Kelly (Nasdaq: KELYA, KELYB) connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We’re always thinking about what’s next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 350,000 people around the world and connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice. Revenue in 2021 was $4.9 billion. Visit kellyservices.com and let us help with what’s next for you.
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.
Completed. Kelly Services has completed the acquisition of Motion Recruitment Partners, LLC (“MRP”), from Littlejohn & Co., LLC, a private investment firm. As we highlighted in past reports, this is a transformational acquisition for Kelly, the largest in its history. We believe MRP will be a key driver in Kelly posting a higher revenue growth rate as well as continued expansion of Kelly’s adjusted EBITDA margin.
MRP Refresher. MRP is the parent company to a group of leading global talent solution providers. The acquisition of MRP strengthens the scale and capabilities of Kelly’s staffing and consulting solutions across technology, telecommunications, and government specialties in North America, and recruitment process outsourcing solutions globally.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
The New York Stock Exchange experienced a technical glitch this morning that triggered trading halts in dozens of stocks, including big names like Chipotle, Berkshire Hathaway, and the meme stock GameStop. The issue stemmed from problems with the price bands published by the Consolidated Tape Association, which are used to prevent excess volatility by pausing trading if prices move too far too quickly.
While the specific cause is still being investigated, the timing raised concerns given the recent move by U.S. stock exchanges to a one-day settlement cycle last week. This SEC-mandated change requires trades to be settled one day after execution instead of two, compressing timeframes for transferring securities.
Regulators and market participants have been on high alert for potential snags as systems adapt to the new settlement cycle. Today’s incident underscores the critical importance of robust trading infrastructure and risk controls as market practices evolve.
Halting Mechanism Kicks In At around 11am ET, the NYSE listed over 60 stocks as temporarily halted due to hitting their “limit up, limit down” (LULD) bands, which are circuit breaker levels to prevent extreme price swings. While some of those may have been unrelated cases of normal volatility, many were likely impacted by the pricing data issue.
Trading resumed around 11:45am after the exchange confirmed the pricing data problems had been resolved. While temporary, such disruptions can impact market quality, trading execution and risk management for investors and firms.
Need for Resilient Systems As financial markets continually evolve, today’s problems highlight the crucial need for exchanges, trading platforms, and market participants to have ultra-resilient, glitch-proof systems able to adapt flawlessly to changes. Even brief failures can undermine market confidence and integrity.
While technological errors are inevitable at times, regulators and investors alike will be scrutinizing today’s NYSE issue and responses carefully. Having rock-solid trading infrastructure and controls in place to prevent and handle disruptions seamlessly is essential for maintaining fair, orderly and efficient markets.
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Proven Finance Executives Amy Schioldager and Evan Levitt to Join the Board
Wendy Schoppert Appointed Board Chair
BOCA RATON, Fla.–(BUSINESS WIRE)–Jun. 3, 2024– The ODP Corporation (“ODP” or the “Company”) (NASDAQ:ODP), a leading provider of business services, products and digital workplace technology solutions to businesses and consumers, today announced the appointment of financial executives Amy Schioldager and Evan Levitt to its Board of Directors.
The Company also announced that Wendy Schoppert, ODP Board member since 2020, will assume the role of independent Board Chair as Joseph Vassalluzzo steps down from the Board after 11 years of service.
These changes will be effective on June 10, 2024. ODP’s Board size will be increased from seven members to eight, with directors having an average tenure of approximately five years.
“We are thrilled to welcome Amy and Evan to the ODP Board at this juncture, as we continue to evolve our business and position our Company to drive future profitable growth,” said Wendy Schoppert, Chair-Elect of the Board. “They bring valuable perspectives to further enhance the diverse skills of our Board, advance our value creation initiatives, and champion the continued growth of our strong 5C Culture.”
“Both Amy and Evan are proven financial executives with decades of leadership experience at Fortune 500 companies,” Schoppert continued. “With 25 years of experience at BlackRock, Amy brings technical and strategic expertise, having led investment teams across markets and segments, and has deep shareholder and public company governance experience. Evan has extensive financial and audit expertise across industries, as well as a strong understanding of distribution and consumer businesses. We look forward to leveraging their unique backgrounds as we continue to focus on driving long-term profitable growth and shareholder value.
“We would also like to thank Joe for his Board service, including as independent Chairman for the past seven years. His leadership and insight have been instrumental through ODP’s evolution. We wish him all the best in the future,” Schoppert concluded.
About Amy Schioldager
Amy has over 25 years of experience in various leadership positions at BlackRock, Inc., where she led investment teams across global equity markets and client segments. Most recently, Amy served as Senior Managing Director and Global Head of Beta Strategies. In this role, she oversaw $2.5 trillion in assets under management across seven global offices. She also served on BlackRock’s Global Executive Committee, which oversaw $11 billion in profit and loss and 13,000 employees across 30 countries. In addition to her investment and business leadership experience, Amy has strong board experience: she currently serves on the public company boards of Intermediate Capital Group plc and Corebridge Financial Inc, as well as the private organization boards of Boardspan Inc and California State University – East Bay. She previously served on the board of American International Group Inc.
About Evan Levitt
Evan brings over 30 years of experience in finance and accounting and has served in numerous leadership positions across industries. Most recently, Evan was Interim Executive Vice President and Chief Financial Officer at BrandSafway, a leading construction company providing solutions to the industrial, commercial and infrastructure markets. Prior to that, he held various leadership roles at The Home Depot, Inc. / HD Supply Holdings over the course of 17 years, during which time he played a pivotal role in negotiating the sale of HD Supply to The Home Depot, Inc. His most recent role at the company was as Senior Vice President, Chief Financial Officer, Chief Administrative Officer of HD Supply Holdings Inc. He currently serves on the private company boards of Artera Services, where he is a member of the Audit Committee, and WASH, where he serves as the Chairman of the Audit and Risk Committee.
About The ODP Corporation
The ODP Corporation (NASDAQ:ODP) is a leading provider of products, services, and technology solutions through an integrated business-to-business (B2B) distribution platform and omni-channel presence, which includes supply chain and distribution operations, dedicated sales professionals, a B2B digital procurement solution, online presence, and a network of Office Depot and OfficeMax retail stores. Through its operating companies ODP Business Solutions, LLC; Office Depot, LLC; Veyer, LLC; and Varis, Inc, The ODP Corporation empowers every business, professional, and consumer to achieve more every day. For more information, visit theodpcorp.com.
Transformational acquisition expected to accelerate EBITDA margin expansion
MRP to continue delivering services through existing operating companies and brands
Kelly management to host live webcast on June 18 to provide more details about the rationale for the acquisition and insights into MRP’s financial profile
TROY, Mich., June 03, 2024 (GLOBE NEWSWIRE) — Kelly (Nasdaq: KELYA, KELYB) (“the Company”), a leading global specialty talent solutions provider, today announced it has completed the acquisition of Motion Recruitment Partners, LLC (“MRP”), from Littlejohn & Co., LLC (“Littlejohn”), a private investment firm based in Greenwich, Connecticut. Kelly previously announced on May 3, 2024, that it had entered into a definitive agreement to acquire MRP from Littlejohn.
The acquisition of MRP strengthens the scale and capabilities of Kelly’s staffing and consulting solutions across technology, telecommunications, and government specialties in North America, and recruitment process outsourcing (RPO) solutions globally. With a margin profile commensurate with a highly specialized technology talent solutions provider, MRP fits exceptionally well with Kelly’s strategy to enhance the revenue growth potential of the company and drive continued EBITDA margin expansion.
“Today marks a transformational step forward on our journey to sharpen Kelly’s focus on higher-margin, higher-growth specialty outcome-based and staffing services in North America, and global RPO and MSP solutions,” said Peter Quigley, president and chief executive officer, Kelly. “I’m excited to welcome MRP to the Kelly team and look forward to the significant growth and value creation we will deliver together.”
“MRP’s capabilities are excellent complements to Kelly SET as we continue our journey to become a leading technology staffing and consulting solutions provider in North America,” said Hugo Malan, president, Kelly SET. “They bring extensive expertise in enterprise technology staffing, as well as robust telecommunications and government specialties that align exceptionally well with our strong offerings in these segments.”
“Sevenstep’s RPO and MSP offerings align exceptionally well with KellyOCG and we believe the combined entities create a powerful story to bring to the market,” said Tammy Browning, president, KellyOCG. “We look forward to authoring this story together with the Sevenstep team and unlocking new opportunities for growth over the long term.”
Kelly acquired MRP for a purchase price of $425 million. Additional cash consideration of up to $60 million may be due in the second quarter of 2025 if certain conditions are satisfied during an earn-out period ending on March 31, 2025. The earn-out payment is based on a multiple of gross profit in excess of an agreed-upon amount during the earn-out period. The Company funded the transaction through debt and available capital, including the rapid redeployment of more than $100 million from the sale of Kelly’s European staffing operations in January 2024.
Kelly will host a live webcast of a conference call with financial analysts on June 18, 2024, at 9 a.m. ET to provide more details about the acquisition of MRP. Quigley and Olivier Thirot, executive vice president and chief financial officer, will present the rationale for the acquisition and insights into MRP’s financial profile, including recent revenue, gross margin, and net margin trends. Following the presentation, Quigley and Thirot will address questions from financial analysts. The live webcast will be accessible on the Investor Relations section of Kelly’s public website. A recording of the webcast will be available after 1:30 p.m. ET on June 18, 2024.
About Kelly®
Kelly Services, Inc. (Nasdaq: KELYA, KELYB) helps companies recruit and manage skilled workers and helps job seekers find great work. Since inventing the staffing industry in 1946, we have become experts in the many industries and local and global markets we serve. With a network of suppliers and partners around the world, we connect more than 500,000 people with work every year. Our suite of outsourcing and consulting services ensures companies have the people they need, when and where they are needed most. Headquartered in Troy, Michigan, we empower businesses and individuals to access limitless opportunities in industries such as science, engineering, technology, education, manufacturing, retail, finance, and energy. Revenue in 2023 was $4.8 billion. Learn more at kellyservices.com.
About Motion Recruitment Partners, LLC
Established in 1989 and headquartered in Boston, Massachusetts, Motion Recruitment Partners, LLC, is parent company to a group of leading global talent solution providers to include Motion Recruitment (IT Staffing & Managed Solutions), Motion Consulting Group (IT Consulting), Motion Telco (IT & Telecom Solutions), Tech in Motion (Tech Networking & Events program), TG Federal (Government IT Subcontracting), and Sevenstep® (RPO, MSP & TA Advisory/Consulting). Learn more at www.motionrecruitment.com, www.sevensteptalent.com, and www.tgfederal.com.
About Littlejohn & Co., LLC
Littlejohn & Co., LLC, is a Greenwich, Connecticut-based investment firm focused on private equity and debt investments primarily in growing middle-market industrial and services companies that can benefit from Littlejohn’s 25+ years of operational and sector expertise. With approximately $8 billion in regulatory assets under management, the firm seeks to build sustainable success for its portfolio companies through a disciplined approach to engineering change. For more information about Littlejohn, visit www.littlejohnllc.com.
Forward-Looking Statements
This release contains statements that are forward looking in nature and, accordingly, are subject to risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about Kelly’s financial expectations, are forward-looking statements. Factors that could cause actual results to differ materially from those contained in this release include, but are not limited to, (i) changing market and economic conditions, (ii) disruption in the labor market and weakened demand for human capital resulting from technological advances, loss of large corporate customers and government contractor requirements, (iii) the impact of laws and regulations (including federal, state and international tax laws), (iv) unexpected changes in claim trends on workers’ compensation, unemployment, disability and medical benefit plans, (v) litigation and other legal liabilities (including tax liabilities) in excess of our estimates, (vi) our ability to achieve our business’s anticipated growth strategies, (vi) our future business development, results of operations and financial condition, (vii) damage to our brands, (viii) dependency on third parties for the execution of critical functions, (ix) conducting business in foreign countries, including foreign currency fluctuations, (x) availability of temporary workers with appropriate skills required by customers, (xi) cyberattacks or other breaches of network or information technology security, and (xii) other risks, uncertainties and factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. In some cases, forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. All information provided in this press release is as of the date of this press release and we undertake no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company’s expectations.
BATAVIA, N.Y.–(BUSINESS WIRE)– Graham Corporation (NYSE: GHM) (“GHM” or “the Company”), a global leader in the design and manufacture of mission critical fluid, power, heat transfer, and vacuum technologies for the defense, space, energy, and process industries, today announced that it has received approximately $17 million of orders for two expansion projects in the energy and petrochemical markets.
Daniel J. Thoren, President and CEO, commented, “We are excited to work with our North American customer as they aim to create the world’s first net-zero carbon emissions integrated ethylene cracker and derivatives site. Graham’s surface condensers with custom venting package allow the turbine drives to operate at peak efficiency and are considered state of the art in our industry. Additionally, we received a notable order to support an expansion project in the Middle East, which we attribute to our strong relationship and our customer’s preference for our high-performance steam jet ejectors.”
The North American order includes three surface condenser systems for critical service in both a main process unit and utility unit. This project aims to advance the eco-friendliness of natural gas refining, with the collective goal to minimize carbon emissions throughout the production process. The order was received in April 2024 and approximately 50% of the revenue is expected to be recognized in fiscal 2025 with the remainder expected in fiscal 2026.
For the Middle East expansion project, the Company was awarded a contract to supply a new vacuum system for a crude to chemical vacuum distillation tower. This project aims to bolster the production of Group II and Group III Base Oils. This order was received in March 2024, with revenue expected to be recognized in fiscal 2025.
About Graham Corporation
GHM is a global leader in the design and manufacture of mission critical fluid, power, heat transfer and vacuum technologies for the defense, space, energy and process industries. The Graham Manufacturing and Barber-Nichols’ global brands are built upon world-renowned engineering expertise in vacuum and heat transfer, cryogenic pumps and turbomachinery technologies, as well as its responsive and flexible service and the unsurpassed quality customers have come to expect from the Company’s products and systems.
Graham Corporation routinely posts news and other important information on its website, www.grahamcorp.com, where additional information on Graham Corporation and its businesses can be found.
Safe Harbor Regarding Forward Looking Statements
This news 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. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “aims,” “expects,” “anticipates,” “potential,” and other similar words. All statements addressing operating performance, events, or developments that Graham Corporation expects or anticipates will occur in the future, including but not limited to, winning potential future or multi-year orders, potential revenues and timing of such revenues, capacity, demand growth, and delivering timely or otherwise on schedule are forward-looking statements. Because they are forward-looking, they should be evaluated in light of important risk factors and uncertainties. These risk factors and uncertainties are more fully described in Graham Corporation’s most recent Annual Report filed with the Securities and Exchange Commission, including under the heading entitled “Risk Factors,” its quarterly reports on Form 10-Q, and other filings it makes with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize or should any of Graham Corporation’s underlying assumptions prove incorrect, actual results may vary materially from those currently anticipated. In addition, undue reliance should not be placed on Graham Corporation’s forward-looking statements. Except as required by law, Graham Corporation disclaims any obligation to update or publicly announce any revisions to any of the forward-looking statements contained in this news release.
MCLEAN, Va., June 3, 2024 /PRNewswire/ — V2X, Inc. (NYSE: VVX) announces it has successfully repriced and extended its $907 million First Lien Term Loan.
Under the repricing, the annual interest margin was reduced by 50 basis points to 2.75%. Additionally, the 10-basis point Credit Spread Adjustment was eliminated from the company’s Secured Overnight Financing Rate, further improving the anticipated savings from the repricing. The company also extended the maturity of the loan by two years to December 2030.
“I’m pleased to report the successful repricing of our first lien term loan, which is another positive step in our efforts to increase shareholder value and enhance the company’s capital structure,” said Shawn Mural, Senior Vice President and Chief Financial Officer at V2X. “The repricing is expected to yield notable interest expense savings and lower the overall cost of capital, while extending those benefits for another two years. This outcome is a testament to the strength in our business, supported by V2X’s robust backlog, strong cash flow generation capabilities, and progress deleveraging the balance sheet.”
About V2X
V2X builds smart solutions designed to integrate physical and digital infrastructure – by aligning people, actions, and outputs. Our lifecycle solutions improve security, streamline logistics, and enhance readiness.
The Company delivers a comprehensive suite of integrated solutions across the operations and logistics, aerospace, training, 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.
Safe Harbor Statement Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995 (the “Act”): Certain material presented herein includes forward-looking statements intended to qualify for the safe harbor from liability established by the Act. These forward-looking statements include, but are not limited to, all the statements in this release that are not historical, including, without limitation, interest expense savings, cost of capital, strength in our business, long-term contracts, cash flow generation capabilities, backlog, and progress deleveraging the balance sheet.
Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may,” “will,” “expect,” “intent,” “estimate,” “anticipate,” “believe,” “could,” “potential,” “continue,” “can,” “goal,” “long-term,” “drive,” “next,” and variations of such words and or similar expressions and terminology. These statements are based on the beliefs and assumptions of the management of the Company based on information currently available to management.
These forward-looking statements are not guarantees of future performance, conditions, or results, and involve a number of known and unknown risks, uncertainties, assumptions, and other important factors, many of which are outside our management’s control, which could cause actual results to differ materially from the results discussed in the forward-looking statements. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the Company’s historical experience and our present expectations or projections. For a discussion of some of the risks and uncertainties that could cause actual results to differ from such forward-looking statements, see the risks and other factors detailed from time to time in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings with the SEC.
We do not undertake, and expressly disclaim, any duty or obligation to update publicly any forward-looking statement after the date of this release, whether as a result of new information, future events or otherwise, except as required by law.
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
Tecarfarin, which recently received Orphan Drug Designation from the FDA for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, has the potential to improve the time in therapeutic range a factor correlated in the ARIES-HM3 trial with better patient outcomes
PONTE VEDRA, Fla., June 3, 2024 — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions, today highlighted a groundbreaking presentation at the International Society for Heart & Lung Transplantation (ISHLT) 44th Annual Meeting & Scientific Sessions.
These new findings from secondary analyses of the ARIES-HM3 trial were released in a presentation titled, “Impact of Vitamin K Antagonist (VKA) Therapy On Outcomes In a Randomized Controlled Trial of Aspirin Removal In Left Ventricular Assist Device (LVAD) Patients – A Pre-Specified Analysis From the Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure, or the ARIES-HM3, Randomized Clinical Trial.”
The ARIES-HM3 trial data demonstrated that lower time in therapeutic range, or TTR, translated directly to excessive bleeding events. The “average” patient in the ARIES-HM3 study had a 30% rate of serious bleeding events even after aspirin was eliminated as part of the antithrombotic regimen, and persistent bleeding was inversely correlated with TTR.
The ARIES-HM3 clinical study was sponsored by Abbott (NYSE: ABT), which evaluated a new clinical approach to patient management that included removal of aspirin as part of the antithrombotic regimen warfarin. The data is currently under review by the FDA. Labeling changes related to the antithrombotic regimen have not been approved by the FDA at this time.
Dr. Mandeep Mehra, who chaired the ARIES-HM3 study, holds the William Harvey Distinguished Chair in Advanced Cardiovascular Medicine and is Executive Director of the Center for Advanced Heart Disease at Brigham and Women’s Hospital, commented, “This comprehensive analysis identifies adequacy of VKA use (as measured by TTR) as a significant risk marker for bleeding events and provides new clinical direction for further mitigation of bleeding to enhance hemocompatibility with the HeartMate 3 LVAD.” Mehra continued, “Each incremental improvement of 10% above the median of 56% TTR trends in a significant further reduction in bleeding rate. Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic anti-coagulation since it does not get affected by drug-drug interactions or changes in kidney function like warfarin and deserves further study.”
“The ARIES-HM3 trial data underscores the deficiencies of warfarin and the need for a new VKA therapy for patients with LVADs. We believe our drug candidate, the next-generation VKA tecarfarin, with its unique retrometabolic design that provides for more stable anticoagulation than warfarin, is the much-needed replacement therapy. We intend to pursue a pivotal trial evaluating tecarfarin effectiveness for LVAD patients,” said Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “Cadrenal commends Abbott’s commitment to LVAD patients in sponsoring this important trial and analyses.”
On April 9, 2024, Cardenal Therapeutics announced that the United States Food and Drug Administration (FDA) had granted tecarfarin Orphan Drug Designation for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, which includes the left ventricular assist device (LVAD).
The current market-leading direct oral anticoagulants (DOACs), such as Eliquis, are not indicated for patients with LVADs due to a lack of evidence of benefit, while the level of anticoagulation achieved with warfarin was achieved in the target range only 56% of the time in the ARIES-HM3 trial. Patients whose level of anticoagulation was in the therapeutic range > 56% had better outcomes than those with lower levels. This highlights the potential role for investigating new VKA agents in improving clinical outcomes in LVAD patients.
VKA anticoagulation is prescribed for the prevention of LVAD-related clotting. However, the only available VKA is warfarin, which was approved for human use in 1954. Tecarfarin has been shown to improve TTR, particularly in patients taking multiple medications, and be more stable in patients with renal dysfunction which is common in LVAD patients.
ABOUT CADRENAL THERAPEUTICS, INC. Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions. Tecarfarin has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib) and just received orphan drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices (VADs). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with thrombotic antiphospholipid syndrome (APS). Tecarfarin is a next-generation Vitamin K Antagonist (VKA) specifically designed to use a different metabolism pathway than the oldest and most commonly prescribed VKA warfarin. Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.
Safe Harbor Statement Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding tecarfarin having the potential to improve the time in therapeutic range which analysis of the ARIES-HM3 trial reveals is associated with better patient outcomes. TTRs as predicting increased risk for bleeding events, the VKA tecarfarin, filling the market void for a next-generation VKA, the Company pursuing a pivotal trial evaluating tecarfarin effectiveness for LVAD patients. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve the time in therapeutic range, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
For more information, please contact:
Cadrenal Therapeutics: Matthew Szot, CFO 858-337-0766 press@cadrenal.com
Investors: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 CVKD@lythampartners.com
Tonmya treatment was associated with improvement in depressive symptoms as measured by the Beck Depression Inventory-II
In addition, post-hoc analyses showed improvement in depression, anxiety, memory and energy items on the Fibromyalgia Impact Questionnaire-Revised
New Drug Application (NDA) submission to the FDA on track for the second half of 2024
CHATHAM, N.J., June 03, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, presented new data from the Phase 3 RESILIENT trial of Tonmya (TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia in an oral presentation at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting on May 29, 2024 in Miami Beach, Fla. A copy of the presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
In the oral presentation titled, “Effects of Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl) on Mood and Anxiety Symptoms in Fibromyalgia: Results of the Phase 3 RESILIENT Trial,” Seth Lederman, MD, Chief Executive Officer, presented new data suggesting activity for improvement in depressive symptoms with Tonmya.
Depression was frequent among patients enrolled in the RESILIENT trial: ~47% reported experiencing depression within the past 6 months upon fibromyalgia diagnosis and ~25% of the intent-to-treat (ITT) population had experienced a lifetime major depressive episode (MDE). The effect of Tonmya on depressive symptoms was studied using the Beck Depression Inventory-II (BDI-II). Patients started with a baseline mean (standard deviation) for placebo of 10.0 (6.72) and Tonmya of 9.6 (6.32). The BDI-II score separated at Week 2 with a nominal p-value of <0.01. By Week 14, the total BDI-II score in the TNX-102 SL group improved over placebo with a nominal p-value of 0.005 and an effect size of 0.27.
Dr. Lederman said, “Although pain is the prototypic symptom in fibromyalgia and the validated FDA endpoint for the approval of a new drug, depression severity is also a prominent factor in the quality of life for fibromyalgia sufferers. In one study, depressive symptoms had a higher correlation with impaired quality of life than any other symptom, including pain frequency and intensity.2 The improvement in depression observed in the Phase 3 RESILIENT was particularly striking since the mean entry score of 10 reflects mild depression. Others have struggled to show benefits of traditional antidepressants in mild depression and consequently many antidepressants have been studied in moderate or severely depressed patients and the benefits of such drugs for patients with mild depression have been inferred.”
Dr. Lederman continued, “In addition to the BDI-II score, in post hoc analyses several individual items on the Fibromyalgia Impact Questionnaire-Revised (FIQR) also improved in the Tonmya-treated group, including : depression (p < 0.001), anxiety (p = 0.001), sensitivity (p = 0.020), memory problems (p = 0.001) and energy (p < 0.001), for which these p-values were not corrected for multiplicity. Together these findings indicate that Tonmya has broad-spectrum activity against fibromyalgia symptoms and may improve fibromyalgia at the syndromal level.”
In the RESILIENT trial, as previously reported, Tonmya improved overall daily pain (p=0.00005), the pre-specified primary endpoint, making it the second Phase 3 study of Tonmya in the management of fibromyalgia to reach statistical significance on the pre-specified primary endpoint. Tonmya also demonstrated statistically significant and clinically meaningful results in all six pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function.”
In the RESILIENT trial, there were no new safety signals, low rates of systemic adverse events, and a favorable tolerability profile.
Tonix remains on track to submit an NDA to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia and has scheduled a Type B pre-NDA meeting with FDA for the second quarter of 2024.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
2Offenbaecher M, et al. Pain is not the major determinant of quality of life in fibromyalgia. Rheumatology International 2021; 41:1995–2006
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Haynes International, Inc. is a leading developer, manufacturer and marketer of technologically advanced, nickel and cobalt-based high-performance alloys, primarily for use in the aerospace, industrial gas turbine and chemical processing industries.
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.
Merger receives regulatory scrutiny in the United Kingdom and in Austria. The Competition and Markets Authority in the United Kingdom (CMA) intends to conduct a formal investigation into Haynes’ proposed merger with North American Stainless, Inc., a wholly owned subsidiary of Acerinox S.A. This follows the Austrian Federal Competition Authority’s referral to the Austrian Cartel Court for a Phase II investigation of the transaction (See our research note dated May 3).
Closing expected in the fourth calendar quarter of 2024. Haynes’ management remains optimistic that the regulatory reviews will be positively resolved, and the required clearances will be obtained. Based on the expected timeline of the U.K. formal investigation and the Austrian Phase II investigation, Haynes now expects the merger will close in the fourth calendar quarter of 2024. While the timeline has been extended one calendar quarter, we remain confident that the new timeline will allow enough time for both examinations to run their course with outcomes that support a fourth calendar quarter closing.
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.
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.
Third and final tranche closed. Aurania closed the third and final tranche of its non-brokered private placement financing. With the third tranche, the company raised gross proceeds of C$724,400.00 with the sale of 3,622,000 units at a price of C$0.20 per unit. In total, the private placement raised gross proceeds of C$3,743,222.40 with the sale of 18,716,112 at a price of C$0.20 per unit. The proceeds will fund exploration and target refinement at the Kuri-Yawi target area in Ecuador, along with general working capital needs.
Exploration plan. Aurania’s 2024 exploration program will focus on the Kuri-Yawi epithermal gold target. In 2020 and 2021, nine scout holes were drilled, totaling 4,957 meters, to test soil geochemistry anomalies and one of the geophysical anomalies detected during a MobileMT survey in 2021. The results revealed intense and pervasive hydrothermal clay mineral alteration and silica-carbonate veinlets exhibiting epithermal textures which are features consistent with proximity to an epithermal system. While Aurania’s property package offers an abundance of promising targets, Kuri-Yawi may offer the quickest path for a successful outcome based on work that has already been completed.
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.
The original meme stock mania has been reawakened with a vengeance. GameStop (GME) shares skyrocketed over 70% amid frantic trading on Monday after retail trader Keith Gill, popularly known as “Roaring Kitty,” revealed a colossal new bullish position in the video game retailer.
In his first major post on Reddit in years, Gill shared a screenshot that appeared to show a staggering $175 million bet on GameStop. The purported stake consisted of 5 million shares valued at $116 million and $65.7 million worth of call options expiring in June.
The revelation instantly reignited the meme stock frenzy. Feverish trading volumes in GameStop stock spiked more than tenfold, briefly surpassing even the mighty Apple (AAPL) at one point. By mid-morning, GameStop’s heavily shorted shares had skyrocketed as high as 75% in an explosive upward move reminiscent of the legendary January 2021 short squeeze.
Fellow meme favorites like AMC Entertainment (AMC) caught a powerful sympathy rally bid as well, surging over 20% on massive volumes before getting temporarily halted. The meme stock comeback had arrived in full force.
Gill’s outsize position punched far above GameStop’s relatively small $7 billion market cap. Analysts noted the dramatic price impact stemmed from the stock’s concentrated short position, which got pulverized as the fortunes quickly shifted.
The sudden lurch higher put short sellers covering their losing bets on a pace to absorb nearly $1 billion in losses, according to analytics firm Ortex. GameStop once again became the most frenzied trading name across no-fee retail platforms like Robinhood (HOOD).
Longtime GameStop investors flooded Reddit forums like WallStreetBets and Superstonk with jubilant scenes. Rocket emojis and feverish rallying cries echoed the legendary meme stock heydays of 2021 as the “diamond hands” crowd smelled redemption.
However, some analysts cautioned that chasing GameStop’s vertigo-inducing rally carried substantial risks. The company continues grappling with operational challenges like slowing sales and a customer shift away from physical games toward digital downloads and streaming.
While May’s hype dissipated quickly without broad staying power, the same explosive ingredients powering 2021’s mania remain in place today – and have only intensified with Gill’s outsized position. GameStop’s short interest spiked to nosebleed levels, leaving bearish traders acutely vulnerable to getting blown out by a sustained rally.
Those dynamics set the stage for an epic rematch between the “diamond hands” unleashed and hedge funds caught flat-footed. Redemption beckons for the OG meme crowd still down on their initial GameStop bets. Meanwhile, a new generation of retail traders is getting initiated into the frenzy, enticed by visions of generational wealth on a lucky long-shot wager.
There are no guarantees the meme stock fever lasts. But the tantalizing combination of high short interest, heavy retail buy interest, and now the return of an idolized icon like Roaring Kitty has all the makings of another wild speculative blowoff. The opening act of 2021’s wildest stock story may ultimately prove just the warmup before a shocking meme stock encore too insane to script.
FLORHAM PARK, N.J. — Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, today announced that NelsonHall, a global analyst firm, has named the company a market leader in the 2024 NelsonHall Evaluation and Assessment Tool (NEAT) for Multi-Process HR Transformation Services for Large Enterprises. This year’s NelsonHall NEAT evaluates participants across a range of criteria and business situations in specific areas of capability, company focus, and geographic coverage.
“Conduent has proven capabilities and well-established HR operational expertise in the Large Enterprise market segment, where 80% of its business supports organizations with over 15,000 employees,” said Liz Rennie, HR Technology and Services Research Director at NelsonHall. “It delivers digital transformations with AI, automation, optimization, engagement, and accuracy, and brings ongoing operational refinements in areas such as employee experience and omni-channel digital solutions. Conduent’s partnership approach and delivery expertise are well-suited to supporting the transformation of complex and large organizations.”
For Large Enterprise Focus, this year’s NEAT report recognizes Conduent for:
The breadth of its Human Capital Solutions, including HR administration, global payroll data management services, benefits administration, and learning services;
Ability to drive global processes and support products such as HRO-in-a-Box, with more than 120 globally configurable and digitally enabled processes spanning the HR lifecycle (from recruitment to retirement);
Investment in front-end proprietary technology with a design approach that uses personas to drive personalization. Proprietary applications include Life@Work Connect, chat automation and real-time dashboards with program analytics and service levels;
Capability to serve clients on leading Cloud HCM platforms, including Oracle Cloud, SAP SuccessFactors, and Workday; and
CX approach to employee experience supported by an employee-centric delivery model.
“As NelsonHall noted, Conduent remains committed to providing our HR clients with solutions that are grounded in leading digital HR technology so that HR functions can perform better, while also increasing employee engagement and satisfaction,” said Jeff Weiner, Vice President and General Manager of Human Capital Solutions at Conduent. “NelsonHall’s recognition is a great affirmation that the work and investments we are putting into our offerings and delivering to our clients is positively impacting the employee’s experience and is a differentiator when HR teams need to select a partner.”
NelsonHall defines leaders as providers that exhibit a high capability relative to their peers to deliver both immediate benefit and future client requirements. In addition to Large Enterprise Focus, Conduent was also a “Leader” in Overall, Efficiency Focus, Europe Focus, Multi-Country Focus and North America Focus in this year’s NelsonHall NEAT Report. Earlier this year NelsonHall named Conduent a leader in HR Benefits Administration.
NelsonHall is the leading global analyst firm dedicated to helping organizations understand the ‘art of the possible’ in digital operations transformation. With analysts in the U.S., U.K., Continental Europe, and Asia, NelsonHall provides buy-side organizations with detailed, critical information on markets and vendors (including NEAT assessments) that helps them make fast and highly informed sourcing decisions. And for vendors, NelsonHall provides deep knowledge of market dynamics and user requirements to help them hone their go-to-market strategies. NelsonHall’s analysis is based on rigorous, all-original research, and is widely respected for the quality and depth of its insight.
About Conduent
Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The Company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 59,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $100 billion in government payments annually, enabling 2.3 billion customer service interactions annually, empowering millions of employees through HR services every year and processing nearly 13 million tolling transactions every day. Learn more at www.conduent.com.
Trademarks Conduent is a trademark of Conduent Incorporated in the United States and/or other countries. Other names may be trademarks of their respective owners.
Established Medium Dose as Safe and Tolerable Dose in Current OCU410 Clinical Trial
DSMB Recommends Continuing with High-Dose Cohort Dosing with Concurrent Phase 2 Dosing
MALVERN, Pa., May 31, 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 a positive outcome of the Data and Safety Monitoring Board (DSMB) Review for its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV5-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). GA affects approximately 2-3 million people in the U.S. and Europe combined.
Six subjects with GA were dosed in the Phase 1/2 clinical trial to date—three subjects were dosed with the low dose and three subjects were dosed with the medium dose. An additional three patients will be dosed with the high dose of OCU410 in the dose-escalation phase.
“The DSMB has recommended to proceed with dosing subsequent GA subjects with the high dose of OCU410 in the dose-expansion phase of the study and concurrently initiate Phase 2 dosing,” said Dr. Peter Chang, MD, FACS, DSMB Chair for the OCU410 clinical trial. “No serious adverse events (SAEs) related to OCU410 have been reported to date in both low- and medium-dose cohorts. I believe that this marks a critical next step towards determining the maximum tolerated dose for OCU410 and is an important milestone for its clinical development.”
“We are delighted to report a second positive DSMB recommendation for the treatment of GA, which significantly builds on the favorable safety and tolerability profile exhibited by OCU410,” said Huma Qamar, MD, MPH, CMI, Chief Medical Officer of Ocugen. “We are very enthusiastic about the potential of OCU410 as a potential one-time treatment for GA with a single sub-retinal injection. The currently approved treatments for GA target only the complement pathway and require approximately 6-12 intravitreal injections annually. OCU410 addresses multiple pathways causing dAMD, including complement, lipid metabolism, inflammation, and oxidative stress, providing long-term benefit to patients.”
The ArMaDa clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL)]. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups or to an untreated control group.
About dAMD and GA dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula. The macula is the part of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function and central vision impairment. dAMD accounts for 85-90% of the total AMD population.
About OCU410 OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in in-vitro and in-vivo (animal model) studies. These results demonstrate the ability for OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of GA.
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.
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