NEW ALBANY, Ohio, April 04, 2025 (GLOBE NEWSWIRE) — Commercial Vehicle Group, Inc. (the “Company” or “CVG”) announced the retirement of Robert C. Griffin, from the Board of Directors of the Company, effective May 15, 2025, without standing for re-election at the 2025 annual meeting of stockholders.
Mr. Griffin has served as a Director since 2005 and is the current Chairman of the Board. Mr. Griffin’s retirement is not as a result of any disagreement with the Company, its management, the Board or any committee of the Board. It is expected that William C. Johnson will serve as the Chairman of the Board following Mr. Griffin’s retirement.
The Chairman of the Nominating, Governance and Sustainability Committee, Michael Nauman, thanked Mr. Griffin for his service and leadership on the Board. “Bob has been an invaluable contributor to the Board since the Company’s earliest days and provided extraordinary leadership to the Board and the Company during his tenure. On behalf of the entire Board of Directors, I want to express my appreciation for Bob’s contributions as we worked together to support the Company’s strategic goals and priorities.”
Mr. Griffin said, “It has been a privilege to serve the shareholders of CVG for 20 years. It has been gratifying to work with the Board and management at CVG and I look forward to following their future success.” He added, ” I wish my fellow directors, and CVG the very best.”
Company Contact Andy Cheung Chief Financial Officer CVG IR@cvgrp.com
Investor Relations Contact Ross Collins or Stephen Poe Alpha IR Group CVGI@alpha-ir.com
About CVG
At CVG, 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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. For this purpose, any statements contained herein that are not statements of historical fact, including without limitation, certain statements herein regarding industry outlook, the Company’s expectations for future periods with respect to its plans to improve financial results, the future of the Company’s end markets changes in the Class 8 and Class 5-7 North America truck build rates, performance of the global construction and agricultural equipment business, the Company’s prospects in the wire harness and electric vehicle markets, the Company’s initiatives to address customer needs, organic growth, the Company’s strategic plans and plans to focus on certain segments, competition faced by the Company, volatility in and disruption to the global economic environment, including global supply chain constraints, inflation and labor shortages, tariffs and counter-measures, financial covenant compliance, anticipated effects of acquisitions or divestitures, production of new products, plans for capital expenditures and our results of operations or financial position and liquidity, may be deemed to be forward-looking statements. Without limiting the foregoing, the words “believe”, “anticipate”, “plan”, “expect”, “intend”, “will”, “should”, “could”, “would”, “project”, “continue”, “likely”, and similar expressions, as they relate to us, are intended to identify forward-looking statements. The important factors discussed in “Item 1A – Risk Factors” in the Company’s Annual Report on Form 10-K, among others, could cause actual results to differ materially from those indicated by forward-looking statements made herein and presented elsewhere by management from time to time. Such forward-looking statements represent management’s current expectations and are inherently uncertain. Investors are warned that actual results may differ from management’s expectations. Additionally, various economic and competitive factors could cause actual results to differ materially from those discussed in such forward-looking statements, including, but not limited to, factors which are outside our control.
Any forward-looking statement that we make in this press release speaks only as of the date of such statement, and we undertake no obligation to update any forward-looking statement or to publicly announce the results of any revision to any of those statements to reflect future events or developments. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless specifically expressed as such, and should only be viewed as historical data.
Profab Electronics is a High-Quality Manufacturer with Mass Production Capabilities and a 60,000 SQF Manufacturing Facility in Florida
April 03, 2025 10:02 ET
MIAMI, April 03, 2025 (GLOBE NEWSWIRE) — SKYX (NASDAQ: SKYX) (d/b/a “SKYX Technologies”), a highly disruptive advanced and smart home platform technology company for homes and buildings, with more than 97 issued and pending patents globally and a portfolio of over 60 lighting and home décor websites, today announces a strategic manufacturing partnership with Profab Electronics, a premier electronic contract manufacturer based in Pompano Beach, Florida. This collaboration marks a significant step forward in SKYX’s commitment to building a resilient, efficient, and localized supply chain for its innovative product lines.
Profab Electronics specializes in full-service of high-quality electronic contract manufacturing, offering capabilities that span new product introduction (NPI), production assembly, robotic inventory management, and integrated supply chain services. With over four decades of experience and a focus on advanced automation, Profab provides high-quality, scalable manufacturing solutions for some of the most demanding sectors.
This U.S. manufacturing expansion reinforces SKYX’s dedication to operational excellence, customer satisfaction, and sustainable business practices.
Rani Kohen, Founder and Executive Chairman of SKYX Platforms Corp., said: “Our partnership with Profab Electronics, a prominent U.S. electronic manufacturer, is significant for SKYX, establishing U.S.-based production capabilities and ensuring greater control over our manufacturing processes and the ability to maintain the high standards of quality and safety our customers expect. We are proud to support American manufacturing and invest in building strong domestic operations.”
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 97 U.S. and global patents and patent pending applications. Additionally, the Company owns over 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://skyplug.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 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.
Vancouver, British Columbia–(Newsfile Corp. – April 3, 2025) – Hemisphere Energy Corporation (TSXV: HME) (OTCQX: HMENF) (“Hemisphere” or the “Company”) is pleased to announce that its board of directors has approved the declaration of a special dividend to shareholders.
Special Dividend
Given the strong financial position and performance outlook of the Company, Hemisphere’s board of directors has approved the declaration of a special dividend of C$0.03 per common share, in accordance with its dividend policy. The special dividend will be paid on April 28, 2025, to shareholders of record on April 17, 2025, and is designated as an eligible dividend for Canadian income tax purposes. It is in addition to the Company’s quarterly base dividend of C$0.025 per common share.
About Hemisphere Energy Corporation
Hemisphere is a dividend-paying Canadian oil company focused on maximizing value-per-share growth with the sustainable development of its high netback, ultra-low decline conventional heavy oil assets through polymer flood EOR methods. Hemisphere trades on the TSX Venture Exchange as a Tier 1 issuer under the symbol “HME” and on the OTCQX Venture Marketplace under the symbol “HMENF”.
For further information, please visit the Company’s website at www.hemisphereenergy.ca to view its corporate presentation, or contact:
Don Simmons, President & Chief Executive Officer Telephone: (604) 685-9255 Email: info@hemisphereenergy.ca
Certain statements included in this news release constitute forward-looking statements or forward-looking information (collectively, “forward-looking statements”) within the meaning of applicable securities legislation. Forward-looking statements are typically identified by words such as “anticipate”, “continue”, “estimate”, “expect”, “forecast”, “may”, “will”, “project”, “could”, “plan”, “intend”, “should”, “believe”, “outlook”, “potential”, “target” and similar words suggesting future events or future performance. In particular, but without limiting the generality of the foregoing, this news release includes forward-looking statements including that a special dividend will be paid to shareholders on April 28, 2025, to shareholders of record on April 17, 2025.
Forward‐looking statements are based on a number of material factors, expectations or assumptions of Hemisphere which have been used to develop such statements and information, but which may prove to be incorrect. Although Hemisphere believes that the expectations reflected in such forward‐looking statements or information are reasonable, undue reliance should not be placed on forward‐looking statements because Hemisphere can give no assurance that such expectations will prove to be correct. In addition to other factors and assumptions which may be identified herein, assumptions have been made regarding, among other things: the timing for payment of the special dividend; the general continuance of current industry conditions; the timely receipt of any required regulatory approvals; the ability of Hemisphere to obtain qualified staff, equipment and services in a timely and cost efficient manner; drilling results; the ability of the operator of the projects in which Hemisphere has an interest in to operate the field in a safe, efficient and effective manner; the ability of Hemisphere to obtain financing on acceptable terms; field production rates and decline rates; the ability to replace and expand oil and natural gas reserves through acquisition, development and exploration; the timing and cost of pipeline, storage and facility construction and expansion and the ability of Hemisphere to secure adequate product transportation; future commodity prices; currency, exchange and interest rates; regulatory framework regarding royalties, taxes and environmental matters in the jurisdictions in which Hemisphere operates; and the ability of Hemisphere to successfully market its oil and natural gas products.
The forward‐looking statements included in this news release are not guarantees of future performance and should not be unduly relied upon. Such information and statements, including the assumptions made in respect thereof, involve known and unknown risks, uncertainties and other factors that may cause actual results or events to defer materially from those anticipated in such forward‐looking statements including, without limitation: changes in project timelines and workstreams; changes in commodity prices; changes in the demand for or supply of Hemisphere’s products, the early stage of development of some of the evaluated areas and zones; unanticipated operating results or production declines; changes in tax or environmental laws, royalty rates or other regulatory matters; changes in development plans of Hemisphere or by third party operators of Hemisphere’s properties, increased debt levels or debt service requirements; inaccurate estimation of Hemisphere’s oil and gas reserve volumes; limited, unfavourable or a lack of access to capital markets; increased costs; a lack of adequate insurance coverage; the impact of competitors; and certain other risks detailed from time‐to‐time in Hemisphere’s public disclosure documents, (including, without limitation, those risks identified in this news release and in Hemisphere’s Annual Information Form).
The forward‐looking statements contained in this news release speak only as of the date of this news release, and Hemisphere does not assume any obligation to publicly update or revise any of the included forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by applicable securities laws.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.
RESTON, Va., April 3, 2025 /PRNewswire/ — V2X, Inc., (NYSE: VVX), announces it has successfully repriced and extended its $238 million Term Loan A and $500 million Revolving Credit Facility (“Revolver”). As of December 31, 2024, there were no outstanding borrowings on the company’s Revolver.
“I’m pleased to announce further enhancements to our capital structure through a successful repricing and extension of our Term Loan A and Revolver,” said Shawn Mural, Senior Vice President and Chief Financial Officer at V2X.
The amendment includes an updated leverage-based pricing grid, offering over 50 basis points of interest savings compared to the prior grid, as well as an extension of the facility by two years to March 2030.
Mr. Mural continued, “This repricing and extension, which was well oversubscribed, builds on our recent Term Loan B repricing and demonstrates the strength and positioning of our business as well as our ongoing commitment to increasing value for shareholders. I’d like to thank our banking partners for their continued support and confidence in our business.”
Safe Harbor Statement Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995 (the “Act”): Certain material presented herein includes forward-looking statements intended to qualify for the safe harbor from liability established by the Act. These forward-looking statements include, but are not limited to, all the statements in this release that are not historical, including, without limitation, interest savings, enhancements to our capital structure, and the strength and positioning of our business.
Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may,” “will,” “expect,” “intend,” “estimate,” “anticipate,” “believe,” “could,” “potential,” “continue,” “can,” “goal,” “long-term,” “drive,” “next,” and variations of such words and or similar expressions and terminology. These statements are based on the beliefs and assumptions of the management of the Company based on information currently available to management.
These forward-looking statements are not guarantees of future performance, conditions, or results, and involve a number of known and unknown risks, uncertainties, assumptions, and other important factors, many of which are outside our management’s control, which could cause actual results to differ materially from the results discussed in the forward-looking statements. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the Company’s historical experience and our present expectations or projections. For a discussion of some of the risks and uncertainties that could cause actual results to differ from such forward-looking statements, see the risks and other factors detailed from time to time in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings with the SEC.
We do not undertake, and expressly disclaim, any duty or obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
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 IR@goV2X.com 719-637-5773
Media Contact Angelica Spanos Deoudes Director, Corporate Communications Angelica.Deoudes@goV2X.com 571-338-5195
Each Betty’s Caramelt Away Chew Uses Rich, Buttery Caramel, To Create Moments of Mellow
NORWOOD, Mass., April 03, 2025 (GLOBE NEWSWIRE) — Betty’s Eddies™, the all-natural cannabis chews handcrafted to fit a variety of needs, is expanding its lineup with the introduction of delicious caramel chews: Betty’s Caramelt Away. Betty’s Eddies is one of the top-selling and award-winning brands developed and distributed by leading multi-state cannabis operator, MariMed Inc. (“MariMed”) (CSE: MRMD) (OTCQX: MRMD).
Debuting in time for National Caramel Day on April 5, Betty’s Caramelt Away chews are now available at select cannabis retailers throughout Massachusetts, with plans for expansion into MariMed’s wholesale markets in the future. Each chew wraps customers in warmth with the rich, comforting flavor of classic caramel. They’re infused with a soothing blend of full-spectrum hash and CBG that lets consumers sink into sweet, cozy melty moments of mellow.
“Betty’s Eddies and caramel is the perfect pairing of two fan favorites,” said Sara Rosenfield, Brand Director at MariMed for Betty’s Eddies. Betty’s Eddies is the most popular edible brand in several of our core markets: Massachusetts, Maryland, and Delaware. Caramel consistently ranks among the most popular ingredients in candy and other sweet treats. Cannabis consumers will love the full-flavor, full-spectrum experience that the brand is known for with the creamy deliciousness of caramel.”
Betty’s Caramelt Away joins a full slate of Betty’s Eddies products that feature specific end-effects, including Bedtime Betty’s for restful nights, Take It Easy Eddies for stress relief, Go Betty Go for an energy boost, Ache Away Eddies for pain relief, Smashin’ Passion for sexual wellness, and Betty Good Times for any time.
About Betty’s Eddies Betty’s Eddies™ all-natural fruit chews are handcrafted with full-spectrum cannabis, supporting cannabinoids, and herbal supplements and vitamins. Designed for whatever life throws at you, varieties include pain relief, immunity, energy, sleep and more. Founded in 2014 by medical cannabis patients on a mission to craft the best tasting and most effective edibles, best-selling Betty’s Eddies encompass the full spectrum of the plant’s benefits, including natural adaptogens, and are handcrafted in small batches with real organic fruits and vegetables. Find Betty’s Eddies in licensed dispensaries in Delaware, Maryland, Massachusetts, and Missouri. Learn more at www.bettyseddies.com.
About MariMed MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, Vibations™, InHouse™, and Nature’s Heritage™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.
Global Restaurant Franchising Company Accepts Cryptocurrency for Franchisee Royalty Payments
LOS ANGELES, April 02, 2025 (GLOBE NEWSWIRE) — FAT(Fresh. Authentic. Tasty.) Brands Inc. (NASDAQ: FAT) (“FAT Brands” or the “Company”), a leading global franchising company and parent company of iconic brands including Round Table Pizza, Fatburger, Johnny Rockets, Twin Peaks, Fazoli’s and 13 other restaurant concepts, announced it is officially accepting Bitcoin for franchisee royalty payments. With over 2,300 locations worldwide, the Company is the first restaurant franchise to accept royalty payments in cryptocurrency. The move underscores FAT Brands’ commitment to financial and technological innovation.
“Over the years, Bitcoin has transformed into a mainstream asset and, as a Company, we see great value in expanding our forms of payments for our franchisees, especially for our international partners, who make up over 20 percent of our portfolio,” said Thayer Wiederhorn, COO of FAT Brands. “We look forward to utilizing Bitcoin as an efficient tool for streamlining and simplifying the payment process and are excited to be at the forefront of this evolution in embracing Bitcoin as it continues to grow in popularity.”
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 18 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Smokey Bones, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.
New gates will be installed at the Secaucus Junction and Newark Liberty International Airport stations
Contract follows a recent agreement with SEPTA to install Conduent’s fare gates at nine different transit stations in the nearby Philadelphia area
FLORHAM PARK, N.J. — Conduent Transportation, a global provider of smart mobility technology solutions and business unit of Conduent Incorporated (Nasdaq: CNDT), today announced a contract with NJ TRANSIT to install state-of-the-art 3D fare gates across two of its stations in New Jersey. NJ TRANSIT will leverage Conduent’s advanced 3D Fare Gate Solution to modernize its infrastructure and enhance the reliability of fare collections.
The nearly 8-foot-tall gates will be installed in the coming months at NJ TRANSIT’s Secaucus Junction and Newark Liberty International Airport stations. The agency also has the option to expand the 3D gates to additional locations, further building on Conduent’s trusted 30 year-partnership with NJ TRANSIT.
“We’re honored to expand our relationship with NJ TRANSIT with their adoption of our 3D Fare Gate Solution,” said Adam Appleby, Group President, Public Sector Solutions at Conduent. “This innovative technology modernizes fare collection and helps ensure fair access to a transit system that benefits the entire region.”
In 2024, NJ TRANSIT awarded a five-year contract to Conduent for the continued implementation and enhancement of its contactless fare collection system.
The new fare gate agreement, for 72 gates in total, comes on the heels of a 2024 contract with the Southeastern Pennsylvania Transportation Authority (SEPTA) to install 100 Conduent 3D fare gates at nine transit stations in the Philadelphia area. SEPTA’s decision followed a successful pilot program at one station, where the integration of 3D fare gates and transit police efforts to deter fare evasion led to an increase in annual revenue. The gates are also used in Paris by Transilien SNCF.
Conduent Transportation is a leading provider of streamlined, high-volume mobility services and solutions, spanning tolling and advanced transit systems, which enhance the services provided by transportation agencies to benefit the citizens who use them. For over 50 years, the company has helped clients advance transportation solutions in more than 20 countries.
About Conduent Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The Company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 55,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $100 billion in government payments annually, enabling 2.3 billion customer service interactions annually, empowering millions of employees through HR services every year and processing nearly 13 million tolling transactions every day. Learn more at www.conduent.com.
Trademarks Conduent is a trademark of Conduent Incorporated in the United States and/or other countries. Other names may be trademarks of their respective owners.
Lead compound THIO (ateganosine) is the only clinical-stage telomere-targeting anticancer agent throughout the field of cancer discovery
Potential FDA filings in 2026 for accelerated approval from THIO-101 and early full approval from THIO-104
Full Shareholder Letter available in Investors section of MAIA’s corporate website
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today published a 2025 Shareholder Letter by CEO Vlad Vitoc, M.D. detailing the Company’s key milestones for 2025 including several clinical trials and regulatory pathways.
“MAIA continues to bring innovation to the biotech industry as one of the earliest pioneers of telomere targeting as a strategy for cancer treatment. Our lead candidate is THIO (ateganosine), the only clinical-stage telomere-targeting anticancer agent throughout the field of cancer discovery,” states Dr. Vitoc at the opening of his shareholder letter. “We are working on multiple potential regulatory pathways that could provide accelerated approval and robust exclusivity for THIO in non-small cell lung cancer (NSCLC). Multiple milestones this year are expected to pave the path toward a potential FDA decision as early as next year.”
Letter Highlights
Phase 2 trial THIO-101 expansion underway; potential filing in 2026 for accelerated approval.
Phase 3 THIO-104 set to begin in mid-2025; potential filing in 2026 for early full approval.
Lead asset THIO shows exceptional efficacy in advanced NSCLC.
Multiple THIO trials planned in additional cancer indications.
Significant market opportunity in hard-to-treat cancers with unmet medical needs.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward-Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
Tonix expands its all-in-one platform, partnering with the world’s leading migraine diary app, enhancing disease education and prescription access
CHATHAM, N.J., April 01, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with a portfolio of marketed products and a pipeline of development candidates, today announced the launch of TONIX ONE™, a fully-integrated digital platform designed to help patients better understand and manage their migraine condition. Through a series of strategic partnerships with UpScript Telemedicine, ProModRx, Blink Health and a leading mobile application specializing in disease tracking, reporting and symptom management, Tonix is streamlining the migraine patient journey into a unified digital platform. Please visit www.tonixone.com for details.
“We developed TONIX ONE to leverage innovation and deliver a full-service digital solution that seamlessly guides patients from their migraine diary app to prescription fulfillment within hours. Our goal is not only to educate and empower patients seeking better treatment options but also to remove the barriers to care that many individuals living with migraines face,” said Scott Szymanski, Vice President of Sales and Marketing, Migraine, of Tonix Pharmaceuticals.
TONIX ONE provides an intuitive, comprehensive journey for patients by offering educational resources about migraine and the limitations of oral medications which can sometimes lead to delayed or ineffective symptom relief. The platform also connects patients directly to migraine specialists via telehealth services and e-prescription requests, simplifying and accelerating access to treatment.
“With the launch of TONIX ONE, we are further strengthening Tonix Pharmaceuticals’ position as a leader in innovation, addressing barriers and inefficiencies that stand between patients and the life-changing medications they need,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “By offering a fully-integrated digital platform that streamlines disease state education, prescription acquisition, and fulfillment, we are enhancing access for patients while creating value across our existing portfolio, pipeline, and future business development opportunities.”
Gpmigraine.com provides patients with valuable insights into migraine management by addressing the challenges associated with oral medications due to gastroparesis. The platform helps patients explore alternative treatments and empowers them to make informed decisions about their care.
ProModRx provides patients with a digital solution, dRx Request, to request an e-prescription from their established migraine clinician.
UpScript Health is the leading telemedicine provider in the U.S. For patients who do not have an established migraine clinician or would rather use telemedicine, UpScript provides patients real-time access to 100’s of expert clinicians.
Blink Health is revolutionizing the pharmacy experience, using digital cutting-edge technology to dramatically improve patient access for branded medications.
A leading mobile application operated by a third party, and accessible on the TONIX ONE platform, designed to empower patients suffering from headaches and migraines through data-driven insights, enabling tracking, reporting, and self-management. By providing valuable health data, the platform helps accelerate diagnosis and optimize treatment options, ultimately enhancing the quality of life for people living with migraine symptoms, which in turn can accelerate diagnosis and fine-tune treatment options.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Please visit www.tonixone.com for Tonix’s fully-integrated digital platform designed to help patients better understand and manage their migraine condition.
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 by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of 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, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
SASKATOON, Saskatchewan, Canada, April 1, 2025 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”), a leading provider of biological and regenerative agriculture solutions, is pleased to announce the addition of three cutting-edge biological solutions to MustGrow’s existing Canadian product lines through its recently acquired Canadian sales and distribution division, NexusBioAg. Product website linked here: NexusBioAg.
MustGrow now proudly offers three new biological solutions designed to enhance crop health, boost yield potential, and improve environmental resilience. Featuring EZ-Gro Max, EZ-Gro Cyto, and Rootella® mycorrhizal inoculants, these innovative products provide farmers with powerful, science-backed tools to maximize every acre.
“At MustGrow, we are committed to accelerating the adoption of biological solutions in agriculture. With this new product lineup, we are offering Canadian farmers proven, science-driven products that support sustainable farming while delivering strong agronomic performance,” said Colin Bletsky, COO of MustGrow.
EZ-Gro Max: Maximize Every Acre
Powered by Bio-APP™ Technology, EZ-Gro Max is a next-generation biostimulant designed to enhance foliar nutrition, improve plant growth, and increase yield potential while mitigating environmental stress.
Key Benefits:
Contains a five-biostimulant stack that promotes plant growth and development
Enhances crop yield potential
Reduces the effects of heat, drought, and other environmental stresses
Compatible with most foliar nutrition and chemistry partners
EZ-Gro Max is designed for Alfalfa, Barley, Canola, Corn, Oats, Potatoes, Rye, Soybeans, and Wheat, ensuring broad-spectrum benefits across multiple crop types.
EZ-Gro Cyto: Power Through the Unpredictable
Designed to help crops thrive under drought, heat, cold, and salinity stress, EZ-Gro Cyto is a stacked biostimulant package that proactively preserves yield potential in unpredictable conditions.
Key Benefits:
Features a four-biostimulant stack to improve resistance to environmental stresses
Activates plant disease resistance traits
Stimulates plant growth and development
Increases the number and size of flowers, grains, and pods
EZ-Gro Cyto is optimized for Alfalfa, Barley, Canola, Chickpeas, Corn, Lentils, Oats, Peas, Rye, Soybeans, Sunflower, and Wheat, making it an essential tool for growers facing variable weather conditions.
Developed by Groundwork BioAg®, Rootella mycorrhizal inoculants enhance root networks by forming fungal mycelia that increase plants’ ability to absorb water and nutrients. Built on more than 30 years of research, these highly efficient inoculants improve plant fertility, resilience, and sustainability.
Key Benefits:
Improved nutrient uptake, leading to increased yield and quality
Fertilizer and water savings, reducing input costs without compromising yield
Enhanced stress resilience, including drought, flooding, salinity, and extreme pH soils
Supports environmental sustainability through carbon sequestration
About MustGrow
MustGrow Biologics Corp. is a fully-integrated provider of innovative biological and regenerative agriculture solutions designed to support sustainable farming. The Company’s proprietary and third-party product lines offer eco-friendly alternatives to restricted or banned synthetic chemicals and fertilizers. In North America, MustGrow offers a portfolio of third-party crop nutrition solutions, including micronutrients, nitrogen stabilizers, biostimulants, adjuvants and foliar products. These products are synergistically distributed alongside MustGrow’s wholly-owned proprietary products and technologies that are derived from mustard and developed into organic biocontrol and biofertility products to help replace banned or restricted synthetic chemicals and fertilizers. Outside of North America, MustGrow is focused on collaborating with agriculture companies, such as Bayer AG in Europe, the Middle East and Africa, to commercialize MustGrow’s wholly-owned proprietary products and technologies. The Company is dedicated to driving shareholder value through the commercialization and expansion of its intellectual property portfolio of approximately 112 patents that are currently issued and pending, and the sales and distribution of its proprietary and third-party product lines through NexusBioAg. MustGrow is a publicly traded company (TSXV-MGRO) and has approximately 51.6 million common shares issued and outstanding and 59.7 million shares fully diluted. For further details, please visit www.mustgrow.ca.
Contact Information
Corey Giasson Director & CEO Phone: +1-306-668-2652 info@mustgrow.ca
MustGrow Forward-Looking Statements
Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.
Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include: the receipt of final approval by the TSXV and those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2023 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available on SEDAR+ at www.sedarplus.ca. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.
Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.
FORT WORTH, Texas, March 31, 2025 /PRNewswire/ — AZZ Inc. (NYSE: AZZ), the leading independent provider of hot-dip galvanizing and coil coating solutions, today announced it will conduct a conference call to review the financial results for the fourth quarter and fiscal year 2025 at 11:00 a.m. ET on Tuesday, April 22, 2025. The Company will issue a press release reporting fourth quarter and full fiscal year financial results after the market closes on April 21, 2025.
Conference Call Details Interested parties can access the conference call by dialing (844) 855-9499 or (412) 317-5497 (international). A webcast of the call will be available on the Company’s Investor Relations page at http://www.azz.com/investor-relations.
A replay of the call will be available at (877) 344-7529 or (412) 317-0088 (international), replay access code: 3079902 through April 29, 2025, or by visiting http://www.azz.com/investor-relations for the next 12 months.
About AZZ Inc. AZZ Inc. is the leading independent provider of hot-dip galvanizing and coil coating solutions to a broad range of end-markets. Collectively, our business segments provide sustainable, unmatched metal coating solutions that enhance the longevity and appearance of buildings, products and infrastructure that are essential to everyday life. For more information, please refer to www.azz.com.
Safe Harbor Statement
Certain statements herein about our expectations of future events or results constitute forward-looking statements for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements by terminology such as “may,” “could,” “should,” “expects,” “plans,” “will,” “might,” “would,” “projects,” “currently,” “intends,” “outlook,” “forecasts,” “targets,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology. Such forward-looking statements are based on currently available competitive, financial, and economic data and management’s views and assumptions regarding future events. Such forward-looking statements are inherently uncertain, and investors must recognize that actual results may differ from those expressed or implied in the forward-looking statements. Forward-looking statements speak only as of the date they are made and are subject to risks that could cause them to differ materially from actual results. Certain factors could affect the outcome of the matters described herein. This press release may contain forward-looking statements that involve risks and uncertainties including, but not limited to, changes in customer demand for our manufactured solutions, including demand by the construction markets, the industrial markets, and the metal coatings markets. We could also experience additional increases in labor costs, components and raw materials including zinc and natural gas, which are used in our hot-dip galvanizing process; supply-chain vendor delays; customer requested delays of our manufactured solutions; delays in additional acquisition opportunities; an increase in our debt leverage and/or interest rates on our debt, of which a significant portion is tied to variable interest rates; availability of experienced management and employees to implement AZZ’s growth strategy; a downturn in market conditions in any industry relating to the manufactured solutions that we provide; economic volatility, including a prolonged economic downturn or macroeconomic conditions such as inflation or changes in the political stability in the United States or Canada; acts of war or terrorism inside the United States or abroad; and other changes in economic and financial conditions. AZZ has provided additional information regarding risks associated with the business, including in Part I, Item 1A. Risk Factors, in AZZ’s Annual Report on Form 10-K for the fiscal year ended February 29, 2024, and other filings with the SEC, available for viewing on AZZ’s website at www.azz.com and on the SEC’s website at www.sec.gov. You are urged to consider these factors carefully when evaluating the forward-looking statements herein and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. These statements are based on information as of the date hereof and AZZ assumes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.
Company Contact: David Nark, Senior Vice President of Marketing, Communications, and Investor Relations AZZ Inc. (817) 810-0095 www.azz.com
Investor Contact: Sandy Martin or Phillip Kupper Three Part Advisors (214) 616-2207 or (817) 368-2556 www.threepa.com
– Oxylanthanum carbonate (OLC) New Drug Application for hyperphosphatemia in chronic kidney disease patients on dialysis under review by the FDA with a PDUFA target action date of June 28, 2025
– Commercial planning in preparation for anticipated commercial launch of OLC in late 2025
LOS ALTOS, Calif., March 31, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the full year ended December 31, 2024, and provided a business update.
“2025 is positioned to be a transformational year for Unicycive, with the near-term potential for FDA approval and commercial launch of oxylanthanum carbonate (OLC),” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “For approximately 75% of people in the U.S. with chronic kidney disease (CKD) on dialysis, hyperphosphatemia remains uncontrolled because of challenges with currently available phosphate binders, potentially increasing their risk of hospitalization and mortality. If approved, we believe OLC is positioned to be an important new option for these patients, distinguished by its high potency and a low pill burden. We continue to actively prepare to launch OLC, including educating key stakeholders on existing OLC data and preparing our commercial infrastructure to rapidly make OLC available to patients upon approval.”
Key Highlights & Upcoming Milestones
Announced the acceptance of the New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for OLC for the treatment of hyperphosphatemia in patients with CKD on dialysis. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025.
Unicycive’s partner in the Republic of Korea, Lotus Pharmaceutical, submitted an NDA for OLC with the Ministry of Food and Drug Safety and anticipates an application decision in June of 2026. Unicycive has an exclusive license agreement with Lotus Pharmaceutical for the development, registration, and commercialization of OLC in the Republic of Korea and has the potential to receive up to $3.7 million in milestone payments and tiered royalties based on regulatory and commercial achievements.
Continued efforts to establish an efficient commercial infrastructure, including building key functions, engaging directly with prescribers and other stakeholders and preparing to support market access are ongoing. Expanded awareness of OLC and its potential to address significant needs for CKD patients through publication of data, including in the peer-reviewed journals Clinical Therapeutics, Clinical and Translational Science, and Journal of Nephrological Science; and late-breaker presentation at the American Society of Nephrology (ASN) Kidney Week 2024. These data included clinical, preclinical and patient survey/literature review data that highlighted OLC’s favorable safety and tolerability profile, efficacy in controlling serum phosphate levels, and the need for new options to overcome the current limitations of phosphate binders and their effects on patients’ quality of life. The data also demonstrated OLC’s bioequivalence to approved lanthanum carbonate chewable tablets, and the potential benefits of combination treatment of OLC and tenapanor on phosphate management.
Successfully completed Phase 1 study of UNI-494 in healthy volunteers, which demonstrated favorable tolerability, with fast absorption and rapid metabolization. Data from the Phase 1 study and supportive preclinical data were presented at ASN 2024 and published in EC Pharmacology and Toxicology.
Financial Results for the Year Ended December 31, 2024
Licensing revenues decreased approximately $0.7 million, from the year ended December 31, 2023 due to an upfront payment of approximately $0.7 million associated with a licensing agreement entered into with Lotus International Pte Ltd. in February 2023. There was no comparable revenue earned in the current period.
Research and Development (R&D) expenses were $20.0 million for the year ended December 31, 2024, compared to $12.9 million for the same period in 2023. The increase in research and development expenses was primarily due to an increase in drug development and labor costs.
General and Administrative (G&A) expenses were $12.1 million for the year ended December 31, 2024, compared to $8.5 million for the same period in 2023. The increase was primarily due to an increase in labor, consulting and professional services costs.
Other Income was $4.6 million for the year ended December 31, 2024 compared to $9.8 million in the same period in 2023 due primarily to a decrease in the fair value of our warrant liability.
Net loss attributable to common stockholders for the year ended December 31, 2024 was $37.8 million, or $0.56 per share of common stock, compared to a net loss attributable to common stockholders of $31.4 million, or $1.28 per share of common stock for the same period in 2023. The increased net loss for the year ended December 31, 2024 was attributable primarily to an increase in drug development costs.
As of December 31, 2024, cash and cash equivalents totaled $26.1 million. The Company believes that it has sufficient resources to fund planned operations into 2026.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.
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 Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’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 candidates; our dependence on third parties for manufacturing; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that the National Medical Products Administration (NMPA) of the People’s Republic of China (“PRC”) has approved its clinical trial application for a potential new indication for pirfenidone in oncology-related pulmonary complications. The trial will evaluate pirfenidone capsules for the treatment of radiation-induced lung injury (RILI), with or without immune-related pneumonitis (CIP).
This regulatory milestone marks the expansion of pirfenidone beyond its established role in idiopathic pulmonary fibrosis (IPF) into the oncology supportive care space, offering a novel lung-protective strategy for cancer patients undergoing radiation therapy or immunotherapy.
In accordance with the NMPA approval, Gyre intends to pursue an adaptive Phase 2/3 clinical trial design, combining dose exploration with efficacy confirmation, to efficiently evaluate pirfenidone’s potential in this new indication.
Radiation-Induced Lung Injury (RILI): Radiation therapy is a cornerstone of lung cancer treatment. However, 5%–25% of patients experience lung damage due to radiation exposure, limiting the ability to escalate doses and thereby compromising treatment efficacy.
Checkpoint Inhibitor Pneumonitis (CIP): Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment, but 13%–19% of patients develop CIP. This condition accounts for approximately 35% of immune-related adverse event (irAE) deaths and often necessitates treatment discontinuation.
Currently, no targeted therapies exist for lung injuries caused by radiation or immunotherapy. Distinguishing between RILI and CIP is challenging, particularly when both occur concurrently. Corticosteroids remain the standard of care despite significant long-term side effects. By targeting and inhibiting fibrotic pathways, pirfenidone may address the root cause of lung injury progression, offering a new treatment option for patients receiving radiation or immunotherapy.
Gyre anticipates initiating the trial in the second half of 2025 at leading academic and oncology centers across the PRC.
About Pirfenidone Pirfenidone is an orally administered small molecule approved for the treatment of IPF. It works by inhibiting TGF-β signaling and fibroblast proliferation. The drug has demonstrated clinical benefit in slowing lung function decline in IPF and is now being evaluated for oncology-related pulmonary complications. Gyre has held first-in-class status for pirfenidone in the PRC since its original approval in 2011, underscoring its pioneering role in treating fibrotic lung diseases.
About Gyre Therapeutics Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of F351 (Hydronidone) for MASH-associated fibrosis in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the PRC, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts and timing of expected clinical trials, including timing of a clinical trial initiation in the second half of 2025. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings the Company may make with the Securities and Exchange Commission.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
For Investors: Stephen Jasper stephen@gilmartinir.com
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