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BIOXYTRAN, INC. COMPLETES $1.2 MILLION PRIVATE PLACEMENT

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BIOXYTRAN, INC. COMPLETES $1.2 MILLION PRIVATE PLACEMENT




BIOXYTRAN, INC. COMPLETES $1.2 MILLION PRIVATE PLACEMENT

Financing strengthens balance sheet and supports advancement of key development initiatives

NEWTON, MA, March 20, 2026 (GLOBE NEWSWIRE) — Bioxytran, Inc. (OTC: BIXT), a clinical-stage biotechnology company focused on developing therapies targeting hypoxia and viral diseases, today announced that it has completed a private placement financing on March 18, 2026, resulting in gross proceeds of approximately $1.2 million.

In connection with the financing, the Company issued an aggregate of approximately 21,071,667 shares of its common stock at a purchase price of approximately $0.055 per share. Investors also received warrants to purchase up to 19,750,001 additional shares of common stock at an exercise price of $0.12 per share. The warrants have a term of five years from the date of issuance.

The securities were offered and sold in a private placement pursuant to an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended, and/or Regulation D promulgated thereunder. The securities have not been registered under the Securities Act and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

The Company intends to use the net proceeds from the financing for working capital and general corporate purposes, including advancing its development programs and supporting selected commercialization initiatives.

“This financing strengthens our balance sheet and supports the advancement of our clinical and development initiatives,” said David Platt, PhD, Chief Executive Officer of Bioxytran. “In parallel, we are beginning to translate our galectin-targeting platform into commercial opportunities, including the market introduction of A-SUQAR®, our plant-derived dietary supplement expected to launch this quarter. This dual-track approach allows us to pursue near-term commercialization while continuing to advance our higher-value pharmaceutical programs.”

The warrants issued in connection with the financing provide the potential for additional capital upon exercise, further supporting the Company’s long-term growth plans.

About Bioxytran, Inc.

Bioxytran, Inc. is a biotechnology company focused on the development of therapeutics targeting hypoxia-related conditions and galectin-targeting carbohydrate technologies, with applications across infectious viral diseases, metabolic health, and inflammation. The company leverages proprietary technologies to address significant unmet medical needs, with programs spanning pharmaceutical development and select commercial applications.

Forward-Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding the use of proceeds, future development plans, anticipated commercialization activities, and potential warrant exercises. Actual results may differ materially from those projected due to various factors. Bioxytran undertakes no obligation to update these statements except as required by law.

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

Investor Contact:
David Platt, PhD
CEO, Bioxytran, Inc.
617-484-1199
David.Platt@bioxytraninc.com

RenovoRx to Host Fourth Quarter and Full Year 2025 Financial Results and Business Highlights Conference Call on March 30th at 4:30 p.m. ET

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RenovoRx to Host Fourth Quarter and Full Year 2025 Financial Results and Business Highlights Conference Call on March 30th at 4:30 p.m. ET




RenovoRx to Host Fourth Quarter and Full Year 2025 Financial Results and Business Highlights Conference Call on March 30th at 4:30 p.m. ET

MOUNTAIN VIEW, Calif., March 20, 2026 (GLOBE NEWSWIRE) — RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, FDA-cleared drug-delivery device, today announced that it will host its fourth quarter and full year 2025 financial results and business highlights conference call on March 30, 2026, at 4:30 p.m. ET. Additional details will be available on the Investor Relations section of the Company’s website at https://ir.renovorx.com/.

On the call, RenovoRx’s management team is expected to discuss the continued progress in RenovoCath adoption among U.S. cancer centers, strengthening clinical and commercial momentum.

Management will also provide an update on the advancement of RenovoRx’s clinical pipeline, including the Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer, which remains on track to complete enrollment in the first half of 2026, with final data expected in 2027. The Company will discuss its strategy for generating new data through post-marketing registry studies in solid tumors and continued support of investigator-initiated trials (IIT) in borderline resectable and metastatic pancreatic cancer, along with exploring physician interest in other areas. Registry and IIT trials achieve cost neutrality as capital-efficient studies providing meaningful data that may further broaden the application for the TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform.

Event: RenovoRx Fourth Quarter and Full Year 2025 Financial Results and Business
Highlights Conference Call
Date: Monday, March 30, 2026
Time: 4:30 p.m. ET
Live Call: 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)
Webcast: https://ir.renovorx.com/news-events/ir-calendar-events
 

For interested individuals unable to join the conference call, a link to the recording will be available on RenovoRx’s Investor Relations website, and a dial-in replay will be available until April 13, 2026 and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number 13758677.

About RenovoRx, Inc.
RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents.

RenovoRx is in the initial stages of actively commercializing its TAMP technology and FDA-cleared RenovoCath as a stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices, and for the first nine months of 2025, approximately $900,000 of revenues were generated from RenovoCath sales. Several customers have already initiated repeat orders in parallel to RenovoRx expanding the number of medical institutions initiating new RenovoCath orders, including several esteemed, high-volume National Cancer Institute-designated centers. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity, either on its own or in tandem with a medical device commercial partner.

RenovoRx is also evaluating its novel drug-device combination oncology product candidate intra-arterial gemcitabine delivered via RenovoCath, (known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, the Company’s patented, FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

The IAG combination product candidate, which is enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA.

For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X.

Cautionary Note Regarding Forward-Looking Statements
This press release, the conference call described herein, and statements of the Company’s management made in connection therewith contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) our clinical trials and studies, (ii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and (iii) our efforts to commercialize our RenovoCath and TAMP technology. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control, and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections, and statements relating to our research and development plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives, and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “estimates,” “intends,” and “potential,” or the negative of these terms or other comparable terminology regarding RenovoRx’s expectations strategy, plans, or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our exploration of commercial opportunities for our TAMP technology may not lead to viable, revenue generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding; (iii) the timing of the initiation, progress, and potential results (including the results of interim analyses) of our preclinical studies, clinical trials, and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate;(v) that the applicable regulatory authorities may disagree with our interpretation of the data, research and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing and our ability to obtain additional capital; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the implementation of our strategic plans for our business and product candidates; (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates, and research programs; (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xx) the pricing, coverage, and reimbursement of our product candidates, if approved; and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission.

Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.

Contact:
KCSA Strategic Communications
Valter Pinto or Jack Perkins
T: 212-896-1254
RenovoRX@KCSA.com

WallabyPhenox Announces First U.S. Patient Treated with p48 & p64 MW HPC Flow Modulation Devices in PIANO IDE Trial

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WallabyPhenox Announces First U.S. Patient Treated with p48 & p64 MW HPC Flow Modulation Devices in PIANO IDE Trial




WallabyPhenox Announces First U.S. Patient Treated with p48 & p64 MW HPC Flow Modulation Devices in PIANO IDE Trial

IRVINE, Calif., March 20, 2026 (GLOBE NEWSWIRE) — WallabyPhenox today announced the successful treatment of the first U.S. patient in the p48 and p64 MW HPC in Aneurysm Occlusion (PIANO) IDE trial, evaluating the p48 and p64 MW HPC Flow Modulation Devices for the treatment of intracranial aneurysms. The first two procedures were performed by Adel Malek, MD, PhD, Chief of Neurovascular Surgery at Tufts Medical Center in Boston, MA.

“Initiating the PIANO IDE trial is an important milestone in our company’s history and demonstrates our commitment to bringing life-saving innovations to patients in the United States,” said Ruilin Zhao, CEO of WallabyPhenox.

Flow diversion is an established therapy for intracranial aneurysms. However, limited device options remain available to U.S. physicians. The p48 and p64 MW HPC flow diverters are the market leader in Germany.

“The p48 and p64 MW HPC devices have been used in the treatment of more than 20,000 patients worldwide, with data from rigorous studies conducted outside the United States demonstrating consistently high aneurysm occlusion rates and low complication rates,” said Gary Brogan, VP of Global Clinical & Regulatory Affairs.

The p48 & p64 MW HPC devices bring multiple novel features including the first Movable Wire (MW) technology designed for stable and controlled positioning. The Hydrophilic Polymer Coating (HPC) is designed to reduce thrombogenicity of the implant. Smaller microcatheter delivery simplifies procedural access. Lastly, the Nitinol wires with platinum core provide full radiographic visibility.

“We are pleased to usher in this unique flow diverter that the U.S. physician community has been eagerly awaiting,” said Demetrius Lopes, MD, who serves as the National Principal Investigator along with Jared Knopman, MD, and Eytan Raz, MD, PhD.

“We always welcome the opportunity to offer new innovations and technologies to our patients through cutting-edge clinical trials,” said Dr. Malek. “A device that proves to be safe, effective and efficient will only enhance our ability to treat intracranial aneurysms and ensure the best-possible outcomes for our patients.”

Enrollment in the PIANO IDE trial is ongoing at leading U.S. centers.

The p48 and p64 MW HPC Flow Modulation Devices are investigational devices in the United States and are limited by federal law to investigational use.

CONTACT Travis May
Director of Upstream Marketing
EMAIL Travis.May@wallabyphenox.com 
COMPANY WallabyPhenox

Biodesix Announces the Largest Lung Nodule Biomarker Clinical Validation Study Ever Published Supporting Earlier Lung Cancer Diagnosis

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Biodesix Announces the Largest Lung Nodule Biomarker Clinical Validation Study Ever Published Supporting Earlier Lung Cancer Diagnosis




Biodesix Announces the Largest Lung Nodule Biomarker Clinical Validation Study Ever Published Supporting Earlier Lung Cancer Diagnosis

A retrospective pooled analysis of 1,100 patients demonstrates the Nodify CDT® test’s consistent clinical performance across nodule sizes and patient populations

LOUISVILLE, Colo., March 20, 2026 (GLOBE NEWSWIRE) — Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostics solutions company, announced the publication of the largest lung nodule biomarker clinical validation study ever conducted. This milestone strengthens the clinical foundation for Nodify CDT® tests as a critical decision-support tool in the early detection of lung cancer, addressing a significant unmet need in the management of the millions of lung nodules detected annually in the United States. 

The study, published in Future Oncology, February 2026, titled Validation of a blood-based autoantibody test to assess lung cancer risk in 4-30mm pulmonary nodules: a retrospective pooled analysis of four cohort studies, highlights that the Nodify CDT® test offers consistently strong performance in identifying a high risk of lung cancer in patients with lung nodules.

Over 1,100 patients with noncalcified lung nodules ranging in size from 4-30 mm and had Nodify CDT test results were analyzed. The data shows that the Nodify CDT test consistently demonstrated high specificity (91-97%), i.e., low false positive rates, regardless of nodule size or baseline patient risk factors. Test performance was also consistent across four distinct clinical studies with patients enrolled from 48 clinical practices in the US, including the CLARIFY study (NCT06728319) where patients received the Nodify CDT test as part of real-world clinical care. These data substantiate that the Nodify CDT test has strong clinical applicability and consistent performance across diverse practice settings.

“Most small nodules are benign and clinicians must balance patient care decisions … whether to ‘watch and wait’ with imaging surveillance or, instead, to expedite intervention based on the limited insights provided by the CT scan,”  said Dr. James Jett, Co-Chief Medical Officer at Biodesix, former Pulmonologist at Mayo Clinic, and Professor of Medicine Emeritus of National Jewish Health in Denver, CO.1 Dr. Jett emphasized, “A recent study reported in the journal THORAX (by The SUMMIT consortium) observed that over 40% of malignant pulmonary nodules progressed in tumor size between the time of first detection and the time of definitive treatment.2 This highlights a clinician’s need for more helpful decision-support tools to expedite diagnosis and treatment, such as Nodify Lung® Nodule Risk Assessment.”

“The data shows that the Nodify CDT test detected lung cancer with minimal false positives for nodules 4-30 mm in size,” confirmed Dr. Luke Yuhico, Pulmonologist, Fort Walton-Destin Hospital, FL.  “In my own practice, I have observed that using Nodify Lung testing, in conjunction with the information on the patient’s scan, significantly assists in my team’s decision-making as we strive to meaningfully impact patient outcomes by finding cancer much earlier, even in very small nodules.”

“This comprehensive validation study supports our continued commercial expansion of the Nodify CDT test and reinforces its clinical utility in addressing the substantial market opportunity and system-wide gaps in patient care that are presented by lung nodule management,” said Scott Hutton, CEO & President, Biodesix. “The demonstrated consistency of Nodify CDT tests, across real-world practice settings, further strengthens the company’s offering with healthcare providers, payers, and clinical guideline committees.”

The Nodify CDT test is available for clinical use in patients with 4-30 mm lung nodules. To learn more about Nodify Lung testing, or to order a test for a patient, please visit www.biodesix.com.

Footnotes:
1.  Dr. James Jett, Co-Chief Medical Officer at Biodesix, is a board-certified physician in pulmonary medicine and served at the Mayo Clinic in Rochester, MN for 28 years. His is also Professor of Medicine Emeritus of National Jewish Health in Denver, CO.  He served as the Editor-in-Chief of the Journal of Thoracic Oncology and as Co-Editor of the Lung Cancer Section of the premier medical electronic textbook Up-To-Date.
2.  Upstaging of screen-detected lung cancers during diagnostic assessment, published as 10.1136/thorax-2025-224006, 2 Feb 2026, http://thorax.bmj.com/. Monica L Mullin, Priyam Verghese, Chuen R Khaw, Andrew Creamer, Amyn Bhamani, Ruth Prendecki, Jennifer L Dickson, Carolyn Horst, Sophie Tisi, Helen Hall, Kylie Gyertson, Esther Arthur-Darkwa, Laura Farrelly, John McCabe, Ricky Thakrar, Arjun Nair, Anand Devaraj, Neal Navani, Allan Hackshaw, The SUMMIT consortium, Sam M Janes.

About Biodesix:
Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests, marketed as Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance, support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. For more information, visit biodesix.com.

Biodesix Contacts:
Media:
Natalie St. Denis, Director Corporate Communications
natalie.stdenis@biodesix.com
(720) 925-9285

Investors:
Chris Brinzey, Partner, ICR
chris.brinzey@icrhealthcare.com
(339) 970-2843

Picard Medical / SynCardia to Present its Next-Generation Emperor Total Artificial Heart Technology at the American College of Cardiology’s Annual Scientific Session

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Picard Medical / SynCardia to Present its Next-Generation Emperor Total Artificial Heart Technology at the American College of Cardiology’s Annual Scientific Session




Picard Medical / SynCardia to Present its Next-Generation Emperor Total Artificial Heart Technology at the American College of Cardiology’s Annual Scientific Session

Poster presentation and conference exhibit will feature early preclinical data on the Company’s fully implantable, autoregulating artificial heart platform

TUCSON, Ariz., March 20, 2026 (GLOBE NEWSWIRE) — Picard Medical, Inc. (NYSE American: PMI) (the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, today announced it will be presenting a poster consisting of new preclinical data related to its next-generation Emperor Total Artificial Heart at the American College of Cardiology (ACC)’s Annual Scientific Session & Expo (ACC.26) to be held in New Orleans, Louisiana from March 28 to March 30, 2026.

Abstract Poster Presentation – ACC.26

  • Title: THE EMPEROR TOTAL ARTIFICIAL HEART: A FULLY IMPLANTABLE, AUTOREGULATING SOLUTION FOR ADVANCED HEART FAILURE
  • Date and Time: Sunday, March 29, 2026 | 11:00 a.m. – 12:00 p.m.
  • Location: Posters, Hall E
  • Presenter: Duffy Elmer, Engineering Project Manager, SynCardia LLC

The poster will present early engineering and preclinical evaluation of the Emperor Total Artificial Heart, which is being developed as a fully implantable electromechanical artificial heart system intended to preserve the physiological autoregulation and hemodynamic performance of the currently approved SynCardia Total Artificial Heart while enabling fully implantable operation.

Exhibition Information

At ACC.26, SynCardia will also exhibit at booth #2554 throughout the conference.

Conference attendees are invited to visit the booth to meet with SynCardia’s engineering and clinical teams, and to learn more about the FDA approved SynCardia Total Artificial Heart, including its clinical use as a bridge to transplant for patients with advanced biventricular heart failure. Company representatives will also be available to discuss the design, development progress, and future clinical direction of the fully implantable Emperor Total Artificial Heart platform. The Company’s participation in the conference will provide an opportunity for clinicians, researchers, and industry participants to learn about SynCardia’s current clinical technology as well as its next-generation artificial heart development program.

Mr. Elmer, Engineering Project Manager, SynCardia LLC and presenter at the conference, commented, “The Emperor Total Artificial Heart represents the next evolution in total artificial heart therapy. The system is being designed to combine a fully implantable architecture with physiologic autoregulation in order to preserve the proven hemodynamic performance of the SynCardia Total Artificial Heart while enabling fully implantable long-term support. By building on the reliability and clinical experience of the SynCardia platform, the Emperor program aims to expand treatment options and improve mobility and quality of life for patients with advanced heart failure. We look forward to informing clinicians about this at the upcoming ACC conference.”

About Picard Medical and SynCardia
Picard Medical, Inc. is the parent company of SynCardia Systems, LLC (“SynCardia”), the Tucson, Arizona–based leader with the only commercially available total artificial heart technology for patients with end-stage heart failure. SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart (“STAH”), an implantable system that assumes the circulatory functions of a failing or failed human heart. It is the first artificial heart approved by both the FDA and Health Canada, and it remains the only commercially available artificial heart in the United States and Canada. With more than 2,100 implants performed at hospitals across 27 countries, the SynCardia Total Artificial Heart is the most widely used and extensively studied artificial heart in the world.

For additional information about Picard Medical, please visit www.picardmedical.com or review the Company’s filings with the U.S. Securities and Exchange Commission at www.sec.gov.

Forward-Looking Statements
This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Registration Statement and related prospectus filed in connection with the initial public offering with the SEC. Copies are available on the SEC’s website, http://www.sec.gov.

Contact:

Investors
Eric Ribner
Managing Director
LifeSci Advisors LLC
eric@lifesciadvisors.com

Picard Medical, Inc./SynCardia Systems, LLC
IR@picardmedical.com

General/Media
Brittany Lanza
blanza@syncardia.com

Daré Bioscience to Host Full Year 2025 Financial Results and Company Update Conference Call and Webcast on March 26, 2026

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Daré Bioscience to Host Full Year 2025 Financial Results and Company Update Conference Call and Webcast on March 26, 2026




Daré Bioscience to Host Full Year 2025 Financial Results and Company Update Conference Call and Webcast on March 26, 2026

SAN DIEGO, March 20, 2026 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, will host a conference call and live webcast at 4:30 p.m. Eastern Time on Thursday, March 26, 2026, to review its financial results for the year ended December 31, 2025 and to provide a company update.

To access the conference call via phone, dial (646) 307-1963 or (800) 715-9871 (toll-free). The conference ID number for the call is 1717423. The live webcast can be accessed under “Presentations, Events & Webcasts” in the Investors section of the company’s website at http://ir.darebioscience.com. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. The webcast will be archived in the same section of the company’s website and available for replay until April 9, 2026.

About Daré Bioscience

Daré Bioscience is a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions. Every innovation Daré advances is based in advanced science and backed by rigorous, peer-reviewed research. From contraception to menopause, pelvic pain to fertility, vaginal health to infectious disease, Daré is working to close critical gaps in care using science that serves her needs.

For decades, women have been told to “wait it out” or “live with it,” while innovations that could improve their quality of life languish in the regulatory or funding pipeline. With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting. However, access to real, evidence-based solutions continues to lag. Daré was founded to change that. As a female-led health biotech company, Daré is accelerating the development of credible, science-based solutions that meet the high standards of clinical rigor – randomized, controlled trials; validated endpoints; peer-reviewed publications; and current Good Manufacturing Practice (cGMP) requirements.

To learn more about Daré’s mission to deliver differentiated therapies for women and its innovation pipeline, please visit www.darebioscience.com.

Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma and Daré’s CEO has been honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space.

Daré may announce material information about its finances, products and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, products and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website.

Contacts:

Daré Bioscience Investor Relations
innovations@darebioscience.com

Source: Daré Bioscience, Inc.

HealthWarehouse.com Reports Full Year 2025 Results

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HealthWarehouse.com Reports Full Year 2025 Results




HealthWarehouse.com Reports Full Year 2025 Results

46% increase in revenues and positive cash flow for the year

Record year for prescriptions processed and cash generated from operations

CINCINNATI–(BUSINESS WIRE)–HealthWarehouse.com, Inc. (OTCQB:HEWA) announced today its results of operations for the year ended December 31, 2025. The Company reported net sales for the year of $49.0 million, a 46% increase over the year ended December 31, 2024, resulting from 87% growth in our partner services prescription revenues, offset in part by a decline in direct-to-consumer sales.

The Company reported net income of $265,000 for the year and positive cash flow of $1.6 million, as reflected by the non-GAAP measure of Adjusted EBITDA defined below. The Company reported net loss of $69,000 and Adjusted EBITDA of $189,000 for the fourth quarter.

HealthWarehouse.com, a technology company with a focus on healthcare e-commerce, sells and delivers prescription and over-the-counter medications to all 50 states as an Approved Digital Pharmacy through the National Association of Boards of Pharmacy (NABP). HealthWarehouse.com provides a platform focused on increasing access to and reducing costs of healthcare products for consumers and business partners nationwide.

Joseph Peters, President and CEO, commented, “2025 was a record year for the Company for total sales and prescriptions processed, while generating record cash from operations. We were able to report net income and positive cash flow by leveraging our prior investments in infrastructure. Our financial results for the past two years, during which our sales have increased $28.7 million and our Adjusted EBITDA $1.5 million, are further proof that our business model can scale profitably.”

“As we said in our third-quarter release in November, our sales of compounded versions of certain GLP-1 prescription medications were declining. Despite slower growth, we generated positive cash flow during the fourth quarter. Additionally, we are optimistic about new product launches that will allow us to continue to serve longstanding partners, and we are focused on adding partners via our new-business pipeline,” Peters said.

HealthWarehouse.com continues to invest in proprietary technology to remain at the forefront of new developments and offerings in the world of healthcare, focusing on patient experience, operational efficiency, and scalability.

Peters added, “Our success would not be achievable without our dedicated employees, who are committed to our mission of providing world-class service to our customers. I truly appreciate their dedication.”

The Company also announced that it will hold its Annual Meeting of Shareholders virtually on May 12, 2026. Shareholders of record as of March 13, 2026, will receive notice of the meeting and instructions for participating in proxy materials to be distributed soon.

2025 Annual Overview

Net Sales: Net sales increased from $33.6 million for the year ended December 31, 2024, to $49.0 million for the year ended December 31, 2025, an increase of $15.4 million, or 45.8%. Prescription sales were $46.2 million for the year ended December 31, 2025, an increase of $15.3 million, or 49.3%, compared with $30.9 million for the year ended December 31, 2024. These increases were primarily due to growth in our partner services (B2B) business related to fulfillment of brand and compounded GLP-1 medications. Sales for the direct-to-consumer (B2C) prescription business were down 24.3% in 2025 due to a reduction in sales of higher-cost branded medications and increased competition. Over-the-counter net sales increased by 15.9% from $2.2 million in the year ended December 31, 2024, to $2.5 million in the year ended December 31, 2025. The increase in B2C over-the-counter sales was primarily due to higher marketplace sales.

Our authority to dispense high-dollar compounded GLP-1 medications has ended this year. That will have a significant impact on our sales in 2026, and beyond until that volume can be replaced with new partners and expansion of the catalogs of our existing partners. The Company currently expects positive cash from operations during 2026.

Gross Profit: Cost of sales was $31.9 million for the year ended December 31, 2025, compared with $19.5 million for the year ended December 31, 2024. That increase of $12.4 million, or 63.4%, was primarily the result of growth in sales of high-cost GLP-1 medications in our B2B prescription businesses. Gross profit for the year ended December 31, 2025, was $17.1 million, a $3.0 million or 21.4% increase compared with the same period in 2024, due to the increase in sales volume, offset in part by lower gross margins. Gross margin percentage decreased year-over-year from 42.0% for the year ended December 31, 2024, to 35.0% for the year ended December 31, 2025. In the B2B prescription business, branded and compounded drugs have lower gross margins, due to higher costs and price competition.

Operating Expenses: Selling, general and administrative (SG&A) expenses totaled $16.7 million for the year ended December 31, 2025, compared with $14.2 million for the year ended December 31, 2024, an increase of $2.5 million, or 17.7%. Despite the increase, SG&A expenses were significantly lower relative to sales, decreasing 8.2 percentage points to 34.1% of sales for the year ended 2025. The growth in sales of high cost GLP-1 medications in our B2B prescription businesses did not result in a comparable increase in operating expenses. For the year ended December 31, 2025, increased expenses were primarily related to the growth in order volume in the B2B segment, which included increases in shipping expense, salaries and related expenses, shipping supplies expense; legal expense, advertising and marketing expense, rent expense, software and engineering expenses, corporate taxes, maintenance and repairs expenses and accounting services expense. Those increases were partially offset by decreases in credit card fees, health and other benefits expense, and stock-based compensation.

Net Income and Adjusted EBITDA: Net income of $265,000 for the year ended December 31, 2025, improved by $598,000 from the net loss of $333,000 for the year ended December 31, 2024, primarily as a result of increased sales and gross profit and continued controls on expenses. Earnings before interest, taxes, depreciation and amortization including amortization of a right-of-use lease asset (“EBITDA”), as adjusted for stock-based compensation and certain non-recurring charges (“Adjusted EBITDA”), were $1.6 million for 2025, up from $1.1 million for 2024. EBITDA and Adjusted EBITDA are non-GAAP financial measures. Definitions of these non-GAAP terms and a reconciliation to GAAP measures are provided below.

2025 Fourth Quarter Overview

Net Sales: Total net sales were $9.9 million for the fourth quarter ended December 31, 2025, a decrease of $3.9 million, or 28.1%, compared with the fourth quarter of 2024. Prescription sales were $9.0 million for the fourth quarter, a decrease of $4.1 million, or 31.0%. That was due to lower sales in the B2B and B2C prescription business, primarily related to lower sales of compounded GLP1 medications. Over-the-counter sales increased by 40.2% to $776,000 due to an increase in marketplace sales.

Gross Profit: Gross profit for the fourth quarter of 2025 was $3.8 million, a $575,000 or 13.0% decrease compared with the fourth quarter of 2024. Lower revenues in the B2B and B2C prescription businesses were partly offset by higher gross margins. Gross margin was 39.0% in the fourth quarter of 2025 versus 32.2% in the same period in 2024, due primarily to improved margins in the prescription business.

Operating Expenses: Operating expenses were $4.0 million for the fourth quarter of 2025, a decrease of $250,000 or 6.0% compared with the same quarter in 2024. The decrease in 2025 was related to decreases in shipping and shipping-supplies expenses, salaries and related expenses, and credit card fees. The decreases were offset by increases in marketing and advertising expenses.

Net Income and (non-GAAP) Adjusted EBITDA: The Company reported a net loss of $69,000 for the fourth quarter of 2025, compared with net income of $189,000 during the same period in 2024. Adjusted EBITDA for the fourth quarter of 2025 was $189,000, compared with $523,000 in the fourth quarter of 2024.

HEALTHWAREHOUSE.COM, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS (Audited)
 
For the Three Months Ended For the Twelve Months Ended
December 31, December 31,

 

2025

 

 

2024

 

 

2025

 

 

2024

 
Dollars in thousands
Net sales

$

9,852

 

$

13,703

 

$

48,994

 

$

33,614

 
 
Cost of sales

 

6,010

 

 

9,285

 

 

31,852

 

 

19,489

 
 
Gross profit

 

3,842

 

 

4,418

 

 

17,142

 

 

14,125

 
 
Selling, general and administrative expenses

 

3,951

 

 

4,202

 

 

16,730

 

 

14,218

 
 
Net income (loss) from operations

 

(109

)

 

216

 

 

412

 

 

(93

)
 
Other expense
Loss on extinguishment of debt

 

–

 

 

–

 

 

–

 

 

(3

)
Interest expense

 

(21

)

 

(27

)

 

(72

)

 

(237

)
 
Income (loss) before taxes

 

(130

)

 

189

 

 

340

 

 

(333

)
 
Income tax expense

 

61

 

 

–

 

 

(75

)

 

–

 
 
Net income (loss)

 

(69

)

 

189

 

 

265

 

 

(333

)
.
Preferred stock:
Series B convertible contractual dividends

 

(86

)

 

(86

)

 

(342

)

 

(342

)
 
Net income (loss) attributable to common stockholders

$

(155

)

$

103

 

$

(77

)

$

(675

)
 
Per share data:
Net income (loss) – basic

$

(0.00

)

$

0.00

 

$

0.00

 

$

(0.01

)
Net income (loss) – diluted

$

(0.00

)

$

0.00

 

$

0.00

 

$

(0.01

)
Series B convertible contractual dividends

$

(0.00

)

$

(0.00

)

$

(0.01

)

$

(0.01

)
 
Net income (loss) attributable to common stockholders – basic

$

(0.00

)

$

0.00

 

$

(0.00

)

$

(0.01

)
Net income (loss) attributable to common stockholders – diluted

$

(0.00

)

$

0.00

 

$

(0.00

)

$

(0.01

)
 
Weighted average common shares outstanding – basic (In thousands)

 

56,734

 

 

55,573

 

 

56,348

 

 

55,186

 
Weighted average common shares outstanding – diluted (in thousands)

 

56,734

 

 

91,832

 

 

56,348

 

 

55,186

 

Use of Non-GAAP Financial Measures

HealthWarehouse.com, Inc. (the “Company”) prepares its consolidated financial statements in accordance with the United States generally accepted accounting principles (“GAAP”). In addition to disclosing financial results prepared in accordance with GAAP, the Company discloses information regarding EBITDA and Adjusted EBITDA, which are commonly used. In addition to adjusting net income or net loss to exclude interest, taxes, depreciation and amortization, including amortization of right of use lease asset, (“EBITDA”), Adjusted EBITDA also excludes stock-based compensation, and certain nonrecurring charges. EBITDA and Adjusted EBITDA are not measures of performance defined in accordance with GAAP. However, Adjusted EBITDA is used internally in planning and evaluating the Company`s performance. Accordingly, management believes that disclosure of this metric offers lenders and other shareholders an additional view of the Company`s operations that, when coupled with GAAP results, provides a more complete understanding of the Company’s financial results.

Adjusted EBITDA should not be considered as an alternative to net income, net loss, or to net cash provided by or used in operating activities, as a measure of operating results or of liquidity. It may not be comparable to similarly titled measures used by other companies, and it excludes financial information that some may consider important in evaluating the Company`s performance.

Reconciliation of Net Loss (GAAP) to Adjusted EBITDA (Non-GAAP)

Three Months Ended Twelve Months Ended
December 31, December 31,

 

2025

 

 

2024

 

2025

 

2024

 
Dollars in thousands
Net income (loss)

$

(69

)

$

189

$

265

$

(333

)
Interest expense

 

21

 

 

27

 

72

 

237

 
Income tax expense

 

(61

)

 

–

 

75

 

–

 
Depreciation and amortization

 

135

 

 

119

 

519

 

434

 
EBITDA (non-GAAP)

 

26

 

 

335

 

931

 

338

 
Adjustments to EBITDA:
Stock-based compensation

 

163

 

 

188

 

661

 

750

 
Loss on extinguishment of debt

 

–

 

 

–

 

–

 

3

 
 
Adjusted EBITDA

$

189

 

$

523

$

1,592

$

1,091

 

About HealthWarehouse.com

HealthWarehouse.com, Inc. (OTCQB: HEWA), a technology company with a focus on healthcare e-commerce, sells and delivers prescription and over-the-counter medications to all 50 states as an Approved Digital Pharmacy through the National Association of Boards of Pharmacy (“NABP”). HealthWarehouse.com provides a platform focused on increasing access and reducing costs of healthcare products for consumers and business partners nationwide. Based in Florence, Kentucky, the Company operates America’s Leading Online Pharmacy and is a pioneer in affordable healthcare. As one of the first Approved Digital Pharmacies by the National Association of Boards of Pharmacy, HealthWarehouse.com services the mission of providing affordable healthcare and incredible patient services to help Americans. Learn more at www.HealthWarehouse.com

Forward-Looking Statements

This announcement and the information incorporated by reference herein contain “forward-looking statements” as defined in federal securities laws, including but not limited to Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which statements are based on our current expectations, estimates, forecasts and projections. Statements that are not historical facts, including statements about the beliefs, expectations and future plans and strategies of the Company, are forward-looking statements. Actual results may differ materially from those expressed in forward looking statements or in management’s expectations. Important factors which could cause or contribute to actual results being materially and adversely different from those described or implied by forward looking statements include, among others, risks related to competition, management of growth, access to sufficient capital to fund our business and our growth, new products, services and technologies, potential fluctuations in operating results, international expansion, outcomes of legal proceedings and claims, fulfillment center optimization, seasonality, commercial agreements, acquisitions and strategic transactions, foreign exchange rates, system interruption, cyber-attacks, access to sufficient inventory, government regulation and taxation and fraud. More information about factors that potentially could affect HealthWarehouse.com’s financial results is included in HealthWarehouse.com’s audited Annual Reports and Quarterly Reports available at otcmarkets.com and prior filings with the Securities and Exchange Commission.

Contacts

Dan Seliga, Chief Financial Officer, (800) 748-7001

IntraBio Announces Submission of Supplemental New Drug Application for Levacetylleucine for Ataxia-Telangiectasia

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IntraBio Announces Submission of Supplemental New Drug Application for Levacetylleucine for Ataxia-Telangiectasia




IntraBio Announces Submission of Supplemental New Drug Application for Levacetylleucine for Ataxia-Telangiectasia

AUSTIN, Texas–(BUSINESS WIRE)–IntraBio Inc. today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for levacetylleucine for the treatment of Ataxia-Telangiectasia (A-T), a rare, progressive, inherited neurodegenerative disorder.


This submission represents the first regulatory application submitted to the U.S. Food and Drug Administration seeking approval of a therapy for the treatment of Ataxia-Telangiectasia.

The sNDA seeks to expand the label of levacetylleucine, marketed as AQNEURSA®, to include A-T. AQNEURSA® is currently approved in the United States for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing at least 15 kg.

The submission is supported by data from a pivotal Phase III clinical trial evaluating levacetylleucine in adult and pediatric patients with A-T. In this randomized, double-blind, placebo-controlled, crossover study, levacetylleucine met its primary endpoint and key secondary endpoints with high statistical significance. Levacetylleucine was generally safe and well-tolerated, with no drug-related serious adverse events observed, consistent with its established safety profile.

About Ataxia-Telangiectasia

Ataxia-Telangiectasia (A-T) is a rare, inherited, progressive neurodegenerative disorder that typically begins in early childhood. It is characterized by degeneration of the cerebellum, resulting in worsening loss of coordination, impaired speech, abnormal eye movements, and eventual wheelchair dependence. Many patients also develop telangiectasia, immune deficiency with recurrent and potentially life-threatening infections, lung disease, and a markedly increased risk of cancer. There are currently no approved therapies for A-T.

About AQNEURSA®

U.S Indication

AQNEURSA® (levacetylleucine) is approved in the United States for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing at least 15 kg.

U.S. IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity

  • Based on findings from animal reproduction studies, AQNEURSA may cause embryo-fetal harm when administered during pregnancy. The decision to continue or discontinue AQNEURSA treatment during pregnancy should consider the female’s need for AQNEURSA, the potential drug-related risks to the fetus, and the potential adverse outcomes from untreated maternal disease.

Pregnancy and Lactation

  • For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment with AQNEURSA. Advise females of reproductive potential to use effective contraception during treatment with AQNEURSA and for 7 days after the last dose if AQNEURSA is discontinued.
  • There are no data on the presence of levacetylleucine or its metabolites in either human or animal milk, the effects on the breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AQNEURSA and any potential adverse effects on the breastfed infant from levacetylleucine or from the underlying maternal condition.

Adverse Reactions

  • The most common adverse reactions (incidence ≥5% and greater than placebo) are abdominal pain, dysphagia, upper respiratory tract infections, and vomiting.

Drug Interactions

  • Avoid concomitant use of AQNEURSA with N-acetyl-DL-leucine or N-acetyl-D-leucine. The D-enantiomer, N-acetyl-D-leucine, competes with levacetylleucine for monocarboxylate transporter uptake, which may reduce the levacetylleucine efficacy.
  • Monitor more frequently for P-gp substrate related adverse reactions when used concomitantly with AQNEURSA; AQNEURSA inhibits P-gp; however, the clinical significance of this finding has not been fully characterized.

To report SUSPECTED ADVERSE REACTIONS, contact IntraBio Inc. at 1-833-306-9677 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for Full US Prescribing Information for AQNEURSA: https://www.aqneursahcp.com/wp-content/prescribing-information.pdf

EMA Indication

AQNEURSA® is authorized in the European Union for the treatment of neurological manifestations of Niemann-Pick disease type C in adults and children aged 6 years and older weighing at least 20 kg, either in combination with miglustat or as monotherapy in patients who cannot tolerate miglustat. EMA Indication and Important Safety Information

About IntraBio

IntraBio Inc. is a global biopharmaceutical company headquartered in Austin, Texas, focused on developing and commercializing targeted therapies for rare and common neurological, neurodevelopmental, and mitochondrial diseases. IntraBio’s platform technologies are built on decades of scientific research and collaboration with leading universities and institutions worldwide, including the University of Oxford and the University of Munich.

Contacts

For further information, please contact:
Cass Fields

Vice-President of External Affairs

ccfields@intrabio.com
www.intrabio.com

Qiagen Announces Form 20-F Annual Report Filing for 2025 Results

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Qiagen Announces Form 20-F Annual Report Filing for 2025 Results




Qiagen Announces Form 20-F Annual Report Filing for 2025 Results

VENLO, the Netherlands–(BUSINESS WIRE)–$QGEN #QIAGEN–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that it has filed its annual report, including its audited consolidated financial statements on Form 20-F, for the year ended December 31, 2025, with the U.S. Securities and Exchange Commission. The document can be accessed on QIAGEN’s website here.


QIAGEN will provide printed copies of the 2025 Annual Report to shareholders free of charge upon request. To obtain a printed copy of the 2025 Annual Report please use our contact form or send an email to ir@qiagen.com.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is a global leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis, while bioinformatics support the interpretation of complex data to deliver actionable insights. Automation solutions integrate these steps into streamlined, cost-effective workflows. QIAGEN serves more than 500,000 customers worldwide in the Life Sciences (academia, pharmaceutical R&D and industrial applications such as forensics) and molecular diagnostics (clinical healthcare). As of December 31, 2025, QIAGEN employed approximately 5,700 people across more than 35 locations. For more information, visit www.qiagen.com.

Source: QIAGEN N.V.

Category: Corporate

Contacts

Investor Relations
e-mail: ir@QIAGEN.com

Public Relations
e-mail: pr@QIAGEN.com

KalVista Pharmaceuticals to Present New EKTERLY® (sebetralstat) Data at the 2026 Global Angioedema Leadership Conference

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KalVista Pharmaceuticals to Present New EKTERLY® (sebetralstat) Data at the 2026 Global Angioedema Leadership Conference




KalVista Pharmaceuticals to Present New EKTERLY® (sebetralstat) Data at the 2026 Global Angioedema Leadership Conference

New interim data from the KONFIDENT-KID trial evaluating sebetralstat in children aged 2-11 accepted for late-breaking oral presentation

FRAMINGHAM, Mass. & SALISBURY, England–(BUSINESS WIRE)–KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that five abstracts, including one late-breaking submission, have been accepted for presentation at the 2026 Global Angioedema Leadership Conference taking place in Madrid, Spain from March 26–29, 2026.


The following late-breaking abstract will be presented during the poster session on Friday, March 27 and as an oral presentation on Saturday, March 28 at 11:50 am CET:

  • On-demand Oral Sebetralstat for Hereditary Angioedema Attacks in Children Aged 2-11: Interim Analysis of KONFIDENT-KID: Emel Aygören-Pürsün, Adil Adatia, John Anderson, Shira Benor, Mélisande Bourgoin-Heck, Mauro Cancian, Bob Geng, Eisuke Inage, Aharon Kessel, Majed Koleilat, H. Henry Li, Michael E. Manning, Heloise Reumaux, Raffi Tachdjian, Paola Triggianese, Andrea Zanichelli, Erik Hansen, Ya-Hsiu Chuang, Matthew Iverson, Michael D. Smith, Paul K. Audhya, H. James Wedner.

The following poster presentations will take place during the poster session on Friday, March 27, beginning at 6:10 pm CET:

  • Satisfaction with Sebetralstat for HAE Attacks in Patients Switching from Parenteral On-demand Treatments in KONFIDENT-S: Mauro Cancian, Laurence Bouillet, Teresa Caballero, Tariq El-Shanawany, Sorena Kiani-Alikhan, Markus Magerl, Michael E. Manning, Inmaculada Martinez-Saguer, Maeve E. O’Connor, Sinisa Savic, Daniel F. Soteres, Maria Staevska, James Hao, Paolo Bajcic, Paul Audhya, Raffi Tachdjian.
  • On-demand Treatment Patterns of Hereditary Angioedema Attacks with Sebetralstat in the KONFIDENT-S Study: Mar Guilarte, Emel Aygören-Pürsün, Jonathan A. Bernstein, Danny M. Cohn, Vesna Grivcheva-Panovska, Tamar Kinaciyan, Damia Leguevaques, William R. Lumry, Michael E. Manning, Daniel F. Soteres, Petra Staubach, Raffi Tachdjian, Marcin Stobiecki, Marc A. Riedl, Anna Valerieva, Patrick F. K. Yong, Andrea Zanichelli, James Hao, Michael D. Smith, Paul K. Audhya, Henriette Farkas.
  • Barriers to Treatment of Hereditary Angioedema Attacks Among Patients Using Subcutaneous On-Demand Therapies: Insights from an International Patient Survey: Thomas Buttgereit, Isabelle Boccon-Gibod, Alexis Bocquet, Laurence Bouillet, Paula Busse, Sandra Christiansen, Timothy Craig, Tariq El-Shanawany, Tomaz Garcez, Padmalal Gurugama, Rashmi Jain, Sorena Kiani-Alikhan, Markus Magerl, Inmaculada Martinez-Saguer, Maeve O’Connor, Cristine Radojicic, Sinisa Savic, Paola Triggianese, H. James Wedner, Patrick Yong, Andrea Zanichelli, Sherry Danese, Julie Ulloa, Paolo Bajcic, Paul K. Audhya, Mauro Cancian.
  • Anxiety in Patients Using Injectable On-Demand Treatments for Hereditary Angioedema Attacks: Results from an International Patient Survey: Alexis Bocquet, Isabelle Boccon-Gibod, Laurence Bouillet, Paula Busse, Thomas Buttgereit, Sandra Christiansen, Timothy Craig, Tariq El-Shanawany, Tomaz Garcez, Padmalal Gurugama, Rashmi Jain, Sorena Kiani-Alikhan, Markus Magerl, Inmaculada Martinez-Saguer, Maeve O’Connor, Cristine Radojicic, Sinisa Savic, Paola Triggianese, H. James Wedner, Patrick Yong, Andrea Zanichelli, Sherry Danese, Julie Ulloa, Paolo Bajcic, Paul K. Audhya, Mauro Cancian.

Links to all presentations will be available on the KalVista website under Publications.

About Hereditary Angioedema

Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. Treatment guidelines recommend treating attacks as early as possible to prevent progression of swelling and shorten the time to attack resolution, and to consider treatment for all attacks, regardless of anatomic location or severity.

About EKTERLY® (sebetralstat)

EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom, Switzerland, Australia, Singapore and Japan for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. EKTERLY is the first and only oral on-demand treatment for HAE, offering efficacious and safe treatment of attacks without the burden of injections. With a US regulatory filing planned for 2026 to expand use to children aged 2–11, and additional filings anticipated in key global markets, EKTERLY has the potential to become the foundational therapy for HAE management worldwide. For more information, including the full US Prescribing Information, visit EKTERLY.com.

About KalVista Pharmaceuticals, Inc.

KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY®—the first and only oral on-demand treatment for hereditary angioedema (HAE)—and continues to work closely with the global HAE community to improve treatment and care for this disease around the world. For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statements

This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “position,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, information relating to our business and business plans, the success of our efforts to commercialize EKTERLY® (sebetralstat), our ability to successfully obtain foreign regulatory approvals for sebetralstat, our expectations about the safety and efficacy of sebetralstat, the timing of clinical trials and their results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and the ability of EKTERLY to treat HAE. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2025, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contacts

Ryan Baker

Head, Investor Relations

(617) 771-5001

ryan.baker@kalvista.com

Molly Cameron

Senior Director, Corporate Affairs

(978) 339-3378

molly.cameron@kalvista.com