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Release – NN, Inc. Announces Chris Bohnert as Chief Financial Officer

Posted on June 24, 2024June 24, 2024 by dburczyk@noblecapitalmarkets.com

30 Year Veteran Brings Decades of Global Manufacturing Experience and Expertise Leading Through Transformative Periods

CHARLOTTE, N.C., June 24, 2024 (GLOBE NEWSWIRE) — NN, Inc. (NASDAQ: NNBR), a global diversified industrial company that engineers and manufactures high-precision components and assemblies, today announced the appointment of Chris Bohnert as Chief Financial Officer, effective June 25, 2024. Bohnert brings over 30 years of global manufacturing leadership experience as an accomplished CFO with significant experience in successful business transitions and deep accounting expertise. Bohnert will report directly to NN’s Chief Executive Officer, Harold Bevis. Bohnert succeeds Mike Felcher, who is departing the company to pursue other opportunities. Felcher will stay on as a consultant to assist with the transition.

“Chris’s deep experience in manufacturing company turnarounds, IT, investor relations, and banking will make an immediate impact,” said Harold Bevis, President and CEO of NN, Inc. “Chris and I have worked together before and now is the right time to make this change. We are going to both pick up the pace and broaden our objectives. Chris is operationally savvy, proactive and has a track record of delivering results. This will be an accelerator for NN’s transformation.”

Bohnert has extensive experience in senior financial leadership roles at public and private equity companies, having most recently served as advisor to the CEO at Commercial Vehicle Group (CVG), and prior to that, EVP and CFO. In his role at CVG, he led a global team of 200 people across finance, accounting and IT, and helped lead a significant transformation of the company. Bohnert has also held senior financial leadership roles at Calumet, Titan International, Silgan Plastics and Fleischmann’s Yeast.

“I am deeply honored to join NN and help the team achieve its transformation goals,” said Bohnert. “This role represents a unique opportunity to blend my financial skills in banking and investor relations with my global operations, IT and manufacturing expertise. The company has significantly enhanced its operations, cash flow and profitability profile in the last year, and I believe we have a significant opportunity to step up the pace and magnitude of our efforts. This will help us drive value for all of our stakeholders.”

As a material inducement to Mr. Bohnert to enter into employment with the Company, the Board of Directors approved the grant of the following inducement equity awards (collectively, the Inducement Awards), granted outside the Company’s stockholder-approved equity incentive plan, with a grant date of June 25, 2024: (i) 189,000 time-vesting restricted stock units (RSUs), which will vest ratably in one-fifth increments on each of the first five anniversaries of the grant date; and (ii) 287,000 performance-vesting RSUs (PSUs), 41,000 of which will be earned upon the Company’s average stock price meeting or exceeding a price of $5.00 per share over a period of 20 consecutive days, with an additional 41,000 PSUs being earned for each dollar increase to the average stock price thereafter, with a cap of $11.00, subject further to a five-year vesting period.

As a result of the Inducement Grants, the Company does not anticipate granting any further equity, as part of his annual compensation or otherwise, to Mr. Bohnert before 2029, and as such, the Inducement Awards effectively serve as his 2024, 2025, 2026, 2027, and 2028 annual long-term incentive awards. The Company designed the Inducement Awards, in part, to (i) align, in case of the PSUs, the interests of Mr. Bohnert and the Company’s shareholders, as the equity is only earned as shareholders experience value creation, and (ii) prioritize retention of Mr. Bohnert through the entire five-year performance and vesting period.

About NN, Inc.

NN, Inc., a global diversified industrial company, combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets on a global basis. Headquartered in Charlotte, North Carolina, NN has facilities in North America, Europe, South America, and Asia. For more information about the company and its products, please visit www.nninc.com.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include this statement for purposes of complying with these safe harbor provisions. Except for specific historical information, many of the matters discussed in this press release may express or imply projections of revenues or expenditures, statements of plans and objectives or future operations or statements of future economic performance. These statements may discuss goals, intentions, and expectations as to future trends, plans, events, results of operations or financial condition, or state other information relating to NN, Inc. based on current beliefs of management as well as assumptions made by, and information currently available to, management. Forward-looking statements generally will be accompanied by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “intend,” “may,” “possible,” “potential,” “predict,” “project” or other similar words, phrases or expressions. Forward-looking statements involve a number of risks and uncertainties that are outside of management’s control and that may cause actual results to be materially different from such forward-looking statements. Such factors include, among others, general economic conditions and economic conditions in the industrial sector; the impacts of pandemics, epidemics, disease outbreaks and other public health crises on our financial condition, business operations and liquidity; competitive influences; risks that current customers will commence or increase captive production; risks of capacity underutilization; quality issues; material changes in the costs and availability of raw materials; economic, social, political and geopolitical instability, military conflict, currency fluctuation, and other risks of doing business outside of the United States; inflationary pressures and changes in the cost or availability of materials, supply chain shortages and disruptions, the availability of labor and labor disruptions along the supply chain; our dependence on certain major customers, some of whom are not parties to long-term agreements (and/or are terminable on short notice); the impact of acquisitions and divestitures, as well as expansion of end markets and product offerings; our ability to hire or retain key personnel; the level of our indebtedness; the restrictions contained in our debt agreements; our ability to obtain financing at favorable rates, if at all, and to refinance existing debt as it matures; new laws and governmental regulations; the impact of climate change on our operations; and cyber liability or potential liability for breaches of our or our service providers’ information technology systems or business operations disruptions. The foregoing factors should not be construed as exhaustive and should be read in conjunction with the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Company’s filings made with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. New risks and uncertainties may emerge from time to time, and it is not possible for the Company to predict their occurrence or how they will affect the Company. The Company qualifies all forward-looking statements by these cautionary statements.

Contact:
Joe Caminiti or Stephen Poe, Investors
Tim Peters or Emma Brandeis, Media
NNBR@alpha-ir.com
312-445-2870

Source: NN, Inc.

Release – Ahead of Artemis 2, V2X Awarded $265 Million Contract to Support NASA Astronauts Going to Space

Posted on June 24, 2024June 24, 2024 by dburczyk@noblecapitalmarkets.com

Research News and Market Data on VVX

MCLEAN, Va., June 24, 2024 /PRNewswire/ — V2X, Inc. (NYSE: VVX) has been awarded a $265 million contract to maintain safe operations at NASA’s Johnson Space Center in Houston, specifically at the Sonny Carter Training Facility, where astronauts receive crucial training to prepare for human spaceflight missions. V2X will deliver technical support to ensure the reliability of the integrated hardware and software systems utilized at the Neutral Buoyancy Laboratory (NBL). The contract’s period of performance extends until 2033, including option periods.

The NBL will serve as a training ground for NASA’s upcoming Artemis 2 mission, scheduled to launch in September 2025. The Artemis 2 missions will include the historic journey of the first woman and person of color to visit the moon, marking humanity’s return to the lunar surface after more than fifty years. The crew will land near the moon’s south pole, a region characterized by immense craters, extreme temperatures, and areas of permanent darkness, thus requiring extensive and meticulous preparation.

“We are honored to continue our partnership with NASA and support their mission to explore the frontiers of space,” said Jeremy Wensinger, President and Chief Executive Officer of V2X. “The Neutral Buoyancy Laboratory is an unparalleled facility, and we are committed to ensuring its readiness for the next generation of space exploration, including the groundbreaking Artemis 2 mission.”

At the NBL astronauts rehearse recovery missions, which are vital for the final stage of spaceflight when the crew’s capsule returns to Earth and splashes down into the ocean. Additionally, the laboratory houses a replica of the International Space Station, where astronauts practice working in microgravity, simulating the reduced gravity experienced in space. Recently, NASA and V2X have upgraded the NBL by converting a section into a realistic model of the moon’s surface.

As a critical asset for NASA, the NBL operates continuously to support the dynamic demands of human spaceflight. For over 30 years, it has been instrumental in training astronauts for space exploration, providing a realistic environment for practicing spacewalks and recovery missions.

About V2X

V2X delivers a comprehensive suite of integrated solutions across defense and commercial training, operations and logistics, aerospace, and technology markets to national security, defense, civilian and international clients. Our global team of approximately 16,000 employees brings innovation to every point in the mission lifecycle, from preparation to operations, to sustainment, as it tackles the most complex challenges with agility, grit, and dedication.

Media Contact
Angelica Spanos Deoudes
Director, Corporate Communications
Angelica.Deoudes@goV2X.com
571-338-5195

Investor Contact
Mike Smith, CFA
Vice President, Treasury, Corporate Development and Investor Relations
IR@goV2X.com
719-637-5773

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SOURCE V2X, Inc.

Vince Holding Corp. (VNCE ) – Fashioning A Growth Company

Posted on June 24, 2024June 24, 2024 by cpereira@noblefcm.com

Monday, June 24, 2024

500 5th Avenue 20th Floor New York, NY 10110 United States Sector(s): Consumer Cyclical Industry: Apparel Manufacturing Full Time Employees: 599 Key Executives Name Title Pay Exercised Year Born Mr. Jonathan CEO & Director 825.62k N/A 1958 Ms. Marie Fogel Senior VP and Chief Merchandising & Manufacturing Officer 633.19k N/A 1961 Mr. John Chief Financial Officer

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

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

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

Initiating coverage. The company appears to be well on its way toward favorable revenue growth and improving margins, along with a healthier balance sheet. We believe that investors have not yet caught up to the story of the company’s transformation. We are initiating coverage with an Outperform rating and a $3 price target.

Attractive position in the fashion industry. The company offers luxury, high quality men’s and women’s apparel that is in a fashion growth category of sophisticated, unstructured, casual wear. We believe that there is a significant price umbrella with other designer brands that should allow the company to reduce discounting, raise prices and increase its market share in the premium brand space.

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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.

The GEO Group (GEO) – A Contract Termination

Posted on June 24, 2024June 24, 2024 by cpereira@noblefcm.com

Monday, June 24, 2024

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.

Lawton Termination. GEO announced the discontinuation of its contract with the Oklahoma Department of Corrections for the company-owned, 2,600-bed Lawton Correctional and Rehabilitation Facility, which is set to expire on June 30, 2024, unless extended for an additional three months under terms proposed by GEO.

Why? In our discussions with management, the facility is not performing up to GEO expectations due to inadequate current funding levels provided by the State and difficulty in attracting sufficient staffing, a problem across the State DOC. GEO noted a closure would not have a material impact on financial guidance for 2024. It is our view that by providing notice to the State, GEO is hopeful a realistic funding solution can be found with the State, either as currently operated or, potentially, with GEO entering into a lease of the facility with the State operating the facility.

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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).

Graham Corp. (GHM) – Mission Critical Supplier With Solid Growth Prospects

Posted on June 24, 2024June 24, 2024 by cpereira@noblefcm.com

Monday, June 24, 2024

Graham Corporation designs, manufactures and sells critical equipment for the energy, defense and chemical/petrochemical industries. The Company designs and manufactures custom-engineered ejectors, vacuum pumping systems, surface condensers and vacuum systems. It is a nuclear code accredited fabrication and specialty machining company. It supplies components used inside reactor vessels and outside containment vessels of nuclear power facilities. Its equipment is found in applications, such as metal refining, pulp and paper processing, water heating, refrigeration, desalination, food processing, pharmaceutical, heating, ventilating and air conditioning. For the defense industry, its equipment is used in nuclear propulsion power systems for the United States Navy. The Company’s products are used in a range of industrial process applications in energy markets, including petroleum refining, defense, chemical and petrochemical processing, power generation/alternative energy and other.

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.

Initiating Research Coverage. We are initiating research coverage of Graham Corporation with an Outperform rating and a $35 price target. GHM is a provider of mission critical fluid, power, heat transfer, and vacuum technologies for the defense, space, energy, and process industries. The Company’s expanding business with the defense industry, specifically the U.S. Navy, has reduced cyclicality, while enabling the Company to target other, high growth end markets.

Improving Margins. With the completion of first order units for the U.S. Navy and the implementation of a strategic plan, Graham is well positioned to drive increased profitability. In fiscal 2024, gross margin expanded by 570 bp to 21.9%, which is expected to grow to 22%-23% in fiscal 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).

Lassonde Industries Expands Specialty Food Presence with $235 Million Acquisition of Summer Garden

Posted on June 24, 2024June 24, 2024 by slightbourne@noblecapitalmarkets.com

In a strategic move to bolster its position in the North American specialty food market, Lassonde Industries Inc. has announced an agreement to acquire Summer Garden Food Manufacturing for $235 million USD. This acquisition marks a significant step in Lassonde’s ambition to become a more diversified food and beverage powerhouse in North America.

Summer Garden, operated by The Zidian Group and based in Boardman, Ohio, is a renowned manufacturer and distributor of premium sauces and condiments. With a workforce of approximately 200 employees, the company has built a strong reputation for its high-quality products, including pasta sauces, BBQ sauces, dipping sauces, and dressings. The acquisition brings popular brands such as Gia Russa, Little Italy in the Bronx, and G Hughes – a leader in the sugar-free BBQ sauce segment – under the Lassonde umbrella.

The deal structure includes an initial payment of $235 million USD at closing, with the potential for additional payments of up to $45 million USD over the next three years, contingent on meeting certain financial targets and conditions. This approach aligns the interests of both parties and incentivizes continued growth and performance.

Financially, the acquisition appears promising for Lassonde. Summer Garden reported impressive figures for the 12-month period ending May 2024, with sales of $148 million USD and adjusted EBITDA of approximately $27.9 million USD. Lassonde expects the transaction to be accretive to margins and earnings, even before considering potential synergies. The company also anticipates that the acquisition’s internal rate of return will exceed its weighted-average cost of capital, indicating a sound financial investment.

Moreover, the transaction structure allows Lassonde to benefit from tax deductibility, generating an estimated $30 million USD in net present value. Post-acquisition, Lassonde projects its pro forma net debt to adjusted EBITDA ratio to remain under 2.20 to 1, providing ample room for future strategic initiatives.

Nathalie Lassonde, CEO and Vice-Chair of Lassonde’s board of directors, emphasized the strategic importance of the acquisition, stating that it supports the company’s ambition to diversify and grow its specialty food activities. She also highlighted the cultural alignment between the two family-owned businesses, noting their shared entrepreneurial spirit and commitment to stakeholders.

For Summer Garden, this acquisition ensures the continuation of its legacy under the stewardship of a larger, like-minded organization. Thomas Zidian, President and CEO of Summer Garden, expressed confidence that the partnership would benefit customers through enhanced products and offer employees new opportunities for development and advancement.

The acquisition is expected to close within 30 to 45 days, subject to regulatory clearance and other closing conditions. Lassonde plans to finance the transaction through its available credit facilities, demonstrating its strong financial position and commitment to growth.

This move by Lassonde Industries represents a significant consolidation in the specialty food sector and aligns with broader trends of larger food and beverage companies expanding their portfolios through strategic acquisitions. By integrating Summer Garden’s products, brands, and manufacturing capabilities, Lassonde is poised to enhance its market presence, diversify its product offerings, and potentially realize operational synergies.

As the food industry continues to evolve, with consumers increasingly seeking premium, specialized products, this acquisition positions Lassonde to capitalize on these trends and reinforce its status as a leading player in the North American food and beverage landscape.

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Release – Cadent, LLC Completes Acquisition of AdTheorent Holding Company, Inc.

Posted on June 21, 2024June 21, 2024 by aweinsoff@channelchek.com

Research News and Market Data on ADTH

Jun 21, 2024

PDF Version

NEW YORK, June 21, 2024 (GLOBE NEWSWIRE) — AdTheorent Holding Company, Inc. (“AdTheorent” or the “Company”) (Nasdaq: ADTH), a machine learning pioneer delivering measurable value for programmatic advertisers, today announced that Cadent, LLC, a leading provider of platform-based converged TV advertising solutions and a portfolio company of Novacap, one of North America’s established private equity firms, completed its acquisition of AdTheorent for $3.21 per share in an all-cash transaction that valued AdTheorent at approximately $324 million.

With the completion of the transaction, AdTheorent’s common stock has ceased trading and is no longer listed on the Nasdaq Stock Market and will not trade in any other public market.

Advisors:

Canaccord Genuity acted as financial advisor and McDermott Will & Emery LLP acted as legal counsel to AdTheorent in connection with the transaction. Moelis & Company LLC acted as lead financial advisor, and Baker Botts LLP provided legal counsel, to Cadent.

About AdTheorent:

AdTheorent uses advanced machine learning technology to deliver impactful advertising campaigns for marketers. AdTheorent’s advanced machine learning-powered media buying platform powers its predictive targeting, predictive audiences audience extension solutions and in-house creative capability, Studio A\T. Focused on the predictive value of machine learning models, AdTheorent’s product suite and flexible transaction models allow advertisers to identify the most qualified potential consumers coupled with the optimal creative experience to deliver superior results, measured by each advertiser’s real-world business goals. AdTheorent is headquartered in New York, with fourteen locations across the United States and Canada.

AdTheorent is consistently recognized with numerous technology, product, growth and workplace awards. AdTheorent was named “Best AdTech Platform” in the 2024 Digiday Media Awards and was honored with an AI Breakthrough Award and “Most Innovative Product” (B.I.G. Innovation Awards) for six consecutive years. Additionally, AdTheorent is the only seven-time recipient of Frost & Sullivan’s “Digital Advertising Leadership Award.” In September 2023, evidencing its continued prioritization of its team, AdTheorent was named a Crain’s Top 100 Best Place to Work in NYC for the tenth consecutive year. AdTheorent ranked tenth in the Large Employer Category and 26th Overall in 2023. For more information, visit adtheorent.com.

About Cadent:

Cadent connects the TV advertising ecosystem. Cadent helps advertisers and publishers identify and understand audiences, activate campaigns, and measure what matters – across any TV content or device. Aperture, the company’s converged TV platform, simplifies cross-screen advertising through a streamlined workflow that brings together identity, data, and inventory with hundreds of integrated partners. For more information, visit cadent.tv.

About Novacap:

Founded in 1981, Novacap is a leading North American private equity firm with over C$8B of AUM that has invested in more than 100 platform companies and completed more than 150 add-on acquisitions. Applying its sector-focused approach since 2007 in Industries, TMT, Financial Services, and Digital Infrastructure, Novacap’s deep domain expertise can accelerate company growth and create long-term value. With experienced, dedicated investment and operations teams as well as substantial capital, Novacap has the resources and knowledge that help build world-class businesses. Novacap has offices in Montreal, Toronto, and New York.

For more information, please visit www.novacap.ca.

Investor Contact:

David DeStefano, ICR
AdTheorentIR@icrinc.com
(203) 682-8383

Press Contact:

Melanie Berger, AdTheorent
melanie@adtheorent.com
(850) 567-0082

Economic Headwinds: Labor Market Softens and Housing Sector Cools

Posted on June 21, 2024June 21, 2024 by slightbourne@noblecapitalmarkets.com

Recent economic reports suggest that the U.S. economy may be facing increasing headwinds, with signs of softening in both the labor market and housing sector. These indicators point to a moderation in economic activity for the second quarter of 2024, potentially setting the stage for a shift in Federal Reserve policy later this year.

The Labor Department reported that initial jobless claims for the week ended June 15 fell by 5,000 to a seasonally adjusted 238,000. While this represents a slight improvement from the previous week’s 10-month high, it only partially reverses the recent upward trend. More tellingly, the four-week moving average of claims, which smooths out weekly volatility, rose to 232,750 – the highest level since mid-September 2023.

Adding to concerns about the labor market, continuing unemployment claims edged up to 1.828 million for the week ending June 8, marking the highest level since January. This uptick in ongoing claims could indicate that laid-off workers are facing increased difficulties in finding new employment, a potential red flag for overall job market health.

The unemployment rate, which rose to 4.0% in May for the first time since January 2022, further underscores the gradual cooling of the labor market. While job growth did accelerate in May, some economists caution that this may overstate the true robustness of employment conditions.

Turning to the housing sector, the news is equally sobering. The Commerce Department reported that housing starts plummeted 5.5% in May to a seasonally adjusted annual rate of 1.277 million units – the lowest level since June 2020. This decline was even more pronounced in the critical single-family housing segment, which saw starts fall 5.2% to a rate of 982,000 units, the lowest since October 2023.

The slowdown in housing construction is mirrored by a drop in building permits, often seen as a leading indicator for future construction activity. Permits for new housing projects tumbled 3.8% in May, again reaching levels not seen since June 2020. This decline in both current and future building activity paints a concerning picture for the housing market’s near-term prospects.

Several factors appear to be contributing to the housing sector’s struggles. Mortgage rates have seen significant volatility, with the average 30-year fixed rate reaching a six-month high of 7.22% in early May before retreating slightly. These elevated borrowing costs are keeping many potential buyers on the sidelines, as noted by the National Association of Home Builders, which reported that homebuilder confidence hit a six-month low in June.

The combination of a softening labor market and a cooling housing sector has led some economists to revise their growth projections downward. Goldman Sachs, for instance, has pared back its GDP growth estimate for the second quarter to a 1.9% annualized rate, down from an earlier projection of 2.0%.

These economic indicators are likely to factor heavily into the Federal Reserve’s decision-making process in the coming months. Despite the Fed’s more hawkish stance at its recent meeting, where officials projected just one quarter-point rate cut for this year, financial markets are anticipating the possibility of multiple rate cuts. The latest data may bolster the case for monetary easing, with some economists now seeing the potential for an initial rate cut as early as September.

Many economists believe that the soft activity and labor market data reinforce expectations for the Fed to begin cutting interest rates in the coming months, with potential cuts in September and December being discussed.

While the U.S. economy continues to show resilience in many areas, the emerging signs of moderation in both the labor and housing markets suggest that the impact of higher interest rates is beginning to be felt more broadly. As we move into the second half of 2024, all eyes will be on incoming economic data and the Federal Reserve’s response to these evolving conditions. The delicate balance between managing inflation and supporting economic growth remains a key challenge for policymakers in the months ahead.

The confluence of a cooling job market and a struggling housing sector paints a picture of an economy at a crossroads. As these trends continue to develop, they will likely play a crucial role in shaping both economic policy and market expectations for the remainder of the year and beyond.

Release – Ocugen Announces Data and Safety Monitoring Board Approves Enrollment In High Dose Cohort 3 In GARDian Study For Stargardt Disease

Posted on June 21, 2024June 21, 2024 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

June 21, 2024

PDF Version

• Established Medium Dose as Safe and Tolerable Dose in Current OCU410ST Clinical Trial
• DSMB Determination to Proceed with High Dose Cohort Dosing

MALVERN, Pa., June 21, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Data and Safety Monitoring Board (DSMB) for the OCU410ST GARDian clinical trial recently convened and approved to proceed with dosing the high dose of OCU410ST in the dose-escalation phase of the study. OCU410ST (AAV5-hRORA) is a modifier gene therapy candidate being developed for Stargardt disease. Stargardt disease affects approximately 100,000 people in the U.S. and Europe combined.

Six patients with Stargardt disease have been dosed in the Phase 1/2 clinical trial to date in the low dose cohort and medium dose cohort. An additional three patients will be dosed with the high dose in cohort 3.

“The DSMB has recommended moving forward to dose subsequent subjects with Stargardt disease at the targeted high dose,” said Dr. Peter Y. Chang, MD, FACS, DSMB Chair for the OCU410ST clinical trial. “No serious adverse events (SAEs) related to OCU410ST have been reported to date. This is an important next step in the clinical progress for OCU410ST and encouraging for patients living with this most common form of inherited retinal disease.”

“We are delighted to report a second positive DSMB recommendation for the treatment of Stargardt disease and build upon the favorable safety and tolerability profile exhibited by OCU410ST,” said Huma Qamar, M.D., MPH, Chief Medical Officer of Ocugen. “We recognize the high unmet medical need for Stargardt patients as there is no approved product. We are enthusiastic about OCU410ST as a potential one-time treatment for life with a single sub-retinal injection. We look forward to sharing a clinical trial update later this year.”

The Phase 1/2 GARDian clinical trial will include up to 42 subjects—30 adults and 12 children with Stargardt disease—who exhibit mild to moderate disease symptoms and will assess the safety of unilateral subretinal administration of OCU410ST. The clinical trial is being conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging/dose-escalation study consisting of three dose levels [low dose (3.75× 10¹⁰ vg/mL), medium dose (7.5× 10¹⁰ vg/mL), and high dose (2.25× 10¹¹ vg/mL)]. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which adult and pediatric subjects will be enrolled in a 1:1:1 ratio to randomize subjects into two different treatment groups at varying dose levels, or a control (untreated group), allowing for a comprehensive assessment of the treatment’s efficacy across different dosages.

Currently, patients with Stargardt disease have no FDA-approved therapeutic options. Ocugen is dedicated to providing a gene-agnostic treatment approach for patients living with inherited retinal diseases and is encouraged that the Phase 1/2 GARDian trial for OCU410ST remains on track.

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 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 pathway links to Stargardt disease such as lipofuscin formation, oxidative stress, complement formation, inflammation, and cell survival networks.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies 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; 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
Head of Communications
Tiffany.Hamilton@ocugen.com

Release – The GEO Group Announces Discontinuation of Lawton Correctional and Rehabilitation Facility Contract in Oklahoma

Posted on June 21, 2024June 21, 2024 by dburczyk@noblecapitalmarkets.com

Research News and Market Data on GEO

BOCA RATON, Fla.–(BUSINESS WIRE)–Jun. 20, 2024– The GEO Group, Inc. (NYSE: GEO) (“GEO” or the “Company”) announced today the discontinuation of its contract with the Oklahoma Department of Corrections for the company-owned, 2,600-bed Lawton Correctional and Rehabilitation Facility, which is set to expire on June 30, 2024, unless extended for an additional three months under terms proposed by GEO.

We are proud of our long-standing public-private partnership with the Oklahoma Department of Corrections, which dates to 1998. Over the last 26 years, we have made significant capital investments to provide needed correctional bedspace to help reduce Oklahoma prison overcrowding. We have implemented a world class rehabilitation program through our GEO Continuum of Care to help lower recidivism in the State of Oklahoma. Throughout this time, the health and safety of all those in our care and of our employees has always been our number one priority. All funding increases we have received from the State of Oklahoma in prior years have been directly allocated to increase wages for staff at the Lawton Correctional and Rehabilitation Facility.

In recent years, wage inflation and staffing shortages, following the COVID pandemic, have negatively impacted staff recruitment and retention at all state correctional facilities. Unfortunately, the recent veto of funding that was approved by the Oklahoma State Legislature will only exacerbate our significant challenges. Upon extensive consideration of the current funding levels and resources relative to the present service requirements, we have determined that we are no longer willing to manage the 2,600-bed Lawton Correctional and Rehabilitation Facility without changes to financial and operational terms. We have proposed a new three-month transition agreement starting July 1, 2024, allowing for an orderly relocation of inmates if new funding and contract terms cannot be mutually agreed upon.

The discontinuation of the Lawton Correctional and Rehabilitation Facility contract will not have a material impact on GEO’s financial guidance.

Additionally, as has been reported in the media, as a result of recent significant damage caused to the physical plant and equipment at our company-owned, 1,940-bed Great Plains Correctional Facility, we have issued a default notice to the State of Oklahoma under our lease agreement for the Great Plains Correctional Facility, which is currently operated and maintained by the Oklahoma Department of Corrections. The default notice provides for a cure period of 30 days for the State of Oklahoma to carry out all necessary physical plant and equipment repairs at an estimated cost of $3 million.

About The GEO Group

The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 100 facilities totaling approximately 81,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

Use of forward-looking statements

This news release may contain “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements and any such forward-looking statements are qualified in their entirety by reference to the following cautionary statements. All forward-looking statements speak only as of the date of this news release and are based on current expectations and involve a number of assumptions, risks and uncertainties that could cause the actual results to differ materially from such forward-looking statements. Risks and uncertainties that could cause actual results to vary from current expectations and forward-looking statements contained in this press release include, but are not limited to, risk factors contained in GEO’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K, 10-Q, and 8-K reports. GEO disclaims any obligation to update or revise any forward-looking statements, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240620963065/en/

Pablo E. Paez (866) 301 4436
Executive Vice President, Corporate Relations

Source: The GEO Group, Inc.

Tonix Pharmaceuticals (TNXP) – Tonix Announces Positive Pre-NDA Meeting – NDA Submission On Schedule

Posted on June 21, 2024June 21, 2024 by cpereira@noblefcm.com

Friday, June 21, 2024

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

NDA For Tonmya Expected In 2H24. Tonix announced that it has received written feedback from the FDA from its pre-NDA meetings. The meetings covered the CMC (chemistry, manufacturing, and controls) section of the Tonmya new drug application (NDA). Based on the written feedback, Tonix believes it is in alignment with the FDA on important issues. This keeps the NDA filing on schedule for submission in 2H24.

Tonix Reaches CMC Agreement and Alignment. Topics of the meetings included the proposed drug substance and commercial specifications, shelf-life assignment, manufacturing, and commercial drug packaging. We see this as a significant milestone toward the NDA submission and approval, as many NDA applications have been delayed or received Complete Response Letters (CRLs) due to issues with manufacturing and the CMC section.

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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).

Cocrystal Pharma (COCP) – Cocrystal Updates Studies On Influenza and Bird Flu

Posted on June 21, 2024June 21, 2024 by cpereira@noblefcm.com

Friday, June 21, 2024

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Potential Efficacy Against A New Strain Of Avian Influenza. Cocrystal has announced that studies of its influenza drug, CC-42344, have shown efficacy against the new avian influenza strain H5N1. Cocrystal has used its proprietary technology to determine the strain’s mutations and structure, then conduct preliminary tests. The binding site for CC-42344 was not changed and can block reproduction of the new strain, making it an effective vaccine against the virus.

Avian Influenza Strain Has Begun To Infect Humans. Avian influenza H5N1 has caused significant illness in commercial bird flocks since 2003. Its impact was limited until recent outbreaks in dairy cattle and infections in diary workers. This ability to mutate and infect other species is a significant step toward causing widespread outbreaks in humans, elevating it to a public health concern.

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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).

Trump Media’s Truth Social Faces Market Turmoil as Shares Plummet

Posted on June 20, 2024June 20, 2024 by slightbourne@noblecapitalmarkets.com

The digital media landscape is witnessing a dramatic shakeup as Trump Media & Technology Group, the company behind the conservative social network Truth Social, experiences a sharp decline in its stock value. The Nasdaq-listed company, trading under the ticker DJT, has seen its shares plummet by over 40% since early June, opening at a mere $27 per share on Thursday. This downturn has sent shockwaves through the social media stock market, raising questions about the future of alternative platforms in an increasingly competitive digital ecosystem.

The sell-off intensified Thursday, with shares sinking as much as 15% shortly after the opening bell, continuing a trend that has wiped billions from the company’s market capitalization. This steep decline has had a profound impact on the paper wealth of former President Donald Trump, the majority stakeholder in the company. Trump’s 114,750,000 shares, once valued at over $5.6 billion in early June, have now plummeted to around $3.2 billion – a staggering loss of approximately $2.4 billion in less than a month.

The catalyst for this market turbulence appears to be rooted in recent legal developments. The company’s stock began its downward spiral on May 30, coinciding with a New York jury’s decision to convict the former president on 34 felony counts of falsifying business records. This legal setback has evidently shaken investor confidence, highlighting the potential risks associated with companies closely tied to controversial public figures.

Adding to the tumult, Trump Media recently reached a crucial milestone in its regulatory journey. The Securities and Exchange Commission (SEC) declared the company’s registration statement effective, a development that triggered significant market reaction. The stock fell nearly 10% during Tuesday’s trading session on more than double the average volume, followed by a further 17% plunge in after-hours trading following the announcement.

This SEC approval marks a pivotal moment for Trump Media, authorizing early investors to exercise warrants and allowing stockholders to publicly resell securities covered by the registration statement. While this development provides greater liquidity for existing shareholders, it also introduces the potential for increased selling pressure, which could further impact the stock’s performance.

The volatility surrounding Trump Media serves as a case study in the challenges faced by emerging social media platforms as they navigate the complex interplay of market forces, regulatory requirements, and public perception. As the digital advertising landscape continues to evolve, investors and industry observers are closely watching how alternative social networks like Truth Social can carve out their niche and sustain growth in a highly competitive market.

The unfolding situation at Trump Media also underscores the importance of diversification in investment portfolios, particularly when dealing with stocks tied to high-profile individuals or emerging technologies. As the company strives to weather this storm, its ability to adapt to changing market conditions and demonstrate sustainable user growth will be crucial in regaining investor confidence.

In the broader context of social media innovation and digital marketing trends, the Trump Media saga highlights the ongoing shifts in online engagement and content monetization strategies. As users increasingly seek out niche platforms that align with their values and interests, the success of companies like Trump Media may hinge on their ability to foster engaged communities while navigating the complex regulatory and financial landscapes of the modern digital economy.

As this story continues to develop, it will undoubtedly remain a focal point for those interested in the intersection of technology, politics, and finance, offering valuable insights into the future of social media entrepreneurship and the challenges of building sustainable digital platforms in today’s rapidly changing online environment.