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PROG Holdings to Release Second Quarter 2023 Financial Results on July 26, 2023

SALT LAKE CITY–(BUSINESS WIRE)–
PROG Holdings, Inc. (NYSE:PRG), the fintech holding company for Progressive Leasing, Vive Financial, Four Technologies, and Build, is scheduled to release financial results for the second quarter of 2023 on Wednesday, July 26, 2023, prior to market open.

The Company has also scheduled a live webcast for Wednesday, July 26, 2023, at 8:30 A.M. ET to discuss its financial results for the second quarter of 2023. The webcast can be accessed via the below link, or through the Events & Presentations section of the PROG Holdings investor relations website, https://investor.progholdings.com/.

Webcast Link: https://edge.media-server.com/mmc/p/9u6ozr8d

The webcast will be archived for playback on the company’s investor relations website following the event.

About PROG Holdings, Inc.

PROG Holdings, Inc. (NYSE:PRG) is a fintech holding company headquartered in Salt Lake City, UT, that provides transparent and competitive payment options and inclusive consumer financial products. The Company owns Progressive Leasing, a leading provider of e-commerce, app-based, and in-store point-of-sale lease-to-own solutions, Vive Financial, an omnichannel provider of second-look revolving credit products, Four Technologies, provider of Buy Now, Pay Later payment options, and Build, provider of personal credit building products. More information about PROG Holdings and its companies can be found at https://investor.progholdings.com/.

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Investor Contact

John A. Baugh, CFA

VP, Investor Relations

[email protected]

Media Contact

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Director, Corporate Communications

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KEYWORDS: Utah United States North America

INDUSTRY KEYWORDS: Technology Other Retail Specialty Office Products Public Relations/Investor Relations Fashion Payments Cosmetics Communications Retail Convenience Store Catalog Bridal Finance Fintech Professional Services Online Retail Luxury Discount/Variety Home Goods Department Stores Software

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Coya Therapeutics (“Coya”) Appoints Industry and Drug Development Veteran, Dr. Fred Grossman, to President and Chief Medical Officer succeeding Dr. Adrian Hepner

• Dr. Grossman brings over 20 years of drug development expertise having held senior executive leadership positions in large and small pharmaceutical companies leading the development and FDA approval of numerous multi-billion dollar blockbuster drugs addressing significant unmet medical needs particularly across CNS disorders.
• Dr. Grossman held executive positions at Eli Lilly, Johnson & Johnson, Bristol Myers Squibb, and Sunovion. He served as President and Chief Medical Officer at Glenmark Pharmaceuticals (BSE: 532296) as well as Chief Medical Officer at Mesoblast, Inc. (NASDAQ: MESO).
• Dr. Grossman is Board-Certified in Psychiatry and a Fellow of the American Psychiatric Association and was a Fellow at the National Institutes of Health (NIH). He has held several academic appointments and authored numerous scientific publications.
• Dr. Grossman will succeed Dr. Hepner, who is transitioning his position due to personal reasons, but will remain committed to Coya as Clinical and Strategic Advisor.

 

HOUSTON–(BUSINESS WIRE)–
Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance Treg function, today announced the appointment of Dr. Fred Grossman to its senior management team as President and Chief Medical Officer.

Dr. Grossman will succeed Dr. Adrian Hepner in this role, effective July 17^th, 2023, and will leverage his over two decades of clinical development expertise to guide and oversee all of Coya’s development programs, including its lead asset, COYA 302, for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Prior to joining Coya, Dr. Grossman held executive positions at Eli Lilly, Johnson & Johnson, Bristol Myers Squibb, and Sunovion. He also served as President and Chief Medical Officer at Glenmark Pharmaceuticals, (BSE: 532296), a $1.5 Billion per annum global pharmaceutical company based in India, overseeing development of the entire pipeline including generics, complex generics including 505(b)(2) candidates, and next-generation biologics (including bi-specific antibodies). He also previously served as Chief Medical Officer at Mesoblast, Inc. (NASDAQ: MESO), developing allogeneic cellular therapies for inflammatory diseases.

“We are grateful for Dr. Hepner’s leadership and excellence in positioning Coya and look forward to having him continue to collaborate with the Company in moving our assets forward. We also welcome Dr. Grossman, who brings decades of clinical development experience and successful execution,” stated Howard H. Berman, Ph.D., CEO of Coya Therapeutics.

“Leading Coya’s development programs was a great honor. I am proud of all the accomplishments we’ve made to date, and I continue to be excited and very optimistic about the future of the Company. This transition due to personal reasons gives me a fantastic opportunity to continue supporting Coya’s strategy and its development programs with the ultimate goal of delivering innovative, safe and effective treatments to patients,” Dr. Hepner said.

Dr. Grossman commented: “I look forward to building upon the achievements of Dr. Hepner and the Team and contributing towards advancing the development of Coya’s very innovative multi-modal Treg pipeline addressing areas of significant unmet medical needs across neurodegenerative and autoimmune disorders.”

About Coya Therapeutics, Inc.

Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to a sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s lead therapeutic programs includes Treg-enhancing biologics (COYA 300 Series product candidates) COYA 301 and COYA 302, which are intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation. For more information about Coya, please visit www.coyatherapeutics.com

Forward-Looking Statements

This press release contains “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230705959229/en/

Investor Contact

David Snyder

[email protected]

Hayden IR:

James Carbonara

(646)-755-7412

[email protected]

Media Contact

Anna Marie Imbordino

[email protected]

917-680-8765

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INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health Clinical Trials

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Posted on July 5, 2023 9:26 am

Limbach Holdings, Inc. Acquires Chattanooga, TN – Based Specialty Industrial Contractor ACME Industrial Piping, LLC

Limbach Holdings, Inc. Acquires Chattanooga, TN – Based Specialty Industrial Contractor ACME Industrial Piping, LLC

WARRENDALE, Pa.–(BUSINESS WIRE)–
Limbach Holdings, Inc. (Nasdaq: LMB) (“Limbach” or the “Company”) today announced the closing of the acquisition of Chattanooga, TN-based specialty industrial contractor ACME Industrial Piping, LLC (“ACME”) for an enterprise value of $5 million in an all-cash transaction.

Transaction Highlights

• ACME specializes in performing industrial maintenance, capital project work, and emergency services for specialty chemical and manufacturing clients, and is a leading mechanical solutions provider for hydroelectric producers.

• ACME’s business model aligns well with Limbach’s emphasis on expanding the Owner Direct Relationships (“ODR”) segment, including significant owner-direct exposure and an indispensable ‘on-premise’ presence at a number of Fortune 500 caliber customers.

• ACME expects to contribute on average $10 million in revenue and in excess of $1 million in EBITDA annually.

• Total consideration paid by Limbach at closing was $5 million (subject to typical working capital adjustments), sourced from available cash, with performance-based, contingent earn-outs totaling $2.5 million potentially being paid out as part of the transaction over the next two years.

Background on ACME

Founded in 1968, ACME serves industrial customers in the greater Chattanooga, TN market and hydroelectric customers nationally, with a concentration in the Southeast region. ACME provides mechanical construction, process piping and pipe fabrication capabilities, with an emphasis on delivering customized, quick response solutions for owners of critical process facilities. ACME is recognized nationally as “The EMTs of the Industrial Market.”

Management Comments

Michael McCann, Limbach’s President and Chief Executive Officer, said, “We’re excited to welcome Jim Bailey and the ACME team. We believe ACME is a perfect fit with Limbach’s dynamic mechanical solutions platform, both operationally and culturally. ACME aligns well with our ODR segment, with a focus on performing mission critical work for customers that value immediate access to a trusted partner to help manage and optimize their facility assets. ACME has a number of Fortune 500 industrial clients as customers. We are excited to expand those relationships and to leverage the rest of Limbach’s capabilities across an entirely new customer base. Additionally, we’re excited by ACME’s niche as a market leader in maintaining and servicing hydroelectric infrastructure. This is a new niche for Limbach, which we intend to expand and leverage further. With the transaction closing mid-year, we expect that ACME’s impact on Limbach’s revenue and earnings in 2023 will be immaterial. Our immediate focus will be on integration and driving revenue synergies that we believe will add meaningfully to 2024 results and beyond. More generally, we continue to view the acquisition environment favorably, and remain committed to executing additional transactions that meet our acquisition criteria.”

ACME owner Jim Bailey added, “We’re excited to join the Limbach family and to bolster its Southeast industrial presence alongside our new colleagues at Chattanooga-based Jake Marshall, LLC. I’m confident that the addition of Limbach’s engineering and design capabilities and corporate services platform, together with our collective focus on revenue synergies and gross profit optimization, will allow us to maximize the opportunities in our market. In addition, I’m most excited about the alignment of the ACME and Limbach corporate cultures, and the significant opportunities available to our employees to develop professionally and to grow and advance their careers.”

About Limbach

Limbach is a building systems solutions firm with expertise in the design, prefabrication, installation, management and maintenance of heating, ventilation, air-conditioning (“HVAC”), mechanical, electrical, plumbing and controls systems. With over 1,500 team members and 17 offices located throughout the United States, we partner with institutions with mission-critical infrastructures, such as data centers and healthcare, industrial & light manufacturing, cultural & entertainment, higher education, and life science facilities. With Limbach’s full life-cycle capabilities, from concept design and engineering through system commissioning and recurring 24/7 service and maintenance, Limbach is positioned as a value-added and indispensable partner for building owners, construction managers, general contractors, and energy service companies.

Forward-Looking Statements

We make forward-looking statements in this press release within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts for future events, including, without limitation, the expected contribution from and related to our acquisition of ACME, our earnings, Adjusted EBITDA, revenues, expenses, backlog, capital expenditures or other future financial or business performance or strategies, results of operations or financial condition, and in particular statements regarding the impact of the COVID-19 pandemic on the construction industry in future periods, timing of the recognition of backlog as revenue, the potential for recovery of cost overruns, and the ability of Limbach to successfully remedy the issues that have led to write-downs in various business units. These statements may be preceded by, followed by or include the words “may,” “might,” “will,” “will likely result,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or similar expressions. These forward-looking statements are based on information available to us as of the date they were made and involve a number of risks and uncertainties which may cause them to turn out to be wrong. Some of these risks and uncertainties may in the future be amplified by the COVID-19 outbreak and there may be additional risks that we consider immaterial or which are unknown. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date, and we do not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Please refer to our most recent annual report on Form 10-K, as well as our subsequent filings on Form 10-Q and Form 8-K, which are available on the SEC’s website (www.sec.gov), for a full discussion of the risks and other factors that may impact any forward-looking statements in this press release.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20230705946463/en/

Investor Relations


The Equity Group, Inc.

Jeremy Hellman, CFA

Vice President

(212) 836-9626 / [email protected]

KEYWORDS: United States North America Pennsylvania Tennessee

INDUSTRY KEYWORDS: Engineering Other Construction & Property Manufacturing Construction & Property Building Systems Other Manufacturing

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Unity Announces Second Quarter 2023 Financial Results Webcast

SAN FRANCISCO–(BUSINESS WIRE)–
Unity (NYSE: U) announced today it will release second quarter 2023 financial results after the market close on Wednesday, August 2, 2023, with a webcast to follow at 2 p.m. PT/5 p.m. ET.

The webcast and shareholder letter can be accessed at investors.unity.com. A replay of the webcast will also be available on Unity’s Investor Relations website.

About Unity Software Inc. (Unity)

Unity is the world’s leading platform for creating and growing interactive, real-time 3D (“RT3D”) content and experiences. Our comprehensive set of software and AI solutions supports content creators of all sizes through the entire development lifecycle as they build, run, and grow immersive, real-time 2D and 3D content and experiences for mobile phones, tablets, PCs, consoles, and augmented and virtual reality devices. For more information, visit Unity.com.

Unity uses its website (investors.unity.com), filings with the SEC, press releases, social media posts, public conference calls, and public webcasts as means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

Source: Unity

View source version on businesswire.com: https://www.businesswire.com/news/home/20230705031575/en/

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Richard Davis

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Janus Henderson Extends Partnership with Greenwood Project, Offers Exclusive Seminar by Nobel Laureate

DENVER–(BUSINESS WIRE)–
Janus Henderson Investors extended its partnership with the Greenwood Project by granting the organization funds, via the Janus Henderson Foundation, to host a unique seminar for college scholars featuring Nobel Prize winner and Janus Henderson Chief Investment Strategist, Myron Scholes, Ph.D.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230705987200/en/

The inaugural seminar, called “The Myron Scholes Experience,” kicked off this month in Chicago, featuring presentations from Scholes, as well as Head of Global Asset Allocation Ashwin Alankar, Ph.D., and Director of Asset Allocation Strategies Philip Maymin, Ph.D.

The topics covered included decarbonization, innovation, compound returns, risk management, asset and option valuation, behavioral finance, and more. Scholes also talked about his background in economics and the significant contributions he’s made to the field.

The goal was to give students access to a storied academic in the field of economics, and experienced leaders from the asset management industry. Approximately 70 Greenwood Project scholars participated.

Myron Scholes, Ph.D., Chief Investment Strategist for Janus Henderson Investors and Nobel Laureate, said:

“It was such a pleasure to spend time with aspiring financial professionals and academics. The enthusiasm of the Greenwood Project scholars was apparent, and their engagement revealed a hunger to learn. We appreciate partnering with an organization that is doing so much to transform the lives of Black and Latinx students while strengthening the future of the financial services industry.”

Eugene Flood, Jr., Ph.D., Independent Non-Executive Director on Janus Henderson’s Board, said:

“Our Board is encouraged by the creative ways in which Janus Henderson and the Foundation continue to build the relationship with the Greenwood Project. We know how important financial literacy is and that careers in financial services can change individuals’ lives and their communities for the better. Access to accomplished professionals and academics like Myron and his team gives students the chance to see what’s possible in the world of finance and develop a vision for achieving their goals.”

Kwesi Smith, Greenwood Project Executive Director, said:

“The remarkable impact of Myron Scholes and his esteemed team on our Greenwood Project scholars cannot be overstated. Their mentorship and guidance created a transformative educational journey for our aspiring financial professionals. We are deeply grateful for this partnership, which not only empowers our Black and Latinx scholars but also strengthens the future of the financial services industry.”

The Greenwood Project exposes high-achieving Black and Latinx students to career opportunities in the financial industry through paid internships, educational field trips, a FinTech coding bootcamp, and a summer Financial Institute that provides simulated training for the financial services and technology industries. All training programs enable students to earn income while learning, further increasing their chances of succeeding.

The Janus Henderson Foundation is Janus Henderson Investor’s charitable giving arm.

Notes to editors

Janus Henderson Group is a leading global active asset manager dedicated to helping clients define and achieve superior financial outcomes through differentiated insights, disciplined investments, and world-class service.

As of March 31, 2023, Janus Henderson had approximately US$311 billion in assets under management, more than 2,000 employees, and offices in 24 cities worldwide. Headquartered in London, the company is listed on the NYSE and the ASX.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230705987200/en/

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Janus Henderson Investors

Media:

Jeremy Osheim, Manager of Corporate Communications and Media Relations, North America

+1 303-336-7464

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Jim Kurtz, Head Investor Relations

303-336-4529

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(Photo: Business Wire)

Hologic to Announce Financial Results for the Third Quarter of Fiscal 2023 on Monday, July 31, 2023

MARLBOROUGH, Mass.–(BUSINESS WIRE)–
Hologic, Inc. (Nasdaq: HOLX) announced today that the Company plans to release its financial results for the third quarter of fiscal 2023 on Monday, July 31, after the market closes. In conjunction with the release, management will host a conference call that day at 4:30 p.m. Eastern Time.

Interested participants may listen to the call by dialing (877) 400-0505 (in the United States and Canada) or +1 (773) 305-6865 (for international callers) and referencing access code 3332917. Participants may also click here to join. Participants should dial in 5-10 minutes before the call begins. A webcast replay will be available approximately two hours after the call ends.

Hologic will provide a live and webcast replay of the call on the Company’s website at investors.hologic.com. The call will be available there for 30 days.

About Hologic

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

SOURCE: Hologic, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230705741853/en/

Paula Izidoro

Manager, Investor Relations and Social Media

858-410-8904

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The Marygold Companies Initiates Plans to Adapt its Mobile Fintech App for the UK Market Following Recent Introduction in U.S.

Experienced Fintech Executive Ian Gass Named Chief Product Officer for Marygold & Co. (UK)

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–
The Marygold Companies, Inc. (“TMC,” or the “Company”) [NYSE American: MGLD], a diversified global holding firm, today announced that it has appointed experienced fintech executive Ian Gass as Chief Product Officer in the UK, a newly created position, effective immediately. The Company plans to launch its mobile banking and financial services app in the UK in 2024 through its Marygold & Co. (UK) subsidiary, following last month’s formal product launch by Marygold & Co. in the United States.

The app is an all-in-one banking and payment services app offering FDIC-insured accounts through its banking partner with a Debit Mastercard^®. It is like having a private banker on a cell phone and having a secure way to send, receive, spend, save and invest with no banking fees or minimum balance requirements. Features include contactless payment options utilizing technology that allows touch-free tap-to-pay transactions with a Marygold Debit Mastercard^®; the capability for unlimited, customized, individual savings accounts called Money Pools to help investors reach their financial goals; and PayAnyone™ capability, which authorizes users to send payments to anyone.

Gass, who assumes responsibility to oversee final development of the app for the UK market, brings extensive experience in the fintech and financial services sector. Most recently, he co-founded an open banking fintech business supporting digital payments in the UK. He previously held senior management positions at Goldman Sachs and Bank of New York Mellon.

“Ian is a perfect fit for the position, bringing extensive hands-on product, operations, and business development experience,” said Nicholas Gerber, TMC’s Chief Executive Officer. “He has an outstanding track record launching, scaling and managing technology businesses targeting B2B and B2C users. We welcome him to the Marygold family.”

Marygold & Co. (UK),under the leadership of Matthew Parden as CEO,was formed in 2021 as a holding company and wholly owned subsidiary of TMC to make acquisitions in the UK. In 2022, it completed the first transaction with the acquisition of Tiger Financial & Asset Management Limited, a UK-based investment adviser, which enabled Marygold to gain a regulatory license and a long-term base of advisory clients. Marygold & Co. (UK) intends to provide multi-channel services to its existing and new clients through both its traditional business and through the new fintech app.

About The Marygold Companies, Inc.

The Marygold Companies, Inc., which changed its name from Concierge Technologies, Inc. in March 2022, was founded in 1996 and repositioned as a global holding firm in 2015. The Company currently has operating subsidiaries in financial services, food manufacturing, printing, security systems and beauty products. TMC’s companies operate under the trade names Marygold & Co., USCF Investments, Tiger Financial & Asset Management Limited, Gourmet Foods, Printstock Products, Brigadier Security Systems and Original Sprout. Offices and manufacturing operations are in the U.S., New Zealand, U.K., and Canada. For more information, visit www.themarygoldcompanies.com.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements, including, but not limited to, launching the app in the UK in 2024, involve significant risks and uncertainties that could cause actual results to differ materially from the expected results and, consequently, should not be relied upon as predictions of future events. These forward-looking statements, including the factors disclosed in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on September 28, 2022, and in the Company’s other filings with the Securities and Exchange Commission, are not exclusive. Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Except as required by law, the Company disclaims any obligation to update or publicly announce any revisions to any of the forward-looking statements contained in this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230705205753/en/

Media and investors, for more information, contact:

Roger S. Pondel

PondelWilkinson Inc.

310-279-5965

[email protected]

Contact the Company:

David Neibert, Chief Operations Officer

949-429-5370

[email protected]

KEYWORDS: California Europe United States United Kingdom North America

INDUSTRY KEYWORDS: Banking Software Mobile/Wireless Other Retail Professional Services Online Retail Fintech Apps/Applications Technology Asset Management Cosmetics Retail Finance

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Posted on July 5, 2023 9:12 am

Guardant Health announces reimbursement approval of Guardant360® CDx liquid biopsy test in Japan

Guardant Health announces reimbursement approval of Guardant360^® CDx liquid biopsy test in Japan

Reimbursement supports expanded access to blood-based comprehensive genomic profiling with Guardant360 CDx for patients with advanced solid tumor cancers and their care teams across Japan

PALO ALTO, Calif.–(BUSINESS WIRE)–
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that it has been informed it will receive national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW), effective July 24, 2023, for its Guardant360^® CDx liquid biopsy test for comprehensive genomic profiling (CGP) for patients with advanced or metastatic solid tumor cancers. This announcement follows the regulatory approval of the Guardant360 CDx test by the MHLW in March 2022.

There were over one million new cancer cases in Japan in 2020 with lung, stomach, prostate, colon and breast being the most prevalent cancer types.¹ The Guardant360 CDx test analyzes circulating tumor DNA (ctDNA) to provide comprehensive genomic profiling, or tumor mutation profiling, for all solid tumor cancers. It is used by healthcare professionals to detect actionable biomarkers in a patient’s blood that may help inform their therapy selection.

Currently, Guardant360 CDx is approved by the MHLW as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda^® (pembrolizumab) and patients with MSI-High advanced colorectal cancer (CRC) who may benefit from Opdivo^® (nivolumab). The MHLW also granted regulatory approval of Guardant360 CDx as a companion diagnostic for identifying patients with metastatic non-small cell lung cancer (NSCLC) who may benefit from treatment with LUMAKRAS™ (sotorasib).

“The decision of the MHLW to provide reimbursement for Guardant360 CDx represents a significant milestone for the company as Japan is the first country in the Asia-Pacific region to reimburse the use of our test to support advanced cancer patients,” said Helmy Eltoukhy, co-CEO of Guardant Health. “We are encouraged by the strong support we have received from oncologists in Japan, and we look forward to furthering these partnerships as we continue our commitment to democratize access to precision oncology and bring blood-based comprehensive genomic profiling to patients and care teams across the region.”

The Guardant360 CDx test has achieved U.S. FDA Approval and is CE-Marked for comprehensive genomic profiling across all solid tumor cancers and has become widely accepted for blood-based CGP worldwide. With more than 350 peer-reviewed publications, the test has been trusted by more than 12,000 oncologists with over 400,000 tests ordered to date.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360^®, Guardant360^® CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantINFINITY™ tests for advanced-stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the commercially launched Shield™ test, aims to address the needs of individuals eligible for cancer screening. For more information, visit guardanthealth.com and follow the company on LinkedIn and Twitter.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2022, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

References:

1. International Agency for Research on Cancer. Japan. Globocan 2020. Accessed online June 29, 2023. https://gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdf

View source version on businesswire.com: https://www.businesswire.com/news/home/20230705875197/en/

Investor Contact:

Alex Kleban

[email protected]

+1 657-254-5417

Media Contact:

Breen Weir

[email protected]

+1 843-384-0095

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Biotechnology Medical Devices Health Genetics Oncology

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