Page 77 – Channelchek

Treasury Rally Pushes Yields Below 4% as Inflation Shows Signs of Cooling

Posted on February 28, 2025February 28, 2025 by slightbourne@noblecapitalmarkets.com

Key Points:
– Short-term Treasury yields fell under 4% as inflation cooled and GDP forecasts weakened, boosting rate-cut expectations.
– Traders anticipate a July rate cut and over 60 basis points of relief by year-end, driving a strong February rally.
– Softer data and policy shifts have investors prioritizing economic slowdown risks over inflation fears.

A powerful rally in U.S. Treasuries has slashed short-term bond yields below 4% for the first time since October, sparked by cooling inflation and shaky economic growth signals. Investors are piling into bets that the Federal Reserve will soon lower interest rates, possibly as early as midyear, giving the bond market a jolt of momentum.

The rally gained steam on Friday as yields on two- and three-year Treasury notes dropped by up to six basis points. This followed a disappointing January personal spending report and a steep revision in the Atlanta Fed’s first-quarter GDP estimate, which nosedived to -1.5% from a prior 2.3%. Even the less volatile 10-year Treasury yield dipped to 4.22%, its lowest since December, signaling broad market confidence in a softer economic outlook.

This month, Treasuries are poised for their biggest gain since July, with a key bond index climbing 1.7% through Thursday. That’s the strongest yearly start since 2020, up 2.2% so far. Analysts attribute the surge to a wave of lackluster economic data over the past week, flipping the script on expectations that the Fed might hold rates steady indefinitely.

Market players are now anticipating a quarter-point rate cut by July, with over 60 basis points of easing baked in by December. The latest personal consumption expenditures data for January, showing inflation easing as expected, has fueled this shift. Investors see it as a green light for the Fed to pivot toward supporting growth rather than just wrestling price pressures.

Still, some warn it’s early days. The GDP snapshot won’t be finalized until late April, leaving room for surprises. For now, two-year yields sit below 4%, and 10-year yields hover under 4.24%. Experts say the rally’s staying power hinges on upcoming heavy-hitters like next week’s jobs report—if it flags a slowdown, the case for rate cuts strengthens.

A week ago, 10-year yields topped 4.5%, with fears of tariff-fueled inflation looming large. But recent tariff threats and talk of federal job cuts have shifted focus to growth risks instead. Investors are shedding bearish positions, and some are even betting yields could sink below 4% if hiring falters and unemployment climbs.

The Fed, meanwhile, is stuck in a tricky spot with inflation still above its 2% goal. If push comes to shove, many believe it’ll lean toward bolstering growth—a move the market’s already pricing in. As February closes, index fund buying could nudge yields lower still, amplifying the rally.

This swift turnaround underscores the bond market’s sensitivity to shifting winds. With jobs data on deck, all eyes are on whether this Treasury boom has legs.

Perfect (PERF) – Positioning for New Revenue Opportunities

Posted on February 28, 2025February 28, 2025 by slightbourne@noblecapitalmarkets.com

Friday, February 28, 2025

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Q4 results. The company reported Q4 revenue of $15.9 million, largely in line with our estimate of $16.2 million and up 12.4%, year-over-year. Adj. EBITDA of $0.25 million was below our estimate of $0.91 million, due primarily to lower-than-expected gross margins. This was likely due to the increased proportion of lower-margin B2C revenue as a share of total revenue.

Total Addressable Market (TAM) expansion. In our view, the company is poised to drive favorable revenue growth through expansion into untapped markets. For example, the emergence of its Skincare AI service allows it to reach new categories of clients. Through the recent Wannaby acquisition, the company also expanded its virtual try-on service offering to include additional fashion categories.

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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 (GEO) – A Look into the Fourth Quarter

Posted on February 28, 2025March 3, 2025 by slightbourne@noblecapitalmarkets.com

Friday, February 28, 2025

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.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

4Q Results. Revenues for the fourth quarter slightly declined to $607.7 million from $608.3 million in the prior year. Adjusted EBITDA totaled $108.0 million, down from $129.0 million last year. Net income was $15.5 million, or $0.11 per diluted share, down from $25.2 million, or $0.17 per share, last year. Adjusted EPS was $0.13 per diluted share versus $0.29 per share the prior year. Earnings and adjusted EBITDA were below expectations, primarily due to higher general and administrative expenses incurred during the fourth quarter of 2024.

New ICE Contract. Also announced was the award of a 15-year, fixed-price contract by ICE to provide support services for the establishment of a federal immigration processing center at the company-owned, 1,000 bed Delaney Hall facility in Newark, NJ. The contract is expected to generate in excess of $60 million in its first full year of operations, with margins consistent with GEO’s Secure Services facilities. The idle facility is expected to be activated in 2Q 2025, with revenues and earnings from the new contract normalizing during the second half of 2025.

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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).

GoHealth (GOCO) – Delivers a Robust Annual Enrollment Period

Posted on February 28, 2025February 28, 2025 by slightbourne@noblecapitalmarkets.com

Friday, February 28, 2025

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Strong Q4. The company delivered impressive Q4 results driven by strong market dynamics during the Medicare Advantage Annual Enrollment Period (AEP). Quarterly revenue of $389.1 million was 16% stronger than our estimate of $336.0 million, and adj. EBITDA of $117.8 million exceeded our estimate of $80.4 million by 47%.

Improved efficiency. Average agent handle time was down roughly 9% from the prior year period and direct operating cost per policy submission was down 27% to $501. We believe these improvements are attributable to the company’s agent training and technology tool enhancements. Moreover, we believe the company’s focus on increasing productivity per agent could drive additional margin improvement over time.

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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).

FAT Brands (FAT) – A Look at the Fourth Quarter

Posted on February 28, 2025February 28, 2025 by slightbourne@noblecapitalmarkets.com

Friday, February 28, 2025

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.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

4Q Results. Revenues for the fourth quarter totaled $145.3 million compared to $158.6 million last year. The prior year included an extra week, resulting in an additional $11.3 million being added. Adjusted EBITDA was $14.4 million compared to $27.0 million last year. Net loss totaled $67.4 million, or $4.06 per share, compared to $26.2 million, or $1.68 per share, in the prior year. Included in the loss was $30.6 million in goodwill impairment.

Development Pipeline. During 2024, the Company expanded its footprint by opening 92 restaurants and signing over 250 new franchise agreements, increasing the development pipeline to 1,000 locations. Management expects to add more than 100 additional restaurants in 2025, with 17 already opened in the new year, which we believe can be further accretive to the Company’s annual adjusted EBITDA.

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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).

Cumulus Media (CMLS) – Revenue Visibility Remains Elusive

Posted on February 28, 2025February 28, 2025 by slightbourne@noblecapitalmarkets.com

Friday, February 28, 2025

Cumulus Media (NASDAQ: CMLS) is an audio-first media company delivering premium content to over a quarter billion people every month — wherever and whenever they want it. Cumulus Media engages listeners with high-quality local programming through 406 owned-and-operated radio stations across 86 markets; delivers nationally-syndicated sports, news, talk, and entertainment programming from iconic brands including the NFL, the NCAA, the Masters, CNN, the AP, the Academy of Country Music Awards, and many other world-class partners across more than 9,500 affiliated stations through Westwood One, the largest audio network in America; and inspires listeners through the Cumulus Podcast Network, its rapidly growing network of original podcasts that are smart, entertaining and thought-provoking. Cumulus Media provides advertisers with personal connections, local impact and national reach through broadcast and on-demand digital, mobile, social, and voice-activated platforms, as well as integrated digital marketing services, powerful influencers, full-service audio solutions, industry-leading research and insights, and live event experiences. Cumulus Media is the only audio media company to provide marketers with local and national advertising performance guarantees. For more information visit www.cumulusmedia.com.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Results in-line with expectations. The company reported Q4 revenue of $218.6 million, in line with our estimate of $219.0 million, and adj. EBITDA of $25.0 million, which was better than our estimate of $21.5 million. In our view, the quarter is illustrative of the company’s successful efforts to reduce costs and drive efficiencies, while managing the impact of macroeconomic headwinds and secular challenges on its businesses.

Continued weak revenue outlook. Management provided revenue pacings of a decline in the mid single digits for Q1 2025, slightly softer than our expectations. The company is being adversely affected by weak local and National spot advertising and headwinds from a loss of flagship podcast programming.

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This Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

CoreCivic, Inc. (CXW) – ICE Adding Capacity

Posted on February 28, 2025February 28, 2025 by slightbourne@noblecapitalmarkets.com

Friday, February 28, 2025

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believe we are the largest private owner of real estate used by government agencies in the United States. We have been a flexible and dependable partner for government for nearly 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Additional Capacity. Yesterday, CoreCivic announced the Company entered into contract modifications with the U.S. Immigration and Customs Enforcement (ICE) at various facilities for up to an additional 1,036 beds. We view this as the first step by ICE to add capacity in its efforts to enforce President Trump’s crackdown on undocumented migrants. We anticipate additional contracting activity that will help satisfy ICE’s growing needs.

Details. ICE entered into contract modifications to add capacity for up to a total of 784 detainees at CoreCivic’s 2,016-bed Northeast Ohio Correctional Center, its 1,072-bed Nevada Southern Detention Center, and its 1,600-bed Cimarron Correctional Facility in Oklahoma. In addition, CoreCivic has obtained a contract modification to specify that ICE may use up to 252 beds at its 2,672-bed Tallahatchie County Correctional Facility in Mississippi.

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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).

Weekly Jobless Data Reveals Unexpected Spike in Unemployment Claims

Posted on February 28, 2025February 28, 2025 by slightbourne@noblecapitalmarkets.com

Key Points:
– Initial unemployment claims jumped 22,000 to 242,000, exceeding economists’ forecast of 221,000
– Federal worker layoffs from Trump’s DOGE initiative haven’t yet appeared in federal unemployment data
– Consumer confidence in job availability declining despite historically low overall layoff rates

The number of Americans filing new applications for unemployment benefits jumped more than anticipated last week, according to the latest data released by the Labor Department. Initial claims for state unemployment benefits increased by 22,000 to a seasonally adjusted 242,000 for the week ended February 22, significantly exceeding economists’ projections of 221,000 claims.

Despite this unexpected rise, experts caution that the increase may not indicate a fundamental shift in labor market conditions. The Labor Department noted that seasonal adjustment factors—the models used to strip out normal fluctuations from the data—tend to artificially inflate claims figures around this time of year.

The report comes amid growing concerns about potential economic impacts from the Trump administration’s recent policies, particularly the mass layoffs of probationary federal government workers. Many of these employees were terminated around February 14 by the Department of Government Efficiency (DOGE), an entity created by President Trump and led by billionaire Elon Musk.

“These firings likely add up to the biggest layoff in the history of the United States,” said Michele Evermore, a Senior Fellow at the National Academy of Social Insurance and former deputy director for policy in the Labor Department’s Office of Unemployment Insurance Modernization. Evermore warned that “economic pain is contagious” and that federal layoffs could trigger broader economic hardship.

Interestingly, the report showed no immediate impact from these federal workforce reductions in the separate unemployment compensation for federal employees program, which is reported with a one-week lag. However, economists warn that the reduction in money flowing through the economy from lost paychecks and spending cuts could eventually lead to private-sector job losses.

The so-called continuing claims—representing people receiving benefits after an initial week of aid—actually fell by 5,000 to a seasonally adjusted 1.862 million during the week ending February 15. This figure is used when surveying households for February’s unemployment rate, which stood at 4.0% in January.

Despite the overall resilience of the labor market, there are signs that households are growing more anxious about their job prospects. A Conference Board survey published Tuesday revealed that the share of consumers who viewed jobs as “plentiful” dropped to a five-month low in February, while the proportion describing jobs as “hard to get” reached its highest level since October.

For the Federal Reserve, these labor market signals provide critical input as policymakers monitor the economic impacts of the administration’s fiscal, trade, and immigration policies—many of which economists view as potentially inflationary. Minutes from the Fed’s January meeting showed policymakers expressing concern about higher inflation resulting from Trump’s initial policy proposals.

The central bank has maintained its benchmark overnight interest rate in the 4.25%-4.50% range after reducing it by 100 basis points since September 2024. This followed an aggressive tightening cycle that raised rates by 5.25 percentage points in 2022 and 2023 to combat inflation.

For now, historically low layoffs continue to support economic expansion, though upcoming reports will be closely watched for any signs that the federal workforce reductions are beginning to impact broader employment trends.

Release – Direct Digital Holdings Introduces Guide to High-Quality AI Data Management for Businesses

Posted on February 27, 2025February 27, 2025 by aweinsoff@channelchek.com

Research News and Market Data on DRCT

February 27, 2025 9:00 am EST Download as PDF

New resource provides a structured framework to help organizations assess, prepare, and govern data for high-quality AI inputs

HOUSTON, Feb. 27, 2025 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”) and Orange 142, LLC (“Orange 142”), today announced the release of The Role of Data in AI Quality, a comprehensive guide developed by Direct Digital Holdings’ AI Council to help organizations enhance the quality and integrity of data used in AI systems.

As artificial intelligence drives innovation across industries, organizations face a fundamental challenge: ensuring they have high-quality data to achieve consistently reliable AI outcomes. Businesses risk inaccurate predictions, biased models, and security vulnerabilities without structured, well-defined instructions and high-integrity data. The Role of Data in AI Quality equips business leaders with the insights needed to establish effective data management practices, ensuring AI solutions produce meaningful and trustworthy results. Additionally, it helps organizations make informed decisions about resource allocation, timelines, and investment in data preparation—critical first steps before embarking on any AI initiative.

Setting a Standard for AI Data Readiness

“AI systems are only as good as the data that powers them,” said Anu Pillai, Chief Technology Officer at Direct Digital Holdings. “Businesses investing in AI must first prioritize data quality, ensuring that information is accurate, complete, and ethically sourced. Our guide provides a practical approach for organizations looking to refine their data management strategies, identify gaps that can affect AI performance, and set a strong foundation for AI success.”

The “The Role of Data in AI Quality” guide offers key insights into:

Understanding the impact of data quality on AI performance
Best practices for data assessment, preparation, and governance
Managing compliance and privacy risks in AI-driven environments
Strategies for eliminating bias and enhancing data integrity
Leveraging data enrichment techniques to optimize AI outputs

“Many organizations are eager to adopt AI but struggle with the foundational step of data readiness,” added Christy Nolan, VP of Delivery Solutions at Direct Digital Holdings. “This guide goes beyond theory and provides actionable steps to help businesses effectively clean, structure, and manage their data. By following these best practices, companies can ensure their AI systems deliver accurate and meaningful insights.”

By addressing the complete data lifecycle and establishing rigorous controls for accuracy and security, the comprehensive resource enables organizations to build the strong data foundation essential for successful AI implementation.

To download “The Role of Data in AI Quality,” please visit our AI Council resource center.

About Direct Digital Holdings

Direct Digital Holdings (Nasdaq: DRCT) combines cutting-edge sell-side and buy-side advertising solutions, providing data-driven digital media strategies that enhance reach and performance for brands, agencies, and publishers of all sizes. Our sell-side platform, Colossus SSP, offers curated access to premium, growth-oriented media properties throughout the digital ecosystem. On the buy-side, Orange 142 delivers customized, audience-focused digital marketing and advertising solutions that enable mid-market and enterprise companies to achieve measurable results across a range of platforms, including programmatic, search, social, CTV, and influencer marketing. With extensive expertise in high-growth sectors such as Energy, Healthcare, Travel & Tourism, and Financial Services, our teams deliver performance strategies that connect brands with their ideal audiences.

At Direct Digital Holdings, we prioritize personal relationships by humanizing technology, ensuring each client receives dedicated support and tailored digital marketing solutions regardless of company size. This empowers everyone to thrive by generating billions of monthly impressions across display, CTV, in-app, and emerging media channels through advanced targeting, comprehensive data insights, and cross-platform activation. DDH is “Digital advertising built for everyone.”

View original content to download multimedia:https://www.prnewswire.com/news-releases/direct-digital-holdings-introduces-guide-to-high-quality-ai-data-management-for-businesses-302387470.html

SOURCE Direct Digital Holdings

Released February 27, 2025

Release – MAIA Biotechnology to Initiate Phase 3 Pivotal Trial of THIO Sequenced with Checkpoint Inhibitor Compared with Chemotherapy Treatment in Advanced Non-Small Cell Lung Cancer Patients

Posted on February 27, 2025February 27, 2025 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

February 27, 2025 8:51am EST Download as PDF

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced plans to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of THIO administered in sequence with a checkpoint inhibitor (CPI) in third-line non-small cell lung cancer (NSCLC) patients who are resistant to checkpoint inhibitors and chemotherapy. The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients.

“THIO has consistently and substantially outperformed standard treatment options in our THIO-101 Phase 2 trial to date. THIO-104 will give us direct comparative data from a randomized study in patients in third line of treatment,” said Vlad Vitoc, M.D., CEO of MAIA. “We expect that the results from this study will further illuminate THIO’s unmatched benefits for advanced stage NSCLC patients.

“Our initiation of THIO-104 will mark an important milestone along our goal for THIO’s FDA commercial approval,” Dr. Vitoc added.

MAIA expects to begin enrolling patients in THIO-104 in the second half of 2025 in select countries in Asia, Europe and in the U.S.

The primary endpoint of the clinical trial is overall survival for THIO sequenced with a CPI compared to investigator’s choice of chemotherapy in a third line setting. The secondary endpoints include disease control rate, overall response rate, duration of response, progression-free survival and safety.

About THIO

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 (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO 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. THIO is presently developed as a third line of treatment for NSCLC for patients that are resistant to checkpoint inhibitors and chemotherapy.

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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250227494509/en/

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released February 27, 2025

Release – Ocugen, Inc. Announces FDA Alignment on Phase 2/3 Pivotal Confirmatory Clinical Trial for Modifier Gene Therapy Candidate OCU410ST for Stargardt Disease

Posted on February 27, 2025February 27, 2025 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

February 27, 2025

PDF Version

MALVERN, Pa., Feb. 27, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that alignment has been reached with the U.S. Food and Drug Administration (FDA) to move forward with a Phase 2/3 pivotal confirmatory clinical trial for OCU410ST which, if positive, can be the basis of a biologics license application (BLA) submission.

The 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 (52%) from baseline in treated eyes versus untreated fellow eyes at 6-month follow-up from the Phase 1 study
Clinically meaningful 2-line (10-letter) improvement in visual function (BCVA) at 6-month follow-up from the Phase 1 study, which is statistically significant (p=0.02) in treated eyes

“I am very pleased that the FDA has recognized the promise of Ocugen’s modifier gene therapy for Stargardt disease and accelerated the regulatory pathway for OCU410ST,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This new development allows us to initiate a pivotal confirmatory trial for this game-changing, one-time treatment for life in the next few months and prepare for a potential BLA filing by 2027. Now patients suffering from Stargardt disease have a new hope where previously none existed. This achievement furthers our mission to cure blindness diseases.”

Stargardt disease affects 100,000 people in the U.S. and Europe combined, and there is no treatment. OCU410ST received orphan drug designations from the FDA and the European Medicines Agency (EMA) in 2023 and 2024, respectively.

“Getting approval for a Phase 2/3 trial is a pivotal milestone, as this approach has never been explored in clinical trials for Stargardt disease. The FDA’s decision underscores the potential of OCU410ST to meet a critical unmet medical need for the approximately 44,000 Stargardt patients in the U.S.,” said Lejla Vajzovic, MD, FASRS, Director, Duke Surgical Vitreoretinal Fellowship Program, Professor of Ophthalmology, Pediatrics and Biomedical Engineering with Tenure, Adult and Pediatric Vitreoretinal Surgery and Disease, Duke University Eye Center, and Retina Scientific Advisory Board Chair of Ocugen.

The Phase 2/3 clinical trial will randomize 51 subjects, 34 of whom will receive a single, subretinal, 200-μL injection of OCU410ST at a concentration of 1.5 x 10¹¹ vector genomes (vg)/mL in the eye with worse visual acuity, and 17 of whom will serve as untreated controls. The primary endpoint in the clinical trial is change in atrophic lesion size. Secondary endpoints include visual acuity as measured by best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA) compared to untreated controls. One-year data will be utilized for the BLA filing.

“This approval pathway, established in collaboration with the FDA, has made it possible to expedite the clinical development of OCU410ST by two to three years and has aided in bringing an innovative gene therapy to patients desperate for a treatment option,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “Recent data from the OCU410ST clinical trial have shown significant improvements in both structural and functional outcomes. Additionally, OCU410ST has consistently demonstrated a very favorable safety and tolerability profile.”

Accelerating the clinical timeline of OCU410ST will save significant costs in addressing disease burden even sooner than anticipated.

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 and cell therapies, biologics, and vaccines that improve health 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 treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “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, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com

Release – CoreCivic Announces Four New Contract Modifications to Add Capacity for U.S. Immigration and Customs Enforcement

Posted on February 27, 2025February 27, 2025 by aweinsoff@channelchek.com

Research News and Market Data on CXW

February 27, 2025

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BRENTWOOD, Tenn., Feb. 27, 2025 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (“CoreCivic”) announced today that it has entered into contract modifications to add capacity for up to a total of 784 detainees from U.S. Immigration and Customs Enforcement (“ICE”) at its 2,016-bed Northeast Ohio Correctional Center, its 1072-bed Nevada Southern Detention Center, and its 1,600-bed Cimarron Correctional Facility in Oklahoma. In addition, CoreCivic has obtained a contract modification to specify that ICE may use up to 252 beds at its 2,672-bed Tallahatchie County Correctional Facility in Mississippi.

CoreCivic currently cares for approximately 650 residents under a contract with the U.S. Marshals Service (“USMS”), as well as 925 residents under a contract with the Ohio Department of Rehabilitation and Correction at the Northeast Ohio Correctional Center. CoreCivic currently cares for approximately 800 residents under a contract with the USMS at the Nevada Southern Detention Center, and approximately 1,100 residents under a contract with the USMS at the Cimarron Correctional Facility. CoreCivic currently cares for approximately 1,400 residents at the Tallahatchie County Correctional Facility under contracts with eight different customers.

Damon T. Hininger, CoreCivic’s Chief Executive Officer, commented, “We are pleased to provide U.S. Immigration and Customs Enforcement with this additional capacity. We have an extensive supply of available beds that provides our government partners the flexibility to satisfy their immediate and long-term needs in a cost-effective manner. I am particularly proud of our dedicated team of professionals at each of these three facilities who are capable of managing these diverse customer requirements. We are entering a period where our government partners, particularly our federal government partners, are expected to have increased demand. We anticipate additional contracting activity that will help satisfy their growing needs.”

About CoreCivic

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believe we are the largest private owner of real estate used by government agencies in the United States. We have been a flexible and dependable partner for government for more than 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements as to our beliefs and expectations of the outcome of future events including increasing demand from our government partners, particularly our federal government partners, and the prospects of growth in CoreCivic’s business. These forward-looking statements may include such words as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “will,” “should,” “can have,” “likely,” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. Such forward-looking statements may be affected by risks and uncertainties in CoreCivic’s business and market conditions. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. Important factors that could cause actual results to differ are described in the filings made from time to time by CoreCivic with the Securities and Exchange Commission (“SEC”) and include the risk factors described in CoreCivic’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 21, 2025. Except as required by applicable law, CoreCivic undertakes no obligation to update forward-looking statements made by it to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events.

Contact:

Investors: Michael Grant – Managing Director, Investor Relations – (615) 263-6957
Media: Steve Owen – Vice President, Communications – (615) 263-3107

Release – GoHealth Reports Strong Fourth Quarter and Fiscal Year 2024 Results, Driven by a Successful Annual Enrollment Period

Posted on February 27, 2025February 27, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GOCO

Feb 27, 2025 at 7:01 AM EST

CHICAGO, Feb. 27, 2025 (GLOBE NEWSWIRE) — GoHealth, Inc. (NASDAQ: GOCO) (“GoHealth” or the “Company”), a leading health insurance marketplace and Medicare-focused digital health company, today announced financial results for the three and twelve months ended December 31, 2024.

Fourth Quarter Highlights

Achieved net revenues of $389.1 million, a substantial 41% increase compared to the prior year period.
Submissions grew to 481,445, representing a 67% increase compared to the prior year period.
Net income of $58.0 million, a substantial improvement of $60.3 million compared to the prior year period.
Adjusted EBITDA¹ surged to $117.8 million, a significant 107% increase compared to the prior year period.
Compared to the prior year period, Direct Operating Cost per Submission² improved 27%, to an industry leading $501.
The integration and transformation of e-TeleQuote Insurance, Inc. (“e-TeleQuote”) has driven growth and efficiency gains, delivering significant performance improvements in the 2024 Annual Enrollment Period.

Full-Year 2024 Highlights

Full-year net revenues reached $798.9 million, reflecting 9% growth compared to the prior year.
Submissions were 1,016,182, a 23% increase compared to the prior year.
Net loss of $7.3 million, an improvement of $144.0 million compared to the prior year.
Adjusted EBITDA¹ of $120.3 million, a 60% increase compared to the prior year.
Successfully refinanced our credit facility with new five-year term and lender group.
Supported nearly 3 million Medicare consumers in assessing benefit options in 2024.
Implemented the PlanFit Save initiative and began receiving health plan compensation for membership retention.
Remained top partner to health plans based on Submission volume.

“GoHealth’s strong 2024 performance highlights our market-leading, technology-driven approach in the digital Medicare marketplace. While we predicted favorable market dynamics, we were even more pleased by the velocity of our efficiency improvements and the immediate impact of our technology initiatives on profitability. We are energized by the opportunities ahead and are already executing on them,” said Vijay Kotte, CEO of GoHealth. “The successful onboarding and optimization of e-TeleQuote, expansion of our health plan partnerships, and continued investment in artificial intelligence and advanced analytics have further strengthened GoHealth’s position as a leading digital Medicare marketplace. As we move into 2025, we continue to focus on driving sustainable, profitable growth, enhancing the consumer experience, and reinforcing our market leadership through continued innovation and operational excellence.”

“Our 2024 financial results demonstrate GoHealth’s capacity to achieve exceptional performance through disciplined execution and strategic investment,” said Brendan Shanahan, CFO of GoHealth. “The substantial year-over-year growth in net income and the 107% year-over-year growth in Adjusted EBITDA¹ during Q4, coupled with significant gains in operating efficiency, reinforces the strength of our strategy. As we begin 2025, we are optimistic that the favorable market dynamics we experienced will persist through at least the first three quarters with cautious optimism for similar favorable dynamics for the fourth quarter, enabling us to build on this solid financial foundation.”

(1)	Adjusted EBITDA is a non-GAAP measure. For a definition of Adjusted EBITDA and a reconciliation to the most comparable GAAP measure, please see below.
(2)	Direct Operating Cost per Submission is an operating metric. For a definition of Direct Operating Cost per Submission and an explanation of its calculation, please see below.

Conference Call Details

The Company will host a conference call today, Thursday, February 27, 2025 at 8:00 a.m. (ET) to discuss its financial results. A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.

About GoHealth, Inc.

GoHealth is a leading health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception. For more information, visit https://www.gohealth.com.

Investor Relations:

John Shave

JShave@gohealth.com

Media Relations:

Pressinquiries@gohealth.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements are made in reliance upon the safe harbor provision of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release may be forward-looking statements. Statements regarding our future results of operations and financial position, business strategy and plans and objectives of management for future operations, including, among others, statements regarding our expected growth, future capital expenditures, debt service obligations, adoption and use of artificial intelligence technologies, the impact on our business from the acquisition of e-TeleQuote and our ability to successfully integrate e-TeleQuote’s operations, technologies and employees into our business, are forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “aims,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “likely,” “future” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions, projections and other statements about future events that are based on current expectations and assumptions. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.

These forward-looking statements speak only as of the date of this press release and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the factors described in the sections titled “Summary Risk Factors,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (“2023 Annual Report on Form 10-K”) and our forthcoming Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (“2024 Annual Report on Form 10-K”), as well as our other filings with the Securities and Exchange Commission. The factors described in our 2023 Annual Report on Form 10-K and our forthcoming 2024 Annual Report on Form 10-K should not be construed as exhaustive and should be read together with the other cautionary statements included in this press release, as well as the cautionary statements and other risk factors set forth in the Quarterly Report on Form 10-Q for the first fiscal quarter ended March 31, 2024, the Quarterly Report on Form 10-Q for the second fiscal quarter ended June 30, 2024, the Quarterly Report on Form 10-Q for the third quarter ended September 30, 2024 and in our other filings with the Securities and Exchange Commission.

You should read this press release and the documents that we reference in this press release completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

View Full Release Here.