CHARLOTTE, N.C., April 22, 2026 (GLOBE NEWSWIRE) — NN, Inc. (NASDAQ: NNBR), a global diversified industrial company that engineers and manufactures high-precision components and assemblies, announced today that it will release its first quarter 2026 financial results for the period ended March 31st, 2026, after the close of the market on Wednesday, May 6th, 2026. The Company will hold a related conference call on Thursday, May 7th, 2026, at 9:00 a.m. E.T. Participants on the call are asked to register five to ten minutes prior to the scheduled start time by dialing 800-715-9871 and from outside the U.S. at +1 646-307-1963.
The conference call will be webcast simultaneously and in its entirety through the NN, Inc. Investor Relations website. Shareholders, media representatives and others may participate in the webcast by registering through the Investor Relations section on the company’s website at https://investors.nninc.com/.
For those who are unavailable to listen to the live call, a replay will be available shortly after the call on NN’s website through May 7th, 2027.
About NN, Inc. NN, Inc., a global diversified industrial company, combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets on a global basis. Headquartered in Charlotte, North Carolina, NN has facilities in North America, Europe, South America, and China. For more information about the Company and its products, please visit www.nninc.com.
Investor Relations: Joe Caminiti or Abe Plimpton [email protected] 312-445-2870
Exits Q1 with 100 Metric Tonnes Per Day Production and Confirms Plan to Achieve 350 Metric Tonnes Per Day by the End of 2026
Kuya Silver to Report Q4/Year End Financial Results Prior to Market Open on Friday, April 24 and Hold a Conference Call Webinar on April 28, 2026 to Update Investors
All references to dollar amounts are references to U.S. Dollars, unless otherwise stated
Toronto, Ontario–(Newsfile Corp. – April 22, 2026) – Kuya Silver Corporation (CSE: KUYA) (OTCQB: KUYAF) (FSE: 6MR1) (the “Company” or “Kuya Silver“) is pleased to report record quarterly production and provide an operational update for the first quarter of 2026 at the Bethania silver project, which delivered record daily and quarterly production rates as the ramp-up continued to track higher during the three month period. In light of the significant progress to date, the Company continues to expect the completion of its Phase 1 ramp-up, achieving 350 metric tonnes per day (“tpd“) production, by the end of the year.
Operational Highlights
3,076 metric tonnes of mineralized material mined at Bethania, a significant improvement over Q4 2025
Milestone 100 tonne per day (tpd) throughput achieved at the end of March and early April, 2026
Continued strong underground development with record 398 meters advanced and 1,967 metric tonnes of development material moved to continue expansion of underground mining operations
91% of record quarterly revenue from Bethania came from silver in the quarter with an average selling price of $82/oz.
Announcement of fully funded letter of intent to acquire the Camila plant to improve silver recoveries and operational control of material processing
Cash position at the end of Q1 2026 of approximately $27 million
Kuya Silver On Track To Achieve 350 tpd Production Rate At Bethania By The End of 2026
Given the successful mine development to date, and strong financial position, Kuya Silver expects to complete its Phase 1 ramp-up at the Bethania silver project by the end of this year. The Company plans to keep the market informed of the progress and will continue to provide details on the production growth on a timely basis.
Christian Aramayo, Kuya Silver’s Chief Operating Officer commented, “Another pivotal quarter for Kuya Silver. We achieved 100 tpd in March and have sustained it into April — a clear proof point in our ramp-up. With continued investment in development, we have direct line-of-sight to completing Phase 1 at 350 tpd by year-end. Beyond that, integrating the Camila Plant gives us full operational control over processing, while our expanded drilling program continues to unlock district-scale upside. Bethania is not just ramping up — it represents a clear growth platform with potential upside from production, exploration, and operational efficiency.”
Mining Operations Continue To Improve In Q1 2026
Production of mineralized material at the Bethania Project totalled 3,076 metric tonnes, another quarterly record as production continues to steadily ramp up. Developing activities focused on driving drifts and a crosscut to access more mineralization material achieving 398 m of development. Importantly, Kuya Silver achieved a 100 tpd production rate at the end of March 2026 and this has been largely sustained in April. Modest increases in daily throughput are expected in Q2 and Q3 of 2026, with a more significant increase anticipated once the new 4.5 m x 4.5 m ramp has been deepened to the 640 level production level by Q4.
Grades improved to 7.53 oz/t during Q1 2026 even as development material — typically lower grade — contributed to throughput. Grades are expected to increase as the mine reaches a steady-state of production later this year and in the meantime grades will reflect a blend of ongoing development and run-of-mine stoping . Silver recoveries improved to 79.2% in Q1 2026 from 73.3% in Q4 2025, due to higher grade being processed during the quarter and a reduction of the lower-grade oxidized material (from historical stockpiles) processed in Q4 2025. Kuya Silver has previously achieved 90+% silver recoveries on specific mineralized batches, reflecting not only higher head grades but also favorable metallurgical composition and tighter moisture controls in the processing circuit. Leveraging that recent experience, the Company has implemented targeted adjustments to the Camila Plant’s operating parameters – including semi real-time monitoring of feed characteristics and moisture levels. Early results in April 2026 are encouraging, and management expects recoveries to continue improving as silver grades increase and operational refinements take full effect.
David Stein, Kuya Silver’s President and CEO remarked, “The first quarter of 2026 marked an important achievement with our ramp-up process, with the mine producing 100 tpd in March and sustaining that rate into April. While there is still significant underground development planned for the remainder of 2026 this new level of production, combined with our strong cash position, significantly improves the Company’s financial flexibility to continue growing silver production and aggressively exploring our now-5,600 ha land package in the Bethania district of Peru.”
Table 1: Production highlights from the Bethania silver mine
(1)prices for silver equivalent calculations use period ending spot prices and are as follows: Mar. 31 2026 silver $74./oz, lead $1,909/tonne, zinc$ 3,230/tonne Dec. 30, 2025 silver $70.13/oz, gold $4,326/oz, lead $2,005/tonne, zinc$ 3,122/tonne Mar. 31, 2025 period; silver $34.46/oz, gold $3122.80/oz, lead $2002/tonne, zinc $2829/tonne, and Dec. 31, 2024 period; silver $28.90/oz, gold $2606.72/oz, lead $1921.50/tonne, zinc $2974/tonne. (2)includes only payable recovery i.e. lead in the silver- lead concentrate and zinc in the zinc concentrate and silver in both concentrates. (3)may include provisional settlements at the end of the period, net of treatment and refining costs.
Camila Plant Acquisition Update
Kuya Silver continues to progress with due diligence and definitive documentation with regards to the Camila Plant acquisition announced on January 27, 2026 and expects to complete the transaction in due course.
Upcoming Conference Call Webinar
Kuya Silver will host a conference call webinar taking place on Tuesday, April 28th at 3 pm ET / 12 pm PT. The Company plans to cover the Q1 2026 production progress and 2025 year end financial reporting. A live Q&A will follow the presentation.
Quality assurance and quality control include two sampling procedures. Underground vein material from stopes are sampled to confirm vein grades and to reconcile against the mine model; and sampling of freshly mined material in stockpiles to determine dilution and the head grade that is sent to the processing plant.
Underground vein sampling was conducted systematically every 4 meters along the galleries. This involved excavating a narrow and continuous channel either parallel to the vein or perpendicular to its orientation. The entire volume of material excavated from the channel was collected as a sample.
Freshly mined material in the stockpiles and concentrate stockpiles were sampled using trenching, a method involving the excavation of narrow trenches perpendicular to the major axis of the pile. Trenches were systematically dug at regular intervals across all depths of the pile. The location of each trench was referenced to a topographic control point and recorded in the sampling log.
All material was carefully collected on plastic sheets, then pulverized at the mine site. The pulverized material was quartered, and one quarter was labeled and secured in vinyl sample bags. The samples were then transported to Dmtri I. Mendelejeff laboratory in Huancayo for processing using fire assay followed by atomic absorption spectroscopy (AAS).
All concentrate assay results are cross-checked against independent analyses conducted by the buyer. Furthermore, sample security protocols include sealed trucks for transporting run-of-mine (ROM) material and concentrate trucks with tamper-proof devices with safety seals, and a documented custody chain overseen by the mine superintendent (Bethania).
National Instrument 43-101 Disclosure
The technical content of this news release has been reviewed and approved by Mr. Kevin J. O’Connell, P.E., Independent Technical Advisor to of Kuya Silver and a Qualified Person as defined by National Instrument 43-101.
About Kuya Silver Corporation
Kuya Silver is a Canadian‐based, growth-oriented mining company with a focus on silver. Kuya Silver operates the Bethania silver mine in Peru, while developing district-scale silver projects in mining-friendly jurisdictions including Peru and Canada.
This news release contains statements that constitute “forward-looking information,” including statements regarding the plans, intentions, beliefs, and current expectations of the Company, its directors, or its officers with respect to the future business activities of the Company. The words “may,” “would,” “could,” “will,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “expect,” “must,” “next,” “propose,” “new,” “potential,” “prospective,” “target,” “future,” “verge,” “favorable,” “implications,” and “ongoing,” and similar expressions, as they relate to the Company or its management, are intended to identify such forward-looking information. Investors are cautioned that statements including forward-looking information are not guarantees of future business activities and involve risks and uncertainties, and that the Company’s future business activities may differ materially from those described in the forward-looking information as a result of various factors, including but not limited to fluctuations in market prices, successes of the operations of the Company, continued availability of capital and financing, and general economic, market, and business conditions. There can be no assurances that such forward-looking information will prove accurate, and therefore, readers are advised to rely on their own evaluation of the risks and uncertainties. The Company does not assume any obligation to update any forward-looking information except as required under the applicable securities laws.
Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.
During the Course of the Agreement the Prominent European Development Group OTT Heritage Hospitality Expects to Market and Deploy SKYX’s Disruptive Technologies into Hundreds of European Hotels, Buildings and Developments
Throughout the Term of the Agreement Prominent Developer and SKYX Expect to Deploy and Market Hundreds of Thousands of Products into Massive European Hospitality Market
124,000 Hotel Rooms are Projected to Open in Europe in 2026, with Over 250,000 Additional Rooms in the Development Pipeline Industry-Wide
Through Its Platform and Network, OTT Heritage Hospitality Provides Access to a Broad Pipeline of Hospitality Projects Across Europe and Intends to Actively Market and Facilitate the Adoption of SKYX’s Technologies Across a Range of Hotel, Building, and Development Opportunities Leveraging Significant Time and Cost Efficiencies of Up to 90%
SKYX’s Technologies are Expected to Offer Long-Term Recurring Revenue Opportunities Through Monitoring, Subscriptions, and AI Services, in Addition to Product Upgrades, Interchangeability and Platform-Wide Integrations for Future Development
MIAMI, April 22, 2026 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), an award winning highly disruptive advanced and smart home and AI platform technology company with over 100 U.S. and global pending and issued patents and a portfolio of 60 lighting and home décor websites, with a mission to make homes and buildings become advanced-safe-smart instantly as the new standard, today announced that it has entered into an agreement with OTT Heritage Hospitality, a prominent European developer, to deploy and market its technologies across the vast European hotel chains segment and buildings.
This agreement marks a significant step in SKYX’s global expansion strategy as it continues to advance its mission to make hotels, homes, and buildings smarter, safer, and advanced.
Under the agreement, SKYX’s advanced and smart home and building technologies are expected to penetrate the vast European hotel market with over 132,000 hotels with hundreds of thousands of additional rooms in the development pipeline in addition to residential and commercial projects throughout Europe.
During the course of the agreement SKYX and OTT Heritage Hospitality expect to deploy and market SKYX’s disruptive technologies to hundreds of European hotels, buildings and developments with the aim of deploying hundreds of thousands of units across European hotel and real estate developments.
OTT Heritage Hospitality provides its platform and network as well as access to a broad pipeline of hospitality projects across Europe and intends to actively market and facilitate the adoption of SKYX’s technologies across a range of hotel, building, and development opportunities, leveraging the significant time and cost efficiencies of up to 90% provided by SKYX’s technologies.
Jean-François Ott, Founder of OTT Heritage Hospitality, said; “As a long-time developer of hotel and real estate projects, I see a tremendous opportunity in marketing and facilitating the penetration of SKYX’s highly disruptive technologies into hotels and real estate projects across Europe. By leveraging significant time and cost efficiencies of up to 90% for hotel renovations as well as new builds, we can enable properties to become smarter, safer, and more technologically advanced.”
Rani Kohen, Founder and Executive Chairman of SKYX Platforms, said; “This partnership marks a significant step in our global expansion strategy as we continue with our goal and mission to advance hotels, homes, and buildings by making them smarter and safer. We look forward to partnering with such an established European hotel and real estate developer.”
For more information about SKYX click here: www.skyx.com
About SKYX Platforms Corp.
As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 100 U.S. and global patents and patent pending applications. Additionally, the Company owns 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://www.skyx.com/ or follow us on LinkedIn.
Forward-Looking Statements
Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s ability to achieve positive cash flows; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.
NEW ALBANY, Ohio, April 22, 2026 (GLOBE NEWSWIRE) — Commercial Vehicle Group (the “Company” or “CVG”) (NASDAQ: CVGI) will hold its quarterly conference call on Wednesday, May 6, 2026, at 8:30 a.m. ET, to discuss first quarter 2026 financial results. CVG will issue a press release and presentation prior to the conference call.
Toll-free participants dial (833) 461-5787 using conference code 496990489. International participants dial (585) 542-9983 using conference code 496990489. This call is being webcast and can be accessed through the “Investors” section of CVG’s website at ir.cvgrp.com where it will be archived for one year.
About CVG
Commercial Vehicle Group, Inc. and its subsidiaries, is a global provider of systems, assemblies and components to global commercial vehicle markets and electric vehicle markets. We deliver real solutions to complex design, engineering and manufacturing problems while creating positive change for our customers, industries, and communities we serve. Information about the Company and its products is available on the internet at www.cvgrp.com.
Investor Relations Contact: Ross Collins or Nathan Skown Alpha IR Group [email protected]
NEW YORK, April 21, 2026 /PRNewswire/ — Travelzoo® (NASDAQ: TZOO):
WHAT:
Travelzoo, the club for travel enthusiasts, will host a conference call to discuss the Company’s financial results for the first quarter ended March 31, 2026. Travelzoo will issue a press release reporting its results before the market opens on April 23, 2026.
WHEN:
April 23, 2026 at 11:00 AM ET
HOW:
A live webcast of Travelzoo’s Q1 2026 earnings conference call can be accessed at http://ir.travelzoo.com/events-presentations. The webcast will be archived within 2 hours of the end of the call and will be available through the same link.
AboutTravelzoo We, Travelzoo®, are the club for travel enthusiasts. We reach 30 million travelers. Club Members receive Club Offers negotiated and rigorously vetted by our deal experts around the globe. Our relationships with thousands of top travel companies give us access to irresistible deals. Our club and its benefits are built around the lifestyle of a modern travel enthusiast.
SAN DIEGO, April 21, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced it will present updated data from CRDF-004, a randomized dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard of care (SoC) regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). The data will be reviewed in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29–June 2 in Chicago.
Rapid Oral Presentation Details:
Abstract Title: Onvansertib plus standard-of-care chemotherapy plus bevacizumab in first-line RAS-mutated metastatic colorectal cancer (mCRC): Interim results from the phase 2 randomized CRDF-004 trial Abstract Number: 3510 Session Title: Gastrointestinal Cancer—Colorectal and Anal Session Date and Time: June 2, 2026, 8:00-9:30 AM CDT
The abstract will be publicly available on Thursday, May 21, 2026 on ASCO’s website, and the presentation will be made available on the Scientific Publications page of the Company’s website following its presentation.
About Onvansertib Onvansertib is a highly specific, oral PLK1 inhibitor currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer. It is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).
About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.
Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
New, Leading Technology Engine Configuration of Firejet is First-to-Market Tactical Jet UAS in the High-Performance, Affordable sub-$500,000 Class
SAN DIEGO, April 21, 2026 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a leader in defense, national security and global markets, today announces that it has completed the initial flight series of the Kratos J85 engine version of the Firejet unmanned aerial system (UAS), dubbed Mk1 Firejet. This second major configuration of the Firejet enables users/customers to select the model that best suits their operational requirements. With the new J85 engine configuration, the Firejet takes a major step forward in the aero-performance category for customers who need the extra performance.
Classic Firejet, the baseline Firejet target system, supports key missions for the U.S. Army Target Systems Management Office (TSMO) at a high level of aerodynamic performance. Flying since the early 2010s with JetCat engines, Classic Firejet has evolved and been adapted to meet the customer performance and threat representation requirements over time. In addition to the U.S. Army operating the Classic Firejet, ally countries around the world operate the Classic Firejet, most recently including Taiwan, which has selected the Tactical Firejet named Mighty Hornet IV for their configuration.
With the new Kratos Spartan engine production facility established in late 2025, production is ramping up for the J85 and other Spartan engine models. Production rates are expected to be in the thousands by later this year and tens of thousands over the next few years meeting the demand for recapitalization which is becoming even more important this year with depletion of U.S. and ally inventories.
Steve Fendley, President of Kratos Unmanned Systems, said, “Kratos is committed to developing and providing threat-representative target aircraft systems and to offering survivable tactical UAS. With this new version of the Firejet in both target or tactical applications, we increase range, endurance, speed, and climb rate without penalizing survivability. Importantly, we also reduce supply chain risk by using an American-made Kratos engine with engine components sourced in the U.S.A. With the two Firejet models, Mk1 and Classic Firejet, we can now meet the cost-performance levels aligned with various customers’ needs.”
Eric DeMarco, President and CEO of Kratos, said, “With our rapid advancement and in production, military-grade jet engines, Kratos is making internal investments to answer the Department of War’s call to industry to deliver affordable, high performance, military capability today. Kratos has invested significant internal resources and together with Army TSMO, have integrated a leading technology engine with the Firejet jet drone system. In addition to the increased performance as a target, this engine configuration of Firejet is first-to-market as a CCA type, tactical jet UAS, in the high-performance, sub-$500,000 arena; another example where affordability is a technology.”
At the high-performance end of the low-cost or affordable jet aerial target market, Kratos’ Firejet delivers unmatched fighter-like performance and versatility, representing the most lethal threats of the United States and its allies’ potential adversaries. Kratos’ Firejet provides the opportunity for customers to train their military personnel and to test multiple weapon systems with a single flexible and affordable high performance unmanned aerial target drone system. The Firejet supports both surface-to-air and air-to-air engagements with a combination of internal and external mission kits including tow targets, proximity scoring, passive & active RF augmentation, and infrared (IR) augmentation.
Additionally, the Tactical Firejet, a variant of the baseline Firejet developed in response to recent years’ world events and configured to enable and perform key tactical drone operations, rather than use for target missions, maintains key Kratos platform features, including high subsonic speed, high-g maneuverability, optimized performance-per-cost class, and sensor/weapons capability.
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, advanced vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 28, 2025, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT), a leading distributor of Medicare insurance policies and owner of a rapidly growing healthcare services platform, today announced it will release its fiscal third quarter 2026 financial results before market open on Tuesday, May 5, 2026. Chief Executive Officer, Tim Danker, and Chief Financial Officer, Ryan Clement, will host a conference call on the day of the release (May 5, 2026) at 8:30 am ET to discuss the results.
For those interested in dialing into the conference call, please register using this link. After registering, confirmation will be sent via email, including dial in details and unique conference call codes for entry. Registration is open through the live call, but to ensure you are connected for the full call, we suggest registering a day in advance or at least 10 minutes before the start of the call.
About SelectQuote:
Founded in 1985, SelectQuote (NYSE: SLQT) pioneered the model of providing unbiased comparisons from multiple, highly rated insurance companies, allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads. Today, the Company operates an ecosystem offering high touchpoints for consumers across insurance, pharmacy, and virtual care.
With an ecosystem offering engagement points for consumers across insurance, Medicare, pharmacy, and value-based care, the company now has three core business lines: SelectQuote Senior, SelectQuote Healthcare Services, and SelectQuote Life. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, SelectPatient Management, a provider of chronic care management services, and Healthcare Select, which proactively connects consumers with a wide breadth of healthcare services supporting their needs.
RESTON, Va., April 20, 2026 /PRNewswire/ — V2X, Inc., (NYSE: VVX), a leading provider of global mission solutions, will report first quarter 2026 financial results on Monday, May 4, 2026, after market close. Senior management will conduct a conference call at 4:30 p.m. ET that same day.
U.S.-based participants may dial in to the conference call at 877-300-8521, while international participants may dial 412-317-6026. A live webcast of the conference call as well as an accompanying slide presentation will be available at https://app.webinar.net/Q291YZzYJpN and on the Investors section of the V2X website at https://gov2x.com/.
A replay of the conference call will be posted on the V2X website shortly after completion of the call and will be available for one year. A telephonic replay will also be available through May 18, 2026, at 844-512-2921 (domestic) or 412-317-6671 (international) with passcode 10208314.
About V2X V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations [email protected] 719-637-5773
ST. PETERSBURG, Fla., April 20, 2026 (GLOBE NEWSWIRE) — Superior Group of Companies, Inc. (NASDAQ: SGC) (the “Company”) today announced that it will release the results of its operations for the first quarter 2026 before the market open on Monday, May 4, 2026. Michael Benstock, Chairman and Chief Executive Officer, and Mike Koempel, President and Chief Financial Officer, will host a teleconference at 8:00 am Eastern Time that day to discuss the Company’s results.
The live webcast and archived replay can be accessed in the investor relations section of the Company’s website at https://ir.superiorgroupofcompanies.com/presentations. Interested individuals may also join the teleconference by dialing 1-844-861-5505 for U.S. dialers and 1-412-317-6586 for international dialers. The Canadian toll-free number is 1-866-605-3852. Please ask to join the Superior Group of Companies call.
A telephone replay of the teleconference will be available through May 11, 2026. To access the replay, dial 1-855-669-9658 in the United States and Canada or 1-412-317-0088 from international locations. Please reference conference number 4789430 for replay access.
About Superior Group of Companies, Inc. (SGC): Established in 1920, Superior Group of Companies is comprised of three attractive business segments each serving large, fragmented and growing addressable markets. Across Healthcare Apparel, Branded Products and Contact Centers, each segment enables businesses to create extraordinary brand engagement experiences for their customers and employees. SGC’s commitment to service, quality, advanced technology, and omnichannel commerce provides unparalleled competitive advantages. We are committed to enhancing shareholder value by continuing to pursue a combination of organic growth and strategic acquisitions. For more information, visit www.superiorgroupofcompanies.com.
CHICAGO, April 20, 2026 (GLOBE NEWSWIRE) — FreightCar America, Inc. (NASDAQ: RAIL), a diversified manufacturer of railroad freight cars, today announced that it will release its first quarter 2026 financial results on Monday, May 4, 2026, after the market close, and host a teleconference to discuss its first quarter 2026 results on the following day. Teleconference details are as follows:
Please note that the webcast is listen-only and webcast participants will not be able to participate in the question and answer portion of the conference call. Interested parties are asked to dial in approximately 10 to 15 minutes prior to the start time of the call.
An audio replay of the conference call will be available beginning at 3:00 p.m. (Eastern Time) on Tuesday, May 5, 2026, until 11:59 p.m. (Eastern Time) on Tuesday, May 19, 2026. To access the replay, please dial (844) 512-2921 or (412) 317-6671. The replay passcode is 13760024. An archived version of the webcast will also be available on the FreightCar America Investor Relations website.
About FreightCar America
FreightCar America, headquartered in Chicago, Illinois, is a leading designer, producer and supplier of railroad freight cars, railcar parts and components. We also specialize in railcar repairs, complete railcar rebody services and railcar conversions that repurpose idled rail assets back into revenue service. Since 1901, our customers have trusted us to build quality railcars that are critical to economic growth and instrumental to the North American supply chain. To learn more about FreightCar America, visit www.freightcaramerica.com.
NEW YORK–(BUSINESS WIRE)– Perfect Corp. (NYSE: PERF) (“Perfect” or the “Company”), a leading artificial intelligence (“AI”) company offering AI and augmented reality (“AR”) powered solutions to beauty, fashion, photo and video creative industries, today announced that the independent special committee (the “Special Committee”) of the Company’s board of directors (the “Board”), formed to evaluate and consider the previously announced preliminary non-binding proposal letter dated March 18, 2026 (the “Proposal”), has selected Kroll LLC. as its financial advisor and DLA Piper as its international legal counsel.
The Special Committee is continuing its review and evaluation of the Proposal. The Board cautions its shareholders and others considering trading in its securities that neither the Board nor the Special Committee has made any decision with respect to the Proposal. There can be no assurance that any definitive offer will be received, that any definitive agreement will be executed relating to the transaction contemplated by the Proposal, or that the transaction contemplated by the Proposal or any other similar transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to any transaction, except as required under applicable law.
About Perfect Corp.
Founded in 2015, Perfect Corp. is a leading AI company offering self-developed AI- and AR- powered solutions dedicated to transforming the world with digital tech innovations that make your virtual world beautiful. On Perfect’s direct consumer business side, Perfect operates a family of YouCam consumer apps and web-editing services for photo, video and camera users, centered on unleashing creativity with AI-driven features for creation, beautification and enhancement. On Perfect’s enterprise business side, Perfect empowers major beauty, skincare, fashion, jewelry, and watch brands and retailers by supplying them with omnichannel shopping experiences through AR product try-ons and AI-powered skin diagnostics. With cutting-edge technologies such as Generative AI, real-time facial and hand 3D AR rendering and cloud solutions, Perfect enables personalized, enjoyable, and engaging shopping journey and helps brands elevate customer engagement, increase conversion rates, and propel sales growth. Throughout this journey, Perfect maintains its unwavering commitment to environmental sustainability and fulfilling social responsibilities. For more information, visit https://ir.perfectcorp.com/.
Forward-Looking Statements
This communication contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, or the Exchange Act, that are based on beliefs and assumptions and on information currently available to Perfect. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” “target,” “seek” or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Any statements that refer to expectations, projections or other characterizations of future events or circumstances, including strategies or plans, are also forward-looking statements. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. These statements are based on Perfect’s reasonable expectations and beliefs concerning future events and involve risks and uncertainties that may cause actual results to differ materially from current expectations. These factors are difficult to predict accurately and may be beyond Perfect’s control. Forward-looking statements in this communication or elsewhere speak only as of the date made. New uncertainties and risks arise from time to time, and it is impossible for Perfect to predict these events or how they may affect Perfect. In addition, risks and uncertainties are described in Perfect’s filings with the Securities and Exchange Commission. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Perfect cannot assure you that the forward-looking statements in this communication will prove to be accurate. There may be additional risks that Perfect presently does not know or that Perfect currently does not believe are immaterial that could also cause actual results to differ from those contained in the forward looking statements. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by Perfect, its directors, officers or employees or any other person that Perfect will achieve its objectives and plans in any specified time frame, or at all. Except as required by applicable law, Perfect does not have any duty to, and does not intend to, update or revise the forward-looking statements in this communication or elsewhere after the date of this communication. You should, therefore, not rely on these forward-looking statements as representing the views of Perfect as of any date subsequent to the date of this communication.
STAFFORD, Texas, April 20, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today presents the published abstract and poster from the AACR Meeting 2026.
The abstract is shown below and the poster being presented today can be seen and downloaded at the bottom of Phase III clinical trial tab on the Company’s website here.
This is the first abstract and poster presented jointly with the Steering Committee of FLAMINGO-01 with statistically significant delayed-type-hypersensitivity (DTH) immune response data, with subgroup analysis by the most prevalent HLA types.
In the non-HLA-A*02 open label arm where all patients (n=247) were treated with GLSI-100, immune responses to GP2 were measured at baseline and over time using skin tests and other methods. The other methods will be presented at a future conference.
A DTH reaction (redness and/or induration) was used to assess in vivo immune responses in patients. The DTH orthogonal mean was also measured 48-72 hours after injection but is not reported here.
In this preliminary data analysis, there was a significant increase in percentage of patients experiencing a DTH reaction (redness) in month 4 or month 6 compared to baseline. There were 191 patients with both baseline and month 4 or 6 assessments.
The frequency of DTH reactions increased by approximately 4x (290%) in the total open-label non-HLA-A*02 population, increasing from 5.2% of the patients experiencing a DTH reaction at baseline, prior to any GLSI-100 administration, to 20.4% of the patients experiencing a DTH reaction in month 4 or month 6 (McNemar, p < 0.001).
As reported in Table 1 of the poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline with frequency increasing from 100% to 700%.
Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.
Mechanism of Action: A positive immune response is an indicator that the immune system has been activated against recurring cancer cells, potentially leading to the prevention of metastatic breast cancer. The Company previously announced that in the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the Primary Immunization Series (PIS) is completed shows an approximately 70-80% reduction in recurrence rate. Thus, the immune response data is supporting the mechanism of action that reduces recurrences and prevents metastatic breast cancer.
This statistically significant non-HLA-A*02 open label arm immune response data is trending similarly to the immune response data in the HLA-A*02 patients in the Phase IIb study and the HLA-A*02 arms of FLAMINGO-01. The study is ongoing and data collection and cleaning continue, while some patients may still be in their PIS vaccination phase, so final results may vary.
A 1% per year recurrence rate is so low that the number of recurrence events is too few to correlate a negative or lack of immune response to recurrence. The same constraint existed with the Phase IIb data which has a similarly low recurrence rate per year. While DTH immune response may be valuable at an aggregate level looking at whole patient populations, the recurrence rate is too low to validate any immune response measure as a biomarker for individual patient treatment decisions. It is also likely that some responding patients may not exhibit any immune response but still could be protected by GLSI-100 vaccination, thus helping to preserve the blind on the randomized arms of FLAMINGO-01.
The immune response abstract and poster conclusion: The statistically significant increase in the incidence of DTH reactions over time found in this preliminary analysis of GLSI-100 treated non-HLA-A*02 patients shows that GLSI-100 treatment should not be limited to HLA-A*02 patients. Patients treated with GLSI-100 were increasingly able to mount an immune response to GP2 as evidenced in this preliminary data. Future investigations may explore the use of immune responses to assess correlation of DTH to ISRs, immunogenicity of GLSI-100 by specific HLA type, timing of boosters to sustain immunity, clinical site performance, and the discontinuation of treatment for non-responders.
In addition, the second poster describing the Phase III trial design, which is being presented on Tuesday, April 21, can be downloaded and seen on the website using the same link. This poster provides an update that over 1,300 patients have been screened to date in FLAMINGO-01. The new protocol amendment, which is still under regulatory review in certain countries, is not discussed.
CEO Snehal Patel commented, “This new immune response data further supports the combination of HLA-A*02 and non-HLA-A*02 patients in the same randomized arms. In the US, the FDA recently reviewed such protocol changes and the many non-HLA-A*02 patients on waiting lists that were previously screened are now being enrolled. The screen rate continues to be encouraging, reflecting the high patient interest in the study as we have now screened over 1,300 patients. The Company will have the option to pursue approval for both HLA-A*02 and non-HLA-A*02 patients together using the increased statistical power of a combined analysis of the two patient groups or to pursue subgroups based on planned multiple interim analyses.”
The abstract from today’s immune response data and the members of the Steering Committee follow:
Abstract Number: CT138 – Poster Section 52 on April 20, 2026, 2-5pm PT
Abstract Title: Preliminary delayed-type-hypersensitivity immune response results from open-label arm of on-going Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01
Snehal S. Patel1, Jaye Thompson1, F. Joseph Daugherty1, Francois-Clement Bidard2, William J. Gradishar3, Marcus Schmidt4, Miguel Martin5, Joyce A. O’Shaughnessy6, Hope S. Rugo7, Cesar A. Santa-Maria8, Laura M. Spring9, Mothaffar F. Rimawi10
1Greenwich LifeSciences, Stafford, TX,2Institut Curie, Paris, France,3Northwestern University, Chicago, IL,4University Medical Center Mainz, Mainz, Germany,5GEICAM, Madrid, Spain,6Sarah Cannon Research Institute, Dallas, TX,7City of Hope Comprehensive Cancer Center, Duarte, CA,8Johns Hopkins University, Baltimore, MD,9Massachusetts General Hospital, Boston, MA,10Lester and Sue Smith Breast Center, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX
Background: This Phase III trial is a prospective, randomized, double-blinded, multi-center study (NCT05232916) in HLA-A*02 patients at approximately 140 sites in the US and Europe. A third non-randomized arm of approximately 250 non-HLA-A*02 patients is now fully enrolled and preliminary immune response data is presented below. GP2 is a biologic nine amino acid peptide of the HER2/neu protein delivered in combination with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) that stimulates an immune response targeting HER2/neu expressing cancers, the combination known as GLSI-100.
Methods: After standard of care neoadjuvant and adjuvant therapy, 6 intradermal injections of GLSI-100 will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years. The participant duration of the trial will be 3 years treatment plus 1 additional year follow-up. Immune responses to GP2 were measured over time using delayed-type-hypersensitivity (DTH) skin tests and injection site reactions (ISRs). The patient population is defined by these key eligibility criteria: 1) HER2/neu positive and HLA, 2) Residual disease or High risk pCR (Stage III at presentation) post neo-adjuvant therapy, 3) Exclude Stage IV, and 4) Completed at least 90% of planned trastuzumab-based therapy.
Results: All patients (n=247) were vaccinated with GLSI-100 and continue in treatment and follow-up. A DTH reaction (redness) was used to assess in vivo immune responses in patients. The DTH orthogonal mean was measured 48-72 hours after injection. In this preliminary data analysis, there was a significant increase in percentage of subjects experiencing a DTH reaction in month 4 or month 6 compared to baseline. The frequency of DTH reactions increased by approximately 4x from 5.2% of the patients experiencing a DTH reaction at baseline, prior to any GLSI-100 administration, to 20.4% of the patients experiencing a DTH reaction in month 4 or month 6 (McNemar, p < 0.001). The study is ongoing and data collection and cleaning continue so final results may vary.
Conclusions: The increase in the incidence of DTH reactions over time found in this preliminary analysis of GLSI-100 treated non-HLA-A*02 patients shows that GLSI-100 treatment should not be limited to the HLA-A*02 genotype. Subjects treated with GLSI-100 were increasingly able to mount an immune response to GP2 as evidenced in this preliminary data. Future investigations may explore the use of immune responses to assess: correlation of DTH to ISRs, immunogenicity of GLSI-100 by specific HLA type, timing of boosters to sustain immunity, clinical site performance, and the discontinuation of treatment for non-responders.
The Steering Committee authoring abstract CT138 is comprised of the following experts in the field of breast cancer oncology representing prominent teaching hospitals in the US and 4 of the largest breast oncology networks in the US, Germany, France, and Spain:
Dr. Mothaffar F. Rimawi – Professor of Medicine at the Baylor College of Medicine and Executive Medical Director and Co-Leader, Breast Cancer Program of the Dan L Duncan Comprehensive Cancer Center
Dr. Francois-Clement Bidard – Professor of Medical Oncology, UVSQ/Paris Saclay University, Head of Breast Cancer Group, Institut Curie, Vice-Chair of the French Breast Cancer research group UCBG (Unicancer)
Dr. William J. Gradishar – Professor of Medicine at the Feinberg School of Medicine at Northwestern University, Chief of Hematology and Oncology in the Department of Medicine, and Betsy Bramsen Professor of Breast Oncology
Dr. Sibylle Loibl – Professor (apl) Goethe University Frankfurt/M, Clinical Consultant Centre for Haematology and Oncology/Bethanien Frankfurt/M, CEO of GBG Forschungs GmbH & Chair of the German Breast Group (GBG)
Dr. Miguel Martin – Professor of Medicine, Head, Medical Oncology Service, Gregorio Marañón General University Hospital, Complutense University, Madrid, CEO of GEICAM
Dr. Joyce A. O’Shaughnessy – Celebrating Women Chair in Breast Cancer, Baylor University Medical Center and Chair, Breast Cancer Program, Texas Oncology, US Oncology, Dallas, Texas
Dr. Hope S. Rugo – Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center, Professor Emeritus, University of California, San Francisco
Dr. Cesar A. Santa-Maria – Associate Professor of Oncology, Breast and Gynecological Malignancies Group, Director of Breast Cancer Trials, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Dr. Laura M. Spring – Assistant Professor, Medicine, Harvard Medical School, Attending Physician, Medical Oncology, Massachusetts General Hospital
About the AACR Annual Meeting 2026
The AACR is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 61,000 members residing in 143 countries and territories. The AACR Annual Meeting is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR Annual Meeting highlights the work of the best minds in cancer research from institutions all over the world.
About FLAMINGO-01 Open Label Phase III Data More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.
About GLSI-100 Phase IIb Study
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
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