DALLAS–(BUSINESS WIRE)–RGP® (Nasdaq: RGP), a global professional services firm, today announced the appointment of Scott Rottmann to the newly created role of President, CFO Advisory.
“As finance leaders confront a future defined by data, digital innovation, and accelerated transformation, Scott’s expertise will enable us to guide clients beyond incremental improvement toward true enterprise reinvention” – Bhadresh Patel, COO, RGPShare
For more than 30 years, RGP has partnered with CFOs and their organizations to strengthen finance, accounting, risk, compliance, and tax capabilities. The creation of this dedicated leadership role formalizes and expands that commitment, positioning RGP to accelerate growth in CFO advisory, digital, technology, and data services.
Rottmann will lead RGP’s Office of the CFO consulting capability area, where the firm sees strong client demand and long-term opportunity. He will oversee the firm’s Finance & Accounting, Governance, Risk & Compliance, and Tax & Treasury practices, reporting to Chief Operating Officer Bhadresh Patel.
“Scott brings not only deep leadership experience but also the ability to help us shape the next era of CFO advisory,” said Patel. “As finance leaders confront a future defined by data, digital innovation, and accelerated transformation, Scott’s expertise will enable us to guide clients beyond incremental improvement toward true enterprise reinvention. His track record of scaling businesses, combined with his understanding of how people, process, technology, and data intersect, will help us deliver bold solutions that anticipate what CFOs need tomorrow, not just today. Scott’s addition strengthens our ability to stand alongside finance leaders as architects of resilience, growth, and long-term value creation.”
Before joining RGP, Rottmann served as a principal and partner at EY-Parthenon, where he helped CXOs, boards, and leadership teams optimize their organizations. Previously, he held senior leadership positions at Genpact and Deloitte.
“I’ve had the opportunity to lead complex, global transformation initiatives for some of the world’s most valuable brands over the past 20 years, and I’m excited to join RGP at this pivotal time of continued growth,” said Rottmann. “RGP was built on a foundation of empowering CFOs and their teams. My role is to evolve that legacy, strengthening our CFO advisory capabilities, and building even deeper, enduring partnerships within the CFO community.”
ABOUT RGP
RGP (Nasdaq: RGP) is an award-winning global professional services firm with three decades of experience helping the world’s top organizations navigate change and seize opportunity. With three integrated offerings—On-Demand Talent, Consulting, and Outsourced Services—we provide CFOs and C-suite leaders with the flexibility to solve today’s most pressing challenges on their terms, uniting strategy, execution, and talent across digital transformation, data, cloud, and global scale. Our people-first approach continues to drive innovation across industries worldwide.
Based in Dallas, Texas, with offices worldwide, we annually engage with over 1,600 clients around the world from 41 physical practice offices and multiple virtual offices. As of May 2025, RGP is proud to have served 88 percent of the Fortune 100 and has been recognized by U.S. News & World Report (2024–2025 Best Companies to Work For) and Forbes (America’s Best Management Consulting Firms 2025, America’s Best Midsize Employers 2025, World’s Best Management Consulting Firms 2024).
RGP is listed on the Nasdaq Global Select Market, the exchange’s highest tier by listing standards. To learn more about RGP, visit: http://www.rgp.com. (RGP-F)
Contacts
Investor Contact: Jennifer Ryu, Chief Financial Officer (US+) 1-714-430-6500 jennifer.ryu@rgp.com
FLORHAM PARK, N.J. — Conduent Incorporated (Nasdaq: CNDT), a global technology-driven business solutions and services company, today announced it has successfully completed a refinancing of its existing term loan and revolving credit agreements.
Key Highlights of the Refinancing:
Full Prepayment of the Term Loan
Renewed Revolving Credit Facility
New Performance Letter of Credit Facility
Giles Goodburn, Conduent’s CFO, commented, “Completing this refinancing marks a key milestone in our strategy, further strengthening our financial foundation and positioning Conduent for future growth. This transaction provides the right mix of debt instruments to support our operations and capital allocation strategy.”
Additional details of the refinancing can be found in Conduent’s 8-K which will be filed with the U.S. Securities and Exchange Commission.
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 56,000 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 $85 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.
Conduent is a trademark of Conduent Incorporated in the United States and/or other countries. Other names may be trademarks of their respective owners.
CHICAGO, Aug. 27, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that a manuscript detailing developments in its Phase 2 THIO-101 clinical trial was accepted and published in the international peer-reviewed open access scientific journal, Cells, in a special issue, “Cellular Mechanisms of Anti-Cancer Therapies”
The manuscript, titled “Perioperative Management of Non-Small Cell Lung Cancer in the Era of Immunotherapy,” was authored by a group of oncology researchers in Turkey and the U.S. including MAIA scientists Sergei Gryaznov, Ph.D., Chief Scientific Officer and Ilgen Mender, Director of Biology Research, along with MAIA Scientific Advisory Board members Z. Gunnur Dikmen, M.D., Ph.D. and Saadettin Kiliçkap, M.D., M.Sc.
MAIA Chairman and CEO Vlad Vitoc, M.D. commented, “The importance of the findings published in Cells cannot be overstated. While conventional immunotherapies have expanded treatment options for patients, intrinsic and acquired resistance by patients remains a challenge. Our novel combination strategy of ateganosine sequenced with a checkpoint inhibitor stands out, showing encouraging results in a population with high unmet medical need.”
About Cells Cells (ISSN 2073-4409) is an international, peer-reviewed, open access journal which provides an advanced forum for studies related to cell biology, molecular biology and biophysics. It publishes reviews, research articles, communications and technical notes. Cells is an MDPI (Multidisciplinary Digital Publishing Institute) publication.
About Ateganosine Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc. 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.
Former MoneyGram Chairman and CEO Brings Two Decades of Payments and Compliance Expertise
ATLANTA, Aug. 26, 2025 (GLOBE NEWSWIRE) — Bitcoin Depot (NASDAQ: BTM), a U.S.-based Bitcoin ATM (“BTM”) operator and leading fintech company, today announced the appointment of Alex Holmes to its Board of Directors and Audit Committee, effective August 20, 2025. Holmes is a globally recognized leader in payments, compliance, and blockchain innovation, with more than 25 years of experience guiding financial services companies through transformation, regulatory complexity, and global expansion. As a member of Bitcoin Depot’s Board and Audit Committee, Holmes will provide strategic guidance as the crypto industry continues to rapidly evolve.
“Alex has a proven track record of scaling financial services companies while maintaining the highest standards of compliance and consumer trust. His expertise will be critical in helping to guide Bitcoin Depot’s next phase of growth,” said Brandon Mintz, CEO and founder of Bitcoin Depot. “As we continue to expand our footprint, set new industry standards of compliance, and expand crypto access for customers across North America and beyond, we couldn’t be more thrilled to welcome Alex on board.”
Holmes currently serves as Executive Vice Chairman of United Texas Bank, a strategic advisor to several Web3 ventures including Orobit Inc., and a board member of Jingle Pay / Acamas Group in Dubai. He previously spent nearly two decades at MoneyGram International, where he served as Chairman and CEO from 2016-2025. During his tenure, Holmes led MoneyGram’s transformation into a global fintech powerhouse, expanding digital adoption, modernizing compliance infrastructure, and pioneering cross-border blockchain integration initiatives. Under his leadership, MoneyGram earned recognition as one of the Best Places to Work, Most Trustworthy Companies in America, and a Top Workplace (2022–2025). He also oversaw the company’s $2 billion acquisition by Madison Dearborn Partners in 2023.
“Bitcoin Depot has built a unique and powerful platform at the intersection of cash and crypto, with a sustained focus on accessibility, consumer value, and compliance,” said Holmes. “I look forward to supporting Bitcoin Depot as it continues to strengthen its leadership in the BTM sector and advances its mission to bring crypto to the masses.”
About Bitcoin Depot Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 47 states and at thousands of name-brand retail locations in 31 states through its BDCheckout product. The Company has the largest market share in North America with over 9,000 kiosk locations as of June 2025. Learn more at www.bitcoindepot.com.
Cautionary Note Regarding Forward-Looking Statements This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, the anticipated effects of the Amendment, and the closing of the Preferred Sale. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,” “plan,” “potential,” “priorities,” “project,” “pursue,” “seek,” “should,” “target,” “when,” “will,” “would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control.
These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.
We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.
CHARLOTTE, N.C., Aug. 25, 2025 (GLOBE NEWSWIRE) — NN, Inc. (NASDAQ: NNBR), a global diversified industrial company that engineers and manufactures high-precision components and assemblies, today announced Mohamad Farhat has joined as its new Chief Technical Officer for its electrical, defense and medical businesses. In this position, Mr. Farhat will lead the technical engineering function for NN’s Power Solutions and Medical businesses, reporting to Tim French, Senior Vice President and Chief Operating Officer.
NN has a distinct focus on electrical, defense and medical products and end markets. The appointment of Mr. Farhat will serve to strengthen NN’s customer solutions as it becomes a more innovation-focused partner. NN recently promoted Robert Esch to lead this initiative in the Mobile Solutions segment, which focuses primarily on the automotive and industrial end markets with high-end machining and grinding process technology solutions.
Tim French, Senior Vice President and Chief Operating Officer of NN, commented, “We have an opportunity to better solve problems for customers through technology leadership. Moe is an accomplished engineering leader who will make an immediate impact for NN and its customers by leading innovation activities to design, develop, and industrialize electrical, defense and medical products across NN’s global platforms. He has valuable experience leading collaborative design activities with customers, managing global engineering teams, and implementing technology roadmaps—all of which will help us to expand further into electrical, defense and medical end markets. Together, I believe Moe, Rob and their teams will significantly level up NN’s innovation game.”
Moe Farhat commented, “I am excited to join the NN team and I look forward to putting my engineering experience to work strengthening NN’s technical acumen to benefit both new and existing customers. NN’s capabilities and process technologies are unique and highly valued in the market, and I feel that my experience in electrical, defense, automotive, healthcare, and aerospace engineering can help NN unlock new paths to innovation.”
Prior to joining NN, Mr. Farhat served as Vice President of Engineering for Commercial Vehicle Group, Inc., managing all development activity in their electrical design and prototype centers. Previously, he held roles of increasing responsibility and expanding market breadth and depth at such firms as Sumitomo, Rigaku, and Flex. He holds a Bachelor of Science in Biomedical and Electrical Engineering from Lawrence Technological University and a Master of Science in Electrical Engineering from Wayne State University.
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 Asia. For more information about the company and its products, please visit www.nninc.com.
This press release contains express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally will be accompanied by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “growth,” “guidance,” “intend,” “may,” “will,” “possible,” “potential,” “predict,” “project”, “trajectory” or other similar words, phrases or expressions. Forward-looking statements involve a number of risks and uncertainties that are outside of management’s control and that may cause actual results to be materially different from such statements. Such factors include, among others, general economic conditions and economic conditions in the industrial sector; the potential impacts of tariffs on the U.S. economy, the economy of other countries in which we conduct operations and our industry, as well as the potential implications and ramifications of tariffs on our business and the local and global supply chains supporting the same, and our ability to mitigate any adverse impacts of such; competitive influences; risks that current customers will commence or increase captive production; risks of capacity underutilization; quality issues; material changes in the costs and availability of raw materials; economic, social, political and geopolitical instability, military conflict, currency fluctuation, and other risks of doing business outside of the United States; inflationary pressures and changes in the cost or availability of materials, supply chain shortages and disruptions, the availability of labor and labor disruptions along the supply chain; our dependence on certain major customers, some of whom are not parties to long-term agreements (and/or are terminable on short notice); the impact of acquisitions and divestitures, as well as expansion of end markets and product offerings; our ability to hire or retain key personnel; the level of our indebtedness; the restrictions contained in our debt agreements; our ability to obtain financing at favorable rates, if at all, and to refinance existing debt as it matures; our ability to secure, maintain or enforce patents or other appropriate protections for our intellectual property; uncertainty of government policies and actions after recent U.S. elections in respect to global trade, tariffs and international trade agreements; and cyber liability or potential liability for breaches of our or our service providers’ information technology systems or business operations disruptions. The foregoing factors should not be construed as exhaustive and should be read in conjunction with the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Company’s filings made with the U.S. Securities and Exchange Commission. Any forward-looking statement speaks only as of the date of this press release and are based on information available to NN at the time those statements are made and/or management’s good faith belief as of that time with respect to future events. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. New risks and uncertainties may emerge from time to time, and it is not possible for the Company to predict their occurrence or how they will affect the Company. The Company qualifies all forward-looking statements by these cautionary statements.
Investor Relations: Joe Caminiti or Stephen Poe, Investors NNBR@alpha-ir.com 312-445-2870
VIRGINIA CITY, Nev., Aug. 25, 2025 (GLOBE NEWSWIRE) — Comstock Inc. (NYSE: LODE) (“Comstock,” “our,” and the “Company”), today announced that on August 15, 2025, immediately following the Company’s previously announced successful public equity offering, that it had immediately placed all of the purchase orders and paid deposits totaling $5.1 million toward the purchase of all of the equipment for its 100,000 ton per year, certified zero-landfill industry-scale solar panel recycling facility to be located in Silver Springs, Nevada. The total purchase price for all the equipment is approximately $10.5 million. The Company also plans on spending an additional $1.5 million for expanded storage capacity, utility upgrades and commissioning of the facility.
“Our equity offering represented a remarkably broad and deep representation of some of the best institutional investors with proceeds dedicated to funding the capital expenditures for our first industry-scale facility, the operating expenses required to reach sustained profitability and the extinguishment of debt and other obligations. Our balance sheet has never been stronger as we are now rapidly deploying our industry leading technology and customer solutions,” stated Corrado De Gasperis, Executive Chairman and CEO of Comstock Inc. “The recycling growth opportunities have developed better and faster than our original plans, and we have now attracted some of the most sophisticated partners for investment, feedstock, operations, and offtake.”
Comstock Metals has now been operating its first commercial demonstration facility for over 18 months and in November of 2024, submitted permits for the first industry-scale photovoltaic recycling facility. Comstock Metals’ billable revenues are expected to be eight times greater in 2025, as compared to 2024, or currently projected to be over $3.5 million, with proportionate future increases in 2026, as we scale up our first industry-scale facility.
The Company’s solar panel recycling objectives for the next 10 months include:
Expand and activate local county storage capacity adjacent to our first industry-scale facility;
Complete permitting for our first industry-scale facility in Silver Springs, NV, by November 2025;
Secure additional Master Service Agreements (MSA) with national and regional customers;
Complete site selection and permit submissions for two additional solar panel recycling locations;
Expand our system globally with strategic and/or international partners;
Procure, deploy, and assemble plant and equipment for our first industry-scale facility during Q4 2025;
Commission the industry-scale facility during Q1 2026;
Continuously operate the zero-landfill industry-scale solar panel recycling facility during Q2 2026; and
Advance and expand R&D efforts to recover more and higher-purity materials from recycled streams for offtake.
“For the remainder of 2025, we plan on accelerating and increasing our lead as our solar panel recycling systems rapidly expand market share nationally while we await our final permits and the delivery of our high-speed, continuous processing system,” said Comstock Metals’ President, Dr. Fortunato Villamagna. “With our system, every component of an end-of-life solar panel (glass, aluminum, semiconductor fines, and other metals) is fully and cleanly reclaimed and repurposed into new, salable raw materials.”
About Comstock Inc.
Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that enable, support and sustain clean energy systems across entire industries by efficiently, effectively, and expediently extracting and converting under-utilized natural resources into reusable electrification metals, like silver, aluminum, copper, and other critical minerals from end-of-life photovoltaics.
Comstock Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its X.com, LinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.
Contacts
For investor inquiries: Judd B. Merrill, Chief Financial Officer Tel (775) 413-6222 ir@comstockinc.com
For media inquiries: Zach Spencer, Director of External Relations Tel (775) 847-7573 media@comstockinc.com
Forward-Looking Statements
This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; divestitures, spin-offs or similar distribution transactions, future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, divestitures, spin-offs or similar distribution transactions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, spin-offs or similar distribution transactions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.
Fourth Quarter of Fiscal Year 2025 – Consolidated Earnings Highlights
Revenue of $345.1 million
Net income of $12.9 million
Adjusted EBITDA* of $2.7 million
Fiscal Year 2026 Guidance Ranges:
Revenue expected in a range of $1.650 billion to $1.750 billion
Adjusted EBITDA* expected in a range of $120 million to $150 million
Fourth Quarter Fiscal Year 2025 – Segment Highlights
Senior
Revenue of $82.5 million
Adjusted EBITDA* of $7.7 million
Approved Medicare Advantage policies of 85,344
Healthcare Services
Revenue of $214.0 million
Adjusted EBITDA* of $11.9 million
108,018 SelectRx members
Life
Revenue of $48.0 million
Adjusted EBITDA* of $6.9 million
OVERLAND PARK, Kan.–(BUSINESS WIRE)– This press release is to correct and replace the previously issued press release to reflect the following:
On the Consolidated Statements of Comprehensive Income (Loss) for the three-month period ending June 30, 2025, the amount reported for the Selling, general and administrative line item is $41,591,000 and for the Technical development line item it is $9,594,000. In the prior version of the press release, these amounts were inadvertently transposed on the Consolidated Statements of Comprehensive Income (Loss). The correction has no impact on the reported Net Income or Adjusted EBITDA for the period presented.
The updated release reads:
SELECTQUOTE, INC. REPORTS FOURTH QUARTER OF FISCAL YEAR 2025 RESULTS
Fourth Quarter of Fiscal Year 2025 – Consolidated Earnings Highlights
Revenue of $345.1 million
Net income of $12.9 million
Adjusted EBITDA* of $2.7 million
Fiscal Year 2026 Guidance Ranges:
Revenue expected in a range of $1.650 billion to $1.750 billion
Adjusted EBITDA* expected in a range of $120 million to $150 million
Fourth Quarter Fiscal Year 2025 – Segment Highlights
Senior
Revenue of $82.5 million
Adjusted EBITDA* of $7.7 million
Approved Medicare Advantage policies of 85,344
Healthcare Services
Revenue of $214.0 million
Adjusted EBITDA* of $11.9 million
108,018 SelectRx members
Life
Revenue of $48.0 million
Adjusted EBITDA* of $6.9 million
SelectQuote, Inc. (NYSE: SLQT) reported consolidated revenue for the fourth quarter of fiscal year 2025 of $345.1 million compared to consolidated revenue for the fourth quarter of fiscal year 2024 of $307.2 million. Consolidated net income for the fourth quarter of fiscal year 2025 was $12.9 million compared to consolidated net loss for the fourth quarter of fiscal year 2024 of $31.0 million. Finally, consolidated Adjusted EBITDA* for the fourth quarter of fiscal year 2025 was $2.7 million compared to consolidated Adjusted EBITDA* for the fourth quarter of fiscal year 2024 of $14.4 million.
Tim Danker, SelectQuote Chief Executive Officer, commented “The strength of our holistic healthcare services model was broadly exhibited in fiscal 2025, and we firmly believe the years ahead will increasingly drive substantial value for each of our stakeholders. Policyholders and patients will continue to benefit from our information advantage through tailored advice and healthcare solutions, which ultimately result in better health outcomes. Our insurance and healthcare service partners benefit from better treatment fit and adherence, which eliminates waste and serves to ease the historical trend of rising healthcare costs for Americans. Additionally, we believe our shareholders will benefit as SelectQuote’s diverse breadth of revenues drive increasing cash flow, which will accelerate and compound with new growth initiatives in the future.”
Mr. Danker continued, “We are proud to have delivered financial results well in excess of our initial expectations for the 3rd consecutive year. Over that period, our Adjusted EBITDA results have outperformed our forecasts by more than 20% each year. Our leadership and workforce have accomplished these results through significant change in Medicare Advantage in each year. We credit the talent and hard work of our people and are exceedingly proud of the track record SelectQuote has built as an agile, innovative and reliable source of value for Americans seeking healthcare that best fits their needs.”
* See “Non-GAAP Financial Measures” below.
Segment Results
We currently have three reportable segments: 1) Senior, 2) Healthcare Services and 3) Life. The performance measures of the segments include total revenue and Adjusted EBITDA.* Costs of commissions and other services revenue, cost of goods sold-pharmacy revenue, marketing and advertising, selling, general, and administrative, and technical development operating expenses that are directly attributable to a segment are reported within the applicable segment. Indirect costs of revenue, marketing and advertising, selling, general, and administrative, and technical development operating expenses are allocated to each segment based on varying metrics such as headcount. Adjusted EBITDA is our segment profit measure to evaluate the operating performance of our business. We define Adjusted EBITDA as income (loss) before income tax expense (benefit) plus: (i) interest expense, net; (ii) depreciation and amortization; (iii) share-based compensation; (iv) goodwill, long-lived asset, and intangible assets impairments; (v) transaction costs; (vi) loss on disposal of property, equipment and software, net; (vii) other non-recurring expenses and income; (viii) changes in fair value of warrant liabilities. Adjusted EBITDA margin is calculated as Adjusted EBITDA divided by revenue.
Senior
Financial Results
The following table provides the financial results for the Senior segment for the periods presented:
Operating Metrics
Submitted Policies
Submitted policies are counted when an individual completes an application with our licensed agent and provides authorization to the agent to submit the application to the insurance carrier partner. The applicant may have additional actions to take before the application will be reviewed by the insurance carrier.
The following table shows the number of submitted policies for the periods presented:
Approved Policies
Approved policies represents the number of submitted policies that were approved by our insurance carrier partners for the identified product during the indicated period. Not all approved policies will go in force.
The following table shows the number of approved policies for the periods presented:
Lifetime Value of Commissions per Approved Policy
Lifetime value of commissions per approved policy represents commissions estimated to be collected over the estimated life of an approved policy based on multiple factors, including but not limited to, contracted commission rates, carrier mix and expected policy persistency with applied constraints. The lifetime value of commissions per approved policy is equal to the sum of the commission revenue due upon the initial sale of a policy, and when applicable, an estimate of future renewal commissions.
The following table shows the lifetime value of commissions per approved policy for the periods presented:
Healthcare Services
Financial Results
The following table provides the financial results for the Healthcare Services segment for the periods presented:
Operating Metrics
Members
The total number of SelectRx members represents the amount of active customers to which an order has been shipped and the prescriptions per day represents the total average prescriptions shipped per business day. These two metrics are the primary drivers of revenue for Healthcare Services.
* See “Non-GAAP Financial Measures” below.
The following table shows the total number of SelectRx members as of the periods presented:
The total number of SelectRx members increased by 31% as of June 30, 2025, compared to June 30, 2024, due to our strategy to grow SelectRx membership.
The following table shows the average prescriptions shipped per day for the periods presented:
Combined Senior and Healthcare Services – Consumer Per Unit Economics
Combined Senior and Healthcare Services consumer per unit economics represents total MA and MS commissions; other product commissions; other revenues, including revenues from Healthcare Services; and operating expenses associated with Senior and Healthcare Services, each shown per number of approved MA and MS policies over a given time period. Management assesses the business on a per-unit basis to help ensure that the revenue opportunity associated with a successful policy sale is attractive relative to the marketing acquisition cost. Because not all acquired leads result in a successful policy sale, all per-policy metrics are based on approved policies, which is the measure that triggers revenue recognition.
The MA and MS commission per MA/MS policy represents the LTV for policies sold in the period. Other commission per MA/MS policy represents the LTV for other products sold in the period, including DVH prescription drug plan, and other products, which management views as additional commission revenue on our agents’ core function of MA/MS policy sales. Pharmacy revenue per MA/MS policy represents revenue from SelectRx, and other revenue per MA/MS policy represents revenue from Population Health, production bonuses, marketing development funds, lead generation revenue, and adjustments from the Company’s reassessment of its cohorts’ transaction prices. Total operating expenses per MA/MS policy represents all of the operating expenses within Senior and Healthcare Services. The revenue to customer acquisition cost (“CAC”) multiple represents total revenue as a multiple of total marketing acquisition cost, which represents the direct costs of acquiring leads. These costs are included in marketing and advertising expense within the total operating expenses per MA/MS policy.
The following table shows combined Senior and Healthcare Services consumer per unit economics for the periods presented. Based on the seasonality of Senior and the fluctuations between quarters, we believe that the most relevant view of per unit economics is on a rolling 12-month basis. All per MA/MS policy metrics below are based on the sum of approved MA/MS policies, as both products have similar commission profiles.
Total revenue per MA/MS policy increased 22% for the twelve months ended June 30, 2025, compared to the twelve months ended June 30, 2024, primarily due to the increase in pharmacy revenue. Total operating expenses per MA/MS policy increased 27% for the twelve months ended June 30, 2025, compared to the twelve months ended June 30, 2024, driven by an increase in cost of goods sold-pharmacy revenue for Healthcare Services due to the growth of the business.
Life
Financial Results
The following table provides the financial results for the Life segment for the periods presented:
Operating Metrics
Life premium represents the total premium value for all policies that were approved by the relevant insurance carrier partner and for which the policy document was sent to the policyholder and payment information was received by the relevant insurance carrier partner during the indicated period. Because our commissions are earned based on a percentage of total premium, total premium volume for a given period is the key driver of revenue for our Life segment.
The following table shows term and final expense premiums for the periods presented:
Earnings Conference Call
SelectQuote, Inc. will host a conference call with the investment community on August 21, 2025, beginning at 8:30 a.m. ET. To register for this conference call, please use this link: https://registrations.events/direct/Q4I547808. After registering, a 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 at least 10 minutes before the start of the call. The event will also be webcasted live via our investor relations website https://ir.selectquote.com/investor-home/default.aspx.
Non-GAAP Financial Measures
This release includes certain non-GAAP financial measures intended to supplement, not substitute for, comparable GAAP measures. To supplement our financial statements presented in accordance with GAAP and to provide investors with additional information regarding our GAAP financial results, we have presented in this release Adjusted EBITDA, which is a non-GAAP financial measure. This non-GAAP financial measure is not based on any standardized methodology prescribed by GAAP and is not necessarily comparable to any similarly titled measure presented by other companies. We define Adjusted EBITDA as net income (loss) before income tax expense (benefit), plus interest expense, depreciation and amortization, changes in fair value of warrant liabilities, and certain add-backs for non-cash or non-recurring expenses, including restructuring and share-based compensation expenses. The most directly comparable GAAP measure is net income (loss) before income tax expense (benefit). We monitor and have presented in this release Adjusted EBITDA because it is a key measure used by our management and Board of Directors to understand and evaluate our operating performance, establish budgets, and develop operational goals for managing our business. In particular, we believe that excluding the impact of these expenses in calculating Adjusted EBITDA can provide a useful measure for period-to-period comparisons of our core operating performance.
Reconciliations of net income (loss) before income tax expense (benefit) to Adjusted EBITDA are presented below beginning on page 12. The Company is unable to provide a quantitative reconciliation of forward-looking Adjusted EBITDA to its most directly comparable GAAP measure without unreasonable effort because it is not possible to predict certain information included in the calculation of such GAAP measure, including the fair value of outstanding warrants to purchase shares of the Company’s common stock. The unavailable information could have a significant impact on the Company’s GAAP financial results.
Forward Looking Statements
This release contains forward-looking statements. These forward-looking statements reflect our current views with respect to, among other things, future events and our financial performance. These statements are often, but not always, made through the use of words or phrases such as “may,” “should,” “could,” “predict,” “potential,” “believe,” “will likely result,” “expect,” “continue,” “will,” “anticipate,” “seek,” “estimate,” “intend,” “plan,” “projection,” “would” and “outlook,” or the negative version of those words or other comparable words or phrases of a future or forward-looking nature. These forward-looking statements are not historical facts and are based on current expectations, estimates and projections about our industry, management’s beliefs and certain assumptions made by management, many of which, by their nature, are inherently uncertain and beyond our control. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.
There are or will be important factors that could cause our actual results to differ materially from those indicated in these forward-looking statements, including, but not limited to, the following: our reliance on a limited number of insurance carrier partners and any potential termination of those relationships or failure to develop new relationships; existing and future laws and regulations affecting the health insurance market; changes in health insurance products offered by our insurance carrier partners and the health insurance market generally; insurance carriers offering products and services directly to consumers; changes to commissions paid by insurance carriers and underwriting practices; competition with brokers, exclusively online brokers and carriers who opt to sell policies directly to consumers; competition from government-run health insurance exchanges; developments in the U.S. health insurance system; our dependence on revenue from carriers in our senior segment and downturns in the senior health as well as life, automotive and home insurance industries; our ability to develop new offerings and penetrate new vertical markets; risks from third-party products; failure to enroll individuals during the Medicare annual enrollment period; our ability to attract, integrate and retain qualified personnel; our dependence on lead providers and ability to compete for leads; failure to obtain and/or convert sales leads to actual sales of insurance policies; access to data from consumers and insurance carriers; accuracy of information provided from and to consumers during the insurance shopping process; cost-effective advertisement through internet search engines; ability to contact consumers and market products by telephone; global economic conditions, including inflation and tariffs; disruption to operations as a result of future acquisitions; significant estimates and assumptions in the preparation of our financial statements; impairment of goodwill; existing or potential litigation and other legal proceedings or inquiries, including the Department of Justice action alleging violations of the federal False Claims Act; our existing and future indebtedness; our ability to maintain compliance with our debt covenants; access to additional capital; failure to protect our intellectual property and our brand; fluctuations in our financial results caused by seasonality; accuracy and timeliness of commissions reports from insurance carriers; timing of insurance carriers’ approval and payment practices; factors that impact our estimate of the constrained lifetime value of commissions per policyholder; changes in accounting rules, tax legislation and other legislation; disruptions or failures of our technological infrastructure and platform; failure to maintain relationships with third-party service providers; cybersecurity breaches or other attacks involving our systems or those of our insurance carrier partners or third-party service providers; our ability to protect consumer information and other data; failure to market and sell Medicare plans effectively or in compliance with laws; and other factors related to our pharmacy business, including manufacturing or supply chain disruptions, access to and demand for prescription drugs, contractual reimbursement rates, and regulatory changes or other industry developments that may affect our pharmacy operations. For a further discussion of these and other risk factors that could impact our future results and performance, see the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended June 30, 2025 (the “Annual Report”) and subsequent periodic reports filed by us with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on any such forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise..
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.
ATLANTA, GA, August 20, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 17/888,131, titled “Vaccines and Uses Thereof to Induce an Immune Response to SARS-CoV-2.”
The allowed claims broadly cover recombinant Modified Vaccinia Ankara (MVA) viral vectors encoding multiple SARS-CoV-2 proteins – including Spike (S), Membrane (M), and Envelope (E) antigens – configured to generate virus-like particles (VLPs) upon expression. These constructs are designed to induce both antibody and T-cell responses, providing durable and broad immune protection against current and emerging variants of SARS-CoV-2.
Key features of the allowed claims include:
Multi-antigen design (Spike, Membrane, and Envelope proteins) to mimic the natural virus structure and induce robust immune responses.
VLP formation within host cells, enabling presentation of antigens in their natural conformation for optimal immune recognition.
Coverage of both ancestral strain sequences and variant-associated mutations (e.g., K417N/T, E484K, N501Y) to address immune escape.
David Dodd, GeoVax President and CEO, commented: “This Notice of Allowance represents an important strengthening of our intellectual property estate protecting our next-generation, multi-antigen COVID-19 vaccines. Unlike single-antigen vaccines, our MVA-based multi-antigen constructs are designed to elicit durable, broad-spectrum protection – even as the virus continues to evolve.”
About GeoVax’s Multi-Antigen COVID-19 Vaccine Portfolio
GeoVax is pioneering a differentiated, multi-antigen approach to COVID-19 vaccination. The newly allowed patent broadly covers constructs central to the Company’s CM01 and CM02 candidates, which express multiple SARS-CoV-2 proteins to generate virus-like particles (VLPs) in vaccinated individuals. These vaccine designs are intended to provide broad and durable protection by engaging both arms of the immune system and countering immune escape by new viral variants.
Together with GEO-CM04S1, which is advancing through Phase 2 clinical trials in immunocompromised and healthy populations, CM01 and CM02 give GeoVax what CEO David Dodd describes as “the corner on the multi-antigen space.” This combined portfolio underscores GeoVax’s position as a leader in next-generation COVID-19 vaccine innovation, uniquely differentiated from single-antigen approaches such as mRNA vaccines.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Hininger to Remain Special Advisor to both CEO and Board Chairman During Transition Agreement
BRENTWOOD, Tenn., Aug. 18, 2025 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (“CoreCivic” or “Company”) announced today that CoreCivic’s Board of Directors (the “Board”) has appointed Patrick D. Swindle to President and Chief Executive Officer, effective January 1, 2026. This follows Mr. Swindle’s appointment as President and Chief Operating Officer on January 1, 2025. Mr. Swindle will succeed Damon T. Hininger, who has served as Chief Executive Officer since August 17, 2009. In addition, effective January 1, 2026, Mr. Hininger will resign from CoreCivic’s Board, and Mr. Swindle will be appointed to fill the vacancy.
“We are excited to welcome Patrick as our new Chief Executive Officer,” said Mark Emkes, CoreCivic’s Board Chairman. “His vision and expertise make him the ideal leader to guide CoreCivic into its next chapter. As Chief Operating Officer, he has overseen the largest component of the business, and he has proven his ability to develop people and solve challenging problems. Since his promotion to President, Patrick’s responsibilities have expanded, and he’s led CoreCivic’s teams exceptionally well during a period of rapid growth.”
Mr. Swindle brings more than eighteen years of industry experience, having served in various leadership positions at CoreCivic. He joined CoreCivic in 2007 as Managing Director, Treasury and has held numerous positions, including Vice President, Strategic Development; Senior Vice President, Operations; Executive Vice President and Chief Corrections Officer; and Executive Vice President and Chief Operating Officer before being promoted to President and Chief Operating Officer in January 2025.
During his tenure, Mr. Swindle has enhanced the practices for our strategic development initiatives, transformed the Company’s operations department, and most recently, led the teams responsible for activations of certain idle facilities. In 2018, he led efforts to restructure CoreCivic’s operational leadership team while standardizing core processes such as workforce management, resident programming, and security functions, based on the evolving needs and opportunities for CoreCivic. Those efforts, which Mr. Swindle has continued to build upon and refine during his tenure, have resulted in greater operational consistency and organizational strength while positioning CoreCivic to meet the increased demand for the Company’s innovative solutions today and going forward. Most recently, Mr. Swindle’s leadership of the teams responsible for the activations of certain idle facilities has shown that the Company can act swiftly and efficiently scale to meet the growing needs of the Company’s government partners while maintaining the high level of professional integrity and quality operations expected by the Company’s stakeholders.
“I’m grateful to the Board for this opportunity and to Damon for his exemplary guidance and partnership,” said Swindle. “CoreCivic is uniquely positioned for growth and future success, and I’m excited to continue working alongside our talented team as we work to fulfill our mission, drive value for our government partners and stockholders, and make a difference in the lives of individuals entrusted to our care.”
Prior to joining CoreCivic, Mr. Swindle spent ten years in equity research in the equity capital markets divisions of SunTrust Equitable Securities, Raymond James Financial Services, Inc. and Avondale Partners, LLC. Mr. Swindle holds a bachelor’s degree in finance from Western Kentucky University.
“As I mentioned when Patrick was promoted to President, he’s an exceptional leader with a broad set of skills and experiences, and over many years, has developed a deep knowledge of CoreCivic’s business, strong relationships with our customers, field leaders, investors, and other key stakeholders,” said Hininger. “Having seen his outstanding performance since stepping into the role of President, I’m more confident than ever in Patrick’s ability to lead CoreCivic forward. Finally, this transition has gone exactly the way I had hoped and on a personal note, I am so extremely proud and happy for Patrick.”
In connection with the appointment of Mr. Swindle as CEO, Mr. Hininger and CoreCivic have entered into a transition agreement with an effective date of January 1, 2026. Under the transition agreement, Mr. Hininger will work closely with both Mr. Swindle and Mr. Emkes, as a Special Advisor to the CEO and Chairman, to ensure a smooth transition.
“On behalf of the Board and management, I would like to thank Damon for his invaluable service and leadership to CoreCivic,” said Emkes. “Damon has boldly led CoreCivic through periods of substantial transformation and innovation. His thoughtful leadership, strategic vision, and dedication to CoreCivic’s mission have established a foundation for continued growth and success. The Board and management extend their deep appreciation for his many years of service and his ongoing support during this transition period.”
“I am humbled by the opportunity to have served this great company since I started my career as a correctional officer in 1992. This has been such an amazing ride! Never in my wildest dreams when starting my career with this company did I think someday I would be CEO,” added Hininger. “To our employees, both current and retired, customers, and investors, it has been a tremendous honor and a privilege to work with you all and to serve as CEO of CoreCivic for the past sixteen years.”
About CoreCivic
CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and one of the largest operators of such facilities in the United States. We have been a flexible and dependable partner for government for more than 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.
This press release contains statements as to our beliefs and expectations of the outcome of future events that are “forward-looking” statements as defined within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning the expected transition of executive leadership at CoreCivic and prospects of growth in CoreCivic’s business. These forward-looking statements may include such words as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “will,” “should,” “can have,” “likely,” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. Important factors that could cause actual results to differ from our expectations are described in the filings made from time to time by CoreCivic with the Securities and Exchange Commission (“SEC”) and include the risk factors described in CoreCivic’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 21, 2025 and subsequent filings.
CoreCivic takes no responsibility for updating the information contained in this press release following the date hereof to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events or for any changes or modifications made to this press release or the information contained herein by any third-parties, including, but not limited to, any wire or internet services, except as may be required by law.
CULVER CITY, Calif., Aug. 18, 2025 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or the “Company”), a leading global independent developer and publisher of interactive digital entertainment, will hold a conference call and webcast on Tuesday, August 19, 2025 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss its financial results for the second quarter ended June 30, 2025.
Snail Games management will host the conference call and webcast. Participants may listen to the live webcast and replay via the link here or on the Company’s investor relations website at https://investor.snail.com/.
About Snail, Inc. Snail, Inc. (Nasdaq: SNAL) is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs, and mobile devices. For more information, please visit: https://snail.com/.
Investor Contact: John Yi and Steven Shinmachi Gateway Group, Inc. 949-574-3860 SNAL@gateway-grp.com
Ensures Intellectual Property Protection Until 2040
LOS ALTOS, Calif., Aug. 18, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the issuance of U.S. Patent 12,377,082 by the U.S. Patent and Trademark Office for UNI-494 to treat Chronic Kidney Disease (CKD). This patent follows the issuance of an earlier method of use patent for the treatment of Acute Kidney Injury with UNI-494.
“While we are focused on seeking FDA approval of our lead product oxylanthanum carbonate, we are pleased to announce the issuance of another patent for our second investigational drug, UNI-494,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “This patent is part of a broader intellectual property portfolio for UNI-494, which supports potential partnership opportunities and future development efforts. We have completed a Phase I clinical study in healthy volunteers and have received Orphan Drug Designation for the prevention of delayed graft function (DGF) in patients undergoing kidney transplantation.”
About UNI-494 UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. UNI-494 has completed a Phase 1 dose-ranging safety study in healthy volunteers.
About Acute Kidney Injury Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined based on increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease and end stage renal disease.
About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.
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; 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; 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.
CERRITOS, Calif., Aug. 18, 2025 (GLOBE NEWSWIRE) — The Oncology Institute of Hope and Innovation (NASDAQ: TOI), a national leader in value-based oncology care, is pleased to announce a strategic partnership with Doctors HealthCare Plans, a Medicare Advantage plan serving members across South Florida. The Oncology Institute will provide delegated utilization management services and clinical advisory support, helping Doctors HealthCare Plans ensure high-quality, cost-effective cancer care for their members.
Under this partnership, The Oncology Institute will deliver comprehensive utilization management functions for oncology services, leveraging its robust clinical protocols, medical director oversight, and technology-enabled workflows. The collaboration also includes advisory services to support optimal oncology benefit design and evidence-based care pathways, empowering the plan’s providers to deliver personalized and clinically appropriate treatment for every patient.
This partnership builds on TOI’s national track record of managing medical cost risk across diverse, value-based arrangements. TOI currently supports delegated risk contracts across multiple states and payer types, consistently achieving cost savings while improving quality and patient satisfaction.
“We are proud to support Doctors HealthCare Plans with our delegated UM and oncology advisory services,” said Dr. Dan Virnich, CEO of The Oncology Institute. “By combining our clinical expertise with a collaborative, data-driven approach to utilization management, we can help ensure that patients receive the right care at the right time, improving outcomes and supporting affordability across the system.”
“This partnership is a reflection of our ongoing commitment to provide high-quality, high-value care to our members,” said Brandon Haushalter, CEO of Doctors HealthCare Plans. “With TOI’s leadership in oncology management and value-based care, we’re confident this collaboration will bring greater transparency, clinical rigor, and support to our providers while enhancing the member experience.”
The partnership underscores a shared commitment to advancing oncology care through smarter utilization management, setting a new standard for how health plans and specialty providers can work together to improve the cancer care journey.
About The Oncology Institute (www.theoncologyinstitute.com): Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.
About Doctor’s Healthcare Plans (https://www.doctorshcp.com/): Doctors HealthCare Plans (DHCP) is a Florida-based, locally owned and operated Medicare Advantage Health Plan offering coverage for eligible Medicare beneficiaries across Miami-Dade and Broward County. The health plan was founded on a deep commitment to the community and provides an extensive network of providers, pharmacies, and hospitals. DHCP’s mission is to develop and establish a healthcare organization that is responsive and attentive to the needs of all beneficiaries by offering high-quality and cost-effective health care services.
Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years
Fibromyalgia is a chronic pain condition that affects more than 10 million adults in the U.S. who are mostly women
Two Pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo; generally well tolerated
Commercial availability of Tonmya is expected in the fourth quarter
Company to host webcast and conference call on Monday August 18, 2025 at 8:30 AM ET
CHATHAM, N.J., Aug. 15, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual (under the tongue) formulation that is designed for rapid absorption into the bloodstream. Tonmya is the first new FDA-approved therapy for the treatment of fibromyalgia in over 15 years.
“The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the U.S. suffering from the debilitating pain this condition causes,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “At Tonix, we recognized the transformative potential of pursuing a new approach with Tonmya for fibromyalgia, a chronic overlapping pain condition (COPC), that has gone without innovation for many years. We are hopeful that effectively treating pain with Tonmya could help improve the lives of people with this chronic syndrome.”
“The chronic pain of fibromyalgia is debilitating to every aspect of a person’s life, including causing sleep disturbance and fatigue, all of which can negatively impact someone’s ability to carry out their daily activities,” said Sharon Waldrop, a person with lived experience and founder of the Fibromyalgia Association. “For over 15 years, this community has been underserved and waiting for new treatment options. This approval is a promising step forward and brings renewed hope to millions.”
The approval incorporated efficacy from two double-blind, randomized, placebo-controlled, Phase 3 clinical trials of nearly 1,000 patients in total that evaluated Tonmya as a bedtime treatment for fibromyalgia. Across both Phase 3 trials, Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking Tonmya experienced a clinically meaningful (≥30%) improvement in their pain after three months, compared to placebo.
Across three Phase 3 clinical trials with over 1,400 patients evaluated, Tonmya was generally well tolerated. The most common adverse events (incidence ≥2% and at a higher incidence in Tonmya-treated patients compared to placebo-treated patients) included oral hypoesthesia (numbness in the mouth), oral discomfort, abnormal product taste, somnolence (drowsiness), oral paresthesia (tingling, pricking or burning in the mouth), oral pain, fatigue, dry mouth, and aphthous ulcer (canker sore).
“For many years, rheumatologists like myself and other healthcare professionals have had to manage fibromyalgia with limited options that do not adequately meet treatment needs for the majority of patients,” said Philip Mease, M.D., Director of Rheumatology Research at the Providence Swedish Medical Center and Clinical Professor at the University of Washington School of Medicine. “Tonmya is a novel treatment approach that targets nonrestorative sleep that is characteristic of fibromyalgia and can impact core symptoms, specifically pain.”
The latest Phase 3 trial, RESILIENT, was recently published in Pain Medicine with data on primary and secondary endpoints measuring pain, patient’s global impression of change, patient-reported symptoms and function, sleep disturbance, and fatigue.
“I know firsthand how the chronic pain of fibromyalgia significantly disrupts my patients’ lives.” Andrea L. Chadwick, M.D., MSc, FASA, Anesthesiology, Pain, and Perioperative Medicine at The University of Kansas Health System. “Treatments that are processed through the liver can result in metabolites that could affect a medicine’s efficacy and safety over time. Tonmya is administered sublingually which is designed to reduce pain quickly and durably with a tolerable safety profile.”
Tonix thanks the participants and investigators involved in its fibromyalgia clinical trials, and FDA for its commitment to approving new treatments for this condition.
Tonmya is expected to be available for adult patients in the U.S. with fibromyalgia beginning in the fourth quarter of this year.
For more information, visit TonmyaHCP.com or download the TONMYA Fact Sheet here.
Webcast Information Tonix will host a webcast and conference call on Monday, August 18 at 8:30 AM ET to discuss the approval of Tonmya. The live webcast of the call will be available on the Investors section of Tonix’s website: https://ir.tonixpharma.com/news-events/ir-events. To participate by phone, please register in advance using this link to obtain a local or toll-free phone number and your personal pin. A replay of the webcast will be available for approximately 90 days following the live event. The slides presented during the webcast will be made available on the “Presentations” page of the “Investors” section of the Company’s website.
About Fibromyalgia Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 10 million adults in the U.S., approximately 80% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep (waking up tired and unrefreshed), fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Patients with fibromyalgia have double the medical costs compared to the general population in the U.S.
About Tonmya™ (cyclobenzaprine HCl sublingual tablets) Tonmya, which was investigated as TNX-102 SL, is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride, which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a tertiary amine tricyclic (TAT) and multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, Tonmya is now approved as a once-daily bedtime treatment for fibromyalgia in adults. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary composition. These patents are expected to provide Tonmya with U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044.
About the Phase 3 Clinical Trials: RELIEF and RESILIENT The RELIEF and RESILIENT studies were double-blind, randomized, placebo-controlled trials designed to evaluate the efficacy and safety of Tonmya™ (cyclobenzaprine hydrochloride sublingual tablets) for the treatment of fibromyalgia. RELIEF and RESILIENT were two-arm trials that enrolled 503 and 457 adults with fibromyalgia across 40 and 33 United States sites, respectively. In both trials, the first two weeks of treatment consisted of a run-in period in which participants started on Tonmya 2.8 mg (1 tablet) or placebo. Thereafter, all participants increased their dose to Tonmya 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint across both trials was the daily diary pain intensity score change (Tonmya 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores). Additional details on RELIEF (NCT04172831) and RESILIENT (NCT05273749) are available on clinicaltrials.gov.
RALLY was a replicate Phase 3 trial to RELIEF and RESILIENT that demonstrated greater but non-significant treatment effect with Tonmya compared to placebo and demonstrated consistent safety. Results of this trial may not have been generalizable due to the presence of factors outside the conduct of the study. Additional details are available on clinicaltrials.gov (NCT04508621).
Tonix Pharmaceuticals Holding Corp. Tonix is a fully-integrated biotechnology company. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology and infectious diseases. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, Inc., our wholly-owned commercial subsidiary, markets treatments for fibromyalgia and acute migraine.
This press release and further information about Tonix can be found at www.tonixpharma.com.
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.
Media Contact Meagen Hagans Weber Shandwick (757)358-2033 MHagans@webershandwick.com
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS
Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS
MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
