Month: January 2025

Release – NN, Inc. Announces Second Consecutive Year of Record-Setting New Business Wins

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on NNBR

New business awards of $73 million in 2024, bringing two-year total to $136 million

CHARLOTTE, N.C., Jan. 14, 2025 (GLOBE NEWSWIRE) — NN, Inc. (NASDAQ: NNBR), a global diversified industrial company that engineers and manufactures high-precision components and assemblies, today announced the results of its new business wins program for the year ended December 31, 2024.

Highlights:

  • Full-year 2024 new business wins were $73 million, exceeding the high end of the Company’s guidance range
  • Record amount of annualized new business wins results for the second consecutive year
  • 2024 new business wins were $73 million, 2023 new business wins were $63 million, 2022 new business wins were $38.5 million
  • New wins in 2024 were in the key focus areas of vehicle control, energy efficiency, electrical grid devices, and medical components
  • NN remains firmly on pace to meet its five-year $325 million new business wins goal, which is the key driver to growing organically to $600 million in sales at 13% adjusted EBITDA margins
  • NN’s new business pipeline has grown to over $720 million and fully supports the 2025 new win program which is already underway
  • NN will launch new programs at a higher rate in 2025 and has over $60 million of prior wins in the last 2 years that are not yet incorporated into its sales run-rate
  • NN has over 50 new business programs underway with Q1 2025 launches; new business is accretive to the Company’s gross margin rates, averaging 16% gross margin
  • Over the trailing two-years NN has captured $136 million in new wins across 300+ new program awards, and expects to win another 100+ programs in 2025
  • NN was recently awarded Cummins Innovation Award at year-end 2024 for its work on new products

Harold Bevis, Chief Executive Officer of NN Inc. commented, “We are excited to announce another record year of new business wins in our targeted growth areas. We have delivered a second consecutive year of record-setting commercial results. We are targeting this level of above-market new wins to achieve our five-year goal of growing to $600 million in sales and delivering 13% adjusted EBITDA rates.

A key pilar of the company’s transformation plan has been to pivot back to innovation and growth. Coupled with best-in-class quality and great on-time delivery performance, we are climbing the ranks and becoming an elite and preferred supplier in our targeted areas.” Bevis continued, “We are attacking desirable high-value markets where our unique capabilities and distinct technical advantages can be put in place for true value. We remain committed to working with our customers and partners to strengthen NN’s position as an innovative supplier of choice and delivery of value-added solutions for complex, high precision machined and stamped metal components and assemblies.”

Bevis continued, “We will continue this pace of new business acquisition into 2025 and 2026 and have a $720 million pipeline to support it. 2025 is off to a great start with the simultaneous launch of fifty [50] new programs during the first quarter.”

  • 50 programs are launching from 11 plants in the US, Brazil, France, Poland and China combine to be $20.8 million of annualized sales
  • For the full-year 2025, we expect to launch eighty [80] new programs of which seventy [70] have already been won

”Our $720 million of new business opportunities has grown more than 40% versus the prior year, and has several focus areas balanced across machined parts, stamped parts, plated parts and complex assemblies.”

  • Electrical Power pipeline $250+ million, Vehicle Control pipeline $100+ million, Fuel Efficiency & Hybrid pipeline $100+ million, Medical and Industrial pipeline $100+ million
  • We have built dedicated teams in each area that we are focused upon

”We are solidly on pace to meet our five-year goal of capturing $325 million in new business wins, and in turn growing NN’s revenue organically to $600 million. We also intend to acquire additional revenue above $600 million in certain areas, specifically medical and electrical, and look forward to updating the market with our progress as we win new business, grow our sales, and deliver expanded profits to drive shareholder value creation.”

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

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. (the “Company”) 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,” “growth,” “guidance,” “intend,” “may,” “will,” “possible,” “potential,” “predict,” “project,” “trajectory” or other similar words, phrases or expressions. Forward-looking statements involve a number of risks and uncertainties that are outside of management’s control and that may cause actual results to be materially different from such 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; our ability to secure, maintain or enforce patents or other appropriate protections for our intellectual property; 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.

Investor Relations: 
Joseph Caminiti or Stephen Poe, Investors 
NNBR@alpha-ir.com  
312-445-2870 

Primary Logo

Source: NN, Inc.

United Rentals’ $4.8B H&E Acquisition Creates Equipment Rental Powerhouse

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Deal offers 109.4% premium to H&E shareholders at $92 per share
– United Rentals to add 64,000 units to rental fleet
– Expected cost synergies of $130 million within 24 months

United Rentals (URI) announced today a landmark $4.8 billion acquisition of H&E Equipment Services, marking a significant consolidation in the equipment rental industry amid strong demand for construction and industrial machinery. The deal, which sent H&E shares soaring over 105% in early trading, positions United Rentals to capitalize on increasing infrastructure spending and reshoring trends across the United States.

The all-cash transaction values H&E shares at $92 each, representing a substantial 109.4% premium to the company’s closing price on Monday. The strategic acquisition will expand United Rentals’ fleet by approximately 64,000 units, strengthening its position as one of the world’s largest equipment rental firms.

“We see United Rentals having a meaningful cross selling opportunity by pairing its specialty rental business with H&E’s portfolio of general rental equipment,” noted CFRA Research analyst Jonathan Sakraida. The merger comes at a time when industrial equipment demand remains robust, driven by increased government infrastructure spending and ongoing manufacturing production delays.

H&E Equipment, founded in 1961, brings to the table a diverse general rental fleet including aerial work platforms, earthmoving equipment, and material handling machinery. This portfolio complements United Rentals’ existing offerings and is expected to generate approximately $130 million in annual cost synergies within two years of the deal’s closing.

The merger agreement includes a 35-day “go-shop” period, allowing H&E to seek potentially better offers from other suitors. However, the substantial premium offered by United Rentals suggests strong confidence in the deal’s strategic value and future growth potential.

The timing of the acquisition appears particularly strategic, as United Rentals aims to capitalize on the continued momentum in U.S. reshoring efforts and infrastructure-related construction projected for 2025. The Stamford, Connecticut-based company has demonstrated consistent growth, reporting rising annual revenue over the past three years.

This consolidation in the equipment rental sector reflects broader industry trends toward scale and efficiency, as companies seek to meet the growing demands of major infrastructure projects and commercial construction across the United States.

Saga Communications (SGA) – Recent Stock Price Drop Is Gaining Investor Attention

Posted on by cpereira@noblefcm.com


Tuesday, January 14, 2025

Saga Communications, Inc. is a broadcast company whose business is primarily devoted to acquiring, developing and operating radio stations. Saga currently owns or operates broadcast properties in 27 markets, including 79 FM and 33 AM radio stations. Saga’s strategy is to operate top billing radio stations in mid sized markets, defined as markets ranked (by market revenues) from 20 to 200. Saga’s radio stations employ a myriad of programming formats, including Active Rock, Adult Album Alternative, Adult Contemporary, Country, Classic Country, Classic Hits, Classic Rock, Contemporary Hits Radio, News/Talk, Oldies and Urban Contemporary. In operating its stations, Saga concentrates on the development of strong decentralized local management, which is responsible for the day-to-day operations of the stations in their market area and is compensated based on their financial performance as well as other performance factors that are deemed to effect the long-term ability of the stations to achieve financial objectives. Saga began operations in 1986 and became a publicly traded company in December 1992. The stock trades on NASDAQ under the ticker symbol “SGA”.

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.

Recent weak stock performance. The SGA shares are down roughly 24% over the past six months and nearly 50% over the past year to near current levels. The performance is in line with its peer group, which is down approximately 45% over the past year. We believe that investors have thrown the baby out with the bath water, given that SGA has virtually no debt, unlike its highly debt levered peers, and has better revenue and cash flow growth potential.

Increased stake. Given the recent stock performance, Gate City Capital Management, LLC, a micro-cap focused investment firm, announced on January 8 that it nearly doubled its position during December 2024. Gate City Capital Management, LLC now owns 863,845 shares or approximately 13.8% of the total outstanding shares.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Comtech Telecommunications (CMTL) – Reports First Quarter Results

Posted on by cpereira@noblefcm.com


Tuesday, January 14, 2025

Comtech Telecommunications Corp. engages in the design, development, production, and marketing of products, systems, and services for advanced communications solutions in the United States and internationally. It operates in three segments: Telecommunications Transmission, Mobile Data Communications, and RF Microwave Amplifiers. The Telecommunications Transmission segment provides satellite earth station equipment and systems, over-the-horizon microwave systems, and forward error correction technology, which are used in various commercial and government applications, including backhaul of wireless and cellular traffic, broadcasting (including HDTV), IP-based communications traffic, long distance telephony, and secure defense applications. The Mobile Data Communications segment provides mobile satellite transceivers, and computers and satellite earth station network gateways and associated installation, training, and maintenance services; supplies and operates satellite packet data networks, including arranging and providing satellite capacity; and offers microsatellites and related components. The RF Microwave Amplifiers segment designs, develops, manufactures, and markets satellite earth station traveling wave tube amplifiers (TWTA) and broadband amplifiers. Its amplifiers are used in broadcast and broadband satellite communication; defense applications, such as telecommunications systems and electronic warfare systems; and commercial applications comprising oncology treatment systems, as well as to amplify signals carrying voice, video, or data for air-to-satellite-to-ground communications. The company serves satellite systems integrators, wireless and other communication service providers, broadcasters, defense contractors, military, governments, and oil companies. Comtech markets its products through independent representatives and value-added resellers. The company was founded in 1967 and is headquartered in Melville, New York.

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.

1Q25 Results. Revenue came in at $115.8 million, down 23.8% y-o-y. Revenue was below our estimate, consensus estimate, and management’s 4Q24 commentary. Adjusted EBITDA loss totaled $19.4 million, again below our estimate, consensus estimate, and management’s 4Q24 commentary. Comtech reported a GAAP net loss of $5.29/sh versus a loss of $0.11/sh in 1Q24. Adjusted net loss was $1.27/sh compared to EPS of $0.26/sh last year.

Segments. Terrestrial &Wireless revenue of $56.9 million rose 14.9% y-o-y. Adjusted EBITDA was $11 million, up 14% y-o-y. Book-to-bill was 1.22x. Satellite & Space segment revenue of $58.9 million declined 42.5% y-o-y, driven by a combination of divestitures and suboptimal performance. Segment adjusted EBITDA was a negative $21.1 million, while book-to-bill was 0.99x.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Comstock (LODE) – Taking Steps to Enhance Financial Flexibility and Close Strategic and Financial Partnerships

Posted on by cpereira@noblefcm.com


Tuesday, January 14, 2025

Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Special meeting of stockholders. Comstock will host a virtual special meeting of stockholders on February 14 at 9:00 a.m. PT. Stockholders of record, as of January 2, are asked to vote to authorize a reverse stock split of the company’s issued and outstanding common stock at a ratio ranging from one-for-five to one-for-twenty, with the timing and ratio to be determined by the Board. There will be no reduction or change to Comstock’s 245,000,000 authorized share count. The primary goal of the reverse split is to increase the number of shares available for issuance should the company need to raise additional capital.

Convertible promissory note financing. Comstock recently executed a 6.0% convertible promissory note agreement with a principal amount of $10,638,298 to Kips Bay Select, LP. The note is due on April 10, 2026. On the initial closing date, Kips Bay will fund $5,000,000 which will result in an aggregate principal amount of $5,319,149, including the original issue discount. Following and contingent on the reverse split, Comstock could receive additional funding of $5,000,000 in a second tranche, likely next month, on the same terms. Kips Bay could also receive restricted shares equal to 2% of the principal amount of the convertible note and registered shares equal to 3% of the principal amount.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Clearwater’s Enfusion Acquisition Bridges Front-to-Back Office Gap

Posted on by slightbourne@noblecapitalmarkets.com

Clearwater Analytics (NYSE: CWAN) announced today its agreement to acquire Enfusion, Inc. (NYSE: ENFN) for $1.5 billion, marking a significant move to create an integrated front-to-back investment management platform. The deal, announced January 13, 2025, will see Clearwater pay $11.25 per share in a mixed cash-and-stock transaction, along with $30 million to terminate Enfusion’s tax receivable agreement.

The acquisition brings together two complementary SaaS providers in the investment management space. Clearwater, known for its middle and back-office solutions, will integrate Enfusion’s front-office capabilities, including investment book of record (IBOR) and portfolio management systems, to create a unified cloud-native platform serving institutional investors.

“Today’s announcement is about creating a future where our clients benefit from the synergy of two highly complementary, innovative software leaders,” said Sandeep Sahai, CEO of Clearwater Analytics. The combination aims to eliminate the error-prone data handoffs that typically occur between front, middle, and back offices in investment operations.

The strategic merger significantly expands Clearwater’s market presence, particularly in the hedge fund sector where Enfusion has established itself as a leading platform provider. The deal is expected to increase Clearwater’s total addressable market by $1.9 billion and strengthen its international footprint, leveraging Enfusion’s strong presence in Europe and Asia, where it generates 38% of its revenue.

Clearwater expects to achieve substantial operational synergies, targeting $20 million in cost savings within the first two and a half years post-closing. The company also projects significant improvements in Enfusion’s adjusted EBITDA margins, anticipating a 400 basis point expansion in the first year and an additional 400 basis points in the second year after closing.

The transaction terms offer Enfusion shareholders $5.85 per share in cash and $5.40 per share in Clearwater Class A Common Stock, representing a 13% premium over Enfusion’s January 10 closing price and a 32% premium over its September 19, 2024 price, before market speculation about a potential sale began.

Enfusion’s CEO Oleg Movchan expressed enthusiasm about the merger, stating, “Together with Clearwater, our shared passion for building innovative technologies and enriching every aspect of the client journey will now accelerate and enhance our combined ability to support our clients’ evolving needs.”

The deal has received unanimous approval from both companies’ boards of directors and a special committee of independent Enfusion directors. Major Enfusion shareholders, including FTV, ICONIQ, and Mr. Movchan, who collectively hold approximately 45% of voting power, have agreed to support the transaction.

Clearwater has secured $800 million in committed financing through a Term Loan B, along with a $200 million revolving credit line to support the transaction. The company expects to close the deal in the second quarter of 2025, subject to regulatory approvals and customary closing conditions. Upon completion, the combined entity will be positioned to offer a comprehensive, cloud-native investment management solution that serves clients across the entire investment lifecycle.

Release – Kratos Receives New Hypersonic System Program Award with Total Potential Value of Approximately $100 Million

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on KTOS

SAN DIEGO, Jan. 13, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology company in Defense, National Security and Global Markets, announced today that it has recently received an approximate $100 million total potential value hypersonic system program award. Approximately $15 million of funding has been received by Kratos at contract award, with significant increased funding expected in the second half of Kratos fiscal year 2025. Under the new program contract award, Kratos will provide engineering, systems and hardware. Work related to the program will be performed at secure Kratos fabrication, manufacturing and system integration facilities. Due to competitive, security related and other considerations, no additional information will be provided.

Tom Mills, President of Kratos C5ISR Division, stated, “Kratos’ reputation as the industry leader in delivering military quality hardware, products and systems at scale, was a key factor in the receipt of this new program award. The design, engineering and production of National Security related hardware, that must work every time, is hard, and I am proud of our entire organization’s commitment to the United States and its allies’ mil spec system requirements.”

Eric DeMarco, Kratos President and CEO, said, “Kratos is the recognized industry leader in the rapid development and fielding of affordable hypersonic systems, including Erinyes and Zeus, tactical unmanned jet drone aircraft including Thanatos and Valkyrie, jet engines for aerial drones and missiles and related C5ISR hardware. At Kratos, it’s products today, not PowerPoints of a hoped for, maybe someday system, at an unknown cost. Kratos warfighter and mission focused customers understand that “better is the enemy of good enough and ready to field today”, while reducing development cost and saving money in today’s increasing fiscally challenging environment.”

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading-edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value-add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 31, 2023, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Claire Burghoff
Claire.Burghoff@kratosdefense.com

Investor Information:
877-934-4687
investor@kratosdefense.com

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Source: Kratos Defense & Security Solutions, Inc.

Release – V2X Names L. Roger Mason to Chief Growth Officer

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on VVX

RESTON, Va., Jan. 13, 2025 /PRNewswire/ — V2X, Inc. (NYSE: VVX) has named L. Roger Mason as Chief Growth Officer, effective January 13, 2025. In this role, Mason will be responsible for driving the company’s growth strategy, identifying new market opportunities, and enhancing business development efforts. He joins the executive team and reports directly to President and Chief Executive Officer, Jeremy C. Wensinger.

Mason joins V2X from Parsons Corporation, where he served as a senior vice president, advising the executive leadership team on market strategy, growth priorities, M&A integration efficiencies, margin expansion, and other key areas for a public company operating in critical infrastructure and national security mission areas. Prior to this, he was the president of Peraton’s Space and Intelligence sector, a $2 billion business delivering hardware and software solutions for national security space, civil space, defense, and intelligence missions.

“We are honored to welcome Roger to V2X,” said Jeremy C. Wensinger, President and CEO of V2X. “His extensive leadership experience and proven track record in driving growth make him a key addition to our executive team as we continue to advance our mission critical solutions and services.”

Mason’s career also includes senior executive leadership positions at Noblis, General Dynamics, and the Institute for Defense Analyses. He holds a PhD in Engineering Physics from the University of Virginia, an MBA from Northwestern University’s Kellogg School of Management, and an MS in Engineering Physics from the University of Virginia. His contributions have been recognized with several prestigious awards, including the National Intelligence Distinguished Service Medal.

About V2X
V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.

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

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

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/v2x-names-l-roger-mason-to-chief-growth-officer-302348485.html

SOURCE V2X, Inc.

Release – Comtech Announces Financial Results for the First Quarter of Fiscal 2025

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on CMTL

CHANDLER, Ariz. – January 13, 2025– Comtech Telecommunications Corp. (NASDAQ: CMTL) (“Comtech” or the “Company”), a global communications technology leader, today reported financial results for its first fiscal quarter ended October 31, 2024. In addition, Comtech separately announced today that its Board of Directors (the “Board”) has named Ken Traub as President and Chief Executive Officer, effective immediately, in addition to his current role as Chairman, and that the Board and management team are undertaking a series of prompt and decisive actions to address the Company’s current challenges and build a stronger company for long-term. That press release can be found on the Company’s investor relations website.

Consolidated Financial Results

  • Net sales of $115.8 million;
  • Net bookings of $127.9 million, representing a book-to-bill ratio of 1.10x;
  • Gross margin of 12.5%;
  • Operating loss of $129.2 million, net loss of $148.4 million and Adjusted EBITDA loss (a Non-GAAP measure) of $19.4 million;
  • Funded backlog of $811.0 million; and
  • Revenue visibility of approximately $1.6 billion.

Business Highlights

  • Awarded a sole source contract valued at over $50.0 million by the U.S. Navy Information Warfare Systems Command;
  • Awarded a contract renewal valued at over $30.0 million for critical enhanced 911 call routing services for one of the largest U.S. wireless carriers;
  • Awarded a large, multi-year location-based services maintenance and support contract valued at over $19.0 million for one of the largest U.S. wireless carriers;
  • Launched a new Digital Common Ground (“DCG”) portfolio of modems for U.S. government and commercial customers; and
  • Subsequent to quarter end, appointed Daniel Gizinski as President of the Satellite & Space Communications (“S&S”) segment, adding deep leadership expertise in satellite communications engineering, operations and product strategy.

Mr. Traub commented, “While Comtech’s recent historical performance has been unsatisfactory, the Company has great assets, including its people, technologies, reputation, customers and relationships. Since I joined the Company as Executive Chairman about six weeks ago, I have learned a lot, which gives me confidence that we can overcome the challenges and create new opportunities to strengthen the business and drive value. We are implementing a comprehensive set of initiatives to better position Comtech for the future including improving operational discipline, streamlining operations, supporting profitable growth initiatives, undertaking a broad review of strategic alternatives and strengthening the capital structure. I am honored to expand my role as President and CEO today, and look forward to leading the Company into a stronger and brighter future.”

Consolidated Results Commentary

Consolidated net sales of $115.8 million in the first fiscal quarter declined 23.8% compared to the prior year period, primarily due to the performance of the S&S segment and partially offset by growth in the Terrestrial & Wireless Networks (“T&W”) segment.

Consolidated net bookings were $127.9 million in the first fiscal quarter, a decrease of 31.1% compared to the prior year period. The book-to-bill ratio in the quarter was 1.10x, as compared to 1.22x in the prior year period. This was driven by several large awards in the prior year period, including funding from the U.S. Army related to the GFSR and EDIM contracts and an order from an international customer and reseller of the Company’s troposcatter solutions.

The first fiscal quarter results also reflect Comtech’s prior decisions to divest of its high-power solid-state amplifier (“PST”) and steerable antenna (“CGC”) product lines in fiscal 2024.

Gross profit was $14.5 million, or 12.5% of consolidated net sales, as compared to $47.9 million, or 31.5% of consolidated net sales, in the prior year period. This was driven by a large, high-margin troposcatter sale in the prior year period; higher-than-expected costs at completion for certain nonrecurring engineering-related projects in the satellite ground infrastructure product line; and late delivery penalties related to an international MTTS troposcatter solutions order. Gross profit in the more recent period was also impacted by a non-cash charge of $11.4 million related to the write-down of certain inventories in the S&S segment resulting from the Company’s review of its product portfolio, which is expected to improve the Company’s profitability in future periods.

Operating loss in the first fiscal quarter was $129.2 million, as compared to operating income of $2.1 million for the prior year period, and net loss in the first fiscal quarter was $148.4 million, as compared to $1.4 million in the prior year period. This was primarily due to a non-cash goodwill impairment charge of $79.6 million in the S&S segment; $17.9 million of restructuring costs (including the aforementioned inventory write down); and a non-cash charge of $17.4 million to fully reserve for an unbilled receivable contract asset related to an international customer and reseller of the Company’s troposcatter solutions, among other things.

Adjusted EBITDA loss (a non-GAAP measure) was $19.4 million in the first fiscal quarter, compared to Adjusted EBITDA income of $18.4 million in the prior year period.

Backlog was $811.0 million as of October 31, 2024, compared to $798.9 million as of July 31, 2024.

Revenue visibility, measured as the sum of funded backlog and the total unfunded value of certain multi-year contracts, was approximately $1.6 billion at the end of the quarter.

Satellite and Space Communications Segment Commentary

Net sales in the S&S segment were $58.9 million in the first fiscal quarter, a decrease of 42.5% compared to the prior year period. This was driven by a decline in sales of troposcatter and SATCOM solutions; the impact of the PST divestiture completed in November 2023; and the impact of the CGC divestiture initiated in the fourth quarter of fiscal 2024. The decrease also reflects the impact of late delivery penalties related to an international MTTS troposcatter solutions order.

Net bookings in the S&S segment were $58.4 million in the first fiscal quarter, a decrease of 57.4% compared to the prior year period. The book-to-bill ratio in the quarter was 0.99x, as compared to 1.34x in the prior year period.

Key S&S contract awards and product launches during the first fiscal quarter included:

  • Securing in excess of $16.0 million of funded orders from the U.S. Army calling for the supply of VSAT equipment and related services;
  • Receiving more than $8.5 million in incremental funding related to the Company’s U.S. Army EDIM contract;
  • Awarded over $6.0 million in funded orders from a new international customer for certain frequency-type power amplifiers;
  • Awarded a production order, valued in excess of $5.0 million, by an existing customer deploying a new LEO constellation (deliveries are anticipated to begin in the mid-2025 timeframe);
  • Awarded a sole source contract, valued in excess of $50.0 million, by the U.S. Navy Information Warfare Systems Command (the contract has a four-year period of performance, and funded orders received to date are valued at approximately $2.0 million);
  • Awarded approximately $2.0 million in funded orders from a new international customer of the Company’s ELEVATE™ networking platform; and
  • Launched the DCG platform, based on the proven success of the Company’s previous software-defined modem platforms.

S&S segment operating loss was $118.8 million in the first fiscal quarter, compared to operating income of $10.1 million in the prior year period, and net loss in the first fiscal quarter was $119.4 million, as compared to net income of $9.3 million for the prior year period. This was driven by a non-cash goodwill impairment charge of $79.6 million; a non-cash charge of $17.4 million to fully reserve for an unbilled receivable contract asset related to an international customer and reseller of the Company’s troposcatter solutions; $13.8 million of restructuring costs (including the aforementioned non-cash charge related to inventory write-downs); $3.0 million of amortization of intangibles; and lower net sales and gross profit in this segment.

Adjusted EBITDA loss in the S&S segment was $21.1 million in the first fiscal quarter, compared to Adjusted EBITDA of $15.1 million in the prior year period, driven by significantly lower net sales and gross profit, and higher selling, general and administrative expenses (due to the aforementioned $17.4 million non-cash charge related to an allowance for doubtful account), offset in part by lower research and development expenses.

At quarter end, the S&S segment had $278.4 million in funded backlog.

Subsequent to quarter end, Daniel Gizinski was appointed as President of the S&S segment, bringing to Comtech over 15 years of experience in satellite communications engineering, operations, product strategy and executive management. He oversees all aspects of this segment, including product development, operations and market expansion.

Terrestrial & Wireless Networks Segment Commentary

Net sales in the T&W segment were $56.9 million in the first fiscal quarter, an increase of 14.9% as compared to the prior year. This growth was driven by higher net sales of call handling and Next Generation 911 (“NG-911”) services, partially offset by lower net sales of location-based solutions.

Net bookings in the T&W segment were $69.4 million in the first fiscal quarter, an increase of 43.4% compared to the prior year period. The book-to-bill ratio in the quarter was 1.22x, as compared to 0.98x in the prior year period.

Key T&W contract wins and renewals during the first fiscal quarter included:

  • Awarded a contract renewal by one of the largest U.S. wireless carriers, valued in excess of $30.0 million, for critical enhanced 911 call routing services;
  • Awarded a large, multi-year contract, valued at over $19.0 million, for location-based maintenance and support services for one of the largest U.S. wireless carriers;
  • Awarded a contract by a municipality located in British Columbia, Canada, valued at more than $2.0 million, for an NG-911 Guardian call handling solution;
  • Awarded over $1.0 million in funding to continue servicing certain PSAPs in a New England state; and
  • Awarded over $1.0 million of funding related to an NG-911 deployment in South Carolina.

The T&W segment recorded operating income of $5.3 million in the first fiscal quarter, an increase of 31.6% compared to the prior year period, and net income of $5.3 million in the first quarter, an increase of 28.9% compared to the prior year period. Adjusted EBITDA was $11.0 million, an increase of 14.0% compared to the prior year period. This growth reflects higher net sales, partially offset by a lower gross profit percentage in this segment.

At quarter end, the T&W segment had $532.6 million in funded backlog.

Cost-Savings and Profit Improvement Initiatives

As announced separately today, the Company is conducting a thorough review of processes, product lines, staffing levels and cost structures to identify actions that are expected to meaningfully reduce costs, enable a more efficient and effective organization and improve its cash conversion cycle. To that end, the Company notes that since July 2024, it has significantly progressed with its plans to wind down its steerable antenna operations located in the U.K. (GAAP operating losses related to this product line in fiscal 2024, 2023 and 2022 were $32.3 million, $8.2 million and $9.9 million, respectively). In addition to discontinuing approximately 70 products within the Company’s satellite ground infrastructure product line to focus on higher margin revenue opportunities, the Company has also reduced its global workforce by approximately 13% since July 31, 2024, which represents approximately $26 million in annualized labor costs. Severance associated with such actions approximated $2.8 million, of which $1.1 million will be expensed in the second quarter of fiscal 2025.

Liquidity

Comtech’s cash and cash equivalents were approximately $30 million as of both October 31, 2024 and January 10, 2025. As previously disclosed, on June 17, 2024, the Company entered into a new $222.0 million credit facility. The credit facility was subsequently amended on October 17, 2024, to, among other things, suspend financial covenant testing for the Company’s first fiscal quarter ended October 31, 2024. On October 17, 2024, the Company also entered into a $25.0 million subordinated credit facility.

As of quarter end, aggregated outstanding debt under these two credit facilities was approximately $225 million, before consideration of GAAP related adjustments to reflect offsetting deferred financing costs and discounts related to each facility. Over the next twelve months, commencing with its fiscal quarter ending January 31, 2025, when financial covenant testing resumes, the Company believes that it will not be able to comply with one or more of these covenants. As a result, such debt was presented as “current” on the Company’s condensed consolidated balance sheet as of October 31, 2024.

Strengthening the balance sheet is a top priority for the Company. This includes lowering investments in working capital, reducing debt levels and cash interest costs and regaining compliance with financial covenants. The Comtech Board is confident that Mr. Traub possesses the requisite skill set, track record and experience to oversee these initiatives.

As announced in a separate press release today, the Company’s Board is conducting a comprehensive review of strategic alternatives. This process will include evaluating capital-raising and de-levering opportunities.

Outlook

Comtech is not providing guidance.

Conference Call and Webcast Information

Comtech will host a conference call with investors and analysts today at 8:30 am Eastern Time. Mr. Traub will lead the call, joined by Michael Bondi, Chief Financial Officer; Daniel Gizinski, President of the Satellite and Space Communications segment; and Jeff Robertson, President of the Terrestrial & Wireless Networks segment. A live webcast of the conference call will be accessible on the Investor Relations section of Comtech’s website at www.comtech.com/investors. Alternatively, investors can access the conference call by dialing (800) 579-2543 (domestic), or (785) 424-1789 (international) and using the conference I.D. “Comtech.” A replay will be available for seven days by dialing (800) 839-9557 (domestic), or (402) 220-6089 (international).

About Comtech

Comtech Telecommunications Corp. is a leading provider of satellite and space communications technologies; terrestrial and wireless network solutions; Next Generation 911 (“NG911”) and emergency services; and cloud native capabilities to commercial and government customers around the world. Through its culture of innovation and employee empowerment, Comtech leverages its global presence and decades of technology leadership and experience to create some of the world’s most innovative solutions for mission-critical communications. For more information, please visit www.comtech.com.

Cautionary Note Regarding Forward-Looking Statements

Certain information in this press release contains, and oral statements made by the Company’s representatives from time to time may contain, forward-looking statements. Forward-looking statements can be identified by words such as: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “future,” “goal,” “outlook,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “strategy,” “target,” “will,” “would,” and similar references to future periods. Forward-looking statements include, among others, statements regarding its expectations for its strategic alternatives process, expectations for further portfolio-shaping opportunities, expectations for other operational initiatives, the intended use of proceeds from the Credit Facility and Subordinated Credit Facility, expectations for completing further financing initiatives, future performance and financial condition, plans to address its ability to continue as a going concern, the plans and objectives of management and assumptions regarding such future performance, financial condition, and plans and objectives that involve certain significant known and unknown risks and uncertainties and other factors not under its control which may cause actual results, future performance and financial condition, and achievement of plans and objectives of management to be materially different from the results, performance or other expectations implied by these forward-looking statements. Factors that could cause actual results to differ materially from current expectations include, among other things: the outcome and effectiveness of the aforementioned strategic alternatives process, further portfolio-shaping opportunities, other operational initiatives, and the completion of further financing activities; its ability to access capital and liquidity so that the Company is able to continue as a going concern; its ability to implement changes in executive leadership; the possibility that the expected synergies and benefits from strategic activities will not be fully realized, or will not be realized within the anticipated time periods; the risk that acquired businesses will not be integrated successfully; impacts from, and uncertainties regarding, future actions that may be taken by activist stockholders; the possibility of disruption from acquisitions or dispositions, making it more difficult to maintain business and operational relationships or retain key personnel; the risk that the Company will be unsuccessful in implementing a tactical shift in its Satellite and Space Communications segment away from bidding on large commodity service contracts and toward pursuing contracts for niche products and solutions with higher margins; the nature and timing of receipt of, and performance on, new or existing orders that can cause significant fluctuations in net sales and operating results; the timing and funding of government contracts; adjustments to gross profits on long-term contracts; risks associated with international sales; rapid technological change; evolving industry standards; new product announcements and enhancements; changing customer demands and/or procurement strategies and ability to scale opportunities and deliver solutions to current and prospective customers; changes in prevailing economic and political conditions, including as a result of Russia’s military incursion into Ukraine, the Israel-Hamas war and attacks in the Red Sea region; changes in the price of oil in global markets; changes in prevailing interest rates and foreign currency exchange rates; risks associated with legal proceedings, customer claims for indemnification, and other similar matters; risks associated with obligations under its credit facilities; risks associated with large contracts; risks associated with supply chain disruptions; and other factors described in this and other Company filings with the Securities and Exchange Commission.

Appendix:

  • Condensed Consolidated Statements of Operations (Unaudited)
  • Condensed Consolidated Balance Sheets (Unaudited)
  • Use of Non-GAAP Financial Measures

Release – Comtech Announces CEO Transition and Comprehensive Transformation Initiatives

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on CMTL

Appoints Kenneth H. Traub as President and Chief Executive Officer, Effective Immediately

Commences Comprehensive Transformation to Immediately Strengthen Company

CHANDLER, Ariz. – Jan. 13, 2025– Comtech Telecommunications Corp. (NASDAQ: CMTL) (“Comtech” or the “Company”), a global communications technology leader, today announced that its Board of Directors (the “Board”) has named Ken Traub as President and Chief Executive Officer, replacing John Ratigan effective immediately. Mr. Traub joined the Comtech Board on October 31, 2024 and became Executive Chairman on November 27, 2024.

Mr. Traub is leading a comprehensive transformation of Comtech. Some highlights of this transformation include:

  • Operational Discipline and Rightsizing. Comtech is taking decisive action to improve processes, streamline product lines, optimize staffing and sharpen its organizational focus. These actions are expected to result in significant cost savings and working capital efficiencies, particularly in the Company’s Satellite & Space Communications (“S&S”) segment, and position Comtech to generate sustainable positive cash flow.
  • Support and Grow Successful Business Units. The Company’s Terrestrial & Wireless Networks (“T&W”) segment is poised for continued strong growth, driven by the need for nontraditional methods to request emergency help from new devices and the segment’s new initiatives in public safety technologies. The growth of the Company’s carrier businesswill be supported by its latest cloud-agnostic 5G passive and emergency location, messaging and alerting services. In the S&S segment, Comtech is strong in designing, manufacturing and supporting sophisticated communications equipment for both defense and commercial users that rely on the Company to provide mission-critical communications infrastructure. Comtech will prudently invest in and support these successful businesses and capitalize on opportunities to build and monetize these valuable assets.
  • Strategic Alternatives Process. TheComtech Board, under Mr. Traub’s leadership, will conduct a comprehensive review of strategic alternatives and explore a range of potential transactions to enhance Comtech’s strategic focus and strengthen the Company’s balance sheet. This process is a broadening of the previously announced review of strategic alternatives for the T&W segment and will include various alternatives for the S&S segment.
  • Strengthening the Capital Structure. Comtech had available liquidity of approximately $30 million of cash and equivalents as of both October 31, 2024 and January 10, 2025. The Company is positioned to generate positive cash flow over the coming months through implementation of the initiatives described above and will consider opportunities to strengthen its capital structure.

Mr. Traub commented, “While Comtech’s recent historical performance has been unsatisfactory, the Company has great assets, including its people, technologies, reputation, customers and relationships. Since I joined the Company as Executive Chairman about six weeks ago, I have learned a lot, which gives me confidence that we can overcome the challenges and create new opportunities to strengthen the business and drive value. We are implementing a comprehensive set of initiatives to better position Comtech for the future including improving operational discipline, streamlining operations, supporting profitable growth initiatives, undertaking a broad review of strategic alternatives and strengthening the capital structure. I am honored to expand my role as President and CEO today, and look forward to leading the Company into a stronger and brighter future.”

“The Board is fully supportive of Ken’s leadership and committed to his strategy that will deliver immediate and necessary improvements for Comtech,” said former Army Chief Information Officer, Lieutenant General (Retired) Bruce T. Crawford, Lead Independent Director of the Comtech Board.

There can be no assurance that the exploration of strategic alternatives will result in a transaction or other strategic changes or outcomes. There is no timeframe for the conclusion of the process, and the Company does not intend to comment further regarding this matter unless and until further disclosure is determined to be appropriate or necessary.

First Quarter Fiscal 2025 Financial Results: Conference Call and Webcast Information

In a separate press release issued today, Comtech announced its financial results for the first quarter of fiscal 2025. That press release can be found on the Investor Relations section of the Company’s website at www.comtech.com/investors.

Comtech will host a conference call with investors and analysts today at 8:30 am Eastern Time. Mr. Traub will lead the call, joined by Michael Bondi, Chief Financial Officer; Daniel Gizinski, President of the Satellite and Space Communications segment; and Jeff Robertson, President of the Terrestrial & Wireless Networks segment. A live webcast of the conference call will also be accessible at www.comtech.com/investors. Alternatively, investors can access the conference call by dialing (800) 579-2543 (domestic), or (785) 424-1789 (international) and using the conference I.D. “Comtech.” A replay will be available for seven days by dialing (800) 839-9557 (domestic), or (402) 220-6089 (international).

About Kenneth H. Traub

Mr. Traub has served as a director on Comtech’s Board since October 2024 and was named as Executive Chairman in November 2024. He is a visionary and transformational corporate leader with a successful track record of building sustainable shareholder value. Mr. Traub has over 30 years of experience as a Chairman, CEO, director and active investor with a demonstrated record of accomplishment in driving strategic, financial, operational and governance improvements. Mr. Traub is adept at managing business challenges, executing turnarounds, optimizing capital allocation, driving operational improvements, implementing M&A and other strategic initiatives and capitalizing on strategic growth opportunities. Mr. Traub received a BA from Emory College in 1983 and an MBA from Harvard Business School in 1988.

About Comtech

Comtech Telecommunications Corp. is a leading provider of satellite and space communications technologies; terrestrial and wireless network solutions; Next Generation 911 (NG911) and emergency services; and cloud native capabilities to commercial and government customers around the world. Through its culture of innovation and employee empowerment, Comtech leverages its global presence and decades of technology leadership and experience to create some of the world’s most innovative solutions for mission-critical communications. For more information, please visit www.comtech.com.

Cautionary Note Regarding Forward-Looking Statements

Certain information in this press release contains, and oral statements made by our representative from time to time may contain, forward-looking statements. Forward-looking statements can be identified by words such as: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “future,” “goal,” “outlook,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “strategy,” “target,” “will,” “would,” and similar references to future periods. Forward-looking statements include, among others, statements regarding our expectations for our strategic alternatives process, our expectations for further portfolio-shaping opportunities, our expectations for other operational initiatives, future performance and financial condition, the plans and objectives of our management and our assumptions regarding such future performance, financial condition, and plans and objectives that involve certain significant known and unknown risks and uncertainties and other factors not under our control which may cause our actual results, future performance and financial condition to be materially different from the results, performance or other expectations implied by these forward-looking statements. Factors that could cause actual results to differ materially from current expectations are described in our filings with the Securities and Exchange Commission. We urge you to consider all of the risks, uncertainties and factors identified above or discussed in such reports carefully in evaluating the forward-looking statements. The risks described above are not the only risks that we face. We do not intend to update or revise publicly any forward-looking statements, whether because of new information, future events, or otherwise, except as required by law.

Investor Relations Contact

Maria Ceriello

631-962-7102

investors@comtech.com

Media Contact

Jamie Clegg

480-532-2523

jamie.clegg@comtech.com

Biotech Merger: Salarius and Decoy Unite to Advance AI-Driven Peptide Therapeutics

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Combined company to focus on ML/AI-powered drug development platform
– Decoy shareholders to own 86% of merged entity
– Pipeline includes treatments for respiratory viruses and GI cancers

In a strategic move to accelerate the development of next-generation therapeutics, Salarius Pharmaceuticals (NASDAQ: SLRX) announced today its merger with privately-held Decoy Therapeutics in an all-stock transaction. The combined company, which will operate under the Decoy Therapeutics name, aims to leverage artificial intelligence and machine learning to revolutionize peptide conjugate drug development.

The merger brings together Decoy’s proprietary IMP3ACT™ platform, which has already attracted approximately $7 million in non-dilutive funding from prestigious organizations including The Bill & Melinda Gates Foundation, with Salarius’ clinical-stage pipeline and public market presence. Under the terms of the agreement, Decoy shareholders will own approximately 86% of the combined company, with Salarius stockholders retaining the remaining 14%.

“Peptide conjugates have become one of the most important drug classes as measured by prescription rates and revenue growth,” said Rick Pierce, Decoy’s Co-founder and CEO, who will lead the combined company. “Our highly experienced team is excited to be able to unlock significant shareholder value from our IMP3ACT platform, which can rapidly design new peptide conjugate drugs by applying ML and AI tools.”

The merged entity’s immediate focus includes advancing a pan-coronavirus antiviral toward an FDA Investigational New Drug (IND) application within the next 12 months. Additionally, the company plans to develop a broad-acting antiviral targeting flu, COVID-19, and respiratory syncytial virus (RSV), as well as a peptide drug conjugate for gastrointestinal cancers.

David Arthur, Salarius’ CEO, emphasized the strategic rationale: “The compelling science supporting Decoy’s peptide conjugate technology and the company’s management team are truly impressive. Based on our diligence, we believe Decoy is poised to advance multiple drug candidates that address significant unmet needs in numerous therapeutic areas.”

The combined company will maintain Salarius’ ongoing Phase 1/2 clinical trial at MD Anderson Cancer Center while exploring strategic alternatives for its seclidemstat program. The merger has received unanimous approval from both companies’ boards of directors and is expected to close following customary closing conditions.

Release – GeoVax Achieves Significant Progress in Next-Generation COVID-19 Vaccine Development Throughout 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 Advancements Position GEO-CM04S1 as a Leading Vaccine Candidate Addressing Unmet Medical Needs, Especially Among Immunocompromised Patients

ATLANTA, GA, January 13, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company specializing in immunotherapies and vaccines against infectious diseases and cancers, is pleased to announce substantial progress in the clinical development of its COVID-19 vaccine portfolio during 2024. These achievements underscore the potential of GEO-CM04S1 to address critical public health needs, particularly among immunocompromised populations.

Project NextGen (PNG) Award

In June 2024, GeoVax received a significant award through the Rapid Response Partnership Vehicle (RRPV), funded by the Biomedical Advanced Research and Development Authority (BARDA) as part of PNG. This award supports a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 compared to an approved COVID-19 vaccine. The study is set to commence in the second half of 2025, with Allucent, a global clinical research organization, selected to conduct and manage the trial.

Chronic Lymphocytic Leukemia (CLL) Interim Study Results

In November 2024, the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical trial of GEO-CM04S1 as a booster vaccine for patients with CLL conducted an interim data review of the study. Following its review, the DSMB recommended that the study should continue enrollment of the experimental arm utilizing GEO-CM04S1, but that the mRNA control arm of the study should be halted as it failed to meet the predetermined primary immune endpoint. This suggests a potentially superior immune response in this vulnerable population. Further enrollment of the remaining patient participants is expected to be completed during 2025.

Completion of Enrollment in Booster Vaccine Study for Healthy Adult Volunteers

GeoVax has successfully completed enrollment in its Phase 2 clinical trial evaluating GEO-CM04S1 as a booster vaccine in healthy adults who previously received COVID-19 vaccines. This study aims to assess the vaccine’s safety and immunogenicity at two different dose levels, with data readouts anticipated in the first half of 2025.

Ongoing Stem Cell Transplant Study

The Company continues to advance its Phase 2 clinical trial of GEO-CM04S1 as a primary vaccine for immunocompromised patients undergoing stem cell transplantation. This study addresses a critical need for effective vaccination strategies in populations that may not respond adequately to existing vaccines.

Potential Benefits of GEO-CM04S1 Over Existing Authorized COVID-19 Vaccines

GEO-CM04S1 offers several potential benefits compared to currently authorized COVID-19 vaccines:

  • Public Health Impact: By providing robust protection for immunocompromised individuals, GEO-CM04S1 could significantly reduce COVID-19-related risks of morbidity and mortality among such high-risk patient populations.
  • Durability: Preliminary data suggest that GEO-CM04S1 may offer longer-lasting immunity, potentially reducing the frequency of booster doses required.
  • Breadth of Protection: The inclusion of both Spike (S) and Nucleocapsid (N) antigens in GEO-CM04S1 may confer broader immunity, making it more effective against a range of variants without the need for frequent reformulation.
  • Primary Vaccine for Immunocompromised Patients: With approximately 40 million immunocompromised individuals in the U.S. and an estimated 400+ million worldwide, many of whom may not respond adequately to current vaccines, GEO-CM04S1 has the potential to become the preferred vaccine for this population.
  • Safety. The safety profile of MVA as the platform for GEO-CM04S1 is well-established, with decades of data supporting its use as a smallpox vaccine, as well as its use as a platform with diverse vaccine candidates. This robust safety record is particularly important as the new HHS administration prioritizes transparency and rigorous oversight in vaccine safety evaluation. GEO-CM04S1 aligns with these priorities, offering a scientifically validated platform backed by comprehensive safety data.

Market Potential and Partnering Opportunities

GEO-CM04S1 offers an alternative approach to boosting existing COVID-19 vaccines, providing enhanced and more durable immunity. Its applicability for immunocompromised patients further broadens its public health and commercial value. GeoVax estimates the annual market potential for GEO-CM04S1 to be approximately $30 billion, reflecting the critical medical need to better address high-risk immunocompromised patients. The global need for a next-generation COVID-19 vaccine with the advantages offered by GEO-CM04S1 creates multiple partnering opportunities for GeoVax.

Looking Ahead to 2025

The continued development of GEO-CM04S1 is a key component of GeoVax’s catalyst-rich agenda for 2025. The Company anticipates multiple data readouts and regulatory milestones that will further define the vaccine’s role in combating COVID-19.

“Our progress in 2024 has been remarkable, particularly in advancing GEO-CM04S1 as a next-generation COVID-19 vaccine,” said David Dodd, Chairman & CEO of GeoVax. “The MVA platform underlying our vaccine offers unique advantages, including the potential for broader and more durable protection, which is especially critical for immunocompromised individuals. We are committed to delivering solutions that address unmet medical needs and improve public health outcomes.”

Upcoming Presentations

GeoVax’s CEO, David Dodd, will present the Company’s 2024 progress and future outlook at the following conferences:

  • Biotech Showcase: January 14, 2025, at 10:30 AM PST
  • Emerging Growth Conference: January 16, 2025, at 2:35 PM ET

For more information on GeoVax’s portfolio and developments, please visit www.geovax.com

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned to initiate during the first half of 2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

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info@geovax.com austin.murtagh@precisionaq.com sr@roberts-communications.com 
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Release – Eledon Pharmaceuticals Highlights Recent Business Milestones and Provides 2025 Outlook

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

January 13, 2025

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Completed enrollment in Phase 2 BESTOW trial assessing tegoprubart in kidney transplantation four months ahead of schedule; on track to report topline results in fourth quarter of 2025

Presented updated data on 13 participants from ongoing Phase 1b trial that continue to support safety and tolerability of tegoprubart for prevention of organ rejection in kidney transplantation

Announced positive initial data from first three subjects with type 1 diabetes treated with tegoprubart as part of immunosuppression regimen following islet transplantation in investigator-initiated trial at UChicago Medicine

Completed two financings totaling $135 million in combined gross proceeds, with funds expected to support operations through end of 2026

IRVINE, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced a summary of 2024 accomplishments and provided guidance for anticipated 2025 business milestones.

“2024 was a transformative year for Eledon as we achieved multiple key clinical milestones for tegoprubart across kidney, islet cell, and xenograft transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Moreover, the data we reported reinforced the potential of tegoprubart to be a best-in-class immunosuppression therapy to prevent transplant rejection and disrupt the current standard of care. We now look forward to another pivotal year ahead.”

2024 Key Highlights

  • Completed enrollment of 120 patients in the Phase 2 BESTOW clinical trial approximately four months earlier than originally planned. The Phase 2 trial is designed to assess the safety and efficacy of tegoprubart for the prevention of organ rejection in patients undergoing kidney transplantation.
  • Presented updated data at the American Transplant Congress (ATC) from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Updated data from 13 participants demonstrated that tegoprubart was generally safe and well tolerated, with an overall mean estimated glomerular filtration rate (eGFR) of 70.5 mL/min/1.73m2 at all reported time points after day 30 post-transplant. Two participants completed more than 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m2 at one-year post-transplant.
  • Announced positive initial data for the first three islet transplant recipients treated with tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection in subjects with type 1 diabetes in an investigator-initiated trial at the University of Chicago Medicine’s Transplant Institute. The data demonstrated potentially the first human cases of insulin independence achieved using an anti-CD40L monoclonal antibody immunosuppression therapy without the use of tacrolimus, the current standard of care for prevention of transplant rejection.
  • Announced the use of tegoprubart as part of the immunosuppression treatment regimen used following the first-ever kidney xenotransplant procedure of a genetically modified pig kidney to a human.
  • Completed two financings for combined total gross proceeds of $135.0 million, before deducting any offering related expenses, which is anticipated to support company operations to the end of 2026.

Anticipated 2025 Milestones

  • Summer 2025: Report updated interim clinical data from the ongoing Phase 1b and long-term efficacy extension studies of tegoprubart in kidney transplantation.
  • 4Q 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
  • 2025: Report longer-term follow up results from the investigator-led clinical trial at UChicago Medicine Transplant Institute for pancreatic islet transplantation in subjects with type 1 diabetes involving use of tegoprubart as part of immunosuppression regimen.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com

Source: Eledon Pharmaceuticals

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Source: Eledon Pharmaceuticals, Inc.