Calidi Biotherapeutics Announces Closing of $6.0 Million Underwritten Public Offering and Full Exercise of Underwriters’ Over-Allotment Option




Calidi Biotherapeutics Announces Closing of $6.0 Million Underwritten Public Offering and Full Exercise of Underwriters’ Over-Allotment Option

$12 Million of Tranche Warrants Potential Financing Within One Year From Closing

SAN DIEGO, March 09, 2026 (GLOBE NEWSWIRE) — Calidi Biotherapeutics, Inc. (NYSE AMERICAN: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today announced the closing of its previously announced underwritten public offering and the exercise in full of the underwriters’ over-allotment option for gross proceeds of approximately $6.0 million, prior to deducting underwriting commissions and offering expenses.

In connection with the offering, the Company sold 12,094,631 shares of common stock (or pre-funded warrants in lieu thereof) Series J warrants to purchase 12,094,631 shares of common stock, Series K warrants to purchase 12,094,631 shares of common stock, and Series L warrants to purchase 12,094,631 shares of common stock, including the full exercise of the underwriter’s option to purchase 1,575,000 shares of common stock and accompanying warrants..

Ladenburg Thalmann & Co. Inc. acted as sole book-running manager for the offering.

The securities described above were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-284229), which was declared effective by the United States Securities and Exchange Commission (“SEC”) on February 7, 2025 and the related registration statement filed under Rule 462(b) of the Securities Act of 1933, as amended, which became automatically effective upon filing. A final prospectus supplement was filed with the SEC and is available on the SEC’s website at http://www.sec.gov. Electronic copies of the final prospectus may also be obtained by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at prospectus@ladenburg.com.

The Series J warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring five years from issuance. The Series K warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring one year from issuance. The Series L warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring six months from issuance. The warrants issued in this offering each include a reset of the exercise price on two separate occasions: (i) on the forty-fifth (45^th) calendar day following the date of issuance and (ii) the sixth (6^th) trading day immediately following the date on which a reverse stock split is approved and deemed effective during the fiscal year ended December 31, 2026.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American: CLDI) is a biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The company’s proprietary Redtail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent genetic medicine(s) to metastatic locations.

CLD-401, the lead candidate from the Redtail platform, currently in IND-enabling studies, targets non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need. Calidi continues to advance its pipeline utilizing the Redtail platform including its novel approach to incorporate BiTEs in solid tumors.
Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com or view Calidi’s Corporate Presentation here.

Forward-Looking Statements

This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning key milestones, including certain pre-clinical data, planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s annual report filed with the SEC on Form 10-K on March 31, 2025, as may be amended or supplemented by other reports we file with the SEC from time to time. We disclaim any obligation to update any forward-looking statement to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

For Investors:

Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com

Nebu Ease Portable Nebulizer Claims Evaluated: 2026 Consumer Research Report on Mesh Nebulizer Technology, Respiratory Comfort Features, and What Buyers Should Verify




Nebu Ease Portable Nebulizer Claims Evaluated: 2026 Consumer Research Report on Mesh Nebulizer Technology, Respiratory Comfort Features, and What Buyers Should Verify

A 2026 informational consumer research report examining portable nebulizer technology, vibrating mesh atomization systems, respiratory comfort features, pricing transparency, and verification considerations for adults researching handheld nebulizer devices

Spring Lake, NJ, March 09, 2026 (GLOBE NEWSWIRE) — This article contains affiliate links. If a purchase is made through these links, a commission may be earned at no additional cost to the buyer. This article is an informational consumer research report and does not constitute medical or health advice. All product details described below are stated as presented by the company and should be verified directly on the official website before any purchasing decision.

NebuEase is a general wellness device designed for comfort, according to the company’s published disclaimer. It is not intended to diagnose, treat, cure, or prevent any disease. Always follow medical advice for health conditions or when using prescribed respiratory solutions. Nothing in this article replaces the guidance of a qualified healthcare provider.

Interest in portable nebulizers has grown steadily as consumers look for quieter, more travel-friendly alternatives to traditional compressor nebulizer systems. For households seeking a more convenient respiratory comfort device, adults dealing with dry winter airways, or frequent travelers who want portable relief without packing bulky equipment — the appeal of a handheld, rechargeable mesh nebulizer makes sense on paper.

NebuEase, a handheld mesh nebulizer device sold online, is one example of the newer portable nebulizer designs currently generating consumer attention in the respiratory comfort device market. The company markets it as a USB-rechargeable, whisper-quiet device that uses vibrating mesh atomization technology to convert liquid solutions into a fine breathable mist — positioned for both adults and children.

This report examines publicly available information about NebuEase, the vibrating mesh nebulizer technology category it belongs to, and what consumers researching portable nebulizers should verify before purchasing any device in this space.

Current product details, pricing, and terms can be confirmed by viewing the current NebuEase offer on the official product page.

Consult a qualified healthcare provider before using any nebulizer device, especially if you have existing respiratory conditions, take prescribed medications, or are considering nebulizer use for a child.

What Is NebuEase and How Portable Mesh Nebulizers Work

Portable mesh nebulizers represent a newer approach to respiratory mist delivery. Unlike traditional compressor nebulizers — which use compressed air forced through tubing to generate aerosolized droplets — vibrating mesh nebulizers push liquid through a microscopic metal plate containing thousands of tiny holes. When the mesh vibrates at high frequency, it produces a consistent mist of fine droplets that can be inhaled through the airways.

This design approach offers several potential advantages over compressor systems. Mesh nebulizers tend to operate more quietly, generate mist more quickly, and maintain a significantly smaller form factor. These characteristics make them appealing for consumers who want nebulization outside a home setting — on flights, in hotel rooms, at the office, or during a child’s naptime.

NebuEase is one device in this category. According to the company’s product materials, the device uses vibrating mesh atomization and is compatible with saline solutions and certain prescribed respiratory medications, subject to healthcare-provider guidance. The company’s FAQ notes that users should always consult a healthcare provider before using any medication in the device. The company’s own published disclaimer states that NebuEase is positioned as a “general wellness device designed for comfort” and is not intended to diagnose, treat, cure, or prevent any disease.

According to the official website, the device ships from a warehouse located in New Jersey. The company describes itself as an American-owned business and states that orders are shipped within 48 business hours via USPS, FedEx, UPS, or DHL depending on delivery efficiency.

Understanding Vibrating Mesh Nebulizer Technology

Nebulizers as a broader technology category have been used in respiratory care for decades. Traditional compressor nebulizers are well-established medical devices commonly prescribed in clinical settings for conditions such as asthma, COPD, and bronchitis. Vibrating mesh nebulizers represent the next generation of this technology, and the category has been studied in both clinical and research settings.

A key factor in any nebulizer’s performance is particle size. Aerosolized particles in the 1 to 5 micron range are often cited in respiratory aerosol research as being capable of reaching deeper areas of the airway. Larger particles tend to deposit in the mouth and throat, while smaller particles may be exhaled without depositing at all. Mesh nebulizers have been studied for their ability to produce particles within this range — and published research on the technology category has generally shown favorable particle size characteristics compared to some older compressor designs.

However, there is an important distinction between the general technology category and any specific consumer product. Published studies on vibrating mesh nebulization typically evaluate medical-grade devices under controlled laboratory or clinical conditions. The quality of the mesh, the consistency of particle size output, the reservoir design, and the power system all affect real-world performance of any individual device.

NebuEase has not published independent clinical trial data evaluating its specific device’s particle output, delivery efficiency, or performance outcomes. The company’s marketing materials reference features such as “clinical-grade nebulizing power” and state the device was “developed in partnership with a certified pulmonary specialist.” These are company claims that have not been independently verified through published research available to this reviewer. Consumers researching any portable nebulizer should ask manufacturers directly for documentation supporting clinical performance claims if those claims factor into purchasing decisions.

The connection between published mesh nebulizer research and any particular consumer product remains a general technology association rather than a product-level validation — unless and until the manufacturer publishes device-specific testing data.

NebuEase Feature Overview Based on Company Statements

According to the official product pages and included documentation, NebuEase includes the following features and components. All descriptions below are stated as presented by the company.

Vibrating Mesh Atomization: The company states the device uses a thin metal plate with microscopic holes that vibrates rapidly to produce aerosolized droplets for inhalation.

Dual Mist Modes: The sales page indicates users can choose between continuous and pulse mist settings depending on session length and comfort preferences.

Self-Cleaning Function: The company describes an auto-cleaning mode activated by holding the power button, designed to flush residue from the mesh plate after each use.

USB Rechargeable Battery: The device charges via USB cable and does not require a wall outlet during operation. Per the company’s product materials, a full charge supports multiple sessions.

Quiet Operation: The company markets NebuEase as “virtually silent” and describes it as suitable for use during sleep, work, or travel without disruption.

Family-Friendly Design: The kit includes both adult and child mask attachments, plus a mouthpiece option. The company states this makes it appropriate for the whole family.

Compact and Portable: The device is described as palm-sized and travel-ready, fitting in bags, backpacks, or carry-on luggage.

The package typically includes the handheld unit, an adult inhalation mask, a child inhalation mask, a mouthpiece attachment, and a USB charging cable. Some listings also reference a protective storage case. Performance in real-world conditions may vary based on factors including the solution used, maintenance practices, and individual respiratory needs.

Who Portable Nebulizers Are Typically Designed For

Portable mesh nebulizers as a category tend to appeal to several consumer groups. The following is not a medical recommendation — it is a framework to help you self-assess whether this type of device aligns with your situation.

A portable nebulizer may align well with people who:

Want a travel-friendly alternative to tabletop nebulizers: Adults who already use nebulizer treatments but want a cord-free option for use outside the home may find the compact, rechargeable design of handheld devices practical for daily life.

Have children who resist traditional inhalers or loud machines: Quiet portable nebulizers with pediatric mask attachments are positioned as less intimidating for young children. NebuEase specifically includes a child-sized mask and markets its quiet operation as suitable for use during naps and rest.

Experience seasonal congestion or airway dryness: Individuals who use saline nebulization for general respiratory comfort during allergy season, dry winter months, or post-illness recovery may appreciate the convenience of a handheld unit that can be used anywhere.

Travel frequently and need respiratory comfort on the go: The USB-rechargeable, pocket-sized design common to portable mesh nebulizers is positioned for travelers who want access to nebulization without packing bulky equipment or searching for outlets.

Other options may be preferable for people who:

Need a medically verified device for a diagnosed condition: If you have been prescribed nebulizer treatments by a physician for asthma, COPD, or another respiratory condition, discuss any device change with your healthcare provider first. Medical-grade nebulizers used in clinical settings have published performance data that consumer wellness devices may not match.

Require specific particle size documentation: Healthcare providers prescribing nebulized medications often need to verify that a device delivers particles within a clinically recognized size range. NebuEase does not publish independent particle size testing data on its website — a consideration worth discussing with your provider.

Expect a device to replace professional medical treatment: The company’s own disclaimer states NebuEase is a general wellness device, not a medical treatment tool. Portable nebulizers in this category should not be viewed as substitutes for professional respiratory care.

Questions to ask yourself before purchasing any portable nebulizer:

Do I currently use a nebulizer under medical guidance, and has my provider approved switching devices? Am I looking for a wellness comfort device or a medically verified treatment tool? Will I primarily use saline solutions, or do I need a device validated for specific prescribed medications? Is portability a genuine daily need, or would a traditional home nebulizer serve me equally well?

Your answers help determine whether any portable nebulizer’s feature set — including NebuEase — matches your actual needs. Consumers ready to explore NebuEase further can review the complete product details by seeing the current NebuEase product details and specifications.

Marketing Claims vs. Verifiable Information: What Consumers Should Evaluate

Several claims on the NebuEase sales pages deserve careful consumer evaluation. These verification considerations are relevant to anyone researching portable nebulizers, not just this specific device.

User Statistics: The company’s shop page states results are “based on feedback from over 300 verified NebuEase users,” while the sales funnel page references “Trusted by 100,000+ Users.” These two figures present different scales. Consumers should note that user feedback surveys and total unit sales are different metrics, and neither has been independently verified through published data available to this reviewer.

“Clinically Effective Relief” and “Clinical-Grade Nebulizing Power”: These phrases appear in the company’s marketing materials. The company’s own published disclaimer simultaneously states that NebuEase is a “general wellness device designed for comfort” that is “not intended to diagnose, treat, cure, or prevent any disease.” These two positionings create a tension that consumers should evaluate carefully. No independent clinical study of the NebuEase device has been published or referenced by the company.

“Developed in Partnership With a Certified Pulmonary Specialist”: The sales page makes this claim, but no specific clinician is named, and no documentation of this partnership is publicly available. Consumers who value this claim should ask the company for verification before purchasing.

Condition-Specific Marketing: The sales page lists specific conditions including asthma, bronchitis, chest congestion, allergies, and respiratory inflammation as situations where NebuEase is “ideal.” These are medical conditions. At the same time, the company’s own disclaimer states the device is not intended for medical purposes. Consumers managing any of these conditions should consult their healthcare provider rather than relying on marketing language to determine whether a general wellness device is appropriate for their situation.

Understanding these distinctions helps set realistic expectations. A device can be well-designed and useful for general respiratory comfort while simultaneously not being validated for addressing specific medical conditions.

NebuEase Pricing and Availability Context

According to pricing information published on the official website at the time of this report, the NebuEase Portable Nebulizer is listed at $49.99 on the company’s online store. The sales funnel page advertises a “50% OFF” promotional price, though the original pre-discount price is not clearly stated on the page. The company also advertises free shipping on all orders and a 30-day money-back guarantee.

An optional 3-Year Warranty and Extended Protection plan is available for an additional $9.95, which according to the company covers defects, scratches, dents, internal component damage, replacement, and loss or theft.

According to the company’s FAQ, orders ship from a New Jersey warehouse and standard delivery takes approximately 5 to 7 business days within the United States, with an additional 1 to 3 business days for processing.

Pricing listed on the official website at the time of this report may change. Readers should verify current terms by checking the latest NebuEase pricing and availability.

Refund Policy Transparency

According to the company’s published return policy, NebuEase purchases are covered by a 30-day money-back guarantee. The company’s marketing describes this as a no-hassle, no-questions-asked return policy.

However, the company’s Terms of Service include a separate provision noting that a minimum 15% restocking fee may be charged to process returns. These two statements — “no questions asked” and “15% restocking fee” — present a potential discrepancy that consumers should clarify directly with the company before purchasing.

Returns and support inquiries can be directed to the company’s support email. Consumers should retain all purchase confirmation details and review the complete return terms on the official website before placing an order.

Device Operation Overview

According to the company’s documentation, NebuEase operates by placing a liquid solution into the device reservoir and activating the vibrating mesh atomizer, which converts the liquid into an inhalable mist. The manufacturer’s documentation describes the device as being used with either a mask attachment or mouthpiece, depending on user preference and intended setup. Session duration varies depending on the liquid solution used and the manufacturer’s guidance. The manufacturer’s documentation also describes routine maintenance procedures intended to keep the mesh plate functioning properly. Consumers should review the full operating instructions included with the device packaging and on the official product website.

Consumer Questions About Portable Nebulizers

Are portable consumer nebulizers like NebuEase FDA-approved medical devices?

The regulatory landscape for consumer nebulizer devices varies by how the manufacturer positions the product. NebuEase does not claim FDA approval or clearance on its published materials. According to the company’s own disclaimer, NebuEase is described as a general wellness device designed for comfort and is not intended to diagnose, treat, cure, or prevent any disease. Consumers who require an FDA-cleared nebulizer for a diagnosed respiratory condition should discuss device options with their healthcare provider.

What solutions are typically used in portable nebulizers?

Portable nebulizers in this category are commonly used with saline solutions — a simple mixture of salt and distilled water that adds moisture to the respiratory tract. According to the company, NebuEase is also compatible with certain prescribed respiratory medications, though the company advises consulting a healthcare provider before using any medication in the device.

Are portable nebulizers safe for children?

Many portable nebulizer manufacturers include pediatric mask attachments and market their devices as child-friendly. NebuEase includes a child-sized mask and promotes its quiet operation as particularly suitable for young children. Parents should consult a pediatrician before using any nebulizer device with children, regardless of manufacturer marketing claims.

How do consumer portable nebulizers compare to medical-grade nebulizers?

Medical-grade nebulizers used in clinical settings typically have published performance data including particle size distribution, drug delivery efficiency, and aerosol output rates. Consumer portable nebulizers — including NebuEase — may not publish this type of independent testing data. While many consumer devices use vibrating mesh technology that has been studied in clinical contexts, individual consumer products should be evaluated based on their own published specifications and testing data rather than research conducted on different devices using similar technology.

What does the NebuEase warranty cover?

According to the company, the optional 3-Year Warranty and Extended Protection plan covers defects, scratches, dents, internal component damage, and replacement. The company also states the plan covers loss or theft. The warranty is available for $9.95 at the time of purchase. Review complete warranty terms on the official website before purchasing.

Who operates NebuEase?

The Terms of Service identify the business entity as “Nebu Ease,” with support communications directed to support@pickdiverse.co. The Terms of Service reference dispute resolution governed by New York law, with the company based for legal purposes in New York. The FAQ states that orders ship from a New Jersey warehouse.

What Would Strengthen Consumer Confidence in Portable Nebulizer Products

This section reflects what informed consumers should look for when evaluating any portable nebulizer sold as a wellness device — these are category-level transparency markers, not criticisms unique to any single product:

Published particle size testing. Independent data confirming a device produces mist particles within the 1 to 5 micron range commonly cited in respiratory research would allow consumers and healthcare providers to evaluate functional capability objectively.

Named clinical partnerships. Claims of development partnerships with medical specialists carry more weight with a named professional, verifiable credentials, or a published statement. The NebuEase claim of development “in partnership with a certified pulmonary specialist” would benefit from this transparency.

Consistent user data. Aligning feedback-based statistics with broader marketing claims — or clearly distinguishing what each number represents — reduces confusion. NebuEase’s “over 300 verified users” feedback figure and “100,000+ users” marketing claim present different scales that could benefit from clarification.

Clarified return terms. When marketing language and Terms of Service provisions present different expectations, reconciling them proactively builds consumer trust. This applies to NebuEase’s guarantee language and restocking fee provision, and to the portable nebulizer category broadly.

These are standard due diligence considerations that apply across the portable nebulizer market. Consumers who evaluate products against these markers tend to make more confident purchasing decisions.

Summary of Key Considerations

NebuEase is one example of a portable vibrating mesh nebulizer device currently available to consumers researching handheld respiratory comfort devices. The device uses vibrating mesh atomization technology — a technology category with published research backing — though the specific NebuEase device has not been independently evaluated through published clinical studies.

The company positions NebuEase as a general wellness device designed for comfort, with explicit disclaimers stating it is not intended to diagnose, treat, cure, or prevent any disease. The marketing materials simultaneously reference clinical-grade performance, condition-specific use cases, and pulmonary specialist involvement — claims that consumers should evaluate carefully against the product’s own wellness device positioning.

The device is listed at $49.99 according to the official store, with free shipping, a 30-day money-back guarantee, and an optional extended warranty. Return terms should be verified directly with the company given potential discrepancies between marketing language and Terms of Service provisions.

Consumers who have completed their own research and consulted with a healthcare provider where appropriate can review the full product details. Complete product details, current pricing, and published terms are available by viewing the current NebuEase offer on the official product page.

Contact Information

For questions before or during the ordering process, according to the company’s published materials:

Company: Nebu Ease

Email: support@pickdiverse.co

Shop Website: nebuease.shop

Location: Spring Lake, New Jersey 07762

Disclaimers

Content and Consumer Information Disclaimer: This article is an independent informational consumer research report and does not constitute medical, health, or professional advice. All product details, feature descriptions, pricing, and policy terms described in this article are stated as presented by the company on its publicly available website and product materials. This content has not been independently audited or verified unless specifically noted. Readers are encouraged to verify all claims directly with the manufacturer and to consult a qualified healthcare professional before beginning any respiratory treatment or using a nebulizer device.

Device and Health Notice: NebuEase is described by the company as a general wellness device designed for comfort. According to the company’s published disclaimer, it is not intended to diagnose, treat, cure, or prevent any disease. Individuals with respiratory conditions including asthma, COPD, bronchitis, or other diagnosed conditions should consult a qualified healthcare provider before using any nebulizer device, changing devices, or modifying treatment protocols. Do not discontinue prescribed treatments without your physician’s guidance.

Results and Product Variability: Individual experiences with portable nebulizers vary based on factors including the solution used, respiratory health baseline, consistency of use, maintenance practices, and individual physiology. Marketing claims about user satisfaction statistics have not been independently verified. Product features, pricing, and shipping terms referenced in this article are based on information published on the official product website at the time of writing and may change without notice.

FTC Affiliate Disclosure and Publisher Responsibility: This article contains affiliate links. If a product is purchased through these links, a commission may be earned at no additional cost to the buyer. This compensation does not influence the accuracy, neutrality, or integrity of the information presented. The publisher of this article is not responsible for typographical errors, manufacturer changes to the product after publication, or individual consumer outcomes. All descriptions are based on publicly available information from the company’s official website and product materials.

CONTACT: Email: support@pickdiverse.co

ProstACT Global Phase 3 Study (Part 1) Achieves Primary Objectives




ProstACT Global Phase 3 Study (Part 1) Achieves Primary Objectives

• Webcast and conference call to be held today, Tuesday March 10 at 9:30 a.m. AEDT (Monday March 9 at 6:30 p.m. EDT). Investors can register at the following link: https://s1.c-conf.com/diamondpass/10053620-ju7y6t.html

MELBOURNE, Australia and INDIANAPOLIS, March 10, 2026 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that Part 1 of the ProstACT Global Phase 3 study, the safety and dosimetry lead-in for its therapeutic candidate – TLX591-Tx (lutetium-177 (¹⁷⁷Lu) rosopatamab tetraxetan) – has achieved its primary objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed.

Key findings include:

• Tolerability profile supported by dosimetry and low-grade non-hematologic events.
• Lesion dosimetry indicates no difference in absorbed dose profile across cohorts.
• No adverse drug-drug interactions observed in TLX591-Tx combinations.
• Hematologic events are in line with expectations and transient and manageable, with similar rates of recovery across all patient cohorts.
• The results from Part 1 are consistent with prior clinical studies of this first-in-class lutetium radio antibody-drug conjugate (rADC) therapy.

Part 1 of the study confirmed the safety profile, biodistribution and dosimetry of TLX591-Tx administered in two doses, 14 days apart, in combination with one of three standard of care (SOC) therapies: abiraterone, enzalutamide or docetaxel. The patient population comprised prostate-specific membrane antigen (PSMA) positive metastatic castration resistant prostate cancer (mCRPC) patients previously treated with one androgen receptor pathway inhibitor (ARPI).

ProstACT Global is a differentiated Phase 3 trial comparing PSMA-targeted ¹⁷⁷Lu-rADC therapy administered with SOC versus SOC alone, a trial design intended to reflect current global clinical practice¹. Telix has already advanced the study into Part 2 – a 2:1 randomized treatment expansion – in jurisdictions where the clinical trial has obtained approval from health authorities². Part 1 data will be presented to the United States (U.S.) Food and Drug Administration (FDA) to seek an Investigational New Drug (IND) amendment to progress Part 2 in the U.S.

Neeraj Agarwal, MD, Professor of Medicine and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, Salt Lake City, and ProstACT Global Principal Investigator and Steering Committee member, commented, “These results reinforce the feasibility of integrating TLX591-Tx with current standard of care therapies for mCRPC, including ARPIs such as enzalutamide or abiraterone, or docetaxel. Hematologic events align with those typically seen in this patient population and therapeutic class, and these cases resolved quickly. The dosimetry profile, along with the low-grade nature of non-hematologic adverse events, further supports the tolerability profile of this investigational therapy.”

David N. Cade, MD, Group Chief Medical Officer, Telix added, “Despite advances in clinical practice, men with advanced prostate cancer still need improved first and second line treatment options. These results build on prior findings and highlight the potential for TLX591-Tx in combination with contemporary standard of care, to become a new first-line option for patients facing this aggressive disease. We are encouraged by the data and look forward to engaging with the FDA at the earliest opportunity, while continuing to advance enrollment in Part 2 in regions where clinical trial initiation has already been approved.”

Summary results

ProstACT Global Part 1 dosed 36 patients, allocated across 3 cohorts:

• Cohort 1 (11 patients): TLX591-Tx + enzalutamide.
• Cohort 2 (11 patients): TLX591-Tx + abiraterone.
• Cohort 3 (14 patients): TLX591-Tx followed by docetaxel.

Safety and tolerability

• An acceptable safety profile was observed across combination cohorts and tolerability of TLX591-Tx was consistent with prior studies.
• All 36 patients received both doses of TLX591-Tx per protocol, no new safety signals were observed.
• Almost all treatment-emergent non-hematologic events were Grade 1 or Grade 2. The most prevalent were fatigue (53%), nausea (28%) and dry mouth (25%).
• Hematologic events were transient and manageable.
• Grade 3 thrombocytopenia (14%) and neutropenia (22%), and Grade 4 thrombocytopenia (31%) and neutropenia (25%) events were in line with the profile expected for this class of therapy and extent of disease.

Dosimetry and biodistribution

• Radiation exposure to key organs was well below established safety limits³.
• Limited dose to salivary glands and kidneys.
• Lesion dosimetry demonstrated uptake across tumor sites and across all cohorts.
• Pharmacokinetics demonstrated sustained activity at 15 days, corroborated by imaging which demonstrated prolonged tumor retention.
• No evidence of drug-drug interactions impacting TLX591-Tx targeting, distribution or clearance.

About ProstACT Global

ProstACT Global (ClinicalTrials.gov ID: NCT06520345) is an international, multicenter trial in two parts: Part 1, safety and dosimetry lead-in with 36 patients (complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a ⁶⁸Ga-PSMA-11 PET⁴ imaging agent (such as Illuccix®, kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection, or Gozellix®, kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection) following prior treatment with one ARPI.

The antibody approach demonstrates different targeting and pharmacology to that observed in other PSMA-targeted small molecule radioligand therapies (RLT). In contrast to these therapies⁵, collective long-term follow-up of patients administered with TLX591-Tx has not observed significant acute or delayed kidney toxicity, as the agent is primarily cleared through the liver, a comparatively radioresistant organ, instead of the kidneys⁶. Due to its large molecular weight, TLX591-Tx also demonstrates minimal salivary and lacrimal gland uptake, reducing dry mouth and dry eyes, common adverse effects of existing PSMA-targeted RLTs⁷.

Additional information on the Phase 3 ProstACT Global study can be found at: https://telixpharma.com/prostact/

About Telix Pharmaceuticals Limited

Telix is a global biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies, with the goal to address significant unmet medical needs in oncology and rare diseases. With international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan, Telix is headquartered in Melbourne, Australia. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Telix’s Precision Medicine franchise includes llluccix®, approved in multiple markets globally, and Gozellix®, approved by the U.S. FDA⁸. TLX591-Tx has not received a marketing authorization in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.

Media Contact

Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com

This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

Legal Notices

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¹ National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology for Prostate Cancer V3.2026; Narayan et al. Clin Genitourin Cancer. 2024.
² Part 2 is enrolling in Australia, New Zealand, and Canada, and has also received regulatory approval to commence in China, Singapore, South Korea, Türkiye, and the United Kingdom.
³ Wahl et al. J Nucl Med. 2021; Emami et al. Int J Radiat Oncol Biol Phys. 1991.
⁴ Positron emission tomography.
⁵ Tagawa et al. Curr Oncol Rep. 2021; Steinhelfer et al. J Nucl Med. 2024.
⁶ Tagawa et al. Cancer. 2019.
⁷ Pepin et al. Pract Radiat Oncol. 2025.
⁸ Telix ASX disclosure March 21, 2025.

TrimRx Telehealth Weight Loss Platform Examined in 2026 Consumer Research Report on GLP-1 Medication Access, Pricing Transparency and Safety Considerations




TrimRx Telehealth Weight Loss Platform Examined in 2026 Consumer Research Report on GLP-1 Medication Access, Pricing Transparency and Safety Considerations

An Informational Analysis of TrimRx Compounded Semaglutide and Tirzepatide Programs, Telehealth Prescription Process, Published Pricing Disclosures, Pharmacy Partnerships and Patient Safety Information for 2026

San Diego, California, March 09, 2026 (GLOBE NEWSWIRE) — Disclaimer: This article is for informational purposes only and does not constitute medical advice. GLP-1 and GLP-1/GIP receptor agonist medications are prescription treatments that require evaluation by a licensed clinician. Always consult a qualified healthcare professional before starting any prescription treatment. Some people purchase through affiliate links in this article, and a commission may be earned at no additional cost to you. This compensation does not influence the accuracy or integrity of the information presented.

As consumer demand for prescription GLP-1 weight-management medications continues to expand, telehealth platforms offering physician-supervised treatment options have emerged as a rapidly growing segment of the healthcare market. TrimRx, a telehealth weight-management platform, reports that it connects patients with licensed healthcare providers who evaluate eligibility for GLP-1 and GLP-1/GIP medications through online consultations.

This consumer research report examines publicly available information about the TrimRx platform, including its telehealth model, medication options, pricing disclosures, pharmacy partnerships, and safety considerations for individuals evaluating compounded GLP-1 treatments.

For anyone who has spent time searching for accessible weight loss medication options online, the sheer number of telehealth platforms can feel overwhelming. The questions that matter before committing to any program are straightforward: Are the providers properly licensed? Do the medications come from legitimate pharmacies? And is the company transparent enough about pricing and process for you to feel confident in what you are signing up for?

What follows is a breakdown of the publicly available information surrounding TrimRx, organized to help you evaluate those questions for yourself.

Growth of Telehealth GLP-1 Weight Loss Services

The telehealth weight loss market has expanded significantly in recent years, driven by several converging factors. GLP-1 receptor agonist medications — originally developed for type 2 diabetes management — have demonstrated substantial effects on body weight in clinical trials, leading to widespread consumer interest that has outpaced the capacity of many traditional healthcare settings.

For many people, access remains the fundamental barrier. In-person weight loss clinics may involve long wait times, limited geographic availability, and out-of-pocket costs that can exceed $1,000 per month for branded medications without insurance coverage. Telehealth platforms have emerged to address these access gaps by connecting patients with licensed providers through virtual consultations, often at lower price points than traditional in-person care.

This expansion has also brought increased scrutiny. Not all telehealth platforms operate with the same level of medical oversight, pharmacy quality, or pricing transparency. Understanding how a specific platform structures its care model — and verifying that structure independently — is an important part of the evaluation process for anyone considering this route.

Understanding the TrimRx Telehealth Weight Loss Platform

TrimRx operates using a three-entity structure that is common across telehealth platforms. Understanding who is actually involved in your care helps clarify what the platform does and does not do.

TrimRx (MetaFit Pharma Solutions LLC) functions as the telehealth platform facilitating connections between patients and healthcare providers. According to the company’s published terms, TrimRx itself is not a healthcare provider. The platform provides the technology infrastructure, customer service, intake forms, and coordination that enables the telehealth experience.

Licensed medical providers are independent healthcare professionals who review patient information submitted through the TrimRx platform and determine whether prescriptions are appropriate. These providers make clinical decisions based on the health information patients provide. According to the platform’s published FAQ, the company cannot guarantee that any individual will receive a prescription, as that determination rests entirely with the evaluating clinician.

Partner pharmacies fulfill prescriptions written by the medical providers. According to the company, TrimRx works with licensed, U.S.-based pharmacies that meet FDA regulations and hold LegitScript certification. Compounded medications are prepared by these pharmacy partners and shipped directly to patients.

This structure means that the platform coordinates your experience, but the medical decisions are made by independent clinicians and the medications are dispensed by separate licensed pharmacies. This separation is worth understanding because it defines where accountability sits at each stage of the process.

Medication Options Available Through TrimRx

According to the company’s website and published safety information, TrimRx offers both FDA-approved branded medications and compounded formulations. The distinction between these two categories carries important regulatory and safety implications.

According to the company’s disclosures, the platform may provide access to FDA-approved semaglutide and tirzepatide medications manufactured by major pharmaceutical companies, depending on clinician evaluation and patient eligibility. The company states that TrimRx has no affiliation with the manufacturers of these branded medications.

Compounded formulations contain the same active molecules used in the brand-name medications but are custom-prepared by licensed compounding pharmacies. Compounded medications are not individually FDA-approved products, though they use FDA-approved active ingredients. Unlike FDA-approved drugs, compounded medications are not reviewed by the FDA for safety, effectiveness, or quality before they are dispensed. They are prepared by pharmacies under federal and state compounding rules. The evaluating clinician determines whether this option is appropriate based on individual health factors.

According to the company’s published materials, compounded medications may be offered when FDA-approved medications are unavailable due to shortages, when a patient has a documented allergy to an inactive ingredient in an FDA-approved version, when a different dosage form is determined appropriate by the evaluating clinician, or when otherwise deemed medically necessary by the healthcare provider.

The company also states that it offers oral GLP-1 and GLP-1/GIP treatment options in addition to injectables, as well as supplements and wellness therapies described as supporting metabolic health.

Published Pricing Disclosures for TrimRx Programs

According to pricing information published on the TrimRx website as of March 2026, the company reports that its telehealth weight-management programs use an all-inclusive pricing model that bundles consultation, prescription services, and medication fulfillment. For compounded semaglutide, the company lists a standard price of $349 per month, with promotional pricing that may reduce the starting cost to approximately $199 per month depending on treatment plan selection.

For compounded tirzepatide, the company lists a standard price of $449 per month, with promotional pricing that may reduce the starting cost to approximately $349 per month.

According to the company, these prices include the telehealth consultation, prescription, medication, shipping, and ongoing medical support.

For FDA-approved branded medications, the published terms list semaglutide at $1,299 per month and tirzepatide at $1,399 per month, also inclusive of consultation, prescription, medication, shipping, and support.

The company advertises flat-rate pricing described as remaining the same regardless of dosage increases, with no hidden fees and no monthly membership charges. According to the website, payment options include monthly billing or bundle pricing across 3-month, 6-month, and 12-month terms. The company also states that installment options are available through third-party financing services.

Readers seeking to confirm current pricing and promotional terms can review the information published on the official TrimRx website, as promotional pricing is subject to change without notice.

Overview of the TrimRx Telehealth Evaluation and Prescription Process

According to the company’s published FAQ and process descriptions, the TrimRx program begins with a digital medical intake questionnaire designed to collect information about health history, current medications, weight management goals, and other relevant health factors.

A licensed provider then reviews the submitted information and determines whether treatment is appropriate for the individual patient. If the provider approves treatment, the patient receives a treatment recommendation and dosage plan. After checkout, the medication is prepared by a licensed pharmacy partner and shipped to the patient’s home.

The company states that prescription fulfillment timelines may vary based on provider approval and pharmacy processing schedules, and that delivery times depend on location and other logistical factors.

Per the company’s published materials, ongoing care includes the ability to message providers, schedule follow-up check-ins, and receive dose adjustments as determined appropriate by the treating clinician. The published FAQ notes that support is available seven days a week from 6am to 6pm Pacific time through phone and text at 888-896-1612.

Refund and Cancellation Terms

The financial terms of any telehealth program are worth understanding before submitting personal health information or payment. According to the TrimRx terms and conditions published on the company’s website, the refund policy contains several provisions that potential patients should evaluate carefully.

According to the published terms, refunds are granted under two circumstances: if a TrimRx medical provider determines during the initial consultation that the patient is not medically eligible for treatment, or if a billing error occurred due to a processing mistake by TrimRx. The terms state that once the initial medical intake has been submitted, the order is considered processed and is non-refundable, citing the utilization of medical and pharmacy resources including provider reviews, prescription processing, and shipping logistics.

The published terms further state that refund requests must be made within 28 days of the original payment date and submitted in writing. Regarding cancellation, the company’s FAQ states that patients can cancel before the next billing cycle and that support staff can assist with pausing or adjusting treatment plans.

Reviewing the complete terms and conditions before submitting an intake form ensures you understand the financial commitment involved.

Safety Considerations for GLP-1 and GLP-1/GIP Medications

GLP-1 and GLP-1/GIP receptor agonist medications are prescription treatments with established safety profiles studied in clinical trials. They are generally well tolerated when used as directed under medical supervision, but understanding the potential risks is an important part of the evaluation process. The following points represent a high-level overview and are not a complete list of risks or precautions.

Boxed warning (applies to the drug class): In animal studies, GLP-1 receptor agonist medications caused thyroid tumors, including thyroid cancer. It is not known whether these medications cause thyroid tumors or medullary thyroid carcinoma in humans. These medications should not be used by anyone with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.

Common side effects reported in clinical trials include nausea, diarrhea, vomiting, constipation, stomach pain, and injection site reactions. According to clinical data, these side effects tend to be most pronounced when starting treatment or during dose increases and often decrease over time.

Serious potential risks documented in prescribing information include pancreatitis, gallbladder problems, kidney injury related to dehydration, and allergic reactions. Patients with type 2 diabetes taking certain other glucose-lowering medications should be monitored for hypoglycemia.

These medications should not be used during pregnancy. According to published prescribing information for tirzepatide-based medications, oral hormonal contraceptives may have reduced efficacy, and patients should discuss alternative or barrier methods with their provider.

This safety overview is not exhaustive and does not replace the full prescribing information for any specific medication. Always review the complete safety information that comes with your prescription and consult your prescriber or pharmacist with any questions.

Regulatory Oversight of Compounded GLP-1 Medications

The regulatory landscape surrounding compounded GLP-1 medications has been an area of active oversight heading into 2026. Understanding the regulatory framework helps consumers evaluate the safety considerations specific to compounded treatments.

Compounded medications are prepared under a different regulatory framework than FDA-approved manufactured drugs. Traditional compounding pharmacies (503A facilities) operate under state pharmacy board oversight and must hold licenses in the states where they dispense medications. Outsourcing facilities (503B) register with the FDA and are subject to federal inspection, though FDA registration alone does not constitute FDA approval of the compounded products themselves.

The FDA has issued communications addressing risks associated with some compounded GLP-1 products, and the regulatory environment around compounding — particularly related to drug shortage designations that affect when compounding is permitted — continues to evolve. This context is relevant for anyone evaluating compounded GLP-1 options from any provider, not just TrimRx.

When evaluating any telehealth platform offering compounded medications, factors worth verifying include whether the pharmacy partners hold appropriate state licenses, whether 503B facilities are FDA-registered, and whether the platform provides transparent information about its pharmacy partnerships. According to TrimRx’s published materials, its pharmacy partners are LegitScript-certified and licensed in the United States.

Factors Consumers Often Consider When Evaluating Telehealth GLP-1 Platforms

Rather than presenting a subjective assessment, this section outlines the factors that publicly available consumer guidance and healthcare resources suggest are worth considering when evaluating any telehealth GLP-1 program.

Provider licensing and medical oversight. Verifying that the treating providers are licensed in your state and that the platform conducts a genuine medical evaluation — rather than auto-approving patients — is a foundational consideration. According to TrimRx’s published materials, the platform states that licensed providers review each intake independently.

Pharmacy transparency. Understanding where your medication comes from, whether the pharmacy holds appropriate licenses, and whether compounded products are prepared under adequate quality controls matters for safety. The company states that its pharmacy partners are U.S.-based and LegitScript-certified.

Pricing clarity. Knowing the full cost before committing — including whether consultation, medication, supplies, shipping, and follow-up care are included or billed separately — helps avoid unexpected charges. According to the company’s published pricing, TrimRx advertises all-inclusive monthly pricing.

Refund and cancellation terms. Understanding what happens financially if you are not approved, if you need to cancel, or if treatment does not proceed as expected is worth reviewing before submitting an intake form. As noted above, TrimRx’s published terms describe a limited refund policy.

Ongoing medical support. Access to providers for dose adjustments, side effect management, and ongoing monitoring contributes to treatment safety and effectiveness. The company states that ongoing support and follow-up consultations are included in its program pricing.

Compounded vs. FDA-approved medication options. Understanding the regulatory differences between compounded and FDA-approved medications — and having the opportunity to discuss both options with a provider — allows for a more informed treatment decision. Readers interested in exploring these options can review the medication information published on the official TrimRx website.

Key Considerations for Consumers Evaluating Telehealth GLP-1 Programs

Based on the publicly available information examined in this consumer research report, TrimRx positions itself as a telehealth platform connecting patients with licensed providers for GLP-1 and GLP-1/GIP medication access. The company reports compounded semaglutide programs starting at approximately $199 per month and compounded tirzepatide programs starting at approximately $349 per month based on current promotional pricing.

The platform describes a structure that includes licensed medical providers making independent prescribing decisions, pharmacy partners the company states are LegitScript-certified, all-inclusive pricing, and ongoing medical support. The company also offers FDA-approved branded medications at higher price points for patients and providers who prefer that route.

Considerations that warrant careful evaluation include the company’s published refund policy — which limits refunds once a medical intake has been submitted — the fact that compounded medications are not FDA-approved finished products, and the evolving regulatory landscape around compounded GLP-1 treatments more broadly. As with any prescription treatment, the determination of whether GLP-1 therapy is appropriate rests with a qualified clinician evaluating your individual health profile.

Important note: The telehealth and compounded medication industry has been under increased regulatory scrutiny in recent years. Consumers should review the most current information about any platform’s compliance, quality, and regulatory standing before starting treatment.

Readers seeking additional information about the TrimRx program can review current program details and pricing on the official TrimRx website.

Contact Information

For questions before or during the process, according to the company’s website, TrimRx offers customer support:

Phone: 888-896-1612
Hours: 7 days a week, 6am–6pm Pacific Time
Email: hello@trimrx.com

Disclaimers

Content and Medical Disclaimer: This article is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. The descriptions of potential benefits are not guarantees and are not a substitute for an individualized medical evaluation. GLP-1 and GLP-1/GIP receptor agonist medications are prescription treatments that require evaluation by a licensed clinician. The information provided here does not replace the professional judgment of your healthcare provider.

Professional Medical Disclaimer: This article is educational and does not constitute medical advice. Prescription weight loss medications are not a substitute for prescribed medical treatment for other health conditions. If you are currently taking medications, have existing health conditions, are pregnant or nursing, or are considering any major changes to your health regimen, consult your physician before starting any new prescription treatment. Do not change, adjust, or discontinue any medications or prescribed treatments without your physician’s guidance and approval.

Compounded Medication Notice: TrimRx offers both FDA-approved branded medications and compounded formulations. Compounded medications are not reviewed or approved by the FDA as finished products. They are prepared using active ingredients by licensed pharmacies under federal and state compounding rules. The evaluating clinician determines whether compounded or FDA-approved options are appropriate based on individual health factors. FDA-approved branded medications (such as Ozempic, Wegovy, Zepbound, and Mounjaro) are the actual products manufactured by their respective companies and have undergone FDA review for safety and effectiveness for their approved indications.

Results May Vary: Individual results will vary based on factors including age, baseline health condition, body composition, lifestyle factors, consistency of use, genetic factors, current medications, and other individual variables. GLP-1 and GLP-1/GIP receptor agonist medications are clinically studied for their approved indications; clinical trial results reflect specific study populations and protocols and may not predict individual outcomes. Results are not guaranteed.

FTC Affiliate Disclosure: This article contains affiliate links. If you purchase through these links, a commission may be earned at no additional cost to you. This compensation does not influence the accuracy, neutrality, or integrity of the information presented. All descriptions are based on publicly available information from the company’s official website, published terms, and general industry context.

Pricing Disclaimer: All prices, discounts, and promotional offers mentioned were accurate based on publicly available information at the time of publication (March 2026) but are subject to change without notice. Always verify current pricing and terms on the official TrimRx website before making your purchase.

Publisher Responsibility: The publisher of this article has made every effort to ensure accuracy at the time of publication. We do not accept responsibility for errors, omissions, or outcomes resulting from the use of the information provided. Readers are encouraged to verify all details directly with TrimRx and their healthcare provider before making decisions.

Insurance Coverage Note: Many direct-to-consumer prescription products are not covered by traditional insurance plans, but coverage policies vary. Always confirm benefits directly with your insurer. Some HSA/FSA plans may reimburse qualifying expenses; check your specific plan rules.

CONTACT: Phone: 888-896-1612
Email: hello@trimrx.com

Sherry Cummings, CEO of Gryphon Healthcare, Named One of the Top 50 Women to KNOW in Texas




Sherry Cummings, CEO of Gryphon Healthcare, Named One of the Top 50 Women to KNOW in Texas

HOUSTON, March 09, 2026 (GLOBE NEWSWIRE) — Sherry Cummings, Chief Executive Officer of Gryphon Healthcare, has been named one of the 2026 Women to KNOW in Texas, a prestigious statewide honor recognizing women who are shaping the future of business, leadership, and community impact.

Cummings was formally recognized during the Women to KNOW in Texas Gala on Sunday, March 1, 2026, at Brake & Clutch in Dallas, Texas. The evening celebration included a red-carpet welcome, live entertainment, and the presentation of the official Women to KNOW Texas hardcover publication.

The Women to KNOW distinction is reserved for exemplary leaders who demonstrate proven professional accomplishment, measurable community impact, and a commitment to supporting and empowering other women. Honorees are interviewed and selected by a panel of previous award recipients and respected community leaders through a rigorous review process.

Cummings serves as CEO of Gryphon Healthcare, a Houston-based revenue cycle management company supporting hospitals, freestanding emergency rooms, urgent care centers, ambulatory surgery centers, and physician groups. With more than 30 years of healthcare experience, she brings a unique combination of clinical insight and financial expertise to her role. After being named President in 2022 during a period of financial and operational challenge, Cummings led Gryphon through a disciplined turnaround, restoring profitability, strengthening operations, and positioning the company for sustainable growth. She was named CEO in October 2025 and now leads the organization into its next phase of expansion. Under her leadership, Gryphon continues to deliver what the company calls the “Gryphon Difference,” a hands-on, results-driven approach that protects revenue, improves operational efficiency, and allows providers to focus on patient care.

Beyond financial performance, Cummings is deeply committed to mentorship and leadership development. She supports the next generation of female leaders by sharing her expertise, encouraging confidence, and creating environments where women are empowered to grow.

“Knowledge is key. Confidence is power. Together, they unlock potential and drive you forward,” said Cummings. “Women empowerment means recognizing and nurturing the strength, intelligence, and potential in one another. It is about lifting as we climb, creating space at the table, sharing opportunity, and supporting women through mentorship, encouragement, and example. I truly believe that the more you know, the better you are, and knowledge should never be guarded.”

The 2026 Women to KNOW in Texas hardcover publication features the highest caliber women from across the state and represents a once-in-a-lifetime honor. To be named a Woman to KNOW is to join a legacy network of leaders recognized for excellence, integrity, and influence.

ABOUT GRYPHON HEALTHCARE
Gryphon Healthcare is a Houston-based revenue cycle management firm providing end-to-end services including billing and collections, coding and compliance, denial management and appeals, federal and state IDR, prompt pay, contract negotiation, credentialing, and patient collections. Backed by decades of experience, Gryphon partners with healthcare organizations to maximize reimbursement, improve operational performance, and protect long-term financial stability. For more information, visit www.gryphonhc.com.

Media Contact
Felicia Perez
felicia@farpublicrelations.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/49ba7ee7-a565-4ee0-8bbc-f5bae599eaf1

Cytek® Biosciences Celebrates One Year of Operations at Singapore Facility, Accelerating Growth and Regional Impact




Cytek® Biosciences Celebrates One Year of Operations at Singapore Facility, Accelerating Growth and Regional Impact

Anniversary Milestone Highlights Expanded Manufacturing Capacity, Stronger Asia-Pacific Presence, and Measurable Contributions to Global Supply Chain Resilience

FREMONT, Calif., March 09, 2026 (GLOBE NEWSWIRE) — One year after opening its 8,500-square-foot Singapore facility, spectral flow cytometry leader Cytek Biosciences, Inc. (Nasdaq: CTKB) is marking a major milestone in its Asia-Pacific (APAC) expansion. Serving as a strategic hub supporting customers across APAC and worldwide, the Singapore facility has contributed to Cytek’s growth over the past 12 months, significantly enhancing Cytek’s manufacturing capacity, regional service and training capabilities, and reinforcing global supply chain resilience while helping mitigate geopolitical and trade-related risks.

As life sciences research continues to expand worldwide, Cytek’s Singapore operations stand as a critical global component of its regional manufacturing strategy, advancing scientific discovery and supporting sustained business growth in one of the fastest-growing regions for biomedical research.

“Establishing operations in Singapore has been a transformative step for Cytek,” said Wenbin Jiang, Ph.D., CEO of Cytek Biosciences. “In just one year, the facility has strengthened our manufacturing footprint, improved supply chain agility, and deepened our engagement with customers across APAC. This milestone reflects our commitment to investing in infrastructure that empowers scientists to move discovery forward.”

Driven by the growing global use of cellular analysis in immunology, immuno-oncology, infectious diseases, cancer diagnosis and cancer drug development, Cytek’s Singapore expansion was designed to address rising demand for cell analysis solutions. Over the past year, the facility has enhanced production scalability and reduced delivery times in key markets. The site also features a dedicated service and training center that provides hands-on, regional access to Cytek instruments and advanced technical expertise in addition to its manufacturing operation.

“Cytek Biosciences’ new facility has been a welcome addition to Singapore’s MedTech ecosystem,” said Marcus Dass, Senior Vice President and Head, Global Enterprises, Singapore Economic Development Board. “The investment strengthens our advanced manufacturing capabilities as well as contributes to life sciences research through the company’s cell analysis technologies. We are also heartened to hear that Cytek Biosciences is working with our Institutes of Higher Learning and Research Institutes to drive innovation and talent development.”

For more information, please visit https://cytekbio.com/.

About Cytek Biosciences, Inc.
Cytek Biosciences (Nasdaq: CTKB) is a leading cell analysis solutions company advancing the next generation of cell analysis tools by delivering high-resolution, high-content and high-sensitivity cell analysis utilizing its patented Full Spectrum Profiling™ (FSP^®) technology. Cytek’s novel approach harnesses the power of information within the entire spectrum of a fluorescent signal to achieve a higher level of multiplexing with precision and sensitivity. Cytek’s platform includes: its core FSP instruments, the Cytek Aurora™, Northern Lights™, Cytek Aurora™ CS and Cytek Aurora™ Evo systems; the Muse^® Micro system; the Cytek Orion™ reagent cocktail preparation system; the Enhanced Small Particle™ (ESP™) detection technology; the flow cytometers and imaging products under the Amnis^® and Guava^® brands; and reagents, software and services to provide a comprehensive and integrated suite of solutions for its customers. Cytek is headquartered in Fremont, California with offices and distribution channels across the globe. More information about the company and its products is available at www.cytekbio.com.

Cytek’s products are for research use only and not for use in diagnostic procedures (other than Cytek’s Northern Lights-CLC system and certain reagents, which are available for clinical use only in China and the European Union).

Cytek, Full Spectrum Profiling, FSP, Cytek Aurora, Northern Lights, Enhanced Small Particle, ESP, Cytek Orion, Muse, Amnis and Guava are trademarks of Cytek Biosciences, Inc.

In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Cytek uses its website (www.cytekbio.com), LinkedIn page and X account as channels of distribution of information about its company, products, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Cytek may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Cytek’s website, LinkedIn page, and X account in addition to following its SEC filings, news releases, public conference calls and webcasts.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. These forward-looking statements include statements regarding Cytek’s manufacturing strategy and capacity, service and training capabilities, supply chain resilience and investments in infrastructure. These statements are based on management’s current expectations, forecasts, beliefs, assumptions and information currently available to management. These statements also deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include global geopolitical, economic and market conditions; Cytek’s ability to manage the impacts of recent and future export controls and licensing requirements, tariffs and NIH funding policies on its business; Cytek’s ability to evaluate its prospects for future viability and predict future performance; Cytek’s ability to accurately forecast customer demand and adoption of its products; Cytek’s ability to recognize the anticipated benefits of collaborations; Cytek’s dependence on certain sole and single source suppliers; competition; market acceptance of Cytek’s current and potential products; Cytek’s ability to manage the growth and complexity of its organization, maintain relationships with customers and suppliers and hire and retain key employees; Cytek’s ability to manufacture its products in high-quality commercial quantities successfully and consistently to meet demand; Cytek’s ability to increase penetration in its existing markets and expand into adjacent markets; Cytek’s ability to secure additional distributors or maintain good relationships with its existing distributors; Cytek’s ability to successfully develop and introduce new products; Cytek’s ability to maintain, protect and enhance its intellectual property; Cytek’s ability to continue to stay in compliance with its material contractual obligations, applicable laws and regulations; and foreign currency exchange impacts. You should refer to the section entitled “Risk Factors” set forth in Cytek’s Annual Report on Form 10-K filed on February 26, 2026 with the SEC, and other filings Cytek makes with the SEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Cytek’s forward-looking statements. Although Cytek believes that the expectations reflected in the forward-looking statements are reasonable, it cannot provide any assurance that these expectations will prove to be correct nor can it guarantee that the events and circumstances reflected in the forward-looking statements will occur. The forward-looking statements in this press release are based on information available to Cytek as of the date hereof, and Cytek disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Cytek’s as of any date subsequent to the date of this press release.

Media Contact:
Stephanie Olsen
Lages & Associates
(949) 453-8080
stephanie@lages.com

Investor Contact:
Paul Goodson
Head of Investor Relations
Cytek Biosciences
pgoodson@cytekbio.com

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Relmada Therapeutics to Present at the Leerink Partners Global Healthcare Conference




Relmada Therapeutics to Present at the Leerink Partners Global Healthcare Conference

CORAL GABLES, Fla., March 09, 2026 (GLOBE NEWSWIRE) — Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today announced that Sergio Traversa, Chief Executive Officer, and Maged Shenouda, Chief Financial Officer, will participate in the Leerink Partners Global Healthcare Conference being held in Miami, Florida, from March 8-11, 2026.

Leerink Partners Global Healthcare Conference Details
Format: Fireside Chat
Date Tuesday, March 10, 2026
Time: 8:40 AM ET
Webcast: Click Here

Management will also be available for one-one-one investor meetings during the conference. Please contact your Leerink Partners representative to schedule a meeting.

The webcast can also be accessed on the Events page the Investors section of the Relmada website at https://www.relmada.com/for-investors/ir-calendar An archived replay will be available for 90 days following the conclusion of the event.

About Relmada Therapeutics, Inc.

Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology and central nervous system conditions. Its lead candidates, NDV-01 and sepranolone, are advancing through mid-stage clinical development with the potential to address significant unmet needs.

For more information, visit www.relmada.com

Investor Contact:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com

Media Inquiries:
Corporate Communications
media@relmada.com

Mesa Laboratories Announces CEO Transition and Appointment of Siddhartha Kadia as President and CEO




Mesa Laboratories Announces CEO Transition and Appointment of Siddhartha Kadia as President and CEO

LAKEWOOD, Colo., March 09, 2026 (GLOBE NEWSWIRE) —  Mesa Laboratories, Inc. (NASDAQ: MLAB) (“Mesa” or “the Company”), a global leader in the design and manufacture of life science tools and critical quality control solutions, today announced that Gary Owens will step down as President and CEO on April 12, 2026, and will enable a smooth leadership transition.

“Gary has served as Mesa’s CEO since 2017, leading Mesa through a period of significant growth, expansion into new markets, the maturation of the company’s foundation, and the implementation of The Mesa Way business system,” said John Sullivan, Chair of the Board. “We are grateful for his leadership and wish him continued success.”

To lead the Company’s next chapter, the Board of Directors has appointed Dr. Siddhartha Kadia as President and Chief Executive Officer, effective April 13, 2026. Dr. Kadia will also join the Board.

Dr. Sullivan added, “Siddhartha is a proven global executive with deep experience scaling life sciences businesses. His track record of commercializing innovative technologies and leading complex organizations makes him the right leader for Mesa’s next chapter.”

Dr. Kadia most recently served as CEO of Calibre Scientific and previously led PhenomeX (formerly Berkeley Lights). Earlier, he was President and CEO of EAG Laboratories, which expanded significantly before being acquired by Eurofins Scientific. He also served as President of Life Sciences at Life Technologies, overseeing a $2 billion global business, and held senior leadership roles in Japan, Greater China, and led the e-commerce business. He began his career at McKinsey & Company in the healthcare practice.

Dr. Kadia has served on the boards of several public life sciences companies, including NuVasive, Volcano Corporation, Newport Corporation, Horizon Discovery Group, Berkeley Lights, and IsoPlexis. He holds a Ph.D. in Biomedical Engineering from the Johns Hopkins University School of Medicine, an M.S. from Rutgers University, and a B.E. from L.D. College of Engineering, Gujarat University.

“I am honored to join Mesa at this important time,” said Dr. Kadia, “I look forward to working with the talented team to build on the Company’s strong foundation and continue delivering long-term value for our customers, employees, and shareholders.”

About Mesa Laboratories, Inc.
Mesa is a global leader in the design and manufacture of life science tools and critical quality control solutions for regulated applications in the pharmaceutical, healthcare and medical device industries. Mesa offers products and services to help our customers ensure product integrity, increase patient and worker safety, and improve the quality of life throughout the world.

Forward Looking Statements

This press release may contain information that constitutes forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our historical experience and present expectations or projections.  Forward-looking statements include statements relating to leadership, strategic matters and future results. Generally, the words “expect,” “anticipate,” “seek,” “intend,” “plan,” “believe,” “could,” “estimate,” “may,” “target,” “project,” and similar expressions identify forward-looking statements. However, the absence of these words or similar expressions does not mean that a statement is not forward-looking. These statements are based upon current information and expectations. Actual results may differ materially from those estimated or anticipated as a result of these risks and unknowns or other risks and uncertainties. For additional information concerning these and other risks and uncertainties that could affect these statements, and our business, see our Annual Report on Form 10-K for the year ended March 31, 2025, as well as other risks and uncertainties detailed from time to time in our reports on Forms 10-Q and 8-K subsequently filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We undertake no obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof, to provide any updates, or to reflect the occurrence of future events.

CONTACT: John Sakys; CFO of Mesa Laboratories, Inc., +1-303-987-8000

For more information about the Company, please visit its website at www.mesalabs.com

Mineralys Therapeutics Announces FDA Acceptance of NDA for Lorundrostat for Treatment of Adults with Hypertension and Topline Explore-OSA Trial Results




Mineralys Therapeutics Announces FDA Acceptance of NDA for Lorundrostat for Treatment of Adults with Hypertension and Topline Explore-OSA Trial Results

– The FDA assigned a PDUFA target action date of December 22, 2026 –

– The NDA is based on positive data from a successful clinical program demonstrating favorable safety and blood pressure reduction in adults with hypertension –

– Topline results from the Phase 2 Explore-OSA exploratory trial did not reduce AHI; demonstrated a clinically meaningful reduction in blood pressure and favorable safety and tolerability in this population with difficult to control hypertension –

RADNOR, Pa., March 09, 2026 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026.

“The FDA’s acceptance of our NDA for lorundrostat marks an important milestone in our efforts to address the clinically significant need faced by millions of patients living with uncontrolled or resistant hypertension,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “While the Explore-OSA trial did not demonstrate a reduction in AHI, the blood pressure reductions and safety profile were clinically meaningful, especially for this difficult to control population. We believe lorundrostat has the potential to become an important new treatment option for resistant and uncontrolled hypertension, and we look forward to working with the FDA as we advance toward potential approval.”

Explore-OSA Trial Topline Results

The Explore-OSA trial was a Phase 2 exploratory trial of lorundrostat in forty-eight participants with an average body mass index (BMI) of 38.2 kg/m², an average apnea-hypopnea index (AHI) of 48.5 events/hr and an average systolic blood pressure (BP) of 142.3 mmHg (range 131-175 mmHg). After four weeks of treatment, lorundrostat 50 mg dosed in the evening did not demonstrate a clinically meaningful difference relative to placebo on the apnea-hypopnea index (AHI), the primary endpoint.

At week four, the trial demonstrated an 11.1 mmHg (p < 0.0001) and a 1.0 mmHg (p = NS) BP reduction with lorundrostat and placebo, respectively, in the pre-planned parallel arm analysis of the first period. There was a 6.2 mmHg placebo-adjusted reduction (p < 0.0003) in BP in the crossover analysis.

Lorundrostat demonstrated a favorable safety profile and was well tolerated, with no serum potassium excursions above 5.5 mmol/L. Analysis is ongoing for other endpoints in the trial and will be reported in future publications or medical meetings.

About Launch-HTN

Launch-HTN (NCT06153693) was a global, randomized Phase 3 double-blind, placebo-controlled trial of adults whose blood pressure (BP) remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: placebo; lorundrostat 50 mg once daily; or lorundrostat 50 mg once daily with the option to increase to 100 mg at week six. The primary endpoint was change from baseline in systolic BP at six weeks versus placebo, measured by automated office blood pressure monitoring.

About Advance-HTN

Advance-HTN (NCT05769608) was a randomized, double-blind, placebo-controlled Phase 2 clinical trial that evaluated the efficacy and safety of lorundrostat for the treatment of uncontrolled or resistant hypertension, when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications in adult participants. Participants who met screening criteria had their existing hypertension medications discontinued and started on a standard regimen of an angiotensin II receptor blocker (ARB) and a diuretic, if previously on two medications, or a standard regimen of ARB, diuretic and calcium channel blocker if previously on three to five medications. Participants who remained hypertensive despite the standardized regimen were then randomized into three cohorts and treated for twelve weeks: lorundrostat 50 mg once daily, lorundrostat 50 mg once daily and an option to titrate to 100 mg once daily at week four based on defined criteria, or placebo. The trial’s primary endpoint was the change in 24-hour ambulatory systolic blood pressure at week twelve from baseline for active cohorts versus placebo.

About Explore-OSA

The Explore-OSA trial (NCT06785454) was a Phase 2 randomized, double-blind, placebo-controlled, crossover trial. This proof-of-concept trial was designed to evaluate the efficacy, safety, and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension. Participants in Explore-OSA received 50 mg of oral, once daily (QD) lorundrostat and placebo in sequential treatment periods, with continuous monitoring of BP during overnight polysomnography. The primary efficacy endpoint of the trial was absolute change from baseline in apnea-hypopnea index (AHI) after four weeks of active treatment compared to placebo. The first secondary endpoint was AOBP, and additional endpoints were nighttime BP and sleep and cardiovascular health measures.

About Obstructive Sleep Apnea

OSA is characterized by repetitive overnight hypoxic episodes and subsequent sleep fragmentation due to a complete or partial collapse of the upper airway. Moderate to severe OSA is associated with increased production of aldosterone and increased nighttime BP; standard treatment with positive airway pressure is not sufficient for BP reduction. OSA impacts almost one billion people globally, including 425 million moderate-to-severe cases. Around 80% of adults with OSA are undiagnosed. As of 2025, untreated OSA is estimated to cost the United States more than $150 billion annually when considering direct medical expenses, productivity losses and accident-related costs.

Between 30-50% of adults with hypertension have OSA, and this number increases to between 70-80% in adults with resistant hypertension (rHTN). Additionally, untreated moderate-to-severe OSA increases the risk of rHTN. Along with hypertension, OSA is a major risk factor of cardiovascular disease, type-2 diabetes mellitus and stroke.

About Hypertension

Having sustained, elevated blood pressure (BP or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019.

Less than 50% of hypertension patients achieve their BP goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients.

About Lorundrostat

Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive participants.

The Company has now completed five successful Phase 2/3 clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. This includes two pivotal, registrational trials, including the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile.

About Mineralys

Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky.

Forward Looking Statements

Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the timing and results of review of additional endpoints evaluated in the  Explore-OSA clinical trial; the anticipated timing of the FDA’s review of the Company’s accepted NDA and any subsequent regulatory approval of lorundrostat; and the planned future clinical development of lorundrostat and the timing thereof; Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; any delays in the FDA’s review of our accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel, the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following submission of an NDA and the FDA’s review of the same; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies;; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Tanabe Pharma Corporation to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:

Investor Relations
investorrelations@mineralystx.com

Media Relations
Melyssa Weible
Elixir Health Public Relations
Email: mweible@elixirhealthpr.com