Day: January 18, 2024

Ranked 37 of 100, Fluence is one of only a few cleantech companies named to the Forbes list

ARLINGTON, Va., Jan. 18, 2024 (GLOBE NEWSWIRE) — Fluence Energy, Inc. (“Fluence”) (NASDAQ: FLNC), a leading global provider of energy storage products, services, and optimization software for renewables and storage, today announced that the company has been named a Forbes 2024 Most Successful Mid-Cap Company. Ranked 37 of 100, Fluence is one of only a few cleantech companies named to the Forbes annual list of America’s Most Successful Mid-Cap Companies. The top 100 Forbes ranking is based on earnings growth, sales growth, return on equity, and total stock return for the last five years, with more of the ranking’s weight given to the latest year’s data.

“This recognition reiterates our position as a leading global provider of energy storage solutions and optimization software for renewables and storage. Our market advantage is fortified by offering our customers an ecosystem of solutions and key competitive differentiators. Among those differentiators are bankability, scale, supply chain security, and industry-leading safety,” said Fluence President and Chief Executive Officer Julian Nebreda. “Our strong performance in fiscal year 2023 serves as a solid foundation as we continue accelerating progress towards our mission of transforming the way we power our world.”

Forbes used data from FactSet to find the best performers and compile its annual list of America’s Most Successful Mid-Cap Companies. The process included screening more than 3,000 companies with a market value between $2 billion and $10 billion – only considering companies that also had positive sales growth over the past 12 months and a share price of at least $5.

Fluence was also recently named the top global provider of battery-based energy storage systems based on market share of installed and planned projects, according to the 2023 Battery Energy Storage System Integrator Report published by S&P Global Commodity Insights. As an industry leader, Fluence recently surpassed 20 GWh of contracted and installed energy storage projects globally. The company has partnered with customers to deploy some of the world’s largest and most complex energy storage systems. The global fleet of Fluence assets has nearly 3 million operating hours to date. Additionally, Fluence’s cloud-based software products have a combined portfolio of more than 22.3 GW of assets contracted or under management globally.

About Fluence

Fluence Energy, Inc. (Nasdaq: FLNC) is a global market leader in energy storage products and services, and optimization software for renewables and storage. With a presence in 47 markets globally, Fluence provides an ecosystem of offerings to drive the clean energy transition, including modular, scalable energy storage products, comprehensive service offerings, and AI-enabled SaaS products for managing and optimizing renewables and storage from any provider. The company is transforming the way we power our world by helping customers create more resilient and sustainable electric grids.

For more information, visit our website, or follow us on LinkedIn or Twitter. To stay up to date on the latest industry insights, sign up for Fluence’s Full Potential Blog.

Forward-Looking Statements

The statements described herein that are not historical facts are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding future financial and operational performance of Fluence. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this press release, words such as “may,” “possible,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” or “continue,” or the negative of these terms or other similar expressions and variations thereof and similar words and expressions are intended to identify such forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

The forward-looking statements contained in this press release are based on our current expectations and beliefs concerning future developments, as well as a number of assumptions concerning future events, and their potential effects on our business. These forward-looking statements are not guarantees of performance, and there can be no assurance that future developments affecting our business will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control), or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, which include, but are not limited to, those factors set forth under Item 1A.“Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended September 30, 2023, filed with the Securities and Exchange Commission (“SEC”) on November 29, 2023, and in other filings we make with the SEC from time to time. New risks and uncertainties emerge from time to time and it is not possible for us to predict all such risk factors, nor can we assess the effect of all such risk 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. Should one or more of these risks or uncertainties materialize, or should any of the assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. You are cautioned not to place undue reliance on any forward-looking statements made in this press release. Each forward-looking statement speaks only as of the date of the particular statement, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that occur, or which we become aware of, after the date hereof, except as otherwise may be required by law.

Media Contact
Shayla Ebsen, Director of Communications
Email: media.na@fluenceenergy.com
Phone: +1 (605) 645-7486

Analyst Contact
Lexington May, Vice President of Investor Relations
Email: investorrelations@fluenceenergy.com
Phone: +1 (713) 909-5629

GlobeNewswire Distribution ID 9019822

MONACO, Jan. 18, 2024 (GLOBE NEWSWIRE) — A carbon footprint calculator for superyachts targeting the environmental objective to mitigate CO2 emissions in yachting. It is the Sea Index, a tool created in 2020 by the Yacht Club de Monaco to accelerate the diffusion of more sustainability in this sector. Basically, it evaluates the energy intensity of superyachts over 25 meters on a scale from 0 to 5 taking a CO2 snapshot of the vessel. As part of its collective ‘Monaco, Capital of Advanced Yachting’ initiative, the YCM remains a key player in the yachting world being both a driving force and a role model.

“The Sea Index is a rating system that was put in place by the Yacht Club de Monaco. We wanted to raise awareness on energy intensity. We’ve also devised a certification process and M/Y Kasper 7 is one of the yachts that’s gone through the process. They’ve been certified by an independent third-party maritime Class Society issuing the certificates on behalf of the Sea Index, that is very important for us and the certification shows the amount of grams of Co2 that’s emitted into the atmosphere by the vessel,” explains the head of the project Natalie Quevert. “The whole point for us is to raise awareness but more importantly to act. We’re a small cog within a bigger wheel which is part of the principality’s national policy,” she adds.

Sea Index has conducted numerous superyacht valuations in conjunction with Lloyd’s Register, a meticulous process that is essential to ensure the accuracy of the ratings. The process is simple and is based on the submission of the boat’s documentation, which is then analyzed using the Sea Index tool, which then provides a summary note of options highlighting the areas for improvement to reduce the impact (engines, generators and energy balance).

The Sea Index tool has been chosen by numerous owners willing to do their part to reduce environmental impact. The Quick Calculator gives any stakeholder a visualization of where their yacht stands compared with the rest of the average fleet. “It is a way to determine which yachts are less impactful, and more aware of the marine environment. It’s a great instrument because it allows you to show how your owners, your crew, your shipyard as well, care about the sea and the environment. We’re very proud about being accepted in this association and to have achieved 3 stars on the certification because this indicates that we’re heading in the right direction,” says Dario Savino M/Y Kasper 7 Captain, also a founding member of the Y.C.M. Captains Club. Being a member of the Yacht Club de Monaco, the owner has chosen the YCM Marina as the yacht’s first port of call. During this visit, the yacht has been awarded a 3-star Sea Index certification.

For more information:
Press Office LaPresse – ufficio.stampa@lapresse.it

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cb62f8e5-dbb7-4e8b-bb1a-f769d6621823

A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4b843053-3ce7-4610-af30-56022cad3241

GlobeNewswire Distribution ID 9019965

MONACO, Jan. 18, 2024 (GLOBE NEWSWIRE) — A carbon footprint calculator for superyachts targeting the environmental objective to mitigate CO2 emissions in yachting. It is the Sea Index, a tool created in 2020 by the Yacht Club de Monaco to accelerate the diffusion of more sustainability in this sector. Basically, it evaluates the energy intensity of superyachts over 25 meters on a scale from 0 to 5 taking a CO2 snapshot of the vessel. As part of its collective ‘Monaco, Capital of Advanced Yachting’ initiative, the YCM remains a key player in the yachting world being both a driving force and a role model.

“The Sea Index is a rating system that was put in place by the Yacht Club de Monaco. We wanted to raise awareness on energy intensity. We’ve also devised a certification process and M/Y Kasper 7 is one of the yachts that’s gone through the process. They’ve been certified by an independent third-party maritime Class Society issuing the certificates on behalf of the Sea Index, that is very important for us and the certification shows the amount of grams of Co2 that’s emitted into the atmosphere by the vessel,” explains the head of the project Natalie Quevert. “The whole point for us is to raise awareness but more importantly to act. We’re a small cog within a bigger wheel which is part of the principality’s national policy,” she adds.

Sea Index has conducted numerous superyacht valuations in conjunction with Lloyd’s Register, a meticulous process that is essential to ensure the accuracy of the ratings. The process is simple and is based on the submission of the boat’s documentation, which is then analyzed using the Sea Index tool, which then provides a summary note of options highlighting the areas for improvement to reduce the impact (engines, generators and energy balance).

The Sea Index tool has been chosen by numerous owners willing to do their part to reduce environmental impact. The Quick Calculator gives any stakeholder a visualization of where their yacht stands compared with the rest of the average fleet. “It is a way to determine which yachts are less impactful, and more aware of the marine environment. It’s a great instrument because it allows you to show how your owners, your crew, your shipyard as well, care about the sea and the environment. We’re very proud about being accepted in this association and to have achieved 3 stars on the certification because this indicates that we’re heading in the right direction,” says Dario Savino M/Y Kasper 7 Captain, also a founding member of the Y.C.M. Captains Club. Being a member of the Yacht Club de Monaco, the owner has chosen the YCM Marina as the yacht’s first port of call. During this visit, the yacht has been awarded a 3-star Sea Index certification.

For more information:
Press Office LaPresse – ufficio.stampa@lapresse.it

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cb62f8e5-dbb7-4e8b-bb1a-f769d6621823

A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4b843053-3ce7-4610-af30-56022cad3241

GlobeNewswire Distribution ID 9019965

SHANGHAI, China, Jan. 17, 2024 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced the publication of results from the prespecified interim analysis for event-free survival (EFS) in patients with stage III non-Small Cell Lung Cancer (NSCLC) of NEOTORCH (NCT04158440) in the Journal of the American Medical Association (JAMA). NEOTORCH is a randomized, double-blind, placebo-controlled phase 3 trial evaluating the efficacy and safety of toripalimab in combination with perioperative platinum-based chemotherapy vs chemotherapy alone in patients with resectable stage II or III NSCLC.

NEOTORCH is the world’s first phase III clinical study of a anti-PD-1 monoclonal antibody for NSCLC perioperative treatment (including neoadjuvant and adjuvant) with positive EFS results. NEOTORCH’s latest study results were announced in an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Plenary Series held last April, as well as during the 2023 ASCO annual meeting.

“Whether it is clinical diagnosis and treatment level or clinical research ability, we have gradually transformed from a ‘follower’ to an ‘equal,’ even becoming a ‘leader’ in certain aspects. An increasing number of innovative solutions are originating from China and going global, ultimately changing international treatment standards. The publication of NEOTORCH by JAMA is a starting point. China’s ‘3+1+13’ perioperative treatment model has the highest evidence-based medical value and will establish new treatment standards for patients, bringing transformative changes to the diagnosis and treatment landscape of lung cancer in China and beyond,” said NEOTORCH’s principal investigator, Dr. Shun LU of the Shanghai Chest Hospital within Shanghai Jiaotong University.

As a phase 3 clinical study of perioperative treatment, NEOTORCH enrolled the largest sample of resectable stage III NSCLC patients in China. Of the 501 randomized patients, 404 stage III NSCLC (202 in the toripalimab + chemotherapy group and 202 in the placebo + chemotherapy group) were included in this interim analysis. Patients were randomized in a 1:1 ratio to receive toripalimab or placebo, once every 3 weeks combined with platinum-based chemotherapy for 3 cycles before and 1 cycle after surgery, followed by toripalimab only or placebo for up to 13 cycles.

As of November 30, 2022 (median follow-up of 18.3 months), results showed that the addition of toripalimab to perioperative chemotherapy led to a significant improvement in event-free survival for patients with resectable stage III NSCLC, and this treatment strategy had a manageable safety profile.

For the primary outcome of event-free survival (assessed by investigator), the median length was not estimable in the toripalimab group compared with 15.1 months in the placebo group (hazard ratio, 0.40 [95%CI, 0.28-0.57], P<0.001). The major pathological response rate (another primary outcome assessed by blinded, independent pathological review) was 48.5% in the toripalimab group compared with 8.4% in the placebo group. The pathological complete response rate (secondary outcome assessed by blinded, independent pathological review) was 24.8% in the toripalimab group compared with 1.0% in the placebo group.

Of the 82.2%(166/202) of patients in the toripalimab group and 73.3% (148/202) of patients in the placebo group who underwent surgery, 95.8%and 92.6%, respectively, had their resections classified as R0. Among the patients who underwent surgery, the median length of disease-free survival (assessed by the investigators) was not estimable vs. 19.3 months, respectively (HR, 0.50 [95% CI, 0.33-0.76], P<0.001). The median length of overall survival was not estimable in the toripalimab group compared with 30.4 months in the placebo group (HR, 0.62 [95% CI, 0.38-1.00]).

“NEOTORCH’s significant research findings have been published by JAMA, underscoring the international academic community’s recognition of toripalimab and the world’s first ‘3+1+13’ perioperative immunotherapy model for lung cancer. We anticipate that toripalimab will guide China’s perioperative lung cancer treatment into a new era. Junshi Biosciences will also continue to innovate, and we aim to bring more advanced and improved treatment options to patients,” said Dr. Jianjun ZOU, General Manager and Chief Executive Officer of Junshi Biosciences.

About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.

More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and Europe. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are seven approved indications for toripalimab in China:

1. unresectable or metastatic melanoma after failure of standard systemic therapy;
2. recurrent or metastatic nasopharyngeal carcinoma (“NPC”) after failure of at least two lines of prior systemic therapy;
3. locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
4. in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
5. in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);
6. in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);
7. in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC.

The first six indications have been included in the National Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma.

In the United States, the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy in October 2023. The FDA has granted toripalimab 2 Breakthrough Therapy designations for the treatment of NPC, 1 Fast Track designation for the treatment of mucosal melanoma, and 5 Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (SCLC).

In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC, in December 2022 and February 2023.

In Australia, the new chemical entity (NCE) application was accepted by the Australia Therapeutic Goods Administration (TGA) in November 2023. The TGA has also granted toripalimab an Orphan Drug designation for the treatment of NPC.

About Junshi Biosciences

Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Four of the company’s innovations have already reached the Chinese or international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in China and the US. Additionally, more than 30 drugs are currently in clinical development. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19.

With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs”, Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 3,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc). For more information, please visit: http://junshipharma.com.

Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-6105 8800

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800

GlobeNewswire Distribution ID 9019797

This industry-leading milestone marks a new era of scale in battery energy storage and underscores the critical role of storage in enabling the energy transition and reducing the cost of clean and reliable power

ARLINGTON, Va., Jan. 17, 2024 (GLOBE NEWSWIRE) — Fluence Energy, Inc. (“Fluence”) (NASDAQ: FLNC), a leading global provider of energy storage products, services, and optimization software for renewables and storage, today announced the company has surpassed 20 GWh of deployed and contracted storage systems globally. This industry-leading milestone marks a new era of scale in battery-based energy storage installations and growth.

The global battery storage market is growing at rapid speed, with front-of-the-meter additions¹ on track to hit approximately 158 GWh annually by 2030 according to the BloombergNEF 2H 2023 Energy Storage Market Outlook. The global transition from traditional power to renewable resources is driving the need for cost-effective and flexible assets like energy storage. As the need grows, so does the scale of projects and the role of energy storage as a key enabler of the clean energy transition.

“As the scale and complexity of battery storage projects continue to grow, few technology providers can deliver the breadth of solutions and experience needed to succeed in this rapidly evolving market. This milestone highlights the trusted role Fluence plays for our customers and partners around the world. Our industry-leading scale and proven success in delivering on the needs of our customers – including competitive products, seamless digital integration, supply chain diversity and security, and best in class reliability, is what sets us apart in this market,” said Fluence President and Chief Executive Officer Julian Nebreda. “As we enter this new era of scale in battery energy storage, Fluence is well positioned to deliver for our customers globally. We will continue bringing new products and capabilities to market while providing services, support, and digital solutions to help customers generate the most value from their operations.”

Fluence has partnered with customers to deploy some of the world’s largest and most complex energy storage systems. The global fleet of Fluence assets has nearly 3 million operating hours to date. Most recently, Fluence was selected by AGL Energy Limited (AGL) to deliver a 500 MW / 1000 MWh energy storage system for the Liddell Battery Project in New South Wales. It is the biggest energy storage system announced to date that Fluence will be designing, engineering, and constructing in Australia and will provide critical firming capacity to help enable the country’s energy transition. In 2022, Fluence announced commercial operation of the Luna Battery Storage Project and the Lancaster Area Battery system, a combined 227 MW / 908 MWh energy storage complex in California that utilizes Fluence storage products, services, and software to support resilient and flexible power grids.

Leading the industry in developing new applications for energy storage, Fluence is shaping how power networks operate and addressing challenges of the energy transition. One of those challenges is increasing grid congestion caused by the massive expansion of renewable energy sources, bringing the need for more grid reinforcement and relief interventions. To address this challenge, Fluence is deploying three energy storage-as-transmission-asset projects for transmission system operators in Germany. These include a 250 MW Grid Booster for TransnetBW and two Grid Booster systems with a combined power capacity of 200 MW for TenneT TSO. These projects will increase transmission capacities of existing power lines, minimize grid interventions, increase renewable penetration, reduce grid expansion, and improve security of supply. TenneT’s Grid Boosters will use Fluence Ultrastack, an advanced energy storage product designed for transmission grids.

Fluence recently announced the release of Gridstack Pro, an advanced energy storage product built for the next era of utility-scale projects. Gridstack Pro is the latest offering in the Gridstack product line, which is trusted by leading power generators around the world to deliver safe and reliable grid services.

¹Global market excluding projected utility-scale deployments in China; does not include commercial or residential deployments.

About Fluence

Fluence Energy, Inc. (Nasdaq: FLNC) is a global market leader in energy storage products and services, and optimization software for renewables and storage. With a presence in 47 markets globally, Fluence provides an ecosystem of offerings to drive the clean energy transition, including modular, scalable energy storage products, comprehensive service offerings, and AI-enabled SaaS products for managing and optimizing renewables and storage from any provider. The Company is transforming the way we power our world by helping customers create more resilient and sustainable electric grids.

For more information, visit our website, or follow us on LinkedIn or Twitter. To stay up to date on the latest industry insights, sign up for Fluence’s Full Potential Blog.

Forward-Looking Statements

The statements described herein that are not historical facts are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the anticipated impact of the global energy transition on energy storage, Fluence potential future impact on energy storage and the energy transition, and expected operational performance of Fluence energy storage projects, including impacts to related grid networks. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this press release, words such as “may,” “possible,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” or “continue,” or the negative of these terms or other similar expressions and variations thereof and similar words and expressions are intended to identify such forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

The forward-looking statements contained in this press release are based on our current expectations and beliefs concerning future developments, as well as a number of assumptions concerning future events, and their potential effects on our business. These forward-looking statements are not guarantees of performance, and there can be no assurance that future developments affecting our business will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, which include, but are not limited to, unforeseen circumstances outside of Fluence’s control which may cause unanticipated operational performance of the Fluence energy storage projects, adoption of laws, regulations, or policies that impact the adoption of energy storage and the global energy transition, and other factors set forth under Item 1A.“Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended September 30, 2023, filed with the Securities and Exchange Commission (“SEC”) on November 29, 2023, and in other filings we make with the SEC from time to time. New risks and uncertainties emerge from time to time and it is not possible for us to predict all such risk factors, nor can we assess the effect of all such risk 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. Should one or more of these risks or uncertainties materialize, or should any of the assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. You are cautioned not to place undue reliance on any forward-looking statements made in this press release. Each forward-looking statement speaks only as of the date of the particular statement, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that occur, or which we become aware of, after the date hereof, except as otherwise may be required by law.

Fluence Media Contact
Shayla Ebsen, Director of Communications
Email: media.na@fluenceenergy.com
Phone: +1 (605) 645-7486

Fluence Analyst Contact
Lexington May, Vice President Finance & Investor Relations
Email: investorrelations@fluenceenergy.com
Phone: +1 (713) 909-5629

GlobeNewswire Distribution ID 9019585

Nyxoah Announces 2024 Strategic Priorities

Mont-Saint-Guibert, Belgium – January 17, 2024, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced, in anticipation of upcoming investor meetings, its strategic priorities for 2024.

2024 Strategic Priorities

• Complete patient follow up in the DREAM U.S. pivotal study and report efficacy and safety data by early April. 12-month efficacy data¹ on the first 34 DREAM patients and safety data on all DREAM patients were presented at SLEEP 2023, demonstrating a 65% AHI responder rate, a 76% ODI responder rate and safety in-line with expectations. These data are preliminary and not conclusive of final DREAM success.
• File the fourth and final module in the modular PMA submission. Anticipate submitting the final module shortly after announcing DREAM results.
• Accelerate investments in the U.S. commercial organization in preparation for a late 2024 launch. Recently hired Francis Kim as Chief Regulatory and Quality Officer and expanded market access to secure reimbursement at launch.
• Complete enrollment in the ACCCESS complete concentric collapse (CCC) U.S. pivotal study. Recently announced investigator-sponsored data in Europe demonstrating Genio’s® success in treating CCC patients.
• Increase hypoglossal nerve stimulation (HGNS) market penetration and Genio market share in Europe. For 2024, we expect continued sales growth driven by an increasing benefit from direct-to-consumer (DTC) initiatives, initial contribution from the ResMed commercial partnership in Germany and geographic expansion.

“Since Nyxoah’s founding we have been guided by the mission to improve the lives of OSA patients. This led to the development of the patient-centric Genio HGNS system. Genio’s single-incision, leadless, upgradable design powered and controlled by a wearable resonated with clinicians and patients and led to a strong European launch. Genio’s bilateral stimulation enables treatment of CCC, and the label was subsequently expanded to include these patients, whose only treatment option after failing CPAP up until then was major palate surgery,” commented Olivier Taelman, Chief Executive Officer.

“In our ongoing effort to provide patients greater control over their therapy, thereby making sleep simple again, we then received approval for Genio 2.1. Genio 2.1 offers patients daily feedback on therapy usage and autonomy to adjust stimulation amplitude within pre-defined boundaries, improving patient comfort and compliance without the need for a surgical procedure to replace the implantable component.”

“We are now on the cusp of the most significant milestone in the Company’s history with the reporting of DREAM results in the coming months. We expect to complete the PMA submission shortly after and are accelerating manufacturing and commercial investments to ensure we are fully prepared to replicate our European success in the U.S. With an approaching U.S. launch and continued growth in Europe, we are excited for the coming years.”

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and U.S. commercialization approval.

For more information, please visit http://www.nyxoah.com/.

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

Forward-looking statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; reporting data from Nyxoah’s DREAM US pivotal trial; filing for FDA approval; entrance to the US market, contributions from the ResMed commercial partnership in Germany; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:
Nyxoah
David DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com
+1 310 310 1313

---

¹ For the trial to be successful, of the 115 patients, at least 63% of patients need to be AHI and ODI responders at the 12-month follow-up.

Attachment

• ENGLISH_Nyxoah Announces 2024 Strategic Priorities

GlobeNewswire Distribution ID 1000909240

Nyxoah Announces 2024 Strategic Priorities

Mont-Saint-Guibert, Belgium – January 17, 2024, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced, in anticipation of upcoming investor meetings, its strategic priorities for 2024.

2024 Strategic Priorities

• Complete patient follow up in the DREAM U.S. pivotal study and report efficacy and safety data by early April. 12-month efficacy data¹ on the first 34 DREAM patients and safety data on all DREAM patients were presented at SLEEP 2023, demonstrating a 65% AHI responder rate, a 76% ODI responder rate and safety in-line with expectations. These data are preliminary and not conclusive of final DREAM success.
• File the fourth and final module in the modular PMA submission. Anticipate submitting the final module shortly after announcing DREAM results.
• Accelerate investments in the U.S. commercial organization in preparation for a late 2024 launch. Recently hired Francis Kim as Chief Regulatory and Quality Officer and expanded market access to secure reimbursement at launch.
• Complete enrollment in the ACCCESS complete concentric collapse (CCC) U.S. pivotal study. Recently announced investigator-sponsored data in Europe demonstrating Genio’s® success in treating CCC patients.
• Increase hypoglossal nerve stimulation (HGNS) market penetration and Genio market share in Europe. For 2024, we expect continued sales growth driven by an increasing benefit from direct-to-consumer (DTC) initiatives, initial contribution from the ResMed commercial partnership in Germany and geographic expansion.

“Since Nyxoah’s founding we have been guided by the mission to improve the lives of OSA patients. This led to the development of the patient-centric Genio HGNS system. Genio’s single-incision, leadless, upgradable design powered and controlled by a wearable resonated with clinicians and patients and led to a strong European launch. Genio’s bilateral stimulation enables treatment of CCC, and the label was subsequently expanded to include these patients, whose only treatment option after failing CPAP up until then was major palate surgery,” commented Olivier Taelman, Chief Executive Officer.

“In our ongoing effort to provide patients greater control over their therapy, thereby making sleep simple again, we then received approval for Genio 2.1. Genio 2.1 offers patients daily feedback on therapy usage and autonomy to adjust stimulation amplitude within pre-defined boundaries, improving patient comfort and compliance without the need for a surgical procedure to replace the implantable component.”

“We are now on the cusp of the most significant milestone in the Company’s history with the reporting of DREAM results in the coming months. We expect to complete the PMA submission shortly after and are accelerating manufacturing and commercial investments to ensure we are fully prepared to replicate our European success in the U.S. With an approaching U.S. launch and continued growth in Europe, we are excited for the coming years.”

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and U.S. commercialization approval.

For more information, please visit http://www.nyxoah.com/.

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

Forward-looking statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; reporting data from Nyxoah’s DREAM US pivotal trial; filing for FDA approval; entrance to the US market, contributions from the ResMed commercial partnership in Germany; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:
Nyxoah
David DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com
+1 310 310 1313

---

¹ For the trial to be successful, of the 115 patients, at least 63% of patients need to be AHI and ODI responders at the 12-month follow-up.

Attachment

• ENGLISH_Nyxoah Announces 2024 Strategic Priorities

GlobeNewswire Distribution ID 1000909240