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XACDURO®, The First and Only Antibiotic Developed to Target Acinetobacter, Now Available to Treat Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP) in Adults

XACDURO®, The First and Only Antibiotic Developed to Target Acinetobacter, Now Available to Treat Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP) in Adults

  • XACDURO is a new FDA-approved treatment used to fight against HABP/VABP infections caused by isolates of Acinetobacterbaumannii-calcoaceticus complex, which can include those resistant to carbapenems (CRAB).

  • In the U.S., it is estimated there are more than 40,000 cases of Acinetobacter each year and approximately 40 percent are carbapenem-resistant.1,2
  • Patients with HABP/VABP caused by Acinetobacter infections face high mortality and significant costs due to drug resistance and limited approved treatment options.

WALTHAM, Mass.–(BUSINESS WIRE)–
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced that XACDURO® (sulbactam for injection; durlobactam for injection) is now available in the United States for patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).

“XACDURO’s pathogen-targeted approach is a significant advancement in the way healthcare professionals treat Acinetobacter, one of the most serious antibiotic-resistant pathogens known to cause life-threatening pneumonia that is associated with high morbidity and mortality rates,” said Pavel Raifeld, Chief Executive Officer, Innoviva. “The addition of XACDURO to our portfolio of critical care medicines underscores our commitment to this space by providing healthcare professionals with differentiated therapeutic options to help improve patient outcomes.”

XACDURO received regulatory approval from the U.S. Food and Drug Administration (FDA) in May 2023 and is now available by prescription through specialty pharmacy distributors in a healthcare setting. The FDA approval was based on strong scientific evidence, including results from the landmark Phase 3 ATTACK trial, published in The Lancet: Infectious Disease, evaluating the safety and efficacy of XACDURO versus colistin in patients with infections caused by Acinetobacter.3 In the trial, XACDURO demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a significant difference in clinical cure rates.3 XACDURO was well tolerated and exhibited a favorable safety profile across the clinical program. In clinical studies, XACDURO was shown to significantly lower the incidence of nephrotoxicity.3 Fewer serious adverse events were observed compared to treatment with colistin, and there was lower treatment discontinuation due to adverse reactions versus colistin with one patient experiencing anaphylactic shock, which lead to discontinuation of treatment for that patient.3

Acinetobacter infections are now the fifth most common cause of deaths attributable to drug resistance across the globe and pose greatest threat to patients on ventilators in hospitals and nursing homes. The Acinetobacter pathogen has become resistant to most antibiotics used to treat HABP and VABP including carbapenems and third generation cephalosporins. This has caused Acinetobacter tobecomeincreasingly difficult to treat with no clear standard of care antibiotic regimen for these resistant infections.

“Every minute matters when managing critical care patients with life-threatening pneumonia, especially when caused by carbapenem-resistant Acinetobacter baumannii pathogen. Antibiotic-resistant pathogens can complicate treatment strategies and compromise treatment efficacy, often resulting in increased mortality rates for intensive care unit patients,” said Margaret Koziel, MD, Chief Medical Officer, Innoviva. “Other treatment options may have high rates of resistance and adverse events, including nephrotoxicity.4 The availability of XACDURO is a much-needed advancement that can now provide healthcare professionals with an innovative therapy option to safely and effectively manage Acinetobacter pneumonia.”

About Acinetobacter

Members of theAcinetobacter baumannii-calcoaceticus complex (Acinetobacter) are Gram-negative, opportunistic human pathogens that predominantly infect critically ill patients, often resulting in severe pneumonia and bloodstream infections.5 They can infect other body sites, such as the urinary tract and the skin.5Acinetobacter is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance.6Acinetobacter is resistant to penicillins and has also acquired resistance genes for almost all antibiotics used to treat Gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems.6

The Centers for Disease Control and Prevention (CDC) has identified carbapenem-resistant micro-organisms as an urgent threat.7 Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 2019.8Carbapenem-resistant Acinetobacter is considered a Priority 1 pathogen by the World Health Organization (WHO).9 Globally, there are about a million cases each year of Acinetobacter, and about two-thirds of those are carbapenem-resistant Acinetobacter baumannii.1 More than 300,000 global deaths annually are associated with carbapenem-resistant Acinetobacter.8

About XACDURO®

XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, approved in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter.

XACDURO® INDICATION & USAGE

Indication

XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.

Limitations of Use

XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XACDURO and other antibacterial drugs, XACDURO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

IMPORTANT SAFETY INFORMATION

Contraindications: XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO or other beta-lactam antibacterial drugs.

Warnings and Precautions:

  • Hypersensitivity was observed in patients treated with XACDURO in clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before initiating therapy with XACDURO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens. If an allergic reaction occurs, discontinue XACDURO.

  • Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with XACDURO should be assessed.
  • Prescribing XACDURO in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions: The most common adverse reactions reported in >10% of patients treated with XACDURO were liver test abnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia (12%).

To report SUSPECTED ADVERSE REACTIONS, contact Innoviva Specialty Therapeutics, Inc. at 1-800-651-3861 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before administering, please see the Full Prescribing Information for XACDURO.

About Innoviva Specialty Therapeutics

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva Specialty Therapeutics’ products, through its affiliate, Entasis Therapeutics Inc., include XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex(Acinetobacter). For more information about Innoviva Specialty Therapeutics, please visit here.

About Innoviva

Innoviva, Inc., is a diversified holding company with a portfolio of royalties and other healthcare assets, including Innoviva Specialty Therapeutics, a subsidiary focused on delivering innovative therapies in critical care and infectious disease. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/vilanterol, FF/VI) and ANORO® ELLIPTA® (umeclidinium bromide/vilanterol, UMEC/VI). Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. For more information on Innoviva, please visit here.

Forward Looking Statements

This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, formerly, TRELEGY® ELLIPTA® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives beyond the existing respiratory portfolio); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (COVID-19). Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2022 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

References

_______________________

1 Spellberg B, Rex JH. The Value of Single-Pathogen Antibacterial Agents. National Review Drug Discovery. 2013 Dec;12(12):963. doi: 10.1038/nrd3957-c1. Epub 2013 Nov 15.

2 Gupta V, Ye G, Olesky M, Lawrence K, Murray J, Yu K. National Prevalence Estimates For Resistant Enterobacteriaceae and Acinetobacter Species In Hospitalized Patients In the United States. International Journal of Infectious Disease. 2019 Aug;85:203-211. doi: 10.1016/j.ijid.2019.06.017. Epub 2019 Jun 20. PMID: 31229615.

3 Kaye, Keith S.,Shorr, Andrew F., et al. Efficacy and Safety Of Sulbactam–Durlobactam Versus Colistin for the Treatment Of Patients With Serious Infections Caused By Acinetobacterbaumannii–calcoaceticus Complex: a Multicentre, Randomised, Active-Controlled, Phase 3, Non-Inferiority Clinical Trial (ATTACK). The Lancet: Infectious Disease. Published May 11, 2023. DOI: https://doi.org/10.1016/S1473-3099(23)00184-6.

4 Katip W, Uitrakul S, Oberdorfer P. Clinical Efficacy and Nephrotoxicity of the Loading Dose Colistin for the Treatment of Carbapenem-Resistant Acinetobacter baumannii in Critically Ill Patients. Pharmaceutics. 2021 Dec 24;14(1):31. doi: 10.3390/pharmaceutics14010031. PMID: 35056926; PMCID: PMC8780224.

5 Ballouz T, Aridi J, Afif C, et al. (2017) Risk Factors, Clinical Presentation, and Outcome of Acinetobacterbaumannii Bacteremia. Front. Cell. Infect. Microbiol. 7:156. doi: 10.3389/fcimb.2017.00156

6 Kyriakidis I, Vasileiou E, Pana ZD, Tragiannidis A. Acinetobacter baumannii Antibiotic Resistance Mechanisms. Pathogens. 2021 Mar 19;10(3):373. doi: 10.3390/pathogens10030373. PMID: 33808905; PMCID: PMC8003822.

7 Centers for Disease Control and Prevention, “Carbapenem-Resistant Acinetobacter baumannii (CRAB): An Urgent Public Health Threat in United States healthcare facilities,” August 2021: https://arpsp.cdc.gov/story/cra-urgent-public-health-threat. Accessed: September 8, 2023

8 Antimicrobial Resistance Collaborators. Global Burden Of Bacterial Antimicrobial Resistance in 2019: a Systematic Analysis. Lancet. 2022; 399(10325):629-655. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext

9 World Health Organization, “WHO Publishes List Of Bacteria For Which New Antibiotics Are Urgently Needed,” February 27, 2017: https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed. Accessed: September 8, 2023

Investors

Argot Partners

(212) 600-1902

[email protected]

Media

Green Room Communications

(973) 975-5421

[email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Biotechnology Infectious Diseases Hospitals Health Pharmaceutical

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Tingo Group Announces Appointment of Interim Co-Chief Executives and Independent Director

MONTVALE, N.J., Sept. 18, 2023 (GLOBE NEWSWIRE) — Tingo Group, Inc. (NASDAQ: TIO) (“Tingo” or the “Company”), a profitable and fast growing fintech, agri-fintech, and food company, today announced the appointments of Dozy Mmobuosi and Kenneth Denos each as interim co-Chief Executive Officers, following the decision by Darren Mercer to retire to spend time with his young family and to coincide with his milestone birthday yesterday. Mr. Mercer has led the Company through numerous key developments and milestones in its recent history, including its transformational acquisitions of Tingo Mobile Limited and Tingo Foods Plc, as well as a rigorous investigation and response to allegations made by short seller Hindenburg Research (the “Investigation”). As the Company announced on May 10, 2022, Mr. Mercer planned to step down as Chief Executive following the merger of MICT and Tingo, Inc. under the original merger transaction. That move, however, was postponed under the new merger structure, which completed on November 30, 2022, and then delayed further by the Investigation.

As the founder and visionary of both Tingo Foods plc (“Tingo Foods”) and Tingo Mobile Limited (“Tingo Mobile”), which has become one of Africa’s leading agri-fintech companies over the past 23 years, Mr. Mmobuosi is uniquely positioned to lead the Company, develop it further and provide continuity, while the Company completes a global search for a permanent world-class Chief Executive Officer, who has relevant expertise and experience. Mr. Denos has served as a director of Tingo since its acquisition of Tingo Mobile in November 2022, and an executive of Tingo Mobile’s prior parent company, Agri Fintech Holdings, Inc. (formerly known as Tingo, Inc.) since August 2021. He also brings decades of experience with U.S. public companies and associated governance, reporting, communication, and compliance requirements.

In addition, the Company is pleased to appoint Jamal (Jamie) Kurshid as an independent member of the Board of Directors. Mr. Kurshid brings more than 20 years of investment banking experience with several leading financial institutions including Goldman Sachs, Credit Suisse and Jacobi Asset Management Holdings Limited, together with executive experience in the technology, digital payments and the fintech sectors, most recently as Chief Operating Officer and Director of Caduceus Foundation, a blockchain technology company in Singapore. Previously, he was COO of Droit Financial Technology, an enterprise technology firm, and a co-founder of Digital RFQ, a leading digital payments service. Mr. Kurshid also serves on the Board of Directors for Financial Strategies Acquisition Corp., 4Phyll Private Limited, and OneCycle Group. Mr. Kurshid’s appointment follows the retirement of Robert Benton as independent member of the Board and Chair of the Audit Committee.

Concurrent with the above three appointments, the Company’s long-standing Deputy Chairman John Scott will move into the role of Chairman, and Sir David Trippier will expand his role as an independent member of the Board of Directors to assume the position of Chair of the Audit Committee.

Darren Mercer, former Chief Executive Officer of Tingo Group, Inc. commented: “While I have known for quite some time that the day of my retirement as Chief Executive Officer of the Company would come since May 10, 2022 when I originally agreed to hand over the role to Dozy Mmobuosi as part of the Tingo Mobile acquisition, today is tinged with some melancholy, as well as pride, as I leave a position I have devoted myself to and worked tirelessly in over the past four years.

“I am privileged to have played a major role in transforming the Company from having de minimis market capitalization into a fast-growing group of innovative businesses at the forefront of their sector, now delivering billions of dollars of revenue each year, generating hundreds of millions of dollars per quarter of profitability, as well as the recently initiated dividend program, which is expected to deliver material dividend increases over the coming quarters. I am enormously proud of what we have achieved, not least of which are the acquisitions of Tingo Mobile and Tingo Foods. I do, however, readily acknowledge that the near unlimited potential of this business requires a Chief Executive Officer that has specific expertise in both the relevant sectors and geographical markets and is able to spend most of their time on the African continent.

“With a young family, including newly born twins, and having reached a milestone birthday yesterday, I believe that now is the appropriate time for me to hand over the baton. I had intended to do this earlier in the year, but clearly had to reassess when the investigation into the Hindenburg allegations became a priority. With that now behind us, and the business currently performing very strongly with material further growth expected in the fourth quarter I feel it is important to have the right team in place, not only to maximize the unlimited opportunities we have at hand, but also to continue the Company’s impressive growth trajectory.

“With our recently launched export business experiencing significant growth, which is expected to increase substantially in the fourth quarter, together with major developments in Tingo Foods including next year’s launch of our own food processing facility among other exciting prospects, I believe I leave the Company very well placed to deliver considerable shareholder value, including regular quarterly dividends moving forward. I feel it is also worth mentioning that the Company’s cash balances have increased significantly over the past two months, and currently stand at more than $400 million, having been $53.2 million as of June 30, 2023, following our investment in the second quarter of close to $1 billion in mobile phones for new customers and inventory payments for Tingo Foods and Tingo DMCC. I am also pleased to report that we have made significant progress with the conversion of $20 million in value of Naira into U.S. Dollars for the purpose of paying the Company’s first quarterly dividend.”

“I wish Dozy, Ken and the Board the very best of fortune and success and would like to thank shareholders for their support during my tenure. As a significant long-term shareholder, I very much look forward to sharing in the Company’s future accomplishments and prosperity.”

John Scott, Chairman of Tingo Group, Inc. commented: “I would like to thank Darren for the significant contribution he has made to both the old MICT shareholders and to the new Tingo shareholders. He has worked tirelessly to deliver shareholder value while embracing and enhancing strong corporate governance procedures.

“Darren leaves the Company in a vastly different position to the one he entered four years ago, and I will miss his vision and commitment to the cause. I wish him and his family happiness in his well-earned retirement.”

“I also wish to thank Robert Benton for his service, and to welcome Dozy, Ken and Jamie into their new positions as we enter this exciting new chapter for the Company and our shareholders.”

Dozy Mmobuosi, Interim Co-Chief Executive Officer of Tingo Group, Inc. commented: “Darren has been a valuable asset to the Company and the Board. His vision and belief in acquiring Tingo Mobile and Tingo Foods has added immense value to the Company’s shareholders. On behalf of our team, I would like to thank Darren for believing in them and the welfare of Africa. His decision to retire is understood by us all and I am sure his continued support of the company will be evident for a long time to come. I wish Darren and his family much happiness in his retirement.

“As we move into this new chapter of the Company’s development with Ken and I each assuming the role of co-Chief Executive Officer on an interim basis while we search for a sector-experienced and accomplished candidate to take on the role permanently, we are delighted to report that the Company’s cash balances have increased significantly to a current level of more than $400 million thanks to a strong period of trade. I am also pleased to report significant progress towards completing our first quarterly dividend and once approved, we will make the next application, this time for a larger amount, with the goal of increasing the amount of the dividend for our third quarter.”

Ken Denos, Interim Co-Chief Executive Officer of Tingo Group, Inc. commented: “Dozy and I are grateful to Darren for the unwavering commitment and devotion he gave to the role of Chief Executive, and we are excited to build on the foundations he established for the Company and its shareholders. Darren will be greatly missed, but as a continued long-term shareholder and friend to the Company I know that should we require his services in the future he will be only too willing to oblige. We have been privileged to witness Darren’s tireless work, including throughout the Tingo Mobile acquisition, and he deserves our thanks and a well-deserved rest in his retirement.”  

About Tingo Group

Tingo Group, Inc. (Nasdaq: TIO) is a global Fintech and Agri-Fintech group of companies with operations in Africa, Southeast Asia and the Middle East. Tingo Group’s wholly owned subsidiary, Tingo Mobile, is a leading Agri-Fintech company operating in Africa, with a comprehensive portfolio of innovative products, including a ‘device as a service’ smartphone and a value-added service platform. As part of its globalization strategy, Tingo Mobile has recently begun to expand internationally and entered into trade partnerships that are contracted to increase the number of subscribed farmers from 9.3 million in 2022 to more than 32 million, providing them with access to services including, among others, the Nwassa ‘seed-to-sale’ marketplace platform, insurance, micro-finance, and mobile phone and data top-up. Tingo Group’s other Tingo business verticals include: TingoPay, a SuperApp in partnership with Visa, offering a wide range of B2C and B2B services including payment services, an e-wallet, foreign exchange and merchant services; Tingo Foods, a food processing business that processes raw foods into finished products such as rice, groundnut oil, nut products, wheat, millet and maize; and Tingo DMCC, a commodity trading platform and agricultural commodities export business based out of the Dubai Multi Commodities Center. In addition to its Tingo business verticals, Tingo Group also holds and operates an insurance brokerage platform business in China; and Magpie Securities, a regulated finance services Fintech business operating out of Hong Kong and Singapore. For more information visit tingogroup.com.

Disclaimer

The information in this news release includes certain information and statements about management and the Company’s board of director’s view of future events, expectations, plans and prospects that constitute forward looking statements. These statements are based upon assumptions that are subject to significant risks and uncertainties. Because of these risks and uncertainties and as a result of a variety of factors, the actual results, expectations, achievements or performance may differ materially from those anticipated and indicated by these forward-looking statements. Any number of factors could cause actual results to differ materially from these forward-looking statements as well as future results. Although the Company believes that the expectations reflected in forward looking statements are reasonable, it can give no assurance that the expectations of any forward-looking statements will prove to be correct. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those discussed and identified in public filings made with the SEC by the Company and: (i) the results of the independent review; (ii) the risk of restatement of the Company’s previously reported financial statements or the identification of one or more material weaknesses in internal control over financial reporting; (iii) costs relating to the independent review, which are likely to be material; (iv) the outcome of any legal proceedings that may be instituted against the Company, including as may result from the independent review and (v) the ability to meet stock exchange continued listing standards. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking statements or otherwise.

Investor Relations Contact

949-491-8235
[email protected]
www.mzgroup.us



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Sonendo to Participate at the Gilmartin Group Emerging Growth Company Showcase

Sonendo to Participate at the Gilmartin Group Emerging Growth Company Showcase

LAGUNA HILLS, Calif.–(BUSINESS WIRE)–
Sonendo, Inc. (NYSE: SONX), a leading dental technology company and developer of the GentleWave® System, today announced that management will participate in the upcoming Gilmartin Group Emerging Growth Company Showcase. Management is scheduled to present on Thursday, September 21st at 9:00 a.m. Pacific Time/ 12:00 p.m. Eastern Time. A webcast of the presentation will be available on the “Investors” section of the company’s website at: investor.sonendo.com.

About Sonendo

Sonendo is a commercial-stage medical technology company focused on saving teeth from tooth decay, the most prevalent chronic disease globally. Sonendo develops and manufactures the GentleWave® System, an innovative technology platform designed to treat tooth decay by cleaning and disinfecting the microscopic spaces within teeth without the need to remove tooth structure. The system utilizes a proprietary mechanism of action, which combines procedure fluid optimization, broad-spectrum acoustic energy and advanced fluid dynamics, to debride and disinfect deep regions of the complex root canal system in a less invasive procedure that preserves tooth structure. The clinical benefits of the GentleWave System when compared to conventional methods of root canal therapy include improved clinical outcomes, such as superior cleaning that is independent of root canal complexity and tooth anatomy, high and rapid rates of healing and minimal to no post-operative pain. In addition, the GentleWave System can improve the workflow and economics of dental practices. Sonendo is also the parent company of TDO Software, the developer of widely used endodontic practice management software solutions, designed to simplify practice workflow. TDO Software integrates practice management, imaging, referral reporting and CBCT imaging, and offers built-in communication with the GentleWave System.

For more information on Sonendo, visit www.sonendo.com. For more information on the GentleWave System, visit www.gentlewave.com/doctor.

Investor Contact:

Greg Chodaczek

Gilmartin Group

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Health Dental Medical Devices

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Allurion Featured at the 2023 International Bariatric Club Oxford University World Congress

Allurion Featured at the 2023 International Bariatric Club Oxford University World Congress

Congress convenes the world’s leading bariatric healthcare professionals to discuss innovative therapies

NATICK, Mass.–(BUSINESS WIRE)–Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced its participation in the 4th International Bariatric Club (IBC) Oxford World Congress, which takes place at Oxford University, September 18-20, 2023.

The IBC event, entitled ‘Managing Obesity and Diabetes: From the Laboratory to the Clinic to the Operating Room to the World’, will bring together many of the world’s most distinguished weight-loss experts.

Brazilian bariatric surgeon Professor Eduardo Grecco’s presentation, ‘The Perfect Intra-gastric Balloon: Combining Safety with Satiety’, will discuss the role the Allurion Balloon—and all the elements of the Allurion Program—can play in safely and effectively delivering weight loss.

Professor Grecco, a gastric surgeon and endoscopist at Instituto Endovitta in São Paulo, is among the specialists worldwide who are now routinely treating patients with the Allurion Program, a full-stack weight loss program featuring the world’s first and only swallowable, procedure-less intragastric balloon, AI-powered remote patient monitoring tools, a proprietary behavior change program, secure messaging, and video telehealth delivered by the Allurion Virtual Care Suite. His clinic has been using the Allurion Balloon to help patients lose weight since it was approved by the Brazilian Health Regulatory Agency ANVISA in 2022.

To build further on this theme, the Congress Experts’ Forum Discussion Session is entitled ‘Battle of the Balloons: Endoscopic Vs Swallowable’. It will be chaired by Professor Grecco and Professor Salman Al Sabah, Director of Surgical Research and a Consultant Surgeon at both Al-Amiri Hospital and the Royale Hayat Hospital in Kuwait.

Allurion’s Senior Director of Global Nutrition, Zoe Griffiths, says the increased focus on balloon technology at industry events such as IBC demonstrates the changing obesity treatment landscape.

“Gastric balloon research has evolved enormously in the last 10 years and Allurion is proud of its commitment to making this technology available to as many people as possible, and combining it with cutting edge techniques in behavior change and artificial intelligence to optimize outcomes,” she said.

“Our research shows that people who are living with overweight and obesity want options, and we believe balloons provide an alternative to surgery that is less invasive and highly effective. We also know that there is no one-size-fits-all solution to weight loss. Gastric balloons can be used on their own or in combination with a range of other treatments, including surgery and weight-loss medications.”

For more information about IBC, please visit: https://www.ibcclub.org

Presentation Information

Title: The Perfect Intra-gastric Balloon: Combining Safety with Satiety

Presenter: Dr. Eduardo Grecco, Bariatric Endoscopist at EndoVitta Institute, Sao Paulo, Brazil

Presentation Date: Monday, September 18th 2023, at 12:35 PM

Title: Experts’ Forum Discussion Session: Battle of the Balloons: Endoscopic Vs Swallowable

Chairs: Drs. Eduardo Grecco (Brazil) & Salman Al Sabah (Kuwait)

Panel: Drs. Joao Henrique Felicio de Lima (Brazil), Carmen Bautista (Spain/Peru), Geoffrey Chow (USA), Necat Memisoglu (Canada), Nabil Tariq (USA), Elaine Moreira (Brazil), Bruno Sander (Brazil), Marcelo Falcao (Brazil), Amny Acosta Then (Dominican Republic)

Presentation Date: Monday, September 18th 2023, at 18:25 PM

About Allurion

Allurion is dedicated to ending obesity. The Allurion Program is a weight-loss platform that combines the Allurion Gastric Balloon, the world’s first and only swallowable, procedure-less gastric balloon for weight loss, the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers, Allurion Insights for healthcare providers featuring the Iris AI Platform, and the Allurion Connected Scale and Health Tracker devices. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor, and manage weight-loss therapy for patients regardless of their treatment plan: gastric balloon, surgical, medical or nutritional. The Allurion Gastric Balloon is an investigational device in the United States.

For more information about Allurion and the Allurion Virtual Care Suite, please visit www.allurion.com.

Forward-Looking Statements

This press release may contain certain forward-looking statements within the meaning of the U.S. federal and state securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions and include statements regarding Allurion’s expectations for, and market acceptance of, the Allurion Program. They reflect the current beliefs and assumptions of Allurion’s management based on information currently available to them. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future results or developments to differ materially from the forward-looking statements in this communication, including but not limited to (i) the ability of Allurion to obtain regulatory approval for and successfully commercialize the Allurion Program, (ii) the results of clinical data from its studies, (iii) the evolution of the markets in which Allurion competes, (iv) the ability of Allurion to defend its intellectual property and satisfy regulatory requirements, (v) the impact of the COVID-19 pandemic on Allurion’s business, (vi) Allurion’s expectations regarding its market opportunities and (vii) the risk of economic downturns and a changing regulatory landscape in the highly competitive industry in which Allurion operates. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of the proxy statement/prospectus contained in Allurion’s Registration Statement on Form S-4 (333-271862), the company’s Form 8-K filed on August 7, 2023 (as amended), and other documents filed by Allurion from time to time with the U.S. Securities and Exchange Commission. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Allurion assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Allurion does not give any assurance that it will achieve its expectations.

Media Contact

Cedric Damour

PR Manager

+33 7 84 21 02 20

[email protected]

KEYWORDS: Europe United States United Kingdom North America Massachusetts

INDUSTRY KEYWORDS: Medical Devices Health Surgery Fitness & Nutrition General Health Pharmaceutical

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Dynex Capital, Inc. Welcomes New Head of Strategy and Research, Acquires Contingent Macro’s Proprietary Models and Data Library

Dynex Capital, Inc. Welcomes New Head of Strategy and Research, Acquires Contingent Macro’s Proprietary Models and Data Library

GLEN ALLEN, Va.–(BUSINESS WIRE)–
Dynex Capital, Inc. (NYSE: DX) announced a significant addition to its leadership team. Terrence (“T.J.”) Connelly, a seasoned expert in global economics, fixed-income investing, and financial modeling has joined Dynex to spearhead its strategic initiatives and research efforts.

With an outstanding track record in the asset management industry, Connelly brings a wealth of knowledge and experience to Dynex. Prior to joining Dynex, he was the Founder and Head of Research at Contingent Macro Advisors, where he was instrumental in developing innovative models and proprietary solutions, advising, and managing assets for some of the largest asset managers in the world.

In a strategic move to bolster its position as a market leader, Dynex has also acquired the cutting-edge models and proprietary data developed by Contingent Macro under Connelly’s leadership. These assets will play a pivotal role in leveraging evolving technologies to enhance Dynex’s capabilities and enable the company to maintain its investment edge and industry-leading risk management in complex global markets.

Commenting on this development, Byron L. Boston, the Company’s Chief Executive Officer of Dynex, said, “We are thrilled to welcome T.J. to our team. His exceptional expertise and the acquisition of Contingent Macro’s models and proprietary data represent a significant step forward for Dynex. We are committed to delivering outstanding results for our investors, and this strategic move aligns perfectly with our goals.”

Connelly also expressed enthusiasm about joining Dynex and the potential for innovation, saying, “I am honored to be part of the Dynex team, an outstanding organization committed to excellence. It is also a joy to be reunited with Byron and Smriti, whose leadership I’ve admired for over 25 years. With the acquisition of Contingent Macro’s assets, we have the opportunity to drive innovation and deliver even greater value to our investors.”

About Dynex Capital

Dynex Capital, Inc. is a financial services company committed to ethical stewardship of stakeholders’ capital; employing comprehensive risk management and disciplined capital allocation to generate dividend income and long-term total returns through the diversified financing of real estate assets in the United States. Dynex operates as a REIT and is internally managed to maximize stakeholder alignment. Additional information about Dynex Capital, Inc. is available at www.dynexcapital.com.

Forward Looking Statement

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding the business of Dynex Capital, Inc. that are not historical facts are “forward-looking statements” that involve risks and uncertainties. For a discussion of these risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the Company’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.

Alison Griffin

804-217-5897

KEYWORDS: United States North America Virginia

INDUSTRY KEYWORDS: Professional Services Residential Building & Real Estate Commercial Building & Real Estate Finance Construction & Property REIT

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GE HealthCare Awarded a $44 Million Grant to Develop Artificial Intelligence-Assisted Ultrasound Technology Aimed at Improving Outcomes in Low-and-Middle-Income Countries

GE HealthCare Awarded a $44 Million Grant to Develop Artificial Intelligence-Assisted Ultrasound Technology Aimed at Improving Outcomes in Low-and-Middle-Income Countries

  • Grant from Bill & Melinda Gates Foundation will facilitate development of AI-assisted applications and tools to enable healthcare professionals with less experience to perform quick and accurate ultrasound scans to help address maternal and fetal health and respiratory diseases

  • AI-assisted ultrasound algorithms will be developed to run on multiple ultrasound devices to expand access to high quality care around the world with an emphasis on low-and-middle income countries (LMIC)

CHICAGO–(BUSINESS WIRE)–
GE HealthCare (Nasdaq: GEHC) today announced it received a grant from the Bill & Melinda Gates Foundation for more than $44 million to create user-friendly, artificial intelligence (AI)-assisted ultrasound imaging auto-assessment tools. These tools will seek to aid healthcare professionals—even those without specialized training or experience with ultrasound—with clinical decision information to support more effective obstetric and lung screening ultrasound scans across maternal and fetal care as well as pediatric lung health, with a goal of expanding access to low-and-middle income countries (LMIC) and across diverse sites of care.

Caption Health, a leader in medical AI acquired by GE HealthCare in February 2023, will design this technology to run across a range of ultrasound devices and probes, including lower-cost handheld devices.

“We are proud and excited to have received this grant from the Bill & Melinda Gates Foundation to make ultrasound more accessible in low-and-middle income countries. Ultrasound is an essential tool for screening and diagnosis of various medical conditions, including the health of expectant mothers and managing respiratory diseases,” said Roland Rott, President and CEO, Ultrasound, GE HealthCare. “However, a key limitation is the guidance of lesser-skilled users to effectively apply affordable point-of-care ultrasound in their care environment. This grant will help bring Caption Health’s leading AI technology customized to more users, and therefore contribute to increased access to higher-quality medical care.”

Maternal and child mortality is a critical healthcare issue around the world. In 2020, almost 800 women died every day from preventable causes linked to pregnancy and childbirth, with approximately 95 percent of all maternal deaths occurring in LMIC.1 In 2019, 2.4 million children around the world died in their first month of life. Ultrasound technologies are used in maternal care to determine fetal health markers and conditions like gestational age, fetal presentation, multiple gestation (more than one fetus), fetal viability, umbilical blood flow, and ectopic pregnancy.

For children younger than five years old, pneumonia is the leading cause of death worldwide.2 Because symptoms of pneumonia can develop suddenly, early diagnosis is vital to effective treatment and preventing complications. Point of care lung ultrasound can provide physicians with a view of the entire lung, is easily repeatable and can diagnose pneumonia with greater accuracy compared with a bedside chest X-ray.3

In 2020, Caption Health received a grant from the Bill & Melinda Gates Foundation to support the development of innovative AI technology for lung ultrasound.

“Caption Health AI applications are designed to guide healthcare professionals, step-by-step, during an ultrasound exam to help them capture and interpret high-quality ultrasound images,” said Karley Yoder, Chief Digital Officer, Ultrasound, GE HealthCare and General Manager, Caption Health. “We are thankful for the continued support of the Bill & Melinda Gates Foundation, which enables us to expand the development of our existing lung ultrasound project and also broaden the reach of this powerful, novel technology to help provide care to mothers and children.”

Currently, Caption Health offers Cardiac Guidance software, which is FDA cleared. With the support of the Bill & Melinda Gates Foundation grant, Caption Health will develop multiple lung ultrasound and obstetric algorithms through clinical validation and regulatory submissions.

About GE HealthCare

GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 100 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are an $18.3 billion business with 50,000 employees working to create a world where healthcare has no limits.

Follow us on Facebook, LinkedIn, Twitter, Instagram and Insights for the latest news, or visit our website https://www.gehealthcare.com/ for more information.

1 World Health Organization. Maternal Mortality. Published February 22, 2023. Accessed August 22, 2023. Available at: https://www.who.int/news-room/fact-sheets/detail/maternal-mortality.

2 World Health Organization. Pneumonia. WHO. https://www.who.int/news-room/fact-sheets/detail/pneumonia. Accessed June 10, 2022.

3 Systematic review and meta-analysis for the use of ultrasound versus radiology in diagnosing of pneumonia, Saeed Ali Alzahrani et al. Crit Ultrasound J. 2017; 9: 6. doi: 10.1186/s13089-017-0059-y

Eric Tatro

+1 312 459 6140

[email protected]

KEYWORDS: Illinois Africa United States North America

INDUSTRY KEYWORDS: Technology Medical Devices Health Technology Philanthropy Radiology Health Other Philanthropy Foundation Artificial Intelligence

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Sidus Space Secures Position on Upcoming Bandwagon Mission

Sidus Space Secures Position on Upcoming Bandwagon Mission

Updated mission date allows inclusion of additional sensors and expanded field of view, increasing both payload and data revenue

CAPE CANAVERAL, Fla.–(BUSINESS WIRE)–
Sidus Space (NASDAQ: SIDU) (the “Company” or “Sidus”), a multi-faceted Space and Data-as-a-Service company confirms its plan to reallocate two LizzieSats to launch on an upcoming Bandwagon mission with SpaceX. The updated LizzieSat constellation configuration will advance cutting-edge Low Earth Orbit data collection and provide enhanced orbital flexibility for government and commercial customers.

While initially planning to launch its first LizzieSat on Transporter-9 in Q4 2023, the Company has adjusted its launch manifest to take advantage of the opportunity to cover more populated areas and increase data revenue. The updated schedule targets a first launch in Q1 2024 followed by two LizzieSats on a Bandwagon mission in Q2 2024.

“The Bandwagon mission is exciting because it gives us the ability to place multiple LizzieSats in dissimilar orbits, enabling us to capture higher revenue generating data while increasing our payload and data customers,” commented Carol Craig, Sidus’ Founder and CEO. “This, when combined with the inclusion of additional sensors and enhanced AI capabilities on our initial flight, adds value as we get closer to initiating these launches and developing new, high-margin business lines.”

The Company continues to be manifested for the launch of a single LizzieSat with SpaceX on Transporter-10 in Q1 2024 and two additional LizzieSats on Transporter-11 in Q2 2024, which will result in an expected five LizzieSats on orbit in the Company’s constellation by the end of the third quarter of 2024. The LizzieSats deployed on Bandwagon will operate in synergy with those on Transporter missions as the complementary orbits increase both the value and the amount of data that can be collected for sale by the Company.

John Curry, Chief Mission Operations Officer, stated, “The convergence of our orbit inclination, advanced payloads, and EdgeAI capabilities enables us to provide an unparalleled data service to our customers. Our capability to address a critical void through wide area spectral data imaging greatly enhances LizzieSat’s overall potential.”

About Sidus Space

Sidus Space (NASDAQ: SIDU) is a multi-faceted Space and Data-as-a-Service company focused on mission-critical hardware manufacturing; multi-disciplinary engineering services; satellite design, production, launch planning, mission operations; and in-orbit support. The Company is located in Cape Canaveral, Florida, where it operates from a 35,000-square-foot manufacturing, assembly, integration, and testing facility focused on vertically integrated Space-as-a-Service solutions including end-to-end satellite support.

Sidus Space has a mission of Bringing Space Down to Earth™ and a vision of enabling space flight heritage status for new technologies while delivering data and predictive analytics to domestic and global customers. Any corporation, industry, or vertical can start their journey off-planet with Sidus Space’s rapidly scalable, low-cost satellite services, space-based solutions, and testing alternatives. More than just a “Satellite-as-a-Service” provider, Sidus Space is a trusted Mission Partner–from concept to Low Earth Orbit and beyond. Sidus Space is ISO 9001:2015, AS9100 Rev. D certified, and ITAR registered.

Forward-Looking Statements

Statements 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’ within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing dates. 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 uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Sidus Space’s Annual Report on Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Sidus Space, Inc. specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Relations

Valter Pinto or Jack Perkins

KCSA Strategic Communications

[email protected]

(212) 896-1254

Media

Pam Davis

Sidus Space

[email protected]

KEYWORDS: United States North America Florida

INDUSTRY KEYWORDS: Other Defense Professional Services Hardware Data Management Technology Defense Artificial Intelligence Data Analytics Satellite Engineering Government Technology Aerospace Manufacturing

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Knowles Announces Next Phase of Transformation to an Industrial Technology Company

Knowles Announces Next Phase of Transformation to an Industrial Technology Company

Enters into Agreement to Acquire Cornell Dubilier for Total Cash Consideration of $263 Million, Adding Film, Electrolytic and Mica Capacitor Product Offerings; Expected to be Accretive to Non-GAAP EPS in 2024

Announces Exploration of Strategic Alternatives for Consumer MEMS Microphones Segment

Actions Reflect Execution of Strategic Roadmap to Increase Exposure to High-Growth Medtech, Defense & Aerospace, and Industrial Electrification End Markets

ITASCA, Ill. & LIBERTY, S.C.–(BUSINESS WIRE)–
Knowles Corporation (NYSE: KN) (“Knowles” or the “Company”), a leading global supplier of high performance components and solutions, including ceramic capacitors and radio frequency (“RF”) filters, advanced medtech microphones and balanced armature speakers and audio solutions, today announced strategic actions to accelerate its transformation to an industrial technology company focused on higher growth and higher value opportunities.

The Company has entered into a definitive agreement to acquire Cornell Dubilier (“CD”) in an all-cash transaction. In parallel, Knowles announced that it is evaluating strategic alternatives for its Consumer MEMS Microphones business (“CMM”).

Proposed Acquisition of Cornell Dubilier

Cornell Dubilier, based in Liberty, South Carolina, is a technology leader and manufacturer of high-quality film, electrolytic and mica capacitors used in demanding medtech, military, aerospace, and industrial electrification applications with an annualized revenue of more than $135 million and over 35 thousand customers. The acquisition:

  • Increases Exposure to High-Growth End Markets: The transaction significantly expands Knowles’ serviceable available market through Cornell Dubilier’s capacitor offerings. In addition, Cornell Dubilier’s end markets are aligned to key growth tailwinds, including increasing defense budgets, medical imaging and critical care application growth as well as industrial electrification and implementation of next generation fast charging architectures.
  • Diversifies and Expands Product Portfolio: The combination of Cornell Dubilier’s broad selection of power film, electrolytic and mica capacitors with Knowles’ Precision Devices segment will deliver a compelling value proposition and wider portfolio of products and solutions to both existing and new customers.
  • Drives Non-GAAP EPS Accretion and Preserves Financial Flexibility: Pro forma, the acquisition is expected to be accretive to Knowles’ non-GAAP EPS in 2024. Following the closing of the acquisition, Knowles expects to have a leverage ratio of 1.4x pro forma EBITDA and maintain its capital deployment strategy focused on balancing R&D and capex investment with accretive M&A while continuing to return cash to shareholders through share repurchases.

“Adding Cornell Dubilier’s impressive, broad-based roster of OEM and distribution partner customers, as well as its leading capabilities in capacitor technology will expand the applications for Knowles’ products,” said Knowles Chief Executive Officer Jeffrey Niew. “We will be well positioned to grow with new and existing customers as we work to generate stronger earnings and cash flow and create shareholder value. We admire the outstanding company and culture built by the Kaplan family over the past 40 years and we look forward to welcoming Cornell Dubilier’s talented employees to Knowles.”

“We are thrilled to be joining Knowles, which shares our culture of innovation,” said Cornell Dubilier Chief Executive Officer Jim Kaplan. “Like Knowles, some of the world’s most respected companies rely on Cornell Dubilier’s technologies, and together, we will be well positioned to offer even more cutting-edge products and solutions to our customers and drive growth.”

Acquisition Terms & Details

The total cost of the acquisition is $263 million and consists of a $140 million cash payment at closing and an interest-free seller note of $123 million, with $50 million maturing one year from closing and the remaining $73 million maturing two years from closing. The total fair value of the consideration transferred is estimated at $250 million and represents 9.6x Cornell Dubilier’s trailing-twelve-month adjusted EBITDA inclusive of run-rate cost synergies. Knowles expects to finance the acquisition with a combination of cash on hand, borrowings from its existing revolving credit facility, and the seller note.

The acquisition is expected to close in the fourth quarter of calendar year 2023, subject to regulatory approvals and other customary closing conditions.

J.P. Morgan is serving as the exclusive financial advisor to Knowles and Foley & Lardner LLP is serving as its legal advisor.

Exploring Strategic Alternatives for Consumer MEMS Microphones Business

The Company also announced today that it is reviewing strategic alternatives for its CMM business. CMM designs and manufactures micro-electro-mechanical systems microphones that enable voice control communication and superior audio recording for customers across the ear, compute, internet of things and smartphone market segments.

Mr. Niew commented, “The CMM segment is an attractive, cash-producing business with differentiated products and a strong customer base. This process is another step in Knowles’ business transformation as we explore potential partners to accelerate a return to growth for CMM.”

The Company has engaged Jefferies LLC to assist in the CMM strategic review. No assurance can be given that any transaction or other strategic outcomes will result from the review. The Company has not set a timetable for the conclusion of the strategic review and does not intend to comment on or provide updates regarding these matters unless and until it determines that further disclosure is appropriate or required.

Investor Presentation

Knowles today posted an investor presentation with details regarding the Cornell Dubilier transaction, which is available at http://investor.knowles.com.

Non-GAAP Financial Measures

Non-GAAP diluted earnings per share (“non-GAAP diluted EPS”) is adjusted for certain non-GAAP reconciling adjustments, including stock-based compensation expense, intangibles amortization expense, impairment charges, restructuring charges, and other infrequent or non-recurring expense and income items that, when removed, result in greater comparability of results between reporting periods. Non-GAAP diluted EPS also includes the income tax effects of non-GAAP reconciling adjustments, which are calculated using the applicable tax rates in the jurisdictions of the underlying adjustments. The number of shares used in the non-GAAP diluted EPS calculations excludes the impact of stock-based compensation expense expected to be incurred in future periods and not yet recognized in the financial statements, which would otherwise be assumed to be used to repurchase shares under the GAAP treasury stock method.

Knowles believes that non-GAAP measures are useful as supplements to its GAAP results of operations to evaluate certain aspects of its operations and financial performance, and its management team primarily focuses on non-GAAP items in evaluating Knowles’ performance for business planning purposes. Knowles also believes that these measures assist it with comparing its performance between various reporting periods on a consistent basis, as these measures remove from operating results the impact of items that, in Knowles’ opinion, do not reflect its core operating performance. Knowles believes that its presentation of non-GAAP financial measures is useful because it provides investors and securities analysts with the same information that Knowles uses internally for purposes of assessing its core operating performance.

About Knowles

Knowles is a market leader and global provider of advanced micro-acoustic microphones and balanced armature speakers, audio solutions, and high performance capacitors and RF products, serving the consumer electronics, medtech, defense, electric vehicle, industrial, and communications markets. Knowles uses its leading position in SiSonic™ micro-electro-mechanical systems (“MEMS”) microphones and strong capabilities in audio processing technologies to optimize audio systems and improve the user experience across consumer applications. Knowles is also a leader in hearing health acoustics, high performance capacitors, and RF solutions for a diverse set of markets. Knowles’ focus on the customer, combined with unique technology, proprietary manufacturing techniques, and global operational expertise, enables it to deliver innovative solutions across multiple applications. Founded in 1946 and headquartered in Itasca, Illinois, Knowles is a global organization with employees in over a dozen countries. The Company continues to invest in high value solutions to diversify its revenue and increase exposure to high growth markets. For more information, visit knowles.com.

About Cornell Dubilier

Cornell Dubilier is a privately held company headquartered in Liberty, South Carolina. Cornell Dubilier is a technology leader and manufacturer of high-performance film, electrolytic and mica capacitors used in demanding medtech, defense & aerospace, and industrial electrification applications.

Cautionary Note Regarding Forward-Looking Statements:

This press release contains certain statements, including those statements relating to the Company’s expectations regarding the CD acquisition, the evaluation of strategic alternatives for the CMM business, plans and objectives of management for future operations and other statements that do not directly relate to any historical or current fact which are “forward-looking” statements within the meaning of the safe harbor provisions of the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. The words “expect,” “estimate,” “budget,” “continue,” “intend,” “will,” and similar expressions, among others, generally identify forward-looking statements, which speak only as of the date the statements were made. The matters discussed in these forward-looking statements are based on current plans, expectations, forecasts and assumptions and are subject to risks, uncertainties and other factors that could cause actual outcomes or results to differ materially from those projected, anticipated or implied in these forward-looking statements. Where, in any forward-looking statement, an expectation or belief as to future results or events is expressed, such expectation or belief is based on the current plans and expectations of management and expressed in good faith and believed to have a reasonable basis, but there can be no assurance that the expectation or belief will be achieved or accomplished. Many factors that could cause actual results or events to differ materially from those anticipated include those matters described under the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, subsequent Reports on Forms 10-Q and 8-K and our other filings we make with the SEC, as well as the occurrence of any event, change or other circumstances that could give rise to the termination of the definitive agreement to acquire CD; the possibility that various closing conditions for the acquisition may not be satisfied or waived; the possibility of a failure to obtain, delays in obtaining or adverse conditions contained in regulatory or other required approvals; the failure of the acquisition to close for any other reason; the amount of fees and expenses related to the acquisition or the strategic alternatives process; the ability to achieve projected financial results; the risk that the anticipated benefits and synergies from the acquisition may not be fully realized or may take longer to realize than expected; the effects of disruption from the acquisition or strategic alternatives process making it more difficult for Knowles or CD to maintain relationships with employees (including potential difficulties in employee retention), collaboration parties, other business partners or governmental entities; other business effects, including the effects of industrial, economic or political conditions outside of Knowles’ control; the timing of the strategic alternatives review; the outcome of the strategic alternatives review, including whether any transaction occurs at all; whether any such strategic alternative will result in additional value for Knowles and its shareholders; and changes in economic, competitive, strategic, technological, regulatory or other factors that affect the operation of Knowles’ businesses. Any forward-looking statement speaks of as of the date on which it is made and the Company does not assume any obligation to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise, except as required by applicable law. The Company does not undertake any obligation to update any forward-looking statements as a result of new information, future developments or otherwise, except as expressly required by law.

Financial Contact:

Patton Hofer

Knowles Investor Relations

Email: [email protected]

KEYWORDS: Illinois South Carolina United States North America

INDUSTRY KEYWORDS: Hardware Other Defense Semiconductor Electronic Design Automation Manufacturing Consumer Electronics Other Health Technology Audio/Video Defense Other Manufacturing Telecommunications Machinery Health Mobile/Wireless Engineering

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SentinelOne® and Mandiant Bolster Strategic Partnership, Empowering Organizations to Harden Defenses and Proactively Protect Against the Latest Threats

SentinelOne® and Mandiant Bolster Strategic Partnership, Empowering Organizations to Harden Defenses and Proactively Protect Against the Latest Threats

Cybersecurity leaders will combine the power of the SentinelOne Singularity™ platform with Mandiant-infused industry-leading intelligence through strategic offering

MOUNTAIN VIEW, Calif. & RESTON, Va.–(BUSINESS WIRE)–SentinelOne (NYSE: S), a global leader in autonomous cybersecurity, and Mandiant, Inc., part of Google Cloud, today announced an expanded strategic partnership through which they intend to arm organizations of all sizes with industry-leading threat intelligence capabilities directly within the SentinelOne Singularity Platform.

“The cybersecurity threat landscape is rapidly evolving, with attacks becoming more numerous and sophisticated by the minute,” said Ric Smith, Chief Product and Technology Officer, SentinelOne. “To keep their critical infrastructure safe, security teams need advanced, intelligence-led solutions that enable them to better understand who’s targeting them and prepare for threats before they impact their business, and we are pleased to be teaming with Mandiant to provide these capabilities.”

Through the expanded partnership, SentinelOne will deliver Mandiant’s industry-leading threat intelligence to customers in the Singularity Platform. The new offering will enhance SentinelOne’s native threat intelligence by providing organizations with a deeper understanding of their threat landscape and enabling them to monitor emerging threats in near-real time, proactively reduce risk and quickly identify adversaries in their environment.

“Over the last 18 months, Mandiant and SentinelOne have partnered to deliver highly adaptable and intelligence-led security solutions to customers,” said Marshall Heilman, Mandiant CTO, Google Cloud. “The expanded strategic partnership marks a major milestone in our journey to democratize our threat intelligence and make it actionable for everyone. By OEMing our frontline threat intelligence and expertise in leading cybersecurity technology, we can enable customers of all sizes to enhance their threat intelligence and investigations with the power of Mandiant in their preferred platform of choice.”

Recognized by enterprises, governments and law enforcement agencies worldwide as the market leader in threat intelligence, Mandiant provides early threat insights through unmatched intelligence and response expertise for the highest-profile incidents. A pioneer and leader in autonomous cybersecurity, SentinelOne provides a market-leading AI-powered platform to protect the entire enterprise. In combining their strengths, the companies can deliver unparalleled innovation, unmatched expertise and superior protection for their customers.

To learn more about the SentinelOne-Mandiant partnership and the value it can deliver, click here.

About SentinelOne

SentinelOne is the leader in autonomous cybersecurity. SentinelOne’s Singularity™ Platform detects, prevents, and responds to cyber attacks at machine speed, empowering organizations to secure endpoints, cloud workloads, containers, identities, and mobile and network-connected devices with speed, accuracy and simplicity. Over 11,000 customers, including Fortune 10, Fortune 500, and Global 2000 companies, as well as prominent governments, trust SentinelOne to secure the future today. To learn more, visit www.sentinelone.com

About Mandiant

Mandiant is a recognized leader in dynamic cyber defense, threat intelligence and incident response services. By scaling decades of frontline experience, Mandiant helps organizations to be confident in their readiness to defend against and respond to cyber threats. Mandiant is now part of Google Cloud.

About Google Cloud

Google Cloud accelerates every organization’s ability to digitally transform its business and industry. We deliver enterprise-grade solutions that leverage Google’s cutting-edge technology, and tools that help developers build more sustainability. Customers in more than 200 countries and territories turn to Google Cloud as their trusted partner to enable growth and solve their most critical business problems.

Karen Master

SentinelOne

[email protected]

+1 (440) 862-0676

KEYWORDS: California Virginia United States North America

INDUSTRY KEYWORDS: Data Management Security Technology Mobile/Wireless Software Networks Internet

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New Study Finds Limited Access to Legal Services Quells Overall Wellness and Productivity Among U.S. Employees

New Study Finds Limited Access to Legal Services Quells Overall Wellness and Productivity Among U.S. Employees

MetLife’s Legal Access Study finds offering legal services improves holistic health of employees and bolsters Diversity, Equity & Inclusion (DEI) initiatives

NEW YORK–(BUSINESS WIRE)–
As today’s workforce continues to navigate changing socioeconomic conditions and a complex legal landscape, research in a new study from MetLife Legal Plans found the interest for legal services is on the rise. According to MetLife’s Legal Access Study, more than two-thirds of today’s employees (67%) have faced a legal situation in the past five years—this is particularly true of those in marginalized and low-income groups.

As these challenges go beyond just impacting workers’ personal lives and affect their overall wellbeing and productivity at work, employers are now seeing first-hand how legal issues can impact their employees. Research shows that one in three employees say they lack adequate access to legal resources, contributing to growing levels of stress and burnout.1 Meanwhile, 61% of employees say they are concerned about the impact of a legal issue on their financial health and nearly half (47%) are concerned about impact on mental health.

“Our research has shown that workers’ holistic wellbeing has worsened in the last year as their need for access to quality legal advice has grown. Employers should consider the valuable role legal plans can play in their benefits offering. By offering a legal plan as a voluntary benefit, employers can improve the overall wellbeing of their workforce, help to deliver on their DEI commitments and support the ever-evolving composition of today’s workforce,” said Ingrid Tolentino, CEO, MetLife Legal Plans.

Legal Access Improves the Employee Experience

When employees have access to legal plans, their financial and mental health improve. MetLife research found that 67% of employees who have legal benefits through their employer feel financially healthy (vs. 52% who don’t). Similarly, 75% of employees with legal benefits feel mentally healthy, compared to 63% without legal benefits who say the same.

The same study found that broadening access to legal services can also drive key business outcomes. In fact, employers who offer legal services are 12% more likely to say they have increased productivity in their workforce, compared to employers who do not offer legal plans.

By offering a benefit that covers a wide range of employee needs, employers are also better able to deliver on their commitments to DEI. The research found that employees with a legal plan are 25% more likely to say that they are satisfied with the availability of fair/equitable opportunities across their organization and 40% more likely to be satisfied with the social wellness benefits/programs that they’re offered.

Addressing the “Justice Gap”

While a majority (67%) of employees have faced a legal situation in the past five years, only 7% of those have sought legal representation. Marginalized groups are even more likely to have faced a legal situation.

  • 78% of employees living with a disability,

  • 75% of those who identify as LGBTQ+,

  • 69% of those who identify as Hispanic,

  • 66% of those who identify as Black,

  • And 58% of those who identify as Asian have also encountered a legal issue.

Yet while these groups have a higher occurrence of legal situations, they make up a small percentage of the 7% who have sought an attorney.

Workers in these groups are often disproportionately affected by a lack of access to legal services—an inequity commonly referred to as the “justice gap.” For instance, while 24% of employees indicated that cost was a barrier to legal access, that percentage increased among minority demographics (38% with a disability, 34% LGBTQ+, 30% Black, and 29% Hispanic). Perceptions of fairness in the legal system among those affected by the justice gap are also lower, too, with many employees in these groups saying they actively avoid the legal system due to a lack of trust.

Supporting and Educating Employees through Legal Access

Beyond the lack of access to legal support, MetLife’s study also uncovered a general lack of understanding of legal plans among employees, which can contribute to the underutilization of these benefits. Many employees hold misconceptions about legal plans, including what they are, what services they cover, how much they cost, and how they can enroll.

“It’s not enough for employers to simply offer legal plans,” said Tolentino. “It’s essential they make it a priority to educate employees about how they can use legal plans to protect themselves in the face of the unknown, and as they approach life’s major milestones.”

In addition to improving employee wellbeing, employers demonstrate an elevated level of care for their workforce by providing increased education around legal services. Employees who use their legal plans are far more likely to feel cared for (73% vs. 54%), MetLife research has found. Benefits communication tactics, including lunch and learns, human resources office hours, and spending time with diverse groups to understand their unique experiences, support employees’ evolving needs and demonstrate workplace equity.

Click here to learn more about MetLife’s 2023 Legal Access Study.

Research Methodology

MetLife Legal Plans’ Legal Access Study was conducted in three parts from October 2022 to January 2023 and fielded by Big Village—a global research and analytics consultancy. Rainmakers conducted part one, which included a three-day online community. Twenty-eight interviews were conducted with full-time employees from diverse backgrounds on the state of legal access and their understanding of legal plans. Part two entailed interviews with three experts active in the legal industry (an EVP of DEI, a lecturer of business law and ethics for a school of social work, and an attorney/consultant), and one DEI subject matter expert (consultant and adjunct professor in the department of social justice and social change/consultant). Part three was a quantitative study of 5,023 employees.

About MetLife

MetLife, Inc. (NYSE: MET), through its subsidiaries and affiliates (“MetLife”), is one of the world’s leading financial services companies, providing insurance, annuities, employee benefits and asset management to help individual and institutional customers build a more confident future. Founded in 1868, MetLife has operations in more than 40 markets globally and holds leading positions in the United States, Japan, Latin America, Asia, Europe, and the Middle East. For more information, visit www.metlife.com.

1 “The Justice Gap: The Unmet Civil Legal Need of Low-income Americans.” Legal Services Corporation.

Apr 2022.  https://justicegap.lsc.gov/the-report/

Media:

Liz Harish

929-343-7473

[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Finance Professional Services Legal Insurance Human Resources

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