Oculis to Participate in Upcoming November Investor Conferences




Oculis to Participate in Upcoming November Investor Conferences

ZUG, Switzerland, Nov. 05, 2025 (GLOBE NEWSWIRE) — Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, announced today that Oculis’ management will participate in upcoming investor conferences in November.

Oculis is pleased to present updates of its innovative, highly differentiated, late-stage portfolio as it enters a pivotal phase in its transformation into a leader in neuro-ophthalmology and ophthalmology. Key highlights include: Privosegtor (PIONEER program) advancement into registrational trials for acute optic neuritis and non-arteritic anterior ischemic optic neuropathy (NAION), following a positive FDA meeting; OCS-01 (DIAMOND registrational  trials) topline results for diabetic macular edema expected in Q2 2026; and Licaminlimab (PREDICT-1 registrational trial) in DED anticipated soon, marking the first genotype-based development program to drive precision medicine.

With a strong balance sheet and robust pipeline, Oculis is well-positioned to deliver 6 pivotal readouts with the current funding, to fulfil its mission to save sight and improve eye care with groundbreaking treatments.

Guggenheim Securities 2nd Annual Healthcare Innovation Conference
November 10-12; Boston, U.S.
Fireside chat with Riad Sherif, M.D., Chief Executive Officer, on November 11^th at 2:30 pm ET.
Webcast link: Register here.

Stifel Healthcare Conference
November 11-13; New York, U.S.
Fireside chat with Riad Sherif, M.D., Chief Executive Officer, on November 12^th at 2:00 pm ET.
Webcast link: Register here.

LifeSci Capital and Sofinnova Partners Growth & Innovation Summit
November 17; London, U.K.
Oculis management will participate in one-to-one meetings.

ICR Healthcare and Sponsors 13th Annual Healthcare Conference
November 17; London, U.K.
Riad Sherif, M.D., Chief Executive Officer, will participate in a panel discussion, entitled ‘Brave New World,’ at 1:50 pm GMT.

The company will be available for one-on-one meetings during the conferences. Interested investors should contact their respective representative at the sponsoring institutions to request meetings.

Webcast links, when available, will be posted to the Oculis website on the Events & Presentation page under the Investors & Media section.

-END-

About Oculis

Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on innovations addressing neuro-ophthalmic conditions with significant unmet medical needs. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: Privosegtor, a neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases; OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); and Licaminlimab, a novel, topical anti-TNFα in Phase 2, which is being developed with a genotype-based approach to drive precision medicine in dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.

For more information, please visit: www.oculis.com

Oculis Contact
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com

Investor Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com

Media Relations
ICR Healthcare
Amber Fennell / David Daley / Sean Leous
oculis@icrhealthcare.com

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements and information. For example, statements regarding the development plans for Privosegtor, OCS-01, and Licaminlimab; the initiation, timing, progress and results of clinical trials of Privosegtor, OCS-01, and Licaminlimab; and Oculis’ research and development programs, regulatory and business strategy, future development plans, and management, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the U.S. Securities and Exchange Commission (SEC). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Oculis to Participate in Upcoming November Investor Conferences




Oculis to Participate in Upcoming November Investor Conferences

ZUG, Switzerland, Nov. 05, 2025 (GLOBE NEWSWIRE) — Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, announced today that Oculis’ management will participate in upcoming investor conferences in November.

Oculis is pleased to present updates of its innovative, highly differentiated, late-stage portfolio as it enters a pivotal phase in its transformation into a leader in neuro-ophthalmology and ophthalmology. Key highlights include: Privosegtor (PIONEER program) advancement into registrational trials for acute optic neuritis and non-arteritic anterior ischemic optic neuropathy (NAION), following a positive FDA meeting; OCS-01 (DIAMOND registrational trials) topline results for diabetic macular edema expected in Q2 2026; and Licaminlimab (PREDICT-1 registrational trial) in DED anticipated soon, marking the first genotype-based development program to drive precision medicine.

With a strong balance sheet and robust pipeline, Oculis is well-positioned to deliver 6 pivotal readouts with the current funding, to fulfil its mission to save sight and improve eye care with groundbreaking treatments.

Guggenheim Securities 2nd Annual Healthcare Innovation Conference
November 10-12; Boston, U.S.
Fireside chat with Riad Sherif, M.D., Chief Executive Officer, on November 11^th at 2:30 pm ET.
Webcast link: Register here.

Stifel Healthcare Conference
November 11-13; New York, U.S.
Fireside chat with Riad Sherif, M.D., Chief Executive Officer, on November 12^th at 2:00 pm ET.
Webcast link: Register here.

LifeSci Capital and Sofinnova Partners Growth & Innovation Summit
November 17; London, U.K.
Oculis management will participate in one-to-one meetings.

ICR Healthcare and Sponsors 13th Annual Healthcare Conference
November 17; London, U.K.
Riad Sherif, M.D., Chief Executive Officer, will participate in a panel discussion, entitled ‘Brave New World,’ at 1:50 pm GMT.

The company will be available for one-on-one meetings during the conferences. Interested investors should contact their respective representative at the sponsoring institutions to request meetings.

Webcast links, when available, will be posted to the Oculis website on the Events & Presentation page under the Investors & Media section.

About Oculis

Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on innovations addressing neuro-ophthalmic conditions with significant unmet medical needs. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: Privosegtor, a neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases; OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); and Licaminlimab, a novel, topical anti-TNFα in Phase 2, which is being developed with a genotype-based approach to drive precision medicine in dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.

For more information, please visit: www.oculis.com

Oculis Contact
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com

Investor Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com

Media Relations
ICR Healthcare
Amber Fennell / David Daley / Sean Leous
oculis@icrhealthcare.com

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements and information. For example, statements regarding the development plans for Privosegtor, OCS-01, and Licaminlimab; the initiation, timing, progress and results of clinical trials of Privosegtor, OCS-01, and Licaminlimab; and Oculis’ research and development programs, regulatory and business strategy, future development plans, and management, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the U.S. Securities and Exchange Commission (SEC). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Wave Life Sciences to Present Preclinical Data Supporting Therapeutic Potential of WVE-007 for Obesity at ObesityWeek® 2025




Wave Life Sciences to Present Preclinical Data Supporting Therapeutic Potential of WVE-007 for Obesity at ObesityWeek® 2025

Presentation will highlight preclinical data supporting the potential of WVE-007 (INHBE GalNAc-siRNA) as a unique approach for the treatment of obesity designed to drive fat loss while preserving muscle mass with once or twice annual dosing

In preclinical models, INHBE GalNAc-siRNA led to adipocyte shrinkage, fewer pro-inflammatory macrophages, less fibrosis, and improved insulin sensitivity in visceral adipose tissue, supporting potential for metabolic improvement

As an add-on to semaglutide, Wave’s GalNAc-siRNA doubled weight loss in mice and prevented weight regain upon cessation of semaglutide

INLIGHT clinical study evaluating WVE-007 is ongoing: last week Wave announced positive target engagement, including dose-dependent decreases in Activin E (up to 85%) observed one month post-single dose of WVE-007, exceeding the reductions seen in preclinical models that led to weight loss; highly durable reductions persisted through six-month follow-up; safe and well tolerated profile

CAMBRIDGE, Mass., Nov. 04, 2025 (GLOBE NEWSWIRE) — Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, today announced the presentation of the company’s preclinical data supporting WVE-007, its GalNAc-siRNA investigational therapeutic for obesity. The data will be highlighted on November 6 in a poster presentation at ObesityWeek^®, the annual congress of The Obesity Society, in Atlanta.

WVE-007 is a GalNAc-siRNA designed to reduce fat while preserving lean mass by silencing INHBE mRNA, an obesity target with strong evidence from human genetics. People living with naturally low levels of INHBE have lower levels of unhealthy visceral fat, lower fasting glucose and triglycerides, and a lower risk of type 2 diabetes and cardiovascular disease. Silencing INHBE mRNA aims to reduce Activin E levels, thereby inducing fat loss without impacting muscle mass.

“With a strong foundation in human genetics, WVE-007 is focused on healthy weight loss driven by fat loss, in particular visceral fat loss, while preserving muscle to make meaningful improvements in cardiometabolic health, which is ultimately the main objective of any obesity medication. GLP‑1 receptor agonists have transformed obesity care, but their impact is often limited by tolerability, frequent dosing, and perhaps most importantly, loss of muscle mass,” said Erik Ingelsson, MD, PhD, Chief Scientific Officer of Wave Life Sciences. “WVE-007 is currently advancing in the INLIGHT clinical study and we announced exciting target engagement data last week, with dose-dependent and durable Activin E reductions observed in the first three dose cohorts, exceeding levels that led to weight loss in our preclinical models. We are particularly encouraged by the durability of silencing observed, which suggests our investigational therapy may only need to be dosed once or twice per year.”

ObesityWeek^® poster presentation information:

Title: Targeting Adipose Lipolysis with INHBE Silencing Promotes a Healthy Weight Loss Profile in Mice (Poster-710)

Presenter: Ginnie (Hsiu-Chiung) Yang, PhD, SVP, Translational Medicine, Wave Life Sciences

Date and Time: November 6, 2025, 2:30-3:30pm ET

Location: Georgia World Congress Center (GWCC), Building A, 285 Andrew Young International Blvd NW, Atlanta, GA 30313

Wave investigated the impact of the company’s GalNAc-conjugated siRNA designed to lower the expression of INHBE mRNA in a diet-induced obesity (DIO) mouse model.

Key results are as follows:

• A single dose of Wave’s GalNAc-conjugated INHBE-siRNA in mice led to statistically significant weight loss compared to placebo (PBS treatment), reductions in visceral adipose fat mass and adipocyte size compared to controls, and no loss of skeletal muscle mass, suggesting Wave’s treatment induces a healthy weight loss comprised of fat loss and preservation of lean mass.
• Wave’s treatment led to decreased infiltration of total and pro-inflammatory macrophages by up to 41% and 80%, respectively, and reduced fibrosis by 58% in visceral adipose tissue of DIO mice. These changes align with lower risk of cardiovascular disease and type 2 diabetes.
• When added to semaglutide, Wave’s GalNAc INHBE-siRNA doubled weight loss in mice and reduced weight regain upon cessation of semaglutide.

The full presentation can be accessed on the Wave Life Sciences website here.

Recent clinical progress for WVE-007:

Last week at its Research Day, Wave shared Activin E target engagement data from its ongoing, first-in-human INLIGHT clinical trial (3:1 active: placebo). One-month follow-up was available from Cohort 2 (240 mg) and Cohort 3 (400 mg), and six-month follow-up was available from Cohort 1 (75 mg). Highly significant (p<0.0001 for all doses), dose-dependent mean Activin E reductions from baseline were observed at Day 29 (one month post single dose) in the first three cohorts: 85% reduction (Cohort 3), 75% reduction (Cohort 2), 56% reduction (Cohort 1), exceeding reductions that led to weight loss in preclinical models. In Cohort 1, Activin E reductions were durable throughout the six-month follow-up, supporting WVE-007’s potential for once or twice yearly doing.

WVE-007 was safe and well-tolerated to date. An independent data monitoring committee supported dose expansion of Cohort 4 (600 mg) and dose escalation beyond that.

Wave expects to deliver multiple near-term clinical data updates from INLIGHT, including body composition and body weight, beginning with three-month follow-up data from the Cohort 2 (240 mg) and data from Cohort 1 (75 mg) in the fourth quarter of 2025, six-month follow-up data from Cohort 2 (240 mg) and three-month follow-up data from Cohort 3 (400 mg) in the first quarter of 2026, and six-month follow-up data from Cohort 3 (400 mg) and three-month follow-up data from Cohort 4 (600 mg) in the second quarter of 2026.

Additional details can be found in the company’s Research Day presentation from October 29, 2025.

About INLIGHT
INLIGHT is an ongoing, first-in-human clinical trial (3:1 active: placebo) evaluating WVE-007 in adults living with overweight or obesity and assesses safety, tolerability, pharmacokinetics, biomarkers for target engagement, body weight and composition, and metabolic health. Key inclusion criteria include A1c of less than 5.9 and BMI between 28 and 35. The lowest dose cohort of 75 mg enrolled eight participants. The subsequent cohorts (Cohorts 2, 3, and 4) were expanded to 32 subjects. An independent data monitoring committee has also approved further escalation to a next higher dose in Cohort 5.

About Wave Life Sciences
Wave Life Sciences (Nasdaq: WVE) is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Wave’s RNA medicines platform, PRISM^®, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and common disorders. Its toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing Wave with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Wave’s diversified pipeline includes clinical programs in alpha-1 antitrypsin deficiency, obesity, Duchenne muscular dystrophy, and Huntington’s disease, as well as several preclinical programs utilizing the company’s broad RNA therapeutics toolkit. Driven by the calling to “Reimagine Possible”, Wave is leading the charge toward a world in which human potential is no longer hindered by the burden of disease. Wave is headquartered in Cambridge, MA. For more information on Wave’s science, pipeline and people, please visit www.wavelifesciences.com and follow Wave on X and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding our plans to present and discuss our preclinical data supporting WVE-007 for obesity at ObesityWeek^®; our expectations for WVE-007 and the anticipated therapeutic benefits thereof; the anticipated timing of clinical data from our INLIGHT clinical trial of WVE-007; the novelty of our approach to silence INHBE mRNA in order to achieve healthy, sustainable weight loss and the potential for once- or twice-yearly dosing in light of the significant durability of the Activin E reductions observed in INLIGHT; the potential benefits of WVE-007 over existing obesity therapies; the potential of WVE-007’s mechanism (INHBE) as a novel and unique obesity treatment to induce fat loss, preserve muscle, and drive weight loss;  our understanding of our preclinical data for WVE-007 and our expectations of how such data will translate in humans, including the ability to make meaningful improvements in cardiometabolic health, the main objective of any obesity; our understanding of the safety profile of WVE-007; beliefs that Wave’s portfolio of RNA medicines is differentiated, potentially best-in-class and potentially transformative; the broad potential of Wave’s RNA medicines pipeline and oligonucleotide chemistry and any benefits that may arise as a result thereof. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release and actual results may differ materially from those indicated by these forward-looking statements as a result of these risks, uncertainties and important factors, including, without limitation, the risks and uncertainties described in the section entitled “Risk Factors” in Wave’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), as amended, and in other filings Wave makes with the SEC from time to time. Wave undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.

Contact:
Kate Rausch
VP, Corporate Affairs and Investor Relations
+1 617-949-4827

Investors:
James Salierno
Director, Investor Relations
+1 617-949-4043
InvestorRelations@wavelifesci.com

Media:
Katie Sullivan
Senior Director, Corporate Communications
+1 617-949-2936
MediaRelations@wavelifesci.com

RPX Enterprises and Xyngular Introduce XMD Wellness, a New Approach to Weight Loss and Wellness




RPX Enterprises and Xyngular Introduce XMD Wellness, a New Approach to Weight Loss and Wellness

New clinician-guided program blends medical science, microdosing, and 24/7 support to make advanced weight loss and wellness accessible nationwide.

XMD Wellness Logo

MINERAL WELLS, Texas, Nov. 04, 2025 (GLOBE NEWSWIRE) — For too long, women have been told to “just deal with it.” Exhaustion, anxiety, and weight gain have often been dismissed as part of aging. XMD Wellness, a new program from Xyngular led by RPX Enterprises, the company’s top independent distributor, aims to change that by combining advanced medical science with holistic wellness care designed to address the root causes of weight gain, low energy, and metabolic imbalance.

Launching November 4, XMD Wellness delivers personalized programs that include semaglutide, tirzepatide (available in both generic and name-brand forms), and clinician-guided microdosing options. Each plan is supervised by certified providers across all 50 states and supported by 24/7 patient care, giving women and men nationwide access to safe, effective, and personalized wellness solutions.

“We’re harnessing modern medical science to empower people to take control of their health like never before,” said Robin Packard, founder of RPX Enterprises and Xyngular’s #1 distributor worldwide. With dual degrees in Biology and Medical Technology and more than 15 years of clinical laboratory experience, Packard added, “Our goal is to make advanced wellness accessible, supervised, and personalized for everyone seeking meaningful change in their health journey.”

Comprehensive, Clinician-Guided Wellness

XMD Wellness takes a medically guided approach to weight management and overall wellness. Supported by a nationwide network of more than 20,000 licensed providers, each participant receives individualized care and ongoing medical oversight. This ensures safe, measurable progress, while participants have access to 24/7 patient support for guidance, questions, or motivation.

All prescriptions are filled through 503A-certified compounding pharmacies operating under strict FDA-regulated safety and quality standards. This combination of telehealth convenience, clinical supervision, and high-quality medications gives participants confidence in their wellness plan while maintaining a safe and professional framework.

Key Features and Benefits

Nationwide Physician Network: Over 20,000 certified providers offer one-on-one medical guidance in all 50 states. Every plan is clinician-supervised, ensuring participants receive expert attention throughout their journey.

24/7 Support: Patients benefit from around-the-clock access to care and coaching, making it easier to address questions and adjust plans whenever necessary.

Advanced Weight-Loss Medications: XMD Wellness offers access to science-backed medications including semaglutide (GLP-1 agonist) and tirzepatide (dual GLP-1/GIP agonist). Clinical studies show semaglutide may help patients lose approximately 15% of body weight on average, while tirzepatide has demonstrated over 20% weight reduction in trials. Programs include full-dose and microdose protocols, allowing individualized treatment plans for optimal results.

Microdosing Options: Participants can opt for a gentler, clinician-guided microdosing program, which uses lower doses of peptides to target outcomes such as metabolic health, mental clarity, blood sugar balance, or energy optimization. This innovative approach allows for gradual, sustainable results with minimized side effects.

Transparency and Affordability: Plans start at approximately $179 per month, depending on treatment and state availability. Pricing includes medication, telehealth consultations, ongoing check-ins, and necessary lab work—without hidden fees or dosage upcharges. Participants have full clarity on costs, creating a stress-free experience.

“We’ve stepped into precision wellness with XMD to provide real medical solutions that get results,” said Packard. “My goal has always been to help people feel healthier and happier—and then share those positive changes with others.”

A Holistic Wellness Experience

XMD Wellness complements Xyngular’s popular natural supplement systems with clinically proven therapies, bridging the gap between nutraceuticals and medical-grade treatments. Participants receive personalized plans integrating nutrition, lifestyle guidance, and prescription therapeutics, creating a balanced, sustainable approach to health.

All prescription medications, including semaglutide and tirzepatide, are provided only after evaluation by a licensed healthcare provider. Partner pharmacies, licensed under 503A, prepare each prescription to order according to FDA-regulated compounding standards, ensuring purity, potency, and safety.

Continuous clinical support monitors each participant’s progress, adjusting doses as needed, and addressing questions, side effects, or concerns. This integrated approach ensures that participants achieve results safely, with ongoing guidance from medical professionals at every step.

The Science Behind XMD Wellness

XMD Wellness combines cutting-edge scientific research with practical lifestyle strategies. Semaglutide and tirzepatide, both clinically proven GLP-1 and GLP-1/GIP agonists, are designed to regulate appetite, improve metabolic function, and support sustainable weight loss. The optional microdosing program leverages peptides to improve energy, mental clarity, and metabolic balance while minimizing risks of side effects.

By blending precision medicine with holistic wellness, XMD Wellness creates a program that is accessible, flexible, and highly personalized. Participants can adjust protocols under supervision, ensuring each individual meets their unique wellness goals.

Launching November 4 – Join the Waitlist

The official launch of XMD Wellness is November 4, 2025. Those interested in joining the program can contact RPX Enterprises to be added to the waitlist.

With obesity and metabolic health challenges on the rise, XMD Wellness provides a timely, evidence-based solution. The combination of innovative therapies, telehealth accessibility, and personalized clinical oversight positions XMD Wellness as a next-generation wellness program that sets a new standard in the health and weight-management sector.

About RPX Enterprises

RPX Enterprises is an independent distributorship owned by Robin Packard, the #1 global distributor for Xyngular. Based in Mineral Wells, Texas, RPX Enterprises specializes in promoting evidence-based wellness and weight-management programs. Robin Packard holds dual degrees in Biology and Medical Technology and has over 15 years of clinical laboratory experience. Her expertise bridges medical precision with practical wellness solutions.

Robin and her team have helped thousands achieve healthier lifestyles through personalized coaching, community support, and now, precision-guided medical programs like XMD Wellness. The launch represents RPX Enterprises’ continued commitment to bringing science-backed health innovations to people nationwide.

Official Website / Source: https://xmdwellness.com/en/rpackard

Media Contact:
RPX Enterprises
Attn: Robin Packard, Founder
Email: hello@robinpackard.com
Phone: (620) 886-0947
Location: Mineral Wells, TX

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ff7475a3-2c30-48f7-b3f3-1348aac1087e

Pennant Acquires Senior Living Communities in Idaho and Wisconsin




Pennant Acquires Senior Living Communities in Idaho and Wisconsin

EAGLE, Idaho, Nov. 04, 2025 (GLOBE NEWSWIRE) — The Pennant Group, Inc. (NASDAQ: PNTG), the parent company of the Pennant group of affiliated home health, hospice, home care and senior living companies, announces two significant acquisitions that strengthen its presences in key markets.

Effective November 1, 2025, Pennant acquired the operations and real property of a 55-bed assisted living community in Lewiston, Idaho. This community, now known as Twin Rivers Senior Living, reinforces Pennant’s strategic commitment to expanding high-quality senior care services across the Mountain West.

In addition, effective today, November 4^th, Pennant completed the acquisition of the real property for Honey Creek Heights Senior Living in West Allis, Wisconsin. This follows its earlier operational acquisition on January 1, 2025. This community adds 135 assisted living beds to Pennant’s growing Midwest portfolio.

“These acquisitions reflect our disciplined growth strategy and our dedication to delivering exceptional care,” said Brent Guerisoli, Chief Executive Officer of Pennant. “Twin Rivers bolsters our home-state presence, while Honey Creek Heights expands our footprint in Wisconsin. The real estate transactions underscore our disciplined approach to capital deployment and value creation. By leveraging favorable market conditions, we secured attractively priced real estate that expands our senior living portfolio.”

“As we strengthen our presence in Idaho and Wisconsin, we are excited to bring our expertise and commitment to excellence to the residents,” added Andrew Rider, President of Pinnacle Senior Living LLC, Pennant’s senior living subsidiary. “These transactions align with our long-term strategy to grow in markets where we can leverage our local leadership and operational expertise to make a meaningful impact on the lives of our new residents and staff. In addition, our affiliated home health and hospice providers are positioned to serve both communities, supporting our vision of building integrated continuums of care across the country.”

Pennant will continue to work closely with residents, families, and staff to deliver life-changing services for these communities.

About Pennant:

The Pennant Group, Inc. is a holding company of independent operating subsidiaries that provide healthcare services through home health and hospice agencies and senior living communities located throughout Alabama, Arizona, California, Colorado, Connecticut, Georgia, Idaho, Montana, Nevada, Oklahoma, Oregon, Tennessee, Texas, Utah, Washington, Wisconsin and Wyoming. Each of these businesses is operated by a separate, independent operating subsidiary that has its own management, employees and assets. References herein to the consolidated “company” and “its” assets and activities, as well as the use of the terms “we,” “us,” “its” and similar verbiage, are not meant to imply that The Pennant Group, Inc. has direct operating assets, employees or revenue, or that any of the home health and hospice businesses, senior living communities or the Service Center are operated by the same entity. More information about Pennant is available at www.pennantgroup.com.

CONTACT: Contact Information
The Pennant Group, Inc.
(208) 401-1400
ir@pennantgroup.com

SOURCE: The Pennant Group, Inc.

HUTCHMED Announces Enrollment Completed of SAFFRON Global Phase III Trial of ORPATHYS® and TAGRISSO® Combination for Certain Lung Cancer Patients with MET Overexpression and/or Amplification After Progression on TAGRISSO®




HUTCHMED Announces Enrollment Completed of SAFFRON Global Phase III Trial of ORPATHYS® and TAGRISSO® Combination for Certain Lung Cancer Patients with MET Overexpression and/or Amplification After Progression on TAGRISSO®

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 04, 2025 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces the completion of patient enrollment of SAFFRON, a global Phase III study of ORPATHYS^® (savolitinib) and TAGRISSO^® (osimertinib) for the treatment of patients with epidermal growth factor receptor (“EGFR”)-mutated, MET-overexpressed and/or amplified, locally advanced or metastatic non-small cell lung cancer (“NSCLC”) following progression on treatment with TAGRISSO^®. The last patient was randomized on October 31, 2025.

This combination represents a promising, chemotherapy-free, all-oral treatment option following progression on an EGFR tyrosine kinase inhibitor (“TKI”), and was granted approval in China in June 2025 based on the results of the SACHI randomized Phase III trial. ORPATHYS^® is an oral, potent and highly selective MET TKI being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. TAGRISSO^® is a third-generation, irreversible EGFR TKI.

SAFFRON is a global Phase III, open-label, randomized, multicenter study to investigate the efficacy and safety of ORPATHYS^® administered orally in combination with TAGRISSO^® versus platinum-based doublet chemotherapy in participants with EGFR-mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on first- or second-line treatment with TAGRISSO^® as the most recent therapy. The primary endpoint of the study is progression free survival (PFS) as assessed by blinded independent central review (BICR) according to RECIST 1.1 criteria. Other endpoints include overall survival (OS), objective response rate (“ORR”), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety. This study randomized 338 patients, screened from over 230 sites across 29 countries. Additional details may be found at clinicaltrials.gov, using identifier NCT05261399.

Topline results from the SAFFRON study are estimated to be reported in the first half of 2026, followed by submission of results for presentation at an appropriate medical congress.  If favorable, the results could support global regulatory filings for the ORPATHYS^® and TAGRISSO^® combination.

About NSCLC and MET aberrations

Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.¹ Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.² The majority of NSCLC patients (approximately 75%) are diagnosed with advanced disease, and approximately 10-15% of NSCLC patients in the US and Europe and up to 40-50% of patients in Asia have EGFR-mutated (“EGFRm”) NSCLC.^3,4,5,6,7

MET is a tyrosine kinase receptor that has an essential role in normal cell development. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is one of the mechanisms of de novo or acquired resistance to EGFR TKI for metastatic EGFRm NSCLC.^8,9

About ORPATHYS^®

ORPATHYS^® (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

ORPATHYS^® is approved in China and is marketed by AstraZeneca for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alterations, representing the first selective MET inhibitor approved in China. ORPATHYS^® is also approved in China for the treatment of patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR tyrosine kinase inhibitor therapy, in combination with TAGRISSO^®.

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.

About TAGRISSO^®

TAGRISSO^® (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. TAGRISSO^® (40mg and 80mg once-daily oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO^® as a treatment for patients across multiple stages of EGFRm NSCLC.

There is an extensive body of evidence supporting the use of TAGRISSO^® in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease.

In late-stage disease, TAGRISSO^® demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. TAGRISSO^® is also being investigated in this setting in combination with ORPATHYS^® (savolitinib) in the SAFFRON Phase III trial and in combination with DATROWAY^® (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials. 

TAGRISSO^® also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO^® is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

About ORPATHYS^® and TAGRISSO^® Combination Development in EGFR-mutated NSCLC

This combination represents a promising chemotherapy-free oral treatment strategy to address mechanisms of resistance in this setting. Among patients who experience disease progression following treatment with a third-generation EGFR TKI, approximately 15-50% present with MET aberration, depending on the sample type, detection method and assay cut-off used. TAGRISSO^® is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Treatment with ORPATHYS^® in combination with TAGRISSO^® has been studied extensively in these patients in the TATTON study (NCT02143466) and the SAVANNAH single-arm Phase II study (NCT03778229). Strong data from SAVANNAH presented at the 2025 European Lung Cancer Congress (ELCC) demonstrated high, clinically meaningful and durable ORR, with consistent safety results. The encouraging results led to the initiation of several randomized Phase III trials in this setting including the SACHI trial in China (NCT05015608) and the global SAFFRON trial (NCT05261399), as well as the SANOVO trial in China (NCT05009836).

SACHI: This Phase III trial in China evaluated the combination of ORPATHYS^® and TAGRISSO^® compared to platinum-based doublet chemotherapy for the treatment of patients with EGFRm, MET-amplified locally advanced or metastatic NSCLC following progression on treatment with an EGFR TKI. Results were presented at the 2025 ASCO Annual Meeting. The treatment combination received approval in China in June 2025.

SAFFRON: This ongoing global Phase III trial is to evaluate the combination of ORPATHYS^® and TAGRISSO^® compared to platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following progression on treatment with TAGRISSO^®. This received Fast Track Designation from the US Food and Drug Administration (FDA) and enrollment was completed in October 2025. We look forward to completing this trial to support potential US and other global registration filings.

SANOVO: This ongoing Phase III trial in China is to evaluate the combination of ORPATHYS^® and TAGRISSO^® compared to TAGRISSO^® monotherapy in previously untreated patients with locally advanced or metastatic NSCLC with EGFRm and MET overexpression. Enrollment was completed in August 2025.

About HUTCHMED

HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of ORPATHYS^®, the further clinical development for ORPATHYS^®, its expectations as to whether any studies on ORPATHYS^® would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of ORPATHYS^®, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in other jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential market of ORPATHYS^® for a targeted indication; and HUTCHMED and/or its partner’s ability to fund, implement and complete its further clinical development and commercialization plans for ORPATHYS^®, and the timing of these events. In addition, as certain studies rely on the use of other drug products such as TAGRISSO^® as combination therapeutics with ORPATHYS^®, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

CONTACTS

¹  World Health Organization. International Agency for Research on Cancer. All cancers fact sheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf. Accessed November 2022.
²  American Cancer Society. What is Lung Cancer? Available at: https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Accessed November 2022.
³  Knight SB, et al. Progress and prospects of early detection in lung cancer. Open Biol. 2017;7(9): 170070.
⁴  Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27.
⁵  Zhang Y, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48).
⁶  Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in 11. Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013:6;2800-12.
⁷  Gou LY, et al. Prevalence of driver mutations in non-small-cell lung cancers in the People’s Republic of China. Lung Cancer: Targets and Therapy. 2014; 5; 1–9.
⁸  Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074).
⁹  Wang Q, et al. MET inhibitors for targeted therapy of EGFR TKI-resistant lung cancer. Journal of Hematology & Oncology. 2019;63.

Mesoblast to Meet With FDA Next Month to Discuss Rexlemestrocel-L and Opioid Cessation




Mesoblast to Meet With FDA Next Month to Discuss Rexlemestrocel-L and Opioid Cessation

NEW YORK, Nov. 04, 2025 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the U.S. Food & Drug Administration (FDA) has scheduled a meeting in early December to discuss Mesoblast’s data on opioid reduction and cessation from its first Phase 3 study (MSB-DR003) of rexlemestrocel-L in patients with chronic low back pain (CLBP).

In Mesoblast’s first randomized controlled Phase 3 trial of 404 patients, 168 of whom were taking opioids at baseline, more than 3-fold higher numbers of patients treated with a single intra-discal injection of rexlemestrocel-L + HA were able to cease use of all opioids by 36 months compared with saline-treated controls (p=0.008).

In light of the devastating opioid crisis that continues to rage in the US, in September 2025 FDA provided new Guidance to Industry on Development of Non-Opioid Agents for Treatment of Chronic Pain.¹ Since CLBP is the principal cause of chronic prescription opioid use, there is a significant need for a safe, effective, and durable opioid-sparing treatment in patients with CLBP associated with degenerative disc disease. 

Mesoblast Chief Executive Silviu Itescu said: “FDA has emphasized the importance of developing non opioid treatments for chronic pain, and we look forward to discussing plans for rexlemestrocel-L as an agent that may result in both amelioration of CLBP as well as opioid reduction or cessation.”

Rexlemestrocel-L has received Regenerative Medicine Advanced Therapy (RMAT) designation for treatment of CLBP due to degenerative disc disease, a serious condition that is a major contributory factor to the nation’s opioid crisis. Mesoblast is seeking FDA approval based on reduction in CLBP through 12 months and is actively recruiting a 300-patient confirmatory Phase 3 trial across 40 sites in the US, with enrollment expected to be completed in the coming quarter.  

About Rexlemestrocel-L for Chronic Low Back Pain associated with Degenerative Disc Disease
The 300-patient randomized controlled confirmatory Phase 3 trial of Mesoblast’s second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell product candidate rexlemestrocel-L in combination with hyaluronic acid (HA) as delivery agent for injection into the lumbar disc is actively enrolling in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease (DDD) of less than five years duration at multiple sites across the U.S.

FDA has previously agreed on the design of this 300-patient randomized, placebo-controlled confirmatory Phase 3 trial, and the 12-month primary endpoint of pain reduction as an approvable indication. This endpoint was successfully met in Mesoblast’s first Phase 3 trial. Key secondary measures include improvement in quality of life and function.

A particular focus is on treatment of patients on opioids, since discogenic back pain accounts for approximately 50% of prescription opioid usage in the US. Significant pain reduction and opioid cessation were observed in Mesoblast’s first Phase 3 trial.

FDA has designated rexlemestrocel-L a Regenerative Medicine Advanced Therapy (RMAT) for the treatment of chronic low back pain. RMAT designation provides all the benefits of Breakthrough and Fast Track designations, including rolling review and eligibility for priority review on filing of a Biologics License Application (BLA).

About Chronic Low Back Pain
Back pain is the leading cause of disability in Americans under 45 years,² with an annual prevalence in the general US adult population of 10-30%.³ CLBP caused by inflammation and degenerative disc disease (DDD) is a serious condition with a prevalence of over 7 million people in the US alone.^4,5 CLBP due to DDD is a leading cause of disability, and is associated with impaired quality of life, severe limitations in ability to perform activities of daily living, reduced ability to work, and negative impacts on mental health. CLBP accounts for approximately 50% of prescription opioid usage in the US,⁵ making the condition a significant contributor to the opioid epidemic.

About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast’s Ryoncil^® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.

Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil^® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.

About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets.

About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

References / Footnotes

1. United States Food & Drug Administration. Development of Non-Opioid Analgesics for Chronic Pain Guidance for Industry. Draft Guidance. September 2025
2. American Academy of Pain Medicine – Get the Facts on Pain. The American Academy of Pain Medicine. http://www.painmed.org/patientcenter/facts-on-pain/ Accessed on June 28, 2017.
3. Urits I, Burshtein A, Sharma M, et al. Low Back Pain, a Comprehensive Review: Pathophysiology, Diagnosis, and Treatment. Current Pain and Headache Reports. 2019;23(3):1-10. doi:10.1007/s11916-019-0757-1.
4. Navigant: Commercial Assessment for a Proprietary Cell-Based Therapy for DDD in the U.S. and the EU3 – August 2014.
5. Decision Resources: Chronic Pain December 2015.

Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For more information, please contact:

Pacific Health Care Organization, Inc. Reports its Third Quarter 2025 Financial Results




Pacific Health Care Organization, Inc. Reports its Third Quarter 2025 Financial Results

Irvine, CA, Nov. 04, 2025 (GLOBE NEWSWIRE) — Pacific Health Care Organization, Inc., (the “Company”) (OTCQB: PFHO) today filed with the Securities and Exchange Commission (the “SEC”) its quarterly report on Form 10-Q announcing its financial results for the quarter ended September 30, 2025.

Results

The Company reported total revenues of $1,586,984 for the quarter ended September 30, 2025, compared to $1,500,837 for the quarter ended September 30, 2024.

The Company reported income from operations of $205,037 for the quarter ended September 30, 2025, compared to income from operations of $151,577 for the quarter ended September 30, 2024.

The Company realized net income of $223,002 or $0.02 per weighted average share outstanding, basic and diluted, for the quarter ended September 30, 2025, compared to net income of $174,863 or $0.01 per weighted average share outstanding, basic and diluted, for the quarter ended September 30, 2024.

Net cash provided by operating activities was $809,710 and $107,110 during the nine months ended September 30, 2025 and 2024, respectively, an increase of $702,600.

Net cash used in investing activities was $665,443 during the nine months ended September 30, 2025, and $183,644 during the nine months ended September 30, 2024. The change in net cash used in investing activities was due to increased investment in US Treasury Bills during the first nine months of 2025 compared to the same period in 2024.

Net cash used in financing activities was $36,055 for the nine months ended September 30, 2025, whereas net cash provided by financing activities for the nine months ended September 30, 2024 was $70,610. The change in net cash used in financing activities from period to period was due primarily to the Company’s insurance financing agreement entered into during fiscal year 2024, which matured early in fiscal year 2025.

The Company’s balance of cash and cash equivalents at September 30, 2025 and December 31, 2024 were $2,178,688 and $2,070,476, respectively.

To better understand the Company’s third quarter 2025 financial results, readers should review the Company’s quarterly report on Form 10-Q filed with the SEC on November 4, 2025.

About Pacific Health Care Organization, Inc.

The Company specializes in workers’ compensation cost containment. The Company’s business objective is to deliver value to its customers that reduces their workers’ compensation related medical claims expense in a manner that will assure that injured employees receive high quality healthcare that allows them to recover from injury and return to gainful employment without undue delay. Through its wholly owned subsidiaries, the Company provides a range of effective workers’ compensation cost containment services, including but not limited to Health Care Organizations, Medical Provider Networks, medical case management, utilization review, medical bill review, workers’ compensation carve-outs and Medicare set-aside services. The Company offers its services as a bundled solution, as standalone services, or as add-on services.

“Safe Harbor” Statement: Statements included in this press release, other than statements or characterizations of historical fact, are forward-looking statements. Forward-looking statements are based on management’s current judgment, expectations, estimates, projections, and assumptions about future events. While management believes these assumptions are reasonable, such statements are not guarantees of future results and involve certain risks and uncertainties which are difficult to predict. Therefore, actual results and trends may differ materially from what is forecast in any forward-looking statement due to a variety of factors. Additional information regarding these factors is contained in the Company’s filings with the SEC, including without limitation, its annual reports on Form 10-K and its quarterly reports on Form 10-Q.

All forward-looking statements speak only as of the date they were made. The Company does not undertake any obligation to update or publicly release any revisions to any forward-looking statements to reflect events, circumstances, or changes in expectations after the date of this press release.

To view the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC, and the Company’s annual, quarterly and current reports and other information the Company files with or furnishes to the SEC go to: http://www.sec.gov. You may also view the Company’s annual reports on Form 10-K and quarterly reports on Form 10-Q on its website at http://www.pacifichealthcareorganization.com.

CONTACT: Pacific Health Care Organization, Inc.
19800 MacArthur Blvd, Suites 306 & 307
Irvine, California 92612
(949) 721-8272
Website:  http://www.pacifichealthcareorganization.com
Contact:   Scott Allen – Controller
Email:       sallen@medexhco.com

Pre-announcement of the Key Financial Results for Third Quarter 2025 and Revised Guidance for 2025




Pre-announcement of the Key Financial Results for Third Quarter 2025 and Revised Guidance for 2025

November 4, 2025                                                
Announcement no. 22

Pre-announcement of the Key Financial Results for Third Quarter 2025 and Revised Guidance for 2025 

Copenhagen, Denmark, November 4, 2025, (GLOBE NEWSWIRE) – BioPorto A/S (“BioPorto” or the “Company”) (CPH:BIOPOR), today pre-announced the key financial results for the third quarter of 2025 and revised guidance for 2025.

Key Financial Results for Q3 2025 reflect Continued NGAL Sales Growth

• Revenue in the third quarter of 2025 totaled DKK 10.4 million, representing a 7% increase compared to the same period last year, and a 10% increase at constant exchange rates. NGAL sales totaled DKK 7.2 million, growing by 5% globally, and by 10% at constant exchange rates.
• Strong US NGAL Research Use Only (RUO) sales growth of 20% compared to the third quarter of 2024. At constant exchange rates, US NGAL RUO sales increased by 27%.
• ProNephro AKI™ (NGAL) sales through distributors in the third quarter of 2025 amounted to DKK 2.1 million.
• NGAL sales in the rest of the world decreased by 87%, due to a bulk order in the third quarter of 2024.
• Adjusted EBITDA loss in the third quarter of 2025 amounted to DKK 16.8 million compared to DKK 19.6 million in the third quarter last year as expected.
• As of September 30, 2025, the Company’s cash position was in line with expectations, DKK 27.6 million compared to DKK 76.3 million in the same period last year.

For the first nine months of 2025 total revenue amounted to DKK 28.7 million, representing a 1% increase compared to the same period last year. At constant exchange rates the total revenue increased by 2%.Total NGAL sales rose by 5% compared to the first nine months of 2024 and by 7% at constant exchange rates, driven by US
NGAL RUO sales and ProNephro AKI^TM sales. US NGAL RUO sales increased by 21% compared to the first nine months of 2024, and at constant exchange rates by 23%. 

NGAL sales for the rest of the world decreased by 49%. Adjusted EBITDA loss for the first nine months of 2025 amounted to DKK 63.3 million, compared to DKK 51.1 million in the same period last year.

Adjustment of guidance

Based on the results for the first 9 months of 2025, the full-year guidance for 2025 is revised as follows:

• Total revenue expectation is lowered to be in the range of DKK 40-45 million (previously DKK 45-50 million).
• Adjusted EBITDA loss is expected to be unchanged in the range of DKK 75-80 million.

The full Interim Report for the third quarter of 2025 is published on 19 November 2025.

To receive BioPorto’s Company Announcements, Press Releases, Newsletters and other business relevant information, please sign up on https://bioporto.com/investor-contact/.

For further information, please contact

Hanne S. Foss, Head of Investor Relations, investor@bioporto.com, C: +45 26368918

Niels Høy Nielsen, CFO, investor@bioporto.com, C: +45 25518724

About BioPorto

BioPorto is an in vitro diagnostics company focused on saving patients’ lives and improving their quality of life with actionable kidney biomarkers – tools designed to help clinicians make changes in patient management. The Company leverages its expertise in assay development to create a pipeline of novel and compelling products that focus on conditions where there is significant unmet medical need, and where the Company’s tests can help improve clinical and economic outcomes for patients, providers, and the healthcare ecosystem.

The Company’s flagship products are based on the NGAL biomarker and designed to aid in risk assessment and management of Acute Kidney Injury (AKI), a common clinical syndrome that can have severe consequences, including significant morbidity and mortality, if not identified and treated early. With the aid of NGAL levels, physicians can identify patients at risk of AKI more rapidly than is possible with current standard of care measurements, enabling earlier intervention and more tailored patient management strategies. The Company markets NGAL tests under applicable registrations including CE mark in several countries worldwide and FDA cleared ProNephro AKI^TM (NGAL) in the US.

BioPorto has facilities in Copenhagen, Denmark and Boston, MA, USA. The shares of BioPorto A/S are listed on the Nasdaq Copenhagen stock exchange. For more information visit www.bioporto.com.

Forward looking statement disclaimer

Certain statements in this news release are not historical facts and may be forward-looking statements. Forward-looking statements include statements regarding the intent, belief or current expectations with respect to the Company’s expectations, intentions and projections regarding its future performance including the Company’s Guidance for 2025; currency exchange rate fluctuations; anticipated events or trends and other matters that are not historical facts, including with respect to implementation of manufacturing and quality systems, commercialization of NGAL tests, and the development of future products and new indications; concerns that may arise from additional data, analysis or results obtained during clinical trials; and, the Company’s ability to successfully market both new and existing products. These forward-looking statements, which may use words such as “aim”, “anticipate”, “believe”, “intend”, “estimate”, “expect” and words of similar meaning, include all matters that are not historical facts. These forward-looking statements involve risks, and uncertainties that could cause the actual results of operations, financial condition, liquidity, dividend policy and the development of the industry in which the Company’s business operates to differ materially from the impression created by the forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Given these risks and uncertainties, prospective investors are cautioned not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date of such statements and, except as required by applicable law, the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Factors that may impact BioPorto’s success are more fully disclosed in BioPorto’s periodic financial filings, including its Annual Report for 2024, particularly under the heading “Risk Factors”.

Attachment

• 2025 11 04 – Announcement No. 22 – UK

Progress Update on BioPorto’s Adult Clinical Study




Progress Update on BioPorto’s Adult Clinical Study

November 4, 2025
Announcement no. 21

Progress Update on BioPorto’s Adult Clinical Study

Copenhagen, Denmark, November 4, 2025, (GLOBE NEWSWIRE) – BioPorto A/S (“BioPorto” or the “Company”) (CPH:BIOPOR), today announced an update on its ongoing adult clinical study in the US.

At the end of October 2025, BioPorto successfully completed patient enrollment in its clinical cut-off study. The Company is in the process of collecting the study data, and this process is taking more time than initially anticipated. To ensure the most effective design of the validation study, the Company has decided to submit a pre-submission meeting request to the US Food and Drug Administration (FDA) once the dataset has been analyzed, now expectedly in Q1 2026.

The clinical validation study is scheduled to begin following feedback from FDA, allowing BioPorto to proceed with a protocol aligned with FDA feedback. Accordingly, the FDA regulatory submission is postponed from the end of 2026 and into H1 2027. However, the Company continues to aim at a regulatory clearance in 2027 and thereafter initiating commercialization focused on the adult population in the US.

Carsten Buhl, BioPorto’s Group Chief Executive Officer (CEO) commented: “As we successfully completed patient enrollment and now are focusing on thorough data analysis, our commitment is to ensure the highest quality and most effective design for the validation study. While this means our FDA submission will shift into the first half of 2027, this approach derisks our design of the validation study.”

About BioPorto’s Adult Clinical Study

BioPorto’s clinical program evaluating an investigational in vitro diagnostic (IVD) urine NGAL assay is designed to aid in identifying adult patients at risk of developing moderate-to-severe acute kidney injury. The program includes a cut-off study to set the decision threshold and a separate clinical validation study, together supporting the FDA regulatory submission in 2027.

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For further information, please contact

Hanne S. Foss, Head of Investor Relations, investor@bioporto.com, C: +45 26368918

Niels Høy Nielsen, CFO, investor@bioporto.com, C: +45 25518724

About BioPorto

BioPorto is an in vitro diagnostics company focused on saving patients’ lives and improving their quality of life with actionable kidney biomarkers – tools designed to help clinicians make changes in patient management. The Company leverages its expertise in assay development to create a pipeline of novel and compelling products that focus on conditions where there is significant unmet medical need, and where the Company’s tests can help improve clinical and economic outcomes for patients, providers, and the healthcare ecosystem.

The Company’s flagship products are based on the NGAL biomarker and designed to aid in risk assessment and management of Acute Kidney Injury (AKI), a common clinical syndrome that can have severe consequences, including significant morbidity and mortality, if not identified and treated early. With the aid of NGAL levels, physicians can identify patients at risk of AKI more rapidly than is possible with current standard of care measurements, enabling earlier intervention and more tailored patient management strategies. The Company markets NGAL tests under applicable registrations including CE mark in several countries worldwide and FDA cleared ProNephro AKI^TM (NGAL) in the US.

BioPorto has facilities in Copenhagen, Denmark and Boston, MA, USA. The shares of BioPorto A/S are listed on the Nasdaq Copenhagen stock exchange. For more information visit www.bioporto.com.

Forward looking statement disclaimer

Certain statements in this news release are not historical facts and may be forward-looking statements. Forward-looking statements include statements regarding the intent, belief or current expectations with respect to the Company’s expectations, intentions and projections regarding its future performance including the Company’s Guidance for 2025; currency exchange rate fluctuations; anticipated events or trends and other matters that are not historical facts, including with respect to implementation of manufacturing and quality systems, commercialization of NGAL tests, and the development of future products and new indications; concerns that may arise from additional data, analysis or results obtained during clinical trials; and, the Company’s ability to successfully market both new and existing products. These forward-looking statements, which may use words such as “aim”, “anticipate”, “believe”, “intend”, “estimate”, “expect” and words of similar meaning, include all matters that are not historical facts. These forward-looking statements involve risks, and uncertainties that could cause the actual results of operations, financial condition, liquidity, dividend policy and the development of the industry in which the Company’s business operates to differ materially from the impression created by the forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Given these risks and uncertainties, prospective investors are cautioned not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date of such statements and, except as required by applicable law, the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Factors that may impact BioPorto’s success are more fully disclosed in BioPorto’s periodic financial filings, including its Annual Report for 2024, particularly under the heading “Risk Factors”.

Attachment

• 2025 11 04 – Announcement No. 21 – UK