Clene Issues Stockholder Letter Highlighting Upcoming CNM-Au8® 2026 Catalysts




Clene Issues Stockholder Letter Highlighting Upcoming CNM-Au8® 2026 Catalysts

• Operating capital runway sufficient into the fourth quarter of 2026 
• In-person Type C FDA meeting scheduled by end of the first quarter of 2026 to discuss the latest CNM-Au8 data submitted in late 2025
• Anticipated submission of a New Drug Application (NDA) to FDA for CNM-Au8 via an accelerated regulatory pathway in the second quarter of 2026
• Potential for FDA acceptance of this NDA and issuance of a Prescription Drug User Fee Act (PDUFA) date in the second half of 2026

SALT LAKE CITY, Feb. 24, 2026 (GLOBE NEWSWIRE) — Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today issued a letter to stockholders outlining key anticipated regulatory and clinical milestones for CNM-Au8^® in 2026.

CEO Letter to Stockholders

As we look to the year ahead, I want to extend my sincere gratitude for your ongoing support of Clene. As the founding CEO with over 12 years at the helm, I am driven by Clene’s mission to develop impactful and safe treatments for neurodegenerative diseases, particularly through our focus on ALS.

Following the completion of multiple Phase 2 clinical trials and continued support of open label expanded access programs, we have now treated over 800 patients with CNM-Au8, our orally administered nanocrystal suspension, encompassing one of the largest sets of clinical experience in ALS. The learnings and data that we have discovered place us at an exciting and critical juncture.

Sufficient cash to fund operations into the fourth quarter of 2026

In January we completed an oversubscribed registered direct offering of over $28 million. The initial tranche of over $6 million is expected to provide operating runway into the fourth quarter of 2026, sufficient funding through a potential NDA acceptance decision by the FDA. Two potential additional financing tranches totaling over $22 million are structured to align with NDA acceptance and FDA approval milestones and are expected to provide the Company with sufficient capital into 2027. We are immensely grateful for the support of our investors who have an unwavering conviction in the value of our programs.

Next Regulatory Steps and 2026 Catalysts

Since late 2024, we have been closely engaged on multiple occasions with the neurology division of the FDA regarding CNM-Au8. Our discussions have culminated in an in-person Type C FDA meeting scheduled by the end of this quarter to discuss the data in our extensive briefing package submitted in late 2025. We expect to receive the FDA minutes from this meeting early in the second quarter, with the Company ready to submit a New Drug Application (NDA) to the FDA for CNM-Au8 via an accelerated regulatory pathway in the second quarter of 2026. FDA acceptance of this NDA and issuance of a Prescription Drug User Fee Act (PDUFA) date for regulatory decision under the accelerated approval pathway could occur in the second half of 2026, with potential approval for commercial launch in 2027.

Based on the significance of our clinical data and our engagement with the FDA, we believe that CNM-Au8 is well suited for the accelerated approval pathway as described below:

1.   Prolonged Survival and Associated Declines in Biomarkers of Neurodegeneration:

We have generated extensive clinical data demonstrating prolonged survival in ALS associated with CNM-Au8 30mg treatment. Survival critically matters in ALS, a fatal condition with median life expectancy of approximately 2-4 years following diagnosis. CNM-Au8 drove a statistically significant and clinically meaningful reduction of mortality risk and slowed clinical worsening, both as pre-specified secondary and/or exploratory endpoints in clinical trials and sustained benefits in open label extensions. This evidence demonstrating prolonged survival benefit with CNM-Au8 treatment was accompanied by statistically significant declines in ALS-relevant biomarkers, including neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP), key markers of neuronal and glial cell injury and degeneration, providing a biological basis for the decreased mortality risk. We believe these combined findings across validated biomarkers of neurodegeneration support NfL as a viable surrogate endpoint for accelerated FDA approval of CNM-Au8. Notably, NfL biomarker change has recently been used for accelerated approval by FDA of another ALS medicine, and we believe this data will address the agency’s requests to link NfL reductions to clinical benefit. Finally, Clene has also provided supporting evidence to address the FDA’s proposed framework for potential accelerated approval consideration as described in our prior FDA meeting minutes which we have previously discussed publicly.

2.   Favorable Safety and Benefit/Risk Profile:

CNM-Au8’s groundbreaking clean-surfaced nanotherapeutic suspension, an oral liquid that patients drink daily and tastes like water, has demonstrated a consistent safety and tolerability profile. Across all our clinical trial and expanded access programs, now totaling over 1,000 patient years of treatment, the adverse event profile has been assessed as predominantly mild-to-moderate. Additionally, there have been no CNM-Au8-related Serious Adverse Events (SAEs), and no safety signals have been associated with long-term use. This benign tolerability profile should be important to the FDA as it considers the benefit/risk profile associated with CNM-Au8 treatment. Furthermore, there is regulatory precedent in ALS whereby other investigational drugs with a derisked tolerability profile have been granted accelerated approval based solely on Phase 2 efficacy data.

3.   Confirmatory Phase 3 RESTORE-ALS Trial Planned to Begin Later in 2026:

To confirm the survival benefit observed with CNM-Au8 30 mg treatment across several Phase 2 trials and to meet FDA requirements for the accelerated approval pathway, we are planning to dose the first patient in our confirmatory Phase 3 RESTORE-ALS trial later this year. The study will be a double-blind, placebo-controlled Phase 3 trial evaluating the effects of CNM-Au8 on survival and clinical worsening events in ALS. The trial design protocol has already been discussed with and reviewed by the FDA.

Our Commitment to the ALS Community Remains Unwavering:

The development of CNM-Au8 has been exceptionally collaborative with many stakeholders involved. Over nearly a decade, we have engaged with the ALS community, including leading scientists, treating physicians, disease advocates, non-profit ALS organizations, and hundreds of patients and their respective caregivers. CNM-Au8 is well known to many of these ALS stakeholders. CNM-Au8 is also well known to the regulators within the FDA, and we look forward to presenting our robust body of evidence supporting CNM-Au8 to them in later in this first quarter of 2026. We expect the totality of our biomarker, survival, and bioanalytic evidence supporting CNM-Au8, coupled with the favorable tolerability profile of the drug and the significant unmet need in ALS, will be extremely compelling in our upcoming discussions with the FDA for consideration of the accelerated approval pathway.  

Other Promising ‘Pipeline-in-a-Product’ Indications Advancing in 2026:

CNM-Au8 has also shown promising clinical benefits in MS and Parkinson’s disease. In our MS program, we plan to build on our 2025 momentum as we incorporate FDA feedback to finalize our Phase 3 clinical trial design focused on cognition in MS as an adjunct to standard of care therapies. We view CNM-Au8 as a potential “pipeline in a product,” with the initial ALS indication serving as the foundation for a much larger clinical development pipeline within the neurodegenerative field.

Thank you for your partnership in this journey.

Sincerely,
Rob Etherington, President and CEO, Clene, Inc.

About Clene
Clene Inc. (Nasdaq: CLNN), along with its subsidiaries, “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis. CNM-Au8^® is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8^® is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on X (formerly Twitter) and LinkedIn.

About CNM-Au8^®
CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8^® is a federally registered trademark of Clene Nanomedicine, Inc.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the “safe harbor” provisions created by those laws. Clene’s forward-looking statements include, but are not limited to, statements regarding the timing of the Company’s meeting with the FDA, the timing of the Company’s NDA submission, and that the biomarker findings support an NDA submission. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include general market conditions, whether clinical trials demonstrate the efficacy and safety of our drug candidates to the satisfaction of regulatory authorities, or do not otherwise produce positive results which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in “Risk Factors” in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

Investor Contact: Kevin Gardner, LifeSci Advisors; kgardner@lifesciadvisors.com; 617-283-2856

Bolt Biotherapeutics to Participate in Upcoming March Conferences




Bolt Biotherapeutics to Participate in Upcoming March Conferences

REDWOOD CITY, Calif., Feb. 24, 2026 (GLOBE NEWSWIRE) — Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today announced that management will participate in two upcoming conferences in March:

• TD Cowen 46th Annual Health Care Conference
  Company presentation on Monday, March 2, 2026 at 9:50 a.m. EST (6:50 a.m. PST)
• Leerink Partners Global Healthcare Conference
  Participating in 1×1 meetings on Wednesday, March 11, 2026

About Bolt Biotherapeutics, Inc.
The mission of Bolt Biotherapeutics is to harness the power of the immune system to improve lives and eradicate cancer. The Company is developing BDC-4182, a next-generation Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) clinical candidate targeting claudin 18.2. BDC-4182 is currently in a Phase 1 dose escalation trial that includes patients with gastric and gastroesophageal cancer. The Company has strategic collaborations with Genmab and Toray built around the Company’s Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) platform technology and its expertise in myeloid biology. The Company is seeking to partner BDC-3042, a Dectin-2 agonist that recently completed a first-in-human Phase 1 dose escalation trial, as well as its preclinical ISAC programs targeting CEA and PD-L1.
For more information, please visit https://www.boltbio.com/.

Investor Relations and Media Contact:
Matthew DeYoung
Argot Partners
(212) 600-1902
boltbio@argotpartners.com

Novo Nordisk: Triple agonist UBT251 delivers up to 19.7% mean weight loss after 24 weeks in phase 2 trial in China




Novo Nordisk: Triple agonist UBT251 delivers up to 19.7% mean weight loss after 24 weeks in phase 2 trial in China

• UBT251 is a triple agonist of the receptors for GLP-1, GIP and glucagon (triple G), being jointly developed by United Biotechnology and Novo Nordisk
• In a placebo-controlled phase 2 trial in Chinese people with overweight or obesity, UBT251 led to a statistically significant mean weight loss of up to 19.7% after 24 weeks
• UBT251 appeared to have a safe and well-tolerated profile consistent with incretin-based therapies.

Guangdong, China and Bagsværd, Denmark, 24 February 2026 – The United Laboratories International Holdings Limited (TUL) and Novo Nordisk A/S (Novo Nordisk) today announced topline results from a Chinese phase 2 trial of UBT251, a triple agonist of the receptors for GLP-1, GIP, and glucagon (triple G).

UBT251 is being jointly developed by TUL’s wholly-owned subsidiary The United Bio-Technology (Hengqin) Co., Ltd. (United Biotechnology) and Novo Nordisk under an agreement signed in March 2025. United Biotechnology is responsible for development in Chinese mainland, Hong Kong, Macau and Taiwan, while Novo Nordisk is responsible for development in the rest of the world.

The trial, conducted by United Biotechnology, investigated the safety and efficacy of once-weekly injectable 2 mg, 4 mg and 6 mg doses of UBT251 compared to placebo in Chinese people with overweight or obesity. From a baseline mean body weight of 92.2 kg, the highest mean weight loss observed for people treated with UBT251 was 19.7% (-17.5 kg) compared to 2.0% (-1.6kg) in the placebo group after 24 weeks of treatment¹.

Moreover, all dose groups of UBT251 showed statistically significant improvements relative to placebo on key secondary endpoints, including waist circumference, blood glucose, blood pressure and lipids.

In the trial, UBT251 appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with incretin-based therapies.

“The success of the phase 2 clinical trial of UBT251 in China represents another significant milestone in TUL’s innovation-driven development,” said Mr Tsoi Hoi Shan, Chairman of TUL. “We will continue to focus on chronic diseases, including endocrine and metabolic disorders, accelerate the further development of UBT251, and strive to bring more high-quality treatment options to patients worldwide at the earliest opportunity.”

“We are very encouraged by these data from the trial in China, which demonstrate the potential of UBT251 and its differentiated clinical profile and safety and tolerability profile,” said Martin Holst Lange, executive vice president, chief scientific officer and head of Research and Development at Novo Nordisk. “We look forward to reporting data from a global trial with UBT251 conducted by Novo Nordisk next year.”

Novo Nordisk recently initiated a global phase 1b/2a trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of different doses of UBT251 for up to 28 weeks in around 330 people living with overweight or obesity. Topline data from that trial is expected in 2027. Novo Nordisk also expects to initiate a phase 2 trial with UBT251 in people with type 2 diabetes in the second half of 2026.

United Biotechnology will present detailed data from the Chinese phase 2 trial at a medical congress later this year. Based on the results of this trial, the company is planning to initiate a phase 3 trial in Chinese patients with overweight or obesity.

About the Chinese phase 2 trial
This randomized, double-blind, placebo-controlled trial enrolled a total of 205 Chinese patients with obesity (BMI ≥ 28.0 kg/m²) or overweight (24.0 kg/m² ≤ BMI < 28.0 kg/m²) with at least one weight-related comorbidity. The baseline mean body weight of the patients was 92.2 kg, with a baseline mean BMI of 33.1 kg/m².

Patients were randomly assigned to receive weekly subcutaneous injections of UBT251 in doses of 2 mg, 4 mg, 6 mg, or placebo for 24 weeks.

The primary endpoint of the trial was the percentage change in body weight from baseline after 24 weeks of treatment.

About UBT251
UBT251 is a long-acting synthetic peptide triple agonist targeting the receptors for GLP-1 (glucagon-like peptide-1), GIP (glucose-dependent insulinotropic polypeptide) and glucagon.

In March 2025, United Biotechnology entered an exclusive license agreement with Novo Nordisk A/S for UBT251. Under the agreement, Novo Nordisk obtained exclusive worldwide rights (excluding Chinese mainland, Hong Kong, Macau, and Taiwan) to develop, manufacture and commercialise UBT251. United Biotechnology retained the rights for UBT251 in Chinese mainland, Hong Kong, Macau and Taiwan.

About TUL and United Biotechnology
Founded in 1990, TUL (HKEX: 3933) is mainly engaged in the research and development, production and sales of pharmaceuticals, and ranks among the leading integrated pharmaceutical companies in China. TUL currently boasts seven production bases, covering intermediate products, bulk medicine, finished products, veterinary drugs, empty capsule casings, and medical devices, with the sales networks dotted across nearly 80 countries and regions. United Biotechnology, located in the Guangdong-Macao In-Depth Cooperation Zone in Hengqin, serves as the biopharmaceutical R&D headquarter of TUL. United Biotechnology focuses on the development of high-end biopharmaceuticals to treat major chronic diseases. For more information, please visit www.tul.com.cn.

About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 68,800 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.

Contacts for further information:

¹ Based on the efficacy estimand according to the trial protocol, regardless of dose modification

Attachment

• PR260224-UBT251

ASTRA Therapeutics appoints Industry Leader Fabian Kausche as Chairman of the Board of Directors




ASTRA Therapeutics appoints Industry Leader Fabian Kausche as Chairman of the Board of Directors

Villigen, Switzerland, Feb. 24, 2026 (GLOBE NEWSWIRE) —

• Dr. Fabian Kausche, a distinguished animal health executive, joins ASTRA Therapeutics to strengthen strategic leadership and long-term value creation.
• Appointment reinforces ASTRA Therapeutics’ commitment to building a scalable, globally competitive animal health company focused on precision anti-parasitic innovation.
• Board strengthened ahead of future value-creation phases, including strategic partnerships and Series A financing.

Villigen, Switzerland, 24 February 2026 – ASTRA Therapeutics AG today announced the appointment of Dr. Fabian Kausche as Chairman of its Board of Directors, reinforcing the company’s governance and strategic leadership as it advances its precision parasitology platform toward global scale.

Fabian Kausche brings decades of executive leadership across animal and human health, with deep expertise in R&D governance, portfolio strategy, and organizational transformation. He has repeatedly led large, multinational R&D organizations through growth, integration, and strategic repositioning. Complementing this corporate background, he also brings hands-on startup and transaction experience, having served as Chairman of the Board of PetMedix and guiding the company through its strategic development and successful acquisition by Zoetis. This combination of global leadership and entrepreneurial value-creation experience provides highly relevant strategic perspective and makes him an ideal leader for ASTRA Therapeutics as it advances toward its next phase of growth.

“Fabian’s leadership experience at the highest levels of global animal health R&D brings exactly the strategic depth we need at this stage. His ability to build high-performing teams and align innovation with disciplined governance will be instrumental as we continue advancing ASTRA Therapeutics’ mission to redefine precision in parasitology,” said Natacha Gaillard, PhD, Co-Founder and Co-CEO of ASTRA Therapeutics.

Fabian Kausche commented: “ASTRA Therapeutics combines scientific differentiation with a clear strategic vision. The company’s precision approach to parasitology directly addresses one of the most urgent challenges in animal health – resistance to existing therapies. I look forward to working closely with the team to strengthen governance, advance the pipeline, and help realize the company’s long-term potential.”

Following the successful closing of its CHF 7.75 million seed financing round in July 2025, ASTRA Therapeutics is deliberately strengthening its Board of Directors and governance framework to support scaling, global partnerships, and future capital formation. The company is building the institutional foundation required to translate its ParaX^® platform into differentiated, globally competitive animal health products and durable shareholder value.

Ashwani Sharma, PhD, Co-Founder and Co-CEO of ASTRA Therapeutics, added: “As we advance our pipeline and prepare for our Series A financing, it is essential that our governance evolves in step with our scientific progress. Fabian’s track record in managing multi-billion-dollar R&D organizations and leading complex integrations provides strong strategic guidance as we position ASTRA Therapeutics for disciplined growth, successful capital formation, and sustained long-term value creation.”

Contact

Beatrix Benz
+41 79 256 77 73
media@astratherapeutics.com

About Dr. Fabian Kausche

Fabian Kausche brings several decades of senior executive experience in animal and human health research and development. He previously served as Global Head of R&D for Novartis Animal Health, Merial, and Boehringer Ingelheim Animal Health, where he led large multinational organizations and oversaw the integration of the industry’s largest R&D structure.

His track record spans innovation strategy, R&D governance, portfolio optimization, and organizational transformation, with a strong focus on aligning scientific excellence with sustainable business growth. He currently leads FK Consulting, LLC, advising private equity firms, venture funds, and growth-stage companies on product innovation, governance structures, and operational effectiveness.

Fabian Kausche also served as Deputy Director General for Research and Innovation at the International Livestock Research Institute (ILRI) in Nairobi, leading global research initiatives to address livestock health challenges in emerging markets. He holds multiple board and advisory roles across the global animal health ecosystem.

He holds a veterinary degree from the University of Veterinary Medicine Hannover, an M.Sc. from Iowa State University, and a German PhD (Dr. med. vet.). Having completed the Advanced Management Program, he is also an alumni of Harvard Business School.

About Astra Therapeutics AG

ASTRA Therapeutics is a Swiss biotechnology company based at the Park InnovAARE innovation campus in Villigen, Switzerland that designs novel precision drugs against eukaryotic pathogens based on its proprietary platform ParaX^®, with a focus on applications in Animal Health.

The company is backed by MIG Capital AG, a leading German venture capital firm, alongside US-based Digitalis Ventures and Borealis Ventures, as well as Kickfund, and Venture Kick.

For more information, please visit www.astratherapeutics.com

Attachments

• Fabian Kausche
• ASTRA_Press Release_Chair_Final_260224

Amber Therapeutics strengthens its Board and Leadership team, opens UK headquarters and expands EU feasibility study for mixed urinary incontinence, increasing momentum towards a pivotal trial in the US




Amber Therapeutics strengthens its Board and Leadership team, opens UK headquarters and expands EU feasibility study for mixed urinary incontinence, increasing momentum towards a pivotal trial in the US

Oxford, UK – 24 February 2026  –   Amber Therapeutics today announced a series of updates to its business highlighting the significant progress it has made since closing its $100 million (£80 million) Series A financing in July 2024—one of the largest Series A rounds ever raised by a European medical technology company.

• New appointees to Board and Leadership team bring global strategic, operational and commercial experience from across the medical device sector.
• New headquarters and state-of-the-art manufacturing site at Harwell, Oxfordshire, enables clinical-scale manufacturing, product development, and team growth.
• AURA-4X study with Amber’s fully implantable, adaptive pudendal Picostim II neuromodulation system for mixed urinary incontinence expanding to multiple European sites following successful completion of its pilot phase.

Strengthening of Board and leadership team

As part of this continued expansion, Amber has appointed Dave Amerson as an Independent Board Member and strengthened its executive leadership team with the appointment of Claire Smith as Vice President, Commercial.

Mr Amerson brings deep leadership experience from across the medical device sector. He previously served as President and CEO of NeoTract, Inc. through its $1.1 billion acquisition, and as Chairman of the Board at Palette Life Sciences through its $600 million acquisition, both by Teleflex Inc. He also served as a Board Member of Relievant Medsystems, Inc. until its acquisition by Boston Scientific in 2023. Mr Amerson currently serves on the boards of ProVerum (Chairman), Calyxo, Moximed, and the Urology Care Foundation.

Ms Smith, a seasoned commercial leader with deep experience in neuromodulation and healthcare innovation, joins Amber from Nevro. During her tenure, Ms Smith successfully led the launch of multiple innovative products, helped establish and expand new markets, and developed scalable business model solutions that enabled the delivery of world-class patient care.

Opening of New UK Headquarters

The Series A financing has also enabled Amber to significantly expand its operational footprint, including the opening of its new headquarters and manufacturing facility at Harwell (near Oxford), the UK’s leading science and innovation campus. The Harwell site will support clinical-scale manufacturing, product development, and team growth as the company prepares for pivotal trials with Picostim II and commercial readiness.

Expansion of AURA-4X to Multiple European Sites

Building on the successful AURA-2 and recently completed AURA-3 studies—which demonstrated proof-of-principle for Amber’s fully implantable, adaptive pudendal Picostim II neuromodulation system for mixed urinary incontinence—the company has completed the pilot phase of AURA-4X (Augmenting Urinary Reflex Activity) and has expanded the study into multiple European sites. AURA-4X represents Amber’s most advanced clinical study to date and is a critical step in a structured pathway toward a future US–European pivotal trial.

The study is enrolling women with mixed urinary incontinence (MUI) and includes expanded cohorts evaluating efficacy in urge urinary incontinence, stress urinary incontinence, and chronic pelvic pain.

Commenting on overall progress, Aidan Crawley, CEO of Amber Therapeutics, said:

“The establishment of our new headquarters within a fully validated, state-of-the-art manufacturing facility and the advancement of the AURA-4X clinical study from pilot phase to multiple site roll out mark two major milestones for Amber. This, coupled with the additions of Dave Amerson to our board and Claire to the leadership team adds a wealth of US industry experience and helps position us to execute at scale as we advance toward our US pivotal trial and, ultimately, commercialisation.”

Dave Amerson, Independent Board Member at Amber, added:

“I am delighted to join Amber’s board at such an exciting time for the company as it looks to convert its incredibly promising early clinical data into a US FDA approved therapy that I believe can truly transform outcomes for the sufferers of mixed urinary incontinence.”

Charles Knowles, CMO of Amber Therapeutics, said:

“The early indications from AURA-4X represent a significant step forward in our mission to deliver a truly disruptive therapy for women with MUI. Demonstrating that we can safely implant and activate the Picostim II system reflects the culmination of many years of focused R&D, addressing both the biological complexity of MUI and the engineering challenges inherent in adaptive neuromodulation.”

– ENDS –

About Urinary Incontinence and the Neuromodulation Market

Urinary incontinence (UI) is a debilitating medical condition that affects millions of women globally. Many of these women experience symptoms of both urge incontinence (urgent and uncontrollable bladder leaks) and stress incontinence (bladder leaks during physical activity or exertion). However, there is no singular therapy available to treat patients with these MUI symptoms which can bring about a sense of loss of control and shame, leading to isolation and depression. Many do not actively seek treatment, with symptoms of UI found in 40 million women in the US but only 16 million currently managed on any form of therapy.

Existing therapies focus on either urge incontinence (e.g. sacral or tibial neuromodulation) or stress incontinence (e.g. bulking agents, slings, mesh supports). Mixed urinary incontinence (both urge and stress), is a sizeable population more than double that of the urge segment that neuromodulation currently addresses.

About Amber Therapeutics

www.amber-tx.com

Contacts
Amber Therapeutics
Aidan Crawley, CEO
press@amber-tx.com

MEDiSTRAVA
Sandi Greenwood / Frazer Hall / Mark Swallow
ambertherapeutics@medistrava.com

Attachment

• Amber Therapeutics’ new headquarters and state-of-art manufacturing facility at Harwell, near Oxford, UK.

Avacta’s pre|CISION Mechanism for Payload Delivery Shows Key Advantages Compared to an Antibody Drug Conjugate in Innovative AI-Driven Analysis




Avacta’s pre|CISION Mechanism for Payload Delivery Shows Key Advantages Compared to an Antibody Drug Conjugate in Innovative AI-Driven Analysis

Experimental data from FAP-Exd (AVA6103) demonstrates a more favorable profile compared to the marketed Antibody Drug Conjugate (ADC) Enhertu^®

Clinical trial with AVA6103 is expected to be initiated in Q1 2026

LONDON and PHILADELPHIA, Feb. 24, 2026 (GLOBE NEWSWIRE) — Avacta Therapeutics (AIM: AVCT, “the Company”, “Avacta”), a clinical stage biopharmaceutical company developing pre|CISION^®, a tumor-activated oncology delivery platform, today published new data which demonstrates the favorable delivery profile and advantages of its proprietary pre|CISION platform’s compared to a marketed antibody drug conjugate (ADC).

The data analysis compares pre|CISION FAP-cleavable payload delivery with that of Enhertu^®, a protease cleavable-linker ADC, approved for both breast cancer and gastric cancer indications (an AstraZeneca/Daiichi Sankyo product, trastuzumab-deruxtecan (T-Dxd), an exatecan-derivative ADC).

Avacta expects to initiate the Phase 1 clinical trial of its FAP-Exd (AVA6103) program in Q1 2026.

Christina Coughlin, CEO of Avacta commented,

“Our analysis demonstrates three potential advantages of our proprietary pre|CISION delivery mechanism when compared to the marketed ADC, Enhertu^®: more rapid drug penetration into the tumor, a one log higher absolute maximum drug concentration in the tumor and the Tumor Selectivity Index (a critical safety and effectiveness measure) being nearly three-fold higher.

“This data analysis supports our belief that our pre|CISION payload delivery mechanism has many key advantages over the ADC mechanism, currently one of the most successful drug classes in oncology.

“This innovative use of AI to recreate a synthetic comparator arm also demonstrated the creativity and expertise of our team. This synthetic comparator allows a direct comparison of the FAP-Exd data with the data published by the Enhertu^® team, rather than repeating their experiments in-house.

“We believe the observations in this dataset have significantly increased the probability of success with FAP-Exd, given both the ability of FAP-Exd to deliver more payload selectively to the tumor in the preclinical setting and success of Enhertu^® in the clinic. We look forward to the start of the clinical trial.”

The analysis uses a synthetic comparator arm that was generated using AI to recreate a published AstraZeneca data set¹ and compare to experimental data generated with FAP-Exd (AVA6103) in a similar experimental design using a FAP-high animal model with two drugs using similar payloads (exatecan and deruxtecan).

The analysis demonstrates three key pharmacokinetic (PK) advantages in the kinetics of the release of payload, specifically:

1. AVA6103 results in more rapid drug penetration into the tumor, with the maximal concentration (C_max) in tumor tissue occurring within minutes of dosing compared with T-Dxd maximum concentration observed at 24 hours;
2. The observed absolute maximum concentration (C_max) observed with FAP-Exd in the tumor was more than a log higher than the C_max observed with T-Dxd; and
3. The Tumor Selectivity Index (TSI, ratio of the area under the curve (AUC) observed over 14 days in the tumor v. plasma) was nearly three-fold higher with pre|CISION^® delivery (FAP-Exd) versus ADC delivery (T-Dxd).

Avacta’s scientists have also described two key impacts of these PK differences in animal efficacy models, including (1) higher activity of FAP-Exd in tumor models having the lowest observed expression of FAP compared with variable activity of T-Dxd at low expression levels of HER2 and (2) deep, durable responses that are observed to persist for many weeks after the 3 dose regimen  with FAP-Exd. 

Avacta scientists plan to present these data at an upcoming scientific congress and submit to a peer-reviewed journal in the near future.

Enhertu is a registered trademark of AstraZeneca and Daiichi Sankyo.

¹Vasalou C, et al. Quantitative evaluation of trastuzumab deruxtecan pharmacokinetics and pharmacodynamics in mouse models of varying degrees of HER2 expression. CPT Pharmacometrics Syst Pharmacol. 2024 (6):994-1005. doi: 10.1002/psp4.13133 (AZ nonclinical data)     

For further information from Avacta, please contact:

About Avacta – https://avacta.com/

Avacta Therapeutics is a clinical-stage life sciences company expanding the reach of highly potent cancer therapies with the pre|CISION^® platform. pre|CISION^® is a proprietary payload delivery system based on a tumor-specific protease (fibroblast activation protein or FAP) that is designed to concentrate highly potent payloads in the tumor microenvironment while sparing normal tissues.

Our innovative pipeline consists of pre|CISION^® peptide drug conjugates (PDC) or Affimer® drug conjugates (AffDC) that leverage the tumor-specific release mechanism, providing unique benefits over traditional antibody drug conjugates.

The pre|CISION^® platform comprises an anticancer payload conjugated to a proprietary peptide that is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumors compared with healthy tissues. The pre|CISION^® platform harnesses this tumor specific protease to cleave pre|CISION^® peptide drug conjugates and pre|CISION^® antibody/Affimer^® drug conjugates in the tumor microenvironment, thus releasing active payload in the tumor and reducing systemic exposure and toxicity, allowing dosing to be optimized to deliver the best outcomes for patients.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

Nicox Highlights Positive NCX 470 Phase 3 Data Confirming Therapeutic Profile at the 2026 American Glaucoma Society Annual Meeting




Nicox Highlights Positive NCX 470 Phase 3 Data Confirming Therapeutic Profile at the 2026 American Glaucoma Society Annual Meeting

Attachment

• EN_AGS 2026 posters presented_FINAL

Boston Vitality Declares To Continue Leading In Men’s Hormone Health Care




Boston Vitality Declares To Continue Leading In Men’s Hormone Health Care

STONEHAM, Mass., Feb. 23, 2026 (GLOBE NEWSWIRE) — Boston Vitality, a medical practice located in Stoneham, Massachusetts, remains committed to further clinical focus on hormone health, diagnostic assessment, and evidence-based management of adult men. The clinic, being a testosterone therapy clinic in Massachusetts, bases its practice on thorough examinations, individual treatment planning, and continuous clinical observation according to modern medical practices.

Discussion of Hormone Health in Adult Men.

There are several systems in which testosterone is central. Ideal ranges help to regulate energy, metabolism, muscle mass, sexual functioning, mood stability, and vitality. As the body ages, and due to some illnesses, the level of testosterone might decrease, and as such, results may include fatigue, lack of sexual desire, change in mood, and loss of muscle power. Clinical assessment of testosterone status not only includes laboratory data but also the interpretation of the overall situation in the state of personal health.

Boston Vitality clinical protocols start with an initial systematic hormone profiling using blood tests. Such objective tests, together with elaborate medical history and physical examination, justify clinical decision-making that is consistent with guidelines of practice in endocrinology and urology.

Organized Clinical Assessment and Care Plan.

Boston Vitality clinical process incorporates various aspects aimed at differentiating between the normal hormone changes with aging and hormone deficiency, which is clinically significant. Primary examinations involve:

• Extensive hormone screening and associated blood tests
• Symptom assessment of possible low testosterone associations.
• Medical history evaluation
• Physical examination

The method facilitates the proper diagnosis of hormone imbalance and factors like chronic disease, metabolic disorders, and lifestyle are considered as the confounding factors.

Testosterone Replacement and Clinical Alternatives.

Taking into account its status as a well-established testosterone therapy clinic in Massachusetts, the practice is able to provide several testosterone replacement options that are medically established in cases of clinical reasons. These may include:

• Testosterone Injectable combinations.
• Transdermal gels or patches
• Subcutaneous pellet treatment.

An example of this is pellet therapy, in which a constant supply of bioidentical hormone is released over time. Pharmacokinetic properties of each method are different, and choices of a suitable modality depend on clinical assessment, preference of the patient, medical appropriateness, and safety factors.

Monitoring and Follow-Up

Continuous monitoring is a necessary part of testosterone management. Frequent follow-up evaluations include repeat hormone panel, clinical response evaluation, and adverse effect surveillance. This is an iterative process that implies the dedication to clinical prudence and patient safety.

The integration with the Broader Health Considerations.

Among a number of factors related to male sexual health, there is the hormone balance. Erectile dysfunction, as well as conditions like diabetes, can be both hormonal and vascular, metabolic, and psychosocial. The clinical framework of Boston Vitality places hormone assessment into a broader medical context in order to make sure that underlying causes are properly assessed.

Metabolism and Systemic Health.

In addition to testosterone, the clinicians might also take into account metabolic markers like glucose tolerance, lipid profile, and cardiovascular risk factors as an integrated health evaluation. Clinical interpretation and management planning can also result in sleep quality, nutrition, stress, and body composition.

Clinical Practice Expert Leadership.

Dr. Michael Zachareas Clinical Leadership.

The medical expert in men’s hormone health in Massachusetts, Dr. Michael Zachareas, can be named as a medical practitioner on the topic of hormone health in men in various professional sources. Having received formal education in the field of urology and a great deal of clinical experience, Dr. Zachareas leads in the analysis of hormone dynamics, sexual health problems, and medical care when it comes to them. His skills cover the study of endocrine functionality in the wider context of men’s health.

The clinical aspect in the case of Dr. Zachareas is to review the level of hormones against patient history, to interpret the diagnosis, and to prescribe a specific plan that follows the established medical systems. This will be in line with the professional standards, which view endocrine assessment as a part of holistic health assessment.

New Ideas and Theoretical Models

In the clinical environment, the novel models deal with the variation of hormone levels outside of chronological age only. The multifactorial dynamics of hormone dynamics are manifested in concepts like popley, employed in some clinical and research discourses to explain patterns of endocrine degradation as a consequence of multiple physiological and lifestyle factors. Although this is not a diagnostic study, the concept indicates how endocrine functionality is affected by systemic health, metabolic stressors, and the environment.

The clinical model of Boston Vitality recognizes that the testosterone levels and the balance of hormones cannot be perceived completely out of context. Testing considers more general patterns of physiology, comorbidity, and interaction of hormonal systems with overall health.

Centered Clinical Monitoring in Patients

Patient monitoring of patients under hormone therapy is aimed at managing the safety as well as the clinical benefit. Follow-up regularly involves hormone level determination, symptom response assessment, and monitoring of the presence of possible treatment reactions. It is a common practice to revise treatment plans according to the changing clinical data and new health requirements.

The progressive model of monitoring is an iterative model that promotes dynamic care, which is responsive to changes in the health status of an individual and follows the best practices in medicine.

Wider Implications of Men and Health Care

Hormone balance clinical assessment is also becoming a part and parcel of preventive medicine, especially with the ageing populations and the increase in prevalence of chronic health-related diseases. One of the components is testosterone in a complex endocrine system that interacts with the metabolic, reproductive, and psychological worlds.

The model of hormone health in Boston Vitality places the subject matter in a larger context, in line with clinical endeavors of focusing on early detection of imbalance, critical interpretation of test findings, and an evidence-based approach to managing the issue.

About Boston Vitality

Boston Vitality is a health care practice in Stoneham, Massachusetts, and the clinical specialization is in the measurement of hormones, testosterone replacement therapy, and its medically related assessment. It focuses its practice on systematic diagnostic assessment, personalized care planning, and continuous clinical follow-up as per the set medical principles. Boston Vitality is a facility that caters to the needs of adult men who require medical evaluation in regard to hormone imbalance and related ailments.

Company Details

Company Name: Boston Vitality
Contact Person: Sean Clark
Email: sclark@bostonvitality.com
Phone: 781-399-5698
Address: 92 Montvale Ave, Suite 3400, Stoneham, MA 02180, United States
Website: https://bostonvitality.com/

Disclaimer:  This content is provided by Boston Vitality. The statements, views, and opinions expressed in this content are solely those of the content provider and do not necessarily reflect the views of this media platform or its publisher. We do not endorse, verify, or guarantee the accuracy, completeness, or reliability of any information presented. This content is for informational purposes only and should not be considered financial, investment, or business advice. All investments carry inherent risks, including the potential loss of capital. Readers are strongly encouraged to conduct their own due diligence and consult with a qualified financial advisor before making any investment decisions. Neither the media platform nor the publisher shall be held responsible for any inaccuracies, misrepresentations, or financial losses resulting from the use or reliance on the information in this press release. Speculate only with funds you can afford to lose. In the event of any legal claims or concerns regarding this article, we accept no liability or responsibility. Globenewswire does not endorse any content on this page.

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Supernus Pharmaceuticals to Participate in March Investor Conferences




Supernus Pharmaceuticals to Participate in March Investor Conferences

ROCKVILLE, Md., Feb. 23, 2026 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that management will participate in the following March investor conferences:

Investors interested in arranging a meeting with the Company’s management during these conferences should contact the respective conference coordinators.

A live audio webcast of the TD Cowen and Barclays Conference presentations can also be accessed on the Events & Presentations section of the Supernus Pharmaceuticals website at www.supernus.com. Archived replays of these webcasts will be available for 60 days on the Company’s website following the conference.

About Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

Our diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson’s disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, postpartum depression (PPD), epilepsy, migraine, cervical dystonia, and chronic sialorrhea. We are developing a broad range of novel product candidates for CNS disorders.

For more information, please visit www.supernus.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management’s current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products, and the products of its subsidiaries; the Company’s ability to increase its net revenue from its products, and the products of its subsidiaries; the Company’s ability to commercialize its products, and the products of its subsidiaries; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; changes to laws and regulations applicable to our industry, the impact of macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.

CONTACTS:

Jack A. Khattar, President and CEO
Timothy C. Dec, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
(301) 838-2591

or

INVESTOR CONTACT:
Peter Vozzo
ICR Healthcare
(443) 213-0505
peter.vozzo@icrhealthcare.com