Market Newsdesk

BOSTON and LONDON, Dec. 16, 2024 (GLOBE NEWSWIRE) — Akari Therapeutics, Plc (Nasdaq: AKTX) today announced the appointment of Torsten Hombeck, Ph.D. as Chief Financial Officer, effective December 16, 2024. Dr. Hombeck is a seasoned executive with over 20 years of experience in the biotechnology industry, finance, capital markets and M&A transactions, as well as clinical and commercial product development and regulatory filings in the U.S. and Europe.

“We are pleased with the continued evolution and progress made across multiple fronts. We believe that adding expertise to our leadership team is a key component of ensuring continued progress and importantly our ability to build upon momentum. Having formerly served as our CFO, Dr. Hombeck is intimately acquainted with our operations and goals and brings to Akari a strong business and financial acumen combined with clinical development and commercial expertise, a unique and valuable combination. We look forward to continuing our work with Torsten and leveraging his expertise moving forward,” commented Samir Patel, MD, Akari’s Interim President & CEO.

Dr. Hombeck added, “I am excited to come back to the Akari team during this exciting time as the Company focuses on advancing its first-in-class ADC platform. I believe as we advance our strategy, we have significant potential to drive value for our shareholders. I look forward to working closely alongside our team with the goal of realizing the full value and potential of our promising therapies and advancing our proprietary platform forward.”

Prior to joining Akari, Dr. Hombeck served as the CFO, Corporate Secretary and SVP at Aspira Women’s Health, Inc., a Nasdaq listed commercial-stage diagnostics company focused on the discovery, development and commercialization of novel diagnostic tools that improve gynecologic health outcomes. Prior to that, Dr. Hombeck served as the CFO of Akari Therapeutics from 2019-June 2023 where he raised over $50 million during his tenure.

Additionally, his previous positions include Chief Commercial and Strategy Officer and Managing Director at Promethera Biosciences, and Co-Chief Executive Officer and Chief Business Officer at Cytonet where he played an integral role in its acquisition by Promethera. Dr. Hombeck also served as Chief Financial Officer at both Agennix and GPC Biotech. Dr. Hombeck holds a Masters in Business Administration and a Ph.D. in Finance from the EBS University of Business and Law, Ostrich-Winkel.

About Akari Therapeutics

Akari Therapeutics, Plc (Nasdaq: AKTX) is a biotechnology company developing advanced therapies for autoimmune, oncology and inflammatory diseases. Akari has two lead assets, investigational nomacopan and an antibody drug conjugate (ADC) platform. Nomacopan is a bispecific recombinant inhibitor of complement C5 activation and leukotriene B4 (LTB4) activity. The Company is conducting pre-clinical research of long-acting PAS-nomacopan in geographic atrophy (GA). The Company’s ADC platform includes novel toxins and linkers coupled with important cancer antibody targets. For more information about Akari, please visit akaritx.com.

Cautionary Note Regarding Forward-Looking Statements

This press release includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), about the Company that involve risks and uncertainties relating to future events and the future performance of the Company. Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are based on the Company’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the risk that Akari may not realize the anticipated benefits of its merger with Peak Bio (the “Merger”) in the time frame expected, or at all; the ability to retain and hire key personnel; potential adverse reactions or changes to business relationships resulting from the Merger; the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the combined business; uncertainties as to the long-term value of Akari’s American Depositary Shares (and the ordinary shares represented thereby), including the dilution caused by Akari’s issuance of additional American Depositary Shares (and the ordinary shares represented thereby) in connection with the Merger; risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations; potential delays or failures related to research and/or development of the Company’s programs or product candidates; risks related to any loss of the Company’s patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for the Company’s product candidates, the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by the Company and/or its collaborators or licensees; the extent to which the results from the research and development programs conducted by the Company, and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of the Company’s product candidates; unexpected breaches or terminations with respect to the Company’s material contracts or arrangements; risks related to competition for the Company’s product candidates; the Company’s ability to successfully develop or commercialize its product candidates; potential exposure to legal proceedings and investigations; risks related to changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing, development or commercialization of any of the Company’s product candidates; the Company’s ability to maintain listing of its ADSs on the Nasdaq Capital Market. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov. The Company assumes no, and hereby disclaims any, obligation to update the forward-looking statements contained in this press release.

Investor Contact:

JTC Team, LLC
Jenene Thomas
908.824.0775
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/918992d4-b852-45e7-9956-2c2a533917d8

CNH designs special edition CASE compact track loader inspired by Metallica frontman James Hetfield

Basildon, December 16, 2024

A special edition compact track loader from CNH construction brand CASE Construction Equipment was on display at the YouTube Theater in Inglewood, California, USA at the Helping Hands charity concert. Held on December 13, this annual event is organized by the rock band Metallica’s All Within My Hands charitable foundation.

Following its debut, this custom-designed CASE TV450B compact track loader is destined for use at the ranch of Metallica frontman and co-founder James Hetfield. Hetfield commissioned the design as part of an equipment supply agreement with our CASE brand.

The CNH Design team brought their expertise to the project to develop proposals inspired by Hetfield’s career and persona.

• The winning proposal was submitted by John Piper, a rising design talent here at CNH. Piper crafted a concept that recalled one of Hetfield’s tattoos, a skull with wings, together with the sharp iconic font reminiscent of his band’s graphics and album artwork. He also drew from the pinstriping in Hetfield’s private hotrod collection. All these elements were integrated atop a sandy camouflage pattern reminiscent of Hetfield’s signature Snakebyte electric guitar – a direct request from the artist.
• CNH Senior Designer Darin Weisensel led the production phase of this project, working to bring the custom design to life on the CASE TV450B.

Built at the CASE production facility in Wichita, USA, the TV450B compact track loader is an industry fixture. Tough and rugged, it performs tasks such as digging, loading and dumping in commercial and residential construction activities as well as landscaping.

Our remarkable people transformed this special edition compact track loader from a designer’s sketch into a one-of-a-kind machine, providing our iconic CASE brand with a unique opportunity to make its distinctive mark with an exceptional delivery.

CNH Industrial

(NYSE: CNH) is a world-class equipment, technology and services company. Driven by its purpose of Breaking New Ground, which centers on Innovation, Sustainability and Productivity, the Company provides the strategic direction, R&D capabilities, and investments that enable the success of its global and regional Brands. Globally,

Case IH

and

New Holland

supply 360° agriculture applications from machines to implements and the digital technologies that enhance them; and

CASE

and

New Holland Construction Equipment

deliver a full lineup of construction products that make the industry more productive. The Company’s regionally focused Brands include:

STEYR

, for agricultural tractors;

Raven

, a leader in digital agriculture, precision technology and the development of autonomous systems;

Hemisphere

, a leading designer and manufacturer of high-precision satellite-based positioning, and heading technologies;

Flexi-Coil

, specializing in tillage and seeding systems;

Miller

, manufacturing application equipment; and

Eurocomach,

producing a wide range of
mini and midi excavators for the construction sector, including electric solutions.

Across a history spanning over two centuries, CNH has always been a pioneer in its sectors and continues to passionately innovate and drive customer efficiency and success. As a truly global company, CNH’s 40,000+ employees form part of a diverse and inclusive workplace, focused on empowering customers to grow, and build, a better world.

For more information and the latest financial and sustainability reports visit:

cnh.com

For news from CNH and its Brands visit:

media.cnh.com

Media contacts:

Rebecca Fabian	Alex Ellis
North America	United Kingdom
Tel. +1 312 515 2249	Tel. +44 (0)758 106 1696

[email protected]

Attachments

• James_Hetfield_CASE_special_edition_CTL
• 20241216_PR_CNH_Hetfield_CASE_Design
• On display

PALO ALTO, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) — Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing the treatments for obesity, neurodegenerative, cardiometabolic disease (following formation of its proposed joint venture with IPMC Company), and non-opioid pain management products for acute and chronic pain, today announced that it has voluntarily made an early installment payment in the aggregate amount of $13.2 million under its senior secured promissory note (the “Oramed Note”) issued to Oramed Pharmaceuticals Inc. (Nasdaq: ORMP, “Oramed”) in September 2023. Subsequent to this early installment payment, the remaining principal balance under the Oramed Note will be payable in one final payment on March 21, 2025, and the Oramed Note will be retired in its entirety.

For more information on Scilex Holding Company, refer to www.scilexholding.com

For more information on Semnur Pharmaceuticals, refer to www.semnurpharma.com

For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability

For more information on ZTlido®, including Full Prescribing Information, refer to www.ztlido.com.

For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com.

For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com.

https://www.facebook.com/scilex.pharm

https://www.linkedin.com/company/scilex-holding-company/

[email protected]

About Scilex Holding Company

Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing the treatment for neurodegenerative and cardiometabolic diseases, and non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.

In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA^TM” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022.

Scilex Holding Company is headquartered in Palo Alto, California.

For more information on Scilex Holding Company, refer to www.scilexholding.com

About Semnur Pharmaceuticals, Inc.

Semnur Pharmaceuticals, Inc. (“Semnur”) is a clinical-late stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s lead program, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica.

Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto, California.

For more information on Semnur Pharmaceuticals, refer to www.semnurpharma.com

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s ability to repay the remaining balance of the Oramed Note, the impact of this early installment payment on Scilex’s balance sheet, Scilex’s proposed joint venture with IPMC Company and the potential development and commercialization of treatments for obesity, neurodegenerative, cardiometabolic disease, Scilex’s belief that it is well-positioned to pursue collaborations, expand commercialization efforts and bring additional innovative products to market, the Company’s outlook, goals and expectations for 2024, and the Company’s development and commercialization plans. Although each of Scilex and its subsidiaries believes that it has a reasonable basis for each forward-looking statement contained in this press release, each of Scilex and its subsidiaries caution you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain.   

Risks and uncertainties that could cause actual results of Scilex to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: Scilex’s ability to make the final installment payment on the Oramed Note, Scilex’s ability to consummate a joint venture or any other transaction with IPMC Company and develop and commercialize treatments for obesity, neurodegenerative, cardiometabolic disease, risks associated with the unpredictability of trading markets; general economic, political and business conditions; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the SEC, including its Annual Reports on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law.

Contacts:

Investors and Media
Scilex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (650) 516-4310

Email: [email protected] 

Website: www.scilexholding.com

SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned.

ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company.

Gloperba® is the subject of an exclusive, transferable license to Scilex Holding Company to use the registered trademark.

ELYXYB® is a registered trademark owned by Scilex Holding Company.

Scilex Bio™ is a trademark owned by Scilex Holding Company.

All other trademarks are the property of their respective owners.

© 2024 Scilex Holding Company All Rights Reserved.

Classic Burger Concept Celebrates Eleven International Openings 

LOS ANGELES, Dec. 16, 2024 (GLOBE NEWSWIRE) —

FAT (Fresh. Authentic. Tasty.) Brands Inc.
, parent company of Johnny Rockets and 17 other restaurant concepts, announces eleven new international openings for Johnny Rockets in 2024. International locations account for approximately 55 percent of Johnny Rockets worldwide and are a key growth area for the brand.

Since January 2024, Johnny Rockets has opened two locations in Chile, two locations in Bali, Indonesia, four locations in Mexico, two locations in Brazil and one ghost kitchen in the United Arab Emirates. Non-traditional locations at Fantislandia II Theme Park in Chile, Juazeiro de Norte Airport in Brazil, Gusti Ngurah Rai International Airport in Bali, Aeropuerto Internacional Felipe Angeles and Aeropuerto Internacional de Ciudad Juarez in Mexico accounted for five of the eleven recent openings abroad, underscoring Johnny Rockets’ strength in and commitment to continued growth in non-traditional spaces such as airports and theme parks.

“The demand for the iconic Johnny Rockets’ experience continues to remain high internationally,” said Jake Berchtold, COO of FAT Brands’ Fast Casual Division. “Similarly, we continue to cement ourselves in key growth countries such as Brazil, where we now tally over 40 locations, and in Mexico, with almost 25 locations.”

The first Johnny Rockets restaurant opened June 6, 1986, on Melrose Avenue in Los Angeles. Since that time, the chain’s timeless all-American brand has connected with customers across the U.S. and in more than 25 other countries around the globe. The Johnny Rockets team’s passion for delivering fresh, classic American fare is only equaled by their commitment to providing a superb guest experience.

For more information on Johnny Rockets, visit www.johnnyrockets.com.

###

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets and develops fast casual, quick-service, casual and polished casual dining restaurant concepts around the world. The Company currently owns 18 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Smokey Bones, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

About Johnny Rockets

Founded in 1986 on Melrose Avenue in Los Angeles, Johnny Rockets is a world-renowned international franchise that offers high-quality, innovative menu items including Certified Angus Beef^® cooked-to-order hamburgers, veggie burgers, chicken sandwiches, crispy fries, and rich, delicious hand-spun shakes and malts. With over 325 locations in over 25 countries around the globe, this dynamic lifestyle brand offers friendly service and upbeat music contributing to the chain’s signature atmosphere of relaxed, casual fun.

For more information, visit www.johnnyrockets.com. 

MEDIA C
ONTACT
:

Erin Mandzik, FAT Brands
[email protected]
860-212-6509

DENVER, Dec. 16, 2024 (GLOBE NEWSWIRE) — EverCommerce (NASDAQ: EVCM), a leading provider of SaaS solutions for service SMBs, announced today that it successfully repriced the fixed rate component of its $533.5 million term loan as part of its continued transformation and optimization efforts. The term loan was repriced at par and will bear an interest rate of SOFR plus 2.50%.

The repricing reduced the fixed component of the interest rate determination by 50 basis points (from SOFR plus 3.0%) and eliminated the credit spread adjustment, resulting in an annualized interest cost savings of approximately $3.3 million on the outstanding principal amount as of September 30, 2024. There were no other material amendments to the term loan credit facility other than the repricing.

EverCommerce previously announced the execution of a series of interest rate swaps with a combined notional amount of $425 million, effectively reducing the company’s floating rate exposure.

Investor Contact: 
Brad Korch 
SVP and Head of Investor Relations 
720-796-7664 
i[email protected]

Press Contact: 
Jeanne Trogan 
VP of Corporate Communications 
512-705-1293 
[email protected]

About EverCommerce 

EverCommerce (Nasdaq: EVCM) is a leading service commerce platform, providing vertically-tailored, integrated SaaS solutions that help more than 690,000 global service-based businesses accelerate growth, streamline operations, and increase retention. Its modern digital and mobile applications create predictable, informed, and convenient experiences between customers and their service professionals. With its EverPro, EverHealth, and EverWell brands specializing in Home, Health, and Wellness service industries, EverCommerce provides end-to-end business management software, embedded payment acceptance, marketing technology, and customer experience applications. Learn more at EverCommerce.com. 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding anticipated annual interest cost savings. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, we may need to incur additional indebtedness or seek capital through new equity or debt financings in order to support the growth of our business as well as the other factors described in our Annual Report on Form 10-K for the year ended December 31, 2023 and updated by our other filings with the SEC. These factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

LEXINGTON, Mass., Dec. 16, 2024 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (NASDAQ: TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that its multi-year capital equipment supplier agreement with Vizient, Inc., the largest member-driven health care performance improvement company in the United States, has been extended through March 31, 2026. The products covered under the contract with Vizient include the T2Dx^® Instrument, the T2Bacteria^® Panel and the T2Candida^® Panel, which detect sepsis-causing bacterial and fungal pathogens directly from whole blood.

“We are pleased to extend our multi-year agreement with Vizient, the nation’s largest group purchasing organization. This reiterates the continued value that our products offer to patients suspected of sepsis,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “We believe there is a strong need for hospitals to have more effective and direct-from-blood rapid diagnostics that enable faster targeted antimicrobial treatment and this Vizient extension provides hospitals with greater access to our life-saving technology.”

Through the extended contract, Vizient members will continue to have access to broader exposure and contracted pricing for the T2Dx^® Instrument, the T2Bacteria^® Panel and the T2Candida^® Panel, the only FDA-cleared products able to detect sepsis-causing pathogens directly from whole blood.

Vizient serves a wide range of health care organizations that represent a combined purchasing volume of approximately $140 billion annually and includes more than 65 percent of the nation’s acute care hospitals and 97 percent of all academic medical centers.

About T2 Biosystems

T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products are powered by the proprietary T2 Magnetic Resonance (T2MR^®) technology and include the T2Dx^® Instrument, the T2Bacteria^® Panel, the T2Candida^® Panel, the T2Resistance^® Panel, and the T2Biothreat™ Panel. T2 Biosystems has an active pipeline of future products, including the U.S. T2Resistance Panel, the T2Lyme™ Panel, and the expended T2Candida Panel to add the detection of Candida auris. For more information, please visit www.t2biosystems.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the likelihood that the extension of the multi-year agreement will result in greater hospital access to T2 Biosystems’ products; and all other statements that include the words “expect,” “may,” “should,” “anticipate,” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission, or SEC, on April 1, 2024, and other filings the Company makes with the SEC from time to time, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

Investor Contact:

Philip Trip Taylor, Gilmartin Group
[email protected]
415-937-5406

WHITE BEAR LAKE, Minnesota , Dec. 16, 2024 (GLOBE NEWSWIRE) — Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a hearing health company focused on providing hearing loss suffers with innovative solutions today announces four new patents.

The US Patent & Trademark Office issued Envoy Medical Corporation US Pat. No. 12,151,102 on November 25, 2024. The title of the patent is Combination Hearing Aid and Cochlear Implant System. This patent relates to updating a transfer function associated with an implanted signal processor of a cochlear implant system to compensate for operation of an external auditory aid device, such as a hearing aid, that affects a stimulus received at an input source of the cochlear implant system and input signals representative of the stimulus.

The European Patent Office will grant European Patent No. 4255554 to Envoy Medical Corporation on January 1, 2025. The title is Combination Hearing Aid and Cochlear Implant System. This patent relates to cochlear implant systems and receiving a status indicator signal indicative of whether an external auditory aid device (e.g., a hearing aid) is active, and updating a transfer function of a signal processor of the cochlear implant system to compensate for operation of the external auditory aid device if it is active.

The European Patent Office will grant European Patent No. 4255555 to Envoy Medical Corporation on January 1, 2025. The title is Cochlear Implant Stimulation Calibration. This patent relates to calibrating current flow in a cochlear implant system. A switching network can be controlled to place a source element of a cochlear implant system in communication with a testing circuit. An amount of electrical current provided to the testing circuit can be determined, and the output of the source element can be adjusted based on the determined amount of electrical current.

The European Patent Office will grant European Patent No. 4319866 to Envoy Medical Corporation on January 1, 2025. The title is Cochlear Implant System with Electrode Impedance Diagnostics. This patent relates to electrode impedance diagnostics in cochlear implant systems.  A cochlear implant system can determine an impedance associated with a current path from a source element to a return electrode and determine one or more stimulation parameters for the source element based on the impedance. An example stimulation parameter can include a compliance voltage for the source element to provide a prescribed current.

“We will continue to invest in the development and protection of intellectual property as we grow,” explained Brent Lucas, CEO of Envoy Medical, “We intend for Envoy Medical to be synonymous with meaningful innovation in the hearing loss industry for decades to come.”

About the Fully Implanted Acclaim® Cochlear Implant

We believe the fully implanted Acclaim Cochlear Implant (“Acclaim CI”) is a first-of-its-kind hearing device. Envoy Medical’s fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.

The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.

The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.

CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.

About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)

The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear’s natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can’t lose it. You don’t clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.

*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.

Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.

Additional Information and Where to Find It

Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operational improvements and capital investments; the ability to obtain additional patents and develop future products or product improvements, the Acclaim CI being the first to market fully implanted cochlear implant,  the timing and results of clinical trials of the Acclaim CI, and the participation of any institution in such trials; the safety, performance, and market acceptance of the Acclaim CI; the size of Envoy Medical’s addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical’s current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical’s Class A Common Stock; changes in or removal of Envoy Medical’s shares inclusion in any index; Envoy Medical’s success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical’s suppliers, or disruptions in Envoy Medical’s own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical’s key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements” in the Annual Report on Form 10-K filed by Envoy Medical on April 1, 2024, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical’s good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical. 

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Investor Relations:

Envoy Medical Investor Relations 
(651) 361-8043
[email protected]

Media Contact:

[email protected]

MOUNTAIN VIEW, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) — LegalZoom (Nasdaq:LZ), a leading online platform for legal services, is pleased to announce a multi-year strategic partnership with 1-800Accountant, a national financial services firm. With this partnership, LegalZoom will offer customers access to year-round, full-service bookkeeping and tax solutions delivered by 1-800Accountant, ensuring small business owners can access tax preparation support that best meets their needs. This collaboration enhances LegalZoom’s ecosystem of products, partnerships and services that support small business owners’ legal, compliance, and business management requirements.

A recent LegalZoom customer survey revealed tax management, liability protection, and legitimacy as key motivations for forming their businesses. As a result, LegalZoom customers frequently cited tax return preparation and advisory as critically important services to support their success, as they struggle to navigate the time consuming, manual, and oftentimes confusing tax preparation process.

“Our partnership with 1-800Accountant provides a timely, meaningful solution for our small business owners as they tackle one of their biggest challenges: tax preparation,” said Jeff Stibel, Chairman and Chief Executive Officer of LegalZoom. “We are dedicated to supporting entrepreneurs at every stage of their journey. By integrating 1-800Accountant’s best-in-class tax services into our ecosystem, we’re offering even more value to our customers and empowering them to focus on what they do best—growing their business.”

1-800Accountant specializes in providing financial expertise to small businesses across all industries. Its full-service bookkeeping and tax solutions are powered by a mix of expert CPAs and technology, providing a streamlined experience which enables business owners to minimize tax management, maximize annual tax savings, and give them peace of mind and time to focus on growing their business.

Brendon Pack, Chief Executive Officer of 1-800Accountant, added, “With this partnership, LegalZoom customers will have access to our year-round expert-led bookkeeping and tax services that can help them identify tax-saving opportunities, file accurate returns, and stay compliant with ever-changing tax regulations. We’re proud to collaborate with LegalZoom to make financial services accessible to every small business owner.”

This product offering is expected to launch to LegalZoom customers by January 2025. The agreement outlines minimum lead requirements and corresponding minimum annual revenue over the multi-year term.

About LegalZoom

LegalZoom is a leading online platform for business formation in the United States. Driven by a mission to unleash entrepreneurship, LegalZoom delivers comprehensive legal and compliance products and expertise for small business owners through easy-to-use technology. From free business formations to business management solutions and professional advisory services, LegalZoom supports millions of small business owners and their families throughout the entrepreneurial journey. Founded on the belief that everyone should have affordable access to legal and financial expertise, LegalZoom empowers entrepreneurs to make their dream a reality. For more information, please visit www.legalzoom.com.

About 1-800Accountant

1-800Accountant’s mission is to provide financial expertise to small businesses in every state and industry. Its services are powered by a mix of expert CPAs and technology, enabling businesses to minimize tasks while maximizing tax savings. This empowers owners and entrepreneurs to focus on growing their business while 1-800Accountant handles the rest. For more information, please visit www.1800accountant.com.

Contact: [email protected]