Key Points: – Lilly acquires Verve Therapeutics to develop one-time gene editing treatments for cardiovascular disease. – Verve’s VERVE-102 targets the PCSK9 gene to lower cholesterol with a single dose. – Deal strengthens Lilly’s position in cardiometabolic and genetic medicine sectors.
In a move set to transform the landscape of cardiovascular care, Eli Lilly and Company (NYSE: LLY) announced its acquisition of Verve Therapeutics, Inc. (Nasdaq: VERV), a clinical-stage biotechnology firm focused on gene editing treatments for atherosclerotic cardiovascular disease (ASCVD). The transaction, valued at up to $1.3 billion, is aimed at accelerating the development of groundbreaking one-time treatments that could offer lifelong benefits to patients with high cardiovascular risk.
Verve’s lead program, VERVE-102, is a promising in vivo gene editing therapy targeting the PCSK9 gene—an established regulator of LDL cholesterol levels. Currently in a Phase 1b clinical trial, VERVE-102 has been granted Fast Track designation by the FDA and is designed for individuals with heterozygous familial hypercholesterolemia (HeFH) and certain forms of premature coronary artery disease. If successful, the treatment could eliminate the need for chronic medication by permanently modifying liver DNA to lower harmful cholesterol levels.
“This acquisition marks a bold step toward shifting cardiovascular care from lifelong therapy to one-time cures,” said Ruth Gimeno, Lilly’s Group VP of Diabetes and Metabolic Research and Development. “Combining Lilly’s global scale with Verve’s scientific innovation positions us to lead the next generation of cardiometabolic treatment.”
The purchase agreement includes an upfront cash payment of $10.50 per share—totaling approximately $1.0 billion—along with an additional contingent value right (CVR) worth up to $3.00 per share, tied to future clinical milestones. If all conditions are met, the total deal value could reach $1.3 billion. The acquisition represents a 113% premium over Verve’s 30-day average stock price prior to the announcement.
Founded just seven years ago, Verve has rapidly built a pipeline of one-time gene editing therapies aimed at the three core lipid-related drivers of ASCVD: low-density lipoproteins, triglycerides, and lipoprotein(a). In addition to VERVE-102, Verve is advancing VERVE-201 (targeting ANGPTL3 for refractory hypercholesterolemia) and VERVE-301 (targeting LPA for lipoprotein(a)-related risks).
“Joining Lilly is the natural next step in our mission to bring one-time gene editing treatments to people with cardiovascular disease,” said Dr. Sekar Kathiresan, co-founder and CEO of Verve. “Lilly’s world-class capabilities will significantly accelerate our clinical development and commercial reach.”
The deal is expected to close in Q3 2025, pending customary regulatory approvals and the successful tendering of Verve shares. Several major shareholders, including co-founders and investors affiliated with GV (formerly Google Ventures), have already agreed to tender approximately 17.8% of Verve’s outstanding stock.
For Lilly, this acquisition reinforces its strategic commitment to expanding in cardiometabolic and genetic medicine sectors—areas already central to its long-term growth strategy. As the race to develop durable, gene-based solutions for chronic illnesses intensifies, the Verve acquisition could position Lilly at the forefront of an entirely new therapeutic paradigm.
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
OCU410ST Cleared To Begin Confirmatory Trial. Ocugen announced that the FDA has approved its IND amendment to allow OCU410ST to begin its Phase 2/3 pivotal confirmatory trial. This will become the second Ocugen product to move into a Phase 2/3 confirmatory trial, and keeps the company on schedule to meet its goal of submitting three BLAs in the three years between 2026-28.
Brief Description of Stargardt Disease. Stargardt disease is a rare autosomal recessive disease caused by mutations in the ABCA4 gene in the retina. Progressive loss of photoreceptor cells in the retina typically starts at a young age, leading to blindness. Ocugen has received Orphan Drug designation and Rare Pediatric Disease Designation (RPDD) for diseases associated with ABCA4 diseases, including Stargardt, retinitis pigmentosa 19, and cone-rod dystrophy 3.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
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Highlights from Noble’s Emerging Growth Virtual Conference. Lenny Sokolow, Co-CEO, presented at Noble’s Virtual Equity conference June 4 & 5th. Mr. Sokolow discussed the company’s innovative technology, commercial partnerships, and its quest for mandatory standardization with the NEC, among other topics. A rebroadcast is available here.
Mandatory standardization efforts getting a boost. Management remains optimistic about its push for mandatory standardization, citing recent backing from a prominent government safety leader. The company’s “Code Team” expects further support from key safety organizations to advance its ceiling receptacle technology as a regulatory standard.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as 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, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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GEO-MVA Gets An Accelerated Pathway To European Approval. GeoVax announced that it has received guidance from the EMA (European Medicines Agency) that provides an accelerated path to approval for GEO-MVA, its modified vaccinia ankara (MVA) based vaccine for smallpox/Mpox. It will only be required to conduct immune-bridging and toxicity studies before moving directly to Phase 3. This cuts several years from development time and saves many millions of dollars in clinical expenses.
Only Phase 3 Will Be Needed. The Committee for Medicinal Products for Human Use (CHMP) of the EMA stated that only requirements before beginning a Phase 3 study will be a non-clinical immuno-bridging and toxicity studies. No Phase 1 or Phase 2 studies are required. An MAA regulatory application can be submitted after a single, Phase 3 immuno-bridging study against the approved MVA vaccine (Imvanex or Jynneos, from Bavarian Nordic). The proposed endpoints of the study would be demonstration of immunogenicity to show non-inferiority.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 103 facilities totaling approximately 83,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
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USMS Contract. The GEO Group, through its GEO Transport subsidiary, has entered into a new 5-year contract, including option periods, with the U.S. Marshals Service (USMS) for the provision of secure transportation and contract detention officer services across three service regions covering 26 federal judicial districts and spanning 14 states. The new contract highlights the Company’s diversified service platform, in our view, which provides the Company with numerous growth avenues.
Impact. The new contract is expected to generate up to approximately $147 million over the five-year period, or up to approximately $29 million in annualized revenues per full-year of operations, with margins consistent with GEO’s Managed-Only services contracts, which average approximately 15%.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Kratos Defense & Security Solutions, Inc. (NASDAQ:KTOS) develops and fields transformative, affordable technology, platforms, and systems for United States National Security related customers, allies, and commercial enterprises. Kratos is changing the way breakthrough technologies for these industries are rapidly brought to market through proven commercial and venture capital backed approaches, including proactive research, and streamlined development processes. At Kratos, affordability is a technology, and we specialize in unmanned systems, satellite communications, cyber security/warfare, microwave electronics, missile defense, hypersonic systems, training and combat systems and next generation turbo jet and turbo fan engine development. For more information go to www.kratosdefense.com.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Hans Baldau, Associate Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
New Award. Kratos was awarded a $25 million task order under the Command and Control System-Consolidated Sustainment and Resiliency contract with the U.S. Space Force Space Systems Command to support ground system capabilities for Evolved Strategic Satellite Communications (ESS). The ESS system will provide the survivable and endurable satellite communications capability for the Nuclear Command, Control, and Communications mission in all operational environments.
Details. The task order has a 34-month period of performance, which began on March 14th and will conclude on November 30, 2027. This was accomplished under the C-SAR single-award indefinite delivery/indefinite quantity (IDIQ) contract awarded to Kratos on November 15, 2023. The C-SAR IDIQ contract has a maximum value of $579 million to cover task/delivery orders to support operations, sustainment, enhancements, and constellation capacity.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Solar energy companies saw their stocks tumble on Tuesday following a draft Senate proposal that would accelerate the expiration of wind and solar tax credits—years ahead of the current schedule. The news has rattled investors and sent shockwaves through the renewable energy sector, raising fears of layoffs, bankruptcies, and a major disruption in project development.
Shares of Sunrun (RUN), the largest residential solar installer in the United States, collapsed over 40%, while SolarEdge Technologies (SEDG) plummeted more than 30%, and Enphase Energy (ENPH) fell nearly 25%. These losses came amid broader market gains, highlighting the severity of the impact specific to clean energy firms.
The Senate’s version of the Trump administration’s new tax bill proposes sunsetting tax incentives for wind and solar by 2028, four years earlier than under current law, which sets the expiration for 2032. Notably, the bill preserves tax breaks for other energy sources—such as hydropower, geothermal, and nuclear—through 2036, raising concerns about an uneven playing field.
The proposal caught investors off guard, especially after recent lobbying efforts suggested that the Senate might resist the aggressive clean energy rollbacks passed by the House in May. Instead, the Senate draft goes even further in some areas, phasing down incentives as early as 2026.
While the bill does include a provision allowing the residential solar credit to expire 180 days after enactment rather than at the end of 2025, analysts say the adjustment is too minor to ease investor fears.
Some early fallout is already visible. Solar financing firm Mosaic recently filed for Chapter 11 bankruptcy, and residential solar provider Sunnova Energy (NOVA) has begun restructuring efforts. Analysts expect more turbulence ahead if the bill is passed in its current form.
The sector has faced multiple headwinds in 2025, including high interest rates that make financing large-scale projects more expensive. President Trump’s return to office has also stoked concerns, with his administration pivoting sharply away from green initiatives and leaning into fossil fuel policies.
Still, not all recent policy news has been negative. The Department of Commerce recently announced tariffs exceeding 3,500% on solar panel imports from Southeast Asian countries—a move designed to bolster domestic manufacturing. However, these protectionist policies may not be enough to offset the demand shock from reduced federal support.
Despite a brief rally earlier this year driven by hopes for bipartisan support of clean energy, the Invesco Solar ETF (TAN) is now down more than 4% year to date, underscoring the sector’s fragility.
As the tax bill moves forward, investors and industry leaders will be watching closely. Without significant changes, the proposed legislation could mark a dramatic shift in the trajectory of America’s clean energy ambitions.
Key Points: – U.S. Steel shares rose 5% after Trump approved its merger with Japan’s Nippon Steel. – The deal includes a rare U.S. “golden share” giving the government veto power over key decisions. – Investors should watch for increased regulatory scrutiny on strategic small-cap M&A deals.
U.S. Steel (NYSE: X) shares surged over 5% Monday morning after President Donald Trump signed off on the company’s controversial merger with Japan’s Nippon Steel—marking a historic moment for both American industrial policy and global M&A precedent. The approval came with a unique twist: a U.S. government “golden share” that grants Washington significant control over key strategic decisions at the newly combined entity.
For small and micro-cap investors, this development has implications far beyond the blue-chip space. It signals a new level of state involvement in cross-border deals and a precedent for national security-focused intervention, which could trickle down to deals in the lower tiers of the market—especially in defense-adjacent, critical minerals, energy, and industrial sectors.
The Trump administration’s executive order, issued late Friday, cleared the final regulatory hurdle for the merger, provided both companies signed a binding national security agreement. That agreement includes provisions giving the U.S. government a golden share—essentially a special class of equity that confers outsized control. Commerce Secretary Howard Lutnick later confirmed this share grants the U.S. president veto power over decisions including moving U.S. Steel’s headquarters, offshoring jobs, plant closures, and even renaming the company.
While the finer legal details remain under wraps, investors can view this as a quasi-government stake—not in equity terms, but in influence. The golden share construct ensures U.S. Steel remains tethered to national priorities, despite being a wholly owned subsidiary of Japan’s Nippon Steel North America, according to the company’s latest SEC filing.
The government’s involvement also reframes how foreign capital may approach U.S. industrial assets moving forward. Trump, who has shied away from calling the merger a “takeover,” prefers to describe it as a “partnership,” signaling an attempt to strike a political and economic balance ahead of the 2026 elections.
For micro-cap investors, this is a strategic signal. Any company operating in or adjacent to national security, critical infrastructure, or industrial manufacturing could now fall under increased scrutiny—especially if foreign buyers or strategic partners are involved. Think niche steelmakers, components suppliers, and rare-earth miners. Even smaller players that feed into the defense or aerospace supply chains may now be seen through a new lens of “strategic value.”
While the golden share model is novel in the U.S., it’s long been used in Europe and Asia to protect domestic champions. Its introduction here could affect deal structures and valuations across the capital spectrum. Investors should watch for similar clauses creeping into M&A activity in the lower end of the market, especially where the government could assert a national interest.
While U.S. Steel is far from a micro-cap, the conditions of this deal offer key insights for small-cap investors. Regulatory risk, particularly geopolitical, is no longer just a big-cap concern. As protectionism and industrial policy take center stage, early-stage investors would be wise to evaluate their portfolios not just on fundamentals—but on flags, borders, and federal influence.
ATHENS, Greece, June 16, 2025 (GLOBE NEWSWIRE) — Euroseas Ltd. (NASDAQ: ESEA), an owner and operator of container carrier vessels and provider of seaborne transportation for containerized cargoes, announced today that it will release its financial results for the first quarter ended March 31, 2025, on June 18, 2025, before market opens in New York.
On the same day, Wednesday, June 18 at 9:30 a.m. Eastern Time, the Company’s management will host a conference call and webcast to discuss the results.
ConferenceCalldetails: Participants should dial into the call 10 minutes before the scheduled time using the following numbers: 877 405 1226 (US Toll-Free Dial In) or +1 201 689 7823 (US and Standard International Dial In). Please quote “Euroseas” to the operator and/or conference ID 13754421. Click here for additional participant International Toll-Free access numbers.
Alternatively, participants can register for the call using the call me option for a faster connection to join the conference call. You can enter your phone number and let the system call you right away. Click here for the call me option.
AudioWebcast‐Slides Presentation: There will be a live and then archived webcast of the conference call and accompanying slides, available on the Company’s website. To listen to the archived audio file, visit our website http://www.euroseas.gr and click on Company Presentations under our Investor Relations page. Participants to the live webcast should register on the website approximately 10 minutes prior to the start of the webcast.
The slide presentation for the first quarter ended March 31, 2025, will also be available in PDF format minutes prior to the conference call and webcast, accessible on the company’s website (www.euroseas.gr) on the webcast page. Participants to the webcast can download the PDF presentation.
AboutEuroseasLtd. Euroseas Ltd. was formed on May 5, 2005 under the laws of the Republic of the Marshall Islands to consolidate the ship owning interests of the Pittas family of Athens, Greece, which has been in the shipping business over the past 140 years. Euroseas trades on the NASDAQ Capital Market under the ticker ESEA. Euroseas operates in the container shipping market. Euroseas’ operations are managed by Eurobulk Ltd., an ISO 9001:2008 and ISO 14001:2004 certified affiliated ship management company, which is responsible for the day-to-day commercial and technical management and operations of the vessels. Euroseas employs its vessels on spot and period charters and through pool arrangements. The Company has a fleet of 22 vessels, including 15 Feeder containerships and 7 Intermediate containerships. Euroseas 22 containerships have a cargo capacity of 67,494 teu. After the delivery of two feeder containership newbuildings in the the fourth quarter of 2027, Euroseas’ fleet will consist of 24 vessels with a total carrying capacity of 76,094 teu.
MALVERN, Pa., June 16, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). The FDA previously granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3.
“We have had a highly productive and collaborative engagement with the FDA’s Center for Biologics Evaluation and Research (CBER) in establishing the pivotal confirmatory trial for OCU410ST,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen. “It’s evident that there is a real sense of urgency by the agency in providing treatment options for patients who currently have nothing available to them. As we initiate the Phase 2/3 registration trial, we are expediting the clinical development of OCU410ST by two to three years and potentially providing an innovative gene therapy to patients desperate for a treatment option.”
Positive data from the Phase 1 GARDian trial for OCU410ST demonstrated:
A favorable safety and tolerability profile with no serious adverse events related to OCU410ST, including no cases of ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization and no adverse events of special interest
Considerably slower lesion growth—48% at 12-month follow up in evaluable treated eyes when compared to untreated eyes
Statistically significant (p=0.031) improvement with clinically meaningful, nearly 2-line gain in visual function (BCVA) at 12-month follow-up in evaluable treated eyes when compared to untreated eyes
The Phase 2/3 clinical trial for OCU410ST will enroll 51 participants diagnosed with Stargardt disease. Of these, 34 will receive a one-time subretinal injection of OCU410ST (200 μL at a concentration of 1.5 × 10¹¹ vector genomes/mL) in the eye with poorer visual acuity, while 17 will be assigned to an untreated control group. The primary objective of the trial is to evaluate the reduction in atrophic lesion size. Key secondary endpoints include improvements in best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA), compared to controls. Data from the one-year follow-up will be used to support the company’s Biologics License Application (BLA).
“The initiation of this pivotal Phase 2/3 study represents a significant milestone in our commitment to bringing transformative genetic therapies to individuals affected by Stargardt disease—a progressive and debilitating condition,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “The recent RPDD granted by the FDA for this program further underscores the urgent need for innovative treatment options for children living with Stargardt disease. OCU410ST, developed through our proprietary modifier gene therapy platform, is designed to target the underlying biological mechanisms of the disease.”
Approximately 100,000 patients in U.S. and Europe combined and 1 million patients globally live with Stargardt disease. Stargardt and ABCA4-associated retinopathies are genetically complex, involving more than 1,200 known mutations and addressing this condition with traditional gene therapy or gene editing approaches remains highly challenging.
“Stargardt disease represents a significant unmet medical need, particularly among children and young adults,” said Lejla Vajzovic, MD, FASRS, Director of the Duke Surgical Vitreoretinal Fellowship Program and Professor of Ophthalmology, Pediatrics, and Biomedical Engineering with Tenure at Duke University Eye Center. “The Phase 2/3 study of OCU410ST is thoughtfully designed with scientific rigor and a patient-centered focus to evaluate both structural and functional outcomes. We are optimistic that this approach will move us closer to a meaningful therapeutic solution for affected families.”
The OCU410ST Phase 2/3 pivotal confirmatory trial represents a major advancement as Ocugen’s second late-stage clinical program. Ocugen plans to submit a BLA for OCU410ST in 2027 in alignment with its strategic goal of filing three BLAs over the next three years.
About OCU410ST OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR-Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathophysiological pathways linked to Stargardt disease, such as lipofuscin formation, oxidative stress, complement formation, inflammation, and cell survival networks.
About Stargardt Disease Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.
Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Cautionary Note on Forward-Looking Statements Thispressreleasecontainsforward-lookingstatementswithinthemeaningofThePrivateSecuritiesLitigationReformActof1995,including,butnot limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,whicharesubjecttorisksanduncertainties.Wemay,insomecases,usetermssuchas “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including,butnotlimitedto,therisksthatpreliminary,interimandtop-lineclinicaltrialresultsmaynotbeindicativeof,andmaydifferfrom,finalclinical data;the ability of OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data;thatunfavorablenewclinicaltrialdatamayemergeinongoingclinicaltrialsorthroughfurtheranalysesofexistingclinicaltrialdata;thatearlier non-clinicalandclinicaldataandtestingofmaynotbepredictiveoftheresultsorsuccessoflaterclinicaltrials;andthatthatclinicaltrialdataare subject to differing interpretations and assessments, including by regulatory authorities.Theseandotherrisksanduncertaintiesaremorefully describedinourperiodicfilingswiththeSecuritiesandExchangeCommission(SEC),includingtheriskfactorsdescribedinthesectionentitled“Risk Factors”inthequarterlyandannualreportsthatwefilewiththeSEC.Anyforward-lookingstatementsthatwemakeinthispressreleasespeakonlyas ofthedateofthispressrelease.Exceptasrequiredbylaw,weassumenoobligationtoupdateforward-lookingstatementscontainedinthispress release whether as a result of new information, future events, or otherwise, after the date of this press release.
TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia: FDA PDUFA goal date of August 15, 2025
TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two double-blind randomized placebo-controlled Phase 3 studies
If approved by FDA, TNX-102 SL would become the first member of a new class of non-opioid analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years
CHATHAM, N.J., June 16, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company) presented data in a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2025, held June 11-14, 2025, in Barcelona, Spain. A copy of the Company’s poster, titled “Advancing Fibromyalgia Treatment: Transmucosal Sublingual Cyclobenzaprine (TNX-102 SL) Targets Non-restorative Sleep and Provides Sustained Pain Reduction” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com. TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is a non-opioid analgesic designed for daily bedtime dosing with an FDA Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025.
“Fibromyalgia is a complex and invisible chronic pain condition which drives many patients to be prescribed chronic opioids which are associated with addiction and overdose,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “To address the chronic symptoms of fibromyalgia, potential therapeutic options must provide durable benefits. TNX-102 SL has shown statistically significant, durable activity (14 weeks) in reducing fibromyalgia pain in two Phase 3 studies. Designed to target the sleep disturbance of fibromyalgia, TNX-102 SL harnesses the therapeutic activity of cyclobenzaprine in part by reducing in the level of the active metabolite norcyclobenzaprine relative to oral cyclobenzaprine. Norcyclobenzaprine is believed to interfere with the durability of oral cyclobenzaprine’s treatment effect in off-label chronic dosing regimens and in a failed double-blind randomized placebo-controlled trial.1 TNX-102 SL now has the potential to be the first new treatment option for fibromyalgia patients in 15 years.”
TNX-102 SL is designed for transmucosal absorption to bypass first-pass hepatic metabolism. The poster presentation shows the day 20 steady state blood levels from a study of nightly TNX-102 SL dosing in which the peak level of cyclobenzaprine exceeds the level of the active metabolite norcyclobenzaprine during sleep time. In contrast, with nightly oral cyclobenzaprine dosing, pharmacokinetic simulations show that norcyclobenzaprine accumulates to higher levels, and the cyclobenzaprine peak level does not exceed the norcyclobenzaprine level during sleep time.
The poster includes data from the RESILIENT Phase 3 study evaluating the efficacy and safety of TNX-102 SL with a primary endpoint of reducing daily pain numeric rating scale scores after 14 weeks of treatment. TNX-102 SL significantly reduced pain and improved clinical outcomes in fibromyalgia patients while demonstrating a favorable tolerability profile. TNX-102 SL employs a novel mechanism targeting the sleep disturbance in fibromyalgia by acting as a potent antagonist at four post-synaptic receptors, each of which is known to regulate sleep.
About Fibromyalgia
Fibromyalgia is a common chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system, called central sensitization. Brain imaging studies have localized the functional disorder to the brain’s insula and anterior cingulate cortex. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including depression, anxiety, headaches and abdominal pain or cramps. Individuals suffering from fibromyalgia often struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. Fibromyalgia is now recognized as the prototypic nociplastic syndrome. Nociplastic pain is the third primary type of pain in addition to nociceptive pain and neuropathic pain. Many patients present with pain syndromes that are mixtures of the three primary types of pain. Nociplastic syndromes are associated with central and peripheral sensitization. Fibromyalgia can occur without any identifiable precipitating event. However, many fibromyalgia cases follow one or more precipitating event(s) including: post-operative pain, acute or chronic nociceptive or neuropathic pain states; recovery from an infectious illness; a cancer diagnosis or cancer treatment; a metabolic or endocrine stress; or a traumatic event. In the cases of recovery from an infectious illness, fibromyalgia is considered an Infection-Associated Chronic Condition. In addition to fibromyalgia cases associated with other conditions or stressors, the U.S. National Academies of Sciences, Engineering, and Medicine, has concluded that fibromyalgia is a diagnosable condition that can occur after recovery from COVID-19 in the context of Long COVID.
About TNX-102 SL
TNX-102 SL is a centrally acting, non-opioid investigational drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for bedtime dosing for the management of fibromyalgia. Cyclobenzaprine potently binds and acts as an antagonist at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia identified by Professor Harvey Moldofsky in 1975. Cyclobenzaprine is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based on a eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. Patents based on TNX-102 SL’s eutectic composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market protection into 2034. The European Patent Office’s Opposition Division maintained Tonix’s European Patent EP 2 968 992 in unamended form after an Opposition was filed against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime somnolence. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine, TNX-102 SL results in higher levels of exposure during the first 2 hours after dosing and in deceased levels of the long-lived active metabolite, norcyclobenzaprine in both single dose and multiple dose studies, consistent with bypassing first pass hepatic metabolism. Cyclobenzaprine is a tertiary amine tricyclic and its active metabolite norcyclobenzaprine is a secondary amine tricyclic. At steady state after 20 days of dosing TNX-102 SL, the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine during sleep time. In contrast, after 20 days of dosing oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background level of norcyclobenzaprine.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
1Carette S, et al. Arthritis Rheum. 1994;37(1):32-40.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
BOCA RATON, Fla.–(BUSINESS WIRE)–Jun. 16, 2025– The GEO Group, Inc. (NYSE: GEO) (“GEO” or the “Company”) announced today that its wholly-owned subsidiary, GEO Transport, Inc. has entered into a new five-year contract, inclusive of option periods, with the U.S. Marshals Service for the provision of secure transportation and contract detention officer services across three service regions covering 26 federal judicial districts and spanning 14 states.
The new contract is expected to generate up to approximately $147 million over the five-year period, or up to approximately $29 million in annualized revenues per full-year of operations, with margins consistent with GEO’s Managed-Only services contracts which average approximately 15 percent.
George C. Zoley, Executive Chairman of GEO, said, “We believe that this important new contract is a testament to the high-quality services GEO delivers on behalf of the U.S. Marshals Service, and it underscores the strength of our diversified services platform which provides our company multiple avenues to pursue quality growth opportunities. We are proud of our long-standing partnership with the U.S. Marshals Service, and we stand ready to continue to help the federal government meet its law enforcement priorities.”
About The GEO Group
The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 98 facilities totaling approximately 77,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.
Use of forward-looking statements
This news release may contain “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements and any such forward-looking statements are qualified in their entirety by reference to the cautionary statements and risk factors contained in GEO’s filings with the U.S. Securities and Exchange Commission including its Form 10-K, 10-Q and 8-K reports. All forward-looking statements speak only as of the date of this news release and are based on current expectations and involve a number of assumptions, risks and uncertainties that could cause the actual results to differ materially from such forward-looking statements. Readers are strongly encouraged to read the full cautionary statements and risk factors contained in GEO’s filings with the U.S. Securities and Exchange Commission, including those referenced above. GEO disclaims any obligation to update or revise any forward-looking statements, except as required by law.
New 50,000-Square-Foot Facility, Located on 20 acres, is Expected to Expand to 100,000 Square Feet and House up to Five GEK Engine Production Lines
PARIS, June 16, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a Technology Company in the Defense, National Security and Global Markets, today announced plans to open a new advanced manufacturing facility in Bristow, Oklahoma to produce its GEK (GE Aerospace-Kratos) family of turbojet engines, with an initial focus on the GEK800.
The announcement was made during the Oklahoma Breakfast in Paris ahead of the 2025 Paris Air Show, with Kratos CEO Eric DeMarco, Kratos Turbine Technologies (KTT) President Stacey Rock, and Oklahoma Governor Kevin Stitt in attendance.
The 50,000-square-foot facility, located on 20 acres, is expected to expand to 100,000 square feet and house up to five GEK engine production lines and initial output of 500 engines annually, supporting thrust classes from 600 to 6000 pounds. Occupancy is expected in mid-2026, with operations fully ramped by Q4 2026.
The facility will include three small engine (200-2000 lbf thrust) test cells, which are expected to be operational in 2027, thanks to approved grant funding from the State of Oklahoma.
The initial engine line is expected to create 60 high-quality jobs at the site, with key positions beginning recruitment in late 2025 and general hiring in Q1 2026. Each additional production line is expected to add approximately 45 new jobs.
“This facility underscores Kratos’ strategy of delivering affordable, high-performance, made-in-America propulsion systems at scale,” said Stacey Rock, President of Kratos Turbine Technologies. “Bristow will be a critical site for delivering mass to the mission and meeting the growing propulsion needs of our defense customers.”
Governor Kevin Stitt of Oklahoma, said, “This is a big win for American workers, for our military, and for every Oklahoman who believes in freedom, innovation, and strength. Kratos could’ve gone anywhere in the world, but they choose to continue investing in Oklahoma because it is the best place to build, grow, and do business. Oklahoma is proud to be a hub for national defense that is leading the way in rebuilding America’s industrial base and powering the technologies that keep our country safe.”
Eric DeMarco, President and CEO of Kratos Defense & Security Solutions, said, “Kratos is truly honored to expand our presence in Oklahoma with this new, state-of-the-art propulsion production facility in Bristow. This new Kratos investment reflects our continued commitment to delivering high-performance, affordable jet engine technology to support the Department of Defense and our allies and answers the rising demand for propulsion systems for cruise missiles and CCA-type aircraft, while being targeted and optimized for cost reduction. The Bristow facility will play a critical role in accelerating production of the GEK family of engines, including the GEK800, and strengthening America’s industrial base in this decisive era. We thank Governor Stitt and the State of Oklahoma for their partnership in helping us build the future of high-performance propulsion right here in the heartland.”
“Oklahoma is proud to be home to Kratos and all they do to provide cutting-edge defense technologies to our warfighters from target drones and unmanned combat aircraft to state-of-the-art turbine engines. Their investment in our state is an investment in our workforce, our warfighters, and our national security.” – Senator Markwayne Mullin
“Kratos’ expansion in Oklahoma is further proof that Oklahoma is a hub for innovative defense technology and high-quality manufacturing jobs. I am proud of all Kratos does day-to-day, providing our servicemembers with the best technology in the world, and ensuring our national security.” – Congressman Kevin Hern
“Kratos’ decision to grow in Oklahoma highlights Oklahoma’s strong workforce and unwavering support for our nation’s defense mission. Kratos continues to excel and I look forward to seeing the positive impact this facility will have on our state and national security.” – Congressman Frank Lucas
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading-edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 29, 2024, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
