Tag: GlobeNewswire

Latest Collaboration Comes Amid Progress in Other Strategic Initiatives, Including Follow-on Investment in Earlier Minority Stake Investment Target

BURLINGTON, Mass. and JERUSALEM, Nov. 02, 2026 (GLOBE NEWSWIRE) — BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, announced a strategic collaboration with Mindful Health Solutions (“MHS”), an established provider of comprehensive behavioral health and interventional psychiatry services. In August, Mindful Health Solutions’ managed services organization was acquired by Radial Health, Inc. The combined management company, operating under the Radial banner, now supports the largest network of brain medicine clinics in the US, operating 27 locations across California, Missouri, New York, South Carolina, Tennessee, Texas and Washington. 

The strategic collaboration aims to expand patient access to innovative, noninvasive mental health treatments including BrainsWay Deep TMS™ and the recently FDA-cleared accelerated SWIFT™ treatment protocol, as well as to explore opportunities to integrate Neurolief’s Proliv™Rx at-home neuromodulation therapy into broader patient care pathways.

In addition, the companies intend to build and facilitate physician education and clinical awareness through joint initiatives, including key opinion leader (KOL) programs, educational events, targeted outreach to healthcare professionals, and research into synergistic treatment approaches. The collaboration reflects a shared commitment to improving clinical outcomes and developing scalable models of care across both clinical and at-home settings.

“We are elated to collaborate with Mindful Health Solutions, an organization that shares our commitment to advancing interventional psychiatry and improving patient outcomes,” said Hadar Levy, Chief Executive Officer of BrainsWay. “We are proud to deepen our relationship with one of the country’s leaders in brain medicine research and real-world clinical operations. By combining our innovative technology and expanding neuromodulation portfolio with MHS’s clinical expertise, we see meaningful opportunities to accelerate the adoption of powerful existing therapies we currently offer as well as to potentially identify new treatment approaches.”

The collaboration comes after additional progress in BrainsWay’s broader strategic initiatives, including its recent follow-on equity investment of $0.8m in the management services organization servicing the Texas-based “Heading Health” clinic network.

These efforts reflect BrainsWay’s broader strategy of partnering with leading behavioral health providers to increase awareness and accelerate the growth of interventional psychiatry.

About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in the United States and Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

Forward-Looking Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “targets,” “believes,” “hopes,” “potential” or similar words, and also includes any financial guidance and projections contained herein. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Historical results or conclusions from scientific research and clinical do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the failure to realize anticipated synergies and other benefits of the proposed transaction; the failure of our investments in management services organizations and/or other clinic-related entities to produce profitable returns; inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.

Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission.

Contacts:
BrainsWay:
Ido Marom
Chief Financial Officer
Ido.Marom@BrainsWay.com

Investors:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com

Latest Collaboration Comes Amid Progress in Other Strategic Initiatives, Including Follow-on Investment in Earlier Minority Stake Investment Target

BURLINGTON, Mass. and JERUSALEM, Nov. 02, 2026 (GLOBE NEWSWIRE) — BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, announced a strategic collaboration with Mindful Health Solutions (“MHS”), an established provider of comprehensive behavioral health and interventional psychiatry services. In August, Mindful Health Solutions’ managed services organization was acquired by Radial Health, Inc. The combined management company, operating under the Radial banner, now supports the largest network of brain medicine clinics in the US, operating 27 locations across California, Missouri, New York, South Carolina, Tennessee, Texas and Washington. 

The strategic collaboration aims to expand patient access to innovative, noninvasive mental health treatments including BrainsWay Deep TMS™ and the recently FDA-cleared accelerated SWIFT™ treatment protocol, as well as to explore opportunities to integrate Neurolief’s Proliv™Rx at-home neuromodulation therapy into broader patient care pathways.

In addition, the companies intend to build and facilitate physician education and clinical awareness through joint initiatives, including key opinion leader (KOL) programs, educational events, targeted outreach to healthcare professionals, and research into synergistic treatment approaches. The collaboration reflects a shared commitment to improving clinical outcomes and developing scalable models of care across both clinical and at-home settings.

“We are elated to collaborate with Mindful Health Solutions, an organization that shares our commitment to advancing interventional psychiatry and improving patient outcomes,” said Hadar Levy, Chief Executive Officer of BrainsWay. “We are proud to deepen our relationship with one of the country’s leaders in brain medicine research and real-world clinical operations. By combining our innovative technology and expanding neuromodulation portfolio with MHS’s clinical expertise, we see meaningful opportunities to accelerate the adoption of powerful existing therapies we currently offer as well as to potentially identify new treatment approaches.”

The collaboration comes after additional progress in BrainsWay’s broader strategic initiatives, including its recent follow-on equity investment of $0.8m in the management services organization servicing the Texas-based “Heading Health” clinic network.

These efforts reflect BrainsWay’s broader strategy of partnering with leading behavioral health providers to increase awareness and accelerate the growth of interventional psychiatry.

About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in the United States and Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

Forward-Looking Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “targets,” “believes,” “hopes,” “potential” or similar words, and also includes any financial guidance and projections contained herein. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Historical results or conclusions from scientific research and clinical do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the failure to realize anticipated synergies and other benefits of the proposed transaction; the failure of our investments in management services organizations and/or other clinic-related entities to produce profitable returns; inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.

Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission.

Contacts:
BrainsWay:
Ido Marom
Chief Financial Officer
Ido.Marom@BrainsWay.com

Investors:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com

REDWOOD CITY, Calif., Nov. 02, 2026 (GLOBE NEWSWIRE) — Rezolute, Inc. (Nasdaq: RZLT) (Rezolute or Company), a late-stage ultra-rare, metabolic disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI), today announced that management will participate in the following investor conferences:

Event: Guggenheim 3^rd Annual Healthcare Innovation Conference
Date: November 9-11, 2026
Fireside Date/Time: Monday, November 9^th at 9:00am ET

Event: Jefferies London Healthcare Conference
Date: November 16-19, 2026
Fireside Date/Time: Thursday, November 19^th at 1:00pm GMT

Management will be participating in one-on-one investor meetings throughout the conferences. Investors interested in scheduling a meeting with the Rezolute management team should contact their Guggenheim and Jefferies representatives.

About Rezolute, Inc.

Rezolute is a late-stage ultra-rare, metabolic disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, has been studied in clinical trials and used in real-world cases for the treatment of refractory hypoglycemia due to a variety of causes of HI. For more information, visit www.rezolutebio.com.

Contacts:

Christen Baglaneas 
Rezolute, Inc. 
1411 Broadway, 16th Floor 
New York, NY 10018 
cbaglaneas@rezolutebio.com 
508-272-6717 

Carrie McKim 
Rezolute, Inc. 
1411 Broadway, 16th Floor 
New York, NY 10018 
cmckim@rezolutebio.com  
336-608-9706 

REDWOOD CITY, Calif., Nov. 02, 2026 (GLOBE NEWSWIRE) — Rezolute, Inc. (Nasdaq: RZLT) (Rezolute or Company), a late-stage ultra-rare, metabolic disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI), today announced that management will participate in the following investor conferences:

Event: Guggenheim 3^rd Annual Healthcare Innovation Conference
Date: November 9-11, 2026
Fireside Date/Time: Monday, November 9^th at 9:00am ET

Event: Jefferies London Healthcare Conference
Date: November 16-19, 2026
Fireside Date/Time: Thursday, November 19^th at 1:00pm GMT

Management will be participating in one-on-one investor meetings throughout the conferences. Investors interested in scheduling a meeting with the Rezolute management team should contact their Guggenheim and Jefferies representatives.

About Rezolute, Inc.

Rezolute is a late-stage ultra-rare, metabolic disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, has been studied in clinical trials and used in real-world cases for the treatment of refractory hypoglycemia due to a variety of causes of HI. For more information, visit www.rezolutebio.com.

Contacts:

Christen Baglaneas 
Rezolute, Inc. 
1411 Broadway, 16th Floor 
New York, NY 10018 
cbaglaneas@rezolutebio.com 
508-272-6717 

Carrie McKim 
Rezolute, Inc. 
1411 Broadway, 16th Floor 
New York, NY 10018 
cmckim@rezolutebio.com  
336-608-9706 

VANCOUVER, British Columbia, Nov. 02, 2026 (GLOBE NEWSWIRE) — Trekor Metals Limited (TSX: TKO; NYSE American: TGB; LSE: TKO) (“Trekor” or the “Company”) will release its third quarter 2026 financial results after market close on Wednesday, November 4, 2026.

The Company will host a telephone conference call and live webcast on Thursday, November 5, 2026, at 11:00 a.m. Eastern Time to discuss these results. After opening remarks by management, there will be a question and answer session open to analysts and investors.

The conference call may be accessed by dialing 800-715-9871 toll free or 646-307-1963, using the access code 1263967.

The webcast may be accessed at https://trekormetals.com/investors/events/ and will be archived until November 5, 2027, for later playback.

For further information on Trekor, see the Company’s website at trekormetals.com or contact:

Brian Bergot, Vice President, Investor Relations – 778-373-4533 or toll-free 1-877-441-4533

Stuart McDonald
President and CEO

No regulatory authority has approved or disapproved of the information contained in this news release.

VANCOUVER, British Columbia, Nov. 02, 2026 (GLOBE NEWSWIRE) — Trekor Metals Limited (TSX: TKO; NYSE American: TGB; LSE: TKO) (“Trekor” or the “Company”) will release its third quarter 2026 financial results after market close on Wednesday, November 4, 2026.

The Company will host a telephone conference call and live webcast on Thursday, November 5, 2026, at 11:00 a.m. Eastern Time to discuss these results. After opening remarks by management, there will be a question and answer session open to analysts and investors.

The conference call may be accessed by dialing 800-715-9871 toll free or 646-307-1963, using the access code 1263967.

The webcast may be accessed at https://trekormetals.com/investors/events/ and will be archived until November 5, 2027, for later playback.

For further information on Trekor, see the Company’s website at trekormetals.com or contact:

Brian Bergot, Vice President, Investor Relations – 778-373-4533 or toll-free 1-877-441-4533

Stuart McDonald
President and CEO

No regulatory authority has approved or disapproved of the information contained in this news release.

SOUTH SAN FRANCISCO, Calif., Nov. 02, 2026 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced three upcoming presentations, including two Late Breaking Oral Abstract presentations and one poster presentation, at the Hypertrophic Cardiomyopathy Medical Society Scientific Sessions, held in collaboration with the American Heart Association Scientific Sessions, taking place in Chicago, IL, November 6, 2026.

Late-Breaking Oral Abstracts

Title: Effect of Aficamten on Cardiac Structure and Function in Nonobstructive Hypertrophic Cardiomyopathy: The ACACIA-HCM CMR Study
Presenter: Ahmad Masri, M.D., M.S., Associate Professor of Medicine, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University
Date: Friday, November 6, 2026
Session Title: Session 4 – Late Breaking Oral Abstracts
Session Time: 2:15 PM – 3:15 PM CT
Presentation Time: 2:30 PM – 2:40 PM CT
Location: Room S406a

Title: Effect of Aficamten on Patient-Reported Health Status in Non-Obstructive Hypertrophic Cardiomyopathy
Presenter: Michael E. Nassif, M.D., Cardiologist, Saint Luke’s Mid America Heart Institute
Date: Friday, November 6, 2026
Session Title: Session 4 – Late Breaking Oral Abstracts
Session Time: 2:15 PM – 3:15 PM CT
Presentation Time: 2:45 PM -2:55 PM CT
Location: Room S406A

Poster Presentation

Title: Left Ventricular Systolic Dysfunction in Long-Term Aficamten Therapy for Obstructive HCM: A FOREST-HCM Analysis
Presenter: Daniele Massera, M.D., Director, Hypertrophic Cardiomyopathy Program, NYU Langone Health, Assistant Professor, Department of Medicine, NYU Grossman School of Medicine
Date: November 6, 2026
Session Title: Poster Reception
Session Time: 5:30 PM – 6:30 PM CT
Presentation Time: 5:30 PM – 6:30 PM CT
Location: Room S406B

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO^® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union, United Kingdom and Canada for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive topline results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to our ability to obtain regulatory approval for aficamten in nonobstructive hypertrophic cardiomyopathy in any jurisdiction by any particular date, if ever, the number of patients comprising the eligible treatment population for aficamten, or market acceptance of aficamten for the treatment of nonobstructive hypertrophic cardiomyopathy. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.

CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZO® is a registered trademark of Cytokinetics in the U.S., the European Union, the United Kingdom and Canada.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

SOUTH SAN FRANCISCO, Calif., Nov. 02, 2026 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced three upcoming presentations, including two Late Breaking Oral Abstract presentations and one poster presentation, at the Hypertrophic Cardiomyopathy Medical Society Scientific Sessions, held in collaboration with the American Heart Association Scientific Sessions, taking place in Chicago, IL, November 6, 2026.

Late-Breaking Oral Abstracts

Title: Effect of Aficamten on Cardiac Structure and Function in Nonobstructive Hypertrophic Cardiomyopathy: The ACACIA-HCM CMR Study
Presenter: Ahmad Masri, M.D., M.S., Associate Professor of Medicine, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University
Date: Friday, November 6, 2026
Session Title: Session 4 – Late Breaking Oral Abstracts
Session Time: 2:15 PM – 3:15 PM CT
Presentation Time: 2:30 PM – 2:40 PM CT
Location: Room S406a

Title: Effect of Aficamten on Patient-Reported Health Status in Non-Obstructive Hypertrophic Cardiomyopathy
Presenter: Michael E. Nassif, M.D., Cardiologist, Saint Luke’s Mid America Heart Institute
Date: Friday, November 6, 2026
Session Title: Session 4 – Late Breaking Oral Abstracts
Session Time: 2:15 PM – 3:15 PM CT
Presentation Time: 2:45 PM -2:55 PM CT
Location: Room S406A

Poster Presentation

Title: Left Ventricular Systolic Dysfunction in Long-Term Aficamten Therapy for Obstructive HCM: A FOREST-HCM Analysis
Presenter: Daniele Massera, M.D., Director, Hypertrophic Cardiomyopathy Program, NYU Langone Health, Assistant Professor, Department of Medicine, NYU Grossman School of Medicine
Date: November 6, 2026
Session Title: Poster Reception
Session Time: 5:30 PM – 6:30 PM CT
Presentation Time: 5:30 PM – 6:30 PM CT
Location: Room S406B

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO^® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union, United Kingdom and Canada for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive topline results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to our ability to obtain regulatory approval for aficamten in nonobstructive hypertrophic cardiomyopathy in any jurisdiction by any particular date, if ever, the number of patients comprising the eligible treatment population for aficamten, or market acceptance of aficamten for the treatment of nonobstructive hypertrophic cardiomyopathy. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.

CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZO® is a registered trademark of Cytokinetics in the U.S., the European Union, the United Kingdom and Canada.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

PARSIPPANY, N.J., Nov. 02, 2026 (GLOBE NEWSWIRE) — CorMedix Therapeutics (Nasdaq: CRMD) today provided a business update in advance of a conference call expected to be held on November 12, 2026 to discuss the Company’s complete quarterly financial performance.

Business Updates

• CorMedix announces unaudited cash and cash equivalents on hand as of September 30, 2026 of approximately $355 million.
• CorMedix reaffirms its August 2026 total revenue guidance of between $325 million and $345 million for the full-year 2026.
• On October 28, 2026, CMS released the 2027 End-Stage Renal Disease Prospective Payment System (ESRD PPS) final rule, which provided for a post-TDAPA Add-on for DefenCath^® (taurolidine and heparin) of $8.32 per dialysis session, for Q1 of 2027, as well as a new quarterly process for calculating Add-On adjustments. The Q1 2027 Add-on of $8.32 is within the Company’s previously guided range of 3x-5x higher than the current $2.37 in effect for the third and fourth quarters of 2026.
• The Company is aware of statements made by a large dialysis organization (LDO) during its investor call about the quarterly trajectory of the 2027 DefenCath post-TDAPA Add-on payments following CMS’s publication of the 2027 ESRD PPS Final rule. CorMedix has not provided the LDO or any other party with past or forecasted utilization or pricing data that would be necessary to estimate future quarterly adjustments to the 2027 Add-on. We believe any third-party projections regarding future quarterly adjustments are subject to significant uncertainty without visibility into the relevant utilization and pricing data. Investors should not interpret third-party projections as guidance provided or endorsed by CorMedix.
• Based on CorMedix evaluation of sales data and insights that the Company has in connection with DefenCath fee-for-service utilization, including terms of its contractual arrangements with customers, the Company anticipates that the DefenCath Add-on will decline in Q2 of 2027 compared to Q1, but increase in Q3 and/or Q4 of 2027 compared to Q2, subject to how CMS applies certain utilization data. In addition, CorMedix believes that the Add-on rate for all four quarters in 2027 will exceed the current rate of $2.37 and that the average Add-on rate for all four quarters in 2027 will equate to more than 2x the current rate of $2.37.
• CorMedix expects to hold a conference call on November 12, 2026 to discuss its financial results and additional business updates at that time. The Company will provide more specifics about its third quarter earnings call approximately one week prior to the scheduled meeting.

About CorMedix

CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases in the United States. CorMedix is focused on selling and marketing products in institutional settings of care in the US and has field based medical and commercial infrastructure deployed in hospitals, clinics and infusion centers. For more information visit: www.cormedix.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements including, but not limited to statements regarding financial and business guidance; sales, revenue and operating expense estimates; the 2027 post-TDAPA Add-on changes for DefenCath; and CorMedix’s forecasts and projections for the 2027 Add-on trajectory. CorMedix estimates for the 2027 Add-on are subject to several factors and assumptions, including known historical utilization and pricing data, DefenCath maintaining fee-for-service utilization in line with current trends, and the method by which CMS will apply certain utilization data in the Add-on calculations. Changes in customer utilization patterns, including fee-for-service utilization, changes in pricing, or differences between CMS’s application of its calculation methodology and the Company’s assumptions could cause the actual CMS-determined quarterly Add-on rates and the resulting full-year average to differ materially from CorMedix’s estimates. Increased reimbursement to dialysis facilities may not result in corresponding increases in CorMedix’s realized pricing, product utilization or revenue. Additional risks include continued pricing pressures and the impact of actions of governmental and private payers affecting pricing of, reimbursement for, and patient access to pharmaceuticals and reporting obligations related thereto; and the expiration or loss of intellectual property protection for certain of the Company’s products and competition from generic and biosimilar products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K and its subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix does not adopt or endorse, and undertakes no obligation to comment on or correct, any projections, estimates or statements regarding its business or results of operations that are made by third parties, including analysts and customers, except as required by law. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576

PARSIPPANY, N.J., Nov. 02, 2026 (GLOBE NEWSWIRE) — CorMedix Therapeutics (Nasdaq: CRMD) today provided a business update in advance of a conference call expected to be held on November 12, 2026 to discuss the Company’s complete quarterly financial performance.

Business Updates

• CorMedix announces unaudited cash and cash equivalents on hand as of September 30, 2026 of approximately $355 million.
• CorMedix reaffirms its August 2026 total revenue guidance of between $325 million and $345 million for the full-year 2026.
• On October 28, 2026, CMS released the 2027 End-Stage Renal Disease Prospective Payment System (ESRD PPS) final rule, which provided for a post-TDAPA Add-on for DefenCath^® (taurolidine and heparin) of $8.32 per dialysis session, for Q1 of 2027, as well as a new quarterly process for calculating Add-On adjustments. The Q1 2027 Add-on of $8.32 is within the Company’s previously guided range of 3x-5x higher than the current $2.37 in effect for the third and fourth quarters of 2026.
• The Company is aware of statements made by a large dialysis organization (LDO) during its investor call about the quarterly trajectory of the 2027 DefenCath post-TDAPA Add-on payments following CMS’s publication of the 2027 ESRD PPS Final rule. CorMedix has not provided the LDO or any other party with past or forecasted utilization or pricing data that would be necessary to estimate future quarterly adjustments to the 2027 Add-on. We believe any third-party projections regarding future quarterly adjustments are subject to significant uncertainty without visibility into the relevant utilization and pricing data. Investors should not interpret third-party projections as guidance provided or endorsed by CorMedix.
• Based on CorMedix evaluation of sales data and insights that the Company has in connection with DefenCath fee-for-service utilization, including terms of its contractual arrangements with customers, the Company anticipates that the DefenCath Add-on will decline in Q2 of 2027 compared to Q1, but increase in Q3 and/or Q4 of 2027 compared to Q2, subject to how CMS applies certain utilization data. In addition, CorMedix believes that the Add-on rate for all four quarters in 2027 will exceed the current rate of $2.37 and that the average Add-on rate for all four quarters in 2027 will equate to more than 2x the current rate of $2.37.
• CorMedix expects to hold a conference call on November 12, 2026 to discuss its financial results and additional business updates at that time. The Company will provide more specifics about its third quarter earnings call approximately one week prior to the scheduled meeting.

About CorMedix

CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases in the United States. CorMedix is focused on selling and marketing products in institutional settings of care in the US and has field based medical and commercial infrastructure deployed in hospitals, clinics and infusion centers. For more information visit: www.cormedix.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements including, but not limited to statements regarding financial and business guidance; sales, revenue and operating expense estimates; the 2027 post-TDAPA Add-on changes for DefenCath; and CorMedix’s forecasts and projections for the 2027 Add-on trajectory. CorMedix estimates for the 2027 Add-on are subject to several factors and assumptions, including known historical utilization and pricing data, DefenCath maintaining fee-for-service utilization in line with current trends, and the method by which CMS will apply certain utilization data in the Add-on calculations. Changes in customer utilization patterns, including fee-for-service utilization, changes in pricing, or differences between CMS’s application of its calculation methodology and the Company’s assumptions could cause the actual CMS-determined quarterly Add-on rates and the resulting full-year average to differ materially from CorMedix’s estimates. Increased reimbursement to dialysis facilities may not result in corresponding increases in CorMedix’s realized pricing, product utilization or revenue. Additional risks include continued pricing pressures and the impact of actions of governmental and private payers affecting pricing of, reimbursement for, and patient access to pharmaceuticals and reporting obligations related thereto; and the expiration or loss of intellectual property protection for certain of the Company’s products and competition from generic and biosimilar products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K and its subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix does not adopt or endorse, and undertakes no obligation to comment on or correct, any projections, estimates or statements regarding its business or results of operations that are made by third parties, including analysts and customers, except as required by law. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576