcomes.

“Our relationship with DeepHealth is a powerful example of how we are advancing our precision care through intelligent technology and a collaborative platform strategy,” said Karley Yoder, Chief Executive Officer of Comprehensive Care Ultrasound, Advanced Visualization Solutions at GE HealthCare. “We look forward to incorporating DeepHealth Thyroid Suite and TechLive into our ultrasound portfolio, and enhancing the capabilities of clinicians to make faster, more confident decisions while helping ensure patients benefit from the best our technology can offer.”

“Together with GE HealthCare, we are advancing a new standard of AI-powered care for better outcomes, improved patient experience and more efficient workflows,” said Kees Wesdorp, President and Chief Executive Officer of RadNet’s Digital Health Division, DeepHealth. “By uniting imaging, informatics and AI, we aim to detect disease earlier and more accurately, enable greater operational efficiency and increase patient access to high-quality care.”

Ultrasound imaging can be complex and challenging, and its quality is heavily dependent upon the skills and experience of the sonographer. Traditional thyroid ultrasound workflows require extensive manual measurements, repetitive worksheet creation and time-consuming reporting processes that may strain staff and impact patient experience.

DeepHealth Thyroid Suite is an AI-powered suite of modular applications designed to seamlessly integrate into existing thyroid imaging workflows and technology, to standardize care,^1,2 and deliver critical workflow efficiency.³ By automating nodule detection, characterization and standardizing worksheets and reporting, Thyroid Suite applications can help radiologists and sonographers work more efficiently and consistently.⁴ RadNet, a leading imaging services provider in the United States, has shown up to a 30% reduction in exam time as a result of increased workflow efficiency.³ In addition, radiologists using Thyroid AI-generated reports in more than 4,070 nodules accepted those reports without correction in greater than 94% of the cases.^1,5

The planned collaboration will also include GE HealthCare distributing DeepHealth’s TechLive^™ remote scanning for use with GE HealthCare’s ultrasound products. The combined solution empowers clinicians to remotely perform or supervise ultrasound across multiple locations from a single, secure location. This allows expert care teams to guide sonographers in real-time, helping improve access to ultrasound imaging regardless of geographic location or staffing constraints.

GE HealthCare and DeepHealth will both exhibit at the Radiological Society of North America (RSNA) Annual Meeting, Nov. 30 – Dec. 4 in Chicago. GE HealthCare will host a panel discussion with DeepHealth in booth #8355 at its Ultrasound Precision Care Education Room on December 2, between 4:00 p.m. – 4:30 p.m. CT and will also host demonstrations of TechLive. The same educational session will be hosted at the DeepHealth Immersive Theater in booth #1329.

About GE HealthCare Technologies Inc. 
GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient’s journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits. 

GE HealthCare is proud to be among 2025 Fortune World’s Most Admired Companies™. 

Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com for more information.

About RadNet, Inc.
RadNet, Inc. is a leading national provider of freestanding, fixed-site diagnostic imaging services in the United States based on the number of locations and annual imaging revenue. RadNet has a network of 407 owned and/or operated outpatient imaging centers. RadNet’s markets include Arizona, California, Delaware, Florida, Maryland, New Jersey, New York and Texas. In addition, RadNet provides radiology information technology and artificial intelligence solutions marketed under the DeepHealth brand, teleradiology professional services and other related products and services to customers in the diagnostic imaging industry. Together with contracted radiologists, and inclusive of full-time and per diem employees and technologists, RadNet has about 11,000 team members. For more information, visit radnet.com.

About DeepHealth
DeepHealth is a wholly owned subsidiary of RadNet, Inc. (NASDAQ: RDNT) and serves as the umbrella brand for all companies within RadNet’s Digital Health segment. DeepHealth provides AI-powered health informatics with the aim of empowering breakthroughs in care through imaging. Building on the strengths of the companies it has integrated and is rebranding (e.g., CIMAR UK cloud-native healthcare image management solutions, eRAD Radiology Information and Image Management Systems and Picture Archiving and Communication System, Aidence lung AI, DeepHealth, Kheiron and iCAD breast AI, Quantib prostate and brain AI, and See-Mode thyroid and breast AI), DeepHealth leverages advanced AI for operational efficiency and improved clinical outcomes in brain, breast, chest, prostate, and thyroid health. At the heart of DeepHealth’s portfolio is a cloud-native operating system – DeepHealth OS – that unifies data across the clinical and operational workflow and personalizes AI-powered workspaces for everyone in the radiology continuum. Thousands of imaging centers and radiology departments around the world use DeepHealth solutions to enable earlier, more reliable, and more efficient disease detection, including in large-scale cancer screening programs. DeepHealth’s human-centered, intuitive technology aims to push the boundaries of what’s possible in healthcare. https://deephealth.com/

GE HealthCare Media Contact:
Eric Tatro
M +1 312 459 6140
Eric.Tatro@gehealthcare.com

DeepHealth Media Contact:
Andra Axente
Director of Communications
+31614440971
andra.axente@deephealth.com

RadNet, Inc. Media Contact:
Jane Mazur
SVP, Corporate Communications
585-355-5978
jane.mazur@radnet.com

References

1. DeepHealth’s AI improves radiologist’s characterization of TI-RADS descriptors and level agreement. Data on file. Summary of Performance Testing Studies, Thyroid 510(k) clearance.
2. DeepHealth’s AI model matches clinical expertise. Data on file. “Evaluation of AI-enhanced Thyroid Ultrasound Reporting Software for Improved Diagnostic Consistency.”
3. Demonstrated up to a 30% reduction in scan slot time. Results from early solution deployment on RadNet sites.
4. DeepHealth Thyroid Suite includes DeepHealth Viewer and DeepHealth Thyroid AI. DeepHealth Viewer is Manufactured as eRAD PACS by eRAD and Distributed by DeepHealth. DeepHealth Thyroid AI is manufactured as See-Mode Augmented Reporting Tool, Thyroid (SMART-T) by See-Mode for DeepHealth Inc. Any claims made about Thyroid Suite may reference claims associated with its individual components.
5. Data on file. Comparison of final radiologist reports and DeepHealth’s Thyroid AI reports in 1,466 studies and 4,070 nodules analyzed between 14 August and 29 August 2025.

Dyadic Announces Third Quarter 2025 Financial Results and Highlights Strategic Progress




Dyadic Announces Third Quarter 2025 Financial Results and Highlights Strategic Progress

• Completed strategic pivot from R&D focus to commercial focus
• Rebranded as Dyadic Applied BioSolutions and launched redesigned website to optimize commercial engagement and investor relations
• Advanced multiple recombinant protein programs toward commercialization
• Achieved key development and commercial milestones across life sciences and nutrition markets
• First purchase order received in cell culture media and molecular biology reagent segments
• Secured ERS Genomics CRISPR license to optimize production and product performance
• Strengthened liquidity and cash position through the completion of equity offering
• Cash, cash equivalents, restricted cash and cash equivalent, and investment grade securities of $10.4 million as of September 30, 2025
• Dyadic to host an earnings call at 5:00 pm ET

JUPITER, Fla., Nov. 12, 2025 (GLOBE NEWSWIRE) — Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), d/b/a, Dyadic Applied BioSolutions, a global biotechnology company producing precision- engineered, animal-free proteins and enzymes for diverse commercial applications, today reported its financial results for Q3 2025 along with significant corporate achievements.

“During the third quarter, Dyadic completed its strategic pivot from a research and development-driven company to a commercially focused biotechnology solutions provider underpinned by our protein production platforms,” said Joe Hazelton, President and Chief Operating Officer of Dyadic. “With our comprehensive rebranding, redesigned website optimized for commercial engagement and investor relations, and the addition of CRISPR technology through our ERS Genomics license, we are strengthening the foundation for scalable growth.”

Mr. Hazelton concluded, “Our third-quarter achievements demonstrate the successful execution of our strategic transformation to a commercial biotech leader. With enhanced capabilities from our CRISPR license, growing commercial traction, and a strengthened financial foundation, we believe Dyadic is well positioned for sustainable revenue growth and long-term value creation.”

Recent Operational Highlights Corporate Development

• CRISPR License Agreement: Dyadic entered into a non-exclusive CRISPR/Cas9 license with ERS Genomics, expanding its genetic engineering capabilities to accelerate strain optimization and pathway enhancement across its proprietary production platforms. The agreement strengthens Dyadic’s ability to improve productivity, product quality, and innovation for both internal programs and partner-driven applications.
• Corporate Rebrand and Website Overhaul: Dyadic rebranded as Dyadic Applied BioSolutions and launched a redesigned corporate website to support commercial growth. The new platform enhances online ordering capabilities for research products, strengthens investor and business development engagement, and expands the company’s digital presence and social media outreach.
• Expanding Commercial Efforts in Asia: Dyadic advanced its international growth strategy by partnering with Intralink to expand in Japan and South Korea, both seen as growing biopharma markets. The initiative focuses on commercializing Dyadic’s high-value animal-free proteins, including DNase1 and Transferrin, to address what is seen as rising regional demand for biologics and cell and gene therapy manufacturing inputs.
• Peer-Reviewed Publication Validates C1 Platform for Vaccine Antigen Production: A study published in “Vaccine” (October 24, 2025) demonstrated the successful production and characterization of full-length SARS-CoV-2 spike protein using Dyadic’s Thermothelomyces heterothallica (C1) platform. The C1- produced spike exhibited comparable structure, stability, and immunogenicity to mammalian cell–derived antigens, highlighting the platform’s potential as a scalable and cost-efficient system for manufacturing complex glycoproteins and vaccine candidates.

Life Sciences

• Non-Animal Cell Culture Media
  
  • Recombinant Serum Albumin: Dyadic, in collaboration with Proliant Health and Biologicals (“Proliant”), has supported the development of animal-free serum albumin which is expected to be commercially launched in late 2025 or early 2026 for use in diagnostic and research markets. Dyadic has received $1.5 million in milestone payments to date, including the third milestone payment of $0.5 million received in October 2025, and anticipates ongoing revenue sharing from future sales in 2026.
  • Recombinant Transferrin: Dyadic’s animal-free transferrin has performed consistently with leading recombinant reference standards in cell proliferation testing for animal muscle cell growth. Designed as a high-quality, cost-effective, non-animal derived alternative to serum-derived transferrin, it targets applications in cell culture media, diagnostics, research, and bioprocessing. The Company is actively expanding validation efforts for diagnostic, research, and cell culture uses, with initial purchase orders expected by the end of 2025.
  • Recombinant Growth Factors: Dyadic’s recombinant Fibroblast Growth Factor (FGF) has shown comparable efficacy to reference standards in supporting animal muscle cell growth. Optimization and validation are ongoing, with initial purchase orders received in October 2025 within the cultured meat segment.

• Reagent Proteins & DNA/RNA Enzymes
  • DNase-1 (RNase-free): Dyadic has completed production validation and is now manufacturing research-grade RNase-free DNase-1 for molecular diagnostics, biopharma, and related applications. Following successful scale-up, sampling is actively underway with initial purchase orders expected by the end of 2025.
  • Expanded Nucleic Acid Enzymes Portfolio: Dyadic continues to advance its portfolio of DNA/RNA manipulation enzymes, including RNase Inhibitors and T7 RNA Polymerase. Prototype development and validation have shown encouraging results, with ongoing optimization expected to yield additional improvements and data through late 2025 and into 2026.

Food and Nutrition

• Non-animal Dairy Applications
  
  • Alpha-Lactalbumin: A key nutritional whey protein that supports healthy growth and cellular function in both infant and adult nutrition applications. Dyadic has agreed to terms with a non- animal dairy development company for the development of recombinant alpha-lactalbumin targeting the infant nutrition segment. The protein has demonstrated positive results in product qualification and application testing, with characterization ongoing and sampling for research and nutritional markets expected early 2026.
  • Human Lactoferrin: An iron-binding glycoprotein found in milk and other secretions, valued for its antimicrobial and immune-supporting properties and widely used in nutritional and health-related research. Dyadic has developed a stable cell line, with continued optimization and characterization underway, and sampling for research use will begin in early 2026.
  • Non-Animal Dairy Enzymes: In Q3 2025, Dyadic received a $250,000 milestone payment from Inzymes for productivity achievements for a second enzyme, bringing total payments received from Inzymes to $1.275 million. Scale-up and commercialization efforts for the first enzyme are progressing toward a late 2025 or early 2026 launch, with additional enzymes in development under the existing license agreement.

Bio Industrial Products

• In partnership with Fermbox Bio, Dyadic launched EN3ZYME™ in May 2024—an enzyme cocktail for converting agricultural residue into fermentable cellulosic sugars, produced using the Dapibus™ production platform. Initial enzyme deliveries have been completed under Fermbox’s purchase order, Dyadic is to receive a 50/50 profit share from commercial sales.
• Sampling efforts are currently underway and have expanded into healthcare applications, with ongoing negotiations in the biomass processing, biofuels, and pulp & paper markets to broaden adoption and explore new enzyme development opportunities.

Biopharmaceutical Programs

• Gates Foundation Collaboration: Dyadic has achieved key milestones in developing low-cost monoclonal antibodies (mAbs) for malaria and RSV receiving a total of approximately $2.4 million funding from a $3 million grant. Early data show C1-produced mAbs perform comparably to mAbs produced from traditional CHO cell lines.
• CEPI–Fondazione Biotecnopolo di Siena: Advancing under a $4.5 million CEPI grant, Dyadic is eligible for up to $2.4 million to support antigen design, cell line development, and cGMP scale-up for vaccines and antibodies.
• European Vaccines Hub: The €170 million EU-backed initiative led by Dr. Rino Rappuoli is assessing C1 for its potential to accelerate timelines, boost productivity, and reduce costs in vaccine and antibody manufacturing.
• Uvax Bio Collaboration: Backed by a $2.6 million CEPI grant, this program is evaluating C1 for rapid, cost-effective MERS vaccine production.
• AdaptVac Consortium: A $12.4 million CEPI and Horizon Europe–funded initiative integrating C1 to develop broad-spectrum filovirus vaccines, underscoring C1’s speed, scalability, and cost-efficiency.

Financial Highlights

Cash Position: As of September 30, 2025, cash, cash equivalents, restricted cash and cash equivalents, and the carrying value of investment-grade securities, including accrued interest, were approximately $10.4 million compared to $9.3 million as of December 31, 2024.

On August 1, 2025, the Company completed an underwritten offering (the “Offering”) of 6,052,000 shares of its common stock, par value $0.001 per share, at a public offering price of $0.95 per share. The net proceeds to the Company from the Offering were approximately $4.9 million, after deducting legal expenses, underwriting discounts and commissions and other offering expenses. The Company intends to use the net proceeds of the Offering for working capital and general corporate purposes, such as product development, sales and marketing.

Revenue: Total revenue for the three months ended September 30, 2025, decreased to $1,165,000 compared to
$1,958,000 for the same period a year ago. The decrease was due to decreases in research and development revenue of $183,000, driven by a reduction in the number of active collaborations, and license and milestone revenue of $1,425,000 from the Proliant agreement and Inzyme agreement for the same period a year ago. The decrease is offset by an increase in grant revenue of $815,000 from the Gates Foundation and CEPI grants in 2025.

Cost of Revenue: Cost of research and development revenue for the three months ended September 30, 2025, decreased to $255,000 compared to $396,000 for the same period a year ago. For the three months ended September 30, 2025, cost of grant revenue from the Gates Foundation and CEPI grants was $769,000, compared to $0 for the same period a year ago.

R&D Expenses: Research and development expenses for the three months ended September 30, 2025, increased to $572,000 compared to $460,000 for the same period a year ago. The increase was driven by a rise in the number of active internal research initiatives undertaken to expedite product development.

G&A Expenses: General and administrative expenses for the three months ended September 30, 2025, increased to $1,481,000 compared to $1,298,000 for the same period a year ago. The increase reflected increases in rebranding and business development expenses of $176,000, legal and accounting expenses of $83,000, and other expenses of $3,000, offset by a decrease in share-based compensation expenses of $79,000.

Loss from Operations: Loss from operations for the three months ended September 30, 2025, increased to $1,925,000 compared to $203,000 for the same period a year ago.

Net Loss: Net loss for the three months ended September 30, 2025, increased to $1,976,000 or $(0.06) per share compared to $203,000 or $(0.01) per share for the same period a year ago.

Conference Call Information

Date: Wednesday, November 12, 2025
Time: 5:00 p.m. Eastern Time
Dial-in numbers: Toll Free: 1-877-407-0784 or 1-201-689-8560 (International)
Conference ID: 13751389
Webcast Link: https://viavid.webcasts.com/starthere.jsp?ei=1706029&tp_key=b177e95e36

An archive of the webcast will be available within 24 hours after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.dyadic.com. To access the replay of the webcast, please follow the webcast link above.

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 Dapibus™ and C1 expression systems support flexible, cost-effective manufacturing, and are the foundation of a growing portfolio of commercial and partnered programs.
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 involve many risks, uncertainties or other factors beyond Dyadic’s control. These factors include, but are not limited to, the following: (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; and (xii) our ability to comply with the listing standards of the Nasdaq Stock Market LLC. For a more complete description of the risks that could cause our actual results to differ from our 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 our expectations.

Contact:

Dyadic International, Inc.
Ping Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: ir@dyadic.com  

See Notes to Consolidated Financial Statements in Item 1 of Dyadic’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2025.

See Notes to Consolidated Financial Statements in Item 1 of Dyadic’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2025.

Kura Oncology to Participate in Upcoming Investor Conference




Kura Oncology to Participate in Upcoming Investor Conference

SAN DIEGO, Nov. 12, 2025 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced its participation in the following investor conference:

Jefferies Global Healthcare Conference
November 19, 2025
3:30 p.m. GMT / 10:30 a.m. ET / 7:30 a.m. PT

A live audio webcast will be available in the Investors section of Kura’s website at https://kuraoncology.com/, with an archived replay available following the event.

About Kura Oncology

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura is developing ziftomenib, a menin inhibitor targeting certain genetic drivers of acute myeloid leukemias, and continues to pioneer advancements in menin inhibition for acute leukemias and solid tumors and in farnesyl transferase inhibition to address mechanisms of adaptive and innate resistance in the treatment of solid tumors. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn.

Contacts

Investors and media:
Greg Mann
858-987-4046
gmann@kuraoncology.com

NurExone Secures over C$3.18 Million Through Accelerated Warrant Exercises




NurExone Secures over C$3.18 Million Through Accelerated Warrant Exercises

NurExone Honored at Berlin and Stockholm Conferences for Breakthrough Contributions to Global Life Sciences and Health Innovation

TORONTO and HAIFA, Israel, Nov. 12, 2025 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) is pleased to announce that, further to its press release dated October 8, 2025 (the “October 8 Release”), the Company has received gross proceeds of over C$3.18M through accelerated warrant exercises.

The breakdown of the proceeds is as follows: (i) C$1,207,418.88 through the exercise of 2,515,456 September 2023 Warrants at a price of C$0.48 per September 2023 Warrant issued from a non-brokered private placement which closed in tranches on August 25, 2023 and September 6, 2023 and (ii) C$1,978,575.55 through the exercise of 5,653,073 January 2024 Warrants at a price of C$0.35 per January 2024 Warrant issued from a non-brokered private placement which closed on January 4, 2024. Capitalized terms not otherwise defined herein have the meanings attributed to them in the October 8 Release.

Following the Company providing the outstanding holders of the September 2023 Warrants and January 2024 Warrants acceleration notices on October 8, 2025 notifying them that their acceleration triggers were met, when the daily volume average trading price of the Common Shares on the TSXV equaled or exceeded C$0.83, in the case of the September 2023 Warrants, and C$0.80, in the case of the January 2024 Warrants, for a period of 20 consecutive trading days, all of the September 2023 Warrants and January 2024 Warrants were exercised their warrants prior to expiry, providing the Company an aggregate of C$3,185,994.43 in gross proceeds.

The proceeds from these exercises strengthen NurExone’s balance sheet and will be used for general corporate purposes and working capital, supporting ongoing development of Company’s exosome-based therapeutic platform.

Management Commentary

“We are very pleased with the full participation from warrantholders during the accelerated exercise period,” said Dr. Lior Shaltiel, Chief Executive Officer of NurExone. “This additional capital enhances our financial strengths as we continue advancing ExoPTEN and our therapeutic pipeline towards clinical readiness.”

Eran Ovadya, Chief Financial Officer of NurExone, added: “The full participation of these warrantholders reflects investor confidence in NurExone’s strategy and our exosome-based platform. The resulting funds provide further financial stability, enabling us to efficiently allocate resources towards clinical development and key operational priorities, while maintaining a strong balance sheet.”

Global Recognition of Translational Innovation

Alongside these financial milestones, NurExone’s scientific progress continues to gain international recognition. The Company has been nominated as a finalist for the Galien Foundation’s inaugural Prix Galien Bridges Awards. The award event, which will be held at the Nobel Forum in Stockholm on December 5, 2025, celebrates life sciences innovation that transcends geographic and disciplinary boundaries. Earlier this month, NurExone was also recognized as a finalist in the Falling Walls Science Breakthroughs of the Year Summit in Berlin.

“Our recognition among leading innovators in Europe, from Prix Galien in Stockholm to Falling Walls in Berlin, highlights our growing leadership position in exosome-based medicine,” noted Dr. Tali Kizhner, Director of Research and Development at NurExone. “We are proud to represent a new wave of regenerative biotechnology with the potential to connect scientific excellence with tangible human impact.”

About the Galien Foundation

The Galien Foundation fosters, recognizes, and rewards excellence in scientific innovation that improves the human condition. Established in honor of Galen, the father of modern medicine, the Galien Foundation oversees the international Prix Galien Bridges Awards, regarded as the industry’s highest accolade for biopharmaceutical research and innovation. The Prix Galien Bridges Awards extend this legacy by connecting innovators across regions and disciplines to advance the next generation of global health breakthroughs.

About NurExone

NurExone Biologic Inc. is a TSX Venture Exchange (“TSXV”), OTCQB, and Frankfurt-listed biotechnology company developing regenerative exosome-based therapies for central nervous system injuries. Its lead candidate, ExoPTEN, has shown compelling preclinical data supporting clinical potential in acute spinal cord and optic nerve injury, both multi-billion-dollar marketsⁱ. Key regulatory milestones, including Orphan Drug Designation from the FDA and EMA, are paving the way towards clinical trials in the U.S. and Europe. NurExone has established Exo-Top Inc., a U.S. subsidiary, to produce and supply GMP-compliant exosomes for self-use, regenerative aesthetics and other indications as part of its commercial 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

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

Allele Capital Partners
Investor Relations – U.S.
Phone: +1 978-857-5075
Email: aeriksen@allelecapital.com

FORWARD-LOOKING STATEMENTS

This press release contains certain “forward-looking statements” that reflect the Company’s current expectations and projections about its future results. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential” or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to: the use of proceeds and benefits from the warrant exercises; the benefits of being selected as a finalist and the opportunities that it may yield; the Company continuing to advance ExoPTEN and their therapeutic pipeline towards clinical readiness; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.

These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including: ExoPTEN will yield the benefits outlined herein; being selected as a finalist will yield the benefits and opportunities outlined herein; the use of proceeds from the warrant exercises will be utilized as set out herein; the warrant exercises will have the benefits on the Company as set out herein; the Company will continue to advance ExoPTEN and their therapeutic pipeline towards clinical readiness; and the NurExone platform technology has the ability to offer novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.

Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to risks related to: the Company’s early stage of development; lack of revenues to date; the inherent uncertainty of preclinical drug development, including the risk that product candidates may not advance to clinical trials or receive regulatory approval; the possibility that results from preclinical studies and early-stage trials may not predict later outcomes; the uncertain timing, cost, and outcome of preclinical and clinical development activities; risks related to the clinical trial process, including potential delays or failure to achieve effective trial design or positive results; the inability to obtain or maintain required regulatory approvals; limited market acceptance of the Company’s products, even if approved; the potential emergence of competing therapies that are safer, more effective, or more affordable; rapid technological change that may impact the relevance of the Company’s technologies; the Company’s dependence on key personnel and strategic partners; the inability to obtain adequate financing; risks related to the Company’s ability to protect its intellectual property; the possibility that the Company’s technologies, including its exosome-based platforms, may not achieve their intended therapeutic impact; the inability to produce or scale exosome-based products for clinical use; limited adoption in regenerative medicine or cell therapy applications; lack of growing clinical demand in targeted indications such as spinal cord injury, optic nerve repair, or other therapeutic areas; failure to meet planned development milestones or achieve commercial breakthroughs; ExoPTEN will not yield the benefits outlined herein; being selected as a finalist will not yield the benefits and/or opportunities outlined herein; the use of proceeds from the warrant exercises will not be utilized as set out herein; the warrant exercises will not have the benefits on the Company as set out herein; the Company will be unable to continue to advance ExoPTEN and/or their therapeutic pipeline towards clinical readiness; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications; and the risks discussed under the heading “Risk Factors” on pages 44 to 51 of the Company’s annual information form dated August 27, 2024, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca . These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.

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

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ⁱ Spinal cord injury, Glaucoma