Nebius Group’s stock price skyrocketed this week after the Amsterdam-based artificial intelligence infrastructure firm announced a multi-year partnership with Microsoft worth up to $19.4 billion. The deal highlights the surging demand for GPU-powered cloud computing capacity and underscores the critical role infrastructure providers play in supporting the global AI boom.
Shares of Nebius, which was spun out of Russian internet company Yandex in 2023, surged more than 40% on Tuesday following the announcement. The rally came on top of a 60% spike in extended trading Monday, marking one of the steepest short-term gains for an AI-related stock in 2025. Under the agreement, Nebius will supply Microsoft with graphics processing units (GPUs) and computing power valued at $17.4 billion through 2031. Microsoft may also secure additional capacity, potentially bringing the total value of the contract to $19.4 billion.
The Nebius-Microsoft deal instantly positions the European company as a top-tier supplier of AI cloud infrastructure. GPUs are essential for training and scaling large language models, generative AI platforms, robotics, and other advanced artificial intelligence applications. As enterprises race to deploy AI, demand for this specialized hardware has grown far faster than traditional cloud services. For Microsoft, the agreement ensures Azure customers, OpenAI projects, and its own AI-powered products have the computing resources required to expand.
This partnership also shows that while Nvidia remains the leader in AI chips, competition is opening up. Nebius joins a growing roster of infrastructure providers—including CoreWeave, which saw its shares climb 8% on the news—benefiting from hyperscalers’ urgent need to lock in GPU supply. Investors see this as a sign that AI infrastructure spending could remain strong despite market concerns about inflated valuations.
Analysts note that the deal comes amid broader predictions of enormous long-term spending on AI hardware. Nvidia executives recently forecast that between $3 trillion and $4 trillion will flow into AI infrastructure globally by 2030. At the same time, some experts, including OpenAI CEO Sam Altman, have warned of a possible AI bubble as valuations for startups like Anthropic and OpenAI itself reach record highs. Nebius’s surge reflects the optimism that demand will outweigh bubble risks, at least for infrastructure suppliers.
For Nebius, the Microsoft partnership provides not only revenue security through 2031 but also credibility as a global player in the AI race. By aligning with one of the world’s largest technology companies, Nebius strengthens its position in a market where trust, scale, and performance are paramount.
The stock market response suggests investors believe infrastructure will be one of the most resilient segments of the artificial intelligence economy. While software companies may face volatile valuations, firms that deliver the backbone of AI workloads—GPUs, cloud data centers, and compute resources—are emerging as long-term winners. With its $19 billion deal, Nebius has firmly secured its spot in the spotlight.
The U.S. oil industry is facing a sharp slowdown, with layoffs and spending cuts rippling across the sector as lower crude prices and industry consolidation squeeze margins. The wave of belt-tightening could mark the end of the rapid production growth that helped the United States overtake other producers to become the world’s top oil supplier in recent years.
International crude prices have fallen roughly 12% this year, dragged lower in part by rising output from OPEC and its allies, who have been steadily ramping up supply to reclaim market share lost to U.S. shale producers. Prices are now hovering just above $62 a barrel, uncomfortably close to breakeven levels for many U.S. operators. For companies already grappling with higher costs and trade-related tariffs, the weaker pricing environment is forcing tough decisions.
ConocoPhillips, the nation’s third-largest oil producer, recently announced plans to cut up to a quarter of its workforce. The move follows Chevron’s decision earlier this year to trim about 20% of its staff, amounting to roughly 8,000 jobs. Oilfield service providers such as SLB and Halliburton have also been cutting jobs, underscoring how the slowdown is spreading beyond producers to the broader energy ecosystem.
The cuts aren’t limited to people. According to a Reuters review of second-quarter results, 22 publicly traded U.S. producers—including ConocoPhillips, Diamondback Energy, and Occidental Petroleum—have reduced their combined capital spending by about $2 billion. Industry insiders say those pullbacks, along with falling rig counts, are early warning signs that production growth is set to level off. Baker Hughes data shows that the U.S. oil rig count has dropped by nearly 70 so far this year, down to just over 400.
In the Permian Basin, the heart of America’s shale boom, the tone has shifted from aggressive expansion to cautious retrenchment. “We’ve gone from ‘drill, baby, drill’ to ‘wait, baby, wait,’” said one Texas producer, pointing out that prices need to stabilize closer to $70–$75 a barrel before rig activity rebounds. Without that, analysts warn that U.S. output will plateau and could even begin to decline, with OPEC quickly stepping in to fill the gap.
Research firms are already forecasting slower momentum. Energy Aspects expects U.S. onshore production to drop by 300,000 barrels per day in 2025, while Wood Mackenzie projects only modest growth of 200,000 barrels per day—far below the record-setting pace of recent years.
Adding to the pressure are rising costs, much of it tied to tariffs on steel and other inputs. Diamondback Energy expects the price of steel casing for wells to climb by nearly 25% this year, inflating breakeven costs across the industry. For ConocoPhillips, controllable costs have already risen by $2 per barrel since 2021, making profitability harder to sustain.
The impact on employment is significant. Texas labor data shows U.S. oil and gas production jobs fell by nearly 5,000 in the first half of 2025, while energy services jobs have dropped by about 23,000 since January. Even with gains in drilling efficiency, industry analysts caution that technology alone won’t be enough to offset the slowdown.
For now, the U.S. oil industry remains a global leader. But with lower prices, higher costs, and fewer rigs in action, the sector’s once-rapid growth story appears to be entering a more uncertain chapter.
Tonmya was approved by FDA on August 15, 2025 for the treatment of fibromyalgia and is the first new FDA approved treatment for fibromyalgia in over 15 years
Two pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo
Tonmya showed consistent improvements across core fibromyalgia symptoms, including widespread pain, sleep disturbance and fatigue
Tonmya was well tolerated, supporting its potential as a long-term treatment option for fibromyalgia
Tonmya is expected to be commercially available in the fourth quarter
CHATHAM, N.J., Sept. 08, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, presented four posters at the PAINWEEK conference 2025, held September 2-5, 2025, in Las Vegas, Nevada entitled:
“TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, Demonstrates Pain Reduction and Favorable Tolerability in Participants With Fibromyalgia”
“Sublingual Cyclobenzaprine (TNX-102 SL) for Fibromyalgia: Efficacy and Safety in Two Randomized, Placebo-Controlled Trials”
“Steady-state Pharmacokinetic Properties of a Sublingual Formulation of Cyclobenzaprine (CBP) HCl (TNX-102 SL): Comparison to Simulations of Oral immediate-release CBP”
“Randomized, Double-Blind, Placebo-Controlled Confirmatory Phase 3 Trial of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Fibromyalgia”
“Fibromyalgia is a chronic and debilitating condition marked by widespread pain, poor sleep, and fatigue and cognitive dysfunction,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The data presented at PAINWEEK show that Tonmya significantly improved pain with a favorable tolerability profile, offering patients and physicians a new, non-opioid treatment option. Now that Tonmya has been approved by FDA, we believe we are well-positioned to execute the launch and remain on track to deliver this drug to patients next quarter.”
The posters included data from two pivotal Phase 3 trials: RELIEF, a 14-week randomized, double-blind, placebo-controlled study of TNX-102 SL 5.6 mg (now Tonmya™), and RESILIENT, a confirmatory trial evaluating efficacy and safety. Across both studies, Tonmya significantly reduced fibromyalgia pain and demonstrated a favorable tolerability profile. By pharmacologically targeting nonrestorative sleep through antagonism of receptors that regulate sleep architecture, Tonmya engages a central mechanism believed to drive the persistence of fibromyalgia symptoms. The availability of a safe and well-tolerated treatment may also support earlier diagnosis and intervention, ultimately improving patient outcomes. Together, these findings suggest Tonmya has the potential to improve a broad spectrum of fibromyalgia symptoms.
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, RALLY 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 Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix recently received FDA approval for TonmyaTM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology and infectious diseases. TNX-102 SL is 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’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.
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.
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.
Please see additional safety information in the full Prescribing Information.
To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
RESTON, Va., Sept. 8, 2025 /PRNewswire/ — V2X, Inc. (NYSE: VVX) today announced the appointment of Greg Lundy as Vice President of Technology, effective immediately. In this role, Lundy will lead the company’s innovation and technology strategy, with a focus on advancing Independent Research and Development initiatives. He will report directly to L. Roger Mason, Chief Growth Officer at V2X.
Lundy brings more than 20 years of leadership experience at the intersection of artificial intelligence, machine learning, cybersecurity, and advanced network architectures. He joins V2X from Collins Aerospace and has also held senior roles with Sony, Booz Allen Hamilton, and the U.S. Navy.
“Greg has a proven track record of driving multibillion-dollar defense and aerospace portfolios, architecting secure and autonomous systems, and leading large-scale engineering teams,” said Jeremy C. Wensinger, President and Chief Executive Officer at V2X. “As a former U.S. Navy officer and mission commander with more than 2,000 combat flight hours and deep operational ISR expertise, he brings mission-critical focus and technical leadership that will strengthen our innovation strategy and support our customers’ most complex challenges.”
Lundy holds a bachelor’s degree from the Maine Maritime Academy, a master’s degree from The George Washington University, an MBA from the University of Virginia’s Darden School of Business, and a doctorate in Artificial Intelligence/Machine Learning from The George Washington University.
About V2X V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations IR@goV2X.com 719-637-5773
Media Contact Angelica Spanos Deoudes Director, Corporate Communications Angelica.Deoudes@oV2X.com 571-338-5195
There are currently no approved vaccines or treatments for norovirus infection
Cocrystal’s CDI-988 is the first antiviral for the potential prevention and treatment of viral gastroenteritis caused by norovirus infections
Phase 1b study is expected to start by year-end 2025
BOTHELL, Wash., Sept. 08, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that the Company received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) to conduct a Phase 1b challenge study evaluating CDI-988 for the prevention and treatment of norovirus infections. Cocrystal’s oral broad-spectrum antiviral candidate CDI-988 represents a potential breakthrough for norovirus – the most common cause of acute viral gastroenteritis. The Phase 1b challenge study is planned to begin before year-end 2025.
CDI-988 is a novel pan-viral 3CL protease inhibitor developed for the treatment of norovirus and coronavirus infections. Preclinical data demonstrate that CDI-988 exhibits broad-spectrum antiviral activity by targeting a highly conserved region in the active site of the viral proteases. CDI-988 has shown effectiveness against major norovirus proteases including the prevalent GII.4 and GII.17. Data from the Phase 1 study showed oral CDI-988 to be well tolerated with a favorable safety profile. Currently, there are no approved vaccines or therapeutics for norovirus infections.
“The FDA’s clearance of our CDI-988 study is an important milestone for Cocrystal and marks a significant step in advancing to the next stage of its clinical development. CDI-988 is the first novel, oral drug candidate for the prevention and treatment for norovirus infection and has demonstrated impressive data to date with broad antiviral activity,” said Sam Lee, PhD, President and co-CEO of Cocrystal Pharma. “We look forward to the planned initiation of our Phase 1b challenge study and further determining the potential efficacy of CDI-988 in norovirus-infected patients.”
About Norovirus Norovirus infections affect millions globally, spreading rapidly through direct contact and contaminated food and surfaces. The virus is particularly problematic in confined environments such as cruise ships, hospitals, and military facilities. In the U.S., norovirus causes an estimated 21 million infections annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. Vulnerable populations, including infants, elderly and those immuno-compromised, can face more severe and prolonged infections. Individuals can remain contagious for weeks after symptoms are resolved, complicating containment efforts.
Cocrystal Structure-Based Platform Technology CDI-988 leverages Cocrystal’s proprietary structure-based drug discovery platform, which provides three-dimensional visualization of inhibitor complexes at near-atomic resolution. This technology enables rapid identification of novel drug binding sites and accelerates the development of broad-spectrum antivirals for the treatment of acute and chronic viral diseases.
About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies to create first- and best-in-class antiviral drugs.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans to initiate a human Phase 1b challenge study for our norovirus product candidate. The words “believe,” “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. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the ability of our clinical research organization to recruit volunteers for, and to otherwise proceed with the challenge study, our contract manufacturing organization’s ability to produce the products needed for the study, geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., economy, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with the study, and our ability to meet our liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. 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.
BOCA RATON, FL / ACCESS Newswire / September 8, 2025 / Newsmax Inc. (NYSE:NMAX) (“Newsmax” or the “Company”) today announced a strategic realignment of its weekday evening schedule, boosting the Company’s late daytime lineup ahead of a pivotal moment in the day.
Starting Monday, September 8, 2025, Carl Higbie will move into the 6:00pm ET slot to host Carl Higbie FRONTLINE, anchoring viewers’ transition from day to night with incisive news analysis, fearless reporting and provocative opinion.
Veteran journalist Greta Van Susteren will pivot from the 6:00pm ET hour to a newly powerful 4:00pm ET timeslot, positioning her at the heart of momentous breaking stories as the market closes, court hearings end and Congress adjourns.
With decades of experience in delivering sharp, fact-based analysis and piercing interviews, Van Susteren’s move underscores Newsmax’s commitment to timely and authoritative journalism.
Simultaneously, The Chris Salcedo Show will shift into the 5:00pm ET hour, continuing his unapologetically conservative commentary in the critical early evening timeframe.
Carl Higbie Takes Evening Lead
Former U.S. Navy SEAL and seasoned political commentator Carl Higbie has been a dynamic presence at Newsmax since launching Carl Higbie FRONTLINE in April 2023.
Now airing at 6:00pm ET, the program adopts a sharper night-time edge, characterized by Higbie’s trademark “fearless exposure of government overreach and sharp critique of the mainstream media” – designed to kick off evening viewing powerfully.
Higbie made headlines in August when Carl Higbie FRONTLINE broadcast from Israel for a full week. Reporting from Jerusalem and other key locations, he provided coverage of Israel’s security concerns, touring defense industries and speaking directly with officials such as Israel’s Prime Minister Benjamin Netanyahu.
Christopher Ruddy, CEO of Newsmax, praised the lineup innovation: “This reshuffle is designed to meet our viewers when the news truly matters,” Ruddy said. “Carl is a bold, unafraid journalist; Greta brings unmatched credibility at a critical juncture; and Chris brings strong voice and insight – together they form a powerful trifecta. We believe this revamped lineup will strengthen our connection with a news-hungry audience as we lead into primetime.”
New Late Day Lineup (Effective September 8, 2025)
4:00pm ET: The Record with Greta Van Susteren
5:00pm ET: The Chris Salcedo Show
6:00pm ET: Carl Higbie FRONTLINE
7:00pm ET: Rob Schmitt Tonight
8:00pm ET: Finnerty
9:00pm ET: Greg Kelly Reports
10:00pm ET: The Right Squad
About Newsmax Newsmax Inc. is listed on the NYSE (NMAX) and operates, through Newsmax Broadcasting LLC, one of the nation’s leading news outlets, the Newsmax channel. The fourth highest-rated network is carried on all major pay TV providers. Newsmax’s media properties reach more than 40 million Americans regularly through Newsmax TV, the Newsmax App, its popular website Newsmax.com, and publications such as Newsmax Magazine. Through its social media accounts, Newsmax reaches 20 million combined followers. Reuters Institute says Newsmax is one of the top U.S. news brands and Forbes has called Newsmax “a news powerhouse.”
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Data. Bit Digital reported its monthly Ethereum (“ETH”) treasury and staking metrics for the month of August 2025. As of August 31, 2025, the Company held approximately 121,252 ETH, including approximately 15,084 ETH and ETH-equivalents held in an externally managed fund, and approximately 5,094 ETH presented on an as-converted basis from LsETH using the Coinbase conversion rate as of 8/31/25. The Company’s total staked ETH was approximately 105,031 as of August 31st.
Yield and Value. Staking operations generated approximately 249 ETH in rewards during August, representing an annualized yield of approximately 2.94%. Based on a closing ETH price of $4,391.91, as of August 31, 2025, the market value of the Company’s ETH holdings was approximately $532.5 million.
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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.
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Return. FAT Brands announced the return of Andrew Wiederhorn as Chief Executive Officer. Recall, Mr. Wiederhorn had stepped down from his CEO role in May 2023 when the U.S. Department of Justice filed fraud and tax evasion charges against Mr. Wiederhorn. With the criminal charges now dropped, Mr. Wiederhorn will resume leading the Company he founded. Current co-CEOs Ken Kuick and Taylor Wiederhorn will return to their original roles as CFO and Chief Development Officer, respectively.
Our View. We view the re-appointment of Mr. Wiederhorn as CEO as a positive, although in his role as Chairman of the Board and consultant over the past two years, we believe Mr. Wiederhorn was still a guiding force for the Company. We believe the Company will continue to focus on its strategic priorities: organic expansion, targeted acquisitions, increasing the manufacturing facility’s capacity, and focusing on the balance sheet.
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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 Canadian gold sector is set for a significant shakeup as New Found Gold Corp. announced plans to acquire Maritime Resources Corp. in a deal valued at approximately $292 million. The combination, announced Friday, will establish an emerging multi-asset gold producer in Newfoundland, a Tier 1 jurisdiction that has been attracting rising investor attention in recent years.
Under the arrangement, Maritime shareholders will receive 0.75 of a New Found Gold common share for each Maritime share they hold. The agreement implies a 32% premium to Maritime’s 20-day volume weighted average price as of September 4 and a 56% premium to its closing price before the two companies entered a letter of intent in late July. Following the closing of the transaction, expected in the fourth quarter of 2025, New Found Gold shareholders will own roughly 69% of the combined company, while Maritime shareholders will hold about 31%.
The merger brings together two strategically located projects: New Found Gold’s Queensway project and Maritime’s Hammerdown project. Hammerdown, which has been advancing toward production, is scheduled to ramp up to full output in early 2026, with ore processing set to begin later this year at the Pine Cove mill. The project is expected to produce 50,000 ounces of gold annually at an all-in sustaining cost of $912 per ounce, according to a 2022 feasibility study. Cash flow from Hammerdown is anticipated to help fund Queensway, which recently delivered a positive preliminary economic assessment and is targeting first production in 2027.
For New Found Gold, the acquisition represents a pivotal step in transforming from an exploration-focused company into a producer. The deal secures access to processing facilities such as Pine Cove and the Nugget Pond Hydrometallurgical Plant, while providing a near-term source of cash flow to support Queensway’s development. The company estimates Queensway could generate more than 1.5 million ounces of gold over a 15-year mine life, with a two-phased development plan designed to balance upfront costs with long-term growth.
For Maritime shareholders, the deal offers both an immediate premium and long-term exposure to a larger platform with greater liquidity. Shares of New Found Gold are actively traded on both the TSX Venture Exchange and the NYSE American, averaging about $4 million in daily volume over the past six months. That visibility is expected to give Maritime investors improved market access while allowing them to participate in the upside potential from Queensway’s development and further exploration across a 110-kilometer strike zone.
The boards of both companies have unanimously approved the deal. Maritime directors and senior officers, along with major shareholders representing nearly half of the company’s outstanding shares, have already agreed to vote in favor of the transaction. A shareholder meeting is planned for late October, with court and regulatory approvals still required.
Advisors on the deal include BMO Capital Markets for New Found Gold and SCP Resource Finance and Canaccord Genuity for Maritime. Both sides have received fairness opinions supporting the financial terms of the agreement. If approved, Maritime shares will be delisted from the TSX Venture Exchange shortly after closing.
With Hammerdown moving toward near-term production and Queensway positioned as one of Canada’s most promising new gold projects, the merger highlights the increasing consolidation trend in the sector. Investors seeking exposure to Canadian gold production are likely to watch closely as New Found Gold positions itself as a new mid-tier player with both cash flow and exploration upside.
PNC Financial Services Group has taken another major step in its national expansion strategy, announcing a $4.1 billion agreement to acquire FirstBank Holding Company, a Colorado-based institution with deep community roots and a strong regional presence. The deal, unveiled Monday, will significantly bolster PNC’s operations in two high-growth markets—Colorado and Arizona—while reinforcing its status as one of the nation’s leading banks.
FirstBank, headquartered in Lakewood, Colorado, reported $26.8 billion in assets as of June 30, 2025. The bank operates 95 branches, with a dominant presence in Colorado and an established footprint in Arizona. The combination will more than triple PNC’s branch network in Colorado to 120 locations and instantly make Denver one of PNC’s largest markets nationwide, securing the number one position in both retail deposit share and branch share in the metro area. In Arizona, PNC will expand its presence to over 70 branches, further solidifying its strategy to grow in fast-expanding regions across the western United States.
For PNC Chairman and CEO William S. Demchak, the acquisition is more than a geographic play. It reflects PNC’s strategy of scaling its franchise by blending organic growth with targeted acquisitions. Over the past decade, PNC has consistently delivered double-digit revenue growth in new and acquired markets, aided by substantial investments in branch expansion, marketing, and digital capabilities. “FirstBank is the standout branch banking franchise in Colorado and Arizona,” Demchak said, praising its trusted relationships, strong retail base, and community focus. “It is an ideal partner for PNC as we continue to expand nationally.”
FirstBank’s legacy of community service is central to its appeal. The bank is well known for sponsoring Colorado Gives Day, which has raised over $500 million for local nonprofits. Its community-first model mirrors PNC’s approach, particularly through initiatives like its $85 billion Community Benefits Plan, which supports affordable housing, small businesses, and economic development, and its $500 million Grow Up Great® program, which promotes early childhood education.
Leadership continuity will also play an important role. FirstBank CEO Kevin Classen will assume the role of PNC’s Colorado Regional President and Mountain Territory Executive, overseeing operations in Colorado, Arizona, and Utah. PNC plans to retain all FirstBank branches and staff, ensuring continuity for customers and communities while leveraging PNC’s scale and resources to enhance offerings.
The acquisition, unanimously approved by the boards of both companies, is expected to close in early 2026 pending regulatory approvals. Shareholders of FirstBank will receive consideration in a mix of PNC stock and cash, totaling approximately 13.9 million shares and $1.2 billion. Advisors to the deal include Wells Fargo and Wachtell, Lipton, Rosen & Katz for PNC, and Morgan Stanley, Goldman Sachs, and Sullivan & Cromwell for FirstBank.
For PNC, the acquisition cements its push into high-growth western markets, expanding beyond its strongholds in the Midwest and East. For FirstBank, it marks a new chapter, pairing its community-driven model with the capabilities of a national financial powerhouse. Together, the institutions are poised to reshape the banking landscape in Colorado and Arizona while reinforcing PNC’s growing influence nationwide.
Gold soared to an all-time high on Friday after a weaker-than-expected U.S. jobs report intensified expectations that the Federal Reserve will cut interest rates later this month. The move marked the latest milestone in a multi-year rally that has been powered by economic uncertainty, rising geopolitical risks, and a steady flight to safe-haven assets.
Spot gold gained as much as 1.5% to break above $3,600 an ounce, eclipsing its previous record and capping a week of sharp gains. By early afternoon in New York, bullion was trading at $3,592.50 an ounce, up 1.3% on the day and on track for a 4.2% weekly advance, the strongest since late May. Silver also edged higher, while Treasury yields and the U.S. dollar slipped in response to the data.
The rally was triggered by a pivotal U.S. payrolls report showing that hiring slowed markedly in August, while the unemployment rate rose to its highest level since 2021. Economists said the numbers signaled clear signs of a cooling labor market, reinforcing the view that the Fed may need to act more aggressively to support growth. Lower interest rates typically enhance the appeal of gold, which does not yield interest or dividends but benefits from reduced opportunity costs in a lower-rate environment.
Investors have also been positioning for heightened volatility around the Fed’s independence. President Donald Trump has escalated his criticism of the central bank this year, vowing to secure a majority on the Fed’s board “very shortly” and pressing for sharp rate cuts. Markets are watching closely for a forthcoming ruling on whether Trump has grounds to remove Fed Governor Lisa Cook, a move that could allow him to appoint a more dovish policymaker and raise questions about the institution’s long-term credibility. Goldman Sachs analysts wrote in a recent note that gold could rally toward $5,000 an ounce if investors lose confidence in the Fed’s independence and begin shifting even a small portion of their holdings from Treasuries into bullion.
Over the past three years, gold and silver have more than doubled in value, with a steady stream of macroeconomic and geopolitical risks bolstering demand. Trade tensions, slowing global growth, and renewed concerns about the trajectory of U.S. monetary policy have all converged to create a powerful tailwind for precious metals. At the same time, strong buying from central banks and institutional investors has added structural support to the market, pushing gold firmly into record territory.
While some analysts warn that prices may be vulnerable to a correction if employment data stabilizes or inflation ticks higher, many expect gold’s appeal to remain strong. With borrowing costs likely heading lower and confidence in traditional policy tools wavering, bullion’s role as a store of value appears more attractive than ever. For now, gold’s latest record marks another reminder that in times of economic uncertainty, investors continue to seek the safety of precious metals.
WEST HARRISON, N.Y.–(BUSINESS WIRE)–Sky Harbour Group Corporation (NYSE: SKYH, SKYH WS) (“SHG” or the “Company”), an aviation infrastructure company building the first nationwide network of Home Base Operator (HBO) campuses for business aircraft, announced the closing of a $200 million tax-exempt warehouse drawdown committed bank facility. The initial borrower is Sky Harbour Capital II, LLC (“SKYH Capital II”), a wholly owned subsidiary of SHG. The lender and administrative agent is JPMorgan Chase Bank (“J.P. Morgan”). The initial tax-exempt note underlying the committed facility (the “JPM Facility”) was issued through the Public Finance Authority (Wisconsin) (“PFA”).
The JPM Facility’s principal terms include: drawdowns for eligible new hangar projects, 65% leverage, a 5-year bullet maturity, 80% of (SOFR+0.10%) plus a 200bps applicable margin as the tax-exempt annual interest rate, capitalized monthly interest during the first three years, and no prepayment penalty at the time of refinancing. At present, the applicable floating interest rate is approximately 5.60%. Subject to credit approval, the JPM Facility may be expanded to $300 million. Additional information may be found in our related filing under Form 8-K with the SEC.
Tal Keinan, Sky Harbour’s CEO, commented: “We thank our new lending partners at J.P. Morgan for their trust and their creativity in designing a facility that elegantly meets Sky Harbour’s specific needs.”
Francisco Gonzalez, Sky Harbour’s CFO, commented further: “After a highly competitive process that included numerous banks and products, we determined that the tax-exempt warehouse drawdown committed bank facility that closed yesterday is the most favorable and cost-efficient borrowing mechanism for the funding of our next set of projects. The JPM Facility provides us with flexibility to draw when we need to and refinance into long term bonds at the optimal time.”
McGuireWoods LLP acted as administrative agent and lender’s counsel to J.P. Morgan. Attolles Law, S.C. acted as issuer counsel to PFA. Greenberg Traurig, LLP acted as tax and bond counsel and Morrison & Foerster LLP acted as corporate counsel to the initial borrower, SKYH Capital II. Lexton Infrastructure Solutions LLC acted as financial advisor to the Company.
About Sky Harbour
Sky Harbour Group Corporation is an aviation infrastructure company developing the first nationwide network of Home-Basing campuses for business aircraft. The company develops, leases, and manages general aviation hangar campuses across the United States. Sky Harbour’s Home-Basing offering aims to provide private and corporate residents with the best physical infrastructure in business aviation, coupled with dedicated service, tailored specifically to based aircraft, offering the shortest time to wheels-up in business aviation. To learn more, visit www.skyharbour.group.
Forward Looking Statements
Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements about the financial condition, results of operations, earnings outlook and prospects of SHG, including statements regarding our expectations for future results, our expectations for future ground leases, our expectations on future construction and development activities and lease renewals, and our plans for future financings. When used in this press release, the words “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would” and other similar words and expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements are based on the current expectations of the management of Sky Harbour Group Corporation (the “Company”) as applicable and are inherently subject to uncertainties and changes in circumstances. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. For more information about risks facing the Company, see the Company’s annual report on Form 10-K for the year ended December 31, 2024 and other filings the Company makes with the SEC from time to time. The Company’s statements herein speak only as of the date hereof, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Poster details durability and efficacy of ateganosine (THIO) treatment in non-small cell lung cancer (NSCLC)
CHICAGO, Sept. 05, 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 an abstract titled “Study of THIO Sequenced with Cemiplimab in 3rd Line Immune Checkpoint Inhibitor-resistant aNSCLC: Improvement in PFS” was selected for poster presentation at the 2025 IASLC World Conference on Lung Cancer (WCLC) taking place September 6–9, 2025, in Barcelona, Spain.
“We are proud to accept IASLC’s invitation to present our exceptional ateganosine (THIO) data at its prestigious World Conference on Lung Cancer. Our participation gives us the opportunity to meet with elite scientists, researchers, and global industry leaders about our shared purpose in driving innovation in lung cancer treatments,” said MAIA Chairman and CEO Vlad Vitoc, M.D.
“Ateganosine is demonstrating substantial efficacy in our ongoing THIO-101 trial, with a median overall survival (OS) of 17.8 months with a 95% confidence interval (CI) lower bound of 12.5 months. We believe our novel anticancer agent could become a breakthrough treatment for those suffering from late-stage non-small cell lung cancer,” said MAIA’s Senior Medical Director Victor Zaporojan, M.D. “We look forward to further discussing our observed progression free survival (PFS) at this year’s World Conference on Lung Cancer.”
Conference details:
MAIA representatives: Victor Zaporojan, M.D., Sr. Medical Director; Tomasz Jankowski, M.D., THIO-101 lead investigator and abstract presenting author
Session time: Sunday, September 7, 2025, from 10:30 a.m. to 12:00 p.m.
Poster available at maiabiotech.com/publications on the day of the presentation
The U.S. Food and Drug Administration (FDA) recently granted Fast Track designation for ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) for the treatment of non-small cell lung cancer (NSCLC). MAIA intends to utilize the incentives of the Fast Track Program to expedite the regulatory process for ateganosine. If relevant criteria are met during the Fast Track process, a drug will be eligible for FDA Accelerated Approval and Priority Review (FDA decision within six months).
About IASLC
The IASLC is a global multidisciplinary organization dedicated to eradication of all forms of lung cancer. From provision of educational events around the world and virtually to research projects and publications that advance the science of lung cancer, the IASLC’s members are raising the bar for care of patients with lung cancer.
IASLC’s annual World Conference on Lung Cancer has played an integral part in facilitating progress by providing a platform for sharing cutting-edge research, collaboration, and networking among industry leaders, experts, and visionaries from around the world.
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 THIO-101 Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.
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.
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